473 Amendments of Elena Oana ANTONESCU
Amendment 19 #
2013/2188(INI)
Motion for a resolution
Recital B
Recital B
B. whereas mutual trust and understanding are key factors in the transatlantic dialogue, partnership and relations;
Amendment 24 #
2013/2188(INI)
Motion for a resolution
Recital C
Recital C
C. whereas in September 2001 the world entered a new phase which resulted in the fight against terrorism being listed among the top priorities of most governments; whereas the revelations based on leaked documents from Edward Snowden, former NSA contractor, put democratically electedput political leaders under an obligation to address the challenges of the increasing capabilities of intelligence agencies in surveillance activities and their implications for the rule of law in a democratic society;
Amendment 75 #
2013/2188(INI)
Motion for a resolution
Recital R b (new)
Recital R b (new)
Rb. whereas the mass collection of personal data for commercial purposes and in the fight against terror and serious transnational crime put at risk the personal data and privacy rights of EU citizens;
Amendment 95 #
2013/2188(INI)
Motion for a resolution
Recital AS
Recital AS
AS. whereas this agreement should provide for clear and precise legally binding data- processing principles and should in particular recognise EU citizens’' right to judicial access, rectification and erasure of their personal data in the US, as well as the right to an efficient administrative and judicial redress mechanism for EU citizens in the US and independent oversight of the data- processing activities;
Amendment 135 #
2013/2188(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. States that trust has been profoundly shaken: trust between the two transatlantic partners, trust among EU Member States, trust between citizens and their governments, trust in the respect of the rule of law, and trust in the security of IT services and communication; believes that in order to rebuild trust in all these dimensions a comprehensive plan is urgently neededof the utmost urgency;
Amendment 142 #
2013/2188(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recalls EU's firm belief in the need to strike the right balance between security measures and the protection of civil liberties and fundamental rights, while ensuring the utmost respect for privacy and data protection;
Amendment 161 #
2013/2188(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is adamant that secret laws, treaties and courts violate the rule of law; pPoints out that any judgment of a court or tribunal and any decision of an administrative authority of a non-EU state authorising, directly or indirectly, surveillance activities such as those examined by this inquiry may not be automatically recognised or enforced, but must be submitted individually to the appropriate national procedures on mutual recognition and legal assistance, including rules imposed by bilateral agreements;
Amendment 172 #
2013/2188(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Strongly rejects the notion that these issuall issues related to mass surveillance programmes are purely a matter of national security and therefore the sole competence of Member States; recalls a recent ruling of the Court of Justice according to which ‘although it is for Member States to take the appropriate measures to ensure their internal and external security, the mere fact that a decision concerns State security cannot result in European Union law being inapplicable’38 ; recalls further that the protection of the privacy of all EU citizens is at stake, as are the security and reliability of all EU communication networks; believes therefore that discussion and action at EU level is not only legitimate, but also a matter of EU autonomy and sovereignty; __________________ 38 No 1 BvR 518/02 of 4 April 2006. No 1 BvR 518/02 of 4 April 2006.
Amendment 215 #
2013/2188(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Member States immediately to fulfil their positive obligation under the European Convention on Human Rights to take measures to protect their citizens from surveillance contrary to its requiremenwhich violates human rights, including when the aim thereof is to safeguard national security, undertaken by third states and to ensure that the rule of law is not weakened as a result of extraterritorial application of a third country’s law;
Amendment 219 #
2013/2188(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the US to revise its legislation without delay in order to bring it into line with international law, to recognise the privacy and other rights of EU citizens, to provide for judicial redress for EU citizens, to put rights of EU citizens on an equal footing with rights of US citizens and to sign the Additional Protocol allowing for complaints by individuals under the ICCPR;
Amendment 264 #
2013/2188(INI)
Motion for a resolution
Paragraph 48
Paragraph 48
48. Asks for an immediate resumption of the negotiations with the US on the ‘'Umbrella Agreement’', which should provide for clearput rights for EU citizens on an equal footing with rights for EUS citizens and, moreover the agreement should provide effective and enforceable administrative and judicial remedies for all EU citizens in the US without any discrimination;
Amendment 270 #
2013/2188(INI)
Motion for a resolution
Paragraph 52 a (new)
Paragraph 52 a (new)
52a. Recalls that the concepts of 'privacy by design' and 'privacy by default' are a strengthening of data protection and should be the guidelines for all products, services and systems provided in the internet;
Amendment 271 #
2013/2188(INI)
Motion for a resolution
Paragraph 52 b (new)
Paragraph 52 b (new)
52b. Considers higher transparency and safety standards for online and telecommunication as a necessary principal towards a better data protection regime, therefore calls on the Commission to bring forward a legal proposal on standardized general terms and conditions for online and telecommunications and to mandate a supervisory body to monitor the compliance of the general terms and conditions;
Amendment 339 #
2013/2188(INI)
Motion for a resolution
Paragraph 73
Paragraph 73
73. Calls on Europol to ask the competent authorities of the Member States, in line with its competences, to initiate investigations with regard to possible cybercrimes and cyber attacks committed by governments or private actors in the course of the activities under scrutiny; calls on the Commission review the activities of the European Cybercrime Centre and to put forward if necessary a proposal for a comprehensive framework for strengthening the competences of the European Cybercrime Centre;
Amendment 371 #
2013/2188(INI)
Motion for a resolution
Paragraph 80
Paragraph 80
80. Calls on all the Members States, the Commission, the Council and the European Council to address the EU’s dangerou's lack of autonomy in terms of IT tools, companies and providers (hardware, software, services and network), and encryption and cryptographic capabilities;
Amendment 378 #
2013/2188(INI)
Motion for a resolution
Paragraph 82
Paragraph 82
82. Points out that both telecom companies and the EU and national telecom regulators have clearly neglected the IT security of their users and clients; calls on the Commission to make full use of its existing powers under the ePrivacy and Telecommunication Framework Directive to strengthen the protection of confidentiality of communication by adopting measures to ensure that terminal equipment is compatible with the right of users to control and protect their personal data, and to ensure a high level of security of telecommunication networks and services, including by way of requiring state-of-the-art encryption of communications;
Amendment 391 #
2013/2188(INI)
Motion for a resolution
Paragraph 85
Paragraph 85
85. Calls on the Commission, to strengthen the technological European infrastructure and the European digital market and therefore in the framework of the next Work Programme of the Horizon 2020 Programme, to assess whether; more resources should be directed towards boosting European research, development, innovation and training in the field of IT technologies, in particular privacy-enhancing technologies and infrastructures, cryptology, secure computing, open-source security solutions and the Information Society in order to make email and telecommunications safer; to promote the internal market for European soft- and hardware, and to promote cryptophones and to encrypt communication infrastructures;
Amendment 396 #
2013/2188(INI)
Motion for a resolution
Paragraph 86
Paragraph 86
86. Asks the Commission to map out current responsibilities and to review, by June 2014 at the latest, the need for a broader mandate, better coordination and/or additional resources and technical capabilities for Europol’'s CyberCrime Centre, ENISA, CERT-EU and the EDPS in order to enable them to be more effective in preventing and investigating major IT breaches in the EU and in performing (or assisting Member States and EU bodies to perform) on-site technical investigations regarding major IT breaches;
Amendment 454 #
2013/2188(INI)
Motion for a resolution
Paragraph 106 a (new)
Paragraph 106 a (new)
106 a. Calls on the Commission to present an action plan for the establishment of a Single European Digital Area (SEDA), including commercial data, data used for law enforcement and intelligence purposes;
Amendment 495 #
2013/2188(INI)
Motion for a resolution
Paragraph 114 – point 4
Paragraph 114 – point 4
Action 4: Suspend the TFTP agreement until (i) the Umbrella Agreement negotiations have been concluded; (ii) a thorough investigation has been concluded on the basis of an EU analysis, and all concerns raised by Parliament in its resolution of 23 October have been properly addressedto conclude the on-going negotiations on a data protection agreement for law enforcement purposes ("umbrella agreement") soon as possible;
Amendment 514 #
2013/2188(INI)
Motion for a resolution
Paragraph 115 – point 1
Paragraph 115 – point 1
April-July 2014: a monitoring group based on the LIBE inquiry team responsible for monitoring any new revelations in the media concerning the inquiry’'s mandate and scrutinising the implementation of this resolution;
Amendment 2 #
2013/2113(INI)
Motion for a resolution
Citation 15
Citation 15
– having regard to the Commission communication of 26 January 2011 entitled ‘A Resource-Efficient Europe – Flagship Initiative Under The Europe 2020 Strategy’ (COM(2011)0021), as well as to the European Parliament resolution of 24 May 2012 on a resource-efficient Europe (P7 – TA(2012)0223),
Amendment 32 #
2013/2113(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the EU coulda better performance in recycling would help the EU to benefit in terms of job creation and growth from a robust effort to move towards a balanced, cradle- to-cradle circular economy, Christian based on the concept of waste as a resource;
Amendment 37 #
2013/2113(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the economic potential for recycling of plastic waste is much higher than the 33% achieved with regard to plastic packaging waste and the 25% achieved with regard to total plastic waste at the moment;
Amendment 39 #
2013/2113(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas statistics on the amount of plastic waste exported outside of the EU are mostly missing;
Amendment 41 #
2013/2113(INI)
Motion for a resolution
Recital E c (new)
Recital E c (new)
Ec. whereas about 80 million tons of plastic waste is estimated to float in the Atlantic Ocean and the Pacific Ocean;
Amendment 44 #
2013/2113(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission’s Green Paper and recognises the need for specific EU legislation on plastic waste, as well as for full transposal and a more rigorous implementation of the existing legislation concerning waste in all the 28 EU Member States;
Amendment 45 #
2013/2113(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission's Green Paper and recognises the need for specific EU legislation on plastic waste, as well as more coherent as well as rigorous implementation of the existing legislation concerning waste;
Amendment 53 #
2013/2113(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Is also aware that some Member States will require transitional periods in which to meet the objectives set at European level;
Amendment 55 #
2013/2113(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Considers that strategic planning can serve as the starting point for effective waste management;
Amendment 64 #
2013/2113(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Emphasises that any future regulation should include waste stream specific recycling targets in order to stimulate plastic waste recycling;
Amendment 74 #
2013/2113(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that the EU legislation on plastic waste should define:be adapted in order to ensure better and more efficient collection systems: - setting specific targets for collection and sorting and mandatory criteria for recyclability (clarifying the distinctions between mechanical/organic recycling and recovery/incineration); the aim should be a target of at least 75 % of recycled plastic by 2020);- introducing separate collection of materials, as well as ensuring a harmonised approach on collection, separation and general waste management across the EU in order to create a level playing field in line with the waste hierarchy; - making possible specific labelling of materials in order to inform consumers concerning their mechanical or organic recyclability; and, finally,about the recyclability of a product, together with indications how consumers could help to increase separate collection, recycling etc.; - identifying criteria for the replacement of single-use and short-lived plastic products by reusable and more durable materials;
Amendment 77 #
2013/2113(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need to remove technical and financial barriers to recycling; stresses that the EU legislation on plastic waste should define: specific targets for collection and sorting and mandatory criteria for recyclability (clarifying the distinctions between mechanical/organic recycling and recovery/incineration; the aim should be a target of at least 75 % of recycled plastic by 2020); specific labelling of materials in order to inform consumers concerning their mechanical or organic recyclability; and, finally, criteria for the replacement of single-use and short-lived plastic products by reusable and more durable materials;
Amendment 88 #
2013/2113(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Agrees that plastic waste should be treated as a valuable resource by promoting its reuse, recycling, and recovery; believes that in any case landfilling should be bannedcalls on the Commission, therefore, to make proposals by 2020,14 without, however, incentivising as a result the energy recovery option over recycling; considers that, alongside the targets mentioned above for recycling, it is therefore advisable to introduce appropriate sanctions for a view to gradually introducing a general ban on waste landfill at European level and for the phasing-out, by the end of this decade, of incineration of recyclable and biodegradcompostable plwastics, in order to level the playing field for different plastic typese; this should be accompanied by appropriate transition measures including the further development of common standards based on life-cycle thinking; points out that this would also invert an unsustainable tendency that has until now privileged the use of virgin products over the more expensive recycled ones; (Adopted text/ European Parliament resolution of 24 May 2012 on a resource- efficient Europe)
Amendment 89 #
2013/2113(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Agrees that plastic waste should be treated as a valuable resource by promoting its reuse, recycling, and recovery; notes with concern the fact that illegal waste dumping still takes place across Europe; believes that in any case landfilling should be banned by 2020, without, however, incentivising as a result the energy recovery option over recycling; considers that, alongside the targets mentioned above for recycling, it is therefore advisable to introduce appropriate sanctions for incineration of recyclable and biodegradable plastics, in order to level the playing field for different plastic types; points out that this would also invert an unsustainable tendency that has until now privileged the use of virgin products over the more expensive recycled ones;
Amendment 104 #
2013/2113(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Believes that the most dangerous plastics, those that are the most disruptive to human health and the environment (such as micro- and oxo-biodegradable plastics) and those which contain heavy metals that can also make recycling processes more difficult, should be phased out of the market or banned outright, as soon as possible before 2020; also believes that, as demanded by a majority of European citizens (and consumers), it is finally time to phase out or ban single-use, non- biodegradable and non-compostable plasticaddress the issue of over-consumption of single-use plastic products seriously, starting by defining precisely what single-use products, also before 2020re;
Amendment 113 #
2013/2113(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Is of the opinion that the two most effective ways of addressing the growing waste burden are awareness raising (with a view to foster waste prevention) and the establishment of innovative waste- management infrastructures;
Amendment 114 #
2013/2113(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers it necessary, owing to the important role consumers play in the management of the waste stream, to adopt measures aimed at changing consumer behaviour;
Amendment 122 #
2013/2113(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that for biodegradable, bio- based and compostable-based plastics, adequate measures should be adopted to promote them, provided their production does not impact negatively on agricultural output for human or animal consumption; also believes that clearer information on their characteristics should be provided to consumers;
Amendment 124 #
2013/2113(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that for biodegradable, bio- based and compostable plastics, adequate measures should be adopted to promote them, provided their production does not impact negatively on agricultural output for human or animal consumption; also believes that clearer information on their characteristics should be provided to consumers; stresses the need to establish European standards which enable a clearer differentiation to be made between degradable, biodegradable and compostable plastic products, and which enhance the existing knowledge base in this field;
Amendment 155 #
2013/2113(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. TBelieves that the financing of waste recycling infrastructure should take priority over the financing of waste dumping and incineration, but also, of course, take into account the needs of each individual community; trusts that European municipalities and local governments will make all possible efforts to motivate citizens to adopt a circular economy concept with regard to plastic waste, by encouraging effective collecting and recycling schemes and establishing adequate collection points for plastic waste, especially in coastal areas; also believes they could make a major contribution towards harmonising plastic waste management activities throughout Europe by agreeing on common standards and practices;
Amendment 159 #
2013/2113(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Trusts that European municipalities and local governments will make all possible efforts to motivate citizens to adopt a circular economy concept with regard to plastic waste, by encouraging effective collecting and recycling schemes and establishing adequate collection points for plastic waste, especially in coastal areas; also believes they could make a major contribution towards harmonising plastic waste management activities throughout Europe by agreeing on common standards and practices; encourages regional authorities to work together with a view to cross-border waste management where this is viable both financially and environmentally;
Amendment 167 #
2013/2113(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls forIn order to foster awareness raising, calls for more concrete action through campaigns, e.g. through the establishment of a European Day for plastic waste, on which citizens could return any volume of plastic waste to predetermined points in return for appropriate monetary compensation, as a means of ensuring the supply of recyclable plastic and increasing public awareness of recycling; considers that this event could also or through events such as a "Clean up Europe" day, includeing community beach cleaning activities, as a symbolic contribution to the containment of coastal pollution caused by plastic waste;
Amendment 57 #
2013/2061(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that eHealth must foster mutual trust between patients and health professionals and that the development of eHealth applications requires not only IT infrastructure and digital literacy, but also measures concerning confidentiality, data protection and liability, in order to ensure that sensitive data are protected from hacking or other forms of abuse.
Amendment 86 #
2013/2061(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Emphasises that eHealth applications must be accessible to everyone. When developing any product or software application, accessibility should be a mandatory condition, in order to prevent that inequality in regard to access will not occur;
Amendment 131 #
2013/2024(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26 a. Recognises that each of the Directives adopted under the roadmap for strengthening procedural rights of suspects and accused persons in criminal proceedings must be implemented effectively to ensure that they improve standards of criminal justice across the EU, by working with Member States towards full transposition into domestic law and by providing training to government officials, judges, prosecutors and defence practitioners.
Amendment 136 #
2013/2024(INI)
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26 b. Considers that further work remains outstanding in relation to pre-trial detention, in relation to which standards in many Member States fall short of human rights and other international standards; recognises the need for an assessment of the effectiveness of non- legislative work on existing Framework Decisions, the widespread recognition of problems with pre-trial detention law and practice across Europe identified as part of the Commission's consultation, and a commitment to revisit the case for establishing minimum and enforceable standards in relation to pre-trial detention through legislative action.
Amendment 42 #
2013/0305(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) The EMCDDA should issue health alerts to all Member States, through the system for rapid exchange of information on new psychoactive substances, if, on the basis of information received on a new psychoactive substance, this seems to cause public health concerns. These health alerts should also contain information regarding prevention, treatment and harm reduction measures that could be taken to address the risk of the substance.
Amendment 91 #
2013/0305(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity, abuse liability and dependence-producing potential, is limited, as it provokes minor injury and disease, and minor physical or mental impairmeinsignificant;
Amendment 10 #
2012/2295(INI)
Motion for a resolution
Recital C
Recital C
C. whereas an innovative and efficient approach will ensure not only greater sustainability but also support for rural development and often SMEs, a potential reduction in greenhouse gas emissions, greater sustainability of the production cycle in addition to the spread of industrial innovation along the entire value chain;
Amendment 14 #
2012/2295(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
D a. whereas bioeconomy is expected to improve health outcomes and help maintain biodiversity;
Amendment 21 #
2012/2295(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Shares the view that the transition to a smart, sustainable and inclusive bioeconomy should be based not only on the production of resources with a low environmental impact, but also on a sustainable use of those resources from an environmental, economic and social point of view;
Amendment 2 #
2012/2258(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to Decision No 940/2011/EU of the European Parliament and of the Council of 14 September 2011 on the European Year for Active Ageing and Solidarity between Generations,
Amendment 4 #
2012/2258(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the Strategic Implementation Plan for the European Innovation Partnership on Active and Healthy Ageing of 17 November 2011,
Amendment 11 #
2012/2258(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission's proposal to promote a new paradigm of viewing ageing as an opportunity for the future rather than a burden on society; howeverfurthermore, emphasises that this opportunity should not be limited to technical (ICT) innovations and its potential for the internal market, for EU industries and enterprises; believes it should also include a clear and unambiguous strategy to promote and formally recognise the value of older people, the value of their experience and of their contribution to society, free of stigma and discrimination;
Amendment 20 #
2012/2258(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Encourages the Commission's proposal to adopt the definition of active and healthy ageing, as formulated by the WHO; however, emphasises that active and healthy ageing encompasses the entire lifespan and that the particularities of the EU context should be part of the definition and more specifically the EU priorities in regard to healthy and ecologically sustainable environmental conditions, health prevention and awareness, health literacy and eHealth, food safety and adequate nutrition, gender equality, and sustainable socio- economic conditions, social security systems and social protection schemes;
Amendment 24 #
2012/2258(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Emphasises that active and healthy ageing encompasses the entire lifespan;
Amendment 25 #
2012/2258(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Believes that the partnership must encompass the current EU priorities in the areas of healthy and ecologically sustainable environmental conditions, health prevention and awareness, access to early diagnosis and treatment, health literacy and eHealth, food safety and adequate nutrition, gender equality, age discrimination, and sustainable socio- economic conditions, social security systems and social protection schemes;
Amendment 28 #
2012/2258(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Supports the Commission's proposal to increase the average number of HLY (Healthy Life Years) by two years as part of the objectives of Horizon 2020; however, emphasises that to achieve this ambitious goal a life-course perspective should be applied; stresses that appropriate mechanisms should be developed so as to fully incorporate overarching policy issues into the equation, such as social security and social protection, employment and economic policies, gender equality and discriminationunderstand the impact of chronic diseases on healthy ageing in the context of a life-course perspective; invites the Commission to provide complete and accessible data on all types of diseases, including chronic diseases, and healthy living to develop the most efficient strategies and permit best practice sharing at both EU and national level;
Amendment 35 #
2012/2258(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Stresses that health issues are to be integrated into all European Union policies including social security and social protection, employment and economic policies, gender equality and discrimination;
Amendment 36 #
2012/2258(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Encourages the Commission to further emphasize that increasing the average number of healthy life years of our citizens by two is the main objective and that all selected actions should measurably contribute first and foremost to this objective;
Amendment 37 #
2012/2258(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Encourages the Commission's proposal to act as a facilitator and coordinator of the EIP-AHA, engaging with stakeholders representing both the demand and supply sides; however, questions to which extent the needs and demands of under- or non- represented groups of Europeans, in particular older people, informal care providers and migrants who are not affiliated to advocacy organisations will be representedpoints out that the Commission should ensure that the EIP benefits to all EU citizens, notably those under- represented or at risk of exclusion; welcomes here the recognition in the Communication (2012)0083 of the role of the EIP in meeting the objectives of the Innovation Union, the Digital Agenda, the New Skills for New Jobs initiative, the European Platform against Poverty and Social Exclusion and the EU Health Strategy;
Amendment 43 #
2012/2258(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reaffirms the Commission's proposal to increase older people's participation in decision- and policy-making and to stimulate regional and local governance; however, stresses that a bottom-up participatory approach requires more in- depth baseline assessments and regular monitoring of the actual and future needs and demands of older people and their informal and formal care providers;
Amendment 55 #
2012/2258(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. InvitWelcomes the Commission’s approach with regard to prevention of frailty and functional decline; encourages the Commission to apply a holistic approach in regard to prevention; points out the systematic correlation between socio- economic status and health outcomes throughout life; invites the Commission and the Member States to tackle structural issues, including health illiteracy, and to eliminate socio-economic inequalities (which lead to health inequalities); further, questionchallenges the responsibility and pressure put on individuals to improve their health status, that is, without appropriately tackling structural issues, including health illiteracy; therefore, invites the Commission and the Member States to create structural conditions which tackle health inequalities;
Amendment 57 #
2012/2258(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Invites the Commission and Member States to acknowledge, promote and fund all forms of prevention, i.e. the promotion of a healthy lifestyle, regular screening for illnesses, early intervention to delay or revert the progression of disease in early stages, and to develop preventive measures aimed at slowing down deterioration for patients affected with chronic diseases;
Amendment 70 #
2012/2258(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Supports the Commission's objective to further develop integrated care systems; however, questions to which extent these systems will be applicable to and appropriate for all EU Member States and/or regions; therefore, invites the Commission to respect regional and local differences in citizens' expectations, norms and values; accordingly, invites the Commission to take into account the appropriateness of the existing, preferred and future care and cure systemsand cure systems; therefore, having due regard to the subsidiarity principle in the field of public health, invites Member States and competent authorities to develop national, regional and local care and cure systems that incorporate a holistic and integrated approach to the management of chronic diseases and invites the Commission to assist Member States in this regard;
Amendment 74 #
2012/2258(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Encourages the Commission to take use of the European Medicines Agency's work on medicines in older people and to integrate it in order to improve access to safe and adequate medicines for older patients;
Amendment 86 #
2012/2258(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Acknowledges the Commission's intention to contribute to making care and cure systems more cost-efficient; however, emphasises that the continuous increase of overall (health) care and social support costs cannot be attributed to population ageing only; furthermore, stresseregrets that the burden of these costs are increasingly being put on the individual, increasingly so, creating a vicious circle in which people's health and well-being are being put at risk as they are compelled to reallocate their often limited resources or when they have to, postpone, abandon or even restrain from treatment, assistance and adequate nutrition;
Amendment 96 #
2012/2258(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Welcomes the Commission's approach in regard to active ageing and independent living, more specifically, its comprehensive view on the role and importance of ‘place in ageing’ as the radius or perimeter in which people live their lives increasingly contracts as they age, and as older people tend to prefer living independently for as long as possible while staying active in their community;
Amendment 102 #
2012/2258(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Supports the Commission's aim towards the creation of age-and disease- friendly environments so as to avoid older people's potential and (remaining)in order to help older people retain their physical and cognitive capacbilities being hindered by their surroundings; however,for as long as possible and live in familiar and safe environment; however, invites the Commission to take into account the creation of ´´Design for all´´ environments and stresses that these surroundingenvironments should be understood in a broad context, not only incorporating the built environment but also the social, psychological, cultural and natural environment; supports measures that will avoid the isolation of elderly and home- bound citizens and break the stigma associated with diseases, age-related or not;
Amendment 116 #
2012/2258(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the foreseen alignment of EU funding instruments to optimise the impact of funding; supports the Joint Programming Initiative "More Years, Better Life" and the decision to identify "Innovation for healthy living and active ageing" as a priority theme for the Knowledge and Innovation Communities (KICs) wave in 2014-2015 of the European Institute of Innovation and Technology (EIT);
Amendment 121 #
2012/2258(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Supports the Commission's approach in regard to age-friendly innovations; however, invites the Commission to ensure that these innovations are end-user- oriented and user-friendly; hence, invites the Commission to develop a methodology through which the current and future needs of older people can be evaluated, since features adapted to older people's needs are proven to be generally to the advantage of younger generations as well;
Amendment 127 #
2012/2258(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Welcomes the existing initiatives on accessibility; calls on the Commission to adopt an ambitious European Accessibility Act to improve the market of accessible goods and services;
Amendment 131 #
2012/2258(INI)
Motion for a resolution
Paragraph 16 f (new)
Paragraph 16 f (new)
16f. Recalls the need to better involve national, regional and local authorities in the creation of "Design for all" environments and innovations; welcomes the Commission's proposal to include active and healthy ageing and innovation as priorities for investment in the cohesion policy package 2014-2020; calls for further initiatives to facilitate exchange of good practices between public authorities;
Amendment 2 #
2012/2043(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls that Article 13 of the Treaty is of general application and as such is equally as important as the environment or consumer protection; stresses that, consequently, the EU's strategy on animal welfare should be coherent with other EU policies and must include initiatives and actions to promote the welfare of all animals in all policy areas;
Amendment 8 #
2012/2043(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses that improved animal welfare relates to food safety and economic benefits for the food chain;
Amendment 15 #
2012/2043(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Stresses the need to improve animal welfare through maintaining and developing policies and legal standards in the area of livestock farming, live animal transport - also called live export, wildlife protection, and animals used in research and testing;
Amendment 478 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibitauthorize the use of additives which are essential for the manufacturein tobacco products which: - contribute to the attractiveness and palatability of tobacco products, as long as th; - are addictives do not result in a product with a or contribute to the addictiveness of tobacco products; - are toxic or characterising flavour.cinogenic or are under suspicion of being carcinogenic;
Amendment 494 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
The Commission shall at the request of a Member State or may on its own initiative determineadopt by means of implementing acts whether a tobacco product falls within the scope of paragraph 1and on the basis of the information provided under Article 5 and the available scientific evidence a common list of additives authorized for use in tobacco products, taking into account the provisions in paragraph 1. Member States may ban additives with known adverse effects prior to their evaluation for approval. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Amendment 801 #
2012/0366(COD)
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
This tobacco product canis damageing to your health and is addictive
Amendment 1257 #
2012/0366(COD)
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
This product can damages your health.
Amendment 1352 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 a (new)
Annex 1 – point 14 a (new)
(14 a) Smoking in presence of children can cause sudden infant death
Amendment 1354 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 b (new)
Annex 1 – point 14 b (new)
(14 b) Smoking during pregnancy causes premature birth
Amendment 1355 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 c (new)
Annex 1 – point 14 c (new)
(14 c) Children that are forced to smoke passive are more vulnerable to asthma and meningitis
Amendment 151 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 16
Annex 1 – point 16
16. The EU’s economic prosperity and well-being is underpinned by its natural capital, which includes ecosystems that provide essential goods and services, from fertile soil and multi-functional forests to productive land and seas, from fresh water and clean air to pollination, flood control and climate regulation and protection against natural disasters. A substantial body of EU legislation seeks to protect, conserve and enhance natural capital, including the Water Framework Directive (WFD) , the Marine Strategy Framework Directive (MSFD) , the Urban Wastewater Directive1, the Nitrates Directive2, the Air Quality and related directives and the Habitats and Birds Directives . Legislation to tackle climate change, chemicals, industrial emissions and waste also contribute to easing the pressures on biodiversity, including ecosystems, species and habitats. __________________ 1 Directive 91/271/EEC. 2 Directive 91/676/EEC.
Amendment 212 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 2 – point f
Annex 1 – point 26 – subparagraph 2 – point f
(f) Taking further steps to reduce emissions of nitrogen and phosphorus, including those from urban and industrial wastewater and from fertilisethrough a better control at source and from fertiliser use through a better control of their use.
Amendment 272 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 38
Annex 1 – point 38
38. Turning waste into a resource, as called for in the Resource Efficiency Roadmap, requires the full implementation of EU waste legislation across the EU, based on strict application of the waste hierarchy and covering different types of waste . Additional efforts are needed to: reduce per capita waste generation in absolute terms, limit energy recovery to non-recyclable materials, phase out landfilling, ensure high quality recycling, and develop markets for secondary raw materials. Hazardous waste will need to be managed so as to minimise significant adverse effects on human health and the environment, as agreed at the Rio+20 Summit. To achieve this, a combination of various market-based instruments that privilege prevention, recycling and re-use should be applied much more systematically across the EU. Barriers facing recycling activities in the EU internal market should be removed and existing prevention, re-use, recycling, recovery and landfill diversion targets reviewed so as to move towards a ‘circular’ economy, with a cascading use of resources and residual waste close to zero.
Amendment 341 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 51
Annex 1 – point 51
51. In addition, the measures to enhance ecological and climate resilience, such as ecosystem restoration and green infrastructure, can have important socioeconomic benefits, includingand significant improvements for public health and wellbeing. The synergies and potential trade-offs between climate and other environmental objectives, such as air quality, need to be adequately managed. For example, fuel switching in response to climate or security of supply considerations could lead to substantial increases in particulate matter and dangerous emissions.
Amendment 383 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 63 – subparagraph 2 - point c
Annex 1 – point 63 – subparagraph 2 - point c
(c) Extendnsuring binding criteria for effective Member State inspections and surveillance to the wider body of EU environment law, and developing a complementary capacity at EU level to address situations where there is due reason for concern, backed up by support for networks of professionals.
Amendment 384 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 63 – subparagraph 2 - point d
Annex 1 – point 63 – subparagraph 2 - point d
(d) Setting upEnsuring consistent and effective mechanisms at national level for the handling of complaints about implementation of EU environment law.
Amendment 411 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 - point a
Annex 1 – point 71 – subparagraph 2 - point a
(a) Coordinating, promoting and focusing research efforts at EU and Member State levels on addressing key environmental knowledge gaps, including the risks of environmental tipping-points.
Amendment 415 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 – point b
Annex 1 – point 71 – subparagraph 2 – point b
(b) Adopting a systematic and integrated approach to risk management.
Amendment 418 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 – point c
Annex 1 – point 71 – subparagraph 2 – point c
(c) Simplifying, streamlining and modernising environmental and climate change data and information collection, management and sharing at all stages of the EU environment and climate policy cycle.
Amendment 2 #
2012/0309(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The imposition of the visa requirement on the nationals of Dominica, Grenada, Kiribati, Marshall Islands, Micronesia, Nauru, Palau, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Timor-Leste, Tonga, Trinidad and Tobago, Tuvalu, the United Arab Emirates and Vanuatu is no longer justified. These countries do not present any risk of illegal immigration or a threat to public policy for the Union in accordance with the criteria set out in recital 5 of Regulation (EC) N° 539/2001. Consequently, nationals of those countries should be exempt from the visa requirement for stays of no more than three months in all and references to those countries should be transferred to Annex II.
Amendment 4 #
2012/0309(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Exemption from the visa requirement for nationals of Dominica, Grenada, Kiribati, Marshall Islands, Micronesia, Nauru, Palau, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Timor-Leste, Tonga, Trinidad and Tobago, Tuvalu, the United Arab Emirates and Vanuatu should not come into force until bilateral agreements on visa waiver between the Union and the countries concerned have been concluded in order to ensure full reciprocity.
Amendment 6 #
2012/0309(COD)
Proposal for a regulation
Article 1 – point 1 – point a
Article 1 – point 1 – point a
(a) in point 1, the references to Dominica, Grenada, Kiribati, Marshall Islands, Micronesia, Nauru, Palau, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Timor-Leste, Tonga, Trinidad and Tobago, Tuvalu, the United Arab Emirates and Vanuatu are deleted and a reference to South-Sudan is inserted;
Amendment 7 #
2012/0309(COD)
Proposal for a regulation
Article 1 – point 2 – point a – two last references
Article 1 – point 2 – point a – two last references
"Tuvalu*", "United Arab Emirates*" and "Vanuatu*"
Amendment 80 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 91 #
2012/0192(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file, while ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials. Against this background, Directive 2001/20/EC introduced the concept of tacit authorisation. This concept should be maintained in order to ensure that timelines are adhered to, unless Member States indicate that exceptional circumstances apply which justify minimal delays. In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly. No minimal timelines for approval should therefore be established.
Amendment 249 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 2 a (new)
Article 3 – paragraph 1 – indent 2 a (new)
- the evaluation of ethical acceptability of the clinical trial is positive
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 280 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 285 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application. Where the sponsor is not notified, the validation datethat the clinical trial application dossier is complete in accordance with paragraphs 2 or 4 shall be the lastvalidation dayte of the time periods referred to in paragraphs 2 and 4application.
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 340 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1 a. Each Member State concerned shall assess the ethical acceptability of the clinical trial in accordance with its national legislation. In this respect, each Member State shall establish Ethics Committees. In case of multi-centre clinical trials, regardless the number of Ethics Committees, each Member State concerned shall establish a procedure for the adoption of a single opinion.
Amendment 351 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – introductory part
Article 8 – paragraph 2 – subparagraph 2 – introductory part
Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the reporting Member Stateto accept Part I of the assessment report only on the following grounds:
Amendment 352 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point a a (new)
Article 8 – paragraph 2 – subparagraph 2 – point a a (new)
(aa) scientific grounds related to aspects stated in Article 6 (1);
Amendment 353 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point a b (new)
Article 8 – paragraph 2 – subparagraph 2 – point a b (new)
(ab) subject safety, in particular with respect to the criteria of inclusion or non- inclusion into the trial, and the monitoring procedures foreseen in the proposed clinical trial;
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 364 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Where tThe Member State concerned shas notll notifiedy the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of. A clinical trial may start only after the Member State concerned has notified the sponsor through the EU Portal that the clinical trial is authorised.
Amendment 375 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 532 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 101 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 4
Article 1 – point 4
Regulation 2009/443/EC
Article 5a – paragraph 1
Article 5a – paragraph 1
1. In calculating the average specific emissions of CO2, each new passenger car with specific emissions of CO2 ofthat are less than 350 g CO2/km shall be counted as 1.32 passenger cars in the period from 2020 to 2023 and as 1 passenger caras from 202416 onwards.
Amendment 107 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 4
Article 1 – point 4
Regulation 2009/443/EC
Article 5a – paragraph 2
Article 5a – paragraph 2
Amendment 145 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 10 – point c
Article 1 – point 10 – point c
Regulation 2009/443/EC
Article 13 – paragraph 5
Article 13 – paragraph 5
5. By 31 December 20142017 at the earliest, the Commission shall review the specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new passenger cars for the period beyond 2020 and not before the new test cycle and test procedures are fully defined, implemented and the first results assessed.
Amendment 45 #
2011/2307(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. invites the Member States to integrate the strategy within their plans, programmes and/or national strategies;
Amendment 207 #
2011/2307(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Requests the Commission and Member States to consolidate their efforts in collecting scientific data on fish populations, where they are deficient, with the aim of offering more reliable scientific advice;
Amendment 252 #
2011/2307(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Encourages the Commission and Member States to continue to promote a common approach to nature conservation throughout the whole EU territory, including the outermost regions and overseas territories of the Member States, which host many biodiversity “hot spots” of global importance;
Amendment 20 #
2011/2297(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the Europe 2020 Strategy stipulates a more efficient use of resources, but current trends in water use are often unsustainable due to inefficient practices resulting in water wastage, and whereas water infrastructure systems are often outdated and there is a lack of information about actual performance and losses;
Amendment 22 #
2011/2297(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the transition to a green economy can only be achieved by taking into account water-related challenges;
Amendment 65 #
2011/2297(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. UPoints out that reducing water consumption should be a priority and underlines the importance of ecodesign, water-saving devices and metering for water efficiency in public water systems and industry;
Amendment 90 #
2011/2297(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses the need for better consistency and better integration of water-related objectives into the legislation at the EU, national and, regional and local levels; calls for a full evaluation of the effects on water resources to be taken into account in the design of the common agricultural policy and cohesion policy frameworks, in order to achieve a thematic concentration of available financing on water issues and to mainstream the issue of water into all policy areas;
Amendment 108 #
2011/2297(INI)
Motion for a resolution
Paragraph 16 e (new)
Paragraph 16 e (new)
16e. Urges Member States to access the funds available for water infrastructure improvements;
Amendment 115 #
2011/2297(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for the strengthening of public awareness ofand education on water issues, in order to bring about a better understanding of the links between water, sanitation, hygiene, health, food safety, food security and disaster prevention to consumers, health operators and policy and decision -makers; underlines the primary role of regional and local authorities and civil society organisations in awareness- raising campaigns and educational activities;
Amendment 120 #
2011/2297(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Welcomes the early achievement of the United Nations Millennium Development Goal on sustainable access to safe drinking water; calls on the Commission and the Member States to reinforce their commitment to achieve the MDG on basic sanitation and to take into account the relevant outcomes of the Rio+20 Conference on Sustainable Development;
Amendment 1 #
2011/2194(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- - having regard to Articles 191 and 192 of the Treaty on the Functioning of the European Union, relating to preserving, protecting and improving the quality of human health and the environment,
Amendment 2 #
2011/2194(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the EEA technical report no. 15/2011 "Revealing the costs of air pollution from industrial facilities in Europe''
Amendment 31 #
2011/2194(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes with concern that implementation of the environmental acquis is still insufficient; considers that full implementation and enforcement, at all levels, as well as further strengthening of key environmental and related policies priorities – climate change, biodiversity, resources, environment and health, as well as social and employment policies, energy, sustainable transport, sustainable agriculture and rural development – are crucial;
Amendment 66 #
2011/2194(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Takes the view that the 7th EAP should include objectives on how to specifically deal with the urban environment and its impact on climate change, transport and energy use, human health and quality of life;
Amendment 125 #
2011/2194(INI)
Motion for a resolution
Paragraph 20 d (new)
Paragraph 20 d (new)
20 d. Efforts should be made to focus on prevention, precaution and promotion of environment-friendly activities at EU level, in the field of research, innovation and development, with the goal of reducing the environmental burden of disease;
Amendment 144 #
2011/2194(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Takes the view that integrating environmental considerations into other relevant sectoral policies – in particular agriculture and rural development, fisheries, cohesion policy, transport, industry, energy, trade, employment, health policies, and research – should be a key priority of the 7th EAP and moreover ensures policy coherence and reinforcement of all EU policies;
Amendment 150 #
2011/2194(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Urges the Commission to include in its 7th EAP proposal an aggregated list of all the existing environment-related targets for the different policy areas, notably climate change, biodiversity, transport, energy, agriculture and rural development, fisheries and cohesion policy, employment, and examine them in conjunction with each other, so as to allow for an appropriate comparison and to ensure that objectives are coherent;
Amendment 5 #
2011/2193(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to the European Parliaments Resolution on the trade in human egg cells from March 10th 2005
Amendment 6 #
2011/2193(INI)
Motion for a resolution
Recital A
Recital A
A. whereas donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic stem cells, are increasingly used in medical therapies and as starting material for advanced therapy medicinal products (ATMP); whereas the Directive2004/23 asks the Member States to endeavour to ensure voluntary and unpaid donation and endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis which is a clear legal obligation which can in the case where a Member State does not follow the principal lead to infringement procedure;
Amendment 16 #
2011/2193(INI)
Motion for a resolution
Recital M a (new)
Recital M a (new)
Ma. Whereas the donation of some tissues and cells creates a severe risk for the donor, whereas this risk is particular high in egg-cell donation because of the hormone treatment which is necessary to prepare the donation;
Amendment 17 #
2011/2193(INI)
Motion for a resolution
Recital M b (new)
Recital M b (new)
Mb. Whereas the Charta of Fundamental Rights which is the leading principle for the European Union and legally binding after entering into force of the Lisbon Treaty prohibits making the human body and its parts as such a source of financial gain.
Amendment 18 #
2011/2193(INI)
Motion for a resolution
Recital M c (new)
Recital M c (new)
Mc. Whereas unpaid donation is not only an ethical principle but also necessary to protect the health of the donor and the recipient as the involvement of high amounts of money in the donation process may stimulate the donor to take risks and may hinder the disclosure of risks in his/her medical history.
Amendment 19 #
2011/2193(INI)
Motion for a resolution
Recital M d (new)
Recital M d (new)
Md. Whereas there is a lot of evidence that allogenic cordbloood transplantation is already successful for many patients and there are also serious reports that in some cases autologes treatment with this kind of cells can be successful.
Amendment 20 #
2011/2193(INI)
Motion for a resolution
Recital M e (new)
Recital M e (new)
Me. Whereas serious media again and again report that in the area of tissues and cells the principle of unpaid donation is violated.
Amendment 24 #
2011/2193(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the concluspresentations of the Second Report on Voluntary and Unpaid Donation of Tissues and Cells; which shows that a lot of activities are performed in the Member States to implement the principle of unpaid donation but also shows that still a lot needs to be done
Amendment 31 #
2011/2193(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Asks the Commission to carefully monitor the development in the Member States and to examine carefully any reports by actors in the civil society and media under violation of the principle and draw appropriate consequences if necessary infringement procedures.
Amendment 40 #
2011/2193(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 63 #
2011/2193(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines the importance of mothers donating cord blood and tissue at birth eitherspecially into public or private banks to help treat illnesses and further research in the field;
Amendment 72 #
2011/2193(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on Member States to raise awareness of public and private cord blood banking through information campaigns that may take place, for example, during antprenatal classes; but at the same times not exclude the activities of public cordblood banks including appropriately regulated information campaigns by those private cordblood banks.
Amendment 97 #
2011/2193(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses that in order to guarantee respect for the existing regulatory diversity across Member States whichUnderlines that it is Member States competence to allow, prohibit or regulate research with human embryonic stem cells and in vitro fertilisation but that Member States in this respect need to reflspects differing national values and practices in this field, the s the rules set out in the Directive 2004/23 including the quality and safety and the principal of unpaid donation. Points out that the European Union has limited compe oftence in this areport does not include issues surrounding embryonic stem cell research, therapeutic cloning and in-vitro fertilisation;a and needs to respect when applying this competence the principles of the charter of fundamental rights and the principles applied in the judgement of the European Court of Justice.
Amendment 98 #
2011/2193(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to consider revising the principles governing tissue and cell donation as laid down inpropose as soon as possible a revision of the Directive 2004/23/EC, in order to bring them into line with the principles governing organ donation laid down in Directive 2010/45/EU, and to take into account of scientific developments and the the new legal situation after the entering into force of the Lisbon Treaty and to take into account the scientific developments, the practical experience of actors in the sector and the recommendations of this report;
Amendment 99 #
2011/2193(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Asks the Commission to also propose a revision of Regulation EC 1394/2007 in order to include provision that guarantees the application of the principle of unpaid donation similar to the Directive 2010/45 and to take into account the problems in the implementation of the regulation especially for SMEs.
Amendment 7 #
2011/2051(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Calls for the post-2013 CAP to pursue food policy objectives which encourage and provide incentives for new forms of sustainable agricultural production whichand consumption which secure supply of food save energy, reduce the use of chemicals and exploit the potential of ecosystems more effectively; points out that it must be capable of responding to environmental, health and social challenges, such as climate change, depletion of resources, water pollution and soil erosion, etc.biodiversity loss (including “agricultural biodiversity”), depletion of resources, water pollution and soil erosion, health inequalities, chronic diseases, poverty and demographic change in the EU;
Amendment 15 #
2011/2051(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Considers it necessary to strike the correct balance between the need for increased productivity requiring intensive production methods and the need for the conservation and sustainable use of resources, showing due regard for the environment, public health and animal welfare;
Amendment 21 #
2011/2051(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that the CAP encompasses farmers and the public in general - who are both taxpayers and consumers - and both as the latter benefit from safe and nutritious food, a healthy environment, good health and prospects of jobs;
Amendment 27 #
2011/2051(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls for CAP funding to be based on a model whichto includes payments linked to natural handicaps and green-point payments or payments for vulnerable regions;
Amendment 34 #
2011/2051(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for a reinforcement of the concept of funding for both pillars subject to the fulfilment of, emphasising the need for CAP to pursue a number of environmental and, biodiversity criteriaand public health objectives, so that food of high- quality food can be producedand nutritional value are produced at affordable prices, using sustainable practices; points out that sufficient funding is the only guarantee of the success of targeted agri-environmental measures; and calls for measures to strengthen the position of consumers and farmers in a better functioning food chain;
Amendment 43 #
2011/2051(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Efforts should be made to promote healthier, more sustainable diets by creating better links between production and consumption policy including public procurement, catering policy and demand driven policies;
Amendment 49 #
2011/2051(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Emphasises that mandatory greening that respects ecosystems will not only benefit the environment, but also ensure multiple co-benefits for a sustainable future for EU farming;
Amendment 54 #
2011/2051(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that food prices paid by European citizens can constitute more than 50% of income and approximately 43 million people are at risk of food poverty in the EU and poor nutrition is one of the strongest detrimental determinants of health associated with lower socio-economic status, poverty and social exclusion;
Amendment 55 #
2011/2051(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Believes that tackling current agricultural challenges cannot depend solely on technological solutions but require addressing current consumption patterns, waste and complex relationships between environment, biodiversity and human health;
Amendment 56 #
2011/2051(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Calls for rural development funding to focus on new challenges, agro-ecological innovation, social and economic development including improved access to public services and infrastructure in rural regions, especially weaker or Less Favoured Areas (LFA); this should include support for regional and local food systems as a strategy for inclusive growth; and assistance for subsistence farming communities, recognizing its contribution to local communities;
Amendment 58 #
2011/2051(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the Commission'’s policy option 2,proposals which would address the EU'’s economic, environmental and social challenges and strengthen the contribution of agriculture and rural areas to the Europe 2020 objective of smart, sustainable and inclusive growth, and encourages Commission to continue to work on the three policy options described in the Commission’s communications as well as further options and combinations of the options which would better address the EU’s economic, environmental and social challenges;
Amendment 68 #
2011/2051(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Believes that under the revised CAP consideration should be given to new ‘carbon credit’economic and financial innovative instruments, because agriculture offers enormous potential for combating climate change;
Amendment 80 #
2011/2051(INI)
Draft opinion
Paragraph 9
Paragraph 9
Amendment 93 #
2011/2051(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Emphasises the need for innovation is extremely important and investment should be channelled towards the growth of economical and environmental performance. Encourages more EU-funded projects in which farmers and researchers can work together to find innovative ways of cultivating land in an environmentally sustainable manner;
Amendment 107 #
2011/2051(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Considers it possible to alleviate the climatic impact of agriculture through improved education and training for farmers in making better use of innovations resulting from research and development; urges that farmers be thoroughly prepared to meet energy challenges through the development of green energies such as biomass, biowaste, biogas, biofuels and small-scale wind, solar and hydroelectric energy generation, thereby creating new jobs;
Amendment 1 #
2011/2024(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. Stresses the need for the current system of automatic recognition to take also into consideration whether the professional is allowed or prevented to practice in the Member State of origin
Amendment 11 #
2011/2024(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Is in favour of modernising and improving Directive 2005/36/EC and encourages the use of the most recent technologies and the introduction of a professional card which should contain accurate information in order to improve the transparency between Member States;
Amendment 16 #
2011/2024(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Stresses the need to ensure that transposition and implementation of the directive is concluded in all Member States. Stresses also the need for adaptation to changes and flexibility in transposition.
Amendment 25 #
2011/2024(INI)
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Stresses the need to develop a sustainable workforce in the field of healthcare services, by framing staff recruitment and retention policies for healthcare systems and promoting gender equality and lifelong education and vocational training, while also placing emphasis on improving working conditions;
Amendment 49 #
2011/2024(INI)
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Stresses the need to update the current set of minimum professional training standards in line with scientific and technical progress;
Amendment 36 #
2011/2023(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Communication from the Commission to the European Parliament and the Council entitled ‘Towards a stronger European disaster response: the role of civil protection and humanitarian assistance’ and its objectives; emphasises that the proposals outlined in the Communication should be further examined to fulfil the expectations for an enhanced, effective, cost-efficient and visibl, visible, cohesive and comprehensive European response;
Amendment 46 #
2011/2023(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls once again on the Commission to bring forward proposals as soon as possible for establishing an EU Civil Protection Force based on the EU Civil Protection Mechanism and enabling the Union to bring together the resources necessary for providing civil protection and immediate emergency relief aid to the victims; believes that the EU response should build on the existing roles and capacities of European civil protection forces and ensure that current gaps and bottlenecks are addressed;
Amendment 75 #
2011/2023(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Believes that a list of the key assets that could be made available by Member States for the EU emergency response to these scenarios should be identified and mapped.
Amendment 85 #
2011/2023(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls for technical assistance and support teams to be mobilised in the event of disasters and for recommendations to be made on the way in which those teams can provide more effective support to those affected by disasters;
Amendment 71 #
2011/2012(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission Communication demonstrating that stepping up to a 30% target isthere are technically feasible and economically affordable options to move beyond 20% target;
Amendment 81 #
2011/2012(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Notes that EU reaffirms its conditional offer to move to a 30% reduction by 2020 compared to 1990, as part of a global and comprehensive agreement for the period beyond 2012 and provided that other developed countries commit themselves to comparable emission reductions and that more advanced developing countries contribute adequately according to their responsibilities and respective capabilities.
Amendment 84 #
2011/2012(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 114 #
2011/2012(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Notes that the European Council has recognised that further reductions in the range of 80-95% by 2050 as compared to 1990 are necessary; points out that a linear trajectory between 2009 and 2050 would result in a 2020 target in the range of 34-38% as compared to 1990;
Amendment 128 #
2011/2012(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Reiterates that cumulative emissions are decisive for the climate system; notes that even with a pathway of 30% reductions in 2020, 55% in 2030, 75% in 2040 and 90% in 2050 the EU would still be responsible for approximately double its GHG emissions per capita share of the global 2°C compatible carbon budget, and that delaying emissions reductions increases the cumulative share significantly;
Amendment 189 #
2011/2012(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Concurs with the Commission analysis thatof moving to a 30% reduction target with cost-efficient effort sharing between ETS and non-ETS, and a 25% domestic effort (the rest with offsets), would correspond to an ETS cap reduction of 1.4 billion allowances;
Amendment 195 #
2011/2012(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes that one of the options of implementing the change in the ETS throughcould be cancelling allowances assigned for auctioning; considers however that all sectors should contribute;
Amendment 269 #
2011/2012(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Considers that a move to a 3beyond 20% climate target for 2020 would restore the incentives for innovation lost by the easing of the 20% target;
Amendment 310 #
2011/2012(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Concludes that stepping up to a 3moving beyond 20% target has more benefits than costs for EU citizens and a domestic achievement of the reduction targets would bring the highest overall benefit;
Amendment 324 #
2011/2012(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Notes that energy-intensiveETS sectors are likely to end up with a very considerable number of unused freely allocated allowances at the end of the second ETS period in 2012, which can then be carried over to 2013- 2020 phase, putting them into a comparatively better position for international competition compared with 2008;
Amendment 39 #
2011/0401(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) With the aim of deepening the relationship between science and society and reinforcing public confidence in science, Horizon 2020 should favour an informed engagement of citizens and civil society on research and innovation matters, particularly their benefits in terms of health and the environment, by promoting science education, by making scientific knowledge more accessible, by developing responsible research and innovation agendas that meet citizens' and civil society's concerns and expectations and by facilitating their participation in Horizon 2020 activities.
Amendment 45 #
2011/0401(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Horizon 2020 should contribute to the attractiveness of the research profession in the Union, particularly as a career prospect for young people. Adequate attention should be paid to the European Charter for Researchers and Code of Conduct for the Recruitment of Researchers, together with other relevant reference frameworks defined in the context of the European Research Area, while respecting their voluntary nature.
Amendment 149 #
2011/0401(COD)
Proposal for a regulation
Article 22 – paragraph 3 – point e
Article 22 – paragraph 3 – point e
(e) initiatives to foster dialogue and debate on scientific, technological and innovation related issues with the public through involvement of the academic community, and to take advantage of social media and other innovative technologies and methodologies, especially in order to help raise public awareness of the benefits of research and innovation in meeting society’s challenges.
Amendment 304 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 2.1 – introductory paragraph
Annex I – part III – point 2.1 – introductory paragraph
The specific objective is to secure sufficient supplies of safe and high quality food and other bio-based products, avoiding the current over-exploitation of ecosystems, by developing productive and resource- efficient primary production systems, fostering related ecosystem services, along side competitive and low carbon supply chains. This will accelerate the transition to a sustainable European bio-economy.
Amendment 364 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 5.3 – point a – paragraph 1
Annex I – part III – point 5.3 – point a – paragraph 1
The aim is to develop and assess innovative, cost-effective and sustainable adaptation and mitigation measures and strategies, targeting both CO2 and non- CO2 greenhouse gases, and underlining both technological and non-technological green solutions, through the generation of evidence for informed, early and effective action and the networking of the required competences. Activities shall focus on: improving the understanding of climate change and the provision of reliable climate projections; assessing impacts, vulnerabilities and developing innovative cost-effective adaptation and risk prevention measures;
Amendment 33 #
2011/0339(COD)
Proposal for a regulation
Citation 1 a (new)
Citation 1 a (new)
– Having regard to the Charter of Fundamental Rights of the European Union, and in particular Article 35 thereof,
Amendment 35 #
2011/0339(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) A high level of health protection should be ensured in the definition and implementation of all Union policies and activities, in accordance with Article 168 of the Treaty and Article 35 of the Charter of Fundamental Rights of the European Union. The Union shall complement and support national health policies, encourage the cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of the national authorities for shaping their health policies and organising and delivering health services and medical care.
Amendment 54 #
2011/0339(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In the context of an ageing society, well-directed investments to promote health and previn health promotion, prevention, early diagnosis and management of diseases, including chronic diseases, can increase the number of ‘healthy life years’ and thus enable the elderly to continue working as they grow older, while encouraging active and healthy ageing. Chronic diseases are responsible for over 80% of premature mortality in the EU. By identifying, disseminating and promoting the up-take of validated best practices for cost-effective prevention measures focused on the key risk factors, namely smoking, abuse of alcohol and ob, sedentary lifesityle, as well as on HIV/AIDSn unhealthy diet and obesity, the Programme will contribute to prevent diseases and promote good health, also bearing in mind underlying factors of a social and environmental nature.
Amendment 72 #
2011/0339(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Non-governmental bodies and hHealth stakeholders, in particular patients' organisations and health professionals' associations, play an important role in providing the Commission the information and advice necessary to implement the programme. In playing this role, they may require contributions from the Programme to enable them to function. That is why the programme shall be accessible to representative NGOs and patient organisations working in the public health area, which play an effective role in civil dialogue processes at EU level, such as for example participation in consultative groups, and in that way contribute to pursuing the Programme's specific objectives.
Amendment 87 #
2011/0339(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
The general objectives of the Health for Growth Programme shall be to work with the Member States to encourage innovation in healthcare and increase the sustainability of health systems, to address the health- related, social and economic challenges posed by the early ageing of population and the increasing number of chronic illnesses, to improve the health of the EU citizens and protect them from cross-border health threats.
Amendment 106 #
2011/0339(COD)
Proposal for a regulation
Article 3 – point 3 – paragraph 1
Article 3 – point 3 – paragraph 1
(3) To identify, disseminate and promote the up-take of validated best practices for cost-effective prevention measure by addressing the key risk factors, namely smoking, abuse of alcohol, and ob sedentary lifesityle, as well as HIV/AIDSn unhealthy diet and obesity, with a focus on the cross border dimension, in order to prevent diseases and promote good health.
Amendment 145 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3 – indent 3.1
Article 4 – paragraph 1 – point 3 – indent 3.1
– 3.1. Exchange best practices on key health issues such as smoking prevention, abuse of alcohol, a sedentary lifestyle, an unhealthy diet and obesity;
Amendment 151 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3 – indent 3.2
Article 4 – paragraph 1 – point 3 – indent 3.2
– 3.2. Supporting the prevention of chronic diseases including cancer, by sharing knowledge and best practice, developing guidelines regarding the underlying environmental factors of chronic diseases and developing joint activities;
Amendment 212 #
2011/0339(COD)
Proposal for a regulation
Annex 1 – point 3 – introductory part
Annex 1 – point 3 – introductory part
3. Identifying, disseminating and promoting up-take of validated best practices for cost-effective prevention measure by addressing the key risk factors, namely smoking, abuse of alcohol, and ob sedentary lifesityle, as well as HIV/AIDSn unhealthy diet and obesity, with a focus on the cross border dimension, in order to prevent diseases and promote good health
Amendment 15 #
2011/0299(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions -European Broadband: investing in digitally driven growth9 concludes that the critical role of the internet means that the benefits for society as a whole appear to be much greater than the private incentives to invest in faster networks. Public support for this area is therefore necessary, but should not unduly distort competition. In its resolution of 6 July 2011 on European Broadband: investing in digitally driven growth, the European Parliament emphasises that broadband services are key to the competitiveness of EU industry and greatly contribute to EU economic growth, social cohesion and the creation of quality employment, as well as to the participation of all regional and social groups in digital life in the EU; recommends promoting a competitive market for investment in, and utilisation of, fixed and wireless broadband infrastructure; notes that a competitive market is a catalyst for additional investment and innovation by communications, applications and content providers, as well as a vital platform for the digital economy. _____________ 1 P7_TA-(2011)0322
Amendment 16 #
2011/0299(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Substantial economic and social benefits, which cannot be captured nor monetised by investors, are associated with higher broadband speeds. Fast and ultra- fast broadband is the key enabling infrastructure for the development and deployment of digital services, which rely on the availability, speed, reliability and resilience of the physical networks. The deployment and take-up of faster networks opens the way for innovative services exploiting higher speeds. Action at Union level is necessary to maximise the synergies and interactions between those two components of digital telecommunications networks. Universal access to broadband networks is essential for the growth of modern economies and for individual wellbeing and digital inclusion. Extension of broadband networks in rural and economically and socially less-favoured areas will facilitate better communications, particularly for persons with reduced mobility or living in isolated conditions, as well as improving access to services and encouraging the development of SMEs in rural areas, thereby helping to create new jobs and develop new services in these localities;
Amendment 17 #
2011/0299(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The use of information technology and communications facilitates a structural adjustment towards goods and services which consume less resources, energy savings in buildings and electricity networks and the development of more efficient and lower-energy intelligent transport systems. The development of broadband networks and digital service infrastructures will contribute to the Union's objective to reduce greenhouse gas emission by enabling energy-efficient solutions in many sectors of Europe's economy. This positive effect will be limited, but only to some extent, by the growing energy and resource demand related mainly to the construction of broadband networks and the operation of digital service infrastructures.
Amendment 18 #
2011/0299(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) In the implementation of this Regulation, any processing of personal data should be carried out in accordance with Union law, as set out, in particular, in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) .
Amendment 23 #
2011/0299(COD)
Proposal for a regulation
Article 4 – point b
Article 4 – point b
(b) the deployment of broadband networks to link island, landlocked and peripheral regions, rural areas and economically and socially less-favoured regions with the central regions of the Union ensuring in those regions that speeds of data transmission are sufficient to permit broadband connectivity of 30 Mbps and above;
Amendment 25 #
2011/0299(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. A project of common interest may encompass its entire cycle, including feasibility studies, implementation, continuous operation, coordination and evaluation. Projects of common interest should respect the principle of technology neutrality, which forms the basis of the EU electronic communications structure.
Amendment 27 #
2011/0299(COD)
Proposal for a regulation
Article 5 – paragraph 8 – point c
Article 5 – paragraph 8 – point c
(c) demonstrates European added value following a feasibility study and cost- benefit analysis.
Amendment 28 #
2011/0299(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The Commission shall be assisted by an Expert Group, composed of a representative of each Member State, for monitoring of the implementation of these guidelines, assisting in the planning through the national strategies for high speed internet and mapping of infrastructures, and exchanging information. The Commission, together with the Expert Group, shall evaluate whether the scope of projects of common interest continues to reflect political priorities, technological development or the situation on the relevant markets, as well as new opportunities to exploit synergies between the different types of infrastructure. The Expert Group may also consider any other issue relating to the development of the trans-European telecommunication networks. .
Amendment 29 #
2011/0299(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. In these reports the Commission shall also evaluate whether the scope of the projects of common interest continues to reflect political priorities, technological developments or the situation in the relevant markets. For major projects, these reports shall includFor major projects, the Commission shall make an analysis of the environmental impact, taking into account climate change adaptation and mitigation needs, and disaster resilience. Such a review may also be carried out at any other time when it is deemed appropriate.
Amendment 31 #
2011/0299(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The delegation of power referred to in the Articles 5(6) shall be conferred on the Commission for an indeterminate period of timefive years from the date of the entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Amendment 35 #
2011/0299(COD)
Proposal for a regulation
Annex – section 2 – paragraph 2
Annex – section 2 – paragraph 2
Investment in broadband infrastructure has been undertaken predominantly by private investors and it is expected that this will remain the case. However, tIn many regions, however, investment in broadband infrastructure is insufficient because of the lack of competition and the high market risk, while public services are rudimentary and are not interoperable because of the fragmentary nature of the technical solutions. The achievement of the Digital Agenda targets will require investment in areas for which there is not a clear business case or where a business case may need to be enhanced within the time frame of the targets. The following types of areas can be characterized on the basis of the likely investment:
Amendment 44 #
2011/0154(COD)
Draft legislative resolution
Paragraph 1 – point 1a (new)
Paragraph 1 – point 1a (new)
1a. Approves its statement annexed to this resolution; For information, the text of the statement is: ‘Article 47 of the Charter of Fundamental Rights of the European Union provides that legal aid shall be made available to those who lack sufficient resources in so far as such aid is necessary to ensure effective access to justice. The Roadmap on procedural rights underlines that the right to legal aid should ensure effective access to the right to legal advice. Having regard to these provisions, considering the need for all the persons to have an effective access to justice and emphasizing the importance of ensuring equal access to justice for all the citizens, The European Parliament calls on the Commission to come up with a proposal on legal aid at the earliest.’
Amendment 7 #
2010/2274(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Member States to promote 112 as the 'EU-wide' emergency number by means of measureinformation campaigns aimed at all EU citizens and travellers and to organise and support promotional activities, in particular in schools, and events held each year on 11 February, which has been established as 'European 112 Day';
Amendment 12 #
2010/2274(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses the need to improve access to the universal emergency service via the new electronic communications technologies or broadband services;
Amendment 14 #
2010/2274(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to take the necessary measures to facilitate access to the universal emergency service via SMS or text messaging for special categories of vulnerable people, such as those with hearing impairments;
Amendment 15 #
2010/2272(INI)
Draft opinion
Recital A m (new)
Recital A m (new)
Am. whereas the number of people with disabilities is expected to rise in step with the gradual ageing of the EU population,
Amendment 16 #
2010/2272(INI)
Draft opinion
Recital A n (new)
Recital A n (new)
An. whereas it should be emphasised that the majority of people with disabilities are frequently unable fully to participate in economic activities in society owing to physical – and other – obstacles, and to discrimination or a social stigma,
Amendment 30 #
2010/2272(INI)
Draft opinion
Paragraph 3 – point c
Paragraph 3 – point c
(c) provide adequate rehabilitation services and promote mental health services and the development of early intervention and needs assessmentpersonal assistance programmes and intervention services,;
Amendment 44 #
2010/2272(INI)
Draft opinion
Paragraph 5 f (new)
Paragraph 5 f (new)
5f. Stresses the need to promote an education system propitious to lifelong learning for schoolchildren and students with disabilities and a personalised inclusion system for the early identification of special needs;
Amendment 21 #
2010/2249(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Urges the Commission to further encourage genetic control of scrapie in sheep through breeding programmesand rearing programmes aimed at avoiding inbreeding or genetic drift;
Amendment 22 #
2010/2249(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to encourage ongoing research to develop ante-mortem BSEand post-mortem rapid BSE-diagnostic tests;
Amendment 28 #
2010/2249(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Takes note of the above-mentioned Commission Report on the overall operation of official controls in the Member States in food safety, animal health and animal welfare, and plant health; points out that the report reveals certain shortcomings with regard to the quality of reports from the Member States and urges the Member States to improve the quality of reporting by improving the conduct of national audits with a view to ensuring fulfilment of the regulatory requirements, by singling out cases of non-compliance and by enhancing the performance of control authorities and food business operators;
Amendment 2 #
2010/2153(INI)
Motion for a resolution
Citation 23
Citation 23
Amendment 12 #
2010/2153(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas, under the International Health Regulations (IHR) – a legal instrument binding on the states parties to it – the remit of the WHO includes public health surveillance, coordinating international public health measures and, in relation to potentially pandemic viruses, determining current phases of alert on a scale of one to six,
Amendment 13 #
2010/2153(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas the phases of a global pandemic are determined in accordance with the provisions of the IHR and in consultation with other organisations and institutions and with the Member States affected,
Amendment 74 #
Amendment 80 #
2010/2153(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises the need to reinforce cooperation between Member States within the EU in the management of the response to a pandemic, within the framework of WHO, according to the International Health Regulation of 2005 ;
Amendment 81 #
2010/2153(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Wants to reinforce the collaboration between Member States by ensuring coherent risk assessment and risk management for fast evolving threats at EU level by putting in place, where necessary, additional structures and coordination mechanisms;
Amendment 84 #
2010/2153(INI)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Urges the WHO to revise the definition of a pandemic, taking into consideration, when a virus is detected, not only its geographical spread but also its severity;
Amendment 85 #
2010/2153(INI)
Motion for a resolution
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Claims that work on the legal basis relating to the implementation of the joint buying guarantee to the Member States an equitable access and a reasonable price to the most effective vaccines as well as the respect of the European legislation in terms of the manufacturer responsibility;
Amendment 86 #
2010/2153(INI)
Motion for a resolution
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Calls on the Member States to involve health professionals more closely at every stage in the preparation and application of strategies for preventing and combating pandemics;
Amendment 100 #
2010/2153(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage;
Amendment 114 #
2010/2153(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls in particular on the European Commission and the EMA to review the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure correcta full assessment of the benefit-risk profile associated with the use of those medicinal products;
Amendment 117 #
2010/2153(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Wants to ensure that the scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality; Request the development of a European code of conduct relating to the exercise of the scientific function of expert in any European authority in charge of safety, of the management and the anticipation of the risks ; require that each expert subscribe to the ethical principles of this code of conduct before any taking up the duties ;
Amendment 118 #
2010/2153(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Asks that experts who are involved in the pharmaceutical sector could be consulted but should be excluded from decision-making ;
Amendment 119 #
2010/2153(INI)
Motion for a resolution
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Requests the installation of a definition of the conflict of interest which is common to all the European agencies ;
Amendment 150 #
2010/2153(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Is aware of the need to communicate more clearly and transparently to help the publics to facilitate the risk communication; Underlines the necessity to arrive to only one and single message bound for the citizens as soon as the health hazard was evaluated ; insists on the importance of consistent communication of the Member States regarding the informative contents of the message (as for the nature of the virus, with the nature of the risk and in the manner of securing and curing);
Amendment 153 #
2010/2153(INI)
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10d. Stresses the need for accountability of information professionals and the prudence required in the processing of health information messages a fortiori in the context of a pandemic;
Amendment 158 #
2010/2153(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Demands precise definition ofRequests to specify and clarify the roles, duties, remits, limits, relations and responsibilities of the key actors and the structures of management of the medical threats at the level of the EU which are the European Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision- making process regarding the management of a health crisis;
Amendment 16 #
2010/2114(INI)
Draft opinion
Point 10 a (new)
Point 10 a (new)
10a. Calls on the Commission and Council to consider developing response models that provide an ideal response in the event of CBRN incidents, and in which special attention is awarded to training establishments, medical care institutions and geriatric care centres;
Amendment 18 #
2010/2114(INI)
Draft opinion
Point 11
Point 11
11. Calls on the Member States, when drafting evacuation plans in case of a CBRN incident, to give special attention to the needs of the elderly, children, people under medical care, persons with disabilities and other such specific groups;
Amendment 21 #
2010/2114(INI)
Draft opinion
Point 11 a (new)
Point 11 a (new)
11a. Calls on the Member States to award special importance to the construction of civil protection shelters both within (public and administrative) institutions and at local and regional level, in which the European public can take refugee in the event of a disaster;
Amendment 4 #
2010/2112(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Points out that food security and safety is essential to the European Union and that continuous joint efforts are needed to guarantee it at CommunityEuropean and world level;
Amendment 9 #
2010/2112(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Is deeply concerned at the effects of the recent economic and financial crisis, which, despite shrinking financial resources in all economic sectors, should not result in reduced vigilance over the safety of food products; calls for improvement of the measures for combating the extreme price volatility of agri-food products and of measures for combating speculation; calls on the Commission to strengthen existing programmes to guarantee agri-food safety in the Member States;
Amendment 18 #
2010/2112(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that food products must be affordable for consumers, while producers should be paid fittingly for the work they do, thereby creating a balance; condemns the agreements entered into by large-scale retailers and calls for measures to be taken to end such practices and ensure transparency in the way in which final consumer prices for food products are formed;
Amendment 55 #
2010/2112(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. The common agricultural policy (CAP) needs to accord far more substantial support to local and regional famers, thereby encouraging biodiversity and organic farming, which afford many benefits both to the consumer and to the environment;
Amendment 132 #
2010/2106(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Member States to cooperate more closely in exchanging information on research in the area of anti-climate change policies, with a view to expanding the knowledge base on forest protection;
Amendment 138 #
2010/2106(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that measures to protect forest ecosystems should include means of protecting ancient trees and data on the existence of such monuments of nature;
Amendment 173 #
2010/2106(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Stresses the importance of including the operational system established by the FAO with regard to identical definitions of forested surface, in order to avoid any confusion that might arise over forest administration techniques;
Amendment 16 #
2010/2089(INI)
Motion for a resolution
Recital C
Recital C
C. whereas health inequalities have also an important gender and age dimension: women in general live longer than men but may spend a longgreater proportion of their lives in ill health, and children, adolescents and the elderly are disproportionately more vulnerable to factors determining their health outcomes,
Amendment 30 #
2010/2089(INI)
Motion for a resolution
Recital E
Recital E
E. whereas comparative measurement of health inequalities is a fundamental first step towards effective action,
Amendment 31 #
2010/2089(INI)
Motion for a resolution
Recital F
Recital F
F. whereas rates of morbidity are usually higher among those in lower educational, occupational and income groups and substantial inequalities are also found in the prevalence of most specific diseases, including mental illness, cardio-vascular, respiratory diseases, obesity, diabetes and other diet-related conditions, and most specific forms of disability,
Amendment 90 #
2010/2089(INI)
Motion for a resolution
Paragraph 2 f (new)
Paragraph 2 f (new)
2f. Calls on Member States to show due regard for the HIAP (Health In All Policies) principle in formulating new policies in all areas which contribute to a high standard of health protection and a reduction in health inequalities;
Amendment 96 #
2010/2089(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Member States, in formulating common policies at EU level, to take into account the social and economic factors affecting living conditions and standards of health thereby creating health inequalities;
Amendment 104 #
2010/2089(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Encourages the Commission and Member States to collaborate in the development of new indicators with the help of those monitoring health inequalities and produce a set of comparable indicators enabling the national authorities to assess progress in this area, thereby making it possible to establish priorities regarding improvements to the health system and good practices;
Amendment 114 #
2010/2089(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Encourages all the Member States to invest in social, educational, environmental, and health services infrastructure following the principle of “health in all policies”;
Amendment 136 #
2010/2089(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Points to the importance of raisimproving the average level ofccess to disease prevention, health promotion, primary and specialised healthcare services, and decreasing the inequalities between different social groups, and underlines that these objectives could be achieved through the optimisation of public spending for preventive and curative healthcare;
Amendment 149 #
2010/2089(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Encourage all the Member States to re-evaluate their policies having main impact on health inequalities such as tobacco, alcohol, food, pharmaceuticals as well as public health and healthcare delivery;
Amendment 160 #
2010/2089(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Encourage all the Member States to foster and build capacity and cross- country learning and cooperation between all relevant multi-sectoral stakeholders in development and implementation of policies that have positive impact on reducing health inequalities;
Amendment 165 #
2010/2089(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
Amendment 166 #
2010/2089(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses that health risks to members of disadvantaged (poorer) social categories are what is behind the problem of health inequalities, bearing in mind that these risks are being aggravated by a combination of poverty and other vulnerabilities;
Amendment 171 #
2010/2089(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to ensure that the reduction of health inequalities is fully addressed in the future initiative on healthy ageing as well as in EU Platform against Poverty and Social Exclusion;
Amendment 174 #
2010/2089(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission to assist Member States in making better use of Open Method of Coordination in order to support projects to address underlying factors of health inequalities;
Amendment 183 #
2010/2089(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Urge all the Member States to recognise the importance of health for the society and to look beyond a GDP- approach to measure societal, community and individual development;
Amendment 191 #
2010/2089(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission to support actions financed under the current and future Public Health to address social determinants of health;
Amendment 10 #
2010/2084(INI)
Motion for a resolution
Recital A
Recital A
A. whereas it is estimated that 35.6 million people worldwide will be living with dementia in 2010 – and that this number is estimaxpected to nearly double every 20 years, to 65.7 million in 2030,
Amendment 17 #
2010/2084(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the number of people suffering from neurodegmenerative diseasestia in Europe is estimated to be 8.67.3 million, with Alzheimer’s accounting for the vast majority of those cases; whereas neurodegenerative diseases represent one of the main causes of disability in the elderly, and whereas the number of people suffering from these diseases is expected to rise dramatically by 2020, owing to increased life expectancy and a decreasing ratio of workilack of social life among tohe retired populations,
Amendment 19 #
2010/2084(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas, according to the World Alzheimer Report for 2009, Europe accounts for over 28% of the total number of persons suffering from dementia, placing it second only to Asia (with 35%), while of all the world's regions western Europe has the highest proportion of sufferers (19%),
Amendment 25 #
2010/2084(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the population of Europe is ageing, with persons aged over 80 constituting the fastest-growing cohort in most European countries, and whereas dementia is therefore expected to be one of the main challenges for social and healthcare systems, including informal care and long-term care facilities, in the coming decades,
Amendment 27 #
2010/2084(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas some two-thirds of sufferers from the diseases in question live in less developed countries, and whereas this proportion will increase thanks to the low standards of living in the regions concerned,
Amendment 29 #
2010/2084(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas Alzheimer’s and other forms of dementia are one of the main causes of incapacity and dependence among old people,
Amendment 35 #
2010/2084(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Db. whereas the consequences of dementia are both social and economic, affecting all health systems in the Member States,
Amendment 36 #
2010/2084(INI)
Motion for a resolution
Recital D c (new)
Recital D c (new)
Dc. whereas in order to anticipate the economic and social impact of Alzheimer’s and other forms of dementia, it is necessary to invest in scientific research and efficient approaches to care systems,
Amendment 60 #
2010/2084(INI)
Motion for a resolution
Recital G g (new)
Recital G g (new)
Gg. whereas Alzheimer’s and the other forms of dementia should not be perceived as a normal problem faced by individuals as part of the ageing process without them being entitled to suitable treatment, medical assistance and specialised care,
Amendment 61 #
2010/2084(INI)
Motion for a resolution
Recital G h (new)
Recital G h (new)
Gh. whereas the overall approach to the problem is still the wrong one, involving the stigmatisation of those affected (both patients and their relatives), which leads to their social exclusion,
Amendment 65 #
2010/2084(INI)
Motion for a resolution
Recital H
Recital H
H. whereas, although social awareness and scientific knowledge of Alzheimer'’s disease have increased dramatically in the past 20 years, underlining in particular how the disease is characterized not only by clinical dementia but also by the onset of pre-dementia earlier in time, therapeutic options are still limited to symptomatic drugs, and diagnosis is still largely based on individual physician experience and subjective judgement,
Amendment 72 #
2010/2084(INI)
Motion for a resolution
Recital H g (new)
Recital H g (new)
H g. Whereas the development of effective disease-modifying agents (as opposed to purely symptomatic agents ) represents an area of critical and urgent unmet need for patients with Alzheimer’s disease,
Amendment 79 #
2010/2084(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Calls on the Council and Commission to take account of the concept of dementia when preparing future actions in the area of preventive health policy, notably in relation to its interaction with cardiovascular illnesses, mental health, physical activity, education in the field of health and new technologies,
Amendment 80 #
2010/2084(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Calls on the Member States to provide EU citizens with lifestyle information with a view to delaying or preventing the onset of Alzheimer’s and other forms of dementia, promoting the concept of 'a healthy lifestyle for a healthy brain';
Amendment 93 #
2010/2084(INI)
Motion for a resolution
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Calls on the Council and Commission to act to raise public awareness in the Union concerning dementia, facilitating recognition of the early symptoms of dementia with a view to early diagnosis and the corresponding treatment and appropriate support,
Amendment 107 #
2010/2084(INI)
Motion for a resolution
Paragraph 4 g (new)
Paragraph 4 g (new)
Amendment 108 #
2010/2084(INI)
Motion for a resolution
Paragraph 4 h (new)
Paragraph 4 h (new)
4h. Urges the Member States to develop policies for facilitating access to research funding in the field of dementia and Alzheimer’s, including research into prevention, on a basis proportionate to those illnesses' economic impact on society;
Amendment 112 #
2010/2084(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points to the importance of a multidisciplinary approach on ways in which cooperation and coordination in the field of research at European level can improve knowledge, diagnosis, treatment, prevention, and social research into the welfare of patients and their families and carers; believes that early diagnostic tests, research into risk factors and criteria for early diagnosis are crucial; this being the case, sees clear added value in conducting large-scale epidemiological and clinical studies in transnational collaborationrecommends that representatives of patients, healthcare organisations and medical-service providers be involved in this process;
Amendment 116 #
2010/2084(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Regards early diagnostic tests, research into risk factors and early diagnosis criteria as crucial; this being the case, sees clear added value in conducting large-scale epidemiological and clinical studies on the basis of transnational cooperation; regards the European Health Examination Survey, which will be able to provide valuable information, through its cognitive test module, on the number of people with early-stage cognitive deficiencies, as equally important;
Amendment 118 #
2010/2084(INI)
Motion for a resolution
Paragraph 5 d (new)
Paragraph 5 d (new)
5d. Calls on the Member States to develop long-term policies and action plans in the field of care and prevention which anticipate and address social and demographic trends, and to focus on the support provided to the families of patients for whom they are caring, thereby affording social protection to vulnerable persons suffering from dementia;
Amendment 124 #
2010/2084(INI)
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Member States to develop action plans aimed at improving the well- being and quality of life of patients suffering from Alzheimer’s and other dementias, and that of their families;
Amendment 137 #
2010/2084(INI)
Motion for a resolution
Paragraph 7 f (new)
Paragraph 7 f (new)
7f. Urges the Commission, the Council and the Member States to consider establishing safety standards applicable to institutions specialising in care for the elderly, to the communities to which they belong and to home care arrangements;
Amendment 153 #
2010/2084(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of psychological support for patients and their families; emphasises the importance of combining the psychosocial approach to ageing with the results of medical and biomedical research; advocates the need for research in the fields of the health economy, social-humanistic aspects and non-pharmaceutical approaches to treatment, in order to gain an understanding of the psychological, economic and social aspects of dementia and to promote the use of existing technologies (e-health, ITC, assistive technologies, etc.);
Amendment 157 #
2010/2084(INI)
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10d. Calls on the Council, the Commission, the European Parliament and the Member States to consider mainstreaming the ‘dementia dimension’ into European policies on flexible working time, into similarly flexible European pensions policies and into measures concerning elderly people under the European Pact for Mental Health and Well-being;
Amendment 158 #
2010/2084(INI)
Motion for a resolution
Paragraph 10 e (new)
Paragraph 10 e (new)
10 e. Encourages Member States and the European Commission to develop new policy-based incentives to facilitate the dissemination of information and market access strategies for innovative therapies and diagnostic tests addressing the current unmet needs of patients with Alzheimer’s disease
Amendment 175 #
2010/2084(INI)
Motion for a resolution
Paragraph 11 k (new)
Paragraph 11 k (new)
11k. Emphasises the scale of the medical costs entailed by Alzheimer’s disease and other dementias and that it is important to find viable solutions which take into account: the direct medical costs (comprising health system costs: specialist costs, medicinal products, medical examinations and regular check-ups); the direct social costs (comprising the cost of formal services outside the medical system: community services, home care, provision of food, transport, and placement of patients in specialist residential centres for the care of the elderly, where they can receive medical assistance); and informal costs (comprising the costs associated with reduced productivity in the event of a prolongation of working life, and loss of output as a result of early retirements, leave for medical reasons or death);
Amendment 185 #
2010/2084(INI)
Motion for a resolution
Paragraph 12 g (new)
Paragraph 12 g (new)
12g. Calls on the Council, the Commission, the European Parliament and the Member States to foster the autonomy of persons with dementia and promote their dignity and social inclusion through the action plan in the field of health, and to provide information on best practices in the field of respect for the rights of the vulnerable and combating the mistreatment of dementia patients;
Amendment 186 #
2010/2084(INI)
Motion for a resolution
Paragraph 12 h (new)
Paragraph 12 h (new)
12h. Calls on the Commission and the Council to foster the development, in connection with the implementation of research projects, of partnerships between public institutions and between private and public institutions, thereby harnessing facilities, resources and experience in the private and public sectors to combat the effects of Alzheimer’s and of other types of dementia;
Amendment 1 #
2010/2010(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Considers the post-crisis economy to be a strong opportunity for sustainable growth based on social justice and eco-efficiency; notes that the transformation of European economies from polluting to eco-efficient economies will lead to profound changes in production, distribution and consumption, which should be used as a chance to move towards true sustainability without endangering prosperity or jobs; believes that the transition to an economy based on non-polluting energy sources needs to be seen as an opportunity for investment in sustainable development and not merely as a charge on public and private budgets;
Amendment 5 #
2010/2010(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Underlines the need to tackle climate change urgently; welcomes the EU’s goal of reducing CO2 emissions by 20% by 2020; looks forward to receiving recommendations on how the EU could move towards a goal of 30%, and consequently urges the Commission to develop specific policies to ensure the transition towards a green economy, especially as regards worker re-skilling for green jobs and temporary compensation for greening European industry in the context of global markets, as well as encouraging the private sector to invest in low- emissions technologies that are favourable to innovation and job creation;
Amendment 39 #
2010/0801(COD)
Draft legislative resolution
Citation 2 a (new)
Citation 2 a (new)
Having regard to the proposal of the European Commission (COM(2010)0082.
Amendment 41 #
2010/0801(COD)
Draft directive
Recital -1 (new)
Recital -1 (new)
(-1) Article 47 of the EU Charter of Fundamental Rights enshrines the right to a fair trial, including the right to legal advice and representation. Article 48 of the Charter guarantees respect for the presumption of innocence and the rights of the defence.
Amendment 43 #
2010/0801(COD)
Draft directive
Recital 7 a (new)
Recital 7 a (new)
(7a) On 30 November 2009, the Council adopted the Roadmap on Procedural Rights which requested the Commission to put forward proposals on a "step by step" basis, on the right to interpretation and translation, the right to information about rights, the right to legal advice, before trial and at trial, the right for a detained person to communicate with family members, employers and consular authorities, and protection for vulnerable suspects.
Amendment 45 #
2010/0801(COD)
Draft directive
Recital 7 b (new)
Recital 7 b (new)
(7b) This Directive, the first measure on the Roadmap, should lay down common standards to be applied in the fields of interpretation and translation in criminal proceedings in order to enhance the necessary confidence among Member States.
Amendment 47 #
2010/0801(COD)
Draft directive
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States should have available, and use, in their police stations, a Letter of Rights drafted in all the languages of the European Union, listing the essential rights of a person concerned, including the right to interpretation and translation in criminal proceedings.
Amendment 48 #
2010/0801(COD)
Draft directive
Recital 7 b (new)
Recital 7 b (new)
(7b) Member States are encouraged to provide information to citizens concerning the minimum standards of procedural rights in criminal proceedings, including the translation of suitable into official languages and their subsequent publication and dissemination, in particular on the Internet homepages of the police and judicial authorities.
Amendment 50 #
2010/0801(COD)
Draft directive
Recital 10 a (new)
Recital 10 a (new)
(10a) The suspected or accused person should be able, inter alia, to explain his version of the events to his legal counsel, point out any statements with which he disagrees and make his legal counsel aware of any facts that should be put forward in his defence.
Amendment 52 #
2010/0801(COD)
Draft directive
Recital 12
Recital 12
(12) The finding that there is no need for interpretation or translation should be subject to the possibility of review, in accordance with the national law. Such review may be carried out, for example, throughappeal. Member States should ensure that the suspect or accused person has the right to challenge a spdecific complaint procedure, or sion finding the context of an at there is no need ford inary appeal procedure against decisions on the meritsterpretation or to challenge the quality of interpretation.
Amendment 59 #
2010/0801(COD)
Draft directive
Recital 16 a (new)
Recital 16 a (new)
(16a) Member States should strive for a high level of qualification for interpreters and translators employed in criminal proceedings, including for those assisting suspected or accused persons with a physical or mental impairment, in order to ensure an adequate standard of interpretation and translation and guarantee the fairness of proceedings. In addition to general language skills, these translators and interpreters should have specialist knowledge of legal terminology. The qualification of interpreters and translators employed in criminal proceedings should be verified by a formal degree or any similar proof of proficiency in the language concerned and attested through accreditation or certification.
Amendment 60 #
2010/0801(COD)
Draft directive
Recital 16 b (new)
Recital 16 b (new)
(16b) Member States should ensure that there is a national register, or registers, of qualified interpreters and translators to be employed in criminal proceedings. The register or registers should be kept up to date so as to reflect, inter alia, the status of the interpreter's or translator’s qualifications, without prejudice to the application of rules on the protection of individuals with regard to the processing of personal data. Member States are encouraged to make their national registers accessible to competent authorities of other Member States. In this context, particular attention should be paid to the aim of facilitating the interconnection of databases for legal translators and interpreters, as envisaged in the European e-Justice action plan of 27 November 2008.
Amendment 61 #
2010/0801(COD)
Draft directive
Recital 16 a (new)
Recital 16 a (new)
(16a) Member States are encouraged to institute a system of Continuous Professional Development, so that legal translators and interpreters can keep their skills up to date.
Amendment 62 #
2010/0801(COD)
Draft directive
Recital 16 b (new)
Recital 16 b (new)
(16b) Therefore, Member States should ensure that a mechanism is in place to ensure quality control of the translation and interpretation used in criminal proceedings.
Amendment 64 #
2010/0801(COD)
Draft directive
Recital 17
Recital 17
(17) This Directive respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to promote the right to liberty, the right to a fair trial and the right of defence and has to be implemented accordingly.
Amendment 66 #
2010/0801(COD)
Draft directive
Recital 18 a (new)
Recital 18 a (new)
(18a) This Directive should set minimum rules. Member States should be able to extend the rights set out in this Directive in order to provide a higher level of protection also in situations not explicitly dealt with in this Directive. The level of protection should never go below the standards provided by the European Convention on Human Rights, as interpreted in the case-law of the European Court of Human Rights.
Amendment 71 #
2010/0801(COD)
Draft directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Member States shall ensure that a suspected or accused person who does not understand or speak the language of the criminal proceedings concerned is provided without delay with interpretation in his/her mother tongue ornecessary in order to ensure he ins another language that he/she understands, in order to safeguard his/her rights to fair proceedings. Interpretation, including of communication between the suspected or accused person and his/her legal counsel, shall be provided during criminal proceedings before investigative and judicial authorities, including during police questioning, during all cble to understand the case against him and exercise his rights and to safeguard the fairness of the proceedings. Interpretation, including of communication between the suspect and his lawyer and covering legal advice received, shall be provided throughourt hearings and during any necessary interim hearings, and maythose proceedings. It shall also be provided in other situations. This provision does not affect rules of national law concerning the presence of a legal counsel during any stage of the criminal proceedings case of detention for official contacts between the detaining authorities and the suspect.
Amendment 89 #
2010/0801(COD)
Draft directive
Article 6
Article 6
Nothing in this Directive shall be construed as limiting or derogating from any of the rights and procedural safeguards that may be ensured under the European Convention for the Protection of Human Rights and Fundamental Freedoms, under the EU Charter of Fundamental Rights, under other relevant provisions of international law or under the laws of any Member States which provide a higher level of protection.
Amendment 91 #
2010/0801(COD)
Draft directive
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 92 #
2010/0801(COD)
Draft directive
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Amendment 93 #
2010/0801(COD)
Draft directive
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
The report of the Commission shall also address the future cost implications of the measures taken by Member States pursuant to this Directive.
Amendment 96 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
4. ‘'new establishment’' means an establishment that is newly constructed or has yet to enters into operation after 31 May 2015;
Amendment 102 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
8a. Member States shall ensure that the competent authority takes into account the domino effect when it elaborates external emergency plans;
Amendment 108 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
18a. “appropriate safety distance” means the minimum distance at which no possible negative effects can be registered on human health or the environment in the event of a major accident;
Amendment 110 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 18 b (new)
Article 3 – paragraph 1 – point 18 b (new)
18b. “domino effect” the possibility of occurrence of a major accident in an establishment, caused by an accident produced in the proximity of that establishment, either in another establishment or in a site that falls outside the scope of this Directive;
Amendment 286 #
2010/0377(COD)
Proposal for a directive
Annex I – Part 2 – Table – row 37 a (new)
Annex I – Part 2 – Table – row 37 a (new)
Sodium hypoclorite 200 500
Amendment 32 #
2010/0254(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 4
Article 3 - paragraph 4
4. Nectars and specific products of Annex III may be sweetened by the addition of sugars or honey. T, honey or other natural sweeteners. In such cases, the sales name shall include the word “sweetened” or the words “with added sugar”, followed by an indication of and added sweetener shall be indicated in the list of ingredients specifying the maximum quantity of sugar added, calculated as dry matter and expressed in grams per litre.
Amendment 38 #
2010/0215(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Adequatppropriate and effective training on procedural rights of suspected and accused persons should be provided to the relevant officials in Member States.
Amendment 52 #
2010/0215(COD)
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1a. "Competent authorities" shall include, but not be limited to police and investigatory authorities, prosecutors, magistrates and judges.
Amendment 58 #
2010/0215(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Member States shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptlyas soon as is practicable and in any event before questioning begins with information on his procedural rights in simple and accessible language.
Amendment 66 #
2010/0215(COD)
Proposal for a directive
Article 3 – paragraph 2 – indent 4 a (new)
Article 3 – paragraph 2 – indent 4 a (new)
– the right to medical care,
Amendment 67 #
2010/0215(COD)
Proposal for a directive
Article 3 – paragraph 2 – indent 4 b (new)
Article 3 – paragraph 2 – indent 4 b (new)
– the right to consular assistance,
Amendment 68 #
2010/0215(COD)
Proposal for a directive
Article 3 – paragraph 2 – indent 4 c (new)
Article 3 – paragraph 2 – indent 4 c (new)
– the right to contact a trusted person,
Amendment 88 #
2010/0215(COD)
Proposal for a directive
Article 5
Article 5
Member States shall ensure that any person subject to proceedings for the execution of a European Arrest Warrant receives an appropriate Letter of Rights setting out all the rights of that person as laid down in the Framework Decision 2002/584/JHA. Annex II to this Directive contains an indicative model of such Letter.
Amendment 93 #
2010/0215(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The information required pursuant to paragraph 1 shall be delivered promptly and in any event in sufficient time to enable the person concerned to prepare their defence. It is to be provided in detail and in a language that the suspected or accused person understands. In the case of a child, information about the charges shall be provided in a manner adapted to his age, level of maturity and intellectual and emotional capacities.
Amendment 102 #
2010/0215(COD)
Proposal for a directive
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. Member States shall ensure that a person who has been charged with a criminal offence is duly and fully informed of any changes in the accusation, including changes in the material facts. He or she shall be provided with adequate time and facilities to adapt his or her defence to them.
Amendment 107 #
2010/0215(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that an accused person or his lawyer is granted access to the case-file once the investigation of the criminal offence is concluded. Access to certain documents contained in the case-file may be refused on the basis of a reasoned decision by a competent judicial authority where access to these documents may exceptionally lead to serious risk to the life or fundamental rights of another person or may seriously harm the internal security of the Member State in which the proceedings take place. Where it is in the interests of justice, the accused person or his lawyer may request an index of the documents contained in the case-file.
Amendment 115 #
2010/0215(COD)
Proposal for a directive
Article 9
Article 9
Amendment 116 #
2010/0215(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
Nothing in this Directive shall be construed as limiting or derogating from any of the rights and procedural safeguards that may bare ensured under the ECHR, the Charter, under the ICCPR and under other relevant provisions of international law or under the laws of any Member States which provide a higher level of protection.
Amendment 122 #
2010/0215(COD)
Proposal for a directive
Annex 1 – paragraph 2 – point D a (new)
Annex 1 – paragraph 2 – point D a (new)
Da. the right to medical care
Amendment 123 #
2010/0215(COD)
Proposal for a directive
Annex 1 – paragraph 2 – point D b (new)
Annex 1 – paragraph 2 – point D b (new)
Db. the right to contact a trusted person
Amendment 124 #
2010/0215(COD)
Proposal for a directive
Annex 1 – paragraph 2 – point D c (new)
Annex 1 – paragraph 2 – point D c (new)
Dc. the right to consular assistance
Amendment 132 #
2010/0215(COD)
Proposal for a directive
Annex 2 – paragraph 2 – point F a (new)
Annex 2 – paragraph 2 – point F a (new)
F a. the right to medical care
Amendment 133 #
2010/0215(COD)
Proposal for a directive
Annex 2 – paragraph 2 – point F b (new)
Annex 2 – paragraph 2 – point F b (new)
F b. the right to contact a trusted person
Amendment 134 #
2010/0215(COD)
Proposal for a directive
Annex 2 – paragraph 2 – point F c (new)
Annex 2 – paragraph 2 – point F c (new)
F c. the right to consular assistance
Amendment 189 #
2010/0065(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States shall take the necessary measures to ensure that in criminal investigations and proceedings, judicial authorities appoint a special representative for the child victim of trafficking in human beings where, by national law, the holders of parental responsibility are precluded from representing the child as a result of a conflict of interest between them and the child victim, or where the child is unaccompanied or separated from the family. The appointed special representative shall advise and protect the child and ensure that all decisions are taken in the child´s best interest and exercise legal capacity for the child where necessary. The special representative should be consulted and informed regarding all actions taken in relation to the child. The representative should have the necessary expertise in order to ensure that the interests of the child are safeguarded and that the child´s legal, social, health, psychological, material and education needs are covered appropriately.
Amendment 13 #
2009/2153(INI)
Motion for a resolution
Recital E
Recital E
E. whereas bio-waste accounts for more than 30% of solid urban waste; whereas the volume of bio-waste is rising in the European Union, representing a significant source of greenhouse gas emissions and other negative environmental effects when dumped in landfills, in conditions thanks to which waste management is now the fourth most important source of greenhouse gases;
Amendment 18 #
2009/2153(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the management of such waste should be structured in line with the 'waste hierarchy': prevention and reduction, reuse, recycling, other types of recovery, in particular for energy purposes, and as the last option, landfilling (in accordance with Article 4 of the Waste Framework Directive); whereas prevention is the priority objective in the management of bio-waste; whereas prevention makes it possible, in particular, to avoid food waste and green waste, for example through the improved planning of public parks with low-maintenance plants and trees,; whereas there exist technologies and methods enabling more efficient bio-waste management, and it is for the public authorities to set an example by adopting them in the public sphere;
Amendment 27 #
2009/2153(INI)
Motion for a resolution
Recital I
Recital I
I. whereas bio-waste should be seen as a precious natural resource that can be used to produce high-quality compost, thereby helping to combat soil degradation in Europe, maintaining soil productivity, reducing the use of chemical fertilisers in agriculture, and especially of those based on phosphorus, and boosting the soil's water retention capacity,
Amendment 7 #
2009/2151(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Supports the key elements of the Community approach, but considers them insufficient for the agricultural sector; is of the opinion that knowledge-based disaster prevention is essential; highlights the need to draw up maps of areas at risk, create a database of economic and social disaster records, in the interest of efficient monitoring, including the mapping of areas at increased risk, as well as to formulate measures appropriate to the specific nature of the major risks in each region;
Amendment 11 #
2009/2151(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Recalls that investments in sustainable ecosystem management or sound environmental management can offer cost-effective solutions to reducing community vulnerability to disasters; healthy ecosystems act as natural buffers to hazard events, are often less expensive to install or maintain, and are often more effective than physical engineering structures; according to the World Bank (2004), investments in preventive measures, including in maintaining healthy ecosystems, are seven times cheaper than the costs incurred by disasters;
Amendment 15 #
2009/2151(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Considers that agricultural and forestry production are vulnerable to climatic phenomena such as drought, storms, frost, hail, forest fires and floods, to health risks such as plagueepidemics and epidemiczootics, to destruction due to wild animals, and to human activities like pollution, acid rain and unintentional genetic contamination, to landslides because of problems related to urban planning, to technological and transport-related hazards, to forest fires due to absence of forest maintenance andor criminal behaviour, and to contamination of rivers due to chemical discharges from factories;
Amendment 21 #
2009/2151(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Recalls that natural and man-madethropogenic disasters endanger the economic viability of farms and lead to rural depopulation, intensify erosion and desertification, damage ecosystems, endanger biodiversity and seriously affect the quality of life of the remaining rural population; believes that the consequences are more critical in areas with natural handicaps and no possibilities of economic diversification, where agriculture is the major or only sector of the economy;
Amendment 24 #
2009/2151(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the need to create a suitable financial instrument for disaster prevention that will strengthen and link instruments such as cohesion policy, rural development policy, regional policy, the Solidarity Fund and the Seventh Framework Programme; requests that means of financing be established in order to support disaster prevention and risk assessment and reduction actions, also taking account of microfinance and microinsurance for low-income population categories; asks that in this context, prevention should be taken into account in the post-2013 Financial Perspective;
Amendment 38 #
2009/2151(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Regards as essential cooperation on the dissemination of information and experience, technical and scientific applications and also the coordination of strategies for the development of intervention capacities.
Amendment 39 #
2009/2151(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Stresses the need to prepare the healthcare systems of the Member States from the point of view of human resource structure, good practice and risk awareness so that they are able to cope with disaster situations.
Amendment 41 #
2009/2151(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Draws attention to the importance of agricultural practices and the choice of periods during which fertilisers are used, to avoid the transportation into lakes or rivers, by water from precipitation, of nitrogen-based fertilisers; calls on the Commission and the Member States to encourage the implementation of good agricultural practices, which in some Member States has made it possible to halve infiltration of nitrogen-based fertilisers without reducing crop yields;
Amendment 42 #
2009/2151(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Recalls that water is often involved in natural disasters, not only throughin floods – often relateddue to inadequate planning – frost, hail and contamination of river basins, but also through its scarcity, which can wreak significant change, such as the desertification of large areas of southern Europe and south-eastern Europe;
Amendment 43 #
2009/2151(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Draws attention to the risk of landslides from overgrazing and agricultural practices such as perpendicular ploughing along contour lines.
Amendment 54 #
2009/2151(INI)
Draft opinion
Paragraph 13
Paragraph 13
13. Considers that an adequate financial framework on response to disasters should be provided and would be better articulated via the Solidarity Fund, the Rural Development Policy, the Regional Policy, the Seventh Framework Programme, State aids, the Forest Focus programme and the Life+ programmes; calls for special funds, outside the CAP, to be partially used for private prevention measures, reforestation, protection of wetlands and associated ecosystems, monitoring erosion and sedimentation in water courses and alternative uses for recovering high-risk land; further calls for prevention and, intervention and public information to be appropriately included in the next financial perspective;
Amendment 70 #
2009/2151(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Underlines the importance of drawing up standards to analyse and express the socio-economic impact of disasters on communities.
Amendment 72 #
2009/2151(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Recommends the development of public information and education programmes of an institutional nature with regard to disasters and their effects, risk management practices and prevention activities so as to raise awareness of the risks and the means of intervention in natural, technological and environmental disaster situations.
Amendment 10 #
2009/2108(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the health check of species and habitat types protected under the Habitat Directive shows that a majority of species and habitat types have an unfavourable conservation status, that the extinction rate is disturbingly high – according to certain estimates the biodiversity rate has fallen by 30% in the last 40 years – and that the drivers of biodiversity change show no evidence of declining; whereas habitats and species of EU interest are potentially threatened by climate change,; whereas scientists estimate there are many unrecorded species, making it impossible to gauge the full extent of biodiversity loss;
Amendment 126 #
2009/2108(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Welcomes the increasing support for measures concerningto reduce the impact of climate change from which biodiversity can also benefit, but which should not have a negative impact on the funding for biodiversity as such;
Amendment 156 #
2009/2108(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Is convinced that public spending alone will not suffice to reach the EU headline target and underlines the importance of corporate responsibility to also take into account biodiversity; calls on the Commission to look into means of implementing policies that encourage positive investments in conserving biodiversity and discourage investment which impacts on biodiversity, in both the public and private sectors;
Amendment 181 #
2009/2108(INI)
Motion for a resolution
Paragraph 39 a (new)
Paragraph 39 a (new)
39a. Urges the Commission to support the creation of an intergovernmental platform for policies in the field of biodiversity and ecosystem services science, under the auspices of the United Nations Environment Programme, and to help create that platform;
Amendment 1 #
2009/2103(INI)
Motion for a resolution
Recital A (new)
Recital A (new)
Aa. whereas certain Member States have made progress in reducing cancer rates thanks to anti-smoking policies, improved secondary prevention and treatment of certain forms of cancer6; 6 Jemal A, Ward E, Thun M (2010) Declining Death Rates Reflect Progress against Cancer. PLoS ONE 5(3): e9584. doi:10.1371/journal.pone.0009584
Amendment 20 #
2009/2103(INI)
Motion for a resolution
Recital N
Recital N
N. whereas the WHO estimates that at least one third of all cancer cases are preventable and that prevention offers the most cost-effective long-term strategy for the control of cancer and it has been estimated that cancer could be prevented by modifying or avoiding key risk factors such as smoking, being overweight, low fruit and vegetable intake, physical inactivity and alcohol consumption, infectious agents and exposure to certain chemical substances and ionising radiation;
Amendment 36 #
2009/2103(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the European Commission and the European Council to cooperate with the European Parliament in a well-coordinated interinstitutional partnership in order to reduce the burden of cancer, grounded in the legal basis established by Article 168(4) and (5) of the Treaty of Lisbon regarding the protection of public health and the prevention of illnesses;
Amendment 43 #
2009/2103(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Underlines that prevention is the most cost-effective response, as one third of cancers are preventable, and urges that more resources are systematically and strategically invested in prevention; underlines that in these times of financial instability it is all the more important to maintain investments in health, in particular through preventive actions; in this sense, considers that the Commission and the Council should examine means of action to ensure an environment favourable to improved health, through, inter alia, measures on smoking, nutrition and alcohol and providing greater opportunities for physical activity;
Amendment 68 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 2020, this Regulation sets a target of 13560 g CO2/km for the, as average emissions ofor the new light commercial vehicles fleet registered in the Community. Union, subject to confirmation of its feasibility, as specified in Article 12 (4).
Amendment 76 #
2009/0173(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation shall apply to motor vehicles of category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2 610 kg and to vehicles of category N1 to which type- approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 ('light commercial vehicles') which are registered in the Community for the first time and which have not previously been registered outside the Community ('new light commercial vehicles').
Amendment 85 #
2009/0173(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point g a (new)
Article 3 – paragraph 1 – point g a (new)
(ga) 'footprint' means the average track width multiplied by the wheelbase as stated in the certificate of conformity and defined in sections 2.1 and 2.3 of Annex I to Directive 2007/46/EC;
Amendment 86 #
2009/0173(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point g b (new)
Article 3 – paragraph 1 – point g b (new)
(gb) 'payload' means the difference between the technically permissible maximum laden mass, stated in the certificate of conformity and defined in section 2.8 of Annex I to Directive 2007/46/EC, and the mass of the vehicle.
Amendment 113 #
Amendment 122 #
Amendment 137 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indent 3
Article 4 – paragraph 2 – indent 3
– 1080 % from 2016 onwards.
Amendment 140 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indent 3 a
Article 4 – paragraph 2 – indent 3 a
– 100 % from 20167 onwards.
Amendment 160 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 1
Article 5 – indent 1
– 23,5 light commercial vehicles in 2014,
Amendment 164 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 2
Article 5 – indent 2
– 13,5 light commercial vehicles in 2015,
Amendment 169 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 3
Article 5 – indent 3
– 12,5 light commercial vehicle from 2016.
Amendment 170 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 3 a (new)
Article 5 – indent 3 a (new)
– 1,5 light commercial vehicles in 2017,
Amendment 171 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 3 b (new)
Article 5 – indent 3 b (new)
– 1 light commercial vehicle from 2018.
Amendment 175 #
2009/0173(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. For the calendar year commencing 1 January 20124 and each subsequent calendar year, each Member State shall record information for each new light commercial vehicle registered in its territory in accordance with Part A of Annex II. This information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall make every effort to ensure that reporting bodies operate in a transparent manner.
Amendment 177 #
2009/0173(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. By 28 February of each year, commencing in 20135, each Member State shall determine and transmit to the Commission the information listed in Part B of Annex II in respect of the preceding calendar year. The data shall be transmitted in accordance with the format specified in Part C of Annex II.
Amendment 182 #
2009/0173(COD)
Proposal for a regulation
Article 7 – paragraph 4 – subparagraph 1 – introductory part
Article 7 – paragraph 4 – subparagraph 1 – introductory part
The Commission shall keep a central register of the data reported by Member States under this Article and this register shall be publicly available. By 30 June 20135 and each subsequent year, the Commission shall provisionally calculate for each manufacturer:
Amendment 186 #
2009/0173(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. In relation to the calendar year 20124 and 20135 and on the basis of the calculations performed pursuant to paragraph 5, the Commission shall notify a manufacturer where it appears to the Commission that the manufacturer's average specific emissions of CO2 exceed its specific emissions target.
Amendment 235 #
2009/0173(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. By 31 October 20135 and 31 October each subsequent year, the Commission shall publish a list indicating for each manufacturer:
Amendment 238 #
2009/0173(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. From the 31 October 20145, the list published under paragraph 1 shall also indicate whether the manufacturer has complied with the requirements of Article 4 with respect to the preceding calendar year.
Amendment 300 #
2009/0173(COD)
Proposal for a regulation
Annex 2 – title A – point 1 – introductory part
Annex 2 – title A – point 1 – introductory part
1. For the year beginning 1 January 20114 and each subsequent year, Member States shall record the following details for each new light commercial vehicle registered in its territory:
Amendment 304 #
2009/0173(COD)
Proposal for a regulation
Annex 2 – title A – point 3 – introductory part
Annex 2 – title A – point 3 – introductory part
3. For the calendar year commencing 1 January 20114 and each subsequent calendar year, each Member State shall determine, in accordance with the methods set out in Part B, for each manufacturer:
Amendment 307 #
2009/0173(COD)
Proposal for a regulation
Annex 2 – title A – point 3 – subpoint d – introductory part
Annex 2 – title A – point 3 – subpoint d – introductory part
(d) for each variantersion of each versionariant of each type of new light commercial vehicle:
Amendment 311 #
2009/0173(COD)
Proposal for a regulation
Annex 2 – title B – point 6 – paragraph 1
Annex 2 – title B – point 6 – paragraph 1
The payload of the vehicle shall be defined as the difference between the technically permissible maximum laden mass stated in the certificate of conformity and defined in section 2.8 of Annex I to Directive 2007/46/EC pursuant to of Annex III to Directive 2007/46/EC and the mass of the vehicle.
Amendment 70 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7
Recital 7
7. In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription and over-the-counter medicinal products should be established at Community level. When introducing obligatory safety features for prescription and over-the-counter medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 96 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should be made aware of the risks of purchasing medicinal products from illegal suppliers. An information campaign should be organised by the Member States and at EU level. The Commission and Member States should adopt measures to make the public aware of the risks of purchasing medicinal products over the internet.
Amendment 118 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) The Member States should collaborate, within Europol and elsewhere, in enforcing existing rules designed to restrict the illegal activities of those supplying medicinal products over the internet.
Amendment 321 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 2
Article 80 – point i – paragraph 2
Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.’ In their turn, holders shall inform the other operators along the supply chain for the medicinal product concerned regarding the infringements or suspected infringements.
Amendment 42 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency12 (hereinafter referred to as the ‘Agency’).
Amendment 174 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder; those measures shall include training for health professionals and for patients and a public information campaign for patients;
Amendment 180 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – point 1 a (new)
Article 102 – point 1 a (new)
(1a) facilitate direct patient reporting through the provision of alternative reporting formats (email, telephone, fax and letter) in addition to web-based formats;
Amendment 19 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the Community, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information. Member States should therefore not impose on marketing authorisation holders any additional reporting requirements. The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public in all the official languages of the European Union.
Amendment 20 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the Community, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information. Member States should therefore not impose on marketing authorisation holders any additional reporting requirements. However, the Member States concerned should be notified at the same time, through the Eudravigilance database, of reports sent by marketing authorisation holders. In order to ensure high-quality information, Member States should support the development of national and regional pharmacovigilance centres' expertise. The national competent authorities should collect the reports from those centres and transfer the data to the Eudravigilance database. The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public.
Amendment 22 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 6
Recital 6
(6) In order to increase transparency as regards pharmacovigilance issues, a European medicines safety web-portal should be created and maintained by the Agency in all the official languages of the European Union.
Amendment 76 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 –- point 14
Article 1 –- point 14
Regulation EC/726/2004
Article 61a – paragraph 1 – point b a (new)
Article 61a – paragraph 1 – point b a (new)
(ba) one representative from the Patient and Consumer’s Working Party and one representative from the Healthcare Professionals Working Group.
Amendment 34 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 42 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 46 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.
Amendment 49 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.
Amendment 53 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 54 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 58 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.
Amendment 64 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 67 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information andcompetent authority- approved high-quality information in approved form and in order to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".
Amendment 72 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 108 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
Directive 2001/83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
Amendment 111 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.
Amendment 112 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a - paragraph 1
Article 100 a - paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 129 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part and point a
Article 100 b – introductory part and point a
The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription may be disseminated by the, marketing authorisation holder available to the general public or members thereof: a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.
Amendment 146 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way;
Amendment 165 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:
Amendment 182 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
b) marketing authorisation holders' internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 190 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1 a (new)
Article 100 d – paragraph 1 a (new)
1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 1
Article 100 g – paragraph 1 – subparagraph 1
1. Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.
Amendment 248 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 1
Article 100 h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Amendment 259 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2
Article 100 h – paragraph 2 – subparagraph 2
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.
Amendment 267 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 a (new)
Article 100 h – paragraph 2 a (new)
2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point a
Article 100 h – paragraph 4 – point a
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point b
Article 100 h – paragraph 4 – point b
(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
Amendment 279 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.
Amendment 288 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.
Amendment 76 #
2008/0241(COD)
Proposal for a directive
Article 3 - point b a (new)
Article 3 - point b a (new)
(ba) “medical device” means the electrical equipment covered by the scope of Directive 93/42/EC and Directive 98/79/EC.
Amendment 80 #
2008/0241(COD)
Proposal for a directive
Article 3 – point j – introductory part
Article 3 – point j – introductory part
(j) ‘producer’ means any natural or legal person in the Member State who, irrespective of the selling technique used, including by means of distance communication in accordance with Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts:
Amendment 82 #
2008/0241(COD)
Proposal for a directive
Article 3 – point j– point i
Article 3 – point j– point i
(i) manufactures electrical and electronic equipment under his own name or trademark, or has electrical and electronic equipment designed or manufactured and markets that electronic equipment under his name or trade mark within the territory of the Member State,
Amendment 84 #
2008/0241(COD)
Proposal for a directive
Article 3 – point j – point iii
Article 3 – point j – point iii
(iii) is established within the Community and places electrical and electronic equipment from a third country on a professional basis onto the Community marketmarket of the Member State.
Amendment 97 #
2008/0241(COD)
Proposal for a directive
Article 3 - point o
Article 3 - point o
(o) "making available on the market” means any supply of a product for distribution, consumption or use on the CommunityMember State national market in the course of a commercial activity, whether in return for payment or free of charge.
Amendment 99 #
2008/0241(COD)
Proposal for a directive
Article 3 - point p
Article 3 - point p
(p) "placing on the market" means the first making available of a product on the CommunityMember State national market;
Amendment 128 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 5(1), Member States shall ensure that producers or third parties acting on their behalf achieve a minimum collection rate of 65%40% in 2016, increasing to 65% in 2020. The collection rate is calculated on the basis of the total weight of WEEE collected in accordance with Articles 5 and 6 in a given year in that Member State, expressed as a percentage of the average weight of electrical and electronic equipment placed on the market in the twohree preceding years in that Member State. This collection rate shall be achieved annually and starting in 2016.
Amendment 223 #
2008/0241(COD)
Proposal for a directive
Article 16 - paragraph 2
Article 16 - paragraph 2
2. Member States shall ensure that any producer on their territory can enter in their national register all relevant information, including reporting requirements and fees, reflecting its activities across all oin ther Member States. . The registers shall be inter-operational to exchange such information, including on quantities of electrical and electronic equipment placed on the national market and for the transfer of money related to the intra-Community transfers of products or WEEE.
Amendment 144 #
2008/0198(COD)
Council position
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Where, following the checks referred to in paragraph 1, shortcomings have been detected, the competent authorities may issue a notice of remedial actions to be taken by the operator. Any failure by the operator to take such remedial action may give rise to penalties in accordance with Article 17. Where the competent authorities have found that the operator failed to implement a due diligence system, the responsible monitoring organisation will be considered to have failed to carry out its functions according to Article 7(1)(a), (b) and (c) of this Regulation and, as a result, its recognition may be withdrawn in accordance with Article 7(6).
Amendment 202 #
2008/0028(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) It is claimed of certain products that specific physical benefits result from their use: such claims should be expressed in a way that ensures that the effect of using the product is measurable or verifiable.
Amendment 205 #
2008/0028(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) When used in the production of foods and still present, certain ingredients or other substances are the cause of allergies or intolerances in consumers, and some of those allergies or intolerances constitute a danger to the health of those concerned. It is important that information on the presence of food additives, processing aids and other substances with allergenic effect or which may increase the risk of illness should be given to enable consumers suffering from a food allergy or intolerance to make informed and safe choices.
Amendment 276 #
2008/0028(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point c a(new)
Article 7 – paragraph 1 – point c a(new)
(ca) Explicit claims concerning a substantial reduction in sugar and/or fat content, where they are not reflected in a corresponding reduction in the energy content (expressed in kilojoules or kilocalories) of the food product concerned, may be interpreted as information which may mislead the consumer;
Amendment 401 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. The nutrition declaration may also include the amounts of one or more of the following: (a) trans fats; (b) mono-unsaturates; (c) polyunsaturates (including their Omega 9 compounds); (c) polyunsaturates (including their Omega 3 and Omega 6 compounds); (ca) cholesterol (LDL and/or HDL); (d) polyols; (e) starch; (f) fibre; (g) protein; (h) any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI. (ha) other substances, under Annex XIII, Part A.
Amendment 477 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. In cases where the amount of energy or nutrient(s) in a product is zero or negligible, the nutrition declaration on those elements may be replaced by a statement such as ‘Contains negligibleDoes not contain significant amounts of …’ in close proximity to the nutrition declaration when present.
Amendment 572 #
2008/0028(COD)
Proposal for a regulation
Annex XI – part B – rows 4 a, b, c, d (new)
Annex XI – part B – rows 4 a, b, c, d (new)
Energy or Reference Intake nutrient Intake Energy 8400 kJ (2000 kcal) (2000 kcal) Total fat 70 g Saturates 20 g Monosaturated 34 g fatty acids Polysaturated fatty 16 g acids Omega-6 fatty 14 g acids Omega-3 fatty 2.2 g acids Carbohydrate 230 g Sugars 90 g Salt 6g
Amendment 127 #
2008/0002(COD)
Council position – amending act
Recital 6
Recital 6
(6) It should also be clarified that a food is to be considered as novel when a production technology which was not previously used for foodthe production of foods to be marketed and consumed in the Union is applied to that food. In particular, emerging technologies in breeding and food production processes which have an impact on food, and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from animals produced by non-traditional breeding techniques and from their offspring, foods derived from plants produced by non-traditional breeding techniques, foods produced by new production processes which might have an impact on food, and foods containing or consisting of engineered nanomaterials. Foods derived from new plant varieties or animal breeds produced by traditional breeding techniques should not be considered as novel foods. Furthermore, it should be clarified that foods from third countries which are novel in the Union can be considered as traditional only when they are derived from primary production as defined in Regulation (EC) No 178/2002, whether they are processed or unprocessed (e.g. fruit, jam, fruit juice). However, foods thus obtained should neither include foods produced from animals or plants to which a non-traditional breeding technique was applied or foods produced from the offspring of such animals, nor foods to which a new production process is applied.
Amendment 146 #
2008/0002(COD)
Council position – amending act
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
(2) The producer or the authority shall forthwith inform the Commission of:
Amendment 147 #
2008/0002(COD)
Council position – amending act
Article 17 – point a
Article 17 – point a
(a) the Union list referred to in Article 7(1) and the list of traditional foods from third countries referred to in Article 7(2), on a single dedicated page of the Commission website, in all the official EU languages;
Amendment 84 #
2007/0286(COD)
Council position
Article 3 – point 17
Article 3 – point 17
(17) "hazardous substances" means substances or mixtures as defined in points 7 and 8 of Article 2 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, or groups of substances as defined in point 29 of Article 2 of Directive 2000/60/EC of the European Parliament and the Council of 23 October 2000 establishing a framework for Community action in the field of water policy;
Amendment 85 #
2007/0286(COD)
Council position
Article 3 – point 22
Article 3 – point 22
Amendment 118 #
2007/0286(COD)
Council position
Article 14 – paragraph 1 – subparagraph 2 – point c –point i
Article 14 – paragraph 1 – subparagraph 2 – point c –point i
(i) measurement methodology, frequency and evaluation procedure or equivalent methods; and
Amendment 138 #
2007/0286(COD)
Council position
Article 15 – paragraph 4 – subparagraph 1
Article 15 – paragraph 4 – subparagraph 1
4. By way of derogation from paragraph 3, temission limit values laid down for installations under point 6.6 of Annex I shall take into account practical considerations appropriate to these categories of installations as well as the costs and benefits of these measures. The competent authority may, in specific cases, on the basis of an assessment of the environmental and economic costs and benefits taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions, set emission limit values deviating from those set by the application of paragraph 3.
Amendment 182 #
2007/0286(COD)
Council position
Article 22 – paragraph 2 – subparagraph 1
Article 22 – paragraph 2 – subparagraph 1
2. Where the activity involves the use, production or release of significant amounts of relevant hazardous substances and having regard to the possibility of soil and groundwater contamination at the site of the installation, the operator shall prepare and submit to the competent authority a baseline report before starting operation of an installation or before a permit for an installation is updated for the first time after …*. In cases where provisions regarding water and soil protection are already being implemented at national level, Member States shall not draft a baseline report.
Amendment 185 #
2007/0286(COD)
Council position
Article 22 – paragraph 2 – subparagraph 2
Article 22 – paragraph 2 – subparagraph 2
The baseline report shall contain the information necessary to determine the state of soil and groundwater contamination so as to make a quantified comparison with the state upon definitive cessation of activities provided for under paragraph 3.
Amendment 205 #
2007/0286(COD)
Council position
Article 23 – paragraph 4 – subparagraph 2
Article 23 – paragraph 4 – subparagraph 2
The period between two site visits shall be based on a systematic appraisal of the environmental risks of the installations concerned and shall not exceed one year for installations posing the highest risks and threfive years for installations posing the lowest risks.
Amendment 209 #
2007/0286(COD)
Council position
Article 23 – paragraph 4 – subparagraph 3– point c
Article 23 – paragraph 4 – subparagraph 3– point c
(c) participation in the Community eco- management and audit scheme (EMAS) or other accredited industry compliance regimes undertaking regular checks or inspections.
Amendment 273 #
2007/0286(COD)
Council position
Article 73 – paragraph 2
Article 73 – paragraph 2