Activities of Andrés PERELLÓ RODRÍGUEZ
Plenary speeches (45)
Reducing the consumption of lightweight plastic carrier bags (debate)
One-minute speeches on matters of political importance
Assessment of the effects of certain public and private projects on the environment (A7-0277/2013 - Andrea Zanoni)
Fluorinated greenhouse gases (debate)
Third programme for the Union's action if the field of health (2014-2020) (debate)
One-minute speeches (Rule 150)
Carbon capture and storage technology (debate)
One-minute speeches (Rule 150)
In vitro diagnostic medical devices - Medical devices (debate)
Climate change conference (debate)
Manufacture, presentation and sale of tobacco and related products (debate)
Assessment of the effects of certain public and private projects on the environment (continuation of debate)
Labour conditions and health and safety standards following the recent factory fires and building collapse in Bangladesh (continuation of debate)
One-minute speeches (Rule 150)
Preparations for CITES COP 16 (debate)
Sound level of motor vehicles (debate)
Transparency of measures regulating the prices of medicinal products for human use (debate)
One-minute speeches (Rule 150)
Environmental impacts of shale gas and shale oil extraction activities - Industrial, energy and other aspects of shale gas and oil (debate)
Follow-up of the elections in the Democratic Republic of Congo (debate)
A resource-efficient Europe (debate)
Our life insurance, our natural capital: an EU biodiversity strategy to 2020 (debate)
Review of the 6th Environment Action Programme and the setting of priorities for the 7th Environment Action Programme (debate)
Addressing the EU diabetes epidemic (debate)
One-minute speeches (Rule 150)
Fruit juices and certain similar products intended for human consumption (debate)
Fruit juices and certain similar products intended for human consumption (debate)
Fruit juices and certain similar products intended for human consumption (debate)
One-minute speeches on matters of political importance
Food information to consumers (debate)
EHEC outbreak in the EU Member States (debate)
Explanations of vote
Patients’ rights in cross-border healthcare (debate)
EU legislation aiming at the conservation of biodiversity (debate)
Question Time (Commission)
Freedom of expression and press freedom in the European Union (debate)
Food information to consumers (debate)
Standards of quality and safety of human organs intended for transplantation - Action plan on organ donation and transplantation (2009-2015) (debate)
Standards of quality and safety of human organs intended for transplantation - Action plan on organ donation and transplantation (2009-2015) (debate)
Explanations of vote (continuation)
One-minute speeches on matters of political importance
Major natural disaster in the autonomous region of Madeira (debate)
Outcome of the Copenhagen Summit on climate change (debate)
Preparation of the Copenhagen Summit on climate change (debate)
Forest fires in the summer of 2009 (debate)
Reports (2)
REPORT on the proposal for a directive of the European Parliament and of the Council amending Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption PDF (298 KB) DOC (429 KB)
REPORT on the Commission Communication: Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States PDF (200 KB) DOC (115 KB)
Shadow reports (2)
REPORT on implementation report 2013: developing and applying carbon capture and storage technology in Europe PDF (207 KB) DOC (97 KB)
RECOMMENDATION on the draft Council decision on the accession of the European Union to the Protocol for the Protection of the Mediterranean Sea against pollution resulting from exploration and exploitation of the continental shelf and the seabed and its subsoil PDF (139 KB) DOC (65 KB)
Opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Union airports within a Balanced Approach and repealing Directive 2002/30/EC of the European Parliament and of the Council
Amendments (574)
Amendment 25 #
2013/2135(INI)
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
- having regard to the Commission report ‘Assessment of Cumulative Cost Impact for the Steel Industry’,
Amendment 26 #
2013/2135(INI)
Motion for a resolution
Citation 16 b (new)
Citation 16 b (new)
- having regard to the Commission Staff Working Document ‘Exploiting the employment potential of green growth’,
Amendment 27 #
2013/2135(INI)
Motion for a resolution
Citation 17 a (new)
Citation 17 a (new)
- having regard to the European Parliament resolution of 23 October 2013 on the Climate Change conference in Warsaw, Poland (COP19),
Amendment 32 #
2013/2135(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
- having regard to the European Council’s conclusions on GHG emissions reductions of 80-95% by 2050 compared to 1990 levels,
Amendment 36 #
2013/2135(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
- having regard to the International Labour Organization report ‘Towards a Green Economy: The Social Dimensions’,
Amendment 39 #
2013/2135(INI)
Motion for a resolution
Citation 18 c (new)
Citation 18 c (new)
- having regard to the Eurostat document ‘Energy Production and imports’,
Amendment 52 #
2013/2135(INI)
Motion for a resolution
Recital A
Recital A
A. whereas security of supply, competitiveness and climate objectives are of the utmost importance for the EU, are inextricably linked and must be addressed and considered on an equal footingmutually reinforcing and should not be considered as conflicting in nature;
Amendment 58 #
2013/2135(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas lessons should be learned from the fact that out of the three headline 2020 targets agreed in 2007 (20% of the Union’s energy mix to come from renewable sources, a 20% increase in energy efficiency compared to projections, and a reduction in GHG emissions of 20% as compared to 1990 levels) the only target not currently on track is the non-binding energy efficiency target;
Amendment 61 #
2013/2135(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas only binding targets offer Member States the necessary flexibility to decarbonise their economies in the most efficient and cost-effective way, taking into account national circumstances and specificities;
Amendment 63 #
2013/2135(INI)
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. whereas the current climate of uncertainty surrounding the future direction of climate and energy policy is deterring much-needed investments in clean technology;
Amendment 64 #
2013/2135(INI)
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. whereas the Commission’s Energy Roadmap 2050 finds that decarbonisation of the energy sector and a high renewables scenario is cheaper than a continuation of current policies, and that over time prices of energy from nuclear and fossil fuels will continue to rise, whereas the cost of renewables will decrease;
Amendment 65 #
2013/2135(INI)
Motion for a resolution
Recital A e (new)
Recital A e (new)
Ae. whereas the 2050 carbon roadmap estimates health savings through improvement in local air quality would save up to €17 billion per year by 2030 and the IEA estimates that by 2035 2°C consistent policies could cut the EU’s annual fossil fuel import bill by 46% or €275 billion (1% of EU GDP);
Amendment 66 #
2013/2135(INI)
Motion for a resolution
Recital A f (new)
Recital A f (new)
Af. whereas attention must be paid to the impact of climate and energy policy not only on the most vulnerable groups in society but also on low and middle-income households whose standards of living have been squeezed in recent years;
Amendment 67 #
2013/2135(INI)
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. whereas energy saving and energy efficiency are the fastest and cheapest routes to addressing issues such as energy security, external dependence, high prices and environmental concerns;
Amendment 68 #
2013/2135(INI)
Motion for a resolution
Recital A h (new)
Recital A h (new)
Ah. whereas the transport sector accounts for a significant share of both greenhouse gas emissions and energy consumption in the EU; whereas greenhouse gas emissions from the transport sector increased by 36 % between 1996 and 2007;
Amendment 72 #
2013/2135(INI)
Motion for a resolution
Recital B
Recital B
B. whereas this is acknowledged in the Treaty on the Functioning of the European Union (TFEU), which stipulates that the objectives of the Union’s energy policy include the functioning of the energy market, security of supply, energy efficiency, energy saving, renewable energy and interconnections; and that the objectives of the Union’s environmental policy include preserving, protecting and improving the quality of the environment, promoting human health, prudent and rational utilization of natural resources and the promotion of measures at international level to deal with regional or worldwide environmental problems and in particular climate change;
Amendment 89 #
2013/2135(INI)
Motion for a resolution
Recital D
Recital D
D. whereas Eurostatpean Environment Agency figures show that the EU has reduced its CO2 emissions by 16.978% between 1990 and 20112 and is on track to achieve its 2020 target in this regard;, mainly due to the economic crisis1; __________________ 1 Trends and projections in Europe 2013, EEA Report nr 10/2013.
Amendment 97 #
2013/2135(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the verified EU emissions from 2005 to 2012 within the ETS fell by 16 % and within the non-ETS sectors by 10 %, indicating that the 2020 reduction targets of -21 % and -10 %, respectively, are likely to be achieved several years ahead of that year;
Amendment 112 #
2013/2135(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the IEA estimates that the EU is responsible for only 11 % of global greenhouse gas (GHG) emissions and the proportion is set to decrease in the future so that,while EU CO2 emissions measured by metric ton per capita still are higher than world average, and the average of emerging economies and developing countries; whereas even if ithe EU has limited capacity in lowering global emissions by means of unilateral action, it has a significant leading role to play, in particular; as regards the achievement of a binding agreement in Paris in 2015; whereas the EU therefore has to define a clear and ambitious position;
Amendment 127 #
2013/2135(INI)
Motion for a resolution
Recital F
Recital F
F. whereas investors and industries need a clear and long-term framework for EU climate and energy policy with greater levels of certainty in order to encourage medium and long-term private investment and reduce the risk associated with this;
Amendment 150 #
2013/2135(INI)
Motion for a resolution
Recital H
Recital H
H. whereas the EU spent EUR 573 billion on imported fossil fuels in 2011 (equivalent to over €1000 per head of population) and its dependency on energy imports is expected to grow; whereas this dependency leaves the Union vulnerable to world energy prices and political shocks, and compromises Union and Member State foreign policy autonomy
Amendment 168 #
2013/2135(INI)
Motion for a resolution
Recital H d (new)
Recital H d (new)
Hd. whereas investment in renewable energy sources and energy efficiency creates jobs in high-technology industries, ensures EU leadership in RES and EE technologies (fields with high global demand which will continue to grow), and also reduces energy dependence;
Amendment 192 #
2013/2135(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas nearly half of the final energy in the EU is used for heating and cooling purposes;
Amendment 215 #
2013/2135(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission Green Paper on a 2030 framework for climate and energy policies and expects the European Council to address these issues with realistic but ambitiousambitious and realistic responses;
Amendment 248 #
2013/2135(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Considers that a strong binding energy efficiency target is of primary importance in order to make the most efficient use of energy within the Union and such a target will also have the knock-on effect of ensuring that less effort will be needed to meet the GHG and renewable energies targets; therefore calls for the current 2020 target to be continued, but be made binding and the level of ambition doubled to 40%;
Amendment 254 #
2013/2135(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Considers that a binding target of 45% for the share of renewable energies in the Union is the best way to ensure the necessary investor certainty for the continued development and promotion of renewable energy sources and related infrastructure and is entirely feasible alongside a strong binding energy savings target;
Amendment 256 #
2013/2135(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Considers that a binding 50% domestic reduction target for greenhouse gas emissions compared to 1990 levels is the absolute minimum required to stay on track for the below 2°C target and is both realistic and affordable, as has been shown by numerous studies, particularly when combined with ambitious energy savings and renewable energy targets
Amendment 274 #
2013/2135(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the European Council to keep up the progress made at EU level and set ambitious but realistic objectivesswiftly endorse the new climate and energy package for the 2030 EU policies that take account of the economic, social, environmental, international and technological contexts, andwith these three binding headline targets, in order to establish a clear, stable, long-term and cost-effective framework for industries and investors;
Amendment 295 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes that as one of the cornerstones of the EU's climate and energy package, the EU Emissions Trading Scheme (ETS) should be the principal instrument for reducing industrial emissions and promoting investment in low carbon technologies; doing so in a manner that creates a level playing field for competing technologies, that gives companies the flexibility to develop their own mitigation strategy, and that provides for specific measures to combat carbon leakage;
Amendment 307 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Recognises that the ETS is experiencing problems not originally anticipated which has led to an accumulation of surplus allowances; calls on the Commission to take into account past experience when proposing structural improvement to the ETS, which is necessary in order to increase the scheme's ability to respond to economic downturns and upturns, enhance investor certainty and strengthen market-based incentives for investment in and the use of low-carbon technologies;
Amendment 315 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Calls on the Member States to increase the proportion of ETS auctioning revenue spent on climate-related purposes so as to spur low-carbon investment in industry and encourage other means of job creation;
Amendment 325 #
2013/2135(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 381 #
2013/2135(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Is of the opinion that support schemes have already been shown to be effective at promoting the development and use of renewable energies; deplores the retroactive changes made to some schemes which have damaged investor confidence; sees an important role for the Commission in providing guidance in this regard;
Amendment 389 #
2013/2135(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Is of the opinion that support schemes have already been shown to be effective at promoting the development and use of renewable energies; recognises however that they have in some cases been inefficient and should be better designed; deplores the retroactive changes made to some schemes which have damaged investor confidence; sees an important role for the Commission in providing guidance in this regard;
Amendment 400 #
2013/2135(INI)
Motion for a resolution
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Highlights that the Commission's 2050 Low-carbon Roadmap showed that renewables and improved energy efficiency could result in annual savings of between 175 and 320 billion euros for the Union.
Amendment 401 #
2013/2135(INI)
Motion for a resolution
Paragraph 5 d (new)
Paragraph 5 d (new)
Amendment 421 #
2013/2135(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that increased energy efficiency and energy savings will play an essential role in the decarbonisation of the energy sectortire Union economy;
Amendment 454 #
2013/2135(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that as one of the cornerstones of the EU's climate and energy package, the EU Emissions Trading Scheme (ETS), should be able to best fulfil its main function, the reduction of GHG emissions, and respond efficiently to economic downturns and upturnchanges; recalls that the main objective of the EU ETS is to reduce GHG emissions and not to provide investors with sufficient incentives to invest in low-carbon technologies, as these should be seen merely as a secondary objective and not as a basis for evaluating if the scheme works as intended; </AmendOr. <Original>bg</Original>
Amendment 496 #
2013/2135(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes that the EU needs a comprehensive policy framework for 2030 that encourages investment in and the long- term decarbonisation of non-ETS sectors; therefore calls on the Commission and the Member States to reviewstrengthen the non-ETS targets while preserving the flexibility for Member States to define their own ways of meeting their effort sharing targets;
Amendment 502 #
2013/2135(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. calls on the Commission to increase dialogue and cooperation with the International Maritime Organisation so as to ensure inclusion of the shipping sector in CO2 reduction commitments; If an international agreement on global measures to reduce greenhouse gas emissions from maritime emissions has not been reached before 31 December 2015, calls on the Commission, through the ordinary legislative procedure, to propose emission reduction targets for international maritime shipping and market based measures to reduce greenhouse gas emissions from the maritime sector.
Amendment 507 #
2013/2135(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9 b. Calls on the Commission to come forward with a specific framework for transport, including targets, as the transport sector accounts for around a quarter of EU greenhouse gas emissions and energy consumption in the EU making it the second biggest greenhouse gas emitting sector after energy production;
Amendment 516 #
2013/2135(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Sees an important role for cogeneration and efficient district heating and cooling in increasing energy efficiency in the future;
Amendment 521 #
2013/2135(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Sees an important role for advanced biofuels in reducing greenhouse gas emissions in transport, while increasing energy security and contributing to growth and jobs;
Amendment 531 #
2013/2135(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Asks Member States for better cooperation and interaction at EU level in order to make national measures more efficient and consistent;
Amendment 541 #
2013/2135(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recalls that a clear, coherent and consistent policy and regulatory framework, based on three binding headline targets is key to helping stimulate the necessary investments in the ‘'no regrets’ technologies' options (energy efficiency, renewable energies and smart infrastructure) defined in the Energy Roadmap 2050 in a cost-effective and sustainable way;
Amendment 547 #
2013/2135(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Asks the Commission to analyse how the use of energy and environmental taxes by the Member States can be facilitated, in order to reduce GHG emissions within the non-ETS sectors in a cost-efficient way;
Amendment 551 #
2013/2135(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 574 #
2013/2135(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Believes that Member States and regions should be encouraged to improve cooperation in order to optimise the efficiency of renewables expansion, notably offshore wind energy; in this context, the Commission has an important role to play as a facilitator in coordinating, financially supporting and preparing appropriate analyses of renewable energy resources and potential for the Member States;
Amendment 578 #
2013/2135(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to submit an analysis of how renewable energy sources can be developed sustainably, taking into account environmental impact, aspects related to dependency on raw materials and life cycle and, above all, how to support stablenon-intermittent sources of renewable energy such as hydropower, biomass or geothermal power;
Amendment 605 #
2013/2135(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 634 #
2013/2135(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Underlines the importance of an energy strategy 2030 climate and energy framework focused on boosting energy security and economic and industrial competitiveness in the EU, job creation, social aspects and environmental sustainability by means of measures such as increasing the deployment of RES, investing heavily in energy efficiency and the diversification of supply routes, suppliers and sources and by increasing the deployment of RES;
Amendment 641 #
2013/2135(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 667 #
2013/2135(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses that as the EU pursues its goal of energy security, emphasis needs to be shifted towards a model of energy interdependence between Member States by ensuring the swift completion of the EU internal energy market, including in particular the construction of interconnectors and elimination of cross- border barriers; believes furthermore that completing the EU supergrid infrastructure linking the north, south, east and west will enable the EU to make the best use of the comparative advantages of each Member State, and calls for further support for decentralised and micro-scale energy production and smart energy infrastructures in all Member States; stresses, therefore, the need for strong coordination between Member States’ policies and for joint action, solidarity and transparency in view of the fact that national energy policy decisions can affect other Member States; suggests that it would be desirable to determine whether and how the expertise and facilities of the Agency for the Cooperation of Energy Regulators (ACER) could be put to use in carrying out the above tasks;
Amendment 697 #
2013/2135(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Stresses that energy end consumers – individuals, SMEs and industry alike – are at the very core of the internal energy market and that they should benefit from lower energy prices, be duly protected, and accurately informed by ensuring easy access to information; for this purpose, calls on the Commission and Members States to achieve, as a matter of urgency, the completion of the internal market, security of supply and the interconnecpay particular attention to energy poverty and propose a specific strategy proposing measures to tackle energy poverty, including ensuring best-practice can be spread and the use of statistics and indicators, including an EU-wide definition of enetworks as requested in Article 194 TFEUrgy poverty;
Amendment 702 #
2013/2135(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Notes that energy is an essential service covered by Protocol No 26 on Services of General Interest, appended to the Lisbon Treaties, which requires a high level of affordability; stresses that the 2030 framework needs to include the principle of affordability and avoid discrimination against vulnerable consumers, particularly those on low income; asks therefore that the Commission give greater priority to the socio-economic dimension of sustainability and introduce measures to address the distributional impact of its policies.
Amendment 703 #
2013/2135(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
Amendment 780 #
2013/2135(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Firmly believes that reducing energy use and costs through high energy efficiency, further developing renewable energy sources and using research and innovation to develop new technologies to slash our CO2 emissions are all necessary in order to boost the Union's competitiveness and create much-needed high-quality growth and jobs which cannot be exported outside the Union
Amendment 783 #
2013/2135(INI)
Motion for a resolution
Paragraph 28 b (new)
Paragraph 28 b (new)
28b. Considers that the setting of ambitious targets would provide the necessary stimulus to revitalise Member States' economies and ensure an end to the current economic downturn, boosting competitiveness through lower production costs for heavy industry by resource and energy efficiency, decrease vulnerability to world energy price fluctuations and ensure a more stable investment environment, as well as ensuring European leadership in the high-tech sustainable technology sector and the first-mover advantage that goes with it.
Amendment 795 #
2013/2135(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission to launch a study analysing new and cost-efficient market designs with a view to ensuring reasonably priced electricitaffordable energy to consumers and toindustry and preventingon of carbon leakage; asks therefore the Commission to come forward as soon as possible with an additional assessment and recommendations for further actions to prevent the risk of carbon leakage caused by reallocation of production facilities outside the EU, focusing in particular on additional scenarios in which limited or no further global action is taken on carbon emission reduction;
Amendment 814 #
2013/2135(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Notes that the EU’'s main competitors on the global market place great emphasis on technological developments, innovation and improving industrial processes; notes also that their economies grow at a much faster pace than the EU; concludes that the EU must give priority to R&D and innovation;concludes that the EU must give priority to R&D and innovation and the setting of long-term targets will incentivise new technologies
Amendment 827 #
2013/2135(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
Amendment 840 #
2013/2135(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Strongly underlines that any future EU policy must address the comparative strengths and weaknesses of its economy, particularly with regard to any free trade agreement the EU signs up to, especially in light of the planned free trade agreement (TTIP) with the US where energy prices have been decreasing significantly while efforts to reduce GHG emissions are not on par with the progress already achieved in the EU although the carbon price in California currently is more than double that in the EU;
Amendment 860 #
2013/2135(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Welcomes the Commission’'s remarks that the EU climate and energy targets can impact differently on each Member State and their citizens, and that this justifies working on a more equitable effort sharing basis, taking into account a country’s GDP, achievements in reducing emissions since 1990, emissions per capita, economic potential and potential forwhen deciding each Member State's effort required to meet the new binding 2030 GHG, RES and EE targets, consideration should be given to each country's individual circumstances and potential for emission reduction, renewable energy sourcesproduction and energy efficiencsaving capacity;
Amendment 872 #
2013/2135(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Underlines, in line with Article 194 TFEU, that Member States are the ultimate decision makers as regards their energy mix and within the framework of the three headline climate and energy targets should be able to use and develop different approaches for technologies and energy sources that are environmentally sound and socially and economically acceptable in respect of the Union's climate and energy policy goals;
Amendment 880 #
2013/2135(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
Amendment 895 #
2013/2135(INI)
Motion for a resolution
Paragraph 36
Paragraph 36
36. Notes that access to capital, even for heavy industry sectors, is often a barrier to investment in cleaner technologies; therefore asks the Commission to study the possibility of creating a fund that could help to leverage investment, possibly financed by a share of ETS revenue; considers that a significant strengthening and reorientation of the EIB would help in this respect;
Amendment 904 #
2013/2135(INI)
Motion for a resolution
Paragraph 37 a (new)
Paragraph 37 a (new)
37a. Points out that a well-functioning EU ETS is pivotal in maintaining the EU's leadership on climate change and that several countries such as China and Australia are implementing or developing legislation to introduce their own emissions trading system following the example of the EU ETS; recalls in this regard that an international cap and trade system is central in order to secure a new legally binding global climate change agreement and that without a stable and predictable emissions trading system the credibility of the EU's climate policy is at risk;
Amendment 23 #
2013/2113(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, in the case of plastic waste, the focus must be placed on prevention and minimisation, encouraging producers to choose alternative, more sustainable materials when designing their products;
Amendment 38 #
2013/2113(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas high recycling rates can help when there is a shortage of raw materials;
Amendment 40 #
2013/2113(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas informed consumers can play a key role in promoting more sustainable production patterns for plastics and plastic products that also improve resource efficiency, and whereas, above all, awareness-raising is needed in order to break the current perception of plastic as an innocuous, cheap material that has no value in itself;
Amendment 65 #
2013/2113(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that to achieve this, and when drawing up future proposals, the Commission ought to bear in mind the fact that plastic waste is not a homogeneous material, and that plastic waste streams are made up of a number of materials, additives and plastic coumpounds of different types that need to be processed in different ways; points out, furthermore, that although this causes problems for current recycling and recovery processes, it should not prevent specific legislation on plastic waste being introduced at EU level – it should actually be an incentive for the Commission to push for improvements in technology with a view to addressing the problem of plastic waste in a more efficient way;
Amendment 72 #
2013/2113(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that the EU legislation on plastic waste should define: specific targets for collection and sorting and mandatory criteria for recyclability (clarifying the distinctions between mechanical/organic recycling and recovery/incineration; the aim should be a progressive target of at least 75 % of recycled plastic by 2020); specific labelling of materials in order to inform consumers concerning their mechanical or organic recyclability; and, finally, criteria for the replacement of single-use and short- lived plastic products by reusable and more durable materials;
Amendment 92 #
2013/2113(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Agrees that plastic waste should be treated as a valuable resource by promoting its reuse, recycling, and recovery; believes that in any case landfilling should be banned by 2020, without, however, incentivising as a result the energy recovery option over recycling; considers that, alongside the targets mentioned above for recycling, it is therefore advisable to introduce appropriate sanctions for incineration of recyclable and biodegradable plastics, in order to level the playing field for different plastic types; points out that this would also invert an unsustainable tendency that has until now privileged the use of virgin products over the more expensive recycled ones; points out, with this in mind, that in the context of new legislation on plastic waste, the Commission should consider establishing more extensive inspections as regards landfill waste acceptance up to 2020 and stepping up checks on incineration facilities;
Amendment 116 #
2013/2113(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. With regard to single-use plastics, particularly non-biodegradable shopping bags, takes the view that the Commission ought to consider the following steps for immediate action: – draw up a schedule for the phasing-out of non-biodegradable, single-use shopping bags with a view to an outright ban; – gradually phase out biodegradable plastic bags in shops’ fruit and vegetables and bakery sections and replace them with recycled paper bags; – place immediate restrictions on small bags (such as those provided in pharmacies), which cannot be re-used; – include, on each conventional bag, and until they phased out in 2020, a short message outlining the effects that such bags have on the environment; – restrict the surface area available for advertising or brand printing (use of ink) on all types of shopping bags; – recommend that the Member States encourage the phasing-out of the practice of supermarkets charging for plastic bags and then keeping the profits (where such a practice is in use), replacing it with an eco-tax to go towards environmental policies promoting waste reduction, re-use and recycling;
Amendment 127 #
2013/2113(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. HighlightsPoints out that, in a world in which natural resources, including arable land, are increasingly scarce, sustainability means consuming fewer resources in absolute terms, and not merely replacing one resource with another; highlights, in this connection, that for biodegradable, bio- based and compostable plastics, adequathe measures shthat could be adopted to promote them, provided should always take into account the fact that their production does not impact negatively on agricultural output for human or animal consumption; also believes that clearer information on their characteristics should be provided to consumers;
Amendment 147 #
2013/2113(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to promote an adequate flow of information from the producers to the recyclers and waste management operators to ensure that they have clear safety information on the materials and the chemicals they contain, including all additives;
Amendment 162 #
2013/2113(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Reminds the Commission that there are other types of plastic waste that should not be forgotten when it comes to legislation, such as plastics for agricultural use (e.g. greenhouse plastics); points out, in this connection, that there would be a need to promote the establishment of ‘agricultural collection centres’ in order to check such waste and send it to plastic recycling centres or to use it in energy production;
Amendment 48 #
2013/2091(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Takes the view that, even though in the majority of cases food fraud does not entail consequences for food safety, it would nevertheless be worthwhile to introduce specific legislative instruments;
Amendment 51 #
2013/2091(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that EU law does not currently provide a definition of food fraud and that Member States adopt different approaches; considers a uniform definition to be essential for developing a European approach to combating food fraud; stresses the need rapidly to adopt a harmonised definition at EU level, including elements such as 1) non-compliance with food law and/or misleading the consumer (including the omission of product information), 2) intent and 3) financial gain;
Amendment 55 #
2013/2091(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes that recent food fraud cases have exposed different types of food fraud, such as replacing key ingredients with cheaper alternatives, wrongly labelling the animal species used in a meat product, incorrectly labelling weight, selling ordinary foods as organic, unfairly using origin or animal welfare quality logos, labelling aquaculture fish as wild-caught, marketing an inferior variety of fish under the name of the superior category, or selling pieces of a low-price species under the name of a similar but more expensive species; making up consignments with pieces of inferior-category fish, counterfeiting and marketing food past its ‘use-by’ date;
Amendment 60 #
2013/2091(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 64 #
2013/2091(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Regrets, further, that the cases of fraud uncovered up to now have often involved products on promotion or large family packs, which tend to be bought by vulnerable consumers and consumers with less purchasing power, or by organisation-based purchasers such as school canteens;
Amendment 77 #
2013/2091(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission, pursuant to Articles 7 and 17 of Regulation 1169/2011 on the provision of food information to consumers, to pursue and prevent the marketing of products that remain on the market under a deliberately inaccurate or misleading name, since this is also to be considered a type of food fraud;
Amendment 85 #
2013/2091(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Recognises the importance of whistle- blowers in uncovering fraudulent practices in the food sector; calls on the Member States to create the right conditions to enable whistle-blowers to denounce malicious practices safely and anonymouslywhile preserving their privacy vis-à-vis the public, if they so wish;
Amendment 118 #
2013/2091(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Draws the industry’s attention to the harm caused, in terms of loss of reputation and confidence, when rogue operators from the industry itself commit fraud, and encourages the industry, independently of the development of future EU legislation on fraud, to continue to use tools such as self- monitoring, analysis, product-tracing plans, audits and certification;
Amendment 138 #
2013/2091(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Welcomes the Commission proposal to strengthen penalties in order at least to offset the estimated economic advantage sought through the violation, but considers that this is not dissuasive enough; believes that the Member States should set penalties for food fraud which are at least double the estimated amount of the economic advance sought through the fraudulent activity; seems it necessary, as an extra deterrent, to set even higher penalties for fraudulent cases in which public health is deliberately endangered; proposes, furthermore, that in the event of repeated offences the food business operator’s registration be withdrawn;
Amendment 142 #
2013/2091(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30a. Considers it appropriate to look into ways of adding a supplementary charge to penalties, on top of the amount equivalent to double the estimated profit, where fraud has been committed on products intended for sensitive consumers such as children or people with particular dietary needs (products for diabetics where the fraud lies in the fact that they do not meet the reduced-sugar requirements, low-salt products for people with high blood pressure, etc.);
Amendment 10 #
2013/2079(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas with current levels of use of fossil fuels and future projections for this, CCS would seem to be essential to achieving the target of keeping the rise in global temperatures below 2°C;
Amendment 12 #
2013/2079(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas developments in carbon capture and storage should not in any way be to the detriment of achieving the EU's mandatory renewables development target;
Amendment 13 #
2013/2079(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas development of carbon capture and storage should be regarded as a strategy that is complementary to development of renewables in the transition to a low carbon economy;
Amendment 15 #
2013/2079(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas development of this technology should not serve as an incentive to increase the share of fossil fuel power plants;
Amendment 21 #
2013/2079(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recognises that CCS deployment is needed for the EU to meet its 2050 low- carbon aspirations at least cost; affirms the urgent need to develop a range of full- chain CCS flagship projects; appreciates that instruments in addition to the EU ETS are needed to drive forward their development; believes that, for their development, other instruments need to be found which can foster research and technical development in the CCS technology field;
Amendment 26 #
2013/2079(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises the importance of deploying CCS in certain industrial processes such as metallurgy, iron and steel, and the cement industry where it can profitably contribute to radical reductions in industrial emissions in the medium term;
Amendment 44 #
2013/2079(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes the decision by certain Member States not to include CCS in their emissions reduction strategies, but points out that this ought not to prevent it being developed by those Member States which consider this technology to be valid and effective in the transition to a low carbon economy provided it can be deployed in a way that is safe for the environment.
Amendment 48 #
2013/2079(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Emphasises that Member States wishing to carry out CCS projects on their territory need to have the key role in providing a transparent revenue stream, such as feed-in tariffs, to support the construction and operation of flagship projects while enabling operators to secure a return on their investment, and in introducing regulatory requirements such as guarantees that first-mover CCS power plants provide baseload electricity generation;
Amendment 104 #
2013/2079(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 109 #
2013/2079(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Mentions again the rules on responsibility for storage of CO2 laid down in the CCS Directive and the obligations incumbent upon holders of a storage permit;
Amendment 110 #
2013/2079(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Points out that the rules on responsibility for storage of CO2 laid down in the CCS Directive ought not to have a dissuasive effect on investments;
Amendment 112 #
2013/2079(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 119 #
2013/2079(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
Amendment 124 #
2013/2079(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 133 #
2013/2079(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the Commission to study the possibility of setting emissions standards for future fossil fuel power plants;
Amendment 2 #
2013/2061(INI)
Motion for a resolution
Recital A
Recital A
A. whereas equal access to high-quality universal healthcare is internationally recognised – especially within the EU – to be a fundamental right;
Amendment 6 #
2013/2061(INI)
Motion for a resolution
Recital C
Recital C
C. whereas, therefore, the European Union’s action in the field of eHealth consists of helping Member States to coordinate their efforts in this area and supporting their actions in fields where its intervention can provide added value, the aim being to improve quality of life for citizens;
Amendment 46 #
2013/2061(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas citizens and healthcare professionals do not all have the opportunity to use IT tools, nor do they have the skills needed to take advantage of eHealth services;
Amendment 60 #
2013/2061(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Urges the Commission and the Member States to provide the economic, human, and material resources necessary to ensure that access to, and the use of, eHealth services will not add to the territorial inequalities already affecting access to existing ICT services;
Amendment 73 #
2013/2061(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Member States and the Commission to provide healthcare professionals and citizens throughout the EU with appropriate assistance and training, so as to help them develop their digital literacy and hence make the most of eHealth services without exacerbating social or territorial inequalities;
Amendment 77 #
2013/2061(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Points to the importance of preserving a human dimension in healthcare, especially in view of the fact that the population is ageing and it is therefore becoming increasingly difficult to distinguish between that which is medical and that which is social;
Amendment 79 #
2013/2061(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Member States and the Commission to run eHealth awareness and training campaigns aimed at the general publicovercoming the lack of knowledge and trust among patients, the general public, and healthcare professionals. These campaigns should be tailored to the social groups they target, since public information and active public participation are key to the effective development of new healthcare delivery models;
Amendment 89 #
2013/2061(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Urges the Commission and the Member States to adopt standards for health-related mobile apps so as to ensure that the information transmitted is accurate and remedy the lack of legal clarity and transparency regarding the use of the data collected by such apps;
Amendment 103 #
2013/2061(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 110 #
2013/2061(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Urges the Commission and the Member States to apply the processing standards for health-related personal data as laid down in the proposal for a regulation on the protection of individuals with regard to the processing of personal data and on the free movement of such data, once that regulation has entered into force;
Amendment 121 #
2013/2061(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
Amendment 126 #
2013/2061(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to publish an annual progress report on the implementation of the eHealth Action Plan in Member States, detailing the innovations brought to this tool in order to provide citizens with efficient healthcare systems, thereby establishing effective indicators for gauging the success and impact of the projected measures;
Amendment 40 #
2013/0371(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) To achieve a goal of reducing the use of plastic bags, it is particularly important to focus on measures to prevent and minimize the use thereof, encouraging producers opt for alternative and more sustainable materials at the product design stage.
Amendment 55 #
2013/0371(COD)
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4a) Furthermore, consumer information has been shown to play a decisive part in achieving any goals regarding reduced plastic bag consumption. It is therefore necessary for efforts to be made at institutional level to heighten awareness of the environmental impact of plastic bags and do away with the current perception of plastic as a harmless, cheap and intrinsically worthless commodity.
Amendment 56 #
2013/0371(COD)
Proposal for a directive
Recital 4 b (new)
Recital 4 b (new)
(4b) In this connection, Member States should also be advised to place in conventional bags brief messages or warnings about the adverse environmental impact of non-degradable plastics disposal.
Amendment 108 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 94/62/EC
Article 4 – paragraph 1a – subparagraph 1
Article 4 – paragraph 1a – subparagraph 1
Member States shall take measures to achieve a reduction in the consumption of lightweight plastic carrier bags on their territory of at least 70% of average consumption in 2010 within two years of entry into force of this Directive. Member States shall take measures to achieve a reduction in the consumption of lightweight plastic carrier bags on their territory of at least 80% of average consumption in 2010 within four years of entry into force of this Directive.
Amendment 137 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Directive 94/62/EC
Article 4 – paragraph 1b (new)
Article 4 – paragraph 1b (new)
(2a) In Article 4, the following paragraph 1b is inserted: '1b. Member States shall take account of ecological design criteria in national prevention programmes before placing a product on the market, so that the use of plastics and especially lightweight bags, is limited to those cases where, for reasons of food hygiene and safety or in the absence of any alternative, more sustainable packaging it is necessary to authorize the use thereof for a particular product.'
Amendment 142 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2 b (new)
Article 1 – point 2 b (new)
Directive 94/62/EC
Article 4 – paragraph 1c (new)
Article 4 – paragraph 1c (new)
(2b) In Article 4, the following paragraph 1c is inserted: '1c. The Commission and the Member States shall, at least during the first year after the entry into force of the directive, promote public information and awareness campaigns concerning the adverse environmental impact of excessive use of conventional plastic bags.'
Amendment 143 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2 c (new)
Article 1 – point 2 c (new)
Directive 94/62/EC
Article 4 – paragraph 1d (new)
Article 4 – paragraph 1d (new)
(2c) In Article 4, the following paragraph 1d is inserted: '1d. Measures to reduce the use of bags may be accompanied by ecological design measures such as restricting the space that may be taken up by printed advertisements or brand names, so as to reduce the use of environmentally harmful inks and dyes. This shall not apply to messages or warnings issued by certain Member States about the environmental impact of using plastic bags.'
Amendment 61 #
2013/0307(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) At Union level, the proposal for a new Regulation of the European Parliament and the Council on Animal Health11 include provisions on disease agents that cause animal diseases, At Union level, the proposal for a new Regulation of the European Parliament and the Council on Animal Health11 include provisions on animal diseases, and the new Regulation of the European Parliament and the Council on protective measures against pests of plants12 provides rules for pests of plants, and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC13 sets out the regime applicable to genetically modified organisms. Therefore, the new rules on invasive alien species should align and not overlap with those Union acts and shall not apply to the organisms targeted by those acts. __________________ 11 12 13COM(2013) 260 final. COM(2013) 260 final. 12 COM(2013) 267 final. COM(2013) 267 final. 13 OJ L 106, 17.4.2001, p. 1. OJ L 106, 17.4.2001, p. 1.
Amendment 70 #
2013/0307(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure compliance with the rules of the World Trade Organisation and ensure the coherent application of these new rules, common criteria should be established to perform the risk assessment. Those criteria should use, when appropriate, existing national and international standards and should encompass different aspects of the characteristics of the species, the risk and modes of eintryoduction into the Union, the negative economic, social and biodiversity impacts of the species, the potential benefits of uses and the costs of mitigation to weight them against the negative impacts, as well as an approximate quantified forecast of the environmental, economic and social damage costs at Union level demonstrating the significance for the Union, so as to further justify action. In order to develop the system progressively and build upon the experience gained, the overall approach should be evaluated after five years.
Amendment 109 #
2013/0307(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) disease agents that cause animal diseases regulated as defined in Article 4(1)(14) of Regulation (EU) No XXX/XXXX [animal health law- COM(2013) 260 final];
Amendment 121 #
2013/0307(COD)
Proposal for a regulation
Article 3 – point 3 a (new)
Article 3 – point 3 a (new)
(3a) ‘Invasive alien species of Member State concern’ means invasive alien species other than invasive alien species of Union concern, for which a Member State considers that the adverse impact of their release and spread, even where not fully ascertained, is of significance for its territory, and which therefore require action to be taken at the level of each Member State concerned;
Amendment 132 #
2013/0307(COD)
Proposal for a regulation
Article 3 – point 10
Article 3 – point 10
(10) '‘introduction pathways'’ means the routes and mechanisms of biological invasions;
Amendment 165 #
2013/0307(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) a description of the potential pathways of eintryoduction and spread, both intentional and unintentional, including where relevant the commodities with which the species are generally associated;
Amendment 166 #
2013/0307(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) a thorough assessment of the risk of eintryoduction, establishment, spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions;
Amendment 178 #
2013/0307(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(g) an approximate quantified forecast of the damage costs at Union level demonstrating the significance for the Union, so as to further justify action because the overall damage would outweigh the cost of mitigation;
Amendment 184 #
2013/0307(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article 6a National lists of invasive alien species of concern to the Member State Each Member State may introduce national lists or keep existing ones in order to prevent the introduction, establishment and spread of invasive alien species of concern to that Member State, applying to these species within its territory any or all of the prohibitions referred to in Article 7(1). 2. Member States shall ban any intentional release into the environment, that is to say the process by which an organism is placed into the environment, for any purpose, unless a risk assessment shows that there is no risk to biodiversity and the competent authority of the Member State issues a permit for such release. 3. Each Member State shall inform the Commission and the other Member States of the invasive alien species of concern to it. 4. Any Member State may cooperate with neighbouring EU countries in taking measures to control invasive alien species of concern to it.
Amendment 227 #
2013/0307(COD)
Proposal for a regulation
Article 10
Article 10
Amendment 50 #
2013/0169(COD)
Proposal for a regulation
Recital 7
Recital 7
Amendment 58 #
2013/0169(COD)
Proposal for a regulation
Article 5
Article 5
Amendment 62 #
2013/0169(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point a
Article 6 – paragraph 3 – point a
(a) cConcern the control of serious health risks for the Uniouman, animal and plant health risks for the Union, along the whole food chain;
Amendment 67 #
2013/0169(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Grants may be awarded to Member States up to the maximum rates set in Article 6(1), (2) and (3) for the measures taken in the event of the confirmation of thesuspected and confirmed occurrence of one of the animal diseases listed pursuant to Article 8, provided that the measures have been applied immediately and the applicable provisions laid down in the relevant Union legislation have been complied with.
Amendment 88 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Annual national programmes and associated funding shall be approved by 31 January each year0 November of the year preceding the year in which the programmes are due to begin, by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January to 31 December of thate eligible year. Following submission of the intermediate reports as referred to in Article 15, the Commission may amend such decisions if necessary in relation to the whole eligibility period.
Amendment 91 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Multiannual national programmes and associated funding shall be approved by 31 January of0 November preceding the first year of implementation by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January of the first year of implementation until the end of the implementation period.
Amendment 97 #
2013/0169(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
In addition, for each approved annual national programme, Member States shall submit to the Commission, by 31 July0 September each year, intermediate technical and financial reports.
Amendment 25 #
2013/0074(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) Natural capital is a public good par excellence. Coastal management by public authorities of each country must be for the benefit of the environment and all citizens, without putting private interests ahead of the general interest.
Amendment 29 #
2013/0074(COD)
Proposal for a directive
Recital 12
Recital 12
(12) While it is appropriate for the Union to lay down rules on maritime spatial plans and integrated coastal management strategies, Member States and their competent authorities remain responsible for designing and determining, within their marine waters and coastal zones, the content of such plans and strategies, including the apportionment of maritime space to the different sector activities, and must always act in accordance with European Union legislation.
Amendment 48 #
2013/0074(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive establishes a framework for maritime spatial planning and integrated coastal management aiming at protecting the coastline, promoting the sustainable growth of maritime and coastal economies and the sustainable use of marine and coastal resources.
Amendment 59 #
2013/0074(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Each Member State shall establish and implement a maritime spatial plan or plans and an integrated coastal management strategy or strategies. They mayshall be prepared in separate documents.
Amendment 86 #
2013/0074(COD)
Proposal for a directive
Article 5 – point e a (new)
Article 5 – point e a (new)
ea) reducing urban pressure resulting from human activity in order to protect delicate coastal areas.
Amendment 87 #
2013/0074(COD)
Proposal for a directive
Article 5 – point e b (new)
Article 5 – point e b (new)
eb) promoting sustainable tourism at the expense of mass tourism.
Amendment 109 #
2013/0074(COD)
Proposal for a directive
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
b) development of infrastructure, energy facilities, transport, ports, maritime works, waste water treatment installations and other structures including green infrastructure;
Amendment 112 #
2013/0074(COD)
Proposal for a directive
Article 8 – paragraph 2 – point e
Article 8 – paragraph 2 – point e
e) conservation, restoration and management of coastal ecosystems, protected deltas and wetland areas, ecosystem services and nature, coastal landscapes and islands;
Amendment 7 #
2012/2259(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the factNotes that renewable energy is beingnot developed in the Member States with a viewing at the same pace in all the Member States and that efforts might need to be redoubled in order to meeting the targets set for 2020; calls on the Commission to propose rationalambitious goals up to 2030, which should take into account the proportions of electricity to be generated from renewable sources, energy efficiency, clean conventional energy technologies, and CO2 storagethe different sources and provide for an ever increasing share of renewables in the mix, as the EU is advocating;
Amendment 16 #
2012/2259(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Greatly deplores the fact that some Member States are implementing extreme austerity policies, with cuts that are having a direct impact on RDI in the renewable energy field and slowing renewables down, preventing them from attaining the technological maturity required in order not just to meet the EU’s 2020 targets, but also to lower energy generation costs and encourage investment;
Amendment 33 #
2012/2259(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Maintains that a transitional periodit is necessary in order to establish European support schemes; suggests that the Commission allow for the effects of the economic crisis and countries’ lower credit ratings, as reflected in the cutbacks – and the degree of risk involved – in renewable energy investment; stresses that the risks to those who invest in renewable energy have to be reduced by means of a clear long- term European strategy;
Amendment 45 #
2012/2259(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Welcomes the Commission’s intention to draw up guidelines for best practice regarding renewable energy support schemes, but regrets that the Commission communication entitled ‘Renewable Energy: a major player in the European energy market’ is inconsistent and confused about the need for support per se; notes that the renewable energy sector is not yet robust enough to withstand market forces on its own and considers, therefore, that rigorously and transparently managed support is still needed in order to consolidate the sector and enable the EU to realise its model for a carbon-free future;
Amendment 47 #
2012/2259(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Accordingly welcomes the fact that some renewable energy technologies are beginning to attain acceptable degrees of competitiveness in relation to conventional forms of energy, even though the social and environmental costs of the latter are, to a large extent, still not being internalised;
Amendment 55 #
2012/2259(INI)
Draft opinion
Paragraph 5
Paragraph 5
Amendment 69 #
2012/2259(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Deplores the fact that in some Member States the mismanagement of energy policy is leading to situations that directly affect consumers – upward price movements being one example – while also jeopardising the viability of hundreds of industries and thousands of jobs and even causing the failure of much of the renewable energy business in countries which have, up to now, shown clear leadership in that field.
Amendment 70 #
2012/2259(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Disagrees with the Commission’s view that small-scale generation is being blocked by ‘Poor public acceptance of certain renewable energy projects’ and considers, on the contrary, that its unpopularity at household level is due to high installation costs and the lack of substantial support for consumers and small-scale entrepreneurs who could become micro producers.
Amendment 71 #
2012/2259(INI)
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Considers that any decision to impose an unjustified moratorium on clean energy gives cause for disquiet and criticises the fact that too much compensation is, conversely, sometimes granted for generation plants which have already been depreciated, as is the case with certain hydroelectric and nuclear power stations still receiving national aid.
Amendment 15 #
2012/2100(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that regional strategies for industrial areas should include, as a focus point, the cleaning-up of land and water, and that the regional strategies should therefore consider measures which support the aims and goals of the Waste Framework Directive and the Water Framework Directive. These strategies must, moreover, seek to protect and conserve the environment and physical spaces, and at the same time ensure a higher level of environmental efficiency and sustainability;
Amendment 22 #
2012/2100(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the importance of an effective transposition by Member States of the SEVESO III Directive, in order to ensure that possible risks to citizens close to the industrial regions concerned are minimised, that they have adequate information regarding any possible risk, and that they are better involved in land- use planning decisions. Lastly, advocates urging, in accordance with EU law, regional governments to draw up the aforementioned strategies in cooperation with groups and associations representing citizens as part of a cross-cutting decision-making process in which the latter will pay a full part as partners at all stages in a reform process in which the general public must be involved.
Amendment 13 #
2012/2066(INI)
Motion for a resolution
Recital A
Recital A
A. whereas hormone-related disorders and illnesschanges in humans have increased over the last 20 years, including impaired sperm quality, early onset of puberty, increased inwhich fact has been connected with a broad spectrum of illnesses, and whereas scidence of deformed sexual organs, increased incidence of ctific research is needed to obtain a better understain forms of cancnding of these disorders and many cases of metabolic illnessestheir aetiology;
Amendment 23 #
2012/2066(INI)
Motion for a resolution
Recital D – indent 3
Recital D – indent 3
Amendment 27 #
2012/2066(INI)
Motion for a resolution
Recital D – indent 5 a (new)
Recital D – indent 5 a (new)
- many elements and substances can affect the endocrine system and studies and scientific tests on the interaction of some chemicals which might be endocrine disruptors need therefore to be carried out in sufficient number;
Amendment 77 #
2012/2066(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers that the criteria ought to help classify the substances in a hierarchy based on their potential for producing adverse effects;
Amendment 101 #
2012/2066(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission, in its review of EU strategy on endocrine disruptors, to place greater emphasistake account onf the precautionary principle and to use a scientific risk assessment as its basis as it works towards reducing human exposure to endocrine disruptors;
Amendment 111 #
2012/2066(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Believes that the precautionary and preventive action principle, required under Article 191(2) of the Treaty on the Functioning of the European Union in order to achieve a high level of protection, has to take account of the principle of scientific assessment of the risk and dangers involved.
Amendment 132 #
2012/2066(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses that endocrine disruptors should be regarded asspecial precautions will need to be taken for those substances for which it is not possible, using validated scientific methods, to set a limit value at which effects may occur (‘non- threshold’ substances) and that any exposure to such substancesand exposure to which may entail a risk;
Amendment 138 #
2012/2066(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to support targeted research projects on endocrine disruptorslements and substances likely to affect the endocrine system and to emphasise the adverse effects at low concentrations or through combined exposure, including the development of new testing and analysis methods;
Amendment 144 #
2012/2066(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls on the Commission to require all products imported from third countries to comply with all present and future EU legislation on endocrine disruptors;
Amendment 285 #
2012/2050(INI)
Motion for a resolution
Paragraph 53 a (new)
Paragraph 53 a (new)
53 a. Recalls the European Parliament resolution of 25 November 2010 on the situation in Western Sahara; urges Morocco and the Polisario Front to continue negotiation for a peaceful and long-lasting solution of the Western Sahara conflict and reiterates the rights of the Sahrawi people to self determination which should be decided through a democratic referendum, in accordance with the relevant United Nations resolutions; condemns the ongoing violation of the human rights of the Sahrawi people; calls for the release of the Sahrawi political prisoners; welcomes the statements by 11 countries during the 13 th session of the Universal Periodic Review of the United Nations raising concerns on the situation in Western Sahara;
Amendment 179 #
2012/0366(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Cross-border distanceInternet sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this Directive. Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services , and should therefore be prohibited, in line with the implementing guidelines of the Framework Convention on Tobacco Control. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014.
Amendment 181 #
2012/0366(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) Directive 2003/33/EC on advertising and sponsorship of tobacco products already prohibits the free distribution of these products in the context of the sponsorship of events. This Directive, which regulates aspects relating to the presentation and sale of tobacco and aims to achieve a high level of health protection and prevention of tobacco consumption among young people, extends the scope of the ban on free distribution to public places and specifically prohibits the distribution of printed material, discount coupons and similar special offers inside packages and wrappings.
Amendment 200 #
2012/0366(COD)
Proposal for a directive
Recital 34
Recital 34
(34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of aHowever, measuring nicotine delivery has proven to be difficult, as it depends on the products and how they are being used. Therefore, subjecting all nicotine -containing product previously authorised under Directive 2001/83/EC, to the same legal frameworks regardless of their nicotine content to Directive 2001/83/EC clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
Amendment 205 #
2012/0366(COD)
Proposal for a directive
Recital 35
Recital 35
Amendment 225 #
2012/0366(COD)
Proposal for a directive
Recital 38
Recital 38
(38) In order to make this Directive fully operational and to keep up with technical, scientific and international developments in tobacco manufacture, consumption and regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission, in particular in respect of adopting and adapting maximum yields forethods of measuring emissions and their measurement methods, setting maximum levels for ingredients that increase toxicity, addictiveness or attractiveness, , the use of health warnings, unique identifiers and security features in the labelling and packaging, defining key elements for contracts on data storage with independent third parties, reviewing certain exemptions granted to tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 236 #
2012/0366(COD)
Proposal for a directive
Recital 41
Recital 41
(41) Member States should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this Directive, provided they are compatible with the Treaty and do not jeopardise the full application of this Directive. Accordingly, Member States could, for instance, maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the Treaty, with WTO obligations and do not affect the full application of this Directive. A prior notification is required for technical regulations pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on Information Society services . (If corresponding amendments introducing standardised packaging are not adopted, this amendment should fall.)
Amendment 341 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 30
Article 2 – paragraph 1 – point 30
(30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least the 10 Member States with the largest market volume, based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least the 10 Member States with the largest market volume, for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;
Amendment 368 #
2012/0366(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 388 #
2012/0366(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar, nicotine and carbon monoxide fixed in paragraph 1.
Amendment 455 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavourcontaining additives which provide a characterising flavour which is not that of tobacco.
Amendment 532 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Member States shall prohibit tThe use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity shall be prohibited. Filters and capsules shall not contain tobacco.
Amendment 597 #
2012/0366(COD)
Proposal for a directive
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. To ensure clearness and visibility, particularly of the graphic warnings, adhesive labels may be used, provided they cannot be removed from the packaging and solely in the case of packaging materials on which it is difficult or impossible to print the combined warning.
Amendment 603 #
2012/0366(COD)
Proposal for a directive
Article 7 – paragraph 7 a (new)
Article 7 – paragraph 7 a (new)
7a. The unit packet and its surrounding packaging shall not include printed vouchers offering discounts, free distribution, two-for-one or other similar offers involving any type of tobacco product covered by this Directive...
Amendment 607 #
2012/0366(COD)
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 1 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1 – subparagraph 1
Tobacco smoke contains over 70 substances known towhich cause cancer
Amendment 729 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The combined health warnings shall be divided into three sets rotating on an annual basis, except for the warnings referred to in paragraph 1(b). Member States shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand.
Amendment 815 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. The labelling of a unit packet and any outside packaging and the tobacco product itself and/or its brand name shall not include any element or feature that:
Amendment 818 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) promotes a tobacco product and encourages its consumption by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions;
Amendment 824 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
b) directly or comparatively suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or social effects;
Amendment 832 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
d) resembles a food, cosmetic or everyday product.
Amendment 1029 #
2012/0366(COD)
Proposal for a directive
Title 2 – chapter 4 – title
Title 2 – chapter 4 – title
Amendment 1031 #
2012/0366(COD)
Proposal for a directive
Article 16 – title
Article 16 – title
Amendment 1032 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authoritiprohibit all forms of cross-border distance selling in their territory, including electronic and postal sales, telephone, television and internet sales or any other form of technological transaction. Member States shall retain the power to decide whether to widen the scope of the above-mentioned prohibition to include national sales:.
Amendment 1043 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
Amendment 1156 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: . (If adopted, paragraphs 1(a) - (c), 2 to 5 of this Article should be deemed to be deleted.)
Amendment 1173 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 1185 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1199 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1330 #
2012/0366(COD)
Proposal for a directive
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
Member States may allow nicotine containing products which are not in compliance with this Directive to be placed on the market until [Publications Office, please insert the exact date: entry into force + 48 months]:
Amendment 1332 #
2012/0366(COD)
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
Amendment 1347 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 10
Annex 1 – point 10
10) Your smoke harmsshortens the life of your children, family and friends; do not expose them to it
Amendment 208 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 2 – point e
Annex 1 – point 26 – subparagraph 2 – point e
(e) Increasing efforts to reduce soil erosion and increase soil organic matter, to remediate contaminated sites and to enhance the integration of land use aspects into coordinated decision-making involving all relevant levels of government, supported by the adoption of targets and binding legislation on soil and on land as a resource, and land planning objectives.
Amendment 216 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 2 – point g
Annex 1 – point 26 – subparagraph 2 – point g
(g) Developing and implementing a new EU Common Forestry Policy, as well as a new EU Forest Strategy that addresses the multiple demands on and benefits of forests and contributes to a more strategic approach to protecting and enhancing forests.
Amendment 217 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 2 – point g
Annex 1 – point 26 – subparagraph 2 – point g
(g) Developing and implementing a new EU Forest Strategy that addresses the multiple demands on and benefits of forests and contributes to a more strategic approach to protecting and enhancing forests, and earmarks the financial and human resources necessary for combating forest fires.
Amendment 242 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 31
Annex 1 – point 31
31. All sectors of the economy will need to contribute to reducing GHG emissions for the EU to deliver its fair share of global efforts. The EU needs to agree the next steps for its climate and energy framework beyond 2020 in order to prepare itself for international negotiations on a new legally binding agreement, but also to provide Member States and industry with a clear framework to make the medium-term investments needed. Hence the EU needs to consider policy options for delivering the reductions set out in the Low-Carbon Economy Roadmap for the period beyond 2020. The 2050 Energy roadmap and the White Paper on transport need to be underpinned by strong policy frameworks. Moreover, Member States need to develop and put in place long-term, cost-effective low-carbon development strategies aimed at achieving the EU objective of reducing GHG emissions by 80% to 95% by mid- century, compared to 1990, as part of a global effort to limit average temperature increase to below 2°C. The EU Emissions Trading System will continue to be a central pillar of EU climate policy beyond 2020. Structural measures will be taken to correct deficiencies and imbalances observed in the functioning of the Emissions Trading System in the early stages of its commercial operation.
Amendment 332 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 42
Annex 1 – point 42
42. EU environment legislation has delivered significant benefits for the health and well-being of the public. However, water, air pollution and, chemicals and noise pollution remain among the general public's top environmental concerns in the EU. The World Health Organisation (WHO) estimates that environmental stressors are responsible for between 15 and 20 % of all deaths in 53 European countries. According to the OECD, urban air pollution is set to become the primary environmental cause of mortality worldwide by 2050.
Amendment 343 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 52 – subparagraph 1 – point a a (new)
Annex 1 – point 52 – subparagraph 1 – point a a (new)
(aa) Legislation on methods of measuring air pollution is revised and guidelines are drawn up on where best to install measuring devices to ensure collection of the most reliable data and prevent fraudulent measurements.
Amendment 346 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 52 – subparagraph 1 – point c a (new)
Annex 1 – point 52 – subparagraph 1 – point c a (new)
(ca) The implementation of policies to internalise the costs of water use in the various Member States – as called for in the Water Framework Directive – is monitored, with a view to working towards ensuring that water rates reflect the real price of water;
Amendment 365 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 54
Annex 1 – point 54
54. The benefits of ensuring that EU environment legislation is actually implemented are threefold: providing a level playing field for economic actors operating in the Single Market, stimulating innovation, and promoting first-mover advantages for European companies in many sectors. The costs associated with failure to implement legislation, by contrast, are high, broadly estimated at around €50 billion a year, including costs related to infringement cases60. In 2009 alone there were 451 infringement cases related to EU environment legislation. The Commission also receives numerous complaints directly from EU citizens, many of which, although they could be better addressed at Member State or local level. still necessitate the mediation of the Commission and, where appropriate, the European Court of Justice.
Amendment 370 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 59
Annex 1 – point 59
59. Third, the way in which complaints about implementation of EU environment law are handled and remedied at national level will be improved, and greater transparency and better access to information on complaints will be ensured.
Amendment 376 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 63 – subparagraph 1 – point a
Annex 1 – point 63 – subparagraph 1 – point a
(a) EU citizens have access to clear information showing how EU environment law is being implemented. For purposes of transparency, this should include online access to a summary of the various complaints that have been lodged with the European Commission and information on the processing status of cases in each Member State
Amendment 412 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 - point a
Annex 1 – point 71 – subparagraph 2 - point a
(a) CAvoiding budget cuts to research, while coordinating and focusing research efforts at EU and Member State levels on addressing key environmental knowledge gaps, including the risks of environmental tipping-points.
Amendment 444 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 82 – subparagraph 2 – point b a (new)
Annex 1 – point 82 – subparagraph 2 – point b a (new)
(ba) Providing more national and EU aid to efforts to ensure energy efficiency, including in the home (thermal insulation, energy efficient appliances, installation of small-scale renewal energy generators, etc.)
Amendment 449 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 88
Annex 1 – point 88
88. Most cities face a common core set of environmental problems, including poor air quality, highexcessive levels of noise that pose a risk to public health, GHG emissions, water scarcity, floods and storms, contaminated sites, brownfields and waste. At the same time, EU cities are standard- setters in urban sustainability and often pioneer innovative solutions to environmental challenges. An ever- growing number of European cities are putting environmental sustainability at the core of their urban development strategies.
Amendment 457 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 91 – subparagraph 1 - point a a (new)
Annex 1 – point 91 – subparagraph 1 - point a a (new)
Amendment 472 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 95
Annex 1 – point 95
95. The time span covered by this programme corresponds to key phases in international climate, biodiversity and chemical policy. To remain within the 2 °C ceiling, global GHG emissions need to be cut by at least 50 % of their 1990 levels by 2050. However, only half the emission reductions required by 2020 have been pledged by Parties under the UNFCCC. Without more resolute global action, climate change is unlikely to be curtailed. Even in a best-case scenario, countries will increasingly face inevitable impacts of climate change because of historical GHG emissions and will need to develop climate adaptation strategies. Under the Durban Platform for Enhanced Action, a comprehensive and robust agreement applicable to all is to be agreed by 2015 and implemented as of 2020. The EU will remain engaged proactively in this process, including in discussions on how to close the gap between current emission reduction pledges by developed and developing countries, and on action needed to stay on an emission pathway compatible with the 2oC objective. The follow-up to Rio+ 20 should also help reduce GHG emissions, thus supporting the fight against climate change. In parallel, the EU should pursue and further intensify climate change partnerships with strategic partners and should take further action to mainstream environment and climate considerations in its development policy. The EU must take the lead in international negotiations to encourage links between the EU emissions trading system and other such schemes with a view to establishing, in the near future, a global carbon market between OECD (Organisation for Economic Cooperation and Development) member states and the major emerging economies.
Amendment 73 #
2012/0297(COD)
Proposal for a directive
Recital 12
Recital 12
(12) When applying Directive 2011/92/EU, it is necessary to ensure a competitive business environment, especially for small and medium enterprises, in order to generate smart, sustainable and inclusive growth, in line with the objectives set out in the Commission's Communication entitled ‘Europe 2020 – A strategy for smart, sustainable and inclusive growth’.
Amendment 92 #
2012/0297(COD)
Proposal for a directive
Recital 22 a (new)
Recital 22 a (new)
(22a) One of the objectives of the Århus Convention, which the EU has ratified and transposed into EU law, is to ensure the right of the public to participate in decision-making in environmental matters. Therefore, that participation, including participation by associations, organisations and groups, in particular non-governmental organisations promoting environmental protection, should continue to be fostered. Moreover, Article 9(2) and (4) of the Århus Convention provides for access to judicial or other procedures for challenging the substantive or procedural legality of decisions, acts or omissions subject to public participation.
Amendment 95 #
2012/0297(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) The protection thresholds for petroleum and natural gas set out in Annex I to Directive 2011/92/EU do not take into consideration the specific case of daily production levels of non-conventional fossil fuels, which are sometimes very variable and lower, obtained using extraction methods that are particularly harsh on the environment, such as hydraulic fracturing. Consequently, and notwithstanding their environmental impact, projects relating to these fossil fuels should be subject to a mandatory impact assessment under Annex I of this Directive, irrespective of the amounts extracted.
Amendment 131 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 1 – point c
Article 1 – point 1 – point c
Directive 2011/92/EU
Article 1 – paragraph 3
Article 1 – paragraph 3
3. Member States may decide, on a case- by-case basis and if so provided under national law, not to apply this Directive to projects having as their sole purpose national defence or the response to civil emergencies, if they deem that such application would have an adverse effect on those purposes and providing that there is no serious risk to human health."
Amendment 214 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 5 – introductory part
Article 4 – paragraph 5 – introductory part
5. The competent authority shall make its decision pursuant to paragraph 2, on the basis of the information provided by the developer and, taking into account any comments made by the public and the local authorities concerned and, where relevant, the results of studies, preliminary verifications or assessments of the effects on the environment arising from other Union legislation, and any complaints submitted by members of the public affected or the local authorities concerned. The decision pursuant to paragraph 2 shall:
Amendment 463 #
2012/0297(COD)
Proposal for a directive
Annex – point -1 (new)
Annex – point -1 (new)
Directive 2011/92/EU
Annex I – point 14 a (new)
Annex I – point 14 a (new)
(-1) In Annex I, the following point 14a is added: "(14a) Exploration, evaluation, hydraulic fracturing and extraction of petroleum and/or natural gas trapped in gas-bearing strata of shale or in other sedimentary rock formations of equal or lesser permeability and porosity, regardless of the amount extracted ."
Amendment 465 #
2012/0297(COD)
Proposal for a directive
Annex –point -1 a (new)
Annex –point -1 a (new)
Directive 2011/92/EU
Annex I – point 19
Annex I – point 19
(- 1a) In Annex I, point 19 is replaced by the following: "19. Quarries and open-cast mining where the surface of the site exceeds 25 hectares, gold mines which use processes involving cyanide ponds, or peat extraction, where the surface of the site exceeds 150 hectares."
Amendment 466 #
2012/0297(COD)
Proposal for a directive
Annex – point -1 b (new)
Annex – point -1 b (new)
Directive 2011/92/EU
Annex I – point 20
Annex I – point 20
(-1b) In Annex I, point 20 is replaced by the following: "20. Construction, modification or extension of overhead, underground or combined overhead and underground electrical power lines, and/or upgrading of such lines of a voltage that is 220 kV or more and of a length of more than 15 km, and construction and/or modification of their related substations (current transformer stations, current converter stations and current distributor stations of the auto-underground type and vice-versa).”
Amendment 467 #
2012/0297(COD)
Proposal for a directive
Annex – point -1 c (new)
Annex – point -1 c (new)
Directive 2011/92/EU
Annex I – point 24 a (new)
Annex I – point 24 a (new)
(-1c) In Annex I, the following point 24a is added: "24a. Theme parks and golf courses planned for areas of water shortage or at high risk of desertification or drought.”
Amendment 481 #
2012/0297(COD)
Proposal for a directive
Annex – point 1
Annex – point 1
Directive 2011/92/EU
Annex II.A – paragraph 1 – point b
Annex II.A – paragraph 1 – point b
(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas or communities likely to be affected.
Amendment 498 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex III – paragraph 1 – point e
Annex III – paragraph 1 – point e
(e) pollution and, including noise pollution, and its potential health impacts, and/or nuisances;
Amendment 521 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex III – paragraph 1 – point j a (new)
Annex III – paragraph 1 – point j a (new)
(ja) assessment of the complaints submitted up to that point by the members of the public affected or the local authorities concerned.
Amendment 530 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex III – paragraph 2 – point c – point vii
Annex III – paragraph 2 – point c – point vii
(vii) densely populated areas close to sensitive zones (containing hospitals, schools, retirement homes and any other type of especially sensitive or vulnerable population group);
Amendment 156 #
2012/0267(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority or medical association or institution, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authoritye applicant. They shall cooperate with thae competent authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 158 #
2012/0267(COD)
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
10a. Manufacturers of medical devices must be covered by an insurance policy or equivalent financial guarantee to meet claims for health damage arising from unsafe medical devices. Manufacturers shall bear the cost to the health system of treatment, operations and diagnostic procedures practiced on patients as a result of defects in or malfunctioning of health devices detected by the health authorities or the manufacturers themselves. They shall also bear the cost of withdrawing, repairing or replacing the products involved in these situations.
Amendment 342 #
2012/0267(COD)
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.
Amendment 312 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority or a medical association or institution, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authoritye applicant. They shall cooperate with thae competent authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 319 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
10a. Manufacturers of medical devices must be covered by an insurance policy or equivalent financial guarantee to meet claims for health damage arising from unsafe medical devices. Manufacturers shall bear the cost to the health system of treatment, operations and diagnostic procedures practiced on patients as a result of defects in or malfunctioning of health devices detected by the health authorities or the manufacturers themselves. They shall also bear the cost of withdrawing, repairing or replacing the products involved in these situations.
Amendment 453 #
2012/0266(COD)
Proposal for a regulation
Article 26 – title
Article 26 – title
Summary of safety and clinical performance report
Amendment 460 #
2012/0266(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary offull safety and clinical performance report, including the results of the clinical research and assessment. It shall be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.
Amendment 478 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to the Agency, notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 750 #
2012/0266(COD)
Proposal for a regulation
Article 87 – paragraph 1
Article 87 – paragraph 1
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. The dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of the Regulation] and shall notify it without delay of any subsequent amendment affecting them.
Amendment 48 #
2012/0202(COD)
Proposal for a decision
Recital 2 a (new)
Recital 2 a (new)
(2a) The allowances subject to such an adaptation should be put in a strategic reserve to improve stability in the EU ETS and to support skills development and re- training of workers for the low-carbon transition. To this effect future structural measures adopted by the European Parliament and the Council should provide for their use as part of a reserve which should make the EU ETS able to better adapt to extreme imbalances between supply and demand based on objective and transparent criteria.
Amendment 68 #
2012/0202(COD)
Proposal for a decision
Article 1
Article 1
Directive 2003/87/EC
Article 10 – paragraph 4 – subparagraph 1
Article 10 – paragraph 4 – subparagraph 1
The Commission shall, where appropriate, adapt the timetable for each period so as to ensure an orderly functioning of the market. Where such an adaptation results in a significant number of allowances not being auctioned early in phase 3 of the EU ETS, those allowances shall be used to create a new reserve to enhance the stability of the EU ETS and contribute to social and skill-related aspects of the low- carbon transition.
Amendment 221 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 10 a (new)
Article 2 – paragraph 2 – point 10 a (new)
(10a) ‘Ethics committee’: an independent body in a Member State – made up of healthcare professionals, laypersons and at least one knowledgeable patient with in-depth clinical experience, or a representative of such a patient – whose responsibility it is to ensure that the rights, safety and welfare of subjects participating in clinical trials are protected and to provide public assurance of that protection;
Amendment 233 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 17 a (new)
Article 2 – paragraph 2 – point 17 a (new)
(17a) ‘Subject from a vulnerable group’: a subject belonging to a particularly vulnerable population group in relation to a clinical trial as a result of their medical, social or economic circumstances;
Amendment 379 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patientn ethics committee shall be taken into account.
Amendment 384 #
2012/0192(COD)
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Where the subjects belong to vulnerable population groups, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease, or the medical or social circumstances of the subject, or after taking advice on the specific clinical, ethical and psychosocial issues in the field.
Amendment 477 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the investigator considers the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result;
Amendment 483 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 2 a (new)
Article 30 – paragraph 2 a (new)
2a. Both the incapacitated subject and their legal representative may revoke their consent at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result.
Amendment 486 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point a a (new)
Article 31 – paragraph 1 – point a a (new)
(aa) the informed and express consent of the minor has been obtained, where they are 12 years old and over,
Amendment 488 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the investigator duly takes into consideration, in accordance with the age and maturity of the minor concerned, the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with hiswithout giving a reason and with no liability or prejudice whatsoever being incurred by the minor concerned or their age and maturity; legal representative as a result;
Amendment 501 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The minor shall take part in the consent procedure in a manner adapted to his or her age and maturity. Minors who are 12 years old and over must also give their informed and express consent to participate in the trial.
Amendment 503 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. Both the minor and their legal representative may revoke their consent at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the minor or their legal representative as a result.
Amendment 504 #
2012/0192(COD)
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31a Clinical trials on subjects from other vulnerable population groups 1. A clinical trial on subjects from other vulnerable population groups may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met: (a) the subject concerned has received all relevant information from professionals trained or experienced in working with that group regarding the trial, the risks and the benefits; (b) the investigator considers the explicit wish of the subject concerned to refuse participation in, or to be withdrawn from, the clinical trial at any time, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject as a result; (c) no incentives or financial inducements are given except compensation for participation in the clinical trial; (d) such research either relates directly to a medical condition from which the subject concerned suffers or it is relevant to the vulnerable population group to which the subject belongs; (e) the clinical trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage and both the risk threshold and the degree of distress are specially defined and constantly observed; (f) some direct benefit for the group of patients to which the subject concerned belongs (e.g. improved quality of life) is obtained from the clinical trial. 2. The subject shall take part in the consent procedure at all times. 3. The subject may revoke their consent at any time, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject as a result.
Amendment 127 #
2012/0055(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The sustainable dismantling of vessels that have reached the end of their operational lives is, together with the reduction of atmospheric emissions, one of the most important sustainability challenges facing the maritime sector.
Amendment 135 #
2012/0055(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) Due attention should, however, also be paid to the rights of workers in third countries and, in particular, to ensuring application of the International Labour Organisation (ILO) guidelines on safety and health in shipbreaking.
Amendment 143 #
2012/0055(COD)
Proposal for a regulation
Article 1
Article 1
The purpose of this Regulation is to prevent, reduce or eliminate adverse effects on human health and the environment caused by the recycling, operation and maintenance of ships flying the flag of a Member State. , as well as to ensure that such vessels are recycled within the EU or at facilities on the European list of the ship recycling facilities referred to in Article 16. The purpose of this Regulation is also to: (a) ensure compliance with EU legislation on workers’ rights and, where appropriate, to ensure that third-country operators comply with equivalent rules agreed by the Union and the OECD countries under international social and labour law conventions; (b) help eradicate current disparities between operators from EU and OECD countries and those from certain third countries in terms of labour costs and workplace health and safety and environmental standards
Amendment 155 #
2012/0055(COD)
Proposal for a regulation
Article 2 – paragraph 2 – subparagraph 1
Article 2 – paragraph 2 – subparagraph 1
Amendment 156 #
2012/0055(COD)
Proposal for a regulation
Article 2 – paragraph 2 – subparagraph 2
Article 2 – paragraph 2 – subparagraph 2
Amendment 192 #
2012/0055(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)
Article 7 – paragraph 2 – point d a (new)
(da) include information on what the facility intends to do with both hazardous materials and reusable waste following processing.
Amendment 221 #
2012/0055(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point e
Article 12 – paragraph 2 – point e
(e) establish and maintain an emergency preparedness and response plan; that specifies both the means at the facility’s disposal to deal with such situations and the hospitals nearby that can receive patients in the event of an accident. Facilities without a primary health care centre in proximity or that cannot ensure the provision of urgent assistance to workers in the event of a work-related accident or medical emergency must, therefore, be excluded from the European list.
Amendment 228 #
2012/0055(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point n
Article 12 – paragraph 2 – point n
(n) ensure that all wastes generated from the recycling activity are only transferred to waste management facilities authorised to deal with their treatment and disposal without endangering human health and in an environmentally sound manner. Therefore draw up a register of secondary operators working at the main facility, including information on their waste management methods and capacities;
Amendment 229 #
2012/0055(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point n a (new)
Article 12 – paragraph 2 – point n a (new)
(na) ensure that all staff working to recycle ships have legal employment contracts, are insured in the country in which the facility is located and have the requisite professional qualifications.
Amendment 234 #
2012/0055(COD)
Proposal for a regulation
Article 15 – paragraph 8
Article 15 – paragraph 8
8. By applying for inclusion in the European List, ship recycling facilities accept the possibility of being subjectgree to site inspections conducted by the Commission or agents acting on its behalf prior tor after their inclusion in the European list in order to verify their compliance with the requirements set out in Article 12.
Amendment 238 #
2012/0055(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b – point 2
Article 16 – paragraph 3 – point b – point 2
(2) where the ship recycling facility has been included in the list for more than fiveour years and has not provided evidence that it still complies with the requirements set out in Article 12
Amendment 56 #
2012/0035(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) The criteria underlying any decision directly or indirectly regulating the prices of medicinal products, as well as any measure determining the extent to which they shall be covered by public health insurance systems should include the assessment of unmet medical needs, clinical and social benefits and innovation, as laid down in the European Economic and Social committee opinion on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, of 12 June 20121. Such criteria should also include protection for the most vulnerable groups of the population. _____________ 1 OJ C 299, 4.10.2012 p. 83
Amendment 91 #
2012/0035(COD)
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) ‘Vulnerable groups’: those sections of the population most sensitive to measures determining the extent to which medicinal products are covered by public health insurance systems, such as children, pensioners, the unemployed, those reliant on orphan drugs, the chronically ill, etc.
Amendment 215 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 7 – subparagraph 2 a (new)
Article 7 – paragraph 7 – subparagraph 2 a (new)
The criteria governing the decisions referred to in the previous paragraph shall include assessments of unmet medical needs and of the clinical benefits, the social benefits, innovation and protection of the most vulnerable groups in the population.
Amendment 217 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
8. Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system.These criteria shall include assessments of unmet medical needs and of the clinical benefits, the social benefits, innovation and the protection of the most vulnerable groups of the population.
Amendment 226 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include assessments of unmet medical needs, the clinical impact and social costs, the protection of the most vulnerable groups of the population and any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 228 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication. These criteria shall include assessments of unmet medical needs, the clinical impact and social costs and the protection of the most vulnerable groups of the population
Amendment 16 #
2011/2307(INI)
Motion for a resolution
Recital B
Recital B
B. whereas biological biodiversity is the irreplaceable basis on which humanity has evolved, and the loss of it and of the natural heritage associated with it causes imbalances and leads to significant economic losses and losses of well-being, and that, therefore, it is essential to the existence of human life and the well-being of societies, both directly and indirectly through the ecosystem services it provides;
Amendment 51 #
2011/2307(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Highlights the importance of mainstreaming biodiversity protection into all EU policies and insists that any production model that eschews the proper preservation of biodiversity is not viable; therefore, asks that the principle of sustainability be incorporated systematically into any future Community policy and, in particular, into legislation on biodiversity;
Amendment 67 #
2011/2307(INI)
Motion for a resolution
Paragraph 6a (new)
Paragraph 6a (new)
6a. Expresses concern at the increasing deterioration of essential habitats, such as wetlands, which should be treated as a priority and addressed with urgent measures that actually correspond to the special protection status that the EU grants them;
Amendment 90 #
2011/2307(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Requests that, based on the importance of the good condition of zones that adjoin areas protected for the very survival of the species they house, the Commission pool guidance and best practices for the management of the territories adjoining the Natura 2000 areas;
Amendment 119 #
2011/2307(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Recognises the great importance of maintaining a close relationship with the local actors and direct managers of the land, and therefore encourages the Commission to make greater efforts in this regard, paying attention to the experience and privileged knowledge that these actors can contribute when drafting legislation to ensure the good condition of the habitats that house the biodiversity that we wish to preserve in the EU;
Amendment 139 #
2011/2307(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Emphasises the connection between water management and biodiversity as an essential component for sustaining life and for sustainable development.
Amendment 233 #
2011/2307(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. In this regard, requests that the new legislation take into account greater preventive and palliative aid in order to confront the infestations of invasive species that already severely affect broad areas of Community territory. Considers that, until the planned legislation on invasive species enters into force, the appropriations to the territories currently affected by infestations of species included in the IUCN catalogue and the DAISIE system should be handled in a urgent manner;
Amendment 7 #
2011/2297(INI)
Motion for a resolution
Citation 9 bis (new)
Citation 9 bis (new)
- having regard to the Communication from the Commission of 18 July 2007 on ‘Addressing the challenge of water scarcity and droughts in the European Union’ (COM(2007)0414),
Amendment 55 #
2011/2297(INI)
Motion for a resolution
Paragraph 6 quinquies (new)
Paragraph 6 quinquies (new)
6d. Recalls that about 20 % of water in the EU is lost due to inefficiency. Therefore, improving efficiency in the use of water resources is key to sustainable water management and, in particular, to dealing with the problems of water scarcity and drought;
Amendment 63 #
2011/2297(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for EU water legislation to be updated to properly take into account technological advances for the reuse and recycling of water, to allow a cost- and energy-efficient reuse of treated wastewater for irrigation, as well as the reuse of greywater in households; calls for measures for proper monitoring of the chemical and biological quality of reclaimed water; requests the Commission consider formulas to create incentives for more widespread use of treated wastewater, greywater and rainwater, in order to help to mitigate water stress;
Amendment 66 #
2011/2297(INI)
Motion for a resolution
Paragraph 9 bis (new)
Paragraph 9 bis (new)
9a. Calls attention to the fact that in some parts of Europe losses caused by water leakage can reach in excess of 40 % of the total supply, so there is great potential for water savings in this area;
Amendment 81 #
2011/2297(INI)
Motion for a resolution
Paragraph 12 quater (new)
Paragraph 12 quater (new)
12c. Recalls that the preferred approach to water resources management should focus on demand and considers that an effective ranking of water use should be promoted. Stresses the importance of ensuring ecological flows in water basins to allow bodies of water to have a good ecological status;
Amendment 88 #
2011/2297(INI)
Motion for a resolution
Paragraph 14 ter (new)
Paragraph 14 ter (new)
14b. Points to the great potential that a water policy based on innovation and knowledge has for ‘green’ job creation. Asks the Commission to evaluate and quantify the impact on employment of its actions to promote the growth of R&D in the area of water;
Amendment 101 #
2011/2297(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to ensure the application of the ‘polluter pays’ and ‘user pays’ principles by means of transparent pricing schemes that aim at full cost recovery; underlines, however, that social issues should be taken into account when setting water tariffs for personal use; stresses that water pricing should reflect the environmental impact of wastewater treatment and. Notes that, although political will exists, the economic crisis and restrictions on public spending make it difficult for local and regional authorities to finance greywater treatment projects and, therefore, calls on the Commission to ensure appropriate financing of wastewater treatment plants;
Amendment 69 #
2011/2193(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Donations of non-family allogeneic UCB — regardless of whether the bank is public or private — should be further developed, so that stored units of UCB are registered in the BMDW and available to any compatible patient who needs them;
Amendment 95 #
2011/2193(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 96 #
2011/2193(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Member States will consider increasing the number of donors of bone marrow and peripheral blood stem cells, improving their registries of bone marrow donors so that, with the collaboration of the national registries of the other countries, through the BMDW any patient in need of a stem cell transplant has the best chance of finding a compatible donor;
Amendment 52 #
2011/2175(INI)
Draft opinion
Paragraph 3a (new)
Paragraph 3a (new)
3a. Stresses the need to introduce separate collection systems for organic waste, so that this type of waste can be recycled and turned to good use whenever possible.
Amendment 55 #
2011/2175(INI)
Draft opinion
Paragraph 4
Paragraph 4
Amendment 69 #
2011/2175(INI)
Draft opinion
Paragraph 4a (new)
Paragraph 4a (new)
4a. Recognises the importance of regulating product labelling and packaging practices to ensure an efficient food chain; believes, in this respect, that the correct labelling of ‘best-before’ and ‘sell-by’ dates for foodstuffs would greatly help prevent food waste;
Amendment 73 #
2011/2175(INI)
Draft opinion
Paragraph 4b (new)
Paragraph 4b (new)
4b. Calls on the Commission to look into the possibility, in the light of new demographic and social trends that are altering consumption patterns (people living alone, single-parent families, etc.), of bringing forward a legislative proposal on individual and single-portion containers that make it easier for consumers to purchase the right amount of a product; such individual containers should be recyclable or reusable and meet EU environmental standards and recommendations on sustainability, so that they do not result in additional waste.
Amendment 75 #
2011/2175(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Refers to its resolution of 6 July 2010 on the Commission’s Green Paper on the management of bio-waste in the European Union, particularly paragraphs 1 to 4 thereof, in which the European Parliament again urged the Commission to come forward as a matter of urgency with a specific legislative proposal for the treatment of bio-waste, of which food waste is only a part;
Amendment 7 #
2011/2068(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the consequences ensuing from a dearth of resources, for example rising prices, are particularly hard to bear for people with less income and in less favoured regions; and whereas, therefore, there is a greater need than ever for synergy between social and environmental policies;
Amendment 9 #
2011/2068(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the over-use of natural resources leads to environmental degradation and destruction of the earth’s natural capital and also affects human health and well-being;
Amendment 22 #
2011/2068(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the Eurobarometer of March 2011 shows that resource efficiency and sustainable production and consumption are key concerns of EU citizens; whereas it will not be possible in any event to progress towards sustainability unless citizens become directly involved as a result of a change of attitude and a change in society’s habits where resource use is concerned;
Amendment 60 #
2011/2068(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Urges the CommissionExpresses its disquiet at the budget cuts which many Member States, ostensibly on account of the crisis, are making in RDI policies and urges the Commission and the Member States to boost research and technological innovation to speed up the transition to a green economy; underlines that the ‘Innovation Union’ is one of the engines for a resource-efficient Europe;
Amendment 76 #
2011/2068(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Draws attention to the proposal by the Committee of the Regions on the possibility of adopting a ‘basket’ of four resource use indicators, namely land footprint, use of raw materials (biodiversity and biological and mineral resources), water footprint, and greenhouse-gas footprint);
Amendment 99 #
2011/2068(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. CMaintains that no action intended to achieve greater resource efficiency can remain confined to the public sector and therefore calls on the Commission, Member States and businesses to base their economic strategies on radically improved resource efficiency leading to a decoupling of economic growth from resource consumption; believes also that there is a need to focus on both the efficiency and effectiveness of resource use;
Amendment 170 #
2011/2068(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Highlights the importance of research, development and innovation for speeding up the transformation to a resource- efficient Europe; notes that greater innovation is particularly needed in environmentally friendly material extraction, water management, chemistry, recycling, re-use potential, and the substitution of environmental impacting material, technologies and design for less material and energy use;
Amendment 196 #
2011/2068(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Urges the Commission and Member States to present concrete plans, within not more than five years, for phasing out all environmentally harmful subsidies before 2020, so as to ensure that, by 2020, projects failing to comply with sustainability will be denied public funding;
Amendment 213 #
2011/2068(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Accordingly welcomes the fact that special measures have been drawn up to control invasive species and calls for them to be implemented without delay, bearing in mind the harmful effects that such species have on natural resources (soil, forests, groundwater, etc.);
Amendment 236 #
2011/2068(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Points to the need to give a Community character to soil protection measures and therefore calls once again for an end to the deadlock regarding the adoption of the soil framework directive;
Amendment 99 #
2011/2023(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
Amendment 75 #
2011/0428(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) The nature of LIFE projects, including those supporting integrated approaches, as a new type of projects focusing on implementation of Union environmental and climate legislation and policy, require action all over the Union and for all sectors targeted. This calls for the introduction of a distributional element in the selection process to facilitate geographical balance.
Amendment 81 #
2011/0428(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) With a view to simplifying the LIFE Programme and reducing administrative burden for applicants and beneficiaries, more use should be made of flat rates and lump-sums, and funding should focus on more specific categories of costs. By way of compensation for ineligible costs and i without compromising the eligibility of VAT and permanent staff costs as established by the Financial Regulation. In order to maintain the effective level of support provided by the LIFE Programme, the co-funding rates should be 7065% as a general rule and 75% - 80% in specific cases.
Amendment 93 #
2011/0428(COD)
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 2
Article 3 – paragraph 2 – subparagraph 2
The Commission shall be empowered to adopt delegated acts in accordance with Article 30 concerfurther defining the performance indicators in view of their application to the thematic priorities as defined in the multiannual work programmes referred to in Article 24.
Amendment 104 #
2011/0428(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. At least 85% of the budgetary resources for the LIFE Programme shall be allocated to projects supported by way of action grants.
Amendment 118 #
2011/0428(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. In accordance with their respective responsibilities, the Commission and the Member States shall ensurin an active and concerted effort endeavour to promote coordination between the LIFE Programme and the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development, and the European Maritime and Fisheries Fund, in order to create synergies, particularly in the context of Integrated Projects referred to in Article 18 point (d), and to support the use of solutions, methods and approaches developed under the LIFE Programme. At Union level, coordination shall take place within the Common Strategic Framework referred to in Article 10 of Regulation (EU) No….... (CSF Regulation).
Amendment 150 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 1
Article 19 – paragraph 3 – subparagraph 1
Integrated Projects referred to in Article 18 point (d) shall involve, where appropriate, stakeholders and promote, when possible, the coordination with and mobilisation of other Union funding sources. From the amount dedicated to action grants, no more than 20% shall be allocated to Integrated Projects.
Amendment 154 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 2
Article 19 – paragraph 3 – subparagraph 2
Amendment 160 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 a (new)
Article 19 – paragraph 3 a (new)
3a. The Commission shall ensure geographical balance in the award process for all projects according to the criteria set out in Annex I to facilitate the distribution of projects referred to in Article 18 among all Member States.
Amendment 161 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 b (new)
Article 19 – paragraph 3 b (new)
Amendment 162 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 c (new)
Article 19 – paragraph 3 c (new)
3c. In line with the principles of solidarity and effort sharing, the Commission shall ensure a proportional distribution of projects under the sub-programme for Climate Action among all Member States by allocating funds to them for the entire programme period for all projects in accordance with the following criteria of population: (i) The total population of each Member State as a proportion of the total EU population (50% weighting). (ii) Reverse GDP per capita to reflect solidarity with less prosperous Member States (50% weighting).
Amendment 163 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 d (new)
Article 19 – paragraph 3 d (new)
3d. If the total amount of funds used by a Member State is less than the allocation for that Member State, the Commission shall use the remaining funds to co- finance the projects submitted by other Member States that make the greatest contribution to the achievement of the objectives set out in Article 3.
Amendment 164 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 3 e (new)
Article 19 – paragraph 3 e (new)
3e. When proposing the list of projects to be co-financed to the Committee referred to in Article 29, the Commission shall provide it with a written explanation of how the allocation criteria in paragraphs 3c or 3d were taken into account.
Amendment 172 #
2011/0428(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The maximum co-financing rate for the projects referred to in Article 18 shall be 765% - 80% of eligible costs. By way of exception,: - the maximum co-financing rate for projects referred to in Article 18 points (d) and (f) shall be 80% of eligible costs: - the maximum co-financing rate for LIFE Nature and Biodiversity may be up to 75% of eligible costs for projects concerning priority habitats and species, in accordance with the Directive 92/43/EEC, or the species of birds considered as a priority for funding by the committee set up pursuant Article 16 of Directive 79/409/EEC when this is necessary to achieve the conservation objective.
Amendment 201 #
2011/0428(COD)
Proposal for a regulation
Article 24 – paragraph 2 – point b
Article 24 – paragraph 2 – point b
Amendment 204 #
2011/0428(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. The Commission shall revise, where appropriate, the multiannual work programmesEach multiannual work programme shall have a duration of at least three years and be renewable, provided that the thematic priorities laid down in that multiannual work programme remain valid. The Commission shall review the multiannual work programme at the latest by the mid-term review of the LIFE Programme. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Amendment 212 #
2011/0428(COD)
Proposal for a regulation
Annex (new)
Annex (new)
Amendment 34 #
2011/0409(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) The Sixth Environment Action Programme set out the framework for environmental policy-making in the EU for the period 2002-2012. The programme called for actions in the field of noise pollution to "substantially reduce the number of people regularly affected by long-term average levels of noise, particularly from traffic".
Amendment 36 #
2011/0409(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to reduce road traffic noise, public authorities may put in place measures and incentives to accelerate the purchase and use of quieter vehicles.
Amendment 37 #
2011/0409(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) The Commission should examine the appropriateness of including vehicle noise information in the context of any review or revision of Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars1. _______________ 1 OJ L 12, 18.1.2000, p. 16.
Amendment 38 #
2011/0409(COD)
Proposal for a regulation
Recital 9 c (new)
Recital 9 c (new)
(9c) The vehicle categories M1, M2, M3, N1, N2, and N3 should be subject to visual inspections in relation to all relevant noise suppressing elements including engine encapsulation and exhaust and intake silencers.
Amendment 39 #
2011/0409(COD)
Proposal for a regulation
Recital 9 d (new)
Recital 9 d (new)
Amendment 43 #
2011/0409(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) The Commission should examine the potential of active safety systems in more silent vehicles such as hybrid and electric vehicles to better serve the objective of improving the safety of vulnerable road users in urban areas, such as blind, visually and auditorily challenged pedestrians, cyclists and children.
Amendment 51 #
2011/0409(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 a (new)
Article 3 – paragraph 1 – point 21 a (new)
(21a) 'point of sale' means a location where vehicles are offered for sale to consumers.
Amendment 52 #
2011/0409(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 b (new)
Article 3 – paragraph 1 – point 21 b (new)
(21b) 'technical promotional material' means technical manuals, brochures and catalogues (whether these appear in printed, electronic or online form), as well as websites, the purpose of which is to market vehicles to customers.
Amendment 56 #
2011/0409(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Amendment 64 #
2011/0409(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article 6a Reductions The sound level of vehicle categories M1, M2, M3, N1, N2, N3 as defined in Annex II to Directive 2007/46/EC, measured in accordance with the provisions of Annex II shall be reduced by 6 dB within 10 years after entry into force. The reductions shall take into account changes to the test method and vehicle categories in a way that ensures the reduction in the limit is relative to the stringency of the existing regulations.
Amendment 69 #
2011/0409(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Within threfive years following the date referred to in Annex III, third column, phase 1, topublication of this Regulation, the Commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate. On the basis of the conclusions of the study, the Commission may, where appropriate, present proposals for amendment to this Regulation.
Amendment 73 #
2011/0409(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The sound emission of the vehicle under typical on-road driving conditions, which are different from those under which the type-approval test set out in Annex II was carried out, shall not deviate from the test result in an unreasonable manner.
Amendment 76 #
2011/0409(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. TNeither the vehicle manufacturer shall not intention, vehicle owner nor vehicle user shally alter, adjust, or introduce any mechanical, electrical, thermal, or other device or procedure solely for the purpose of fulfilling the noise emission requirements under this Regulation which is not operational during typical onon-road and off-road operation under conditions applicable to ASEP.
Amendment 79 #
2011/0409(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. In the application for type-approval, the manufacturer shall provide a statement, supported by the outcome of appropriate test results established in accordance with the model set out in Appendix 1 of Annex VIII, that the vehicle type to be approved complies with the requirements of Article 8(1) and 8(2).
Amendment 80 #
2011/0409(COD)
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8a Information Vehicle manufacturers and distributors shall ensure that the noise level in decibels (dB(A))in accordance with harmonised type-approval testing methods for each vehicle is displayed in a prominent position at the point of sale and in technical promotional material.
Amendment 91 #
2011/0409(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13a Review The Commission shall assess the need to review this Regulation, taking into account, inter alia, whether active safety systems can better serve the objective of improving the safety of vulnerable road users in urban areas, in addition to, or as compared to acoustic vehicle alerting systems.
Amendment 94 #
2011/0409(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Approval authorities shall continue to grant extension of approvals to those vehicles, systems, components or separate technical units under the terms of Directive 70/157/EEC2007/34/EC for a limit of five years after the date of publication of this Regulation.
Amendment 96 #
2011/0409(COD)
Proposal for a regulation
Annex I Appendix 2 a (new)
Annex I Appendix 2 a (new)
Appendix 2a Type approval values from vehicle and test data: 1.Elements of capsulation 1.1 Elements of noise encapsulation as defined by the vehicle manufacturer 2. Noise level of moving vehicle: Test result (Lurban): dB(A) Test result (Lwot): dB(A) Test result (Lcruise): dB(A) kP – factor: 3. Noise level of stationary vehicle: Position and orientation of microphone (according to figure 2 in Appendix 1 of Annex II) Test result for stationary test: dB(A)
Amendment 97 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 2.2.
Annex II – point 2.2.
Compliance of the acoustic measurement instrumentation shall be verified by the existence of a valid certificate of compliance. Those certificates shall be deemed to be valid if certification of compliance with the standards was conducted within the previous 12-month period for the sound calibration device and within the previous 24 month period for the instrumentation system. All compliance testing must be conducted by a laboratory, which is authorized to perform calibrations traceable to the appropriate standards.
Amendment 98 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.1. – paragraph 4
Annex II – point 3.1. – paragraph 4
The meteorological instrumentation should be positioned adjacent to the test area at a height of 1.2 m ± 0.02 m. The measurements shall be made when the ambient air temperature is between +5 °C and +4025 °C.
Amendment 99 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.1. – paragraph 7
Annex II – point 3.1. – paragraph 7
Amendment 101 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.1. – paragraph 9
Annex II – point 3.1. – paragraph 9
The background noise (including any wind noise) shall be at least 10 5dB below the A- weighted noise pressure level produced by the vehicle under test. If the difference between the ambient noise and the measured noise is between 10 and 15 dB(A), the appropriate correction must be subtracted from the readings on the noise-level meter in order to calculate the test results, as in the following table: 1/ In conformity with Annex VII to this Regulation.
Amendment 102 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.1. – table
Annex II – point 3.1. – table
Amendment 105 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.2.1. – table – row 4 'Vehicle category N2, N3 – paragraph 1
Annex II – point 3.2.1. – table – row 4 'Vehicle category N2, N3 – paragraph 1
Extra loading to reach the test mass of the vehicle shall be placed above the driven rear axle(s). The extra loading is limited to 75 per cent of the maximum mass allowed for the rear axle. The test mass must be achieved with a tolerance of ± 5 per cent.
Amendment 111 #
2011/0409(COD)
Proposal for a regulation
Annex II – point – 3.2.4.
Annex II – point – 3.2.4.
3.2.4. If the vehicle is fitted with more than two-wheel drive, it shallould be tested in thewith the maximum number of driven which is intended for normal useeels.
Amendment 113 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 3.2.6 a (new)
Annex II – point 3.2.6 a (new)
3.2.6a. Testing shall be representative of real world noise emissions, by correcting limit values for trucks by -1 dB(A) to account for ultra-quiet tyres used in the test but never used on the road.
Amendment 114 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 4.1.2.1. – paragraph 1
Annex II – point 4.1.2.1. – paragraph 1
The path of the centreline of the vehicle shall follow line CC' as closely as possible throughout the entire test, from the approach to line AA' until the rear of the vehicle passes line BB'. If the vehicle is fitted with more than two-wheel drive, test it in the drive selection which is intended for normal road useit should be tested with the maximum number of driven wheels.
Amendment 116 #
2011/0409(COD)
Proposal for a regulation
Annex II – point 4.1.2.2. – paragraph 1
Annex II – point 4.1.2.2. – paragraph 1
The path of the centreline of the vehicle shall follow line CC' as closely as possible throughout the entire test, from the approach to line AA' until the rear of the vehicle passes line BB'. The test shall be conducted without a trailer or semi-trailer. The test shall be conducted without a trailer or semi-trailer. If a trailer is not readily separable from the towing vehicle, the trailer shall not be taken into consideration when assessing the crossing of line BB'. If the vehicle incorporates equipment such as a concrete mixer, a compressor, etc, this equipment shall not be in operation during the test. The test mass of the vehicle shall be according to the table set out in point 3.2.1.
Amendment 131 #
2011/0409(COD)
Proposal for a regulation
Annex III – point 1 – below table (new)
Annex III – point 1 – below table (new)
And shall not exceed 90 dB(A) in any driving conditions, below a maximum speed of130 km/h, in accordance with Anne VIII.
Amendment 137 #
2011/0409(COD)
Proposal for a regulation
Annex VII – point 4.3.
Annex VII – point 4.3.
4.3. For the purpose of this standard, texture depth measurements shall be made on at least 10 positions evenly spaced along the wheel tracks of the test strip and the average value taken to compare with the specified minimum texture depth. See ISO 10844:19942011 for the description of the procedure.
Amendment 90 #
2011/0339(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
The general objectives of the Health for Growth Programme shall be to work with the Member States to encourage innovation in healthcare, comparability of health data and indicators and increase the sustainability of health systems, to improve the health of the EU citizens and protect them from cross-border health threats.
Amendment 114 #
2011/0339(COD)
Proposal for a regulation
Article 3 – point 4 a (new)
Article 3 – point 4 a (new)
(4a) To contribute to evidence-based decision making by fostering health information, collecting and analysing harmonized health data and disseminating key health indicators.
Amendment 84 #
2011/0309(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation shall apply without prejudice to Directives 85/337/EC, 2008/1/EC, 2003/4/EC and Directive 20031/42/EC.
Amendment 107 #
2011/0309(COD)
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3a. Authorization for exploring operations shall be subject to environmental impact assessment, as provided for under Directive 2001/42/EC, based on the findings of previous seismic, geophysical and geochemical surveys.
Amendment 110 #
2011/0309(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Licensing authorities pursuant to Directive 94/22/EC shall, when assessing the technical and financial capacity of the entities that apply for authorisation for offshore oil and gas activities, take into account the risks, hazards and any other relevant information related to the location concerned and the particular stage of exploration and production operations. Specifically, account will be taken of any risks and possible effects on vulnerable resources in the Natura 2000 network and of fishing and tourism activities and the abstraction of seawater for desalination and public supply purposes.
Amendment 649 #
2011/0294(COD)
Proposal for a regulation
Article 47 – paragraph 1 – indent 1 a (new)
Article 47 – paragraph 1 – indent 1 a (new)
- major airports with more than 1% passenger air traffic within the EU.
Amendment 878 #
2011/0294(COD)
add the following multimodal platforms to the comprehensive network: – Pontevedra – Zalia – Torrelavega – Júndiz – Monzón – El Vallés – El Prat – El Gorguel – Ciudad Real – Albacete – San Roque – Mérida – Ponferrada/El Bierzo – Castellón – Alicante – Benavente – Zamora – Miranda de Ebro – Burgos – Palencia – Área Central – Aranda de Duero – Soria – Arévalo – Ávila – Segovia
Amendment 887 #
2011/0294(COD)
Proposal for a regulation
Annex I – Volume 17/33
Annex I – Volume 17/33
add the following airports to the core network: – Alicante – Gran Canaria – Málaga – Tenerife South (‘Tenerife Sur’) – Tenerife North (‘Tenerife Norte’) – Santiago de Compostela
Amendment 892 #
2011/0294(COD)
Proposal for a regulation
Annex I – Volume 17/33
Annex I – Volume 17/33
add the following rail passenger transport sections to the comprehensive network: – Almendricos – Águilas – Barcelona – Massanet – Barcelona – Puigcerdá – Játiva – Alcoy – Lleida – Manresa – Barcelona – Los Rosales – Zafra – Madrid – Burgos – Villalba – Segovia
Amendment 894 #
2011/0294(COD)
add the following high-quality road sections to the comprehensive network: – Valladolid – Aranda de Duero – Soria – Ourense – Santiago – Ourense – Guntín – Ponferrada – Ourense – Monforte – Chantada – Astorga – León – Burgos – Burgos – Logroño – Pamplona – Ávila – Salamanca – León – Valladolid – Segovia – Valladolid – Ávila – Maqueda – Toledo – Ocaña – Tarancón – Cuenca – Teruel – Alfajarín – Fraga -Catalayud – Daroca – Alcolea del Pinar – Monreal del Campo – Badajoz – Zafra – Córdoba – Baena – Granada – Huelva – Jabugo – Zafra – Estepa – Lucena – Baena – Jaén – Úbeda – Blanca – Avarán – La Font de la Figuera – Alicante – Alcoy – Játiva – Elche – Cartagena – Vera – Figueras – Puigcerdá – Ávila – Villacastín – San Rafael – Segovia
Amendment 23 #
2011/0231(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sugar content indicated in the first subparagraph is expressed as inverttotal sugar.
Amendment 25 #
2011/0231(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Other voluntary food information may also be included in the labelling of aromatised wine products, provided this is in accordance with Chapter V of Regulation (EU) No 1169/2011 the European Parliament and of the Council, of 25 October 2011, on the provision of food information to consumers1. _______________ 1 OJ L 304, 22.11.2011, p. 18.
Amendment 41 #
2011/0231(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) a description of the product, in particular its principal analytical characteristics as well as an evaluation or indication of its organoleptic characteristics;.
Amendment 42 #
2011/0231(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. Member States shall adopt the laws, regulations or administrative provisions necessary to comply with this Article by 1st December 20123.
Amendment 43 #
2011/0231(COD)
Proposal for a regulation
Article 15 – paragraph 3 – subparagraph 1
Article 15 – paragraph 3 – subparagraph 1
Where the Commission considers that the conditions laid down in this Chapter are met, it shall, by means of implementing acts without the assistance of the Committee referred to in Article 36, decide to publish in the Official Journal of the European Union the single document referred to in Article 11(1)(d) and the reference to the publication of the product specification referred to in Article 14(5).
Amendment 44 #
2011/0231(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
Within twohree months from the date of publication provided for in the first subparagraph of Article 15(3), any Member State or third country, or any natural or legal person having a legitimate interest, resident or established in a Member State other than that applying for the protection or in a third country, may object to the proposed protection by lodging a duly substantiated statement relating to the conditions of eligibility as laid down in this Chapter with the Commission.
Amendment 48 #
2011/0231(COD)
Proposal for a regulation
Article 27 – title
Article 27 – title
Existing protected geographical designindications
Amendment 49 #
2011/0231(COD)
Proposal for a regulation
Article 27 – paragraph 3
Article 27 – paragraph 3
3. Existing geographical designations referred to in paragraph 1, for which the information referred to in paragraph 2 is not submitted by [2 years after entry into force], shall lose protection under this Regulation. The Commission shall, by means of implementing acts without the assistance of the Committee referred to in Article 36, take the corresponding formal step of removing such names from the register provided for in Article 22.
Amendment 50 #
2011/0231(COD)
Proposal for a regulation
Article 27 – paragraph 4 – subparagraph 1
Article 27 – paragraph 4 – subparagraph 1
Amendment 53 #
2011/0231(COD)
Proposal for a regulation
Article 31 – title
Article 31 – title
Implementing acts to be adopted without the assistance of the Committee referred to in Article 36nadmissibility of an application or request
Amendment 54 #
2011/0231(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
Where an application or a request submitted under this Chapter is deemed inadmissible, the Commission shall, by means of implementing acts without the assistance of the Committee referred to in Article 36, decide to reject it as inadmissible.
Amendment 57 #
2011/0231(COD)
Proposal for a regulation
Annex II – part B – paragraph 3 – subparagraph 2
Annex II – part B – paragraph 3 – subparagraph 2
The descriptionword ‘Sangria’ must be accompanied by the words ‘produced in …’ followed by the name of the Member State of production or of a more restricted region except where the product is producay replace the sales denomination ‘aromatised wine-based drink’ only where the drink is manufactured in Spain or Portugal.
Amendment 59 #
2011/0231(COD)
Proposal for a regulation
Annex II – part B – paragraph 3 – subparagraph 3
Annex II – part B – paragraph 3 – subparagraph 3
Amendment 61 #
2011/0231(COD)
Proposal for a regulation
Annex II – part B – paragraph 4 – subparagraph 2
Annex II – part B – paragraph 4 – subparagraph 2
The description «word ‘Clarea»’ must be accompanied by the words «produced in …» followed by the name of the Member State of production or of a more restricted region except where the product is producay replace the sales denomination ‘aromatised wine-based drink’ only where the drink is manufactured in Spain.
Amendment 63 #
2011/0231(COD)
Proposal for a regulation
Annex II – part B – paragraph 4 – subparagraph 3
Annex II – part B – paragraph 4 – subparagraph 3
Amendment 18 #
2011/0229(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The use of electronic identification systems would potentially streamline traceability processes through automated and more accurate reading and recording into the holding register. It would enable also automated reporting of animal movements into the computerised data base and thus improve speed, reliability and accuracy of the system, even though, following the publication of Council Regulation (EC) No 21/2004 in 2003, there is still no automated reporting of movements in the case of ovine and caprine animals.
Amendment 20 #
2011/0229(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Electronic identification systems based on radio frequency identification have considerably improved in the last ten years, even though ISO standards still need to be applied, and they need to be tested for bovines. That technology allows a faster and more accurate reading of individual animal identity codes directly into data processing systems resulting on a reduction of time needed to trace potential infected animals or infected food, saving labour costs but at the same time increasing equipment costs.
Amendment 24 #
2011/0229(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) A Report from the Commission to the Council and the European Parliament on the possibility of introduction of electronic identification for bovine animals concludes that it has been demonstrated that radio frequency identification has been developed to the extent that it can be applied in practice. The report also concludes that it is highly desirable to switch to electronic identification of bovine animals within the Union since among other benefits, it will contribute to reduce the administrative burden, in spite of the extremely high costs involved.
Amendment 25 #
2011/0229(COD)
Proposal for a regulation
Recital 14
Recital 14
Amendment 37 #
2011/0229(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Animals and meat entering the Union from third countries should be subject to the same identification and traceability requirements that apply to animals born in the Union.
Amendment 47 #
2011/0229(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Section II of Title II of Regulation (EC) No 1760/2000 lays down rules for a voluntary beef labelling system which provide for the approval of certain labelling specifications by the competent authority of the Member State. The administrative burden and the costs incurIn view of developments in the beef sector since the above Regulation was adopted, the voluntary beef labelling system needs to be revised. That Section should therefored by Member States and economic operators in applying this system are not proportionate to thee deleted. Without prejudice to the above, in order to ensure the suitable regulation of the voluntary beef labelling system in line with the remaining sectors, this deletion should not come into force until Section II has beenefits of the system. That Section should therefore be deleted replaced by developing the provisions of Union legislation on marketing standards for animal products, or any other rules having equivalent effect.
Amendment 68 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 4
Article 1 – point 4
Regulation (EC) No 1760/2000
Article 4c – paragraph 2 – point a
Article 4c – paragraph 2 – point a
Amendment 95 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 1760/2000
Articles 16 - 18
Articles 16 - 18
(14) Articles 16, 17 and 18 are deleted. Without prejudice to the provisions of Article 1a, the Commission shall ensure that the provisions contained in the deleted articles are reflected in Community rules relating to beef, updated and improved as necessary.
Amendment 104 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 19 a (new)
Article 1 – point 19 a (new)
Regulation (EC) No 1760/2000
Article 23 a
Article 23 a
(19a) The following article is inserted: Article 23a Report No later than five years after the entry into force of this Regulation, the Commission shall submit a report to Parliament and the Council.
Amendment 105 #
2011/0229(COD)
Proposal for a regulation
Article 1 a (new)
Article 1 a (new)
Article 1a Transitional provisions Article 1(14) shall enter into force on 1 January 2014.
Amendment 60 #
2011/0190(COD)
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) Islands and sparsely populated areas are exposed to particular challenges such as poor accessibility. Taking into account that territorial cohesion is an objective of the Union, a special derogation with regard to passenger ships is needed for Spain, for the Canary Islands, France, for the French Overseas Departments, Greece, for the whole or part of its territory, and Portugal, for the archipelagos of Madeira and Azores.
Amendment 152 #
2011/0190(COD)
Proposal for a directive
Article 1 – point 6 – point e
Article 1 – point 6 – point e
Directive 1999/32/EC
Article 4 a – paragraph 4 a (new)
Article 4 a – paragraph 4 a (new)
4a. By way of derogation from paragraph 4, for Spain, for the Canary Islands, France, for the French Overseas Departments, Greece, for the whole or part of its territory, and Portugal, for the archipelagos of Madeira and Azores, the sulphur content of these fuels by mass shall not exceed: - 0,10 as from 1 January 2025
Amendment 30 #
2010/2249(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Expresses its concern about the contamination of food and feed, e. g. with dioxin, and calls on the Member States to enforce and apply existing regulations on food and feed controls very strictly and if needed, to strengthen those rules;
Amendment 33 #
2010/2249(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
Amendment 35 #
2010/2106(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, when fires affect Natura 2000 sites, the subsequent regeneration does not always succeed in restoring habitats and species satisfactorily, which hinders considerably achievement of the network’s original goals,
Amendment 86 #
2010/2106(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas, on average , 500.000 ha of forests are burned every year in the EU, often at great cost to human life, property, biodiversity and the protective functions of forests,
Amendment 99 #
2010/2106(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises, however, that pursuant to Article 5 of the Lisbon Treaty, the EU may act in areas where demonstrably the objectives of the proposed action cannot be sufficiently achieved by the Member States.
Amendment 114 #
2010/2106(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Congratulates the Commission on the exhaustive analysis of biotic and abiotic threats in its Green Paper, and draws attention to the need to examine, in addition, other factors directly linked to the impact of climate change on forests, such as defoliation, recalling that the defoliated treetop surface in southern European forests has doubled in the last twenty years, resulting, in terms of direct consequences, in reduced capacity and efficiency in the carbon-fixing processes and in the reduction of forests' tempering effect in periods of drought or heatwaves thanks to trees' premature loss of leaves;
Amendment 115 #
2010/2106(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Welcomes the recognition, in the Green Paper and by the Council itself, that the threats to the European forest heritage are clearly crossborder in nature, and that it is therefore essential to develop all reasonable means of preventing or reducing hostile phenomena such as fires or diseases, which do not stop at Member States' borders;
Amendment 135 #
2010/2106(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers that the northern boreal forests (taiga) and the Mediterranean forests are of immense value for European biodiversity and as sinks of atmospheric carbon and should benefit from enhanced protection;
Amendment 140 #
2010/2106(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Regrets the current obstacles to sustainable forest management arising from the absence of a common definition of forests at EU level or a Community classification of types of protective forest;
Amendment 145 #
2010/2106(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that SFM reconciles production and protection aspects of forests, ensuring the continuity of their economic, social and environmental functions according to national and regional priorities; stresses, in this connection, that any future policy for forests or Community forest protection programme must also regulate the various aspects of forestry and wood production in a form that is sustainable and complies with the EU environmental legislation;
Amendment 204 #
2010/2106(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the Commission as a matter of urgency to present a legislative proposal for Forest Fire Prevention incorporating funding for the European Forest Fires Information System (EFFIS), infrastructure, training and prevention planning; forestation and forest recovery after fires;
Amendment 217 #
2010/2106(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Urges the Commission to present a legislative proposal for Forest Information taking into account climate threats and the need for a standard system of harmonised and comparable data in the context of the UNFCCC, CBD, and environmental accounts;
Amendment 224 #
2010/2106(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Urges the Commission, for the purposes of all its future legislative proposals on forests, to take over the EEA classification of forest types and use it as the standard frame of reference at European level;
Amendment 240 #
2010/2106(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Points out that the new challenges entailed in climate change make it plain that forest protection requires greater funding and new forms of assistance beyond those covered by the rural development pillar of the CAP;
Amendment 241 #
2010/2106(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Welcomes the fact that the latest Commission communication on CAP reform recognises the important role that farmers play as indispensable actors of forest fire prevention, stewards of forest ecosystems who protect them from threats to biodiversity – such as pests – and, above all, territorial mainstays, since the continuation of their livelihood is the most effective way to avert depopulation;
Amendment 248 #
2010/2106(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Draws attention, as the Council did in its June 2010 conclusions, to the fact that serious problems can arise from forest abandonment in so far as it may no longer be possible to ensure that forests continue to perform their functions;
Amendment 258 #
2010/2106(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Urges the Commission and Member States to control forguarantee the long-term horizons of forestry and forest protection projects in all EU financing;
Amendment 261 #
2010/2106(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
Amendment 262 #
2010/2106(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Considers that forest fire prevention through landscape planning and connectivity, infrastructure and training should be firmly anchored in the EU’s forest protection, adaptation and civil protection policies;
Amendment 281 #
2010/2106(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to develop legally binding sustainability criteria for woody biomass and ILUC factors for all forms of biomass for energy and for forest timber;
Amendment 107 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
17. ‘the public concerned’ means the public affected or likely to be affected, or having an in terms of safety, health or having a legitimate interest in the taking a decision on any of the matters covered by Article 14(1), including non-governmental organizations promoting environmental protection and meeting any applicable requirements under national law ;
Amendment 143 #
2010/0377(COD)
Proposal for a directive
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. The document defining the MAPP shall be sent to the competent authority within the following time-limits:
Amendment 145 #
2010/0377(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The operator shall periodically review and where necessary update the MAPP, at least every five years. The document defining the updated MAPP shall be sent to the competent authority without delay.
Amendment 162 #
2010/0377(COD)
Proposal for a directive
Article 9 – paragraph 6 – point a
Article 9 – paragraph 6 – point a
(a) communicate the conclusions of its examination of the safety report to the operator, if necessary after requesting further information,
Amendment 166 #
2010/0377(COD)
Proposal for a directive
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) the operator supplies the necessary information to the competent authorities, including the safety report as accepted by the competent authority, to enable the latter to draw up external emergency plans;
Amendment 63 #
2010/0254(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 2001/112/EC
Annex I – part II – point 2 – indent 6 a (new)
Annex I – part II – point 2 – indent 6 a (new)
Juice obtained from Citrus reticulata and/or Citrus reticulata hybrids may be added to orange juice in a proportion not exceeding 10% of soluble Citrus reticulata solids in relation to the total amount of soluble orange juice solids. Any such addition must be mentioned in the list of ingredients, as already stipulated by the legislation in force.
Amendment 89 #
2010/0032(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. The investigation shall, whenever possible, be concluded within six months of the initiationone hundred and eighty days of the invesitigation. In exceptional circumstances duly justified by the Commission, that time limit may be extended by a further period of three months of the investigation.
Amendment 5 #
2009/2153(INI)
Motion for a resolution
Recital Aa (new)
Recital Aa (new)
Aa. whereas the proper management of bio-waste brings not only environmental but also social and economic advantages,
Amendment 10 #
2009/2153(INI)
Motion for a resolution
Recital Ca (new)
Recital Ca (new)
Ca. whereas the conclusions of the conference on the recycling of bio-waste in Europe, held in Barcelona on 15 February 2010 with the participation of the Council, the Commission and the European Parliament, (*) stated that it is necessary to act in order to create a European legislative framework on bio- waste, since we are at a key moment for moving forward on regulating the matter, *Council of the EU - Note of the Secretariat, 9 March 2010
Amendment 23 #
2009/2153(INI)
Motion for a resolution
Recital H
Recital H
H. whereas bio-waste has a role to play in combating climate change and offers potential in combating soil degradation andif we are to move towards an environmentally effective management of bio-waste, the matter needs to be viewed from an integrated perspective in energy and soil protection policies, in line with climate change mitigation goals; whereas, in particular, bio-waste has a role to play in promoting the production of renewable energies,
Amendment 30 #
2009/2153(INI)
Motion for a resolution
Recital J
Recital J
J. whereas quality standards need to be defined for the treatment of bio-waste and the quality of compost; whereas regulating the quality parameters for compost, including an integrated approach ensuring traceability, quality and safe use, will make it possible to build consumer confidence in this product; whereas, in addition, compost should be graded in line with its quality,
Amendment 59 #
2009/2153(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Urges the Commission to adopt a quality-grading system for the various types of compost obtained through the treatment of bio-waste in the framework of a strategy based on an integrated approach ensuring, in addition to quality, product traceability and safe use;
Amendment 78 #
2009/2153(INI)
Motion for a resolution
Paragraph 7 – subparagraph 1 (new)
Paragraph 7 – subparagraph 1 (new)
7a. Urges the Commission to include in all current or additional impact studies on the matter the question of what type of economic incentives, funds or aids could be mobilised or created for the development and implantation of technologies enabling the proper management of bio-waste;
Amendment 10 #
2009/2152(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the three sectoral papers accompanying the White Paper (on agriculture, health and water) are welcome, but given the global dimension of climate change the Commission should submit papers on further sectors such as air quality, biodiversity, etc. by 2011,
Amendment 15 #
2009/2152(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the section headed 'External dimension and ongoing work under the UNFCCC' in the White Paper is an important one and the EU needs to speak with one voice in order to resume the leading role in the fight against climate change, helping to create a new 'climate diplomacy', as called for in the European Parliament resolution of 10 February 2010 on the outcome of the Copenhagen Conference,
Amendment 29 #
2009/2152(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. UTakes the view that vulnerability indicators should be drawn up as a matter of urgency, given the diverse range of climate scenarios within the Community, and underlines the need for further research into appropriate modelling at regional and local levels, as well as the need to define adaptive capacity across the territory of the EU;
Amendment 120 #
2009/2152(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Given that protected Community areas are especially vulnerable to climate change, calls for future mitigation and adaptation measures to also be strengthened for areas close to the protected area, protection belts, pre-parks, ecological corridors, etc.
Amendment 167 #
2009/2152(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Supports the proposal of the Commission to set up an impact and adaptation steering group; stresses that it is important for this group to involve regional and local actors in addition to state representatives; asks the Commission to ensure that this group includes representatives of Parliament as observers;
Amendment 6 #
2009/2151(INI)
Motion for a resolution
Recital D
Recital D
D. whereas a holistic and effective approach to disaster prevention should incorporate various levels of cooperation between local, regional and national authorities and should also involve other actors with links to and, therefore, a knowledge of the land;
Amendment 9 #
2009/2151(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas persistent drought and fires are also speeding up the process of desertification, especially in southern Europe, above all affecting Mediterranean forest areas and extensive woodlands comprising a single, non- native species which is highly vulnerable to fire, threatening the lives of citizens and the quality of life of the populations affected;
Amendment 22 #
2009/2151(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Takes note of the proposal to set up a network made up of representatives of the various competent national services of all the Member States; stresses that this network should operate within the scope of the cooperation between national, regional and local authorities with responsibilities in disaster management, spatial planning and risk mapping and management; emphasises the role of this network in exchanging experience and prevention measures; calls for consideration also to be given to hearing social organisations working in this area and other actors with links to and, therefore, a knowledge of the land;
Amendment 33 #
2009/2151(INI)
Motion for a resolution
Paragraph 6 - point d a (new)
Paragraph 6 - point d a (new)
d a) including and carrying out fire and flood prevention measures within the framework of their rural development plans, with special support for measures to encourage forest profitability, for example;
Amendment 45 #
2009/2151(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. RIn view of the interconnections between drought, forest fires and desertification, calls on the Commission to present a proposal for a directive, similar to the directive on floods, to promote the adoption of an EU policy on water scarcity, drought and adaptation to climate change; to this end, also reiterates the importance of setting up a European Drought Observatory which would be responsible for the study and the mitigation and monitoring of the effects of drought;
Amendment 52 #
2009/2151(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission to carry out,Since European forests are net CO2 sinks, the fact that they are threatened by fire is an issue of concern toge ther with the Member States, a specific initiative EU as a whole and to the objectives that the EU has set itself in combating climate change; therefore calls on the Commission to present an EU legislative proposal in the area of forest protection and fire prevention; considers that forestation and reforestation projects should be supported, with preference given to native species and mixed forests, to encourage biodiversity and greater resistance to fire, storms and disease;
Amendment 55 #
2009/2151(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Given that the starting of fires and the increase in their frequency are by nature environmental offences, calls on the Commission to study and propose to the Council and the European Parliament ways of implementing coercive measures which will discourage negligence and deliberate action in the starting of fires;
Amendment 65 #
2009/2151(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that the natural characteristics and constraints of sparsely populated regionsisolated regions, mountainous regions, regions with low population density and those suffering from depopulation, as well as outlying and outermost regions, need to be acknowledged and taken into due account;
Amendment 1 #
2009/2108(INI)
Motion for a resolution
Recital D(a) (new)
Recital D(a) (new)
D(a) whereas any production model which circumvents biodiversity conservation is unviable, and this makes it essential to integrate the principle of sustainability into any development template,
Amendment 16 #
2009/2108(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the loss of biodiversitybiological biodiversity is the irreplaceable pillar on which mankind has evolved and its loss and that of the natural heritage it brings with it creates disequilibrium and gives rise to substantial economic and welfare losses,
Amendment 20 #
2009/2108(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the disappearance of species may break the food chain that is key to the survival of other animal and plant species of vital importance for food production, adaptation to climatic conditions, resistance to external agents and the preservation of genetic values,
Amendment 66 #
2009/2108(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Stresses that the few remaining roadless areas in Europe should be an important focus of conservation efforts and that the design of new routes should strongly avoid dissecting them; calls also for roadless areas to be included in the Habitats Directive as new target or site category.
Amendment 81 #
2009/2108(INI)
Motion for a resolution
Paragraph 18 – point a (new)
Paragraph 18 – point a (new)
18a. Takes the view that since areas protected at Community level are a constituent part of the EU’s natural heritage, additional support is needed for those Member States which have greater Natura 2000 surface areas;
Amendment 82 #
2009/2108(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 96 #
2009/2108(INI)
Motion for a resolution
Paragraph 20 – point a (new)
Paragraph 20 – point a (new)
21a. Highlights the link between water management and biodiversity as a key factor in supporting life and in sustainable development;
Amendment 116 #
2009/2108(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Urges Member States to design their forestry policy in a way that takes fully into account the role of forests as a reserve for biodiversity, soil retention and formation, carbon sequestration and air purification characteristics and for purposes of recreation for our citizens;
Amendment 122 #
2009/2108(INI)
Motion for a resolution
Paragraph 24 – point a (new)
Paragraph 24 – point a (new)
24a. Calls on the Commission to consider the possibility of presenting a recommendation to the Member States containing guidelines and good practices for the management of areas adjoining Natura 2000 areas, with the aim of helping the competent authorities curb the adverse impacts of agriculture, tourism and housing, etc., which exert pressure on habitats and species in protected areas;
Amendment 125 #
2009/2108(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Regrets the failure to formulate a policy for soil protection, as foreseen in the 6th Environment Action Programme; calls on the Commission and the Council to take action for the prevention of soil degradation and the loss of soil biodiversity.
Amendment 142 #
2009/2108(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30 a. Calls therefore on the Commission to give biodiversity its own budget line for the 2014-2020 period.
Amendment 147 #
2009/2108(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Welcomes the increase in spending for LIFE+ (+ 8% in the 2011 draft budget), but underlines that this instrument continues to represent only a very small part of the EU budget (0.2%) and should be revised on a horizontal basis to factor in the new challenges the EU is addressing as regards climate change;
Amendment 125 #
2009/0076(COD)
Council position
Article 3 – paragraph 1 – point aa
Article 3 – paragraph 1 – point aa
(aa) ‘nanomaterial’ means nanomaterial as defined in Commission Recommendation 20../…/EC of … … … concerning the definition of nanomaterials; The Commission shall regularly review and update the definition in light of latest advances in technical and scientific development.
Amendment 155 #
2009/0076(COD)
Council position
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 65 and 66, information on potential candidates for substitution during a period of no more than 690 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion.
Amendment 310 #
2009/0076(COD)
Council position
Article 88 – paragraph 3 – subparagraph 2
Article 88 – paragraph 3 – subparagraph 2
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than approved existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States' competent authorities no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product-type.
Amendment 311 #
2009/0076(COD)
Council position
Article 88 – paragraph 3 – subparagraph 3 – point a
Article 88 – paragraph 3 – subparagraph 3 – point a
(a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
Amendment 351 #
2009/0076(COD)
Council position
Annex VI – Introduction – point 2
Annex VI – Introduction – point 2
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information. The guidance, for substances falling under Recommendation 20../.../EC of ... with regard to specific requirements under this Regulation relating to their nature as nanomaterials shall not apply where these substances contain: -less than 10 w-% of nano-objects as defined by ISO, or -have not been intentionally manufactured at the nanoscale in order to take advantage of their specific nano qualities.
Amendment 159 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 1 – point 17 a
Article 1 – point 17 a
17a. Tradhird party intermediation in the trading and brokering of medicinal products: All activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products, or billing or brokering medicinal products, apart from supplying medicinal products to the public, and not falling under the definition of whorelating to the buying and selling of medicines, except for the supply of medicinal products to the public and wholesale distribution, as defined in paragraph 17 of this Article, which do not include the physical handling of such products and take the form of independent negotiation on behalf of another natural or lesgale distribution person or of a body provided for in national law.
Amendment 176 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by. The Commission shall draw up a list of certain categories of excipients on the basis of risk criteria, taking into account their origin and intended use. Those acts, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the procedure referred to in Article 290 of the Treaty on the Functioning of the European Union. The manufacturer shall apply, for those competent authority of a Member Stateategories of excipient, the relevant good manufacturing practices on the basis of a risk analysis conducted in accordance with the Directives referred to in Article 47(2), taking into account other quality system requirements that may be applicable; they shall properly document this.
Amendment 202 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
‘(o) safety features making is possible to ascertain identification, and authenticity and traceability of medicinal products other than radiopharmaceuticals, subject tomake it possible to detect any tampering with the packaging of medicinal products other than radiopharmaceuticals which are at risk of being falsified or tampered with. . The decision to require these safety features for medicinal prescription as defined in Title VIoducts or categories thereof shall be based on a risk assessment carried out under the provisions of paragraph (4) of Article 54a’.
Amendment 215 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 1 - introductory part
Article 54a – paragraph 1 - introductory part
1. The safety features referred to in point (o) of Article 54 shall allow wholesale distributors or pharmacists orand persons authorised or entitled to supply medicinal products to the public to perform all of the following:
Amendment 216 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 1 – point a
Article 54a – paragraph 1 – point a
a) verify authenticity by assessing overt, covert or forensic devices;
Amendment 229 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceabilityinviolability of the external packaging of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
Amendment 245 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 3
Article 54a – paragraph 3
(3) Manufacturing authorisation holders engaged in the activities referred to in paragraph (2) of Article 54a shall be liable for damages in accordance with Council Directive 85/374/EEC caused by medicinal products which are falsified in terms of their identity. . .
Amendment 269 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point e a (new)
Article 54a – paragraph 4 – subparagraph 3 – point e a (new)
(ea) other potential public health hazards.
Amendment 271 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 4
Article 54a – paragraph 4 – subparagraph 4
Amendment 291 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 a (new)
Article 54a – paragraph 4 a (new)
4a. Five years from the entry into force of this Directive, the Commission shall present a report to the European Parliament and the Council concerning the implementation thereof. In this report the Commission shall assess the effectiveness of the provisions adopted further to Article 54 concerning measures to prevent falsified medicinal products entering the legal distribution chain.
Amendment 292 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 b (new)
Article 54a – paragraph 4 b (new)
4b. Any Member State may extend the scope of the safety features referred to in paragraph (o) of Article 54 to other medicinal products and to other relevant areas of national policy such as reimbursement.
Amendment 295 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 10
Article 1 – point 10
Directive 2001/83/EC
Article 57
Article 57
In Article 57, the fourth indent of the first paragraph is replaced by the following: ‘- without prejudice to point (o) of Article 54, identification and authenticity.’
Amendment 324 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point c
Article 1 – point 13 – point c
Directive 2001/83/EC
Article 80 – subparagraph 1 a
Article 80 – subparagraph 1 a
‘For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a Member State, including checking that the latter is an authorised wholesale distributor.
Amendment 346 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 - point a a (new)
Article 1 – point 15 - point a a (new)
Directive 2001/83/EC
Article 111 – paragraph 1 – subparagraph 2
Article 111 – paragraph 1 – subparagraph 2
aa) The second subparagraph of paragraph 1 is replaced by the following: The competent authority shall have a supervisory system responsible for: - regular inspections in the Union of the premises of the manufacturers and importers of active substances employed as starting materials, and - the effective follow-up of said inspections. The competent authority shall be able to inspect the premises of manufacturers or importers of excipients whenever it considers that there are grounds for suspecting non-compliance with the law or the guidelines on good manufacturing practice referred to in Article 47. Inspections may also be carried out on the premises of marketing authorisation holders, distributors and brokers in the medicinal products trade. Inspections in the Community and in non-EU countries may be requested by a Member State, the Commission or the Agency.
Amendment 358 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118a
Article 118a
Amendment 168 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 101 – paragraph 2
Article 101 – paragraph 2
2. Member States shall by means of the pharmacovigilance system referred to in paragraph 1 evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action as necessary. To that end they shall also obtain the relevant information concerning use of the medication so as to assess the impact of the risks on public health. They shall perform a regular audit of their pharmacovigilance system and report the results to the Commission on [insert concrete date - two-years after the date of transposition referred to in Article 3(1)] at the latest and then every two years thereafter.
Amendment 257 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 n – paragraph 1
Article 107 n – paragraph 1
1. This Chaptee procedures laid down in Articles 107o to 107r shall apply to non- interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder, voluntarily or following a requirement in accordance with Articles 21a or 22a, and which involve the collection of data from patients or health- care professionals.
Amendment 270 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 28
Article 1 – point 28
Directive 2001/83/EC
Article 2 a (new)
Article 2 a (new)
Article 2a Transitional provision 1. With regard to the requirement for the marketing authorisation holder to submit information on adverse reactions electronically to the Eudravigilance database, laid down in Article 107(3) of the present Directive, Member States shall ensure that the said requirement is applied once the functionalities of the database make it possible to provide information on adverse reactions that is complete and of proper quality and includes essential health data, codified data on the medicinal products, proper differentiation of follow-up reports and the elimination of duplicate cases. 2. The Agency’s Management Board shall confirm, on the basis of an independent inquiry, that the functionalities referred to in paragraph 1 are operational.
Amendment 67 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 - point 11
Article 1 - point 11
Regulation EC/726/2004
Article 28f
Article 28f
The Agency shall perform regular independent audit of its pharmacovigilance tasks and report the results to its Management Board on a two- yearly basis.
Amendment 102 #
2008/0241(COD)
Proposal for a directive
Article 3 – point q
Article 3 – point q
(q) “remove” means manual, or mechanical, chemical or metallurgic handling with the result that hazardous substances, preparations and components are contained as an identifiable stream or identifiable part of a stream at the end of the treatment process. A substance, preparation or component is identifiable if it can be monitored to prove environmentally safe treatment. separation of the hazardous substances, preparations and components specified in Annex II;
Amendment 119 #
2008/0241(COD)
Proposal for a directive
Article 5 – paragraph 2 - point a a (new)
Article 5 – paragraph 2 - point a a (new)
(aa) distributors when offering a product in category 3, shall be responsible for ensuring that, such waste can be returned to the distributor at least free of charge as long as the equipment is of equivalent type and has fulfilled the same functions as the offered equipment, even if no new product of such type is purchased;
Amendment 124 #
2008/0241(COD)
Council position
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States may require producers to show purchasersIn order to raise users’ awareness, Member States shall ensure that producers of EEE: (a) set up, in conjunction with distributors, a collection network for very- small-volume WEEE that: (i) enables end-users to discard very- small-volume WEEE at an accessible and visible collection point in the distributor’s shop; (ii) requires small shops to collect, and subsequently make available, very-small- volume WEEE without incurring any costs; (iii) does not involve any charge to end- users when discarding very small-volume- WEEE, nor any obligation to buy a new product of the same type; (b) are able to show, at the time of salpurchase of new products, the differentiated costs of collection, treatment and disposal in an environmentally sound way. The costs mentioned shall not exceed the best estimate of the actual costs incurred. , thus making the costs of collecting and recycling WEEE more evident; the various costs mentioned should not exceed the best estimate of the actual costs incurred, based on how easily the products and the critical raw materials they contain can be collected and recycled; (c) actively inform end-users about how and where they can discard very-small- volume WEEE correctly and safely. Distributors supplying EEE directly to private households or users other than private households solely by means of distance communication shall only be subject to the obligations under paragraph 1(a)(i) and (ii). The collection scheme put in place by these distributors shall enable end-users to return very- small-volume WEEE without those users having to incur any charges, including delivery or postal charges. No later than ...*, the Commission shall adopt delegated acts, in accordance with Article 20, with respect to a definition of ‘very-small-volume WEEE’, taking into account the risk of such waste not being collected separately due to its very small size. The obligations in this paragraph shall not apply to micro-enterprises operating on a very small surface area. No later than ...*, the Commission shall adopt delegated acts, in accordance with Article 20, with respect to a definition of ‘micro-enterprises operating on a very small surface area’. _______________ * Date 12 months after the entry into force of this Directive.
Amendment 133 #
Amendment 136 #
2008/0241(COD)
Council position
Annex 3 – point 4
Annex 3 – point 4
4. Large equipment (one length greater than 50cm) including: Householdappliances other than cooling appliances; IT and telecommunication equipment; consumer equipment; luminaires; equipment reproducing sound or images, musical equipment; electrical and electronic tool; toys, leisure and sports equipment; medical devices; monitoring and control instruments; automatic dispensers; equipmentradiators, screens and monitors and lamps and luminaires. Large appliances are all those appliances which are not in principle movable or which are intended in principle to remain in their place of use for the geneduration of electric currents. This category does not include equipment included in categories 1 to 3their service life.
Amendment 140 #
2008/0241(COD)
Council position
Annex 3 – point 5
Annex 3 – point 5
5. Small equipment (no length more than 50cm) including: Householdappliances other than cooling appliances; IT and telecommunication equipment; consumer equipment; luminaires; equipment reproducing sound or images, radiators, screens and monitors, lamps and luminaires, and IT and telecommusnicaltion equipment; electrical and electronic tool; toys, leisure and sports equipment; medical devices; monitoring and control instruments; automatic dispensers; equipment. Small appliances are all those appliances which are in principle movable and which are not intended in principle to remain in their place of use for the geneduration of electric currents. This category does not include equipment included in categories 1 to 3their service life.
Amendment 150 #
Amendment 152 #
2008/0241(COD)
Council position
Annex 4 – point 3 – paragraph 1
Annex 4 – point 3 – paragraph 1
Straight fluorescent lamps, Compact fluorescent lamps, Fluorescent lamps, High intensity discharge lamps - including pressure sodium lamps and metal halide lamps, Low pressure sodium lamps, LED lamps, luminaires and other devices that emit or control light.
Amendment 156 #
2008/0241(COD)
Council position
Annex 4 – point 4
Annex 4 – point 4
4. Large equipment Wappliances – Large appliances used for cooking and other processing of foods (e.g. electric hot plates, electric ovens, electric stoves, microwaves, fixed coffee machines) – Extractor hoods – Large machines for cleaning (e.g. washing machines, Cclothes dryers, Ddish washing machines, Cookers) – Large heating appliances (e.g. large heat blowers, Eelectric stoves, Electric hot plates, Luminaires,systems for heating marble and natural stone and other large appliances for heating rooms, beds and seating furniture); – Large body-care appliances (e.g. solariums, saunas, massage chairs) – Large IT and telecommunications appliances (e.g. large computer mainframes, servers, fixed network installations and appliances, large printing machines, copying equipment, coin- operated telephones) – Large sports and leisure appliances (e.g. sports equipment with electrical or electronic components, large slot machines) – Equipment reproducing sound or images, – Musical equipment (excluding pipe organs installed in churches), Appliances for knitting and weaving, Large computer- mainframes, Large printing machines, Copying equipment, Large coin slot machines, – Large electrical and electronic industrial tools and machinery except large-scale stationary industrial tools and non-road mobile machinery and appliances intended exclusively for professional users (e.g. appliances for knitting and weaving) – Large appliances for generating or transferring current (e.g. generators, transformers, uninterruptable power supplies (UPS), inverters) – Large medical devices, – Large monitoring and control instruments, – Large measuring instruments and installations (e.g. scales, fixed machines) – Large appliances whichfor automatically deliver products and money,ed product sales or dispensing and for the automated provision of simple services (e.g. product dispensers, cash machines, machines for the return of empties, photo machines) – Photovoltaic panels.
Amendment 161 #
2008/0241(COD)
Council position
Annex 4 – point 5
Annex 4 – point 5
5. Small equipment Vacuum cleaners, Carpet sweepers, Appliances for sewing, Luminairappliances – Small appliances used for cooking and other processing of foods (e.g. toasters, electric hotplates, electric knives, electric kettles, immersion coils, chopping machines, Mmicrowaves, Ventilation equipment) – Small cleaning appliances (e.g. vacuum cleaners, carpet sweepers, Iirons, Toasters, Electric knives, Electric kettles, Clocks, Electric shavers, Scales, Appliances for hair andetc.) – Fans, air fresheners, ventilation equipment – Small heating appliances (e.g. electric blankets) – Clocks, watches, alarm clocks and other time-measuring instruments – Small body -care, Personal computers, Printers, Calculators, Telephones, Mobile phones, Radio sets, Vide appliances (e.g. electric shavers, toothbrushes, hairdryers, massage machines) – Cameras (e.g. video cameras) – Consumer electronics appliances (e.g. radios, audio cameras, Vplifiers, car radios, DVD players, video recorders, Hhi-fi equipment,) – Musical instruments, Equipment reproducing sound or images, Electrical and electronic toys, S and sound equipment (e.g. amplifiers, mixing desks, headphones and speakers, microphones) – Toys (e.g. model railways, model aircraft, etc.) – Small items of sports equipment, C (e.g. computers for biking, diving, running, rowing, etc., Smoke detector, Heating regulators, Thermostats,) – Small leisure appliances (e.g. video games, fishing and golf equipment, etc.) – Small Eelectrical and electronic tools, Small medical devices, including gardening equipment (e.g. drills, saws, pumps, lawn-mowers) – Sewing machines – Small appliances for generating or transferring current (e.g. generators, battery chargers, uninterruptable power supplies (UPS), converters) – Small medical devices including veterinary devices – Small Mmonitoring and control instruments, Small Appliances which automatically deliver products, (e.g. smoke detectors, heating regulators, thermostats, movement detectors, monitoring appliances and products, remote handling and control devices) – Small measuring appliances (e.g. scales, display devices, telemeters, thermometers) – Small appliances for automated product sales or dispensing – Small equipment with integrated photovoltaic panels.
Amendment 206 #
2008/0241(COD)
Proposal for a directive
Article 12 – paragraph 2 - subparagraphs 2 a - 2 c (new)
Article 12 – paragraph 2 - subparagraphs 2 a - 2 c (new)
Fulfilment of the obligation by producers participating in a collective scheme shall be executed upon payment into the scheme on a yearly basis, from the moment products are placed on the market, of a sum in proportion to the producers’ respective annual market share of the costs incurred by that scheme in respect of the type of equipment defined in Annex 1B. Upon the aforementioned payment by the producers into a collective scheme, their obligation for financing the operations referred to in paragraph 1 is transferred to the collective scheme. Fulfilment of the obligation by producers participating in an accredited individual scheme shall be executed by financing and organising the operations referred to in paragraph 1 in respect of only their individual products labelled in accordance with Article 15. Producers that fulfil their obligation through the establishment of such an individual scheme shall, at the moment of placing a product on the market and in addition to the financing and organisation of the operations referred to in paragraph 1 in the current year, provide for sufficient financial coverage in a blocked bank account to guarantee the future operations referred to in paragraph 1 in respect of all products placed on the market by the producer which have not been collected. The blocked bank account shall have one third-party beneficiary, being an accredited collective scheme, which will be obliged to ensure the operations referred to in paragraph 1 in the event that the aforesaid producer is declared insolvent, bankrupt or alike, or in the case of withdrawal from the market.
Amendment 225 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. Member States shall ensure collective schemes provide evidence that the fulfilment of the obligation in a collective scheme is executed upon payment into the scheme on a yearly basis, from the moment products are placed on the market, of a sum in proportion to the producers’ respective annual market share of the costs incurred by that scheme in respect of the type of equipment defined in Annex 1B.
Amendment 226 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 2 b (new)
Article 16 – paragraph 2 b (new)
2b. Member States shall ensure, and provide information to confirm, that, upon the aforementioned payment into a collective scheme, the producer’s obligation for financing the operations referred to in Article 12(1), relating to the waste from his own products, is transferred to the collective scheme.
Amendment 227 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 2 c (new)
Article 16 – paragraph 2 c (new)
2c. Member states shall provide evidence that fulfilment of the obligation by producers participating in an accredited individual scheme is executed by financing and organising the operations referred to in Article 12(1) in respect only of their individual products labelled in accordance with Article 15.
Amendment 228 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 2 d (new)
Article 16 – paragraph 2 d (new)
2d. The producer that fulfils its obligation through the establishment of such an individual scheme shall provide sufficient evidence that, at the moment of placing its product on the market, besides the financing and organisation of the operations referred to in Article 12(1) in the current year, it has provided for sufficient financial coverage in a blocked bank account to guarantee the future operations referred to in Article 12(1) in respect of all products placed on the market by the producer which have not been collected. Furthermore, the information shall provide evidence of the identification of the third-party beneficiary referred to in Article 12.
Amendment 233 #
2008/0241(COD)
Proposal for a directive
Article 16 a (new)
Article 16 a (new)
Amendment 241 #
2008/0241(COD)
Proposal for a directive
Article 20 – paragraph 1 - subparagraph 2
Article 20 – paragraph 1 - subparagraph 2
Those inspections shall at least cover (a) exports of WEEE outside the Community in accordance with the Waste Shipment Regulation and the operations at treatment facilities in accordance with Directive 2008/xx/EC on waste and Annex II of this Directive. (b) compliance by producers with their financing obligations in accordance with Article 12 and 13 of this Directive. (c) compliance by individual and collective schemes with their obligations in accordance with Articles 12 and 16 (new article) of this Directive.
Amendment 265 #
2008/0241(COD)
Proposal for a directive
Annex I A (new)
Annex I A (new)
ANNEX IA Categories of equipment in accordance with Article 11 1. Cooling appliances and radiators; 2. Screens and monitors; 3. Lamps and luminaires; 4. Large appliances other than cooling appliances, radiators, screens, monitors, and lamps; ‘Large appliances’ means those which in principle are not movable or which, in principle, are intended to remain in the place where they were installed throughout their useful life; 5. Small appliances other than cooling appliances, radiators, screens, monitors, and lamps; ‘Small appliances’ means all those appliances which in principle are movable and which, in principle, are not intended to remain in their place of use throughout their useful life.
Amendment 269 #
2008/0241(COD)
Proposal for a directive
Annex I B (new)
Annex I B (new)
Amendment 59 #
2008/0238(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimisze any risks associated with the transmission of diseases. Well-organized national transplant systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients.
Amendment 60 #
2008/0238(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases. Well-organised national transplant systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients.
Amendment 67 #
2008/0238(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) In accordance with Article 168(7) of the Treaty of the Functioning of the European Union, the measures adopted under paragraph 4(a) of that Article do not affect national provisions on the medical use of organs. Therefore the surgical act of transplantation itself does not fall within the scope of this Directive. However, in view of the objective of reducing the associated risks of the transplanted organs, it is necessary to include within the scope of this Directive certain provisions concerning the transplantation process and in particular provisions aimed at addressing those unintended and unexpected situations occurring during the transplantation that might affect the quality and safety of organs.
Amendment 72 #
2008/0238(COD)
Proposal for a directive
Recital 10
Recital 10
(10) Pre-transplant evaluation of potential donors is an essential part of organ transplantation. This evaluation must provide enough information for the transplant centre to undertake a proper risk-benefit analysis. The risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient. Information from clinical history, physical examination and complementary tests should be collected for complete characterisation of the organ and the donor. To obtain an accurate, reliable and objective history, the medical team should interview the living donor or the relatives of the deceased donor. This is essential since the time constraints of the process of deceased donation reduce the ability to rule out potentially serious transmissible diseases. During the interviews, the team should properly inform the interviewees of the risks and consequences of donation and transplantation so as to make them aware of the importance of providing the medical team with all relevant information.
Amendment 74 #
2008/0238(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Personnel directly involved in the donation, testing, characterisation, procurement, testing, preservation, transport and transplantation of human organs should be suitabley qualified and trainedcompetent.
Amendment 76 #
2008/0238(COD)
Proposal for a directive
Recital 16
Recital 16
(16) This Directive should respect the fundamo ensure the quality and safety of organs for transplantation, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation. This is an essential rights and observeaspect, since the violation of these principles recognised in particular by the Charter of Fundamental Rights of the European Union11. In lmight be associated with unacceptable risks and poor outcomes for recipients and living donors. When donation is not voluntary and/or provides for financial gain, the quality of the process of donation cannot be fully guaranteed, since with that charter and to take account of, as appropriate the Convention on human rights and biomedicine12 , organ transplantation programmes should bimproving the quality of life or saving the life of a person is not the main and/or the sole objective to be achieved. Even if the process is developed in accordance with appropriate quality standards, the clinical history obtained either from the potential living donor or the relatives of the potential deceased donor might not be accurate enough in terms of those conditions and/or diseases which are potentially transmissible from donors to recipients when donors are seeking financial gain or are subjected to any kind of coercion. This would imply a safety problem for potential recipients since the team would have a limited capability for performing an appropriate risk analysis. This Directive should respect the founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s)amental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In line with that Charter it should also take account of, as appropriate, the Convention on Human Rights and Biomedicine and the Revised World Health Organisation Guiding Principles on Human Cell, Tissue and Organ Transplantation.
Amendment 77 #
2008/0238(COD)
Proposal for a directive
Recital 16
Recital 16
(16) This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In line with that charter and tit should also take account of, as appropriate, the Convention on hHuman rRights and bBiomedicine12 , org and transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s)he Revised World Health Organization Guiding Principles on Human Cell, Tissue and Organ Transplantation.
Amendment 79 #
2008/0238(COD)
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) The competent authority may consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 80 #
2008/0238(COD)
Proposal for a directive
Recital 16 b (new)
Recital 16 b (new)
(16b) As a general principle, the identity of the recipient(s) should not be disclosed to the donor or his/her family or vice versa, without prejudice to legislation in force in Member States which under specific conditions might allow such information to be made available to donor or donors' families and organ recipients, with the consent of both parties.
Amendment 81 #
2008/0238(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data13 prohibits in principle the processing of data concerning health. Limited exemptions to this prohibition principle are laid down. Directive 95/46/EC also requires the controller to implement appropriate technical and organiszational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing. In line with that Directive, strict confidentiality rules and security measures should be in place for the protection of the donors’ and the recipients’ personal data. Moreover, the competent authority may also consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 82 #
2008/0238(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data13 prohibits in principle the processing of data concerning health. Limited exemptions to this prohibition principle are laid down. Directive 95/46/EC also requires the controller to implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing. In line with that Directive, strict confidentiality rules and security measures should be in place for the protection of the donors’ and the recipients’ personal data. Moreover, the competent authority may also consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 86 #
2008/0238(COD)
Proposal for a directive
Article 1
Article 1
This Directive lays down rules to ensure high standards of quality and safety for organs of human origin intended for transplantation to the human body, in order to ensure a high level of human health protection.
Amendment 88 #
2008/0238(COD)
Proposal for a directive
Article 3 – point a
Article 3 – point a
(a) "authoriszation"‘ means authoriszation, accreditation, designation or licensing or registration, depending of the concepts used in each Member State;
Amendment 90 #
2008/0238(COD)
Proposal for a directive
Article 3 – point a a (new)
Article 3 – point a a (new)
aa) "competent authority means one (or more than one) non-profit authority, body, organisation and/or institution responsible for implementing the requirements of this Directive.
Amendment 91 #
2008/0238(COD)
Proposal for a directive
Article 3 – point a a (new)
Article 3 – point a a (new)
(aa) 'competent authority' means one or more than one non-profit authority, body, organisation and/or institution responsible for implementing the requirements of this Directive.
Amendment 93 #
2008/0238(COD)
Proposal for a directive
Article 3 – point c
Article 3 – point c
(c) "donor"' means every human source of organs, whether living or deceasedperson who donates one or several organs, whether the donation occurred during that person's lifetime or after death;
Amendment 94 #
2008/0238(COD)
Proposal for a directive
Article 3 – point c
Article 3 – point c
(c) "donor" means every human source of organs, whether living or deceased person who donates one or several organs, whether the donation occurred during that person's lifetime or after death;
Amendment 96 #
2008/0238(COD)
Proposal for a directive
Article 3 – point e
Article 3 – point e
(e) "‘donor characteriszation"’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability, to undertake a proper risk assessment in order toand minimisze the risks for the recipient, and to optimisensure an effective organ allocation;
Amendment 97 #
2008/0238(COD)
Proposal for a directive
Article 3 – point f
Article 3 – point f
(f) "'European organ exchange organisation"' means a non-profit organisation, whether public or private, dedicated especially toto national and/or cross-border organ exchange; the countries members of such an organisation are in their majority Member States of the Community;
Amendment 100 #
2008/0238(COD)
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) "'organ"' means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; a part of an organ is also considered to fall within the scope of this definition if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
Amendment 101 #
2008/0238(COD)
Proposal for a directive
Article 3 – point h
Article 3 – point h
(h) "'organ characterisation"' means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, to undertake a proper risk assessment in order toand minimise the risks for the recipient, and to optimisensure an effective organ allocation;
Amendment 109 #
2008/0238(COD)
Proposal for a directive
Article 3 – point n
Article 3 – point n
(n) "'serious adverse reaction"' means an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life- threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;
Amendment 112 #
2008/0238(COD)
Proposal for a directive
Chapter II – title
Chapter II – title
Amendment 113 #
2008/0238(COD)
Proposal for a directive
Article 4 – title
Article 4 – title
Amendment 115 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – introductory part
Article 4 – paragraph 2 – introductory part
2. The national quality programmesframework for quality and safety shall provide for the adoption and implementation of:
Amendment 116 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) standard operating procedures for the verification of donor identity;
Amendment 117 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) standard operating procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules applying where donation and procurement take place;
Amendment 119 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) standard operating procedures for the verification of the completion of the organ and donor characterisation in accordance with Article 7 and with the model set out in the Annex;
Amendment 120 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – point e
Article 4 – paragraph 2 – point e
(e) rulprocedures for the transportation of human organs in accordance with Article 8.
Amendment 121 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 2 – points a – ec (new)
Article 4 – paragraph 2 – points a – ec (new)
Amendment 122 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. The national quality programmes shalIn addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal is suitably qualified and competent, and shall develop specific training programmes for such personnel
Amendment 123 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – point a – introductory part
Article 4 – paragraph 3 – point a – introductory part
Amendment 124 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – point b – introductory part
Article 4 – paragraph 3 – point b – introductory part
Amendment 127 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
Amendment 128 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) establish the qualifications required by thor competencies required for the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal, and develop specific training programmes for such personnel in accordance with recognised international standards.
Amendment 137 #
2008/0238(COD)
Proposal for a directive
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the organisations, bodies or companies involved in the transportation of organs have appropriate standard operating procedures in place to ensure the integrity of the organ during transport and that transport time is optimised and where possible minimised.
Amendment 141 #
2008/0238(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 4
Article 8 – paragraph 1 – point b – indent 4
Amendment 145 #
2008/0238(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it. Member States shall ensure that this donor identification system are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymoue confidentiality of patient data is respected in accordance with national rules.
Amendment 146 #
2008/0238(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it. Member States shall ensure that this donor identification system are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymoue confidentiality of patient data is respected in accordance with national rules.
Amendment 147 #
2008/0238(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing, characterisation, procurement, testing,preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Amendment 148 #
2008/0238(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing, characterisation, procurement, testing,preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Amendment 151 #
2008/0238(COD)
Proposal for a directive
Chapter III – title
Chapter III – title
DONOR AND RECIPIENT PROTECSELECTION AND EVALUATION
Amendment 152 #
2008/0238(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that donations of human organs from deceased and living donors are voluntary and unpaid. This should not prevent living donors from receiving compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In that case, Member States shall define the conditions under which compensation may be granted.
Amendment 157 #
2008/0238(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a In order to meet the quality and safety requirements laid down in this Directive, Member States shall endeavour to obtain all necessary information from living donors and to provide them with the information which they need to understand the consequences of donation. In the case of deceased donation, Member States shall endeavour to obtain such information from relatives or other persons authorizing donation. Member States shall also make all parties from whom information is requested aware of the importance of the swift transmission of such information.
Amendment 158 #
2008/0238(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
In order to meet the quality and safety requirements laid down in this Directive, Member States shall endeavour to obtain all necessary information from living donors and to provide them with the information which they need to understand the consequences of donation. In the case of deceased donation, Member States shall endeavour to obtain such information from relatives or other persons authorizing donation. Member States shall also make all parties from whom information is requested aware of the importance of the swift transmission of such information.
Amendment 159 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 165 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. Donors may receive compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In such cases, Member States shall define the conditions under which compensation may be granted.
Amendment 166 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2aThis should not prevent living donors from receiving compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In such cases, Member States shall define the conditions under which compensation may be granted.
Amendment 168 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Member States shall ensure that the competent authority keeps a register of the living donors after the donation, in line with provisions on the protection of the personal data and statistical confidentiality, and collects information on their follow up and, and specifically, on complications related to their donation that might appear in the short, mid and long term.
Amendment 169 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3 a. Member States shall ensure that living donors are followed up in accordance with national provisions, in order to identify, report, and manage any event potentially relating to the quality and safety of the donated organ, and hence of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation.
Amendment 170 #
2008/0238(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Community provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Articles 8 (3), 16, 17 and 28 (2) of that Directive.
Amendment 179 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
Member States shall designate the competent authority, or authorities (hereafter competent authority), responsible for implementing the requirements of this Directive.
Amendment 181 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) put in place and keep updated a national quality programmeframework for quality and safety in accordance with Article 4;
Amendment 182 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
(aa) Each Member State may delegate, or may allow a Competent Authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed appropriate under national provisions. Such a body may also assist a Competent Authority in carrying out its functions.
Amendment 183 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
(aa) Each Member State may delegate, or may allow a Competent Authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed appropriate under national provisions. Such a body may also assist a Competent Authority in carrying out its functions.
Amendment 194 #
2008/0238(COD)
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Member States shall report to the Commission before …………*.and every three years thereafter on the activities undertaken in relation to the provisions of this Directive, and on the experience gained in implementing it. * 6 years after the entry into force of this Directive.
Amendment 195 #
2008/0238(COD)
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. Before …….** and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ,a report on the implementation of this Directive **5 years after the entry into force of this Directive
Amendment 200 #
2008/0238(COD)
Proposal for a directive
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a This Directive shall not prevent a Member State from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty.
Amendment 201 #
2008/0238(COD)
Proposal for a directive
Article 27 – subparagraph 2 a (new)
Article 27 – subparagraph 2 a (new)
1a. This Directive shall not prevent a Member State from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty.
Amendment 202 #
2008/0238(COD)
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Amendment 81 #
2008/0198(COD)
Council position
Recital 3
Recital 3
(3) Illegal logging is a pervasive problem of major international concern. It poses a significant threat to forests as it contributes, along with changes in land use, fires, extreme weather phenomena and forest diseases, to the process of deforestation, which is responsible for about 20 % of CO2 emissions, threatens biodiversity, and undermines sustainable forest management and development including the commercial viability of operators acting in accordance with applicable legislation. In addition, it also has social, political and economic implications.
Amendment 96 #
2008/0198(COD)
Council position
Recital 21
Recital 21
(21) Taking into account the international character of illegal logging and related trade, competent authorities should cooperate with each other, with civil society organisations, with industry organisations and with the administrative authorities of third countries and the Commission.
Amendment 540 #
Amendment 545 #
2008/0196(COD)
Proposal for a directive
Article 4 – paragraph 1 and paragraph 1 a (new)
Article 4 – paragraph 1 and paragraph 1 a (new)
1. Member States may not maintain or introduce, in their national laws, provisions diverging from those laid down in this Directive, including more or less stringent provisions to ensure a different level of as long as they guarantee a higher degree of consumer protection. 1a. The rights resulting from this Directive shall be exercised without prejudice to the provisions of another Community act governing consumer protection.
Amendment 101 #
2008/0142(COD)
Council position
Recital 9
Recital 9
(9) This Directive should apply to individual patients who decide to seek healthcare in a Member State other than the Member State of affiliationall types of healthcare. As confirmed by the Court of Justice, neither itsthe special nature of healthcare nor the way in which it is organised or financed removes healthcareit from the ambit of the fundamental principle of the freedom to provide servicesof movement. However, the Member State of affiliation may choose to limit the reimbursement of cross-border healthcare for reasons relating to the quality and safety of the healthcare provided, where this can be justified by overriding reasons of general interest relating to public health. The Member State of affiliation may also take further measures on other grounds where this can be justified by such overriding reasons of general interest. Indeed, the Court of Justice has laid down that public health protection is among the overriding reasons of general interest that can justify restrictions to the freedom of movement envisaged in the Treatiesof general interest relating to public health, such as the risk of seriously undermining the financial balance of a social security system, or the objective of maintaining a balanced hospital service open to all.
Amendment 103 #
2008/0142(COD)
Council position
Recital 13
Recital 13
(13) Given their specificity, access to and the allocation of organs for the purpose of organ transplantsation should fall outside the scope of this Directive.
Amendment 121 #
2008/0142(COD)
Council position
Recital 39
Recital 39
(39) The criteria attached to the grant of prior authorisation should be justified in the light of the overriding reasons of general interest capable of justifying obstacles to the free movement of healthcare. The Court of Justice has identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on national territory, essential for the public health, and even the survival of the population. It is also important to take into consideration the general principle of ensuring the safety of the patient, in a sector well known for information asymmetry, when managing a prior authorisation system. Conversely, the refusal to grant prior authorisation may cannot be based solely on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities, without carrying out an objective medical. Prior authorisation may be refused only if the patient is not entitled to the treatment in question, or on the basis of a clinical evaluation, or on the basis of exposure of the general public or the individual patient to a substantial safety hazard. The decision should be based on an objective assessment of the patient's medical condition, the history and probable course of his illness, the degree of pain he is in and/or the nature of his disability at the time when the request for authorisation was made or renewed. In the event of refusal, an appeal procedure should be available.
Amendment 127 #
2008/0142(COD)
Council position
Recital 48
Recital 48
(48) The Commission should support the continued development of European reference networks between healthcare providers and centres of expertise in the Member States. European reference networks can improve the access to diagnosis and the provision of high-quality healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases. This Directive should therefore give incentives to Member States to facilitatreinforce the continued development of European reference networks. European reference networks are based on the voluntary participation of their members, but the Commission should develop criteria and conditions that the networks should be required to fulfil in order to receive support from the Commission.
Amendment 137 #
2008/0142(COD)
Council position
Article 1 – paragraph 3 – point b
Article 1 – paragraph 3 – point b
(b) allocation of and access to organs for the purpose of organ transplantsation;
Amendment 139 #
2008/0142(COD)
Council position
Article 2 – paragraph 1 – point q a (new)
Article 2 – paragraph 1 – point q a (new)
(qa) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (*) (*) OJ L 207, 6.8.2010 , p. 14.
Amendment 176 #
2008/0142(COD)
Council position
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Healthcare that may be subject to prior authorisation shall be set out in a list, by the Member State of affiliation, to be transmitted to the Commission. It shall be limited to healthcare which:
Amendment 180 #
2008/0142(COD)
Council position
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) involves treatments presenting a particular risk for the patient or the population or which could raise serious and specific concerns relating to the quality or safety of the care with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Unionincluding situations when those treatments could jeopardise patient safety or when a minimum level of quality of care to be provided cannot be ensured.
Amendment 182 #
2008/0142(COD)
Council position
Article 8 – paragraph 5 – introductory part
Article 8 – paragraph 5 – introductory part
5. The Member State of affiliation may refuse to grant prior authorisation for reasons including, but not limited to,only for the following reasons:
Amendment 188 #
2008/0142(COD)
Council position
Article 8 – paragraph 5 – point e
Article 8 – paragraph 5 – point e
(e) if thise healthcare is to be provided by healthcare providers that raise serious and specific concerns relating to the respect of standards and guidelines on quality of care and pprovider in question is not authorised, registered, licensed, certified or accredited, to provide or perform the care or treatiment safety, including provisions on supervision, whetherfor which the authorisation has been sought, according to these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment.
Amendment 141 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point k
Article 2 – paragraph 2 – point k
(k) 'field of vision' means all the surfaces of a package that can be read from a single viewing point, permitting rapid and easy access to labelling information by allowing consumers to read that information without needing to turn the package back and forth;
Amendment 144 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
Amendment 240 #
2008/0028(COD)
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
Amendment 241 #
2008/0028(COD)
Proposal for a regulation
Recital 41
Recital 41
Amendment 267 #
2008/0028(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b – letter ii
Article 4 – paragraph 1 – point b – letter ii
ii) durability, storage, conservation requirements once the product is opened, if applicable, and safe use;
Amendment 274 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b
Article 29 – paragraph 1 – subparagraph 1 – point b
(b) the amounts of fat, saturates, trans fats, carbohydrate, sugars, protein and salt.
Amendment 288 #
2008/0028(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5 a. Pursuant to Article 14(6), the operators of food companies shall ensure that the companies for which they are responsible do not distribute products which are incorrectly or illegibly labelled.
Amendment 293 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
g) any special storage conditions or conditions of use, including specifications for the conservation of the product once opened;
Amendment 318 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d a (new)
Article 34 – paragraph 1 – point d a (new)
(da) they are objective and non- discriminatory;
Amendment 319 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d b (new)
Article 34 – paragraph 1 – point d b (new)
(db) their application may not create obstacles to the free movement of goods.
Amendment 320 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 330 #
2008/0028(COD)
Proposal for a regulation
Article 42 – paragraph 1 – point a
Article 42 – paragraph 1 – point a
(a) Member States may request the provision of the particulars specified in point (c) of Article 9(1) is mandatory;
Amendment 336 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The minimum font size referred to in paragraph 1 shall not apply in case of packaging or containers the largest surface of which has an area of less than 10 cm2, provided it is ensured that the information is legible or exists in another format easily available to the consumer.
Amendment 386 #
2008/0028(COD)
Proposal for a regulation
Annex VII – Part B – table – point 1 – right-hand-column – first paragraph
Annex VII – Part B – table – point 1 – right-hand-column – first paragraph
'Oil', together with - either the adjective 'vegetable' or 'animal'animal' (or the indication of their specific animal origin), or, as appropriate, or - an indication of their specific vegetable or animal origin. See amendment 263 from first reading.igin. Or. es Justification
Amendment 388 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – point b
Article 29 – paragraph 1 – point b
(b) the amounts of fat, saturatestrans fats, saturates, protein, carbohydrates with specific reference to sugars, and salt.
Amendment 390 #
2008/0028(COD)
Proposal for a regulation
Annex VII – Part B – table – point 2 – right-hand-column – first paragraph
Annex VII – Part B – table – point 2 – right-hand-column – first paragraph
'Fat', together with - either the adjective 'vegetable' or 'animal', as appropriate, or an indication of their specific vegetable or animal origin.
Amendment 54 #
2007/0286(COD)
Council position
Recital 2
Recital 2
(2) In order to prevent, reduce and as far as possible eliminate pollution arising from industrial activities in compliance with the "polluter pays" principle and the principle of pollution prevention, it is necessary to establish a general framework for the control of the main industrial activities, giving priority to intervention at source and, ensuring prudent management of natural resources and taking into account, when necessary, the socio-economic situation and specific local characteristics of the place in which the activity is taking place.
Amendment 63 #
2007/0286(COD)
Council position
Recital 15
Recital 15
(15) In order to take into account certain specific circumstances where the application of emission levels associated with the best available techniques would lead to disproportionately high costs and have a particularly adverse socio- economic impact compared to the environmental benefits, competent authorities should be able to set emission limit values deviating from those levels. Such deviations should be based on an assessment taking into account well- defined criteria. The emission limit values set out in this Directive should not be exceeded. In any event, no significant pollution should be caused and a high level of protection of the environment taken as a whole should be achieved.
Amendment 175 #
2007/0286(COD)
Council position
Article 21 – paragraph 3 – subparagraph 2 a (new)
Article 21 – paragraph 3 – subparagraph 2 a (new)
In specific cases where permit reconsideration and updating identifies that a longer period than five years after the publication of a decision on BAT conclusions might be needed to introduce new best available techniques, competent authorities may set a longer time period in permit conditions where this is justified on the basis of the criteria laid down in this Directive.