292 Amendments of Anne FERREIRA
Amendment 1 #
2008/2330(INI)
Draft opinion
Recital A
Recital A
A. whereas the number of European citizens affected by poverty, insecurity and, declining living conditions and an increase in social and health inequalities is increasing all the time,
Amendment 5 #
2008/2330(INI)
Draft opinion
Recital C
Recital C
C. whereas poor social and environmental conditions have an impact on the emergence and gravity of some diseases; whereas there has been a steady increase in the incidence of cancer linked to environmental and dietary factors,
Amendment 7 #
2008/2330(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes presentation of the Renewed Social Agenda and the European Union’s recognition of the imbalances in the present agenda; deplores the lack of ambition and innovation in the measures proposed by the Commission;
Amendment 8 #
2008/2330(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 10 #
2008/2330(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Shares the Commission’s determination to extend the Social Agenda to include new areas; deplorwelcomes the fact that the environment is being considered only from the point of view ofrenewed declarations by the Commission in favour of a sustainable economy with low CO2 emissions, but regrets the fact that the Commission’s proposal contains no specific measure to take into account the social and health consequences of the environmental and climate changerises;
Amendment 11 #
2008/2330(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Again draws attention to the need to incorporate the Lisbon strategy and the strategy of sustainable development and to incorporate the fight against climate change in all Union policies; regrets the lack of real and practical Union commitment, as particularly of its proposal on the renewed Social Agenda and in its recovery plan, to the ‘greening’ of the European economy and the creation of ‘green’ jobs;
Amendment 12 #
2008/2330(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Considers that the Union should henceforth rapidly endow itself with an ambitious environmental agenda, proposing a review of environmental legislation so as to achieve an economy which is more environmentally and health friendly; stresses that this environmental agenda must be in line with and coordinated with the Union’s social agenda;
Amendment 14 #
2008/2330(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Regrets the mismatch between the aim of living longer and in better health, and the measures proposed; draws attention to the responsibility of Member States for organising and funding social protection schemes, and to the right to health services within easy reach; deplores the lack of reference to action plans and programmes for the Uneplores the lack of reference to the various European action plans and programmes for the environment or public health in 2004-2010 and for health at work and calls on the Commission to incorporate therein the position’s environment or public healthadopted in this area by the European Parliament;
Amendment 15 #
2008/2330(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that the health and health systems of Member States are a matter of general interest and that the health systems of Member States are a key component of the high levels of social protection in Europe and contribute to social cohesion and justice and to sustainable development; recalls the competence of Member States in organising, providing and financing social protection systems and the right of each citizen to high quality healthcare and services within easy reach; takes note of the proposal for a directive on the application of patients’ rights as regards cross-border health services; stresses that it cannot be a solution to medical shortcomings or problems of access to healthcare in some Member States;
Amendment 17 #
2008/2330(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the importance of general- interest social services to fulfilling the Union’s social, environmental and health objectives and the need for the rules of the internal market to facilitate their tasks; draws attention to the rolimportance of the social economy and its contribution to creating numerous, sustainable and good- quality jobs and the role it plays in sustainable development and in territorial cohesion, innovation and social justice.
Amendment 3 #
2008/2306(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- having regard to the study on NK603 and MON810 GM maize published by the Austrian Ministry of Health, Family and Youth in November 2008,
Amendment 12 #
2008/2306(INI)
Motion for a resolution
Recital C
Recital C
Amendment 14 #
2008/2306(INI)
Motion for a resolution
Recital D
Recital D
D. Whereas two GMOs are authorised for cultivation in the European Union, but no GMO has been authorised for cultivation since 1998 either under Directive 2001/18/EC or Regulation (EC) No 1829/2003, since authorisation of GMO crops is a very controversial issue for a large majority of European citizens,
Amendment 16 #
2008/2306(INI)
Motion for a resolution
Recital E
Recital E
E. Whereas a little fewer than 30s of the end of 2008, 28 GMO products are currently authorised in the EU, directly or as derived products - cotton, maize, oilseed rape, biomass, soybean, sugar beet - almost exclusively for import; whereas the European Union has authorised fewer GMOs than the United States and Canada, but more than China, Argentina, Brazil and India,
Amendment 21 #
2008/2306(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. Whereas both the Commission and the European Food Safety Authority have always adopted favourable positions on applications for authorisation and whereas the authorisations proposed by the Commission are based solely on the opinions of the European Food Safety Authority,
Amendment 22 #
2008/2306(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. Whereas applications for authorisation are processed and evaluated on the basis of dossiers submitted by the industry,
Amendment 23 #
2008/2306(INI)
Motion for a resolution
Recital E c (new)
Recital E c (new)
Ec. Whereas it is necessary to improve scientific assessment of the risks associated with cultivating GM crops in order to take account of their long-term effects on health and the environment and of the specific characteristics of the ecosystems and geographical areas hosting such crops,
Amendment 24 #
2008/2306(INI)
Motion for a resolution
Recital E d (new)
Recital E d (new)
Ed. Having regard to the Council conclusions of 4 December 2008 calling for improvement of the Community legislative framework relating to GMOs in order to meet the Union's health and environmental protection objectives,
Amendment 25 #
2008/2306(INI)
Motion for a resolution
Recital E e (new)
Recital E e (new)
Ef. Whereas since December 2008 the Commission and the European Food Safety Authority have issued positive opinions on three applications for marketing authorisation for GMOs; whereas the Commission has called for the safeguard measures taken by three Member States to be repealed,
Amendment 39 #
2008/2306(INI)
Motion for a resolution
Recital I
Recital I
I. Whereas GMOs, notably their cultivation, give rise to discussion and questions within society as well as among the scientific community; whereas GMOs are often perceived by society in a very emotional way not necessarily ba because of the impact of GMO crops on health, the environment and ecosystems, and becaused on scientific groundf the implications of GMOs for the patentability of living organisms,
Amendment 43 #
2008/2306(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. Whereas four multinationals in the world control virtually all GMO seeds, one of them alone holding 75% of GMO patents,
Amendment 44 #
2008/2306(INI)
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. Whereas GMO crops change farming practices and have an impact on the genetic resources of the regions where the GMOs are cultivated because of their inevitable dispersion and contamination of other crops and plant varieties,
Amendment 45 #
2008/2306(INI)
Motion for a resolution
Recital I c (new)
Recital I c (new)
Ic. Whereas the study by the Joint Research Centre in 200212concluded that extending GMO cultivation will undoubtedly cause mass accidental contamination, substantially increasing the cost of protection and segregation measures to avoid contamination of conventional and organic crops,
Amendment 46 #
2008/2306(INI)
Motion for a resolution
Recital I d (new)
Recital I d (new)
Amendment 47 #
2008/2306(INI)
Motion for a resolution
Recital J
Recital J
J. Whereas Member States should work more closely with each other on the issue of GMOs; whereas Member States should address this issue in a practical and rational way rather than in a political way,
Amendment 70 #
2008/2306(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the need to increase transparency at European level and national level, especially regarding the environment and health dimensions, in order to improve citizens' confideknowledge conce rning the authorisation procedure and of the obligations applying to the cultivation and marketing of GMOs in the European Union;
Amendment 76 #
2008/2306(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that the EU authorisation procedure is facing substantial delays, and that more than 50 applications for authorisation are currently pending; calls on the Commission and Member States to ensure that such undue delays are avoidedmore than 50 applications for authorisation are currently pending, as evaluation of a dossier is often suspended because some of the documents are missing that must be included in the dossier for an application for authorisation of a GMO pursuant to Directive 2001/18/EC;
Amendment 81 #
2008/2306(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Points out that, during the authorisation procedure, a qualified majority in favour or against is never reached, either in the regulatory Committee or in the Council, and that, in fine, the authorisation decision is taken by the Commission; therefore urges Member States to assume their responsibilities in order to avoid this situatcalls for the decision procedure to be changed so that the final decision is not taken by the Commission;
Amendment 93 #
2008/2306(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Underlines the need for further harmonisation of practices and methods of assessing the environmental risks of GMOs, especially as, under Regulation (EC) No 1829/2003, the environmental evaluation is not centralised but delegated by the European Food Safety Authority (EFSA) to a Member Stto ensure that they are based on a case-by-case assessment of each application for authorisation of a GMO, taking account of the specific features of the ecosystems and the geographical areas in which the GMOs could be cultivated;
Amendment 103 #
2008/2306(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the need to further develop environmental risk assessment, in particular regarding the impact on non- target species, the potential long-term effects as well as the potential consequences of the changes in the use of herbicides caused by herbicide-tolerant genetically modified plants; calls for environmental risk assessment to take into account the nine biogeographical regions defined in Directive 92/43/EEC;
Amendment 107 #
2008/2306(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls, in accordance with the letter from the Directorate-General for the Environment and the Directorate-General for Health and Consumers to the European Food Safety Authority, for the latter to take into account the effects of cultivating herbicide-tolerant GMOs on human health and the environment when conducting risk assessment;
Amendment 108 #
2008/2306(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Underlines the need to ensure coherence in environmental risk assessment between GMO crops which produce herbicides and the corresponding herbicides covered by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market1; 1 OJ L 230, 19.8.1991, p. 1.
Amendment 125 #
2008/2306(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls for the rapporteurs for the opinions on GMOs of the European Food Safety Authority to have the requisite skills for conducting the assessments, especially scientific environmental and ecological knowledge; calls for the European Environment Agency to be consulted when drafting the opinions of the European Food Safety Authority;
Amendment 126 #
2008/2306(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on the Commission and the European Food Safety Authority to stop putting forward views on GMO authorisation applications until the conclusions of the Council of 4 December 2008 have been implemented;
Amendment 131 #
2008/2306(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8c. Calls on the Commission and the European Food Safety Authority to ensure compliance with the provisions of Article 30 of Regulation (EC) No 178/2000 concerning different scientific opinions, in particular regarding the identification and publication of points of uncertainty in the data;
Amendment 134 #
2008/2306(INI)
Motion for a resolution
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Calls on the Commission, the Member States and the European Food Safety Authority to establish a network of European scientific bodies representing all the disciplines concerned with risk assessment in the cultivation, use and marketing of GMOs, in accordance with Article 36 of Regulation (EC) No 178/2002;
Amendment 135 #
2008/2306(INI)
Motion for a resolution
Paragraph 8 e (new)
Paragraph 8 e (new)
8e. Calls on the Commission and the Member States to ensure that systematic, independent research or assessment is carried out on the possible dangers of the deliberate release or the marketing of GMOs, and that those conducting the research or assessment have access to all necessary information, with due regard to intellectual property rights;
Amendment 141 #
2008/2306(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses the importance of taking into account socio-economic considerations into the risk management process, such as potential benefits or disadvantages for farmers, for consumers, for the society in general, and for European agriculture and for the different economic sectors (such as food)in the medium and long term;
Amendment 142 #
2008/2306(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Acknowledges that the cultivation and placing on the market of GMOs has negative socio-economic effects, in particular the loss of more environmentally sound cultivation practices, contamination of conventional and organic crops and the considerable cost of measures to protect conventional and organic crops, etc., factors which must therefore be taken into account during the GMO authorisation procedure;
Amendment 150 #
2008/2306(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Takes note of the existing possibility, under current authorisation procedure, to take into account other legitimate factors; takes the view, in particular, that socio- economic considerations should be taken into account as other legitimate factorsrisks linked to the deliberate release of GMOs should also be assessed;
Amendment 153 #
2008/2306(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Invites the Commission and Member States to develop a methodological framework at EU level to identify relevant socio-economic criteria; , which must at the very least deal with the cost of licences for access to seeds, measures to protect and segregate conventional and organic crops, the contamination and loss or the downgrading of conventional and organic crops (including animals), and the loss of biodiversity, given that the Commission acknowledged, in December 2008, that the European Union will fail to bring to an end the loss of biodiversity in the European Union by 2010.
Amendment 157 #
2008/2306(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the need to dramatically improve public information; calls upon Member States and the Commission to launch information campaigns to raise public awareness and public understanding in order to allow citizens to make informed choices;
Amendment 161 #
2008/2306(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 164 #
2008/2306(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
Amendment 176 #
2008/2306(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Notes that some Member States have adopted national measures on coexistence in accordance with Article 26a(1) of Directive 2001/18/EC, which lays down the obligation to take measures to avoid the unintentional presence of GMOs in other products; invites the Commission to adopt as soon as possible a report on progress made on the implementation of national measures on coexistence;
Amendment 177 #
2008/2306(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Takes the view that coexistence rules should set clear provisions regarding liability; calls on the Commission and the Member States to put forward, as soon as possible, a legislative framework dealing with responsibility for the contamination of conventional and organic crops by GMOs and the other effects of using or placing on the market GMOs, based on the ‘polluter pays’ principle and extended producer responsibility;
Amendment 207 #
2008/2306(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Stresses the need to take full account of the specific regional and local features of the Member States, in particular ecosystems and geographical zones which are unique or have special value in terms of biodiversity, agriculture, etc., or which employ special methods of cultivation;
Amendment 210 #
2008/2306(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Notes that GMO-free zones can also be set up by means of a voluntary (possibly tacit) agreement between all operators concerned in a determined area; calls for the Council decision to be transcribed in any subsequent review of Community legislation on GMOs;
Amendment 220 #
2008/2306(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Stresses that, in addition to those possibilities, Member States must be allowedhave the right to prohibit completely the cultivation of GMOs in restricted geographical areas, for instance in sites belonging to the Natura 2000 networkgeographical areas with special characteristics in terms of the environment, agriculture, biodiversity, methods of cultivation, etc., for instance in sites belonging to the Natura 2000 network; recalls that the precautionary principle has been expressly laid down in the Treaty since 1992 and that the Court of Justice of the European Communities has on numerous occasions specified that the content and scope of this principle in Community law is one of the cornerstones of the protection policy pursued by the Community in the areas of the environment and health1;
Amendment 50 #
2008/2250(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Supports the fact that the components of the social economy should be recognised in the European sectoral and inter-sectoral social dialogue and insists that the process for including social economy actors in social consultations and the civil dialogue should be encouraged;;
Amendment 86 #
2008/2250(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission to aim for conditions which will facilitate investments in the social economy, in particular through investment funds, the grating of guaranteed loans and in the form of subsidies;
Amendment 2 #
2008/2208(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
– having regard to the opinion of the Scientific Committee on New and Emerging Health Risks published on 19 January 20092,
Amendment 11 #
2008/2208(INI)
Motion for a resolution
Recital C
Recital C
C. whereas nanomaterials are likely to be the next "big thing", especially given that manipulating all matter has been man's ultimate dream for centuries,
Amendment 14 #
2008/2208(INI)
Motion for a resolution
Recital D indent 1
Recital D indent 1
− while nanomaterials are generally considered to be materials of a size in the order of 100 nm or less, this is often misrepresented as a range between 1 and 100 nm, even though the term “order” relates to a dimension rather than to a precise size,
Amendment 16 #
2008/2208(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the regulatory aspects of nanomaterials should also cover nanoparticles and the different nanotechnologies and nano-objects such as nanotubes, nanofibres, nanofilms, nanoaggregates, nanoagglomerates (or aggregates of nanoparticles or nanomaterials), etc. and their applications, as well as nanostructured materials, and this situation would suggest a need to adopt a methodological approach, test protocols and other specific measures,
Amendment 18 #
2008/2208(INI)
Motion for a resolution
Recital E
Recital E
E. whereas in the context of REACH, it has so far not even been possible to agree on guidance on the identification of nanomaterials, leaving and on the need for specific tests and assessments of nanotechnologies and nanomaterials; whereas this situation leaves important decisions in the context of registration to economic operators,
Amendment 23 #
2008/2208(INI)
Motion for a resolution
Recital G
Recital G
G. whereas presentations about the potential benefits of nanotechnologies predict an almost infinite diversity of future applications of nanomaterials; however, the same diversity shrinks to near zerconsiderably when it comes to wthen it comes to reality and use of nanotechnologies and nanomaterials in numerous applications and products and a regulatory discussion about nanomaterials,
Amendment 28 #
2008/2208(INI)
Motion for a resolution
Recital H
Recital H
H. whereas there is a major controversy about the possibility of assessing the safety of nanomaterials: while even though the scientific committees of the Commission point to major deficiencies not only in key data, but even in methods of obtaining such data, and closing the knowledge gap regarding nanotechnologies and nanomaterials; whereas many representatives of industry claim that all relevant data are available and that there are no methodological deficiencies,
Amendment 33 #
2008/2208(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas a significant proportion of the funds in the 7th Framework Programme for research and technological development earmarked for nanotechnologies are allocated to research and development programmes for nanotechnologies, at the expense of evaluation and the drafting and development of specific methodologies to assess the safety and environmental and health impact of nanotechnologies and nanomaterials,
Amendment 35 #
2008/2208(INI)
Motion for a resolution
Recital I
Recital I
I. whereas, in its resolution of 28 September 2006 on nanosciences and nanotechnologies: an action plan for Europe 2005-20091, Parliament had called for investigation of the effects of nanoparticles that are not readily soluble or biodegradable, in accordance with the precautionary principle, before such particles are put into production and placed on the market, 1 OJ C 306 E, 15.12.2006, p. 426.Or. fr
Amendment 36 #
2008/2208(INI)
Motion for a resolution
Recital J
Recital J
J. whereas the value of the Commission Communication on "Regulatory aspects of nanomaterials" is seriously undermindiminished by the complete absence of any information about the specific properties of nanomaterials, their actual uses, and potential risks and benefits, raising doubts about the interest and specific value added of nanotechnologies and nanomaterials in comparison to conventional technologies, materials and substances,
Amendment 42 #
2008/2208(INI)
Motion for a resolution
Recital L a (new)
Recital L a (new)
La. whereas substances that may be used in the form of nanomaterials are excluded from the scope of Regulation (EC) No 1907/2006 (REACH), thus ruling out evaluation of these substances, including their nanometric forms; whereas under Regulation (EC) No 1907/2006 (REACH), nanomaterials are not considered as high- risk substances and, as regards the substances covered by the Articles, notification of substances classified as CMR is only compulsory above a 0,1% threshold; whereas the assessment of exposure to the substances is only required if the substance is assessed as toxic for human health or the environment,
Amendment 50 #
2008/2208(INI)
Motion for a resolution
Recital N
Recital N
N. whereas the likely convergence of nanotechnology with biotechnology, biology, cognitive sciences and information technology raises serious ethical questions relating to ethics, safety, security and respect for fundamental rights,
Amendment 53 #
2008/2208(INI)
Motion for a resolution
Recital N a (new)
Recital N a (new)
Na. whereas the precautionary principle, the polluter-pays principle and sustainability objectives should form the basis of the regulatory and guidance framework for nanotechnologies and nanomaterials, these principles and objectives should help steer the development of nanotechnologies and nanomaterials towards uses that are of greatest benefit to society,
Amendment 55 #
2008/2208(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Is convinced that the benefits of nanotechnologies and nanomaterials can only be realised within a clear regulatory and policy framework that fully addresses nanotechnologies and materials and their current and future applications as well as the very nature of potential safety problems relating to nanomaterials;
Amendment 66 #
2008/2208(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Urges that no market authorisation be given for products containing nanotechnologies or nanomaterials that present a risk linked to the exposure of workers or consumers or to an uncontrolled spread in the environment; considers that such a measure is necessary pending the development of specific assessment methods that make it possible to obtain scientific data showing that the nanotechnologies and nanomaterials used are safe for human health and the environment;
Amendment 67 #
2008/2208(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Urges that products already on the market which contain nanotechnologies or nanomaterials be re-assessed on the basis of the "no data, no market" principle contained in Regulation (EC) No 1907/2006 (REACH), and be withdrawn from the market if it turns out that no data are available or that the data are not sufficient to determine that they are safe for human health and the environment;
Amendment 68 #
2008/2208(INI)
Motion for a resolution
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Calls for packaging and segregation measures to be taken concerning waste from products containing nanotechnologies and nanomaterials, and for air treatment and waste water treatment in the nanotechnologies and nanomaterials industries in order to avoid the uncontrolled spread of nanotechnologies and nanomaterials;
Amendment 73 #
2008/2208(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 76 #
2008/2208(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls for an inventory to be compiled of the different types and uses of nanotechnologies and nanomaterials and of public and private research, and for this inventory to be publicly accessible;
Amendment 85 #
2008/2208(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Reiterates its call for labelling of consumer products containingmandatory labelling at Community level of products manufactured using nanotechnologies and/or containing nanomaterials, intended for intermediate or final use, in order to ensure that workers and consumers have clear, reliable and transparent information; emphasises the need to adopt provisions relating to the protection of workers working with nanotechnologies and/or nanomaterials;
Amendment 97 #
2008/2208(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission and the Member States to launch an EU-wide public debate on nanotechnologies and nanomaterials in order to find out which developments regarding nanotechnologies and nanomaterials are considered desirable or necessary and under which conditions,
Amendment 104 #
2008/2208(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Underlines the need for a rapid improvement of the scientific knowledge and thus calls for a Community research policy to be drawn up in the field of nanotechnologies and nanomaterials;
Amendment 105 #
2008/2208(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls, therefore, for a substantial proportion of the funding earmarked for nanotechnologies and nanomaterials in the 7th Framework Programme for research and technological development to be allocated to projects for developing specific methods for the assessment of nanotechnologies and nanomaterials, in order to reduce the gaps in knowledge about nanotechnologies and nanomaterials, their safety and their effects on the environment and human health, including at work;
Amendment 106 #
2008/2208(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Calls on the Commission and Member States to propose, as soon as possible, the establishment of a permanent and independent European decision-making platform responsible for monitoring nanotechnologies and nanomaterials, and a basic and applied research programme on the methodology for this monitoring (particularly metrology, detection, toxicity and epidemiology);
Amendment 110 #
2008/2208(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Considers that regulatory action on nanomaterials should also address nanomaterials that are created as unintended by-products of combustion processes, given that the legislation on air quality does not cover the emission of very fine particles (of under 2,5µm) into the ambient air and in view of the very high number of air pollution-related deaths every year;
Amendment 389 #
2008/2015(INI)
Motion for a resolution
Recital A
Recital A
Amendment 439 #
2008/2015(INI)
Motion for a resolution
Recital Z
Recital Z
Amendment 442 #
2008/2015(INI)
Motion for a resolution
Recital Z a (new)
Recital Z a (new)
Za. whereas the world is currently experiencing rising food prices and severe food scarcity; whereas any development of biofuels must take this into account and not aggravate the existing situation,
Amendment 50 #
2008/0142(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Articles 95, 137 and 152 thereof,
Amendment 53 #
2008/0142(COD)
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) whereas citizens’ entitlements to social security derive from their status as workers, in accordance with Article 137, in particular paragraphs 1, 2 and 4 thereof, and the Commission has a duty to guarantee the Member States’ responsibility with regard to health,
Amendment 58 #
2008/0142(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Given that the conditions for recourse to Article 95 of the Treaty as a legal basis are fulfilled, the Community legislature shall rely on this legal basis even when public health protection is a decisive factor in the choices made; in this respect Article 95(3) of the Treaty explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts.
Amendment 59 #
2008/0142(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 34(1) and (2) and Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 61 #
2008/0142(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Health and health systems in the Member States are a matter of general interest. The health systems of the CommunityMember States are a central component of Europe’s high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development. They are alsoAlthough their specific nature should be noted, at the same time they are part of the wider framework of services of general interest.
Amendment 72 #
2008/0142(COD)
Proposal for a directive
Recital 8
Recital 8
(8) This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensurepermit patients’ mobility under certain conditions and freedom to provide healthcare and high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness. (The third modificationalready uses the terms in the FTrench original does not apply to the English version whichaty.)
Amendment 75 #
2008/0142(COD)
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movementindividual patients who decide to seek treatment in a Member State other than the Member State of affiliation; it may therefore apply to all types of healthcare. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionals.
Amendment 108 #
2008/0142(COD)
Proposal for a directive
Recital 18
Recital 18
(18) The right to reimbursement of the costs of healthcare provided in another Member State from the statutory social security scheme of patients as insured persons was recognised by the Court of Justice in several judgements. The Court of Justice has held that the Treaty provisions on the freedom to provide services includes the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member Sate in order to receive it there. The same applies to recipients of healthcare seeking to receive healthcare provided in another Member State through other means, for example through e-health services. Whilst Community law does not detract from the power of the Member States to organise their healthcare and social security systems, Member States must when exercising that power comply with Community law, in particular with the Treaty provisions on the freedom to provide services. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector.
Amendment 119 #
2008/0142(COD)
Proposal for a directive
Recital 23
Recital 23
(23) The patient may choose which mechanism they prefer, but iIn any case, where the application of Regulation 1408/71 is more beneficial for the patient, the patient should not be deprived of the rights guaranteed by that Regulation.
Amendment 138 #
2008/0142(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Any healthcare which is not regarded as hospital care according to the provisions of this Directive and the law of the Member State of affiliation should be considered as non-hospital care. In the light of the case- law of the Court of Justice on the free movement of services, it is appropriate not to set a requirement of prior authorisation for reimbursement by the statutory social security system of a Member State of affiliation for non- hospital care provided in another Member State. In so far as the reimbursement of such care remains within the limits of the cover guaranteed by the sickness insurance scheme of the Member State of affiliation, the absence of a prior authorisation requirement will not undermine the financial equilibrium of social security systemsHowever, the provision of non- hospital care in another Member State requires the patient to notify the social security administration of the Member State of affiliation about it, this notification being accompanied by a statement that the patient has received all the necessary information before his departure to the other Member State where the care is to be provided. This stipulation does not call into question the principle of automatic authorisation in the case of non-hospital care.
Amendment 140 #
2008/0142(COD)
Proposal for a directive
Recital 30
Recital 30
(30) There is no general definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Communitygeneral definitions of hospital care and specialised care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may beis also appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost- intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedurEach Member State of affiliation should draw up a list of such treatments which will be paid for by its social security system. This list must be published and should not constitute a disproportionate obstacle.
Amendment 151 #
2008/0142(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should therefore provide for a system of prior authorisation for assumption of costs for hospital and specialised care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8.
Amendment 159 #
2008/0142(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely manner and with due care and regard for both those overall principles and the individual circumstances of each case, the period being reduced where the state of health of the patient and the urgency of the treatment so warrant. This applies also to the actual reimbursement of costs of healthcare incurred in another Member State after the patient's return. It is appropriate that patients should normally have a decision regarding the cross-border healthcare within fifteen calendar days. However, that period should be shorter where warranted by the urgency of the treatment in question. In any event, recognition procedures and rules on the provision of services as provided for by Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications should not be affected by these general rules.
Amendment 164 #
2008/0142(COD)
Proposal for a directive
Recital 37
Recital 37
(37) Realising the potential of the internal market for cross-border healthcare requires cooperationCooperation is required between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders. This is particularly the case for cooperation in border regions, where cross- border provision of services may be the most efficient way of organising health services for the local populations, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States. Such cooperation may concern joint planning, mutual recognition or adaptation of procedures or standards, interoperability of respective national information and communication technology systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Directive 2005/36/EC on the recognition of professional qualifications stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to those provisions of Directive 2005/36/EC.
Amendment 167 #
2008/0142(COD)
Proposal for a directive
Recital 37 a (new)
Recital 37 a (new)
(37a) Directive 2005/36/EC stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to the provisions of Directive 2005/36/EC. However, Directive 2005/36/EC takes account only very imperfectly of the specific details of health care qualifications, to the detriment of patients' safety. Appropriate procedures for the recognition of qualifications should therefore be established either as part of the revision of Directive 2005/36/EC or in a specific legislative instrument.
Amendment 178 #
2008/0142(COD)
Proposal for a directive
Recital 41 a (new)
Recital 41 a (new)
(41a) The interoperability of on-line health solutions should be achieved in compliance with national rules on health services adopted to protect patients, including legislation on Internet pharmacies.
Amendment 185 #
2008/0142(COD)
Proposal for a directive
Recital 45
Recital 45
(45) In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 197 #
2008/0142(COD)
Proposal for a directive
Article 1
Article 1
Amendment 209 #
2008/0142(COD)
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or privatcross-border healthcare and to individual patients who independently choose to seek healthcare abroad. This Directive shall not serve to encourage the provision of cross-border healthcare or the referral of patients by the social security scheme of a Member State to the healthcare system of another Member State in order to receive treatment there.
Amendment 223 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 1 - point (f)
Article 3 - paragraph 1 - point (f)
(f) Regulations on coordination of social security schemes, in particular Article 22 of Regulation (EC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community and Council Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems and their implementing regulations;
Amendment 224 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 1 - points (g a) and (g b) (new)
Article 3 - paragraph 1 - points (g a) and (g b) (new)
(ga) Directive 2005/36/EC on the recognition of professional qualifications; (gb) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market.
Amendment 229 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 2
Article 3 - paragraph 2
Amendment 239 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 3
Article 3 - paragraph 3
Amendment 242 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 4
Article 3 - paragraph 4
Amendment 244 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) ‘healthcare’ means a health service provided by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is publics and products provided or prescribed by a health professional to patients with a view to assessing, maintaining or restoring their state of health or preventing the appearance orf privateathologies;
Amendment 275 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) ‘patient’ means any natural person who receives or wisheseeks to receive healthcare in a Member State;
Amendment 296 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) ‘harm’ means adverse health outcomes or injuries stemming from the provision of healthcare where these outcomes or injuries can be linked only to the best- endeavours obligation which requires health professionals to do everything in their power to restore a patient’s state of health.
Amendment 312 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 1 – introduction
Article 5 – paragraph 1 – introduction
1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that: [Translator’s note: The first change in French, not shown here, introduces the term used in the EC Treaty. The English already uses the term used in the Treaty (Article 152(5).]in accordance with principles of general interest, universality, access to effective, uninterrupted, good quality care close to home and at a reasonable cost, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 328 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices, and that they are properly met;
Amendment 337 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on their contract status, availability, prices and outcomes of the healthcare providedreimbursement levels and procedures, quality indices and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 353 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory and that health professionals inform the competent authorities that they have taken out such insurance;
Amendment 392 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided.
Amendment 402 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Amendment 412 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation mayshall impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons.
Amendment 423 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Member States shall have a mechanism for calculation of costs that are to be reimbursed to the insured person by the statutory social security system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had the same or similar healthcare been provided in the territory of the Member State of affiliation, in accordance with the provisions contained in paragraph 2.
Amendment 426 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed, by the Member State of affiliation, access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.
Amendment 437 #
2008/0142(COD)
Proposal for a directive
Article 7
Article 7
The Member State of affiliation shall not make the reimbursement of the costs of non-hospital care provided in another Member State subject to prior authorisation, where the cost of that care, if it had been provided in its territory, would have been paid for by its social security system. . Any patients who receive non-hospital care in another Member State shall notify this care to the social security scheme of their Member State of affiliation before they leave to receive the care They shall also declare that they have received information concerning the care, in accordance with Article 10 of this Directive. If such a declaration is not sent with the notification of non-hospital care in another Member State, the social security scheme of the Member State of affiliation shall ascertain from the patients that they have taken steps prior to their departure to receive all the necessary information relating to this non-hospital care in another Member State.
Amendment 443 #
2008/0142(COD)
Proposal for a directive
Article 8
Article 8
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care and specialised care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night; (b) healthcare, included in a specific list, that does noas defined in the legislation of the Member State of affiliation, which shall be subject to planning if it requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that or requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcare involvinges treatments presenting a particular risk for the patient or the population. 23. This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).3. 3. The Member State of affiliation may provide for a system ofe Member State of affiliation shall submit for prior authorisation fthe payment or reimbursement by its social security system of the cost of hospital or specialised care provided in another Member State where the following conditions are met : (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriousl, as defined by the Member State of affiliation in accordance with Paragraph 1. 4. The refusal of prior authorisation shall be limited to what is necessary uandermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. 4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination proportionate and shall not constitute a means of arbitrary discrimination. 4a. The authorisation required under Paragraph 1 may be refused if it is established that a move may compromise the patient's state of health or the provision of medical treatment. 5. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.
Amendment 508 #
2008/0142(COD)
Proposal for a directive
Article 9
Article 9
1. The Member State of affiliation shall ensure that administrative procedures regarding the use of healthcare in another Member State related to any prior authorisation referred to in Article 8(32), reimbursement of costs of healthcare incurred in another Member State and other conditions and formalities referred to in Article 6(3), are based on objective, non- discriminatory criteria which are published in advance, and which are necessary and proportionate to the objective to be achieved. In any event, an insured person shall always be granted the authorisation pursuant to Regulations on coordination of social security referred to in Art. 3.1 f) whenever the conditions of Art.22.1 c) and Art. 22.2 of Regulation 1408/71 are met. 2. Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within time limits set out and made public in advance by the Member States. 3. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(32). 4. Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with, and when considering these requests, take into account: (a) the specific medical condition, (b) the patient's degree of pain, (c) the nature of the patient's disability, and (d) the patient's ability to carry out a professional activity. 5. Member States shall ensure that any administrative or medical decisions regarding the use of healthcare in another Member State are subject to administrative review, possibly on the basis of a medical opinion, and also capable of being challenged in judicial proceedings, which include provision for interim measures.
Amendment 545 #
2008/0142(COD)
Proposal for a directive
Article 10
Article 10
1. The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received. In particular, the information shall contain: • a list of the healthcare covered by the health system of the Member State of affiliation and the rates of reimbursement or coverage; • the quality and safety standards applicable in another Member State. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall include information on of treatment; • the availability, prices, quality certifications and risks inherent in the healthcare provided, and details of the insurance cover or other means of personal or collective protection with regard to professional liability of the healthcare providers in the Member State of treatment; • a list of the healthcare providers recognised by the competent authorities of the Member State of treatment; • patients' entitlements, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlementsredress if patients are deprived of such entitlements; • the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. The Member States shall ensure that this information complies with public health considerations, and is impartial, comparative, unbiased and complete. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall be gathered in accordance with the cooperation mechanism described at Article 13. 3. The Commission may, in accordance with the procedure referred to in Article 19(2), develop a standard Community format for the prior information referred to in paragraph 1.
Amendment 562 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall designate nationWithout prejudice to the particular organisation of their healthcare systems, Member States shall designate existing structures such as central contact points for cross-border healthcare and communicate their names and contact details to the Commission.
Amendment 611 #
2008/0142(COD)
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall exchange information on disciplinary and criminal law proceedings taken on their territory against health professionals.
Amendment 612 #
2008/0142(COD)
Proposal for a directive
Article 13 – paragraph 2 b (new)
Article 13 – paragraph 2 b (new)
2b. Member States shall guarantee that Member States' registers of health professionals can be consulted by the counterpart competent authorities in other Member States.
Amendment 613 #
2008/0142(COD)
Proposal for a directive
Article 13 – paragraph 2 c (new)
Article 13 – paragraph 2 c (new)
2c. Member States shall inform the Commission of the failure by a Member State to fulfil its obligations to provide mutual cooperation and assistance. If necessary, the Commission shall take the appropriate action under Article 226 of the Treaty. The Commission shall keep Member States regularly informed about the application of provisions relating to the duty of cooperation.
Amendment 621 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
These prescriptions shall be recognised without prejudice to: a) national provisions concerning the form of the medicinal product dispensed, including provisions concerning the substitution of generics; (b) national provisions concerning the reimbursement of European prescriptions; (c) all professional or moral obligations that allow the pharmacist to refuse to dispense the medicinal product that is the subject of the prescription issued in the Member State of treatment.
Amendment 631 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible; prescriptions issued using this Community form must be formulated in accordance with the international non-proprietary name (INN) system;
Amendment 640 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 648 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Member States shall facilitate the development of the European reference networks of healthcare provider services and healthcare providers for rare diseases. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.
Amendment 653 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 2 - point c
Article 15 - paragraph 2 - point c
(c) to maximise cost-effective use of resources by concentrating them where medically appropriate;
Amendment 679 #
2008/0142(COD)
Proposal for a directive
Article 16
Article 16
The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them. Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law. They shall specify in particular: - the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high- quality and efficient provision of cross- border health services; - the rules on access to the medical file and, more specifically, the rules on obtaining the explicit consent of the patient for access to his medical file.
Amendment 700 #
2008/0142(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representativea representative of the Member States. The Committee shall consult stakeholders, such as the representatives of payer organisations, including health mutuals, patients and health professionals (including hospitals), as it deems necessary or if one of the stakeholders so requests.
Amendment 703 #
2008/0142(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
The Commission shall within fivthree years after the date referred to in Article 22(1) draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council, and thereafter at least every five years. That report shall pay particular attention to the effects of the application of this Directive on access to healthcare and health services from a financial and geographical viewpoint, and on the mobility of patients and of all the actors in the Member States’ health systems. It shall involve all stakeholders and all actors, infrastructures and health systems in the Member States, including hospitals and payer organisations. If necessary, the Commission shall enclose proposals for legal amendments with the report.
Amendment 706 #
2008/0142(COD)
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by … [onthree years after its entry into force].
Amendment 22 #
2008/0045(COD)
Proposal for a directive – amending act
Article 2 – point 1 a (new)
Article 2 – point 1 a (new)
Directive 2001/83/EC
Article 23 c (new)
Article 23 c (new)
(1a) The following Article 23c is inserted: “Article 23c The appropriate arrangements adopted by the Commission must take the following considerations into account: – For practical reasons of efficiency, the possibility should be extended to all the categories of change of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations; – In the framework of extensions of marketing authorisations, the possibility should be provided, on the basis of arguments in justification, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary. That application shall be deemed to form part of the marketing authorisation referred to in Article 6 of this Directive.”
Amendment 43 #
2008/0035(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point k a (new)
Article 2 – paragraph 1 – point k a (new)
(ka) 'nano-object' means a solid and intentionally manufactured or used object, structure or facility with one or two dimensions on a scale between 100 and 500 nm,
Amendment 77 #
2008/0035(COD)
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article 12a Nanomaterials 1. A nanomaterial may only be used in a particular cosmetic product if the substance has been evaluated by the SCCP and found to be safe for use in this cosmetic product. To this end the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 27(3). 2. If a manufacturer has placed on the market a cosmetic product containing one or more nanomaterials before the date of entry into force referred to in Article 34(1), it should provide notification within two months of the nanomaterials used in this product. No later than ...*, the manufacturer shall submit the safety data related to the nanomaterials to the SCCP in order for these substances to be assessed. If no safety data is provided within the period laid down in the previous subparagraph, the cosmetic products containing the nonmaterial(s) shall immediately be removed from the market. No later than …**, the SCCP shall assess the nanomaterials notified by the manufacturers and enter them in the relevant annexes on the basis of the assessment results. 3. On imperative grounds of urgency or if the SCCP raises further concerns about the safety of a specific nanomaterial, the Commission may have recourse to the urgency procedure referred to in Article 27(4). 4. The Commission shall mandate the SCCP to re-evaluate these substances as soon as safety concerns arise and at the latest every 5 years after their inclusion in the annexes. * Six months after the date of entry into force of this regulation. ** Two years after the date of entry into force of this regulation.
Amendment 85 #
2008/0035(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point g – subparagraph 3 a (new)
Article 15 – paragraph 1 – point g – subparagraph 3 a (new)
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be preceded by the word 'nano'.
Amendment 97 #
2008/0035(COD)
Proposal for a regulation
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
1a. The Commission shall compile Annex VIa within 24 months of the date of entry into force of this Regulation, on the basis of risk assessments carried out by the SCCP.
Amendment 150 #
2008/0028(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Food information law should provide sufficient flexibility to be able to keep up to date with new information requirements from consumers and ensure a balance between the protection of the internal market and the differences in the perception of consumers in the Member States.
Amendment 156 #
2008/0028(COD)
Proposal for a regulation
Recital 23
Recital 23
Amendment 158 #
2008/0028(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Food labels should be clearprecise, clear, easily readable and understandable to assist consumers wanting to make better-informedconscious food and dietary choices. Studies show that legibility is an important element in maximising the possibility that labelled information can influence its audience and that the small print size is one of the main causes of consumer dissatisfaction with food labels.
Amendment 161 #
2008/0028(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) With a view to provide consumers with food information that is necessary to make an informed choice, alcoholic mixed beverages should alsobe labelled as such, provide information on their ingredients and state the alcohol content.
Amendment 181 #
2008/0028(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) To appeal to the average consumer and to serve the informative purpose for which it is introduced, and given the current level of knowledge on the subject of nutrition, the information provided should be simple and easily understood. Research in certain Member States has indicated that consumers find the information on the main nutrients/ingredients in the principal field of view or ‘front of pack’ is useful when making purchasing decisions. Therefore, to ensure thatus consumers can readily see the essential nutrition information when purchasing foods such information should be in the principal field of view of the label. if this information is placed in the principal field of view on the label. But if consumers are to be able to buy this food on the basis of a sufficiently informed choice, it should be mandatory for an easily visible, readable, clear and comprehensible indication, placed under the essential information on the ‘front-of- pack labelling’, to refer consumers to the nutrition declaration on the back or side of the package.
Amendment 187 #
2008/0028(COD)
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) At the latest five years after the entry into force of this Regulation, the Commission shall present to the European Parliament and the Council a report on the research into consumer understanding in the Member States of the various schemes and provisions for information on foods; it shall put forward, if necessary, a legislative proposal for a better framework for the various information schemes and provisions.
Amendment 261 #
2008/0028(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. At the latest three years after the entry into force of this Regulation, the Commission shall present to the European Parliament and the Council a report showing the particular properties of natural mineral water with regard to the prevention, treatment or cure of a human disease,
Amendment 264 #
2008/0028(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Food business operators, within the business under their control, shall not modify the information accompanying a food if such modification would mislead the final consumer or otherwise reduce the level of consumer protection, particularly with regard to health and the ability to make an informed choice, and the possibility of making a sufficiently informed choice.
Amendment 273 #
2008/0028(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Food business operators within the business under their control shall ensure that information relating to non-prepacked food shall be transmitted to the operator receiving the food in order to enable, where appropriate, the provision of the mandatory food information specified in Article 9(1) points (a) to (cd), (f) and (fi) to the final consumer.
Amendment 297 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The particulars referred to in paragraph 1 shall be indicated with words and numbers unless the consumers are informed, as regards one or more particulars, by other forms of expression established by implementing measures adopted by the Commission. Those measures designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
Amendment 306 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 373 #
2008/0028(COD)
Proposal for a regulation
Article 16 - paragraph 1
Article 16 - paragraph 1
1. Without prejudice to Article 9(2), mandatory food information shall appear in athe language easily understood by the consumers of(s) used in the Member States where a food is marketed.
Amendment 379 #
2008/0028(COD)
Proposal for a regulation
Article 17 - paragraph 1
Article 17 - paragraph 1
1. In the case of glass bottles intended for reuse which are indelibly marked and which therefore bear no label, ring or collar only the particulars listed in Article 9(1) (a), to (cd), (e), (f), (g) and (l) shall be mandatory.
Amendment 723 #
2008/0028(COD)
Proposal for a regulation
Annex IX – paragraph 1 – point d – indent 5
Annex IX – paragraph 1 – point d – indent 5
– bakers’ or pastry cooks’ wares which, given the nature of their content, are normally consumeen they have been sold within 24 hours of their manufacture,
Amendment 724 #
2008/0028(COD)
Proposal for a regulation
Annex IX – paragraph 2 – point c a (new)
Annex IX – paragraph 2 – point c a (new)
(ca) the ‘use by date’ shall be indicated on each individual prepackaged portion.
Amendment 72 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 10
Recital 10
(10) Where equivalent measures to reduce greenhouse gas emissions, in particular taxation, are in place for small installations whose emissions do not exceed a threshold of 1025 000 tonnes of CO2 per year, there should be a procedure for enabling Member States to exclude such small installations from the emissions trading system for so long as those measures are applied. This threshold relativelyis the economically most advantageous option, which offers the maximum gain in terms of reduction of administrative costs for each tonne excluded from the system, for reasons of administrative simplicity. As a consequence of the move from five-year allocation periods, and in order to increase certainty and predictability, provisions should be set on the frequency of revision of greenhouse gas emission permits.
Amendment 275 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2003/87/EC
Article 9 – paragraph 1
Article 9 – paragraph 1
The Community-wide quantity of allowances issued each year starting in 2013 shall decrease in a linear manner beginning from the mid-point of the period 2008 to 2012. The quantity shall decrease by a linear factor of 1.74% compared to the average annual total quantity of allowances issued by Member States in accordance with the Commission Decisions on their national allocation plans for the period 2008 to 2012. The linear factor shall correspond to meeting a Community wide greenhouse gas emission reduction target of 30% below 1990 by 2020, with the sectors covered by the Community scheme undertaking two-thirds of this emission reduction effort. Verified emissions in 2005 shall be the year from which effort is determined. The Commission shall publish the linear factor by 30 June 2010. Failing conclusion of an international agreement on climate change, leading by 2020 to mandatory greenhouse gas emissions comparable to the reduction levels agreed upon by the European Council, the linear factor shall decrease to correspond with meeting a Community wide greenhouse gas emission reduction target of 20% below 1990 by 2020, with the sectors covered by the Community scheme undertaking two thirds of this emission reduction effort. Verified emissions in 2005 shall be the year from which effort is determined.
Amendment 327 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10 - paragraph 3 - point a
Article 10 - paragraph 3 - point a
(a) to reduce greenhouse gas emissions, including by means of national measures in support of energy efficiency and by contributing to the Global Energy Efficiency and Renewable Energy Fund, to adapt to the impacts of climate change, taking into account in particular local health care and welfare facilities, and to fund research and development for reducing emissions and adapting, including participation in initiatives within the framework of the European Strategic Energy Technology Plan;
Amendment 331 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10 - paragraph 3 - point b a (new)
Article 10 - paragraph 3 - point b a (new)
(ba) to finance research and development activities focusing on energy efficiency and clean technologies in sectors falling within the scope of this Directive;
Amendment 337 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10 - paragraph 3 - point d
Article 10 - paragraph 3 - point d
(d) for measures to avoid deforestation, in particular in Least Developed Countries, both in the EU and in least developed countries, to combat deforestation and promote afforestation and reafforestation, and to encourage forest conservation and the use of timber for constructional or industrial purposes (wood panels, paper pulp, etc.) or as fuelwood by setting up or promoting a value chain for the utilisation of forest timber, encompassed within the broader aims of sustainable forest management and preserving and fostering biodiversity;
Amendment 414 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking account of the most efficient techniques, substitutes, alternative production processes, use of biomass and greenhouse gas capture and storage, and shall not give incentives to increase emissions. No free allocation shall be made in respect of any electricity production and oil refineries.
Amendment 435 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 2
Article 10a – paragraph 2
2. Subject to paragraph 3, no free allocation shall be given to electricity generators, to oil refineries, to installations for the capture, pipelines for the transport or to storage sites for greenhouse gas emissions.
Amendment 624 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2003/87/EC
Article 11a
Article 11a
Use of CERs and only Gold Standard certified CERUs from project activities in the Community scheme before the entry into force of a future international agreement on climate change 1. . Until a future international agreement on climate change has entered into force, and in advance of the application of paragraphs 3 and 4 of Article 28, paragraphs 2 to 7 of this Articleparagraphs 2 to 6 shall apply. 2. Operators may request the competent authority, to the extent that the levels of CER/ERUonly Gold Standard certified CER use allowed to them by Member States for the period 2008 to 2012 have not been used up, to issue allowances to them valid from 2013 onwards in exchange for CERs and only Gold Standard certified CERUs issued in respect of emission reductions up until 2012 from project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012. The amount of allowances issued, including allowances issued under paragraphs 3, 4 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. Until 31 December 2014, the competent authority shall make such an exchange on request. 3. To the extent that the levels of CER/ERUonly Gold Standard certified CER use allowed to operators by Member States for the period 2008 to 2012 have not been used up, competent authorities shall allow operators to exchange only Gold Standard certified CERs from projects that were established before 2013 issued in respect of emission reductions from 2013 onwards for allowances valid from 2013 onwards. The amount of allowances issued, including allowances issued under paragraphs 3, 4 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. The first subparagraph shall apply for all project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012. 4. To the extent that the levels of CER/ERU use allowed to operators by Member States for the period 2008 to 2012 have not been used up, competent authorities shall allow operators to exchange only Gold Standard certified CERs issued in respect of emission reductions from 2013 onwards for allowances from new projects started from 2013 onwards in Least Developed Countries. The first subparagraph shall apply to CERs for all project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012, until those countries have ratified an agreement with the Community or until 2020, whichever is the earlier. The amount of allowances issued, including allowances issued under paragraphs 3, 4 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. 5. To the extent that the levels of CER/ERU use allowed to operators by Member States for the period 2008 to 2012 have not been used up and in the event that the conclusion of an international agreement on climate change is delayed, credits from projects or other emission reducing activities may be used in the Community scheme in accordance with agreements concluded with third countries, specifying levels of use, as long as they are Gold Standard certified. In accordance with such agreements, operators shall be able to use credits from project activities in those third countries, to comply with their obligations under the Community scheme. The amount of allowances issued, including allowances issued under paragraphs 3, 4 and 5, may not exceed 50% of the external credits as referred to above that have not been used up. 6. Any agreements referred to in paragraph 5 shall provide for the use of certified Gold Standard credits in the Community scheme from renewable energy or energy efficiency technologies which promote technological transfer, sustainable development. Any such agreement may also provide for the use of credits from projects where the baseline used is below the level of free allocation under the measures referred to in Article 10a or below the levels required by Community legislation. 7. Once an international agreement on climate change has been reached, only Gold Standard certified CERs from third countries which have ratified that agreement shall be accepted in the Community scheme, at up to 10% of the additional reduction effort under Article 9.
Amendment 727 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 27 - paragraph 1
Article 27 - paragraph 1
1. Member States may exclude, from the Community scheme, combustion installations which have a rated thermal input or normal operating capacity below 25 MW, reported emissions to the competent authority of less than 1025 000 tonnes of carbon dioxide equivalent, excluding emissions from biomass, in each of the preceding 3 years, and which are subject to measures that will achieve an equivalent contribution to emission reductions, if the Member State concerned complies with the following conditions: (a) it notifies the Commission of each such installation, specifying the equivalent measures that are in place, (b) it confirms that monitoring arrangements are in place to assess whether any installation emits 1025 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year; (c) it confirms that if any installation emits 1025 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year or the equivalent measures are no longer in place, the installation will be re-introduced into the system; (d) it publishes the information referred to in points (a), (b) and (c) for public comment.
Amendment 738 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 28
Article 28
Amendment 783 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 1
Annex I - point 1
Directive 2003/87/EC
Annex I - point 1
Annex I - point 1
1. Installations or parts of installations used for research, development and testing of new products and processes, installations subject to equivalent emissions reduction measures and utilised for the supplying of health services and educational activities/establishments, and combustion installations exclusively using biomass are not covered by this Directive.
Amendment 788 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 1
Annex I - point 1
Directive 2003/87/EC
Annex I - point 2
Annex I - point 2
When calculating the total capacity of combustion installations, units with a rated thermal input under 3 MW shall not be taken into account for the purposes of this calculation. Units with a rated thermal input of less than 50 MW which are in operation for no more than 350 hours per year shall not be included for the purposes of this calculation.
Amendment 54 #
2008/0002(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Whereas the European Group on Ethics in Science and New Technologies stated in its Opinion (no. 23) on ethical aspects of animal cloning for food supply of 16 January 2008 that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’. Whereas the Scientific Committee of the European Food Safety Authority concluded in its Opinion1 of 15 July 2008 that ‘the health and welfare of a significant proportion of clones … have been found to be adversely affected, often severely and with a fatal outcome’’. 1 The EFSA Journal (2008) 767, 1-49
Amendment 55 #
2008/0002(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Nanomaterials present in food packaging should be entered on a list of approved nanomaterials, accompanied by a limit on migration into or onto the food products contained in such packaging.
Amendment 62 #
2008/0002(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Criteria for the evaluation of the potential risks arising from novel foods should also be laid down. In order to ensure a harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority ("the Authority") in cooperation with the Member States’ authorities.
Amendment 80 #
2008/0002(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
(ba) foods derived from cloned animals and their descendants. Before the date of entry into force of this Regulation referred to in Article 20, the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council.
Amendment 96 #
2008/0002(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point (c a) (new)
Article 3 – paragraph 2 – point (c a) (new)
(ca) ‘nanomaterial’ means any solid and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale of 100 nm or less.
Amendment 97 #
2008/0002(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point (c b) (new)
Article 3 – paragraph 2 – point (c b) (new)
(cb) ‘nano-object’ means any solid and intentionally manufactured or used object, structure or facility with one or two dimensions on a scale between 100 and 500 nm.
Amendment 102 #
2008/0002(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission mayshall collect information from the Member States and/or from food business operators to determine to what extent a food has been used for human consumption within the Community before 15 May 1997. Business operators in this sector shall be obliged to supply, at the request of the competent authority of the Member States concerned or of the Authority, information on foods which have been used for human consumption in the Community before 15 May 1997.
Amendment 109 #
2008/0002(COD)
Proposal for a regulation
Article 6 – point (c)
Article 6 – point (c)
(c) in the case where it is intended to replace another food, it does not differ from that food to such an extent that its normal consumption would be nutritionally disadvantageous for the consumerand the consumption of such food does not pose a danger to the health of the consumer or of animals.
Amendment 115 #
2008/0002(COD)
Proposal for a regulation
Article 6 – point (c a) (new)
Article 6 – point (c a) (new)
Amendment 121 #
2008/0002(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The entry of a novel food in the Community list shall include a specificationstate the specific ingredients of the food, and, where appropriate, specify specify, where necessary, the conditions of use, additional specific labelling requirements to inform the final consumer and/or a post- market monitoring requirement.
Amendment 134 #
2008/0002(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Amendment 135 #
2008/0002(COD)
Proposal for a regulation
Article 7 b (new)
Article 7 b (new)
Article 7b Migration limits for constituents of food packaging The packaging of novel foods shall comply with the requirements relating to migration limits set out in Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food 1. Where necessary, the Commission shall instruct the relevant scientific committee to set lower migration limits for packaging made from or containing nanomaterials. The Commission shall adopt a decision in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). 1 OJ L 338, 13.11.2004, p. 4.
Amendment 159 #
2008/0002(COD)
Proposal for a regulation
Article 10 – point (a)
Article 10 – point (a)
Amendment 160 #
2008/0002(COD)
Proposal for a regulation
Article 10 – point (a) a (new)
Article 10 – point (a) a (new)
aa) set a maximum limit value for daily consumption of a novel food or novel food ingredient, in excess of which consumption is demonstrably harmful to consumer health;
Amendment 161 #
2008/0002(COD)
Proposal for a regulation
Article 10 – point (a) b (new)
Article 10 – point (a) b (new)
ab) ask the competent authorities, in connection with scientific evaluations of the risks posed by novel foods or novel food ingredients, to supply it with any scientific evaluation they have carried out on the novel food or novel ingredient in question.
Amendment 164 #
2008/0002(COD)
Proposal for a regulation
Article 11
Article 11
1. The Commission mayshall impose for food safety reasons and following the opinion of the Authority, a requirement for post- market monitoring. The on food business operators placing the food in the Community market shall be responsible for the implementation of the post- marketing requirements specified in the entry of the food concerned in the Community list of novel foods. 2. The producer shall forthwith inform the Commission of: (a) any new scientific or technical information which might influence the evaluation of the safety in use of the novel food; (b) any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market. . All novel foods which have been placed on the market shall be subjected to an inspection whenever doubts arise as to their safety, and at any rate no later than five years from the entry into force of this regulation and at five-yearly intervals thereafter. They shall be re-assessed by the Authority if necessary. A specific inspection shall be established for persons with a high consumption of the novel foods in question. 2. Food business operators shall forthwith inform the Commission of: (a) any new scientific or technical information which might influence the evaluation of the safety in use of the novel food; (b) any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market. All food business operators shall notify the Commission and the competent authorities of the Member State in which they operate, on an annual basis, of any health problem of which they have been informed by consumers or consumer protection organisations. The Member States’ relevant market supervision authorities shall be responsible for the inspection. They shall report to the Commission within three months of the completion of the inspection. The Commission shall submit a report to the European Parliament and the Council no later than a year after the expiry of the five-year period referred to in paragraph 1.
Amendment 188 #
2008/0002(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13a Safeguard clause Where a Member State, as a result of new information or the re-evaluation of existing information, has specific reasons for considering that the use of a novel food or a novel food ingredient within the meaning of this regulation poses a risk to human health, that Member State may restrict or suspend the placing on the market and use of the novel food or ingredient in question on its territory. It shall immediately notify the other Member States and the Commission accordingly, specifying the reasons for its decision.
Amendment 2 #
2008/0000(INI)
Motion for a resolution
Recital A
Recital A
A. whereas health is one of the most precious values and, whereas our goal is health for all and whereas we must guarantee a high level of health,
Amendment 7 #
2008/0000(INI)
Motion for a resolution
Recital B
Recital B
B. whereas increasing rates of cancer, diabetes, cardiovascular disease, mental illness, overweight and obesity problems and HIV/AIDS, the poor quality of the environment and the re-emergence of certain diseases associated with growing social inequalities, as well as new challenges are increasingly threatening health in the European Union and beyond,
Amendment 16 #
2008/0000(INI)
Motion for a resolution
Recital D
Recital D
D. whereas population ageing is changing disease patterns and putting pressure on the sustainability of health systemsproper functioning and the guarantee of health care for all,
Amendment 17 #
2008/0000(INI)
Motion for a resolution
Recital E
Recital E
E. whereas wide disparities in healthcare exist between and within Member States, which are associated with the increase in social inequalities,
Amendment 19 #
2008/0000(INI)
Motion for a resolution
Recital F
Recital F
F. whereas citizens expect increasingly common action on health to be increasingly linked to research and good practices in health,
Amendment 23 #
2008/0000(INI)
Motion for a resolution
Recital G
Recital G
G. whereas there are areas where Member States cannot act alone effectively and whereas the European Union is committed to a common health policy with which it can provide added value (e.g. information and good practice exchange) and whereas this action can be improved by means of Community financing under social cohesion policies,
Amendment 24 #
2008/0000(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the organisation of health care is a matter for which Member States are responsible (pursuant to Article 152 of the EC Treaty),
Amendment 25 #
2008/0000(INI)
Motion for a resolution
Recital H
Recital H
H. whereas the demand for mobility of patients, health professionals and health services is risingnot the prime concern of Europe's citizens,
Amendment 27 #
2008/0000(INI)
Motion for a resolution
Recital I
Recital I
I. whereas investment in health is essential for the development of human capital and has an indirect impact on economic successthe various sectors of the economy,
Amendment 32 #
2008/0000(INI)
Motion for a resolution
Recital K
Recital K
K. whereas 40% of health spending is linked to unhealthy lifestyles (alcohol, tobacco, inactivity, diet) and whereas this is to some extent linked to difficult socio- economic situations,
Amendment 38 #
2008/0000(INI)
Motion for a resolution
Recital L a (new)
Recital L a (new)
La. whereas health is a specific field calling for precise knowledge entailing a high level of specialisation and whereas self-medication can have a disastrous impact on people's health,
Amendment 39 #
2008/0000(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the CommissionEncourages the initiative by the Commission with regard to its White Paper on a Community health strategy for the period 2008-2013 and supports the values, principles, strategic goals and specific actions set out therein;
Amendment 40 #
2008/0000(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Regrets, however, the references to the desire to prioritise patient mobility, as the priority of the European Union is to promote care for all in every Member State;
Amendment 44 #
2008/0000(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Believes that, given the existence of new threats to health, there is a need to address health as a key political issue in the spirit of the Lisbon Treaty and the Lisbon Strategy;
Amendment 55 #
2008/0000(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that action plans should address, in particular, the causes of the appearance of certain diseases and the need to reduce communicable and non-communicable diseases;
Amendment 61 #
2008/0000(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that actions aimed at reducing inequities in health should include targeted promotion and public educationthat it should be possible to finance them using Community funds earmarked for them;
Amendment 65 #
2008/0000(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Believes that disease prevention efforts should be stepped up significantly, particularly by promoting exchanges of good practices between Member States, and agrees that spending on health is not only a cost, but also an investment;
Amendment 75 #
2008/0000(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Believes that the rights of citizens and their responsibility for their own health should be fundamental in the context of a European Union which imposes high health and food safety standards; emphasises the importance of health literacy programmes and encouraging all sectors of society to lead healthy lifestyles;
Amendment 79 #
2008/0000(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Encourages the Commission to abandon the idea that the patient should 'become an active subject', taking the view that there is no precise definition of this concept;
Amendment 83 #
2008/0000(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Expects the Commission to pay particular attention to the question of the sustainability of health systems and, in that context, also to the role and responsibility of the pharmaceutical industry;
Amendment 84 #
2008/0000(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Welcomes the intention to define fundamental health values and establish a system of health indicators (at national and sub-national level) and to promote health literacy programmes and programmes to prevent health problems;
Amendment 86 #
2008/0000(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Welcomes the intention, in the spirit of ‘health for all’, to promote health and disease prevention among all age groups; stresses the need to highlight key health- related issues, such as nutrition, obesity, physical activity, consumption of alcohol, drugs and tobacco and environmental risks, including air pollution, while taking into account the role of gender, providing support for healthy ageing and reducing the burden of chronic illnesses;
Amendment 96 #
2008/0000(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Considers that poor application of Community environmental legislation also has an adverse impact on the state of health of European citizens;
Amendment 97 #
2008/0000(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses that, in certain situations, European citizens face health problems such as air pollution which represent a considerable threat to health, affecting the proper development of children and reducing life expectancy in the EU1; 1 Report, 'Europe's environment: 4th assessment, summary – European Environment Agency (10 October 2007).
Amendment 102 #
2008/0000(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Reminds the Commission of the call by the European Parliament1 for the inclusion in the action plan of the subject of occupational health, this point being essential in this white paper, 'Together for health'; 1 Cf. Paragraph 22 of the EP's Resolution of 23 February 2005 on the Environment and Health Action Plan.
Amendment 110 #
2008/0000(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to support the development of e-health, drawing up precise rules and defining a clear framework for this concept;
Amendment 112 #
2008/0000(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Stresses that preventing diseases by means of new technologies such as the 'on-line health' programme remains an inadequate approach and cannot be the main objective in the field of prevention;
Amendment 113 #
2008/0000(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Expresses its concern about the importance assigned to the development of 'on-line health', as access to new technologies is extremely uneven among the people of the European Union;
Amendment 24 #
2007/2285(INI)
Motion for a resolution
Recital E
Recital E
E. considering physical activity, coupled with a balanced diet, to be the primary prevention against overweight and noting with alarm that one in three Europeans do not exercise at all in their free time, while the average European spends over five hours a day sitting down, and that many Europeans do not follow a balanced diet,
Amendment 47 #
2007/2285(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Amendment 50 #
2007/2285(INI)
Motion for a resolution
Recital J
Recital J
J. considering the importance of different traditional cuisines which should be preserved as part of our cultural heritage and which should be promoted as valid alternatives to fast-food or pre-cooked food; whereas the quality and diversity of food products and diet are a major element in the acquisition of healthy eating culturehabits,
Amendment 69 #
2007/2285(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the White Paper on nutrition as a starting point to stem the rise in obesitycases of obesity and overweight in Europe;
Amendment 90 #
2007/2285(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Recognises the substantial role of self-regulation, but emphasises that it cannot on its own resolve all the proble and effectiveness of self-regulationms facing us, and that the implementation of legislation and adapted forms of regulation can ensure consumer protection and high standards of public health;
Amendment 95 #
2007/2285(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls, however, for more tangible measures especially targeted at childrenthe social categories most affected by falling purchasing power, and at-risk groups such as elderly people, especially womwomen and children, disabled persons, and poor and unemployed people;
Amendment 133 #
2007/2285(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses the need to provide special funding for SMEs in order to enable these actors to contribute to reaching the objective of reducing obesity by developing new products,at the private sector has a role to play in reducing obesity by developing new and healthier products; believes, however, that there is a need to step up encouragement of the private sector to develop information systems and improve labelling;
Amendment 143 #
2007/2285(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls for information campaigns to raise awareness among pregnant women about the importance of a balanced diet and about the importance of exclusive breastfeeding for a minimum of six months; recalls that bfor themselves and for the foetus; calls on the Member States to raise pregnant women’s awareness concerning breastfeeding; stresses, nonetheless, that breastfeeding is not the sole means of fighting obesity, and that balanced eating habiets bareastfed for nine months show an overall reduction of risk of 31% acquired over a long period; emphasises that awareness campaigns should recall that breastfeeding is a private matter and should respect women’s free will and choice;
Amendment 151 #
2007/2285(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Considers that informing and educating parents on nutritional issues should be carried out via the relevant professionals (teachers, cultural organisers, health professionals) at the appropriate locations;
Amendment 190 #
2007/2285(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Considers it essential that every kind of sponsorship and advertising for so-called HSSF products (high in sugar, salt, fat) should be banned in schools; asks for a voluntary commitment by all sports organisations and teams in order to promote balanced nutrition and physical activity and urges them to avoid sponsorship and promotion of food of poor nutritional value; calls on schools to hold theoretical and practical workshops on taste and food, in partnership with health professionals and reputed chefs;
Amendment 236 #
2007/2285(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Invites Member States to promote the distribution of coupons for fresh fruit and vegetables for low-income people, especially the elderly and women with children, to be used only at approved local food markets to guarantee the nutritional quality of productsand the Union to adopt measures enabling low-income social groups to buy fruit and vegetables at reasonable prices and, more generally, to follow a more balanced diet;
Amendment 243 #
2007/2285(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on industry to review single- serving portion sizes, providing a broader range of smaller portion options; calls on supermarkets, and restaurants and fast-food operators to promote the availability of organic products at a reasonable price;
Amendment 252 #
2007/2285(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Asks the Commission to accelerate the revision of Council Directive 90/496/ EEC of 24 September 1990 on nutrition labelling for foodstuffs1 taking care that labelling is meaningfulvisible, clear and easily understandable to the consumer;
Amendment 1 #
2007/2252(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to Articles 152 and 174 of the EC Treaty targeting a high level of protection for human health and the environment;
Amendment 6 #
2007/2252(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the Cardiff process – a political process enabling environmental considerations to be integrated into other policies – has been abandoned;
Amendment 11 #
2007/2252(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas atmospheric pollution caused, in particular, by fine particles and ground-level ozone, is a significant threat to human health which is affecting the proper development of children and reducing life expectancy in the EU1; 1 Europe's environment, the fourth assessment – European Environment Agency (add the date)
Amendment 27 #
2007/2252(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls uponUrges the Commission to respond by 2010June 2009 at the latest to two essential objectives which the Commission set itself in 2004, namely to make members of the general public aware of environmental pollution and the impact thereof on their health, and to reconsider and adapt European risk- reduction policy; strongly encourages the Commission to implement the few practical measures set out in its action plan;
Amendment 29 #
2007/2252(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that failure properly to implement Community environmental legislation also has an adverse effect on public health in Europe; strongly recommends that the Member States and the Commission meet their obligations as regards implementation of Community legislation;
Amendment 33 #
2007/2252(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Urges the Commission, when drafting proposals for the revision of existing laws, not to weaken those laws under pressure from lobbies or regional or international organisations;
Amendment 49 #
2007/2252(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
Amendment 65 #
2007/2252(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Advises the Commission to envisage (by 2010 andJune 2009 at the latest under the ‘second round’ of the health and environment action plan and with a view to the fifth ministerial conference in late 2009) refocusing its initiatives on vulnerable populations and to devise new methods of risk-assessment, taking into account the fundamental fact that children are particularly vulnerable;
Amendment 66 #
2007/2252(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission to reincorporate into its second action plan the pillar relating to the reduction of exposure to pollution, as set out in the European Environment and Health Strategy (SCALE) (COM(2003)0338);
Amendment 69 #
2007/2252(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Urges the Commission and Member States therefore to acknowledge the advantages of the prevention and precautionary principles and to develop and implement tools enabling potential environmental and health threats to be anticipated and countered; recommends that the Commission cost the 'second cycle' of this action plan and make provision for appropriate funding covering a larger number of practical measures to reduce environmental impact on health and to implement prevention and precautionary measures;
Amendment 160 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2.. The excess emissions premium under paragraph 1 shall be calculated using the following formula: Excess emissions x number of new passenger cars which emit more than 130 g CO2/km x excess emissions premium prescribed in paragraph 3. Where: 'Excess emissions' means the positive number of grams per kilometre by which the manufacturer's average specific emissions exceeded its specific emissions target in the calendar year rounded to the nearest three decimal places; and 'Number of new passenger cars' means the number of new passenger cars for which it is the manufacturer and which were registered in that year.
Amendment 243 #
2007/0297(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
Amendment 81 #
2007/0286(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) The co-incineration of waste in plants not primarily intended to incinerate waste should not be allowed to cause higher emissions of polluting substances in that part of the exhaust gas volume resulting from such co-incineration than those permitted for dedicated incineration plants and should therefore be subject to appropriate limitations.
Amendment 393 #
2007/0286(COD)
Proposal for a directive
Annex I – point 5.2.
Annex I – point 5.2.
5.2. Incineration and co-incineration of non-hazardous waste with a capacity exceeding 3 tonnes per hour.
Amendment 508 #
2007/0286(COD)
Proposal for a directive
Annex VI – Part 6 – point 2.5 – subparagraph 1
Annex VI – Part 6 – point 2.5 – subparagraph 1
2.5. The competent authority may decide not to require continuous measurements for HCI, HF and SO2 in waste incineration plants or waste co-incineration plants and require periodic measurements as set out in point 2.1(c) or no measurements if the operator can prove that the emissions of those pollutants can under no circumstances be higher than the prescribed emission limit values.
Amendment 514 #
2007/0286(COD)
Proposal for a directive
Annex VI – Part 6 – point 2.5 – subparagraph 2
Annex VI – Part 6 – point 2.5 – subparagraph 2
Amendment 526 #
2007/0286(COD)
Proposal for a directive
Annex VI – Part 8 – point 1.1 – point d – subpoint i a (new)
Annex VI – Part 8 – point 1.1 – point d – subpoint i a (new)
(ia) in the case of incineration plants treating hazardous waste: - at least 95 % of all 10-minute average values or all of the half-hourly average values determined in any 24-hour period do not exceed the emission limit values set out in points 1.5(b) and (c) of Part 3;
Amendment 97 #
2007/0121(COD)
Proposal for a regulation – amending act
Article 23 - point (b)
Article 23 - point (b)
b) the signal words, hazard statements and precautionary statlabel elements shall be placed on the label in the supplemental information section as referred to in Article 27.
Amendment 27 #
2007/0064(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point (b)
Article 1 – paragraph 1 – point (b)
(b) the tolerance levelin respect of a residues of a pharmacologically active substance below which human exposure to that residue through food containing the substance is considered negligibles which are not subject to a classification in accordance with Article 13(2)(a), (b) or (c), the minimum content of an analyte in a sample, which at least has to be detected and confirmed by a reference control laboratory designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated according to Community requirements ("reference point for action").
Amendment 84 #
2007/0064(COD)
Proposal for a regulation
Article 16
Article 16
Member States may notshall prohibit or impede the import and placing on the market of food of animal origin on grounds related to maximum residue limits where the provisions of this Regulation and its implementing measures have been complied withcontaining residues of pharmacologically active substances which are not subject to a classification in accordance with Article 13(2)(a), (b) or (c).
Amendment 90 #
2007/0064(COD)
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 3
Article 17 – paragraph 1 – subparagraph 3
The reference points for action shall be reviewed regularly in the light of technological progressany new information relating to the protection of human health and the food chain.
Amendment 96 #
2007/0064(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The reference points for action shall be based on the content of an analyte in a sample, which canat least has to be detected and confirmed by a reference control laboratory designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated according to Community requirements. In this, the Commission shall be advised by the relevant Community reference laboratory on the performance of analytical methods.
Amendment 98 #
2007/0064(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 100 #
2007/0064(COD)
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
Amendment 105 #
2007/0064(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
1. 1. Regulation (EEC) N° 2377/90 is repealedand Decision 2005/34/EC are repealed. Decision 2002/657/EC is amended as follows: (a) Article 4 is repealed; (b) the term 'minimum required performance limits (MRPL)' is replaced by the term 'reference points for action'.
Amendment 233 #
2006/0136(COD)
Article 4 – paragraph 7
7. By way of derogation from paragraph 1, where on the basis of documented evidence, particularly an analysis of the scientific documentation, an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means, such active substance may be approved for a timeperiod limited period not exceeding fiveto two years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For suchThis approval may be renewed once, in accordance with the provisions of the previous subparagraph. In the case of these substances, the maximum limits applicable to residue levels shallve be seten laid down in accordance with Regulation (EC) No 396/2005. This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1 oror genotoxic, substances toxic for reproduction cof Category 1ies 1 and 2 or substances classified as endocrine disruptors.
Amendment 14 #
2006/0132(COD)
Recital 1
(1) In line with Articles 2 and 7 of Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme, this Directive establishes a common legal framework for achieving a sustainable use of pesticides should be established, taking account of the precautionary principle.
Amendment 16 #
2006/0132(COD)
Recital 4
(4) National Action Plans aimed at setting quantitative objectives, targets, measures, indicators and timetables to reduce risks and impacts of pesticide use onpesticide use and the risks to human health and the environment and at encouraging the development and introduction of Integrated Pest Management and of alternative non-chemical approaches or techniques in order to reduce dependency on the use of pesticides should be used by Member States in order to facilitate the implementation of this Directive. National Action Plans mayshould be coordinated with implementation plans under other relevant Community legislation and could be used for grouping together objectives to be achieved under other Community legislation related to pesticides.
Amendment 18 #
2006/0132(COD)
Recital 9
(9) Considering the possible risks from the use of pesticides, in particular their acute and chronic health effects and their environmental effects, consumers and the general public should be better informed on the overall impacts of the use of pesticides particularly through the media but also through awareness- raising campaigns, information passed on through retailers and other appropriate measures about both the health and environmental risk and short and long-term adverse effects related to the use of pesticides and about non-chemical alternatives. Member States should monitor and collect data on impacts of pesticide use, including poisoning incidents, and promote long- term research programmes on the effects of pesticide use.
Amendment 21 #
2006/0132(COD)
Recital 12
(12) Aerial spraying of pesticides has the potential to cause significant adverse impacts on human health and the environment, in particular from spray drift. Therefore, aerial spraying should generally be prohibited with derogations possible where it represents clear advantages in terms of reduced impacts on human health and the environment in comparison with other spraying methods, or where there are no viable alternatives, provided that the best available technology to reduce drift is used (e.g. low-drift nozzles) and the health of residents or bystanders is not affected.
Amendment 22 #
2006/0132(COD)
Recital 14
(14) Use of pesticides can be particularly dangerous in very sensitive areas, such as Natura 2000 sites protected in accordance with Directives 79/409/EEC and 92/43/EEC. In other places such as residential areas, public parks, sports grounds or children's playgroundsand recreation grounds, school grounds and children's playgrounds, and in the vicinity of public healthcare facilities (clinics, hospitals, rehabilitation centres, health resorts, hospices), the risks from exposure to pesticides of the general public are high. Use of pesticides in those areas should, therefore, be prohibited, restricted or the risks arising from such use minimised.
Amendment 30 #
2006/0132(COD)
Article 1
This Directive establishes a framework to achieve a sustainable use of pesticides by reducing their use and the risks and impacts of pesticide use on human health and the environment in line with the precautionary principle and promoting the use of Integrated Pest Management and of alternative approaches or technique, giving priority to non-chemical methods.
Amendment 32 #
2006/0132(COD)
Article 2 – paragraph 2 b (new)
2b. The provisions of this Directive shall not prevent Member States from applying the precautionary principle in restricting or prohibiting the use of pesticides.
Amendment 33 #
2006/0132(COD)
Article 3 – point 1 a (new)
1a) "use" means all operations carried out with a pesticide, such as storage, handling, dilution, mixing, and application;
Amendment 39 #
2006/0132(COD)
Article 3 – point 9 a (new)
9a) "use reduction" means reduction of applications of pesticides and is not necessarily dependent on volume;
Amendment 42 #
Amendment 44 #
2006/0132(COD)
Article 4 – paragraph 1 – subparagraph 1
1. Member States shall adopt, and implement without undue delay, National Action Plans to set up targets, measures and timetables to reduce risks, including hazards, and impacts of pesticide use on human health and the environment and to encouragsure the development and introduction of integrated pest management and of alternative approaches or techniques, giving priority to non-chemical methods of plant protection and pest and crop management, in order to reduce dependency on and the use of pesticides. The National Action Plans shall as a minimum include: (a) for other than biological pesticides and low-risk plant protection products as defined in Article [50(1)] of Regulation (EC) No ... [concerning the placing of plant protection products on the market], quantitative use reduction targets measured as a treatment index. The treatment index will be adapted to the specific conditions of each Member State. The treatment index will have to be communicated immediately to the Commission for its approval. For active substances of very high concern the reduction target shall be a reduction of at least 50% in relation to the treatment index calculated for the year 2005 by the end of 2013, unless the Member State can prove that it has already achieved a comparable or higher target based on another year of reference from the period 1995-2004; (b) for pesticide formulations classified as toxic or very toxic pursuant to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations1, a quantitative use reduction target measured as sold volumes. This target shall be a reduction of at least 50% calculated in relation to the year 2005 by the end of 2013, unless the Member State can prove that it has already achieved a comparable or higher reduction target based on another year of reference from the period 1995-2004. Member States shall establish a mechanism for financing the introduction of the National Action Plans. 1 OJ L 200, 30.7.1999, p. 1.
Amendment 49 #
2006/0132(COD)
Article 4 – paragraph 1 a (new)
1a. By ...*, Member States shall adopt background reports in accordance with Annex IIa with the objective of identifying national trends in pesticide use and risks and the priority areas and crops to be addressed in the National Action Plan. * One year after the entry into force of this Directive.
Amendment 57 #
2006/0132(COD)
Article 7
1. Member States shall take measures to inform the general public and to promote and facilitate information and awareness- raising programmes and the availability of accurate and balanced information relating to pesticides for the general public, in particular regarding the risks, including hazards, and the potential acute and chronic effects for human health, non-target organisms and the environment andrising from their use, and to the use of non-chemical alternatives. 2. Member States shall put in place mandatory systems for gathering information on pesticide acute and chronic poisoning incidents, especially among pesticide operators, workers, residents and any other groups that may be exposed to pesticides regularly. 3. Member States shall regularly monitor and collect information on indicator species exposed to pesticides and on pesticides in the environment, such as in fresh and marine waters, soil and air, and report on this information regularly to the Commission. 4. Member States shall carry out research programmes into specific situations where pesticides have been linked to impacts on human health and the environment, including studies on high-risk groups, biological diversity and combination effects. 5. To enhance comparability of information, the Commission, in cooperation with the Member States, shall develop by ...* a strategic guidance document on monitoring and surveying of impacts of pesticide use on human health and the environment. * Three years after the entry into force of this Directive.
Amendment 64 #
2006/0132(COD)
Article 9 - paragraph 2 – point b
(b) the pesticides used must be explicitly approvuthorised for aerial spraying by the Member State following a specific assessment addressing risks from aerial spraying; substances classified as very toxic (R50) to aquatic organisms shall not be authorised for aerial spraying;
Amendment 65 #
2006/0132(COD)
Article 9 - paragraph 2 – point d a (new)
(da) the area to be sprayed must not be in close proximity to public or residential areas and there must be no effects on the health of residents or bystanders;
Amendment 66 #
2006/0132(COD)
Article 9 - paragraph 2 – point d b (new)
(db) the aerial craft must be equipped with the best available technology to reduce spray drift (e.g. low-drift nozzles); where helicopters are used, the spray booms must be equipped with injection jets to reduce drift.
Amendment 69 #
2006/0132(COD)
Article 9 - paragraph 2 – point d a (new)
(da) the authorisation shall specify the measures necessary for warning in good time residents and bystanders and for protecting the environment in the vicinity of the area sprayed.
Amendment 71 #
2006/0132(COD)
Article 9 - paragraph 3
3. Member States shall designate the authorities competent for establishing the specific conditions by which aerial spraying may be carried out and. The competent authority is responsible for authorising aerial spraying following a request pursuant to paragraph 4 and for makeing public information on crops, areas, circumstances and particular requirements for application including weather conditions where aerial spraying may be allowed. TIn the authorisation the competent authorities shall specify the measures necessary for warning residents and bystanders in good time and to protect the environment in the vicinity of the area sprayed.
Amendment 72 #
2006/0132(COD)
Article 9 - paragraph 4
4. A professional user wishing to apply pesticides by aerial spraying shall submit a request in due time to the competent authority to apply pesticides by aerial spraying accompanied by evidence to show that the conditions referred to in paragraphs 2 and 3 are fulfilled. Member States may provide that requests for which no answer was received on the decisiThe notification shall con taken within the time period laid down by the competein information about the time of spraying and the amounts authorities shall be deemed to bend the type of pesticides approvlied.
Amendment 73 #
2006/0132(COD)
Article 9 - paragraph 6
6. The competent authorities shall keep records of the requests submitted under paragraph 4 and shall make them available to the public.
Amendment 81 #
2006/0132(COD)
Article 11 –title - introductory part and point 1
Reduction of pesticide use orand risks in specificensitive areas Member States shall, having due regard tofor the necessary hygiene and public health requirements and biodiversity, or the results of relevant risk assessments, ensure that the use of pesticides is prohibited, or restricted tor the risks arising from such use minimisedminimum necessary, in: 1) all areas used by the general public or by vulnerable populations, such as groups, at least in residential areas, parks, public gardens, sports and recreation grounds, school grounds and playgrounds; and in the vicinity of public healthcare facilities (clinics, hospitals, rehabilitation centres, health resorts, hospices) as well as in substantial no-spray zones including in fields around these areas.
Amendment 92 #
2006/0132(COD)
Article 14 – paragraph 3
3. Member States shall communicate the results of the evaluations carried out pursuant to paragraph 2 to the Commission and to other Member States and shall make this information available to the public.
Amendment 103 #
2006/0132(COD)
Annex I – paragraph 6
6. Procedures for preparing pesticide application equipment for work, including its calibration, and for its operation with minimum risks to the user, other humans, non-target animal and plant species, biodiversity and, the environment and water resources..
Amendment 104 #
2006/0132(COD)
Annex I – paragraph 8
8. Emergency action to protect human health and, the environment and water resources in case of accidental spillage and, contamination and extreme weather events that would result in pesticides leaching risks.
Amendment 105 #
2006/0132(COD)
Annex I – paragraph 8 a (new)
8a. Special care in protection areas established under Articles 6 and 7 of Directive 2000/60/EC.
Amendment 38 #
2005/0281(COD)
Recital 12
(12) The classification of waste as hazardous waste should be based, inter- alia, on the Community legislation on chemicals, in particular concerning the classification of preparations as hazardous, including concentration limit values used for that purpose. Furthermore, it is necessary to maintain the system by which waste and hazardous waste have been classified in accordance with the list of the types of waste as last estHazardous wastes are qualified by hazard and risk criteria. As a result, they must be subject to strict specifications in order to prevent or limit, as far as possible, negative effects due to inappropriate management which may affect the environment, and to prevent risks to human health and safety. Because of their hazardous properties, hazardous wastes need an appropriate management which involves specific and adapted collection and treatment techniques, particular controls and dedicated waste traceabilished by Commission Decision 2000/532/EC , in ordty modalities. All hazardous waste oper ato encourage a harmonised classification of waste and ensure the harmonised determination of hazardous waste within the Community. rs need to have adequate qualifications and training. Or. fr (Reinstatement of Amendment 11 adopted at first reading)
Amendment 45 #
2005/0281(COD)
Recital 20
(20) There should be no confusion between the various aspects of the waste definition, and appropriate procedures should be applied, where necessary, to by-products that are not waste, on the one hand, or to waste that ceases to be waste, on the other hand. In order to specify certain aspects of the definition of waste, this Directive should clarify: - when substances or objects resulting from a production process not primarily aimed at producing such substances or objects are by-products and not waste. The decision that a substance is not waste can be taken only on the basis of a coordinated approach, to be regularly updated, and where this is consistent with the protection of the environment and human health. If the use of a by-product is allowed under an environmental licence or general environmental rules, this can be used by Member States as a tool to decide that no overall adverse environmental or human health impacts are expected to occur, and - when certain waste ceases to be waste, laying down end-of-waste criteria that provide a high level of environmental protection and an environmental and economic benefit; possible categories of waste for which "end-of-waste" specifications and criteria should be developed are, among others, construction and demolition waste, some ashes and slags, scrap metals, compost, waste paper and glass. For the purposes of reaching end-of-waste status, a recovery operation may be as simple as the checking of waste to verify that it fulfils the end-of-waste criteria.
Amendment 69 #
2005/0281(COD)
Article 2 – paragraph 1 – point (c)
(c) uncontaminated soil and other naturally occurring material excavated in the course of construction activities where it is certain that the material will be used for the purposes of construction in its natural state on the site from which it was excavated, on condition that these natural geological materials do not have any characteristics which are likely to result in a notable impact on the receiving environment;
Amendment 86 #
2005/0281(COD)
Article 3 – point 14
14) "recovery" means any operation the principal result of which is waste serving a useful purpose by replacing other materials which would otherwise have been used to fulfil a particular function, or waste being prepared to fulfil that function, in the plant or in the wider economy. Annex II sets out a non-exhaustivecommon list of recovery operations; it shall be evaluated and revised regularly in the light of scientific and technological progress;
Amendment 104 #
2005/0281(COD)
Article 4
Amendment 120 #
2005/0281(COD)
Article 5 – paragraph 1 – point b
(b) a market or demand exists for such a substance or object;
Amendment 124 #
2005/0281(COD)
Article 5 – paragraph 3 a (new)
Amendment 126 #
2005/0281(COD)
Article 5 – paragraph 4
4. WherThe criteria have not been set at Community leveladopted under the procedure set out in paragraphs 1 and 2, Member States may decide case b 2 must be defined in such as way case whether certain waste has ceased to be waste taking into account the applicable case law. They shall notify the Commission of such decisions in accordance with Directive 98/34/EC of the European Parliame to guarantee that the product, material or secondary substance resulting from a treatment operation fulfils the requirements necessary for its being placed on the market. The criteria shall take into and of the Council of 22 June 1998 laying down a procedurccount any risks of environmentally harmful use for the provision of information in the field of technical standards and regulations and of rules on Information Society services where so required by that Directiveshipment of the secondary material or substance, and shall be set at a level that guarantees a high level of protection for human health and the environment.
Amendment 145 #
2005/0281(COD)
Article 8 – paragraph 1
1. Member States shall take the necessary measures, in accordance with Article 1, to ensure that waste undergoes recovery operations, in accordance with Articles 10 and 11. These shall include at least the operations listed in Annex II, provided that they satisfy the definition of recovery in Article 3, paragraph 14. Or. fr (ii)
Amendment 147 #
2005/0281(COD)
Article 8 – paragraph 2 a (new)
2a. Member States shall take measures to promote high quality recycling and to this end they shall adopt separate collection schemes wherever necessary to guarantee the necessary quality standards for the relevant recycling sectors. By 2015 the Member States shall set up separate waste collection schemes for at least the following: paper, metal, plastic, glass, textiles, other biodegradable wastes, oil and hazardous wastes. This shall apply without prejudice to existing or future waste stream legislation or the requirements of Article 18.
Amendment 156 #
Amendment 172 #
2005/0281(COD)
Article 15 – paragraph 2 – point ca (new)
(ca) the treatment chosen for the mix shall be based on the most hazardous waste contained in the mix, or it shall be demonstrated that each hazardous waste going to make up the mix can be treated separately.
Amendment 192 #
2005/0281(COD)
Article 19 – paragraph 2
The Commission shall carry out an assessment on the management of bio- waste by 31 December 2008 with a view to submitting a legislative proposal if appropriate.
Amendment 200 #
2005/0281(COD)
Article 21
Amendment 203 #
2005/0281(COD)
Article 22
Amendment 208 #
2005/0281(COD)
Article 23 – paragraph 1 – point (c)
(c) establishments or undertakings which are subject to exemptions from the permit requirements pursuant to Article 21.
Amendment 212 #
2005/0281(COD)
Article 25 – paragraph 3 – point e and ea (new)
(e) general waste management policies, including planned waste management technologies and methods, or policies for waste posing specific management problems; if appropriate, they shall retain or exclude a given mode of recovery or elimination for reasons specific to the planning area and in order to comply with the objectives laid down in Articles 1 and 10 or with any other Community rules in existence elsewhere in the environmental sphere; (ea) where appropriate, the planning area’s waste import or export restrictions or prohibitions.
Amendment 217 #
2005/0281(COD)
Article 28
Member States shall ensure that relevant stakeholders and authorities and the general public have the opportunity to participate in the elaboration of the waste management plans and waste prevention programmes, and have access to them once elaborated, in accordance with Directive 2003/35/EC or, if relevant, Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment . They shall place the plans and programmes on a publicly available website. The Member States shall ensure that decisions of the public authorities or of operators acting on their behalf in the area of waste management allow for public participation, information and access to justice in accordance with Directive 2003/35/CE1 when those decisions relate to the choice of mode of waste recycling, recovery or elimination or siting of the relevant equipment. 1 OJ L 156, 25.6.2003, p. 17.
Amendment 219 #
2005/0281(COD)
Article 31 – paragraph 3