450 Amendments of Paolo BARTOLOZZI
Amendment 5 #
2013/2183(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that this should be without prejudice to the freedom to express and display one’s beliefs and opinions in keeping with the principle of pluralism of ideas, provided that this does not incite hatred, violence or discrimination;
Amendment 137 #
2013/2062(INI)
Motion for a resolution
Paragraph 34 a (new)
Paragraph 34 a (new)
34a. Calls on the Member States, in the absence of an agreed solution at EU level, to take appropriate measures to implement the provisions of paragraph 7 of the supplementary guidelines on vertical restraints in agreements for the sale and repair of motor vehicles and for the distribution of spare parts for motor vehicles contained in Commission Notice 2010/C 138/05, so as to ensure contractual relations between dealers and automobile manufacturers based on fairness, transparency and compliance with the principles of good faith;
Amendment 81 #
2013/2045(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on Member States, in agreement with the Commission, to establish a tax incentive scheme to promote youth employment and support under-35 undertakings, by means of incentives for undertakings, particularly SMEs, to recruit young people on permanent contracts; to this end, proposes that, as suggested by the Commission in the employment package, the Member States could use the instrument of employment subsidies and reduction of the tax wedge, particularly to meet the cost to employers of social security and health insurance contributions;
Amendment 82 #
2013/2045(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on Member States, in agreement with the Commission, to establish measures and concessions for apprenticeship contracts and bonuses for business start-ups by young people aged under 35; considers, in particular, that Member States should provide greater and better support services for start-ups, organise awareness-raising campaigns concerning the opportunities and prospects involved in self-employment, arrange more cooperation between employment services, and provide support for businesses, including with the aid of (micro-) financing;
Amendment 230 #
2013/2045(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on Member States, in agreement with the Commission, to establish a tax incentive scheme to promote youth employment and support under-35 undertakings, by means of incentives for undertakings, particularly SMEs, to recruit young people on permanent contracts; to that end, proposes that, as suggested by the Commission in the employment package, the Member States could use the instrument of employment subsidies and reduction of the tax wedge, particularly to meet the cost to employers of social security and health insurance contributions;
Amendment 277 #
2013/2045(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on Member States, in agreement with the Commission, to establish measures and concessions for apprenticeship contracts and bonuses for business start-ups by young people aged under 35; in particular, Member States should provide greater and better support services for start-ups, organise awareness- raising campaigns concerning the opportunities and prospects involved in self-employment, arrange more cooperation between employment services, and provide support for businesses, including with the aid of (micro-) financing;
Amendment 94 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 1
Article 1 – point 1
Directive 94/62/EC
Article 3 – point 2a
Article 3 – point 2a
Amendment 131 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Directive 94/62/EC
Article 4 – paragraph 1b (new)
Article 4 – paragraph 1b (new)
Amendment 70 #
2013/0240(NLE)
Proposal for a Regulation
Recital 8
Recital 8
(8) Research related to the future of medicine shall be undertaken in areas where combination of societal, public health and biomedical industry competitiveness goals requires pooling of resources and fostering collaboration between the public and private sectors, with the involvement of SMEs. The scope of the initiative should be expanded to all areas of life science research and innovation. The areas would be of public health interest, as identified by the World Health Organisation report on priority medicines for Europe and the World, which is currently being updated with the new version expected to be released in 2013. The initiative should consequently seek to involve a broader range of partners, including mid-capsSMEs (micro, small and medium size enterprises) and mid-caps and medium size companies that are not on equity capital markets and with innovation potential, from different sectors (e.g. biomedical imaging, medical information technology, diagnostic and/or animal health industries). A wider participation would help to advance the development of new approaches and technologies for the prevention, diagnosis and treatment of diseases with high impact on public health.
Amendment 1 #
2012/2153(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the ongoing negotiations for an enhanced PCA and calls for this update to be ambitious, comprehensive and mutually beneficial; insists that these negotiations must be accompanied bystresses the strategic role played by Kazakhstan in the process of modernisation of Central Asia, moving towards a democratic stability through political and, economic reform in Kazakhstaand social media reforms, such as the important Media Forum event; recognizes that, Kazakhstan is a key trade partner of the European Union and insists on these negotiations to increase the relations with the Union and to booster the economy of the region;
Amendment 4 #
2012/2153(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Draws attention to the criticalsteps made in order to improve the situation as regards human rights and fundamental freedoms, especially workers’ rights, which also gives rise to unfair competitive advantage in Kazakhstan and encourages the country to maintain its commitment to further reforms in the these areas; stresses, therefore that a binding trade and sustainable development chapter must be included in the new agreement;.
Amendment 7 #
2012/2153(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the EU and Kazakhstan shouldwill benefit mutually from closer cooperation; whereas the conclusion of the new PCA negotiation, based on common efforts, should provide a comprehensive framework for enhanced cooperation and opportunities for socio-economic development in particular regarding Kazakhstan's outstanding position in the region; social and economic development are closely interconnected;
Amendment 10 #
2012/2153(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Encourages Kazakhstan to take the necessary steps to swiftly conclude negotiations on its accession to the WTO; calls on Kazakhstan to ensure that the Russia-Kazakhstan-Belarus Customs Union does not constitute a barrier to trade with the EU or to fulfilling its obligations arising from WTO membership and pave the way for structural reforms and the creation of a working market economy;
Amendment 12 #
2012/2153(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Kazakhstan has been admitted to the Venice Commission of the Council of Europe; whereas, however, the past year has been marked by the deterioration of the situation of fundamental rights and freedoms during the negotiations for an enhanced PCA a common language on human rights and democracy was found;
Amendment 12 #
2012/2153(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a (new). Calls on Kazakhstan to ensure that the Russia-Kazakhstan-Belarus Customs Union does not constitute a barrier to trade and to economic and financial cooperation with the EU or to fulfilling its obligations arising from WTO membership;
Amendment 14 #
2012/2153(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Stresses that a strong services and establishment chapter and convergence of Kazakhstan towards EU standards and regulatory systems (including SPS, TBT and IPR) would lead to increased trade flows and investments, which would favour modernisation and diversification of Kazakhstan’s economy; underlines the importance of improving licensing procedures in Kazakhstan in order to facilitate services and investment;
Amendment 20 #
2012/2153(INI)
Motion for a resolution
Recital C
Recital C
C. whereas, notwithstanding the Kazakh government's stated ambition to strengthen Kazakhstan's democratic process and to conduct elections in line with international standards, the general elections held on 15 January 2012 were deemed by the OSCE not to be fully in line with itsnternational standards;
Amendment 21 #
2012/2153(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on Kazakhstan not to restrict trade and investment in the raw material sectors in an unfair and unjustified manner; calls on Kazakhstan to comply with the Extractive Industries Transparency Initiative (EITI).
Amendment 22 #
2012/2153(INI)
Motion for a resolution
Recital D
Recital D
D. whereas after the events of December 2011 in Zhanaozen, there have been opposition parties and, independent media and trade unions which have become targets of intensified repression, with politically motivated detentions of activists and human rights defendersrepression, including detentions without proven violation of law which could be considered as politically motivated;
Amendment 27 #
2012/2153(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas official representatives of Kazakhstan have participated in open and constructive meetings with Members of European Parliament with the participation of the civil society and NGOs since January 2012 in the European Parliament and have provided information in an open and transparent manner;
Amendment 28 #
2012/2153(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Db. whereas recently the Kazakh authorities have undertaken important efforts in the cooperation with NGOs in West Kazakhstan in order to improve the situation for people in the region, in particular for workers on strike;
Amendment 33 #
2012/2153(INI)
Motion for a resolution
Recital F
Recital F
F. whereas despite the attempts toon 17 February 2012 the President of Kazakhstan signed several laws aiming at improveing the law of 17 February 2012egal basis for labour relations, workers' rights and social dialogue and strengthening the independence of the judiciary; whereas despite these attempts, the right to collective bargaining and the right to strike are not being fully respected, and an independent judiciary is not yet in place;
Amendment 35 #
2012/2153(INI)
Motion for a resolution
Recital G
Recital G
Amendment 36 #
2012/2153(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the EU is a key trading partner for Kazakhstan and the biggest investor in the country; whereas Kazakhstan has clearly expressed its wish to come close to the EU standards and its social and economic models implying a consistent reform of the Kazakh state and public administration;
Amendment 37 #
2012/2153(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas Kazakhstan plays an important role in securing regional stabilisation and can become a bridge between the EU and the whole Central Asian region;
Amendment 38 #
2012/2153(INI)
Motion for a resolution
Recital G c (new)
Recital G c (new)
Gc. whereas Kazakhstan has reached important results in the field of poverty reduction, public health and education;
Amendment 40 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point a
Paragraph 1 – point a
(a) ensure that the new PCA takes the form of a comprehensiveis a comprehensive and forward looking framework for the further development of relations, addressing all priority areas, including: human rights, the rule of law, good governance and democratisation; youth and education; economic development, trade and investment; energy and transport; environmental sustainability and water; and combating common threats and challenges;
Amendment 45 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point b
Paragraph 1 – point b
(b) welcome Kazakhstan's political will and concrete engagement to further deepen partnership with the EU; ensure that the EU's engagement is consistent with other Union policies and that the principle of ‘more for more’ is applied;
Amendment 48 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point c
Paragraph 1 – point c
(c) work closely with Kazakhstan to promote regional cooperation and the improvement of neighbourly relations in the Central Asia region, including by support for confidence building measures where appropriate, particularly in such areas as water and resource management, border management, fight against extremism and counter-terrorism;
Amendment 53 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point e
Paragraph 1 – point e
(e) cooperate with Kazakhstan, other Central Asian states as well as local, regional and international actors to promote security and development in Afghanistan;
Amendment 55 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point f
Paragraph 1 – point f
(f) reinforce the EU's action in the fields of education, the rule of law, the environment and water, inter alia through newly established support platforms and targeted assistance; bring local NGOs and CSOs into the EU's dialogue with the Kazakh government in those areas where appropriate and possible;
Amendment 58 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point f a (new)
Paragraph 1 – point f a (new)
(fa) support policy reforms and institutional capacity building through targeted technical assistance (i.e. exchange of experts);
Amendment 63 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point h
Paragraph 1 – point h
(h) underline that progress in the negotiation of the new PCA must be linked to the progress of political reform and a genuine commitment on the part of Kazakhst; support Kazakhstan in maintaining its declared self-commitment to further reforms and to human rights and democracy, in order to build up an open and democratic society including an independent civil society and opposition, respectful of fundamental rights and the rule of law; offer adequate assistance on the EU's part for implementing the reforms;
Amendment 65 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point i
Paragraph 1 – point i
(i) express deep concern over the politically motivated detentions of activists and human rights defendersdetentions without proven violation of law which could be considered as politically motivated;
Amendment 68 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point j
Paragraph 1 – point j
Amendment 70 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point k
Paragraph 1 – point k
(k) insist that Kazakhstan further translates its Human Rights Action Plan into legislation and continues to implements it in full, drawing on the recommendations of the Venice Commission and making use of EU technical assistance under the Rule of Law initiative;
Amendment 71 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point l
Paragraph 1 – point l
(l) call upon Kazakhstan as a member of the Venice Commission, to demonstrate its commitment to Council of Europe standards by submitting specific draft laws and recently adopted laws for comments to the Venice Commission and implementing the recommendations of the Commissioncooperating with the Venice Commission regarding specific draft laws and recently adopted laws;
Amendment 77 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point p
Paragraph 1 – point p
(p) urge the Kazakh authorities to amend the Article 164 of Kazakhstan's Criminal Code of 'inciting social discord‘ to bring it into line with the International Human Rights Law, or else to repeal it;
Amendment 80 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point q
Paragraph 1 – point q
(q) insist that Kazakhstan comply with the recommendations of the UN Committee Against Torture and the 2009 recommendations of the UN Special Rapporteur on Torture; call on Kazakhstan to ensureallow for independent NGO participation in consultations on the upcoming reform of the Criminal Code and the Criminal Procedural Code;
Amendment 81 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point r
Paragraph 1 – point r
Amendment 88 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point x a (new)
Paragraph 1 – point x a (new)
(xa) highlight that the conclusion of the new PCA negotiation will have positive impact on the deepening of the economic cooperation between EU and Kazakh companies, including SMEs;
Amendment 90 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point x
Paragraph 1 – point x
(x) encourage Kazakhstan to take the necessary final steps for swift WTO accession and pave the way for subsequent structural reforms and the creation of a market economy;
Amendment 92 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point x b (new)
Paragraph 1 – point x b (new)
(xb) call upon the removal of tariff and non-tariff barriers in order to extent trade, particularly trade of services and foreign investments; support the ambitions to harmonise standards in the trade of goods beyond the conditions set by the WTO which would also lead to a broadening of trade opportunities;
Amendment 98 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point y
Paragraph 1 – point y
(y) acknowledgensure that Kazakhstan's participation in the Russian-led customs union and the Eurasian Economic Union is not an obstacle to closer cooperation between the EU and Kazakhstan;
Amendment 102 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point z a (new)
Paragraph 1 – point z a (new)
(za) push for regulatory and rules-based convergence in specific sectors and key areas of mutual interest;
Amendment 109 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point aa
Paragraph 1 – point aa
(aa) consult the EP regarding the provisions on parliamentary cooperation; enhance the role of Parliament, Parliamentary Cooperation Committees and inter-parliamentary meetings as means to monitor the negotiation and the implementation of partnership agreements; encourage the Parliament's work to promote dialogue and regular bilateral and multilateral parliamentary cooperation;
Amendment 110 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point ab
Paragraph 1 – point ab
(ab) include clear benchmarks and binding deadlines for the implementation of the new PCA and provide for monitoring mechanisms, including regular reports to the EPdevelop together with the Kazakh authorities an effective monitoring mechanism including clear benchmarks for the implementation of the new PCA and regular reports to the EP, in order to ensure a successful implementation beneficial for both, the EU and Kazakhstan;
Amendment 114 #
2012/2153(INI)
Motion for a resolution
Paragraph 1 – point ab a (new)
Paragraph 1 – point ab a (new)
(aba) provide sufficient EU-funding for a comprehensive and sustainable cooperation with the Central Asian countries including for the successful implementation of the new PCA with Kazakhstan;
Amendment 146 #
2012/0366(COD)
Proposal for a directive
Recital 23
Recital 23
(23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed.
Amendment 262 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
Amendment 266 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Amendment 303 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
(18) ‘ingredient’ means an additive, tobacco (leaves and other natural, processed or unprocessed partsy substance used in the manufacture or preparation of a tobacco plants including expanded and reconstituted tobacco), as well as any substance present in a finished tobacco product roduct or of any constituent thereof (including paper, filter, inks, capsules and adhesives) and still present in the finished tobacco product;
Amendment 316 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 19
Article 2 – paragraph 1 – point 19
(19) ‘maximum level’ or ‘maximum yield’ means the maximum content or emission, including 0, of a substance in a tobacco product measured in grams;
Amendment 325 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 25
Article 2 – paragraph 1 – point 25
(25) ‘place on the market’ means to make products available to consumers located in the Union, with or without payment, including by means of distance sale; in case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;
Amendment 366 #
2012/0366(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 386 #
2012/0366(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar, nicotine and carbon monoxide fixed in paragraph 1.
Amendment 468 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Member States shall not restrict or prohibit the use of additiveingredients which are essential for the manufacture of tobacco products, as long as the additiveuse of those ingredients does not result in a product with a characterising flavour.
Amendment 575 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 617 #
2012/0366(COD)
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
Amendment 633 #
2012/0366(COD)
Proposal for a directive
Article 8 – paragraph 4 – point b
Article 8 – paragraph 4 – point b
Amendment 672 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover 750 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 688 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) be positioned at the bottopm edge of the unit packet and any outside packaging, and in the same direction as any other information appearing on the packaging;
Amendment 711 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
Amendment 745 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 3 – point c
Article 9 – paragraph 3 – point c
Amendment 788 #
2012/0366(COD)
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 822 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or social effects;
Amendment 829 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
Amendment 833 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
(d) in the case of tobacco for oral use, resembles a food product.
Amendment 837 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Prohibited elements and features may include but are not limited to texts, symbols, names, trade marks, figurative or other signs, misleading colours, inserts or other additional material such as adhesive labels, stickers, onserts, scratch-offs and sleeves, or relate to the shape of the tobacco product itself. Cigarettes with a diame. The provision to consumers of factual information on the product may not be prohibited. Trade marks registered prior to the dater of less than 7.5 mm shall be deemed to be misleadingn which this Directive enters into force may not be prohibited.
Amendment 863 #
2012/0366(COD)
Proposal for a directive
Article 13
Article 13
Amendment 947 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point g
Article 14 – paragraph 2 – point g
Amendment 953 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point h
Article 14 – paragraph 2 – point h
Amendment 955 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point i
Article 14 – paragraph 2 – point i
(i) the actual shipment route from manufacturing to the first retail outletpurchaser, including all warehouses used;
Amendment 963 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point j
Article 14 – paragraph 2 – point j
(j) the identity of all purchasers from manufacturing to the first retail outletpurchaser;
Amendment 969 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point k
Article 14 – paragraph 2 – point k
(k) the invoice, order number and payment records of all purchasers from manufacturing to the first retail outletpurchaser.
Amendment 976 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outletfirst purchaser, record the entry of all unit packets into their possession, as well as all intermediate movements and the final exit from their possession. This obligation can be fulfilled by recording in aggregated form, e.g. of outside packaging, provided that tracking and tracing of unit packets remains possible.
Amendment 983 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 4
Article 14 – paragraph 4
4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outletpurchaser, including importers, warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased, sold, stored, transported or otherwise handled. The equipment shall be able to read and transmit the data electronically, in accordance with international standards, to a data storage facility pursuant to paragraph 6.
Amendment 1002 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 9 – introductory part
Article 14 – paragraph 9 – introductory part
9. TWith due regard for current practices, technologies and commercial arrangements, as well as for international standards governing the tracking, tracing and authentication of consumer products and the requirements relating thereto that are set out in the WTO Protocol to Eliminate Elicit Trade in Tobacco Products, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to:
Amendment 1006 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 9 – point b
Article 14 – paragraph 9 – point b
(b) to define the technical standards to ensure that the systems used for the unique identifiers and the related functions are fully compatible with each other across the Union and in line with international standards.
Amendment 1008 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 9 – point c
Article 14 – paragraph 9 – point c
Amendment 1037 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage inprohibit cross- border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authorities:.
Amendment 1053 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 1061 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 1069 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 1076 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 1086 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 1095 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 1103 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 1117 #
2012/0366(COD)
Proposal for a directive
Article 17 – title
Article 17 – title
Notification of novel tobacco products and granting of pre-marketing authorisation for reduced-risk tobacco products
Amendment 1136 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Member States shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point (a) to (c) of paragraph 1. Member States shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information. Member States shall make available to the Commission all information received pursuant to this Article. In connection with the placing on the market of reduced-risk tobacco products, Member States shall be entitled to introduce an authorisation system and charge a proportionate fee. Member States shall be entitled to lay down specific rules for reduced-risk products governing consumer information, packaging and labelling, ingredients and emissions, as well as the methods used to measure tar, nicotine and carbon monoxide, which may differ from the requirements of this Directive. Member States shall notify those rules to the Commission.
Amendment 1141 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Novel and reduced-risk tobacco products placed on the market shall respect the requirements set out in this Directive. Reduced-risk tobacco products shall be covered by special provisions laid down by Member States under paragraph 2. The provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point (29) of Article 2 or tobacco for smoking in point (33) of Article 2.
Amendment 1146 #
2012/0366(COD)
Proposal for a directive
Article 18
Article 18
Amendment 1273 #
2012/0366(COD)
Proposal for a directive
Article 22 – paragraph 2
Article 22 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall be conferred on the Commission for an indeterminate period of timehree years from [Office of Publications: please insert the date of the entry into force of this Directive]. the date of the entry into force of this Directive]..
Amendment 98 #
2012/0297(COD)
Proposal for a directive
Recital 24
Recital 24
(24) The new provisions should alsoonly apply to projects for which the request for development consent is introduced before the time-limit for transposition but for which the environmental impact assessment has not been concluded before that dateenvironmental impact assessment has not started yet at the date of transposition of Directive 2011/92/EU.
Amendment 107 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
- the execution of construction orand of the related demolition works, or of other installations or schemes,
Amendment 228 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 6 – subparagraph 1
Article 4 – paragraph 6 – subparagraph 1
6. The competent authority shall make its decision pursuant to paragraph 2 within three month90 days from the request for development consent and provided that the developer has submitted all the requisite information. Depending on the nature, complexity, location and size of the proposed project, the competent authority may extend that deadline by a further 3 monthmaximum 90 days; in that case, the competent authority shall inform the developer of the reasons justifying the extension and of the date when its determination is expected and inform the Commission about the entity and causes of the delay.
Amendment 240 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Where an environmental impact assessment must be carried out in accordance with Articles 5 to 10, the developer shall prepare an environmental report. The environmental report shall be based on the determination pursuant to paragraph 2 of this Article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project, taking into account current knowledge and methods of assessment, the characteristics, technical capacity and location of the project, the characteristics of the potential impact, alternativesn outline of reasonable alternatives relevant and specific to the proposed project and the extent to which certain matters (including the evaluation of alternatives) are more appropriately assessed at different levels including the planning level, or on the basis of other assessment requirements. The detailed list of information to be provided in the environmental report is specified in Annex IV.
Amendment 251 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Article 5 – paragraph 2 – subparagraph 1 – introductory part
2. TIf the developer so requests before submitting an application for development consent, the competent authority, after having consulted the authorities referred to in Article 6(1) and the developer, shall determine the scope and level of detail ofshall provide guidance on the information to be included by the developer in the environmental report, in accordance with paragraph 1 of this Article. In particular, the competent authority shall determineconsider:
Amendment 266 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – point c
Article 5 – paragraph 2 – subparagraph 1 – point c
(c) the individual stages of the procedure and binding timeframes for their duration;
Amendment 271 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – point d
Article 5 – paragraph 2 – subparagraph 1 – point d
Amendment 279 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – point e
Article 5 – paragraph 2 – subparagraph 1 – point e
Amendment 282 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – point f
Article 5 – paragraph 2 – subparagraph 1 – point f
Amendment 290 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 2
Article 5 – paragraph 2 – subparagraph 2
The competent authority may also seek assistance from accredited and technically competent experts referred to in paragraph 3 of this Article. Subsequent requests to the developer for additional information may only be made if these are justified by new circumstances and duly explained by the competent authority.
Amendment 303 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 3 – subparagraph 1 – point a
Article 5 – paragraph 3 – subparagraph 1 – point a
(a) the developer shall ensure that the environmental report is prepared by accredited and technically competent experts or
Amendment 308 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 3 – subparagraph 1 – point b
Article 5 – paragraph 3 – subparagraph 1 – point b
(b) the competent authority shall ensure that the environmental report is verified by accredited and technically competent experts and/or committees of national experts.
Amendment 341 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 6 – point a
Article 1 – point 6 – point a
Directive 2011/92/EU
Article 6 – paragraph 6 – introductory part
Article 6 – paragraph 6 – introductory part
Amendment 378 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
If the competent authority decides to grant development consent, it shall ensure that the development consent includesconsider whether measures to monitor the significant adverse environmental effects should be included in the development consent, in order to assess the implementation and the expected effectiveness of mitigation and compensation measures, and to identify any unforeseeable adverse effects during the phases of construction, management, demolition, and post-closure.
Amendment 384 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
The type of parameters to be monitored and the duration of the monitoring shall be consistent with prescriptions resulting from other Union legislation and shall be proportionate to the nature, location and size of the proposed project and the significance of its environmental effects.
Amendment 388 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 4
Article 8 – paragraph 2 – subparagraph 4
Amendment 396 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 3 – subparagraph 1
Article 8 – paragraph 3 – subparagraph 1
3. When all necessary information gathered pursuant to Articles 5, 6 and 7 has been provided to the competent authority, including, where relevant, specific assessments required under other Union legislation, and the consultations referred to in Articles 6 and 7 have been completed, the competent authority shall conclude its environmental impact assessment of the project within three month90 days.
Amendment 402 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 3 – subparagraph 2
Article 8 – paragraph 3 – subparagraph 2
Depending on the nature, complexity, location and size of the proposed project, the competent authority may extend that deadline by a further 3 months;90 days and inform the Commission about the entity and the causes of the delay, in that case, the competent authority shall inform the developer of the reasons justifying the extension and of the date when its decision is expected.
Amendment 449 #
2012/0297(COD)
Proposal for a directive
Article 3
Article 3
Projects for which the request for development consent was introduced beforeafter the date referred to in the first subparagraph of Article 2(1) and for which the environmental impact assessment has not been concluded before that date shall be subject to the obligations referred to in Articles 3 to 11 of Directive 2011/92/EU as amended by this Directive.
Amendment 576 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex IV – paragraph 5 – subparagraph 1 – point e
Annex IV – paragraph 5 – subparagraph 1 – point e
Amendment 331 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point b a (new)
Article 2 – point 2 – point b a (new)
Directive 2009/28/EC
Article 3 – paragraph 1 – subparagraph 2 a (new)
Article 3 – paragraph 1 – subparagraph 2 a (new)
(ba) in paragraph 1, the following subparagraph is added: "In 2020, at least 3% of the final consumption of energy in transport shall be met with energy from advanced biofuels. In 2025, at least 5% of the final consumption of energy in transport shall be met with energy from advanced biofuels."
Amendment 352 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point c – point ii
Article 2 – point 2 – point c – point ii
Directive 2009/28/EC
Article 3 – paragraph 4 – subparagraph 2 – point d
Article 3 – paragraph 4 – subparagraph 2 – point d
(d) for the calculation of biofuels in the numerator, the share of energy from biofuels produced from cereal and other starch rich crops, sugars and oil crops shall be no more than 5%, the estimated share at the end of 2011, of the final consumption of energy in transport in 2020feedstock listed in Part A of Annex IX (advanced biofuels) shall be no less than 3% of the final consumption of energy in transport in 2020. Biofuels produced from feedstocks listed in Part B of Annex IX shall be considered to be twice their energy content.
Amendment 373 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point c – point iii
Article 2 – point 2 – point c – point iii
Directive 2009/28/EC
Article 3 – paragraph 4 – subparagraph 2 – point e – subparagraph 1
Article 3 – paragraph 4 – subparagraph 2 – point e – subparagraph 1
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 115 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services;
Amendment 120 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 177 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 179 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Amendment 189 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 259 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 282 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1 a (new)
Article 49 – paragraph 2 – subparagraph 1 a (new)
In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA.
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 235 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1 a (new)
The medical devices produced by the various manufacturers and intended for use with a coupling or connection system for the supply of fluids shall be type approved/standardised in order to ensure that patients with chronic conditions receive appropriate treatment; otherwise it would be impossible to ensure that the devices are used as intended.
Amendment 242 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
(2a) The accessories to medical devices produced by the various manufacturers shall be type approved/standardised in order to ensure that, at all times and in all places, they perform as specified and are used as intended when treating patients.
Amendment 291 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 564 #
Amendment 758 #
2012/0266(COD)
Proposal for a regulation
Article 97 – paragraph 3 – subparagraph 1 – point a
Article 97 – paragraph 3 – subparagraph 1 – point a
(a) Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date of application referred to in paragraph 2] provided that the relevant electronic system has been validated and in operation;
Amendment 777 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
Amendment 780 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 11 – point 11.1 a (new)
Annex 1 – part II – point 11 – point 11.1 a (new)
11.1a. Coupling systems shall be subject to uniform type approval procedures in order to ensure that the specified performance of such devices is not impaired. Not requiring type approval of coupling systems undermines the guarantees that such devices will be used for their intended purpose, as well as patient rights.
Amendment 797 #
2012/0266(COD)
Proposal for a regulation
Annex 2 – paragraph 1 – point 6 – point 6.2 – point e
Annex 2 – paragraph 1 – point 6 – point 6.2 – point e
(e) If the device is to be connected to other device(s) by means of a coupling system in order to operate as intended, a description of this combination including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer. This coupling system shall be type approved in order to ensure that it is used as intended and that the patient receives appropriate treatment.
Amendment 857 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9
Annex 7 – part III – point 6 – point 6.9
Amendment 861 #
2012/0266(COD)
Proposal for a regulation
Annex 8 – point 3 – point 3.3 – point a
Annex 8 – point 3 – point 3.3 – point a
(a) The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 3.2. Unless duly substantiated, iIt shall presume that quality management systems which satisfy the relevant harmonised standards or CTS conform to the requirements covered by the standards or CTSreferred to in Section 3.2.
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 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 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 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 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 248 #
2012/0035(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Applications, dDecision-making procedures and decisions to regulate the prices of medicinal products in accordance with Article 3 or towhich determine their inclusion within the scope of public health insurance systems in accordance with Articles 7 and 9 shall be considered by Member States as administrative procedures which, as such, are independent from the enforcement of intellectual property rights.
Amendment 250 #
2012/0035(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property. With a view to ensuring that the provisions of this article are properly applied, those provisions shall not prevent applications submitted to the competent authorities or decisions by competent authorities regarding the setting of the price of a given product or the inclusion of that product in public health insurance systems from being considered objective and reasonable factors that may be taken into account by the competent judicial authorities when determining whether an intellectual property right is being or will be infringed.
Amendment 253 #
2012/0035(COD)
Proposal for a directive
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. Paragraphs 1 and 2 may be waived in Member States in which the issue of a marketing authorisation or a reimbursement authorisation for a generic product results in a change in the price of and/or reimbursement terms for the relevant reference product.
Amendment 255 #
2012/0035(COD)
Proposal for a directive
Article 14 – paragraph 3 b (new)
Article 14 – paragraph 3 b (new)
3b. Member States may adopt specific measures and legal procedures to protect intellectual property rights in cases where the issue of a marketing authorisation or a reimbursement authorisation for a generic product results in a change in the price of and/or reimbursement terms for the relevant reference product.
Amendment 23 #
2011/2308(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the Energy Roadmap 2050 indentifies that gas will be critical for the transformation of the energy system by helping to reduce emissions; whereas the Commission notrecognizes that shale gas and other UFF will become a very important new source of supply in or around Europemay boost overall availability of natural gas supply and play an important role in reducing carbon emissions, relative to coal, in a cost-competitive manner;
Amendment 37 #
2011/2308(INI)
Motion for a resolution
Recital E
Recital E
E. whereas any type of fossil fuel and minerals extraction might involves potential risks for the environment; whereas, it is essential that a precautionary principle beis applied to any future development of resources in Europe in order to minimiseing such risks via continuous research, proper management, regulation and monitoring at all stages of the exploration and exploitation process;
Amendment 103 #
2011/2308(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recogniszes the relatively high water volumes involved in hydraulic fracturing;, yet points out, however, that such volumes are not as significant in comparison to the needs of other industrial activities; and the water used in fracture stimulation compares favourably to the volumes of water used to produce other forms of energy such as nuclear, coal, biomass and solar power; highlights the need for advance water provision plans based on local hydrology;
Amendment 116 #
2011/2308(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Stress out that as it has been proven by the U.S. Environmental Protection Agency (EPA) in an extensive survey on fracture stimulation practices and the potential effect on drinking water (in 2004)[1], hydraulic fracturing does not create pathways for fluids to travel between rock formations to affect the water supply; looks forward to other forthcoming EPA reports and encourages Commission and Member States to exchange best practices and experiences with the Agency;
Amendment 125 #
2011/2308(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Believes that on-site closed-loop water recycling, using steel storage tanks, whether on- or off-site, offers the most environmentally sound way of treating flow-back water byto minimisinge water volumes,demand, reduce the potential for surface spills and costs/traffic/road damage relminimise transportationg to water treatment transportationand from the well site;
Amendment 145 #
2011/2308(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Recognizes that constant technological improvements in hydraulic fracturing and horizontal drilling enable to safely develop vast deposits of UFF and to limit potential environmental effects; encourages industry to continue efforts to advance technology and to use the best technological solutions in development of UFF resources.
Amendment 150 #
2011/2308(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Underlines that additional natural gas from unconventional resources can significantly lower the level of GHG emissions, and thus help achieve EU's GHG reduction goals while at the same time maintaining security and affordability of energy supplies and preserve Europe's competitiveness.
Amendment 153 #
2011/2308(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19 c. Further notes that the use of multi- horizontal well drilling pads is to minimize transport traffic and need for new road construction which would also significantly reduce noise level and lessen adverse impact on air quality.
Amendment 154 #
2011/2308(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19 d. Stresses that unconventional gas can make a substantive contribution to reducing greenhouse gas emissions in the transportation sector;
Amendment 155 #
2011/2308(INI)
Motion for a resolution
Paragraph 19 e (new)
Paragraph 19 e (new)
19 e. Recognizes that natural gas from shale rock can play an important complementary role supporting development of renewable energy sources in Europe, like solar and wind power plants, which need an additional, stabilizing energy source.
Amendment 159 #
2011/2308(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Calls on industry to engage local communities and discuss shared solutions to minimise the impact of shale gas developments on traffic, road quality, and noise where development activities are being carried out;
Amendment 164 #
2011/2308(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Encourages Member States and the Commission to use the framework of the EU-U.S. Energy Council to exchange expertise and best practices on environmental issues related to the UFF;
Amendment 165 #
2011/2308(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21 b. Recognizes that in order to address all issues related to UFF a much better exchange of information among industry, regulators and the public is required;
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 3 #
2011/2072(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Considers that the Deepwater Horizon oil spill in the Gulf of Mexico must lead the EU to urgently and deeplyreview and, where necessary, revisew its legislation, in respect of the precautionary principle, on allthose aspects of offshore oil and gas extraction and exploration in its territories that require modification; in this context, welcomes the Commission’s will to fill the gap in the existing EU legislation;
Amendment 12 #
2011/2072(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Urges the Commission and the Members States to strengthen effective mutual cooperation and to establish an EU 'Control the controllers' systempromote better coordination between the competent national authorities, so as to improve the pooling of good practice and optimise authorisation procedures;
Amendment 19 #
2011/2072(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Reiterates its calls to the Commission to bring forward proposals as soon as possible for establishing an EU Civil Protection Force based on the EU Civil Protection Mechanism, integrating specific mechanisms which en coordinated EU response strategy integrating the various technologies already available in the EU to faceMember States for use in the event of massive pollutions being caused by oil offshore installations;
Amendment 49 #
2011/2072(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Calls for an extension of the Environment Impact Assessment (EIA) directives to cover all offshore projects phases (exploratory, and operational, and decommissioning) and calls for specific requirements for EIAs in case of drilling activities in deep water; considers, furthermore, that the Commission should ensure that EIAs for offshore projects approved by national authorities also cover the procedures operators must follow during decommissioning;
Amendment 56 #
2011/2072(INI)
Draft opinion
Paragraph 11
Paragraph 11
11. Calls onWelcomes the Commission to re-examine its proposal on Industrial major accidents: control of hazards involving dangerous sub’s explanatory memorandum concerning the revision of Directive 96/82/EC, in which the Commission stanctes (SEVESO III) in order to extend its scope to oil rigsthat it will assess the appropriate way to strengthen environmental legislation;
Amendment 62 #
2011/2072(INI)
Draft opinion
Paragraph 13
Paragraph 13
13. Notes that offshore oil and gas activities are excluded from the key provisions of the Industrial Emissions Directive; sSuggests that the European IPPC Bureau defines Best Available Practices (BAT) for offshore hydrocarbon activities;
Amendment 5 #
2011/2012(INI)
Motion for a resolution
Citation 1 b (new)
Citation 1 b (new)
- having regard to the Commission Communication "A Roadmap for moving to a competitive low carbon economy by 2050"(COM(2011)0112), and the statement that “The EU already has legislation in place that ensures a 20% cut in greenhouse gas emissions by 2020 compared with 1990 levels. It maintains its conditional offer of a 30% reduction, provided there are comparable reductions by other developed countries and appropriate contributions from developing countries.”
Amendment 8 #
2011/2012(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to Council Conclusions of June 2010 agreeing that the Commission should “conduct more detailed analysis on the policy options and costs and benefits, including at Member State level, as appropriate."
Amendment 15 #
2011/2012(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the EU's climate objective is to limit climate change to 2°C above the pre- industrial level; whereas the climate package adopted in December 2008 represents a first step towards ensuring EU action in line with this objective; whereas countries representing some 80% of global emissions have pledged to reduce emissions, although the Parties to the UNFCCC acknowledged in Cancun that current pledges are insufficient to meet the 2°C objective,. Taking into account that the Cancun conference did not reach a global agreement to turn these pledges into legally binding targets and the European Union is still the only large economic community having adopted unilateral emissions reduction targets.
Amendment 126 #
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 per capita share ofn the global 2°C compatible carbon budget, and that delaying emissions reductionslevel. The EU per capita share must however be considered inc reases the cumulative share significantly;lation to per capita shares in a global context.
Amendment 172 #
2011/2012(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Recalls that the Roadmap for moving to a competitive low carbon economy in 2050 confirms the EU's offer in the international negotiations to take on a 30% reduction target for 2020, if the conditions are right. Recalls that, according to the Commission analysis, stepping up to the 30% reduction target with 25% domestic effort now represents an increase of EUR 11 billion as compared to 2008 projections for the absolute costs of the climate and energy package in 2020; notes the Commission assessment that this will raise the carbon price in the EU ETS to some EUR 30/tonne of CO2, i.e. similar to the level estimated necessary for the 20% reduction target in 2008;
Amendment 196 #
2011/2012(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Considers for encouraging investments in new technologies by the private sector, it is essential to maintain the stability of the legal and economic framework where industries shall operate. A disruption in the current framework would generate uncertainties in the decision-making process and also negatively affect possible investments in this sector.
Amendment 275 #
2011/2012(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Notes that European eco-industries employ approximately 3.4 million (FTE), which is ten times the figure for direct employment in the EU steel sector in 2007; points out that, according to recent studies, raising the EU climate target to 30% can foster up to 6 million additional jobs in Europe;deleted
Amendment 285 #
2011/2012(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Concurs with the European Commission’s Roadmap for a low carbon economy by 2050 where it states that ‘the creation and preservation of jobs will depend on the EU's ability to lead in terms of the development of new low carbon technologies through increased education, training, programmes to foster acceptability of new technologies, R&D and entrepreneurship, as well as favourable economic framework conditions for investments’
Amendment 286 #
2011/2012(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Notes the lack of a thorough assessment of the impacts on employment caused by the low carbon transition which would primarily entail a shift of jobs across sectors, and that there is a need to better identify ‘winners’ and ‘losers’ of such transition.
Amendment 12 #
2011/2008(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the poorinadequate records of Central Asian states in governance and regional cooperation are important reasons for their bleak political, social and economic situation and for the limited achievements of development cooperation,
Amendment 20 #
2011/2008(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Stresses the importance of increasing bilateral and multilateral cooperation between the EU and the countries in the region with regard to crucial issues such as fighting terrorism, trafficking in drugs and human beings, and migration, both internal and external to the region;
Amendment 35 #
2011/2008(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Supports the opening of fully-fledged EU delegations in all the countries of Central Asia where the EU is not represented as a means of increasing the presence and visibility of the EU in the region and long-term cooperation and engagement with all sectors of society and fostering progress towards better understanding and the emergence of the rule of law and respect for human rights;
Amendment 39 #
2011/2008(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. DeplorNotes the difficulty encountered by the EU in some countries in the region in engaging with independent civil society in the area of human rights and good governance in the context of the continued harassment of NGOs in the region; calls for support for genuinely independent NGOs so as to help them play an effective role in the development and consolidation of civil society;
Amendment 50 #
2011/2008(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Approves the holding of regular regional EU-Central Asia summits and calls for consideration to be given to the possible future establishment of an EU-Central Asia parliamentary forum to be established as a means of assessing and contributing to the contents of the summit talks; underlines the importance of the regular bilateral parliamentary cooperation in the framework of the existing Parliamentary Cooperation Committees and interparliamentary meetings with the Central Asian countries;
Amendment 56 #
2011/2008(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. RegretConsiders that, although some positive developments have taken place in the region (abolition of the death penalty in Uzbekistan, some constitutional and judicial procedure reforms, etc.), the overall situation in the fields of human rights and the rule of law remains worryingunsatisfactory;
Amendment 62 #
2011/2008(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for a strengthening of the human rights dialogues in order to make them more effective and result-oriented; urges the Council and the European External Action Service (EEAS) to issue benchmarks fortake account of the progress made by the states of the region in the field of human rights and the rule of law, and ofto assess the effectiveness of EU measures and assistance projects towards this aim;
Amendment 68 #
2011/2008(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Is concerned about the continued use of torture and the severe restriction of the media and of freedom of expression, assembly and association; urges the EU and its HR/VP to raise publicly the cases of political prisoners, imprisoned human rights defenders and journalists and call for their immediate releasemonitor respect for human rights and make their views known where such abuses occur;
Amendment 77 #
2011/2008(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Calls for promotion of the development of education programmes to foster international cultural contacts and exchanges;
Amendment 82 #
2011/2008(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Stresses that, with a view to the economic development of the countries of central Asia, investment – particularly foreign direct investment – will have to play a very important role; notes, however, that such investment requires a background of political stability and a secure and stable legal framework, creating a climate favourable to it;
Amendment 111 #
2011/2008(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Reaffirms its support for actions aimed at fostering regional cooperation as the onlymain way to address the many cross- border security, resource management, ethnic, environmental and development problems of the states concerned;
Amendment 119 #
2011/2008(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Takes note of the accession of Kazakhstan to the customs union with Russia and Belarus and hopes that the development of this entity will be conducted in an inclusive manner towards those Central Asian states that are not part of it and in cooperation with these countries’ trading partners;
Amendment 155 #
2011/2008(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Expresses its concern at the inefficiency of EU development aid in the country resulting from the high level of corruption and the looming regional fragmentation fuelled by the dire economic and social conditions; calls, therefore, for an alternative approach based on human security through alternative channels of assistancecountry’s fragile economic situation, the political tensions and the obvious inadequacy and limited effectiveness of international aid;
Amendment 307 #
2011/0437(COD)
Proposal for a directive
Recital 13
Recital 13
(13) It is appropriate to exclude from the scope of this Directive certain services concessions awarded to an economic operator which is itself a contracting authority or a contracting entity on the basis of an exclusive right which that operator enjoys under published national law or an administrative act, as in the case of public-domain maritime concessions for recreational tourist purposes, and which has been granted in accordance with the Treaty and Union sectoral legislation concerning the management of networks infrastructure related to the activities set out in aAnnex III, since such an exclusive right makes it impossible to follow a competitive procedure for the award. By way of derogation and without prejudice to the legal consequences of the general exclusion from the scope of this Directive, concessions as defined in aArticle 8(1) should be subject to the obligation to publish a concession award notice in view of ensuring basic transparency unless the conditions of such transparency are provided for in sectoral legislation.
Amendment 324 #
2011/0437(COD)
Proposal for a directive
Recital 19
Recital 19
(19) In view of the detrimental effects on competition, awarding concessions without prior publication should only be permitted in very exceptional circumstances. This exception should be limited to cases where it is clear from the outset that a publication would not trigger more competition, notably because there is objectively only one economic operator who can perform the concession, as is the case with owners of seaside businesses set up on property under concession. Only situations of objective exclusivity can justify the award of a concession without publication to an economic operator, where the situation of exclusivity has not been created by the contracting authority or contracting entity itself in view of the future award procedure, and where there are no adequate substitutes, the availability of which should be assessed thoroughly.
Amendment 466 #
2011/0437(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. With regard to public works concessions and works concessions, calculation of the estimated value shall take account of both the cost of the works and the total estimated value of the supplies and services that are made available to the contractor by the contracting authorities or entities provided that they are necessary for executing the works. In the case of public- domain concessions for the provision of services to the public, the threshold shall be estimated and calculated on an annual basis.
Amendment 748 #
2011/0437(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1 – point c a (new)
Article 26 – paragraph 5 – subparagraph 1 – point c a (new)
(ca) where the public property under concession has been assigned for the provision of seaside tourism services on the initiative and at the request of an economic operator and become a prerequisite for the operator’s business to the extent that, were the operator to lose the concession, it would forfeit the right of ownership of the business.
Amendment 293 #
2011/0429(COD)
Proposal for a directive
Annex II a (new)
Annex II a (new)
Directive 2008/105/EC
Annex II (new)
Annex II (new)
ANNEX IIa ‘ANNEX II SUBSTANCES TO BE INCLUDED INTER ALIA IN THE FIRST WATCH LIST DRAWN UP BY THE COMMISSION CAS number1 EU number2 Name of substance 57-63-6 200-342-2 17-alpha ethinylestradiol 50-28-2 200-023-8 17-beta estradiol 15307-79-6 239-346-4 Diclofenac __________________________ 1 CAS: Chemical Abstracts Service. 2 EU number: European Inventory of Existing Commercial Substances (Einecs) or European List of Notified Chemical Substances (ELINCS).
Amendment 44 #
2011/0339(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The programme should respect the competences of Member States in the field of health and their freedom to decide what kind of health services they consider it appropriate to provide, in strict compliance with the principle of subsidiarity, including respect for the different management systems and for the specific approaches chosen by the Member States in integrating public and private provision of healthcare services.
Amendment 45 #
2011/0339(COD)
Proposal for a regulation
Recital 5 b (new)
Recital 5 b (new)
(5b) Where ethical issues arise, it remains within the competence of the Member States to determine whether or not a given service constitutes a health service.
Amendment 96 #
2011/0339(COD)
Proposal for a regulation
Article 3 – point 1 – paragraph 1
Article 3 – point 1 – paragraph 1
(1) To develop common tools and mechanisms at EU level to address shortages of resources, both human and financial, and to facilitate voluntary up- take of innovation in healthcare in order to contribute to innovative, efficient and sustainable health systems.
Amendment 116 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – introductory part
Article 4 – paragraph 1 – point 1 – introductory part
(1) Contributing to innovative, efficient and sustainable health systems:
Amendment 134 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – indent 2.3
Article 4 – paragraph 1 – point 2 – indent 2.3
– 2.3. Strengthen collaboration on patient safety and quality of healthcare, by increasing the availability of information to patients, exchange of best practices and development of guidelines; support action on chronic diseases care and research including development of European guidelines;
Amendment 139 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – indent 2.5
Article 4 – paragraph 1 – point 2 – indent 2.5
– 2.5. Actions required by or contributing to the objectives of EU legislation in the fields of tissues and cells, blood, organs, patients’ rights in cross-border healthcare and medicinal products, fully respecting the competences and ethical choices of Member States in these fields;
Amendment 188 #
2011/0339(COD)
Proposal for a regulation
Annex 1 – point 1 – introductory part
Annex 1 – point 1 – introductory part
1. Developing common tools and mechanisms at EU level to address shortages of resources, both human and financial, and facilitating voluntary up-take of innovation in healthcare in order to contribute to innovative, efficient, and sustainable health systems
Amendment 231 #
2011/0282(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o
Article 2 – paragraph 1 – point o
(o) “adverse climatic event”: weather conditions, such as frost, storms and, cyclonic winds, hail, ice, heavy rain or severe drought, which can be assimilated to a natural disaster;
Amendment 238 #
2011/0282(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point t
Article 2 – paragraph 1 – point t
(t) "short supply chain": a supply chain involving a limited number of economic operators, who have direct relations with consumers or are committed to co- operation, local economic development, and close geographical and social relations between producers and consumers;
Amendment 412 #
2011/0282(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point 5 – point a a (new)
Article 5 – paragraph 1 – point 5 – point a a (new)
(a a) Secure and improve the income in some areas by favouring the access at the water ´s resource and irrigation;
Amendment 417 #
2011/0282(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point 5 – point b
Article 5 – paragraph 1 – point 5 – point b
(b) increasing efficiency in water and energy use in agriculture and food processing;
Amendment 492 #
2011/0282(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1 – point c a (new)
Article 8 – paragraph 1 – subparagraph 1 – point c a (new)
(c a) irrigators in Mediterranean area;
Amendment 650 #
2011/0282(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
Support under this measure shall be for the benefit of persons engaged in the agricultural, food and forestry sector, land managers and other. Such support shall also be for the benefit of economic actors which are SMEs operating in rural areas provided that their activities are directly connected with the agricultural, agro-food and forestry sector and have obvious beneficial effects on that sector.
Amendment 837 #
2011/0282(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) concern infrastructure related to the development and adaptation of agriculture, including access to farm and forest land, land consolidation and improvement, energy supply and water management, giving preference to joint management systems for land use, water supply and irrigation; or
Amendment 908 #
2011/0282(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) investments in preventive actions aimed at reducing the consequences of probable natural disasters, adverse ambient conditions and catastrophic events;
Amendment 909 #
2011/0282(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
(b) investments for the restoration of agricultural land and production potential damaged by natural disasters, adverse ambient conditions and catastrophic events.
Amendment 986 #
2011/0282(COD)
Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 4
Article 20 – paragraph 2 – subparagraph 4
Support under paragraph 1(b) shall be granted to non- agricultural micro- and small- enterprises in rural areas, provided that they relate to projects generating economic benefits for the agricultural sector, and to farmers or members of the farm household.
Amendment 1139 #
2011/0282(COD)
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. Both agricultural and non-agricultural land shall be eligible; however, with regard to agricultural land, provision shall be made for set-aside for a maximum period of one year between two successive plantings on the same land. Species planted shall be adapted to the environmental and climatic conditions of the area and answer to minimum environmental requirements. No support shall be granted for the planting of short rotation coppice, Christmas trees or fast growing trees for energy production. In areas where afforestation is made difficult by severe pedo-climatic conditions support may be provided for planting other perennial woody species such as shrubs or bushes suitable to the local conditions.
Amendment 1157 #
2011/0282(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. "Agro-forestry systems" shall mean land use systems in which trees are grown in combination with extensive agriculture on the same land. The maximum number of trees to be planted per hectare shall be determined by the Member States taking account of local pedo-climatic conditions, forestry species and the need to ensure sustainable agricultural use of the land, demonstrable by specifications that are recognised by the Member States.
Amendment 1184 #
2011/0282(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point d
Article 25 – paragraph 1 – point d
(d) restoring forest potential damaged or destroyed from fires and other natural disasters including pests, diseases as well as catastrophic events and climate change related events.
Amendment 1191 #
2011/0282(COD)
Proposal for a regulation
Article 25 – paragraph 2 – subparagraph 1
Article 25 – paragraph 2 – subparagraph 1
In the case of preventive actions concerning pests and diseases, the risk of a relevant disaster occurrence must be supported, as quickly as possible, by scientific evidence and acknowledged by scientific public organisations. Where relevant, the list of species of organisms harmful to plants which may cause a disaster must be provided in the programme.
Amendment 1721 #
2011/0282(COD)
Proposal for a regulation
Article 46 – paragraph 4
Article 46 – paragraph 4
4. In the case of agricultural investments, the purchase of agricultural production rights, payment entitlements, animals, annual plants and their planting shall not be eligible for investment support. However, in case of restoration of agricultural production potential damaged by natural disasters and adverse climatic events in accordance with Article 19(1)(b), expenditure for the purchase of animals may be eligible expenditure.
Amendment 1769 #
2011/0282(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall, by means of implementingdelegated acts, set out the organisational structure and operation of the EIP network. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 91.
Amendment 1798 #
2011/0282(COD)
Proposal for a regulation
Article 56
Article 56
Amendment 1807 #
2011/0282(COD)
Proposal for a regulation
Article 57
Article 57
Amendment 1817 #
2011/0282(COD)
Proposal for a regulation
Article 58
Article 58
Amendment 1825 #
2011/0282(COD)
Proposal for a regulation
Article 59
Article 59
Amendment 1830 #
2011/0282(COD)
Proposal for a regulation
Article 59 – paragraph 1
Article 59 – paragraph 1
Amendment 1831 #
2011/0282(COD)
Proposal for a regulation
Article 59 – paragraph 2
Article 59 – paragraph 2
Amendment 1832 #
2011/0282(COD)
Proposal for a regulation
Article 59 – paragraph 3
Article 59 – paragraph 3
Amendment 1836 #
2011/0282(COD)
Proposal for a regulation
Article 60
Article 60
Amendment 1841 #
2011/0282(COD)
Proposal for a regulation
Article 60 – paragraph 1
Article 60 – paragraph 1
Amendment 2003 #
2011/0282(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point f a (new)
Article 68 – paragraph 1 – point f a (new)
(fa) non-recoverable VAT, when it is genuinely and definitively borne by the ultimate beneficiaries.
Amendment 2004 #
2011/0282(COD)
Proposal for a regulation
Article 68 – paragraph 3
Article 68 – paragraph 3
3. ContribWork carried outi ons in kind in the form of provision of works, goods, services, land and real estate for which no cash payment supported by invoices or documents of a ‘time and materials’ basis as part of rural development measures by the ultimate beneficiaries using the manpower, materials and equivalpment probative value has been made, may be eligible for support provided that the conditions of Article 59 of Regulation (EU) No [CSF/2012] are fulfillwhich a firm has to hand shall be eligible for an EAFRD contribution; in such cases, the amount of expenditure eligible for a EAFRD contribution shall be calculated on the basis of a price list for the various works performed.
Amendment 500 #
2011/0281(COD)
Proposal for a regulation
Recital 84 a (new)
Recital 84 a (new)
(84 a) In order to align the EU import regime for sugar and isoglucose with the 2006 sugar reform as well as with the end of the quota system, the Commission should modify the Common Customs Tariff for the following products: (a) sugar falling within CN code 1701; (b) isoglucose falling within CN codes 1702 30 10, 1702 40 10, 1702 60 10 and 1702 90 30. Until the end of the quota system, the Commission should be able to suspend the import tariffs in case of supply shortages.
Amendment 623 #
2011/0281(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point f a (new)
Article 7 – paragraph 1 – point f a (new)
(fa) as regards the olive oil sector: (i) EUR 2540/tonne for extra virgin olive oil; (ii) EUR 2330/tonne for virgin olive oil; (iii) EUR 1524/tonne for lampante olive oil having two degrees of free acidity; this amount shall be reduced by EUR 36.70/tonne for each additional degree of acidity.
Amendment 643 #
2011/0281(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article 7 a Prices, production costs and margins reporting systems The Commission shall, by means of implementing acts, set up an information system on prices, production costs and margins in the commodities market, including a system for the publication of price levels, production cost and margin indicators for the commodities market. The system shall be based on information submitted by operators involved in the commodities trade. This information shall be treated with confidentiality. The Commission shall ensure that the information published does not permit the identification of individual operators.
Amendment 773 #
Amendment 834 #
2011/0281(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission may, by means of implementing acts, restrict the granting of private storage aid or fix the private storage aid per Member State or region of a Member State on the basis of recorded average market prices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 162(2). As regards the olive oil sector, the activation price for private storage for each category of olive oil shall reflect the real market situation, in particular taking into account the production costs. A periodic review should also be put in place. The aid provided must cover all storage costs as well as the financial implications of production being left in storage. The Commission shall automatically activate the private storage when all the conditions are fulfilled.
Amendment 970 #
2011/0281(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point c a (new)
Article 27 – paragraph 1 – point c a (new)
(ca) the commercial promotion of products;
Amendment 985 #
2011/0281(COD)
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27 a National programmes to support olive oil and table olives 1. The European Union will finance national programmes in the field of olive oil and table olives with the following objectives: a) improve the competitiveness of the sector through the modernization of the productive potential; b) increase consumption of olive oil and olives in and outside the European Union. c) improve the quality of the production systems of olive oil and table olives;
Amendment 1124 #
2011/0281(COD)
Proposal for a regulation
Article 43 a (new)
Article 43 a (new)
Article 43a A support system similar to existing one for the wine sector should be implemented for the olive sector, on the basis of national programmes financed through the single CMO. This urges the Commission to design, within one year after the entry into force of this Regulation, the scheme that would frame the National Support Programme in the olive sector, measures that could be included and need for co-financing.
Amendment 1930 #
2011/0281(COD)
Proposal for a regulation
Article 130 a (new)
Article 130 a (new)
Article 130 a Suspension of import duties in the sugar sector 1. Until the end of the quota regime, the Commission shall, by means of implementing acts, suspend import duties in whole or in part for the following products in order to guarantee the supply required for the manufacture of the products referred to in Article 101m (2): sugar falling within CN code 1701; isoglucose falling within CN codes 1702 30 10, 1702 40 10, 1702 60 10 and 1702 90 30. 2. The suspension of import duties as referred to in paragraph 1 shall be automatically triggered as soon as the reported EU price for white sugar is 150% of the reference price. The normal duty will be automatically restored when the reported EU price will be below 150% of the reference price.
Amendment 1933 #
2011/0281(COD)
Proposal for a regulation
Article 130 b (new)
Article 130 b (new)
Article 130 b 1. Before 31 December 2013, the Commission will propose, by means of implementing act, a revised Common Customs Tariff for the following products: (a) sugar falling within CN code 1701; (b) isoglucose falling within CN codes 1702 30 10, 1702 40 10, 1702 60 10 and 1702 90 30. The new tariffs for sugar shall reflect the difference between the reference prices before and after the 2006 reform to offer a comparable level of protection. 2. Before the end of the sugar quota, the Commission will present a proposal on the further elimination of import tariffs for the products mentioned in the first paragraph of this Article.
Amendment 179 #
2011/0280(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Due to the successive integration of various sectors into the single payment scheme and the ensuing period of adjustment granted to farmers, it has become increasingly difficult to justify the presence of significant individual differences in the level of support per hectare resulting from use of historical references. Therefore direct income support should be more equitably distributed between Member States, by reducing the link to historical references and having regard to the overall context of the Union budget. To ensure a more equal distribution of direct support, while taking account of the differences that still exist in wage levels and input costs, the levels of direct support per hectare should be progressively adjusted. Member States with direct payments below the level of 90 % of the average should close one third of the gap between their current level and this level. This convergence should be financed proportionally by all Member States with direct payments above the UnThe redistribution of direct payments should comply with the basic principles of Europa 2020, while highlighting the need to use Union resources for economic growth. To that end, direct payments should be redistributed on the basis of appropriate, objective and non-discriminatory criteria such as the value of agricultural production, averagedded value, labour and purchasing power. In addition, all payment entitlements activated in 201922 in a Member State or in a region should haveapproximate to or reach a uniform unit value following a convergence towards this value that should take place during the transition period in linear steps. However, in order to avoid disruptive financial consequences for farmeproductive sectors, Member States having used the single payment scheme, and in particular the historical model, should be allowed to partially take historical factors into account when calculating the value of payment entitlements in the first year of application of the new scheme. The debate on the next Multiannual Financial Framework for the period starting in 2021 should also focus on the objective of complete convergence through the equal distributionmay retain an element of differentiation in relation to direct support in order to take account of differecnt support across the European Union during that periodtypes of land use.
Amendment 414 #
2011/0280(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point h
Article 4 – paragraph 1 – point h
(h) "“permanent grassland" and permanent pastures” means land used to grow grassfor forage herbaceous plants, shrubs and/or trees or any other herbaceous foragespecies suitable for grazing, naturally (self-seeded) or through cultivation (sown), and that hais not been included in the crop rotation of the holding for five years or longer; it may include other species suitable for grazing provided that the grasses and other herbaceous forage remain predominant;
Amendment 1288 #
2011/0280(COD)
Proposal for a regulation
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) to have threewo different crops on their arable land where the arable land of the farmer covers more than 315 and up to 20 hectares, and is not entirely used for grass production (sown or natural), entirely left fallow or entirely cultivated with crops under water for a significant part of the yearthree different crops where the arable land of the farmer covers more than 50 hectares;
Amendment 1508 #
2011/0280(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. Where the arable land of the farmer covers more than 315 hectares and is not entirely used for grass production (sown or natural), entirely left fallow or entirely cultivated with crops under water for a significant part of the yearup to 50 hectares, cultivation on the arable land shall consist of at least two different crops. None of those crops shall cover less than 10 % of the arable land. Where the arable land of the farmer covers more than 50 hectares, cultivation on the arable land shall consist of at least three different crops. None of those threeThe main crops shall not cover lessmore than 570 % of the arable land and the two main one shall not exceed 70crops together shall not cover more than 95 % of the arable land.
Amendment 1557 #
2011/0280(COD)
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1a. The first paragraph shall not apply to farms: – where the arable land is mainly used for grass production or other forage, mainly left fallow, mainly cultivated with crops under water for a significant part of the growing cycle, or a combination of these, or – where the arable land of the farmer covers up to 50 hectares and more than 80% of the eligible agricultural area of the holding is covered by permanent grassland and historical pastures, or by permanent crops.
Amendment 1705 #
2011/0280(COD)
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. FWhere the agricultural area, excluding areas under permanent grassland, covers more than 15 hectares, farmers shall ensure that at least 73 % of their eligible hectares as defined in Article 25(2), excluding areas under permanent grassland, is ecological focus area such as land left fallow, terraces, landscape features, buffer stripland under permanent crops, terraces, landscape features such as hedges or stone walls, buffer strips, land cultivated with crops under water for a significant part of the growing cycle, land under soil-improving crops such as pulses and afforested areas as referred to in article 25(2)(b)(ii).
Amendment 2019 #
2011/0280(COD)
Proposal for a regulation
Article 38 – paragraph 1 – subparagraph 2
Article 38 – paragraph 1 – subparagraph 2
Amendment 2251 #
2011/0280(COD)
Proposal for a regulation
Article 49 – paragraph 1 – subparagraph 1 – point b a (new)
Article 49 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) a level equal to the amount to which the farmer would be entitled in respect of the number of hectares declared for the 2014 calendar year.
Amendment 13 #
2011/0229(COD)
Proposal for a regulation
Recital 5
Recital 5
Amendment 43 #
2011/0229(COD)
Proposal for a regulation
Recital 20
Recital 20
Amendment 88 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 1760/2000
Articles 16 - 18
Articles 16 - 18
Amendment 96 #
2011/0194(COD)
Proposal for a regulation
Article 42 – paragraph 1 – point b
Article 42 – paragraph 1 – point b
(b) the production method, in particular by the following words "…caught…" or "…caught in freshwater …' or "… farmed…";Does not affect English version.)
Amendment 98 #
2011/0194(COD)
Proposal for a regulation
Article 42 – paragraph 1 – point d
Article 42 – paragraph 1 – point d
Amendment 102 #
2011/0194(COD)
Proposal for a regulation
Article 42 – paragraph 1 – point e
Article 42 – paragraph 1 – point e
(e) wThether the product is fresh or has been defrosted requirement provided for in Article 68(3) of Commission Regulation No 404/2011 is repealed. Products that have been frozen prior to sale and are sold defrosted shall be labelled in accordance with Annex VI to Regulation (EU) No 1169/2011;
Amendment 103 #
2011/0194(COD)
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
Amendment 107 #
2011/0194(COD)
Proposal for a regulation
Article 44 – paragraph 1 – point a
Article 44 – paragraph 1 – point a
(a) in the case of fishery products caught at sea, the name of one of the areas, subareas or divisions listed in the FAO Fishing Areas;
Amendment 116 #
2011/0194(COD)
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – paragraph 2
It shall apply from 1 January 2013 with the exception of Articles 32, 35 and 36, which shall apply from 1 January 2014. The consumer information provisions laid down in Article 42 shall apply on the basis of the dates of entry into force established in Regulation (EU) No 1169/2011.
Amendment 141 #
2011/0172(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. 1. Each Member State shall set up an energy efficiency obligation scheme. This scheme shall ensure that either all energy distributors or all retail energy sales companies operating on the Member State's territory achieve annual energy savings equal to 1.5%as a quota of their energy sales, by volume, in the previous year in that Member State excluding energy used in transport. This amount of energy savings shall be achieved by the obligated parties among final customers, as contribution to the national target as set pursuant to Article 3 of this Directive, taking into account the Union’s target of 20% energy savings by 2020. This amount of energy savings shall be achieved by the obligated parties among final customers. The energy saving target shall be introduced gradually and with a starting level differentiated on a national basis in order to take into full account early actions and results achieved so far, including efficiency measures already adopted in the fuel sector. Measures that target long-term savings or structured programs proposed by operators in the energy efficiency sector should be encouraged through incentives or specific fiscal treatment.
Amendment 186 #
2011/0172(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject and encouraged to an energy audit carried out in an independent and cost- effective manner by qualified or accredited experts at the latest by 30 June 2014 and every three years from the date of the previous energy audit.
Amendment 218 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. By 1 January 2014, Member States shall establish and notify to the Commission a national heating and cooling plan for developing the potential for the application of high-efficiency cogeneration and efficient district heating and cooling, containing the information set out in Annex VII.. Each national plan shall identify: (a) national cogeneration development targets for year 2020 and corresponding intermediate targets; (b) district heating promotion areas for which cost-benefit analysis have identified cogeneration potential; (c) the information set out in Annex VII. (d) The plans should be based on a comprehensive costs/benefits analysis for each of the planned investments, taking into account the existing level of heat demand and evaluating the different consumption profiles (e. g. industrial, residential or tertiary consumption patterns). Moreover, different types of cogeneration (micro, for self- consumption…) should be considered on the basis of the specificities of different national demand and consumption patterns. (e) The plans shall be updated and notified to the Commission every five years. Member States shall ensure by means of their regulatory framework that national heating and cooling plans are taken into account in local and regional development plans, including urban and rural spatial plans, and fulfil the design criteria in Annex VII.
Amendment 229 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 3 – subparagraph 1 – introductory part
Article 10 – paragraph 3 – subparagraph 1 – introductory part
3. Member States shall ensure that in the promotion areas with cogeneration potential as identified according to paragraph 2, all new thermal electricity generation installations with a total thermal input exceeding 20 MW:
Amendment 262 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 6 – subparagraph 1
Article 10 – paragraph 6 – subparagraph 1
6. Member States shall ensure that, in the promotion areas with cogeneration potential as identified according to paragraph 2, whenever an existing electricity generation installation with a total rated thermal input exceeding 20 MW is substantially refurbished or when, in accordance with Article 21 of Directive 2010/75/EC, its permit is updated, the technical and economic feasibility of a conversion to allow its operation as a high- efficiency cogeneration installation is set as a preferential condition in the new or updated permit or licence, provided that the installation is sited in a location where the waste heare is sufficient can be used by heat demand points in accordance with point 1 of Annex VIIId long-term stable heat demand. The equipment of electricity generation installations with carbon capture or storage facilities shall not be considered as refurbishment for the purpose of these provisions.
Amendment 334 #
2011/0172(COD)
Proposal for a directive
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2a. Member States should not set targets for the industries which are exposed to a significant risk of carbon leakage, as determined in Commission Decision 2010/2/EU. Should they nonetheless decide to do so, Member States shall express possible sectoral targets for production processes in these industries in energy use per output unit so as to avoid impeding industrial growth.
Amendment 338 #
2011/0172(COD)
Proposal for a directive
Article 19 – paragraph 5
Article 19 – paragraph 5
Amendment 341 #
2011/0172(COD)
Proposal for a directive
Article 19 – paragraph 5 – subparagraph 2
Article 19 – paragraph 5 – subparagraph 2
Amendment 8 #
2011/0156(COD)
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on food for special medical purposes and foodstuffs for people intolerant to gluten(presented by the Commission pursuant to Article 114 of the Treaty on the Functioning of the European Union)(Text with EEA relevance)
Amendment 17 #
2011/0156(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and food for special medical purposes, and food for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children and to food for special medical purposes, and food for people intolerant to gluten taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009.
Amendment 20 #
2011/0156(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 23 #
2011/0156(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on, foods for special medical purposes and foodstuffs for people intolerant to gluten (presented by the Commission pursuant to Article 114 of the Treaty on the Functioning of the European Union) (Text with EEA relevance)
Amendment 30 #
2011/0156(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 33 #
2011/0156(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten, taking into account Regulation 953/2009, Commission Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 33 #
2011/0156(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes and foodstuffs for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/EC and Commission Regulation (EC) No 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal- based food and baby food for infants and young children and to, food for special medical purposes and foodstuffs for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC and Commission Regulation (EC) No 41/2009.
Amendment 37 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumptiofor specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application of this RegulationIn addition, the statement ‘gluten-free’ may be used for foodstuffs for normal consumption and other food for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten which do not allow the use of the statement ‘very low gluten’ for these foods. Such food for specialized nutrition intended for people intolerant to gluten shall be maintained in this Regulation, as providing such safe food intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease. This is in line with the international standard for food for special dietary use for persons intolerant to gluten (CODEX STAN 118-1979 revised in 2008). Also the conditions of use of the claim ‘gluten-free’ for food for normal consumption should be maintained in Regulation (CE) No 41/2009.
Amendment 38 #
2011/0156(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC and Commission Regulation (EC) No 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 43 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialized nutrition:
Amendment 44 #
2011/0156(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC and Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 46 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(c a) food for people intolerant to gluten
Amendment 50 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(h a) ‘food for people intolerant to gluten’ means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten
Amendment 52 #
2011/0156(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be addedsubstances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten, taking into account Regulation (EC) No 953/2009, and Commission Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 54 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘infant formula’, ‘follow-on formula’, ‘processed cereal-based food’ and ‘baby food’ and ‘food for special medical purposes’, and ‘food for people intolerant to gluten’ taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 56 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumptios for specialised nutrition intended for people intolerant to gluten under the rules specified in CommissionArticle 3 of Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations. In addition, the statement ‘gluten-free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in Article 4 of Regulation (EC) No 41/2009 which do not allow the use of the statement ‘very low gluten’ for these foods. Such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this Regulation, as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease. This is in line with the international standard for foods for special dietary use for puersuant to Regulation (EC) No 1924/2006, incorporatingons intolerant to gluten (CODEX STAN 118- 1979 revised in 2008). Also the nutrconditions of use of the claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application of this Regulationfor foods for normal consumption should be maintained in the Regulation (EC) No 41/2009.
Amendment 57 #
2011/0156(COD)
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and, on food for special medical purposes and on foodstuffs for people intolerant to gluten
Amendment 65 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TParagraph 3 shall not prevent the dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively byexclusively intended for persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.
Amendment 68 #
2011/0156(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes, and foods for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/EC, and Commission Regulation 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal- based food and baby food for infants and young children and to, food for special medical purposes, and foods for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009.
Amendment 71 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC, and Regulation (EC) No 41/2009 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, for foods covered under Article 1(1) no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 76 #
2011/0156(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC, and Commission Regulation 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 77 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foodstuffs for people intolerant to gluten;
Amendment 88 #
2011/0156(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC, Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 91 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 94 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) ‘foodstuffs for people intolerant to gluten’ means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten.
Amendment 101 #
2011/0156(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be addedsubstances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby foods, and food for special medical purposes, and foods for people intolerant to gluten, taking into account Regulation (EC) No. 953/2009, Commission Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 103 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘infant formula’, ‘follow-on formula’, ‘processed cereal-based food’ and ‘baby food’ and, ‘food for special medical purposes’ and ‘foodstuffs for people intolerant to gluten’ taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 112 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘'gluten-free’' and ‘'very low gluten’' may be used for food intended for particular nutritional uses and for food for normal consumptios for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as deIn addition, the statement 'gluten-free' may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specifined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application ofarticle 4 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten which do not allow the use of the statement 'very low gluten' for these foods. Such foods for specialized nutrition intended for people intolerant to gluten shall be maintained in this Regulation, as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease. This is in line with the international standard for foods for special dietary use for persons intolerant to gluten (CODEX STAN 118-1979 revised in 2008). Also the conditions of use of the claim "gluten- free" for foods for normal consumption should be maintained in thise Regulation (CE) 41/2009.
Amendment 121 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialised nutrition:
Amendment 122 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TParagraph 3 shall not prevent the dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively byexclusively intended for persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.
Amendment 130 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) food for people intolerant to gluten.
Amendment 130 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC and Regulation (EC) No 41/2009, as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, for foods referred to in Article 1(1) no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 145 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 153 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g – point ii
Article 2 – paragraph 2 – point g – point ii
Amendment 163 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) 'food for people intolerant to gluten' means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten;
Amendment 170 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘'infant formula’', ‘'follow-on formula’', ‘'processed cereal-based food’' and ‘'baby food’ and ‘', 'food for special medical purposes’', and 'food for people intolerant to gluten' taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 200 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TParagraph 3 shall not prevent the dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively byexclusively intended for persons having qualifications in medicine, nutrition, and pharmacy or other professionals responsible for maternal and child health care.
Amendment 208 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC and Regulation (EC) No 41/2009, as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, for foods covered by Article 1(1) no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 229 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Without prejudice to the criteria for certain contaminants levels laid down in Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, the microbiological criteria laid down in Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs shall apply to milk-based drinks intended for young children currently on the market during the transition period laid down in Article 18 of this Regulation.
Amendment 230 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 b (new)
Article 10 – paragraph 2 b (new)
Amendment 268 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 41 #
2011/0092(CNS)
Proposal for a directive
Recital 15
Recital 15
(15) Article 5 of Directive 2003/96/EC permits the application of differentiated rates of taxation in certain cases. However, in order to ensure the consistency of the CO2 price signal, the possibility for Member States to differentiate national rates should be restricted to general energy consumption taxation. Moreover, the possibility to apply a lower level of taxation to oil derived motor fuel used by taxis is no longer compatible with the objective of policies promoting alternative fuels and energy carriers and the use of cleaner vehicles in urban transport and should thus be removed.
Amendment 45 #
2011/0092(CNS)
Proposal for a directive
Recital 18
Recital 18
(18) In the case of liquefied petroleum gas (LPG) and natural gas used as propellantsused as motor fuel, advantages in the form of lower minimum levels of general energy consumption taxation or the possibility to exempt thoseis energy products from taxation are no longer justified, in particular in the light of the need to increase the market share of renewable energy sources and should therefore be removed in the medium term. In the case of natural gas and biomethane used as motor fuels, advantages in the form of lower minimum levels of general energy consumption taxation or the possibility to exempt this energy product from taxation should only be removed after an assessment, by 2023, on the implementation of the provisions of this Directive relating to the level of taxation applicable to natural gas in road transport. This assessment shall, inter alia, examine the progress in the availability of natural gas and biomethane, the growth of the refilling stations network in Europe, the market share of natural gas vehicles in the EU, the innovation and technological developments of biomethane as fuel in transport, the real value of the minimum level of taxation
Amendment 53 #
2011/0092(CNS)
Proposal for a directive
Recital 21
Recital 21
(21) The general rules introduced by this Directive take account of the specificities of fuels that are biomass or made of biomass complying with the sustainability criteria laid down in Article 17 of Directive 2009/28/EC with regard both to their contribution to the CO2-balance and to their lower energy content per quantitative unit of liquid biofuels, as compared to some of the competing fossil fuels. Consequently, the provisions in Directive 2003/96/EC authoriszing reductions or exemptions for those fuels should be removed in the medium term. For the interim period, it should be ensured that the application of these provisions is made consistent with the general rules introduced by this Directive. Biofuels and bioliquids defined in Article 2(h) and (i) of Directive 2009/28/EC should therefore only benefit from additional tax advantages applied by Member States if they fulfil the sustainability criteria laid down in Article 17 of this Directive. In the case of biomethane, the energy content per quantitative unit is the same as for natural gas. Given the fact that biomethane injected into the natural gas grid helps to increase the share of renewable sources, biomethane will be tax exempted with respect to the CO2 and energy content, provided it is produced according the sustainability criteria.
Amendment 65 #
2011/0092(CNS)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point b
Article 1 – paragraph 1 – point 4 – point b
Directive 2003/96/EC
Article 4 - paragraph 3 - subparagraph 1 a (new)
Article 4 - paragraph 3 - subparagraph 1 a (new)
In the case of natural gas and biomethane as motor fuels, higher minimum levels of general energy consumption taxation should apply only after an assessment, by 2023, on the implementation of the provisions of this Directive relating to the level of taxation applicable to natural gas in road transport. The report shall, inter alia, examine the progress in the availability of natural gas and biomethane, the growth of the refilling stations network in Europe, the market share of natural gas vehicles in the EU, the innovation and technological developments of biomethane as fuel in transport, the real value of the minimum level of taxation.
Amendment 69 #
2011/0092(CNS)
Proposal for a directive
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Directive 2003/96/EC
Article 5 – third indent
Article 5 – third indent
– for the following uses: local public passenger transport (excluding taxis running on oil derived motor fuels), waste collection, armed forces and public administrations, disabled people, ambulances;
Amendment 77 #
2011/0092(CNS)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point (a) – point (i)
Article 1 – paragraph 1 – point 13 – point (a) – point (i)
(i) Until 1 January 2023, natural gas, biomethane and LPG used as propellantsmotor fuels, without prejudice to Art 1 point 21 par 4 (new);
Amendment 82 #
2011/0092(CNS)
Proposal for a directive
Article 1 – paragraph 1 – point 13(1) – point (a) – point (i) a (new)
Article 1 – paragraph 1 – point 13(1) – point (a) – point (i) a (new)
Directive 2003/96/EC
Article 16 – paragraph 1– subparagraph 1 a (new)
Article 16 – paragraph 1– subparagraph 1 a (new)
(ia) A new subparagraph is added: In the case of biomethane, the energy content per quantitative unit is the same as for natural gas. Given the fact that biomethane injected into the natural gas grid helps to increase the share of renewable sources, biomethane will be tax exempted with respect to the CO2 and energy content, provided it is produced according to the sustainability criteria.
Amendment 90 #
2011/0092(CNS)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/96/EC
Article 29 - subparagraph 3 a (new)
Article 29 - subparagraph 3 a (new)
By 2023 the Commission submits to the Council an assessment on the implementation of the provisions of this Directive relating to the level of taxation applicable to natural gas in road transport and a proposal for its modification. This assessment shall, inter alia, examine the progress in the availability of natural gas and biomethane, the growth of the refilling stations network in Europe, the market share of natural gas vehicles in the Union, the innovation and technological developments of biomethane as fuel in transport, the real value of the minimum level of taxation.
Amendment 129 #
2010/2084(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Points to the importance of research into the connection between the ageing process and dementia and between dementia and depression in the elderly; encourages the Member States, furthermore, to promote research programmes that give great importance to patient choice and perspectivespecific healthcare programmes and research programmes on the subject that prioritise full respect for the dignity of the patient;
Amendment 132 #
2010/2084(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Member States to devote suitable resources to healthcare for Alzheimer’s patients and to exchanges of information and networking with regard to the results obtained;
Amendment 133 #
2010/2084(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Stresses the importance of home help for patients and for the elderly, and the vital contribution made by non-profit and voluntary organisations to the care of Alzheimer’s patients and those suffering from other ageing-related diseases; encourages the Member States to create forms of partnership with those organisations and support for their activities; calls on the Member States, in addition, to give due credit and recognition to the role played by the informal care provided by the relatives of those suffering from these diseases;
Amendment 1 #
2010/2080(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Article 67 TFEU emphasises respect for the different legal systems and traditions and access to justice, which is to be facilitated, in particular through the principle of mutual recognition; whereas this requires mutual trust and, in turn, mutual trustthe development of the area of freedom, security and justice requires a reinforced understanding and evaluation of the different legal traditions and methods, as well as genuine respect for them,
Amendment 3 #
2010/2080(INI)
Motion for a resolution
Recital D
Recital D
D. whereas in the face of this ambitious plan and the huge achievements already made by the EU in this field, it is time to stand back and reflect on what we are doing in the field of civil law with a view primarily to adopting a more strategic and less fragmented approach based on the real needs of citizens and businesses when exercising their rights and freedoms in the single market, and taking account of the difficulties of legislating in an area of shared competence where harmonisation is only infrequently an option and there is a need tooverlapping needs to be avoided, and there is a consequent need to respect and accommodate radically different legal approaches, but and constitutional traditions, as also to conceptualising the Union's approach to this area in order better to understand what we are seeking to accomplish and how best to tackle the problems that have to be confronted, as part of an overall plan,
Amendment 6 #
2010/2080(INI)
Motion for a resolution
Recital F
Recital F
F. whereas, next, there is harmonisation or approximation which lends itself to certain areas where standardisation is desirable, if not essential – e.g. in the area of consumer protection, but recourse to which is limited in the AFJS; secondly, there are forward-looking projects such as the CFR which aim at achieving common legal concepts and could be of great assistance, for instance, in the case of contracts concluded via the internet; consideration should also be given to the so-called optional 28th regime as an alternative to the traditional way of harmonising legislation in specific areascould be taken into consideration n the area of consumer protection, but recourse thereto is limited in the AFJS,
Amendment 15 #
2010/2080(INI)
Motion for a resolution
Recital M
Recital M
M. whereas Union law must be in the service of citizens notably in the area of family law and civil statu, notably, in the area of family law and civil status, there must be strict respect for Member States' powers, also taking into account the existence of radically different approaches and attitudes, as well as of the diversity of legal and constitutional traditions,
Amendment 133 #
2010/0377(COD)
Proposal for a directive
Article 6 – paragraph 4 – point a
Article 6 – paragraph 4 – point a
(a) any significant increase in the quantity or significant change in the nature or physical form of the dangerous substance present which could have significant repercussions on major accident hazards, as indicated in the notification provided by the operator pursuant to paragraph 1, or any change in the processes employing it,
Amendment 153 #
2010/0377(COD)
Proposal for a directive
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
b) cooperate in informing the public and neighbouring establishments that fall outside the scope of this Directive, and in supplying information to the authority responsible forsupply details to the authority responsible so as to facilitate cooperation with the public and with neighbouring establishments, as well as the preparation of external emergency plans.
Amendment 179 #
2010/0377(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that the information referred to in Annex V is permanently available to the public, including in an electronic format. The information shall be reviewed and where necessary updated at least once a yearThe information shall be reviewed every three years and, where necessary, repeated and updated, at least if there is any modification within the meaning of Article 10. It shall also be permanently available to the public. The maximum period between the repetition of the information to the public shall, in any case, be no longer than five years. Such information shall contain, at least, the information listed in Annex V.
Amendment 214 #
2010/0377(COD)
Proposal for a directive
Article 14 – paragraph 6 – point b
Article 14 – paragraph 6 – point b
(b) the results of the consultations held before the decision was taken and an explanation of how they were taken into account in that decision.
Amendment 288 #
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)
Mineral products (a) crude oil 5000 50000
Amendment 1 #
2010/0323(NLE)
Motion for a resolution
Recital E
Recital E
E. whereas the Uzbek political regime still has important steps to accomplish in ordergovernment is in the process of taking important steps to achieve democracy,
Amendment 4 #
2010/0323(NLE)
Motion for a resolution
Recital I
Recital I
Amendment 5 #
2010/0323(NLE)
Motion for a resolution
Recital J
Recital J
Amendment 6 #
2010/0323(NLE)
Motion for a resolution
Recital L
Recital L
L. whereas only independent monitoring can bring out the facts and so far the Uzbek Government has refused access to independent monitoring missions, whereas this refusal constitutes in itself a breach of its commitments and should be reacted to accordingly in order to bring out the facts and inform on the duration of the Autumn Harvest period, the working health conditions of students, their ages and eventually risk punishments for non- obedience,
Amendment 8 #
2010/0323(NLE)
Motion for a resolution
Recital O
Recital O
O. whereas, on the basis of the principles and objectives of the Union’s external action, the EU has the moral responsibility to use its leverage, as one of the main trading partners and a major importer of cotton from Uzbekistan, to stop the use of forced child labour in this country, whereas, therefore, the protocol cannot be treated as a purely technical agreement, as long as human rights concerns, such as forced child labour, are raised precisely with regards to cotton harvest,
Amendment 10 #
2010/0323(NLE)
Motion for a resolution
Recital U
Recital U
Amendment 14 #
2010/0323(NLE)
Motion for a resolution
Paragraph 1 subparagraph (i)
Paragraph 1 subparagraph (i)
(i) Strongly condemn the use of forced and child labour in Uzbekistan;
Amendment 17 #
2010/0323(NLE)
Motion for a resolution
Paragraph 1 subparagraph (iii)
Paragraph 1 subparagraph (iii)
(iii) Urge the Government of Uzbekistan to ensure an end to the usallow an ILO monitoring mission and to ensure that the practice of forced and child labour on the ground and to work closely with the ILO International Program on the Elimination of Child Labouris effectively in the process of being eradicated at national, viloyat and local level;
Amendment 21 #
2010/0323(NLE)
Motion for a resolution
Paragraph 1 subparagraph (vi)
Paragraph 1 subparagraph (vi)
Amendment 24 #
2010/0323(NLE)
Motion for a resolution
Paragraph 1 subparagraph (vii)
Paragraph 1 subparagraph (vii)
Amendment 26 #
2010/0323(NLE)
Motion for a resolution
Paragraph 1 subparagraph (viii)
Paragraph 1 subparagraph (viii)
Amendment 30 #
2010/0323(NLE)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Concludes that it will only consider the consent when the recommendations set out in paragraph 1 are duly addressed by the Commission, the Council and concretely implemented by the Uzbek Government;
Amendment 84 #
2010/0306(NLE)
Proposal for a directive
Article 5 – paragraph 1 – point f a (new)
Article 5 – paragraph 1 – point f a (new)
(fa) measures to ensure that the funding required for the management of spent fuel and radioactive waste and for emplacement purposes is set by the competent regulatory authority on the basis of a transparent process which is regularly reviewed and in which the licence holder is involved at all times.
Amendment 92 #
2010/0306(NLE)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
(1a) Member States shall determine the moment at which responsibility for the management of spent fuel and radioactive waste is transferred from the licence holder to the body entrusted with such management under national law.
Amendment 26 #
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
Amendment 37 #
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 a (new)
Article 3 - paragraph 4 a (new)
4a. The nutritional claim 'no added sugar' may be used for the labelling of fruit juices in accordance with Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
Amendment 57 #
2010/0254(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 2001/112/EC
Annex I – part I – point 5 – paragraph 1
Annex I – part I – point 5 – paragraph 1
The fermentable but unfermented product obtained by adding water and/or, with or without the addition of sugars and/or honey, to the products defined in Parts I.1, I.2, I.3 and I.4, to fruit purée and/or to concentrated fruit purée and/or to a mixture of those products, that product, moreover, meeting the requirements of Annex IV.
Amendment 84 #
Amendment 90 #
2009/2152(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Underlines that medium and long-term investments in infrastructure projects, particularly as regards the transport sector, should take full account of the predicted future climatic conditions, while maintaining a certain flexibility; considers it essential in this context to support a modal shift as one means of moving towards the decarbonisation of transport;
Amendment 97 #
2009/2152(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Stresses also that in order to promote a modern and sustainable transport policy, the appropriate financial support needs to be provided to priority TEN railway, maritime and waterways projects during the next EU financial programming period, 2014-2020;
Amendment 103 #
2009/2152(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20a. Stresses the need for the transport sector also to form an integral part of the European strategy on climate change, and calls on the Commission to bring forward a proposal for a ‘European Climate and Transport Package’ as soon as possible; that proposal should take into account the overall reduction of emissions;
Amendment 104 #
2009/2152(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20b. Stresses the need to proceed with the ‘Eurovignette’ Directive legislative process in order to facilitate the internalisation of external costs on the basis of the ‘polluter pays’ principle, establishing a level playing-field for competition between modes of transport;
Amendment 158 #
2009/2152(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Underlines that a substantial part of the revenues generated by the auctioning of allowances in the Community greenhouse gas emission allowance trading system (EU ETS), including auctioning for aviation and maritime transport, should be earmarked for enabling Member States and developing countries to adapt to climate change; such provisions should also support sustainable modes of transport in Europe, such as rail transport;
Amendment 17 #
2009/2105(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that diversity should continue to be Europe's fundamental asset and that all quality products that meet the criteria laid down by the EU should be recognised and protected; considers that after 2013 the CAP should support the quality policy and the efforts of producers to promote more environment-friendly production methods in particular; points out that regions are the CAP's partners, and co- finance and manage rural development; adds that, by their geographical proximity, regions are the partners of producers and, in particular, producers of traditional and organic products; takes the view that regions should be involved in the recognition and promotion of products with an indication, traditional products and organic products;
Amendment 88 #
2009/2105(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Proposes enhancing the role of geographical indication owners' consortia with regard to both volume management and use of geographical indications in the goods produced; considers that consortia should be able to play a role in the coordination of economic operators with a view to bringing the quantities produced and placed on the market as closely into line as possible with the quantities which the market can absorb, and in promotion measures vis-à-vis farmers and consumers; considers that this would more effectively guarantee the long-term viability of the different stages of production, processing and distribution, which is essential to the life of rural areas; adds that quantity control is one of the requirements of quality control; takes the view that the definition of the role of consortia should be included in Community legislation; considers that the practices and experiences identified in the various EU Member States could be recorded and used to define the rights and duties of consortia;
Amendment 22 #
2009/0173(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In those Communications an integrated approach was proposed with a view to reaching the Community target of average emissions of 120 g CO2/km from new passenger cars registered in the Community by 2012 by focusing on mandatory reductions of emissions of CO2 to reach an objective of 130 g CO2/km for the average new car fleet by means of improvements in vehicle motor technology and a further reduction of 10 gCO2/km, or equivalent if technically necessary, by means of other technological improvements, including fuel efficiency progress in, whose installation shall be extended to other types of vehicles, including light commercial vehicles.
Amendment 29 #
2009/0173(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Manufacturers should have flexibility to decide how to meet their targets under this Regulation and should be allowed to average emissions over their new vehicle fleet rather than having to respect CO2 targets for each individual vehicle. Manufacturers should therefore be required to ensure that the average specific emission for all the new light commercial vehicles registered in the Community for which they are responsible does not exceed the average of the emissions targets for those vehicles. This requirement should be phased in between 20145 and 20168 in order to facilitate its introduction. This is consistent with the lead times given and the duration of the phase-in period set in Regulation 443/2009.
Amendment 39 #
2009/0173(COD)
Proposal for a regulation
Recital 15
Recital 15
Amendment 60 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This regulation is part of the complementary measures stated in the community's integrated approach.
Amendment 63 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 2020, tThis Regulation sets a target of 135 60g CO2/km for the, starting in 2020, as average emissions ofor the new light commercial vehicles registered in the Communityfleet, in accordance with Article 12(4). This Regulation sets a target of 145g CO2/km, starting in 2025, as average emissions for the new light commercial vehicles fleet, in accordance with Article 12(5).
Amendment 98 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the calendar year commencing 1 January 20145 and each subsequent calendar year, each manufacturer of complete light commercial vehicles shall ensure that its average specific emissions of CO2 do not exceed its specific emissions target determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.
Amendment 108 #
Amendment 115 #
Amendment 124 #
Amendment 132 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indent 3
Article 4 – paragraph 2 – indent 3
– 100 % from 20168 onwards. As of 1 January 2016 completed vehicles shall also be included in determining each manufacturer’s average specific CO2 emissions.
Amendment 252 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 a (new)
Article 12 – paragraph 4 a (new)
Amendment 288 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 7
Article 12 – paragraph 7
7. TBy 2011 the Commission shall by 2015 review the method of determining the specificset up a procedure to obtain representative values of CO2 emissions of CO2and mass of completed vehicles in paragraph 7 of Part B of Annex II and, if appropriate, submit a proposal to the European Parliament and to the Council to amend Annex IIfor monitoring purposes.
Amendment 122 #
2009/0157(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty establishon the Functioning of the European CommunityUnion, and in particular Article 681(c) and the second indent of Article 67(53) thereof,
Amendment 141 #
2009/0157(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Considerations of public interest shouldmust allow courts in the Member States the opportunity in exceptional circumstances to disregard the application of foreign law in a given case where this would be contrary to the public policy of the forum. However, the courts should not be able to apply the public-policy exception in order to disregard the law of another Member State or to refuse to recognise or enforce a decision, an authentic instrument, a legal transaction or a European Certificate of Succession drawn up in another Member State when this would be contrary to the Charter of Fundamental Rights of the European Union, and in particular Article 21, which prohibits all forms of discrimination.
Amendment 146 #
2009/0157(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) This Regulation respects the fundamental rights and observes the principles recognisenshrined in the Charter of Fundamental Rights of the European Union, in particular Article 21 thereof which states that any discrimination based on any ground such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited. This Regulation must be applied by the courts of the Member States in observance of these rights and principles.
Amendment 220 #
2009/0157(COD)
Proposal for a regulation
Article 27 – paragraph 2 bis (new)
Article 27 – paragraph 2 bis (new)
2a. No provision of this Regulation shall oblige the courts of a Member State to issue a decision relating to succession in respect of a surviving spouse by virtue of the application of this Regulation where there are no such requirements under that State's national marriage and family laws.
Amendment 221 #
2009/0157(COD)
Proposal for a regulation
Article 30 – paragraph 1 bis (new)
Article 30 – paragraph 1 bis (new)
No provision of this Regulation shall oblige the courts of a Member State, where there are no such requirements under that State's national marriage and family laws, to recognise, by virtue of the application of this Regulation, a succession-related decision issued in another Member State concerning a surviving spouse.
Amendment 241 #
2009/0157(COD)
Proposal for a regulation
Article 42 – paragraph 5 bis (new)
Article 42 – paragraph 5 bis (new)
Amendment 21 #
2009/0054(COD)
Proposal for a directive
Recital 10
Recital 10
(10) This Directive should regulate all commercial transactions irrespective of whether they are carried out between private or public undertakings or between undertakings and public authorities, having regard to the fact that the latter handle a considerable volume of payments to business. It should therefore also regulate all commercial transactions between main contractors and their suppliers and subcontractors as well as collective agreements on commercial transactions, including continuous or recurring ones, between undertakings or associations representing undertakings and public authorities.
Amendment 58 #
2009/0054(COD)
Proposal for a directive
Article 2 – point 1
Article 2 – point 1
(1) “commercial transactions” means transactions between undertakings or between undertakings and public authorities, including transactions governed by collective agreements, which lead to the delivery of goods or the provision of services for remuneration;
Amendment 144 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. Member States shall ensure that, in commercial transactions leading to the delivery of goods or the provision of services for remuneration to public authorities, or on behalf of public authorities to third parties, the creditor is entitled, without the necessity of a reminder, to interest for late payment equal to statutory interest if the following conditions are satisfied:
Amendment 175 #
2008/2334(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. calls on the European Union and the Member States to launch important and effective plans for the realisation of transport infrastructure at national level, with the aim of improving national traffic flows, in particular in areas where there are bottlenecks, and to connect them in an effective manner using trans-European assets, possibly through the application of measures introduced by the proposal of Parliament and Council, which establishes the general norms for the granting of Community financial aid in the area of trans-European networks in transport and energy and which also modifies Council Regulation (EC) No 2236/95;
Amendment 42 #
2008/2154(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Asks that only a clearly identified group of people be allowed to take part in representative actions, and that identification must have taken place by the time the claim is brought; asks also that subsequent collective actions against the same defendant and relating to the same multiple offence should not be possible; stresses that only the damage actually suffered may be compensated; notes that in the case of a successful claim the compensation sued for must be paid to the identified group of people and that the qualified entity may only ever be compensated for the costs it has incurred in the course of prosecuting the claim;
Amendment 69 #
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 medicinal products should be established at Community level. When introducing obligatory safety features for prescription 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 84 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, in consultation with stakeholders, should be free to determine the particular aspects of technologies for combating counterfeiting of pharmaceuticals which they consider most appropriate for their pharmaceutical distribution systems, taking account of the authentication seal adopted by this Directive.
Amendment 94 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) The European public should be made aware of the risks run when purchasing pharmaceuticals through illegal channels. In particular, information campaigns should be promoted at both national and European level. The Commission, in conjunction with the Member States, should adopt effective measures to improve public awareness of the risks arising from purchases of pharmaceuticals over the internet.
Amendment 119 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
Member States should cooperate with each other, and with Europol, to step up the existing restrictions on the illegal supply of pharmaceuticals over the internet.
Amendment 205 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
‘o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’
Amendment 251 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1 a (new)
Article 54a – paragraph 4 – subparagraph 1 a (new)
Before formulating a specific proposal, the Commission shall perform an impact assessment of the costs and benefits of the anti-counterfeiting systems currently in force and seek the views of those involved in the implementation and use of such authenticating seals.
Amendment 289 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5 a (new)
Article 54 a – paragraph 4 – subparagraph 5 a (new)
Member States shall ensure that the ownership and confidentiality of the data generated by using technology to combat counterfeiting of pharmaceutical products are respected.
Amendment 329 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 14
Article 1 – point 14
Directive 2001/83/EC
Article 85 a (new)
Article 85 a (new)
Article 85a Member States, in cooperation with the Commission and after consulting interested parties, shall devise an information strategy concerning the reliability of suppliers of pharmaceuticals. This strategy should take into account the various national laws regulating the supply of pharmaceuticals and the risks linked to certain methods of supply of pharmaceuticals, such as illegal internet channels.
Amendment 370 #
2008/0261(COD)
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. This Directive shall not in any way alter the right of Member States to restrict or prohibit the sale of prescription pharmaceuticals over the internet.
Amendment 84 #
2008/0241(COD)
Council position
Recital 8
Recital 8
(8) This Directive should cover all EEE used by consumers and EEE intended for professional use. This Directive should apply without prejudice to Union legislation on safety and health requirements protecting all actors in contact with WEEE, as well as specific Union waste management legislation, in particular Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators, and Union product design legislation, in particular Directive 2009/125/EC. The preparing for re-use, recovery and recycling of waste cooling equipment and the substances, mixtures or components thereof should be in accordance with the relevant legislation of the Union, in particular, Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer and Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17 May 2006 on certain fluorinated greenhouse gases. The objectives of this Directive can be achieved without including large-scale fixed installations such as oil platforms, airport luggage transport systems or elevators within its scope.
Amendment 94 #
2008/0241(COD)
Council position
Article 3 – paragraph 1 – point c – point iii
Article 3 – paragraph 1 – point c – point iii
(iii) can only be replaced by the same specifically designed equipment with equivalent functionalities;
Amendment 107 #
2008/0241(COD)
Council position
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
For this purpose, Member States may require that collection schemes or facilities, as appropriate, provide for the separation at the collection points of WEEE that is to be prepared for re-use from other separately collected WEEE.
Amendment 127 #
2008/0241(COD)
Council position
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The costs of appropriate analyses and inspections, including storage costs, of used EEE suspected to be WEEE may be charged to the producers, to third parties acting on their behalf or to other persons arranging the shipment of used EEE suspected to be WEEE only in cases where the used EEE analysed and inspected indeed proves to be WEEE.
Amendment 90 #
2008/0198(COD)
Council position
Recital 10 a (new)
Recital 10 a (new)
(10a) Forest certification is increasingly developing in Europe and globally. Moreover, a growing number of governments and public authorities, in particular in the EU, are using forest certification as a means of securing the legality and sustainability of their public procurement. Considering third-party verified and certified timber and timber products as legally harvested would be a recognition of the achievements of the forest sector in combating illegal harvesting and an incentive to further expand sustainable forest management and its certification globally.
Amendment 103 #
2008/0198(COD)
Council position
Article 2 – point d
Article 2 – point d
(d) "country of harvest" means the country or territory where the timber or the timber embedded in the timber products was harvested;
Amendment 111 #
2008/0198(COD)
Council position
Article 3 – title
Article 3 – title
Status of timber and timber products covered by FLEGT and CITES and third- party verified certification systems
Amendment 113 #
2008/0198(COD)
Council position
Article 3– paragraph 2 a (new)
Article 3– paragraph 2 a (new)
Timber and timber products that have been certified in accordance with a third- party verified forest certification system that contains a legality obligation, and which complies with this Regulation and its implementing provisions shall be considered to have been legally harvested for the purpose of this Regulation.
Amendment 120 #
2008/0198(COD)
Council position
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) risk assessment procedures enabling the operator to analyze and evaluate the risk of illegally harvested timber or timber products derived from such timber being placed on the market. Such procedures shall take into account the information set out in point (a) as well as relevant risk assessment criteria, including: - assurance of compliance with applicable legislation, which may include certification or other third-party-verified schemes which cover compliance with applicable legislation; - prevalence of illegal harvesting of specific tree species; - prevalence of illegal harvesting or practices in the country of harvest and/or sub-national region where the timber was harvested; - complexity of the supply chain of timber products;
Amendment 132 #
2008/0198(COD)
Council position
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
Amendment 30 #
2008/0191(COD)
Proposal for a directive – amending act
Recital 3
Recital 3
(3) Therefore, it is important to lay down criteria for those capital instruments to be eligible for original own funds of credit institutions and to align the provisions in Directive 2006/48/EC to that agreement. The amendments to Annex XII to Directive 2006/48/EC result directly from the establishment of those criteria. The eligibility criteria shouldOriginal own funds referred to in Article 57(a) of Directive 2006/48/EC include all instruments that are regarded under national law as equity capital, and rank after all other claims during liquidation. Original own funds referred to the most subordinatedin Article 57(a) of Directive 2006/48/EC also include any other instruments of a under credit institution that does not have proprietors or shareholders' statutory terms taking into account the specific constitution of mutuals, cooperative societies uander national law, such as certain members' certificates of cooperative banks, insofar as the respective capital has been paid up and similar institutions and which are deemed broadly equivalent to ordinary shares in terms of their capital qualities. Instruments that do not ranks after all other claims. during liquidation are included in the category of hybrids referred to in Article 57(ca) of Directive 2006/48/EC.
Amendment 75 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2006/48/EC
Article 61 – paragraph 1
Article 61 – paragraph 1
The concept of own funds as defined in points (a) to (h) of Article 57 embodies a maximum number of items and amounts. Member States may decide on the use of those items and on the deduction of items other than those listed in points (i) to (r) of Article 57.
Amendment 78 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 11
Article 1 – point 11
Directive 2006/48/EC
Article 63a – paragraph 3
Article 63a – paragraph 3
3. The statutory or contractual provisions governing the instrument shall allow the credit institution to cancelwaive, when necessary, the payment of interest or dividends for an unlimited period of time, on a non- cumulative basis. However, the credit institution shall cancelwaive such payments if it does not comply with the capital requirements set out in Article 75. The competent authorities may require the cancellation of such payments based on the specific financial and solvency situation of the credit institution. Such cancellationwaiver shall not prejudice the right of the credit institution to substitute the payment in cash of interest or dividend by a payment in the form of an instrument referred to in point (a) of Article 57, provided that any such mechanism allows the credit institution to preserve financial resources. Such substitution may be subject to specific conditions established by the competent authorities.
Amendment 80 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 11
Article 1 – point 11
Directive 2006/48/EC
Article 63a – paragraph 4
Article 63a – paragraph 4
4. The statutory or contractual provisions governing the instrument shall provide for principal, unpaid interest or dividend to be such as to absorb losses and to not hinder the recapitalisation of the credit institution through appropriate mechanisms, as elaborated by the Committee of European Banking Supervisors under paragraph 6.
Amendment 102 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 18
Article 1 – point 18
Directive 2006/48/EC
Article 110 – paragraph 2
Article 110 – paragraph 2
2. Member States shall provide that reporting is to be carried out at least twice a year.
Amendment 126 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 21 – point d
Article 1 – point 21 – point d
Directive 2006/48/EC
Article 113 – paragraph 4 – introductory part
Article 113 – paragraph 4 – introductory part
"4. Member States may fully or partiallyshall exempt the following exposures from the application of Article 111(1):
Amendment 130 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 21 – point d
Article 1 – point 21 – point d
Directive 2006/48/EC
Article 113 – paragraph 4 – point f
Article 113 – paragraph 4 – point f
(f) asset items constituting claims on and other exposures to institutions, provided that these exposures do not constitute such institutions' own funds, and do not last longer than the following business day and are denominated in a currency of the Member State exercising this option, provided that such currency is not the euro.
Amendment 261 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 28 – point b
Article 1 – point 28 – point b
Directive 2006/48/EC
Article 129 – paragraph 3 – subparagraph 7
Article 129 – paragraph 3 – subparagraph 7
The joint decision referred to in the first subparagraph and the decision referred to in the sixth subparagraph shall be recognised as determinative and applied by the competent authorities in the Member State concerned. The Committee of European Banking Supervisors shall elaborate guidelines for the convergence of supervisory practices with regard to the joint decision process referred to in this paragraph and with regard to application of Articles 123, 124 and 136(2) with a view to facilitating the joint decision referred to in the first subparagraph.
Amendment 265 #
2008/0191(COD)
Proposal for a directive – amending act
Article 1 – point 30
Article 1 – point 30
Directive 2006/48/EC
Article 131a – paragraph 2 – subparagraph 2
Article 131a – paragraph 2 – subparagraph 2
The Committee of European Banking Supervisors shall elaborate guidelines for the operational functioning of colleges. The consolidating supervisor shall consider such guidelines, and explain any significant deviation therefrom.
Amendment 27 #
2008/0150(CNS)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 92/79/EEC
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Member States shall ensure that excise duty (specific duty and ad valorem duty) on cigarettes represents at least 57 % of the weighted average retail selling price of cigarettes sold. That excisecombined, or minimum duty) shall not be less than EUR 64 per 1 000 cigarettes irrespective of the weighted average retail selling price. However, Member States which levy an excise duty of at least EUR 101 per 1 000 cigarettes on the basis of the weighted average retail selling price need not comply with the 57% requirement set out in the first subparagraph.
Amendment 28 #
2008/0150(CNS)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive92/79/EEC
Article 2 – paragraph 2
Article 2 – paragraph 2
2. As from 1 January 2014, Member States shall ensure that excise duty (specific duty and ad valorem duty) on cigarettes represents at least 63 % of the weighted average retail selling price of cigarettes sold. That excise duty shall not be less than EUR 90 per 1 000 cigarettes irrespective of the weighted average retail selling price. However, Member States which levy an excise duty of at least EUR 122 per 1 000 cigarettes on the basis of the weighted average retail selling price need not comply with the 63% requirement set out in the first subparagraphon cigarettes shall not be less than EUR 90 per 1 000 cigarettes.
Amendment 45 #
2008/0150(CNS)
Proposal for a directive – amending act
Article 3 – point 4 a (new)
Article 3 – point 4 a (new)
Directive 95/59/EC
Article 9 − paragraph 1 subparagraph 3a (new)
Article 9 − paragraph 1 subparagraph 3a (new)
(4a) Add the following subparagraph 3a to Article 9(1): "The second subparagraph shall, however, not prevent the competent authority of a Member State from applying a minimum consumer price in the context of national public health policy and discouraging the consumption of tobacco, especially by the young.".
Amendment 107 #
2008/0142(COD)
Council position
Recital 19
Recital 19
(19) Members States should ensure that all patients are treated equitably on the basis of their healthcare needs rather than on the basis of their Member State of affiliation. In doing so, Member States should respect the principles of free movement of persons within the internal market, non- discrimination, inter alia with regard to nationality and necessity and proportionality of any restrictions on free movement. However, nothing in this Directive should oblige healthcare providers to accept for planned treatment patients from other Member States or to prioritise them to the detriment of other patients, for instance by increasing the waiting time for treatment of other patients. Inflows of patients may create a demand exceeding the capacities existing in a Member State for a given treatment. In such exceptional cases, the Member State should retain the possibility to remedy the situation on the grounds of public health, in accordance with Articles 52 and 62 of the Treaty. However, this limitation should be without prejudice to Member States' obligations under Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems.
Amendment 126 #
2008/0142(COD)
Council position
Recital 47
Recital 47
(47) Where medicinal products are authorised within a Member State and have been prescribed in a Member State by a member of a regulated health profession within the meaning of Directive 2005/36/EC for an individual named patient, it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another Member State in which the medicinal products are authorised. The removal of regulatory and administrative barriers to such recognition should be without prejudice to the need for appropriate agreement of the patient's treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. The recognition of prescriptions from other Member States shouldmust not affect any professional or ethical duty that would require pharmacists to refuse to dispense the prescription. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products among the benefits covered by the social security system of affiliation. It should further be noted that the reimbursement of medicinal products is not affected by the rules on mutual recognition of prescriptions, but covered by the general rules on reimbursement of cross-border healthcare in Chapter III of this Directive. The implementation of the principle of recognition should be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. These measures should include the adoption of a non-exhaustive list of elements to be included in prescriptions. Nothing should prevent Member States from having further elements in their prescriptions, as long as this does not prevent prescriptions from other Member States that contain the common list of elements from being recognised. The recognition of prescriptions should also apply for medical devices that are legally placed on the market in the Member State where the device will be dispensed.
Amendment 162 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Without prejudice to specific Union provisions applicable to particular foods as regards the requirements referred to in points (a) to (k) of Article 9(1), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in characters using a font size where the x- height, as defined in Annex IV, is equal to or greater than 1,2 mm. The mandatory particulars shall be presented in such a way as to ensure a significantCriteria other than font size, such as font type, contrast between the prifont and the background, line and character pitch, should also be considered.
Amendment 173 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. In case of packaging or containers the largest printable surface of which has an area of less than 680 cm2, the minimum x- height of the font size referred to in paragraph 2 shall be equal to or greater than 0,9 mmnot apply.
Amendment 267 #
2008/0028(COD)
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
25a. The name or address of the food business operator placed on the label does not constitute an indication of the country of origin or place of provenance of the food product concerned.
Amendment 294 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
2a. The energy content, expressed in kcal per 100g or 100ml or per portion, shall be repeated in the bottom right-hand corner of the front-of-pack, in a font size of 3 mm and surrounded by a boarder.
Amendment 304 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 3 – introductory part
Article 33 – paragraph 3 – introductory part
3. The particularsWhere the labelling of a prepacked food provides the mandatory nutrition declaration referred to in Aarticle 29(3) may1), the information on energy shall be presented togepeated on the front of pack per 100 g/ml and per portion. In addition, the amounts of fat, saturates, sugars, salt expressed per 100 g/ml or per portion may be repeated thereon:
Amendment 126 #
2007/0286(COD)
Council position
Article 15 – paragraph 2 – subparagraph 1a (new)
Article 15 – paragraph 2 – subparagraph 1a (new)
For BAT reference documents adopted before the entry into force of the Directive, emission limit values shall also take into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions.
Amendment 136 #
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, tThe 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.