Frédérique RIES
Constituencies
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Belgium
Mouvement Réformateur
2009/07/14 - 9999/12/31
Show earlier Constituencies...
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Belgium
Mouvement Réformateur
2004/07/20 - 2009/07/13
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Belgium
Mouvement Réformateur
2004/07/20 - 2009/07/13
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Belgium
Parti réformateur libéral/Front démocratique des francophones
1999/07/20 - 2004/02/11
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Belgium
Parti réformateur libéral/Front démocratique des francophones
1999/07/20 - 2004/02/11
Groups
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ALDE
Member
Group of the Alliance of Liberals and Democrats for Europe
2009/07/14 - 9999/12/31
Show earlier groups...
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ALDE
Member of the Bureau
Group of the Alliance of Liberals and Democrats for Europe
2006/02/27 - 2009/07/13
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ALDE
Member
Group of the Alliance of Liberals and Democrats for Europe
2004/07/20 - 2007/02/26
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ELDR
Member of the Bureau
Group of the European Liberal, Democrat and Reform Party
2003/06/12 - 2004/02/11
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ELDR
Member
Group of the European Liberal, Democrat and Reform Party
1999/07/20 - 2003/06/11
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ELDR
Member
Group of the European Liberal, Democrat and Reform Party
1999/07/20 - 2003/06/11
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ELDR
Member
Group of the European Liberal, Democrat and Reform Party
2003/06/12 - 2004/02/11
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ALDE
Member
Group of the Alliance of Liberals and Democrats for Europe
2004/07/20 - 2007/02/26
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ALDE
Member
Group of the Alliance of Liberals and Democrats for Europe
2006/02/27 - 2009/07/13
Committees
| Role | Committee | Start | End |
|---|---|---|---|
| Member of | Committee on the Environment, Public Health and Food Safety | 2012/01/19 | 9999/12/31 |
| Substitute of | Committee on Industry, Research and Energy | 2012/01/19 | 9999/12/31 |
Show earlier commitees...
Delegations
| Role | Delegation | Start | End |
|---|---|---|---|
| Member of | Delegation to the Parliamentary Assembly of the Union for the Mediterranean | 2009/09/16 | 9999/12/31 |
| Member of | Delegation to the Euro-Latin American Parliamentary Assembly | 2009/09/16 | 9999/12/31 |
| Member of | Delegation for relations with Israel | 2009/09/16 | 9999/12/31 |
| Member of | Delegation to the EU-Chile Joint Parliamentary Committee | 2009/09/16 | 9999/12/31 |
| Member of | Delegation for relations with the United States | 2012/12/11 | 9999/12/31 |
Show earlier delegations...
| Role | Delegation | Start | End |
|---|---|---|---|
| Member of | Delegation for relations with Israel | 2007/03/14 | 2009/07/13 |
| Substitute of | Delegation for relations with the countries of the Andean Community | 2007/03/15 | 2009/07/13 |
| Substitute of | Delegation for relations with Mercosur | 2007/03/26 | 2009/07/13 |
| Substitute of | Delegation to the ACP-EU Joint Parliamentary Assembly | 2004/09/15 | 2007/03/14 |
| Substitute of | Delegation for relations with Canada | 2007/03/14 | 2007/03/14 |
| Member of | Delegation for relations with Israel | 2004/09/15 | 2007/03/13 |
| Substitute of | Delegation for relations with Canada | 2004/09/15 | 2007/03/13 |
| Member of | Delegation for relations with Israel | 2002/02/07 | 2004/02/11 |
| Member of | Delegation for relations with Israel | 1999/09/29 | 2002/01/14 |
| Member of | Delegation for relations with Israel | 1999/09/29 | 2002/01/14 |
| Member of | Delegation for relations with Israel | 2002/02/07 | 2004/02/11 |
| Member of | Delegation for relations with Israel | 2004/09/15 | 2007/03/13 |
| Substitute of | Delegation for relations with Canada | 2004/09/15 | 2007/03/13 |
| Substitute of | Delegation to the ACP-EU Joint Parliamentary Assembly | 2004/09/15 | 2007/03/14 |
| Member of | Delegation for relations with Israel | 2007/03/14 | 2009/07/13 |
| Substitute of | Delegation for relations with Canada | 2007/03/14 | 2007/03/14 |
| Substitute of | Delegation for relations with the countries of the Andean Community | 2007/03/15 | 2009/07/13 |
| Substitute of | Delegation for relations with Mercosur | 2007/03/26 | 2009/07/13 |
Contact
Online
- Homepage
- http://www.frederiqueries.be
- [javascript protected email address]
Brussels
- Phone
- +322 28 45549
- Fax
- +322 28 49549
- Office
- Bât. Altiero Spinelli 09G165
- Full Address
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- City
- Bruxelles/Brussel
- Zip
- B-1047
- Street
- 60, rue Wiertz / Wiertzstraat 60
Strasbourg
- Phone
- +333 88 1 75549
- Fax
- +333 88 1 79549
- Office
- Bât. Winston Churchill M02111
- Full Address
-
- City
- Strasbourg
- Zip
- CS 91024 - F-67070
- Street
- 1, avenue du Président Robert Schuman
Postal
- Parlement Européen
- Rue Wiertz
- Altiero Spinelli 09G165
- B-1047 Bruxelles
Rapporteur
| Shadow | 2012/0366(COD) | Tobacco and related products: manufacture, presentation and sale. Approximation of Member States legislation |
| Shadow | 2011/2193(INI) | Voluntary and unpaid donation of tissues and cells |
| Responsible | 2011/0156(COD) | Food intended for infants and young children and food for special medical purposes |
| Shadow | 2010/2084(INI) | European initiative on Alzheimer’s disease and other dementias |
| Responsible | 2008/2211(INI) | Health concerns associated with electromagnetic fields |
| Responsible | 2007/2252(INI) | Mid-term review of the European Environment and Health Action Plan 2004 - 2010 |
| Responsible | 2006/2231(INI) | Promoting healthy diets and physical activity: a European dimension for the prevention of overweight, obesity and chronic diseases |
| Opinion | 2006/0802(CNS) | Instrument for Nuclear Safety Cooperation 2007-2013: establishment |
| Responsible | 2006/0291(COD) | Environment: setting of ecodesign requirements for energy-using products (amend. Directives 2005/32/EC, 92/42/EEC, 96/57/EC and 2000/55/EC, as regards the implementing powers conferred on the Commission) |
| Responsible | 2004/2132(INI) | Environment and health: the European Action Plan 2004-2010 |
| Responsible | 2003/0172(COD) | Environment: setting of ecodesign requirements for energy-using products (repeal. Directives 78/170/EEC and 86/594/EEC; amend. Directives 92/42/EEC, 96/57/EC and 2000/55/EC) |
| Responsible | 2001/0018(COD) | Dangerous substances: marketing and use of pentaBDE in polyurethane foam (24th amend. Directive 76/769/EEC) |
Born
1959/05/14 Balen-Wezel- First university qualification in economics, Liège University (1979). Degree in journalism, University of Liège (1981).
- Commercial director, Radio FM56 (1981-1984). Producer and presenter, RTL-TV Luxembourg (1984-1987). Reporter and news editor, RTL-TVI (1987-1998).
- State Secretary for foreign affairs and European affairs (2004).
- Municipal Councillor, Brussels City Council (since December 2006).
- Member of the European Parliament (from 1999 to February 2004 and since June 2004).
Amendments
| Amendments | Dossier |
| 10 |
2007/0286(COD) Industrial emissions. Integrated pollution prevention and control (repeal. Directives 78/176/EEC, 82/883/EEC, 92/112/EEC, 1999/13/EC, 2000/76/EC and 2008/1/EC). Recast
2010/03/30
ENVI
10 amendments...
Amendment 101 #
Council position Article 13 – paragraph 3 – subparagraph 3 Taking into account the opinion of the forum, the guidance referred to in point (c) and (d) of the second subparagraph shall consistently be adopted in accordance with the regulatory procedure referred to in Article 75(2) and shall be consistent with the opinion of the Forum.
Amendment 105 #
Council position Article 13 – paragraph 5 5.
Amendment 133 #
Council position Article 15 – paragraph 4 – subparagraph 1 4. By way of derogation from paragraph 3
Amendment 145 #
Council position Article 15 – paragraph 4 – subparagraph 2 The competent authority shall
Amendment 151 #
Council position Article 15 – paragraph 4 – subparagraph 3 Emission limit values shall, however, not exceed the minimum requirements for emission limit values set out in
Amendment 163 #
Council position Article 15 – paragraph 4 – subparagraph 4 The Commission
Amendment 172 #
Council position Article 21 – paragraph 3 – subparagraph 1 a (new) In specific cases where reconsideration and updating of permit conditions identifies that a longer period than five years from the publication of a decision on BAT conclusions might be needed to introduce new best available techniques, competent authorities may set a longer time period for the reconsideration and updating of permit conditions where this is justified on the basis of the criteria laid down in this Directive.
Amendment 191 #
Council position Article 22 – paragraph 3 – subparagraph 1 3. Upon definitive cessation of the activities, the operator shall inform the competent authority and assess the state of the soil and groundwater contamination by relevant hazardous substances used, produced or released by the installation. Where the installation has caused
Amendment 197 #
Council position Article 22 – paragraph 3– subparagraph 2 Without prejudice to the first subparagraph, upon definitive cessation of the activities, and where the contamination of soil and groundwater at the site poses a
Amendment 200 #
Council position Article 22 – paragraph 4 4. Where the operator is not required to prepare a baseline report referred to in paragraph 2, the operator shall, upon definitive cessation of the activities, take the necessary actions aimed at the removal, control, containment or reduction of relevant hazardous substances,
source: PE-439.994
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| 24 |
2008/0028(COD) Provision of food information to consumers (amend. Regulations (EC) No 1924/2006 and (EC) No 1925/2006; repeal. Directives 90/496/EEC and 2000/13/EC)
2009/12/22
ENVI
6 amendments...
Amendment 224 #
Proposal for a regulation Recital 31 a (new) (31a) Regulation (EC) No 1829/2006 lays down positive labelling rules for foods containing derivatives of GMOs pursuant to which labels need not make specific reference to the fact that foods contain no GMOs or that they unintentionally contain traces of approved GMOs if those traces account for no more than 0.9% of the food concerned. At the same time, non-identical national laws have been adopted which allow operators to label animal-based products in such a way as to make clear that the animals concerned were not fed GMOs. It would be useful for both producers and consumers if the Commission were to propose the establishment of a harmonised 'GMO-free' labelling system which would foster the development of a Community market and enable consumers to make informed choices on the basis of the positive labelling of GMO-free products.
Amendment 252 #
Proposal for a regulation Article 2 – paragraph 2 – point e a (new) (ea) 'non prepacked food' means any food which is offered to the final consumer without prepackaging, or is packed on the sales premises at the consumer’s request or prepacked for direct sale;
Amendment 481 #
Proposal for a regulation Article 35 – paragraph 1 and 1a (new) 1. Where food information covered by this Regulation is provided on a voluntary basis, such information shall comply with the relevant specific requirements laid down in this Regulation. Where food information pursuant to Articles 9 and 10 or voluntary information is provided for non-prepacked foods, it shall comply with national law pursuant to Article 13(4) and Article 41. 1a. Voluntary information shall not be displayed to the detriment of the space available for mandatory information.
Amendment 491 #
Proposal for a regulation Article 35 – paragraph 3 and 4 3.
Amendment 501 #
Proposal for a regulation Article 36 Amendment 513 #
Proposal for a regulation Article 41 1. Where foods are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer's request or prepacked for direct sale,
source: PE-431.051
2011/03/23
ENVI
18 amendments...
Amendment 124 #
Proposal for a regulation Recital 33 a (new) 33a. Consumers also have high expectations concerning information on the origin of the principle components of foodstuffs, especially where these consist of a single ingredient and in the case of ingredients comprising the most weighty part of the final foodstuff. It should therefore be compulsory to give a declaration of origin for an ingredient accounting for 50% or more of the total weight of a manufactured foodstuff. The specific requirements regarding the indication of origin may, however, vary between different types of ingredients, depending on their characteristics and what they are used for. Implementing measures should be drawn up which take into account the proportionality principle and the administrative burden falling to food business operators and the authorities responsible for applying the legislation.
Amendment 127 #
Proposal for a regulation Recital 34 (34) Mandatory origin provisions have been developed on the basis of vertical approaches for instance for honey16, fruits and vegetables17, fish18, beef and beef products19 and olive oil20. There is a need to explore the possibility to extend mandatory origin labelling for other foodstuffs. It is therefore appropriate to request the Commission to prepare a reports covering the following foodstuffs: types of meat other than beef, swine, sheep, goat and poultry meat; milk, milk used as an ingredient in dairy products; meat used as an ingredient
Amendment 166 #
Proposal for a regulation 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
Amendment 169 #
Proposal for a regulation Article 13 – paragraph 2 2. Without prejudice to specific Union provisions applicable to particular foods as regards to 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 IIIa, is equal to or greater than 1
Amendment 171 #
Proposal for a regulation Article 13 – paragraph 2 a (new) 2a. The criteria in terms of minimum font size set out in paragraph 1 shall not apply to infant formulae, follow-on formulae and diversification foods intended for infants and young children which fall within the scope of Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and Commission Directive 2006/125/EC of 5 December 2006 on processed cereal- based foods and baby foods for infants and young children.
Amendment 179 #
Proposal for a regulation Article 13 – paragraph 3 3. In case of packaging or containers the largest printable surface of which has an area of less than
Amendment 183 #
Proposal for a regulation Article 13 – paragraph 4 Amendment 185 #
Proposal for a regulation Article 13 – paragraph 5 – subparagraph 1 For the purpose of achieving the objectives of this Regulation, the Commission shall, together with the stakeholders concerned, including consumer organisations, establish, by means of delegated acts, in accordance with Article 49 and subject to the conditions laid down in Articles 50 and 51, criteria on legibility
Amendment 224 #
Proposal for a regulation Article 25 – paragraph 2 – point b (b) for meat falling within the Combined Nomenclature ('CN') codes listed in Annex XI.
Amendment 228 #
Proposal for a regulation Article 25 – paragraph 2 – point b a (new) (ba) ingredients that represent more than 50 % of a food. The application of points (b) and (c) is subject to the adoption of the implementing rules referred to in paragraph 6.
Amendment 246 #
Proposal for a regulation Article 25 – paragraph 3 – subparagraph 1 – point a a (new) (aa) Putting the name or address of the food business operator on the label shall not constitute an indication of the country of origin or place of provenance of the foodstuff in question;
Amendment 257 #
Proposal for a regulation Article 25 – paragraph 5 – subparagraph 1 – point f Amendment 258 #
Proposal for a regulation Article 25 – paragraph 5 – subparagraph 1 – point g Amendment 261 #
Proposal for a regulation Article 25 – paragraph 5 – subparagraph 3 a (new) 3a. 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 265 #
Proposal for a regulation Article 25 – paragraph 6 6. By …, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 46(2), implementing rules concerning the application of points (b) and (c) of paragraph 2 of this Article and the application of paragraph 3 of this Article. __________________ 40 OJ: please insert the date 2 years from the entry into force of this Regulation.
Amendment 267 #
Proposal for a regulation 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 273 #
Proposal for a regulation Article 29 – paragraph 1 – subparagraph 1 – point b (b) the amounts of fat, saturates, carbohydrate, sugars, protein, artificial trans fatty acids and salt.
source: PE-460.950
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| 22 |
2008/0238(COD) Organ transplantation: standards of quality and safety of human organs intended for transplantation
2010/04/03
ENVI
22 amendments...
Amendment 57 #
Proposal for a directive Recital 1 (1) Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients. The use of human organs for transplantation has steadily increased during the last two decades. Organ transplantation is now the
Amendment 58 #
Proposal for a directive Recital 2 (2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to improve the risk/benefit ratio while minimis
Amendment 63 #
Proposal for a directive Recital 3 a (new) (3a) The principal challenge faced by the European Union and Member States with regard to organ transplantation is that of reducing the shortage of organs and donors. It is therefore crucial to expand the pool of available organs by acquiring the means, at Union level, of optimising the number of donations after brain death or cardiac failure, increase the number of living donors and broaden the pool of potential donors to cover persons who meet 'expanded' donor criteria.
Amendment 64 #
Proposal for a directive Recital 4 (4) Every year organs are exchanged between Member States. The exchange of organs is an important way of
Amendment 70 #
Proposal for a directive Recital 7 (7) In order to reduce the risks and maximise the benefits of the transplantation process. Member States need to operate an effective national quality programme, ensuring that they have a precise description of the donor and the organs. This programme should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the personnel and organisation, premises, equipment, materials, documentation and record-keeping involved. The national quality programme should include auditing where necessary. Member States should be able to delegate, through written agreements, the responsibility for parts of this programme to European organ exchange organisations.
Amendment 71 #
Proposal for a directive Recital 8 (8) The conditions of procurement should be supervised by the Competent Authorities, t
Amendment 78 #
Proposal for a directive Recital 16 (16) This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union11. In line with that charter and to take account of, as appropriate the Convention on human rights and biomedicine12, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the living donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s).
Amendment 84 #
Proposal for a directive Recital 22 (22) In particular, power should be conferred on the Commission to lay down, where the organs concerned are to be exchanged between Member States, the procedures for the transmission to transplantation centres of the information on the characteristics of the donor and the organs, the procedures needed to ensure the traceability of the organs, including labelling requirements, and the procedures for the reporting of serious adverse events or reactions. Since these measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive with new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 85 #
Proposal for a directive Article 1 This Directive lays down
Amendment 99 #
Proposal for a directive Article 3 – point g (g) "organ" means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; and parts of organs, if it is their function to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
Amendment 118 #
Proposal for a directive Article 4 – paragraph 2 – point b (b) standard operating procedures for the verification of the details of
Amendment 126 #
Proposal for a directive Article 4 – paragraph 3 – point b a (new) (ba) authorise, in life-threatening emergencies, transplant operations using an organ which is not optimal, after consultation between the medical staff and the patient or his close family if the patient is unable to state his choice.
Amendment 129 #
Proposal for a directive Article 4 – paragraph 3 – point c a (new) (ca) determine the status of transplant coordinators from the organ donation stage to monitoring of the recipient.
Amendment 131 #
Proposal for a directive Article 5 – paragraph 2 – introductory part Amendment 133 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 2. Member States shall ensure that procurement takes place in dedicated facilities
Amendment 135 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 – introductory part Amendment 139 #
Proposal for a directive Article 8 – paragraph 1 – point b – indent 3 – a statement that the package contains a human organ and marked
Amendment 140 #
Proposal for a directive Article 8 – paragraph 1 – point b – indent 4 Amendment 142 #
Proposal for a directive Article 9 – paragraph 2 2. The Competent authority shall indicate in the accreditation, designation, authorisation or licence which
Amendment 144 #
Proposal for a directive Article 9 – paragraph 4 4. Member States shall, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of transplantation centres. Member States shall seek to render authorisation criteria uniform throughout the Union.
Amendment 153 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that donations of human organs from deceased and living donors are voluntary and unpaid. The principle of non-payment must not prevent a living donor from receiving compensation for expenses incurred or for loss of income, provided that this does not constitute a financial benefit.
Amendment 156 #
Proposal for a directive Article 14 – paragraph 1 Procurement shall only be carried out only after compliance with all
source: PE-439.155
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| 4 |
2008/0240(COD) Electrical and electronic equipment: restriction of the use of certain hazardous substances (repeal. Directive 2002/95/EC). Recast
2010/03/19
ENVI
4 amendments...
Amendment 118 #
Proposal for a directive Article 2 - paragraph 3- point b (b)
Amendment 173 #
Proposal for a directive Article 3 - point p a (new) (pa) 'large scale fixed industrial installations' mean a particular combination of several types of apparatus and, where applicable, other devices, which are intended for use in an industrial environment, assembled and installed permanently at a predefined location, including heating installations, and which cannot normally be removed without destruction of the building or part of the building.”
Amendment 206 #
Proposal for a directive Article 4 - paragraph 7 - subparagraph 1a (new) Further to new recommendations for the inclusion of substances in Annex XIV to Regulation (EC) No 1907/2006, the Commission shall propose the addition of those substances to Annex III.
Amendment 311 #
Proposal for a directive Annex III 1.
source: PE-439.865
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| 2 |
2008/0241(COD) Waste electrical and electronic equipment (WEEE). Recast
2011/09/13
ENVI
2 amendments...
Amendment 85 #
Council position 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
Amendment 96 #
Council position Article 3 – paragraph 1 – point c – point iii (iii) can only be replaced by
source: PE-472.180
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| 2 |
2008/0257(COD) Medicinal products for human use: pharmacovigilance of products [amend. Regulations (EC) No 726/2004 (Community procedures) and (EC) No 1394/2007]
2010/01/03
ENVI
1 amendments...
Amendment 49 #
Proposal for a regulation – amending act Article 1 – point 11 Regulation EC/726/2004 Article 25 The Agency, in collaboration with the Member States
source: PE-438.413
2010/05/02
ITRE
1 amendments...
Amendment 24 #
Proposal for a regulation – amending act Article 1 – point 11 Regulation (EC) No 726/2004 Article 25 The Agency, in collaboration with the Member States
source: PE-438.505
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| 7 |
2008/0260(COD) Medicinal products for human use: pharmacovigilance of products (amend. Directive 2001/83/EC, Community code)
2010/03/15
ENVI
5 amendments...
Amendment 75 #
Proposal for a directive – amending act Article 1 – point 1 – point a Directive 2001/83/EC Article 1 – point 11 Amendment 190 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 102 – paragraph 1 – point 3 (3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25(1) of Regulation (EC) No 726/2004 and implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;
Amendment 242 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 b 1. Marketing authorisation holders shall be required to submit to the Agency periodic safety update reports
Amendment 260 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 108 – point 5 (5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders, including the presentation of the collected information. The collected information must be presented, with the purpose of an appropriate evaluation and follow-up, in a way that makes it possible to distinguish the different adverse reactions, including overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure;
Amendment 262 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 108 – paragraph 2 Those guidelines shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress. For the purposes of this Article and Article 102(3), the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record- keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records that would be needed in the event of needing to file a pharmacovigilance report or to provide information needed by a marketing authorisation holder conducting an evaluation of an adverse event and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.
source: PE-438.412
2010/08/02
ITRE
2 amendments...
Amendment 54 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 102 – paragraph 1 – point 3 (3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25 of Regulation (EC) No 726/2004 and shall implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;
Amendment 66 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 108 – paragraph 2 a (new) For purposes of Article 102(3) and this Article, the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record-keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records required in the event of needing to file a pharmacovigilance report or to provide information required by a marketing authorisation holder conducting an evaluation of an adverse event, and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.
source: PE-438.514
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| 15 |
2008/0261(COD) Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products (amend. Directive 2001/83/EC)
2010/02/15
ITRE
5 amendments...
Amendment 56 #
Proposal for a directive – amending act Recital 8 (8) Any actor in the supply chain who
Amendment 62 #
Proposal for a directive – amending act Recital 17 a (new) (17a) In order to identify each individual package of medicinal products subject to medical prescription other than radiopharmaceuticals, certain product characteristics (i.e. product code, expiry date, lot number) should appear amongst the safety features. This information should be available in a machine-readable format which is harmonised across Europe using an international coding standard.
Amendment 88 #
Proposal for a directive – amending act Article 1 – point 9 Directive 2001/83/EC Article 54 a – paragraph 2 – point c a (new) (ca) The manufacturing authorisation holder clearly indicates on the outer packaging when original safety features have been partly or fully removed or covered up;
Amendment 90 #
Proposal for a directive – amending act Article 1 – point 9 Directive 2001/83/EC Article 54 a – paragraph 3 (3) Manufacturing authorisation holders
Amendment 99 #
Proposal for a directive – amending act Article 1 – point 9 Directive 2001/83/EC Article 54 a – paragraph 4 a (new) As from [insert concrete date 36 months after publication] all medicinal products subject to medical prescription other than radiopharmaceuticals must, from the time of the batch release pursuant to Article 51, carry a serialisation number that identifies the individual package unequivocally. The serial number should be integrated into an internationally recognised and harmonised coding standard.
source: PE-439.067
2010/12/03
ENVI
10 amendments...
Amendment 57 #
Proposal for a directive – amending act Recital 4 a (new) (4a) The European Union should support the drafting of an international agreement stepping up the penalties for falsifying medicinal product, and of an additional protocol to the Palermo Convention against Transnational Organised Crime.
Amendment 92 #
Proposal for a directive – amending act Recital 8 (8) Any actor in the supply chain who
Amendment 99 #
Proposal for a directive – amending act Recital 11 a (new) (11a) The Commission and the Member States should adopt measures such as awareness campaigns to inform the public more fully of the risks of purchasing pharmaceutical products online.
Amendment 114 #
Proposal for a directive – amending act Recital 17 a (new) (17a) 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.
Amendment 211 #
Proposal for a directive – amending act Article 1 - point 8 Directive 2001/83/EC Article 54 - point o ‘(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medicinal prescription as defined in Title VI. 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.’
Amendment 240 #
Proposal for a directive – amending act Article 1 - point 9 Directive 2001/83/EC Article 54a – paragraph 2 – point c a (new) (c a) Manufacturing authorisation holders clearly indicate on the outer packaging where the original safety features have been partly or fully removed or covered up.
Amendment 244 #
Proposal for a directive – amending act Article 1 - point 9 Directive 2001/83/EC Article 54a – paragraph 3 Amendment 360 #
Proposal for a directive – amending act Article 1 – point 17 Directive 2001/83/EC Article 118b 1. Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.
Amendment 364 #
Proposal for a directive – amending act Article 1 – point 17 Directive 2001/83/EC Article 118c a (new) Article 118c a The Commission, working with the Member States, shall support the drafting, under the auspices of the United Nations, of an international convention on the combating of the falsification of medicinal products, with a view to ensuring that stiffer penalties are imposed on those guilty of such falsification.
Amendment 366 #
Proposal for a directive – amending act Article 1 – point 17 Directive 2001/83/EC Article 118c c (new) Article 118c c The Commission, working closely with the Member States, shall organise an information campaign aimed at the general public on the dangers of counterfeit medicinal products, including the Internet-related risks.
source: PE-439.406
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| 11 |
2009/0076(COD) Placing on the market and use of biocidal products
2010/03/18
ENVI
2 amendments...
Amendment 144 #
Proposal for a regulation Article 3 – paragraph 1 – point u a (new) ua. ‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocide products. These include inter alia pregnant and nursing women, infants and children, and the elderly ;
Amendment 179 #
Proposal for a regulation Article 5 – paragraph 2 – point d a (new) da) active substances which have developmental neurotoxic or immunotoxic effects.
source: PE-439.902
2010/03/19
ENVI
6 amendments...
Amendment 355 #
Proposal for a regulation Article 38 – paragraph 1 – point a a) new knowledge or information on the effects of the active substance or biocidal product for humans or the environment, especially those regarding vulnerable groups;
Amendment 410 #
Proposal for a regulation Article 47 – paragraph 2 – point d d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product, especially regarding vulnerable groups.
Amendment 419 #
Proposal for a regulation Article 54 – paragraph 2 a (new) 2 a. Within 4 years after entry into force of this Regulation action plans shall be established and implemented at national level in order to support the sustainable use of biocidal products. Action plans shall be reviewed every three years.
Amendment 422 #
Proposal for a regulation Article 54 – paragraph 3 – point b b) information on any poisonings involving biocidal products, especially regarding vulnerable groups.
Amendment 441 #
Proposal for a regulation Article 58 – paragraph 2 – point g g) if accompanied by a leaflet, the sentence "Read attached instructions before use" and where applicable warnings for vulnerable groups;
Amendment 448 #
Proposal for a regulation Article 66 – paragraph 2 – point i a (new) (ia) providing guidance and tools for the use phase, particularly: - measures for integrated pest management, for specified vermin, - monitoring biocidal product use - best practice of biocidal product use to limit use of such products to the minimum necessary dose, - pest management in sensitive areas like schools, workplaces, kindergartens, public spaces, lake, canal and river sides, geriatric care centres, - technical equipment for of biocidal product application and its inspection.
source: PE-439.891
2010/08/04
ENVI
3 amendments...
Amendment 239 #
Proposal for a regulation Article 16 – paragraph 1 – point b – subpoint iii iii) it has no immediate or delayed unacceptable effects itself or as a result of its residues, directly or indirectly, on human or animal health, taking into account vulnerable groups;
Amendment 248 #
Proposal for a regulation Article 16 – paragraph 5 – point b a (new) ba) developmental neurotoxic or immunotoxic effects.
Amendment 574 #
Proposal for a regulation Annex VI – evaluation – point 20 – indent 9 a (new) – – immunotoxicity
source: PE-439.904
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| 4 |
2009/0173(COD) Reduction of CO2 emissions from light-duty vehicles: emission performance standards for new light commercial vehicles
2010/05/21
ENVI
4 amendments...
Amendment 99 #
Proposal for a regulation Article 4 – paragraph 1 For the calendar year commencing 1 January 201
Amendment 131 #
Proposal for a regulation Article 4 – paragraph 2 – indent 3 source: PE-442.811
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| 8 |
2009/2103(INI) Report on the Commission communication on Action against cancer: European partnership
2010/03/15
ENVI
8 amendments...
Amendment 6 #
Motion for a resolution recital G a (new) Ga. Whereas prevention involves both primary prevention of incidence, which can be accomplished by reducing population exposure to cancer-related contaminants in the environment, in addition to secondary prevention via screening and early detection;
Amendment 9 #
Motion for a resolution recital H b (new) Hb. whereas environmental factors include not only environmental tobacco smoke, radiation and excessive UV exposure but also other chemical contaminants in air, soil and water, and many of which are in present in both occupational and residential settings through industrial and consumer products;
Amendment 45 #
Motion for a resolution Paragraph 7 b (new) 7b. Considers that primary prevention is essential and shall involve actions on a broader scope of environmental factors defined as not only Environmental Tobacco Smoke (involuntary exposure to smoking), radiation, and excessive UV exposure, but also hazardous chemicals in the indoor and outdoor environment to which people are involuntarily exposed;
Amendment 52 #
Motion for a resolution Paragraph 15 15. Calls on the Commission to provide funding for the further development of blood- and urine-based tests (biomarker tests) within the seventh research framework programme, bearing in mind that these early diagnosis procedures are promising tools for detecting different types of cancer (prostate, colon, ovarian, kidney, and bladder cancer);
Amendment 54 #
Motion for a resolution Paragraph 16 16. Calls for support to be stepped up for research into cancer prevention, including research into the effects of harmful chemicals and environmental pollutants, nutrition, lifestyle, genetic factors, and the interaction of all these, and calls for the links between breast cancer and potential risk factors such as tobacco, alcohol and synthetic environmental and pharmaceutical hormones to be investigated;
Amendment 58 #
Motion for a resolution Paragraph 16 c (new) 16c. Calls upon the Commission to ensure that swifter action is taken under the Community Strategy on Endocrine Disruptors,
Amendment 62 #
Motion for a resolution Paragraph 17 17. Calls on the Commission to encourage Member States to invest more of their resources in prevention, both primary (exposure to environmental pollutants) and secondary via screening and early detection;
Amendment 78 #
Motion for a resolution Paragraph 27 27. Urges the Commission and Member States to ensure that cancer medicines are uniformly available to all patients who need them in all Member States and that, whenever possible, the provision made for the above purpose includes the new ‘targeted’ cancer drugs recently put on the market;
source: PE-439.847
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| 7 |
2009/2104(INI) Report on the Commission communication: Action Plan on organ donation and transplantation (2009-2015): strengthened cooperation between Member States
2010/02/17
ENVI
7 amendments...
Amendment 2 #
Motion for a resolution Recital E a (new) Ea. whereas at present there is neither a database covering the whole of the European Union which contains information about organs intended for donation and transplantation or on living or deceased donors, nor, moreover, a pan- European certification system which provides proof that human organs and tissues have been legally obtained,
Amendment 6 #
Motion for a resolution Recital N a (new) Na. whereas the fact that people are living longer is serving to reduce the quality of available organs, which in turn is leading in many cases to a reduction in the number of transplants, including in those Member States where the number of donors is increasing,
Amendment 10 #
Motion for a resolution Paragraph 3 a (new) 3a. Considers, therefore, that with a view to addressing the problem of the shortage of organs a global strategy is needed at national and Community level in order to optimise the number of donations after brain death or cardiac failure, increase the number of living donors and broaden the pool of potential donors to cover persons who meet 'expanded' donor criteria;
Amendment 17 #
Motion for a resolution Paragraph 15 15. Stresses that continuous education should form an essential part of all Member States' communication strategies on the issue; in particular, suggests that people should be better informed and encouraged to speak about organ donation and to communicate their wishes about donation to their relatives; notes that only 41% of European citizens seem to have discussed organ donation within their families;
Amendment 18 #
Motion for a resolution Paragraph 15 a (new) 15a. Encourages the Member States to make it easier for living persons to make explicit statements of willingness to donate organs by offering on-line enrolment in a national and/or European donors' register with a view to speeding up procedures for verifying consent to donate organs;
Amendment 19 #
Motion for a resolution Paragraph 15 b (new) 15b. Calls, further, on the Member States to take steps to facilitate the inclusion, on national identity cards or driving licences, of references or symbols which identify the holder as an organ donor;
Amendment 20 #
Motion for a resolution Paragraph 17 17. Calls on Member States to reach the full potential of deceased donation by establishing efficient systems for identifying organ donors and by promoting transplant donor coordinators in hospitals across Europe; asks Member States to evaluate
source: PE-439.156
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| 3 |
2009/2134(INI) Proposal for a modification of the Act concerning the election of the Members of the European Parliament by direct universal suffrage of 20 September 1976
2011/03/14
AFCO
3 amendments...
Amendment 48 #
Motion for a resolution Recital Q Q. the redistribution of parliamentary seats among States needs to take place on a regular basis in order to reflect demographic change in the resident populations of the States and to strictly respect the principle of degressive proportionality
Amendment 78 #
Motion for a resolution Paragraph 3 3. Proposes that a redistribution of the existing 751 seats among States will take place, if justified objectively by figures established by Eurostat, based on the total resident population, before every election;
Amendment 114 #
Article 2 a (new) Article 2a 1. For the purposes of distributing seats between Member States in accordance with the principle of degressive proportionality pursuant to Article 14(2a) of the Treaty on European Union, the ratio between the population and the number of seats of each State must vary in relation to their respective populations in such a way that each Member from a more populous State represents more citizens than each Member from a less populous State and also, conversely, that no less populous State has more seats than a more populous State. 2. The seats will be distributed following the principle of degressive proportionality, in accordance with the provisions of the Treaty of Lisbon, that will serve as a parameter for assessing whether the decision which the competent institutions take to establish the composition of the European Parliament complies with the rules applicable. The aforementioned framework makes it possible to combine the principle of efficiency, by imposing a ceiling on the number of Members at a level which is still compatible with the role of a legislative assembly, the principle of plurality, by allowing the main constituents of the spectrum of political opinion in each Member State – particularly the majority and the opposition – to be represented, and the principle of solidarity.
source: PE-460.673
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| 2 |
2009/2225(INI) Defining a new Digital Agenda for Europe: from i2010 to digital.eu
2010/02/25
ITRE
2 amendments...
Amendment 32 #
Motion for a resolution Recital E a (new) Ea. whereas European democratic society, the participation of citizens in public debate and access to information in the digital world depends on a vibrant and competitive press sector as the fourth pillar of democracy,
Amendment 168 #
Motion for a resolution Paragraph 8 a (new) 8a. Stresses that, in order to respond to users’ demands and expectations, the European digital agenda should ensure appropriate market and legal conditions for the growth and competitiveness of the press sector, including copyright protection, a competitive advertising market and zero rate VAT, in order to strengthen publishers’ investment and innovation in digital content;
source: PE-439.243
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| 10 |
2010/0065(COD) Preventing and combating trafficking in human beings, and protecting victims (repeal. Framework Decision 2002/629/JHA)
2010/07/29
LIBE, FEMM
10 amendments...
Amendment 54 #
Proposal for a directive Recital 1 a (new) (1a) Trafficking in human beings is a crime where the exploitation of an individual is the central aspect and where a combination of three elements (action, means, purpose) has to apply in order for the crime to be constituted.
Amendment 68 #
Proposal for a directive Recital 5 a (new) (5a) For effective prevention, protection and prosecution, it is necessary to distinguish between trafficking in human beings for the purpose of organ removal which can only be committed if organs are removed from living donors and trafficking in organs, tissues and cells. A targeted approach to the two problems should be developed and implemented by the Commission and Europol which should as a priority improve monitoring of both cases of organ trafficking.
Amendment 92 #
Proposal for a directive Recital 14 (14) In addition to measures available to all victims of trafficking in human beings, Member States should ensure that specific assistance, support and protective measures are available to child victims. These measures should be provided in the best interests of the child and in accordance with the UN Convention on the Rights of the Child. Where the age of a person subject to trafficking is uncertain, and there are reasons to believe he/she is below the age of 18 years, that person should be presumed to be a child and receive immediate assistance, support and protection. Assistance and support measures for child victims should focus on their physical and psycho-social recovery and on a durable solution for the person in question. As the child victim should be reintegrated into society and into normal life within their natural family or adoption family as soon as possible, this will by necessity include a right to access to education. Given that child victims of trafficking are particularly vulnerable, additional protective measures should be available to protect them during interviews forming part of criminal investigations and proceedings.
Amendment 96 #
Proposal for a directive Recital 15 (15) Member States should establish and/or strengthen policies to prevent trafficking in human beings including measures to discourage the demand that fosters all forms of exploitation, and measures to reduce the risk of people falling victims to trafficking in human beings, by means of research, information, awareness raising, and education. In such initiatives Member States should adopt a gender perspective and a child rights approach. Any officials likely to come into contact with victims or potential victims of trafficking in human beings should be adequately trained to identify and deal with such victims. This training obligation would in particular cover police officers, border guards, labour inspectors, health care personnel and consular staff, but could depending on local circumstances also involve other groups of public officials that are likely to encounter trafficking victims in their work. Member States shall take measures to ensure that clear and comprehensive guidance for social services, health, education, immigration and law enforcement to persons who have been victims of human trafficking is provided.
Amendment 114 #
Proposal for a directive Recital 19 (19) This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably equality between women and men, human dignity, prohibition of slavery, forced labour and trafficking in human beings, prohibition of torture and inhuman or degrading treatment or punishment, the rights of the child, the right to liberty and security, freedom of expression and information, protection of personal data, the right to an effective remedy and to a fair trial and the principles of legality and proportionality of criminal offences and penalties. In particular, this Directive seeks to ensure full respect for these rights and principles and has to be implemented accordingly.
Amendment 121 #
Proposal for a directive Article 2 – paragraph 3 3. Exploitation shall include, as a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, including begging, slavery or practices similar to slavery, servitude, or the exploitation of criminal activities, or the removal of organs, cells, tissues and body parts.
Amendment 160 #
Proposal for a directive Article 10 – paragraph 4 4. Member States shall take the necessary measures to establish appropriate mechanisms aimed at early identification, assistance and support for victims, in cooperation with relevant support organisations, including those providing services to victims of trafficking, male violence against women and different forms of exploitation.
Amendment 180 #
Proposal for a directive Article 12 – paragraph 1 1. Child victims of trafficking in human beings shall be provided with assistance, support and protection, taking into account the best interests of the child and respecting international human rights standards.
Amendment 184 #
Proposal for a directive Article 13 – paragraph 1 a (new) 1a. Member States shall take the necessary measures to ensure that special assistance and support is provided to children who are victims of illegal adoption.
Amendment 223 #
Proposal for a directive Article 16 – paragraph 1 Member States shall take the necessary measures to establish National Rapporteurs or equivalent mechanisms. The tasks of such mechanisms shall include the carrying out of assessments on trafficking in human beings trends, the measuring and monitoring of results of anti-trafficking actions and reporting to the relevant national and EU authorities.
source: PE-445.701
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| 9 |
2010/0254(COD) Fruit juices and certain similar products intended for human consumption
2011/04/26
ENVI
9 amendments...
Amendment 17 #
Proposal for a directive - amending act Recital 1 (1) In order to ensure that fruit juice are clearly labelled and consumers are able to distinguish between types of products and to enhance the free movement of fruit juices and certain similar products within the European Union, Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption4 has laid down specific provisions regarding production, composition and labelling of the products concerned. Those rules should be adapted to technical progress and should take account, if necessary, of developments in relevant international standards, in particular the Codex Standard for fruit juices and nectars (Codex Stan 247-2005) which was adopted by the Codex Alimentarius Commission during its 28th session on 4-9 July 2005 and the Code of Practice of the European Fruit Juice Association (AIJN).
Amendment 18 #
Proposal for a directive - amending act Recital 2 Amendment 20 #
Proposal for a directive - amending act Recital 3 (3) Without prejudice to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs5
Amendment 29 #
Proposal for a directive - amending act Article 1 – point 1 Directive 2001/112/EC Article 3 - paragraph 4 4) Nectars and specific products of Annex III may be sweetened by the addition of sugars
Amendment 35 #
Proposal for a directive - amending act Article 1 – point 1 Directive 2001/112/EC Article 3 - paragraph 4 a (new) 4a. The claim "with no added sugars" may be used for the labelling of fruit juice included in category 1 of Annex I, 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 45 #
Proposal for a directive - amending act Article 2 – paragraph 1 – subparagraph 1 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive
Amendment 49 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 1 – point a – paragraph 2 Amendment 53 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 1 – point b – paragraph 1 The product obtained by reconstituting concentrated fruit juice defined in Part I.2 with potable water that meets the criteria of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption* and/or national guidelines set up for many years.
Amendment 56 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 5 – paragraph 1 The fermentable but unfermented product obtained by adding water
source: PE-464.677
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| 2 |
2010/0298(COD) Detergents: use of phosphates and other phosphorous compounds
2011/05/19
ENVI
2 amendments...
Amendment 19 #
Proposal for a regulation – amending act Recital 5 (5) It is not appropriate to extend limitations of the use of phosphates and other phosphorous compounds in household laundry detergents to household automatic dishwasher detergents or to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available. It is, however, appropriate for phosphates to be excluded under the new criteria for the award of the eco-label, both for dishwasher detergents and for washing machine detergents.
Amendment 32 #
Proposal for a regulation – amending act Article 1 – point 8 Regulation (EC) No 648/2004 Article 16 By 31 December 201
source: PE-464.931
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| 17 |
2010/2084(INI) European initiative on Alzheimer’s disease and other dementias
2010/11/11
ENVI
17 amendments...
Amendment 16 #
Motion for a resolution Recital B B. whereas the number of people suffering from
Amendment 18 #
Motion for a resolution Recital B B. whereas the number of people suffering from neurodegenerative diseases in Europe is estimated to be 8.6 million, with Alzheimer's accounting for the vast majority of those cases; whereas neurodegenerative diseases represent one of the main causes of disability in
Amendment 24 #
Motion for a resolution Recital C C. whereas the population of Europe is ageing, with persons aged over 80 constituting the fastest-growing cohort in most European countries, and whereas dementia is therefore expected to be one of the main challenges for the sustainability of national healthcare systems, including informal care and long-term care facilities, in the coming decades,
Amendment 47 #
Motion for a resolution Recital F b (new) Fb. whereas this European initiative is not intended to replace existing national plans to combat Alzheimer's disease and other forms of dementia, but instead should be used as a means of coordinating European research in this area more effectively and giving proper consideration to the establishment of a European centre of excellence which would facilitate cross-disciplinary exchanges among researchers,
Amendment 73 #
Motion for a resolution Recital H h (new) Hh. whereas, further, the diagnosis of Alzheimer's disease delivered in almost 70% of cases of dementia fails to take full account of the variety of cerebral lesions encountered in sufferers and of the fact that young and elderly sufferers do not show the same pathological and clinical picture,
Amendment 88 #
Motion for a resolution Paragraph 2 2. Suggests that the Council and the Commission consider launching a European Year of the Brain, complementing World Alzheimer's Day on 21 September, in order to raise awareness of brain-related diseases associated with ageing, and measures to prevent them;
Amendment 96 #
Motion for a resolution Paragraph 3 3. Underlines the relevance of early diagnosis for preventive interventions, and the need for epidemiological and clinical data to help direct research and action, in particular during the asymptomatic phases and before patients become disabled;
Amendment 97 #
Motion for a resolution Paragraph 3 a (new) 3a. Notes that at present there is no specific policy on the prevention of Alzheimer's disease, and calls, therefore, for the establishment of such a policy, including at European level, which would be based on the need to maintain an environment conducive to patients' physical and intellectual activity and a diet consistent with that recommended by the European Platform for Action on Diet, Physical Activity and Health and on the promotion of all policies to reduce smoking, both active and passive;
Amendment 110 #
Motion for a resolution Paragraph 5 5. Points to the importance of a multidisciplinary approach on ways in which cooperation and coordination in the field of research at European level can improve knowledge, diagnosis, treatment, prevention, and social research into the welfare of patients and their families and carers;
Amendment 115 #
Motion for a resolution Paragraph 5 a (new) 5a. Recognises the current importance of the European Union’s support, totalling EUR 159 million, for 34 projects on neurodegenerative diseases; considers it essential, nevertheless, in the context of the forthcoming 8th RDFP, to address the fragmented nature of research, particularly that on Alzheimer’s, and to concentrate on a few major projects, including those in the insufficiently explored fields of non-drug, behavioural and cognitive therapies;
Amendment 122 #
Motion for a resolution Paragraph 6 6. Invites the Member States to develop a Strategic Research Agenda establishing medium- to long-term research needs and objectives in the area of neurodegenerative diseases, especially Alzheimer's; takes the view that the strategic research agenda should be further developed towards an implementation plan establishing priorities and timetables and specifying the actions, instruments and resources required for its implementation; Recommends to foster the development of centres of excellence for specific research areas and to involve representatives of patients, carers organisations and public/ private healthcare providers;
Amendment 125 #
Motion for a resolution Paragraph 6 c (new) 6 c. Invites European Institutions to support as far as possible Alzheimer Europe's Dementia Research Observatory as a useful tool for the dissemination of best practises and research results to patients and their carers;
Amendment 130 #
Motion for a resolution Paragraph 7 7. Points to the importance of research into the connection as well as the distinction between the ageing process and dementia and between dementia and depression in
Amendment 139 #
Motion for a resolution Paragraph 8 8.
Amendment 150 #
Motion for a resolution Paragraph 9 9. Underlines that the recent advances in imaging and biomarker research
Amendment 177 #
Motion for a resolution Paragraph 12 12. Encourages Member States to develop information campaigns for the general public and for specific groups such as schoolchildren, health care professionals and social workers, comparing and exchanging experiences on support measures for family carers, patients’ associations and non-governmental organisations
Amendment 187 #
Motion for a resolution Paragraph 12 i (new) 12i. Points out that considerable progress still needs to be made in the area of access to therapeutic trials for patients with Alzheimer’s and similar diseases in order to ensure that the new molecules are effective; emphasises that this problem should be addressed in the next revision of the European Directive on clinical trials on medicinal products (2001/20/EC);
source: PE-452.652
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| 2 |
2010/2089(INI) Reducing health inequalities in the EU
2011/10/01
ENVI
2 amendments...
Amendment 173 #
Motion for a resolution Paragraph 12 a (new) 12a. Calls for better coordination between the EU agencies which have a major role to play in combating health inequalities, in particular between the European Foundation for the Improvement of Living and Working Conditions, the European Centre for Disease Prevention and Control and the European Agency for Health and Safety at Work;
Amendment 176 #
Motion for a resolution Paragraph 13 a (new) 13a. Draws attention to the particular importance, among the various health determinants, of a varied, high-quality diet, and in this connection urges the Commission to make greater use of the effective programmes established under the CAP (free distribution of milk and fruit in schools and of food to the most deprived groups);
source: PE-454.655
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| 5 |
2010/2153(INI) Evaluation of the management of H1N1 influenza in 2009-2010 in the EU
2010/12/20
ENVI
5 amendments...
Amendment 43 #
Motion for a resolution Recital E Amendment 68 #
Motion for a resolution Recital I c (new) Ic. whereas lawsuits were taken in various Member States, alleging corruption and conspiracy on the part of civil servants in relation to contracts signed in summer 2009 between ministries of public health and manufacturers of A/H1N1 influenza vaccines,
Amendment 106 #
Motion for a resolution Paragraph 4 4. Calls for
Amendment 131 #
Motion for a resolution Paragraph 8 8. Considers
Amendment 148 #
Motion for a resolution Paragraph 10 10. Calls for full liability for the quality, safety and effectiveness of a medicinal product to rest with the manufacturer once it has been established that the product is defective and that compensation is therefore payable;
source: PE-454.473
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| 10 |
2011/0156(COD) Food intended for infants and young children and food for special medical purposes
2012/01/26
ENVI
10 amendments...
Amendment 82 #
Proposal for a regulation Recital 17 a (new) (17a) Maximum concentrations of pesticide residue defined by the applicable Community legislation, in particular Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in products of plant and animal origin1, should be without prejudice to the specific provisions established by this Regulation. The principle of prohibiting the use of pesticides should therefore be maintained whenever possible and in all cases of the use of pesticides or metabolites of pesticides with an acceptable daily intake of less than 0.0005 mg/kg body weight in the production of agricultural products intended for infant and follow-on formulae. This principle, which is set out in Directive 2006/141/EC, is also applicable to processed cereal-based food and baby food covered by Directive 2006/125/EC and should be extended to other categories of foodstuffs for particular nutritional uses. ___________________ 1 OJ L 70, 16.3.2005, p. 1.
Amendment 84 #
Proposal for a regulation Recital 17 b (new) (17b) It is important for pesticides authorised by Annex IX of Directive 2006/141/EC and Annex VI of Directive 2006/125/EC and which do not satisfy the safety conditions set out in Articles 4 and 6 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products1 on the market to be banned from the market and not be carried over into this Regulation. ______________________ 1 OJ L 309, 24.11.2009, p. 1.
Amendment 108 #
Proposal for a regulation Recital 25 (25) 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 establishes the rules and conditions for the use of nutrition and health claims on food. Those rules should apply as a general rule to the categories of food covered by this Regulation, unless otherwise specified in this Regulation or non-legislative acts adopted pursuant to this Regulation, as is already the case for foods included in infant formulae and follow-on formulae which are covered by special rules on nutrition claims.
Amendment 110 #
Proposal for a regulation 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 consumption under the rules specified in Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.
Amendment 115 #
Proposal for a regulation Recital 26 a (new) (26a) Labelling indicating ‘lactose free’ and ‘very low lactose content’ currently have no legal cover at EU level: neither under Regulation (EC) No 1924/2006 nor under specific provisions to deal with different kinds of food intolerance. These indicators are, however, important for people who are intolerant to lactose. They should therefore be covered by the new Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers1, which makes possible the establishment of criteria for including allergens on labelling. _________________ 1 OJ L 304, 22.11.2011, p. 18.
Amendment 132 #
Proposal for a regulation Article 1 – paragraph 1 – point c a (new) (ca) food for people intolerant to gluten.
Amendment 164 #
Proposal for a regulation Article 2 – paragraph 2 – point h a (new) (ha) ‘gluten’ means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof, to which some persons are intolerant and which is insoluble in water and 0.5 M sodium chloride solution;
Amendment 167 #
Proposal for a regulation Article 2 – paragraph 2 – point h b (new) (hb) ‘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 216 #
Proposal for a regulation Article 10 – paragraph 2 – point c (c) the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1), including the authorisation of nutrition and health claims thereof, with the exception of infant formulae with their own rules regarding such claims;
Amendment 231 #
Proposal for a regulation Article 10 – paragraph 2 a (new) 2a. There are specific compositional and labelling requirements for foodstuffs intended for people intolerant to gluten referred to in Article 1(1)ca. The foodstuffs referred to in the first subparagraph, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer. Foodstuffs sold to the final consumer which contain a level of gluten not exceeding 100 mg/kg may be labelled ‘very low gluten content’. Foodstuffs sold to the final consumer which contain a level of gluten not exceeding 20 mg/kg may be labelled ‘gluten free’. Foodstuffs referred to in this paragraph shall also comply with the following criteria: – they shall provide roughly the same amount of vitamins and mineral salts as the foodstuffs they are replacing, – they shall be prepared with special care, in compliance with good manufacturing practice (GMP), to avoid gluten contamination, – appropriate labelling is provided, indicating ‘very low gluten content’ or ‘gluten free’ close to the name under which the product is marketed.
source: PE-480.592
|
| 16 |
2011/0172(COD) Energy efficiency
2011/07/11
ENVI
8 amendments...
Amendment 29 #
Proposal for a directive Recital 15 (15) The rate of building renovation needs to be increased, as the existing building stock represents the single biggest potential sector for energy savings. Moreover, buildings are crucial to achieving the EU objective of reducing greenhouse gas emissions by 80-95% by 2050 compared to 1990. Buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life. It is therefore appropriate to set an annual rate of renovation of all buildings owned by public bodies to upgrade their energy performance. This renovation rate should be without prejudice to the obligations with regard to nearly- zero energy buildings set in Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings27 . The obligation to renovate public buildings complements the provisions of that Directive, which requires Member States to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements. Specific attention shall be paid to ensuring good indoor air quality e.g. through adequate ventilation requirements and the use of low-emission building materials, equipment and products. Where energy efficiency measures concern public buildings, such as day care centers, kindergardens or schools, a health impact assessment should be carried out.
Amendment 65 #
Proposal for a directive Article 2 – paragraph 1 – point 12 12. ‘energy audit’ means a systematic procedure to obtain adequate knowledge of the existing energy consumption profile of a building or group of buildings, an industrial or commercial operation or installation or a private or public service, identify and quantify cost-effective energy savings opportunities, taking into account health impacts, and report the findings;
Amendment 105 #
Proposal for a directive Article 4 – paragraph 1 1. Without prejudice to Article 7 of Directive 2010/31/EU, Member States shall ensure that as from 1 January 2014, 3% of the total floor area owned by their public bodies is renovated each year to meet at least the minimum energy performance requirements set by the Member State concerned in application of Article 4 of Directive 2010/31/EU. The 3% rate shall be calculated on the total floor area of buildings with a total useful floor area over 250 m2 owned by the public bodies of the Member State concerned that, on 1 January of each year, does not meet the national minimum energy performance requirements set in application of Article 4 of Directive 2010/31/EU. Specific attention shall be paid to ensuring good indoor air quality through adequate ventilation requirements and the use of low-emission building materials, equipment and products.
Amendment 106 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 1 (new) 1.(a) Where energy efficiency measures concern public buildings such as day care centers, kindergardens or schools a health impact assessment shall be carried out.
Amendment 123 #
Proposal for a directive Article 4 – paragraph 4 – point b (b) put in place an energy management system as part of the implementation of their plan. The energy efficiency plan and management system shall take due account of health risks and beneficial measures.
Amendment 127 #
Proposal for a directive Article 4 – paragraph 4 – point b a (new) (b a) (c) Member States shall encourage the development of criteria for energy efficient and healthy buildings, checklists, information campaigns and exchange of good practice.
Amendment 192 #
Proposal for a directive Article 7 – paragraph 4 4. Energy audits may stand alone or be part of a broader environmental audit. As a minimum requirement, such audits shall include a health impact assessment.
Amendment 363 #
Proposal for a directive Annex 3 – paragraph 1 – point a (a) where a product is covered by a delegated act adopted under Directive 2010/30/EU or Commission Directive implementing Directive 92/75/EEC, purchase only the products that comply with the criterion of belonging to the highest energy efficiency class while taking into account cost-effectiveness, health impact, economical feasibility and technical suitability, as well as sufficient competition;
source: PE-475.843
2011/11/16
ITRE
4 amendments...
Amendment 185 #
Proposal for a directive Recital 15 (15) The rate of building renovation needs to be increased, as the existing building stock represents the single biggest potential sector for energy savings. Moreover, buildings are crucial to achieving the EU objective of reducing greenhouse gas emissions by 80-95% by 2050 compared to 1990. Buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life. It is therefore appropriate to set an annual rate of renovation of all buildings owned by public bodies to upgrade their energy performance. This renovation rate should be without prejudice to the obligations with regard to nearly- zero energy buildings set in Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings. The obligation to renovate public buildings complements the provisions of that Directive, which requires Member States to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements. Specific attention shall be paid to ensuring good indoor air quality through e.g. adequate ventilation requirements and the use of low-emission building materials, equipment and products. Where energy efficiency measures concern public buildings such as day care centres, kindergartens or schools a health impact assessment shall be carried out.
Amendment 391 #
Proposal for a directive Article 2 – paragraph 1 – point 12 12. ‘energy audit’ means a systematic procedure to obtain adequate knowledge of the existing energy consumption profile of a building or group of buildings, an industrial or commercial operation or installation or a private or public service, identify and quantify cost-effective energy savings opportunities, taking into account health impacts, and report the findings;
Amendment 498 #
Proposal for a directive Article 4 – paragraph 1 1. Without prejudice to Article 7 of Directive 2010/31/EU, Member States shall ensure that as from 1 January 2014, 3% of the total floor area owned by their public bodies is renovated each year to meet at least the minimum energy performance requirements set by the Member State concerned in application of Article 4 of Directive 2010/31/EU. The 3% rate shall be calculated on the total floor area of buildings with a total useful floor area over 250 m2 owned by the public bodies of the Member State concerned that, on 1 January of each year, does not meet the national minimum energy performance requirements set in application of Article 4 of Directive 2010/31/EU. Specific attention shall be paid to ensuring good indoor air quality through adequate ventilation requirements and the use of low-emission building materials, equipment and products.
Amendment 535 #
Proposal for a directive Article 4 – paragraph 1 a (new) 1a. Where energy efficiency measures concern public buildings such as day care centers, kindergartens or schools a health impact assessment shall be carried out.
source: PE-475.873
2011/11/17
ITRE
3 amendments...
Amendment 608 #
Proposal for a directive Article 4 – paragraph 4 – point b (b) put in place an energy management system as part of the implementation of their plan. The energy efficiency plan and management system shall take due account of health risks and beneficial measures.
Amendment 621 #
Proposal for a directive Article 4 – paragraph 4 – subparagraph 1 a (new) Member States shall encourage the development of criteria for energy efficient and healthy buildings, checklists, information campaigns and exchange of good practice;
Amendment 897 #
Proposal for a directive Article 7 – paragraph 4 4. Energy audits may stand alone or be part of a broader environmental audit. As a minimum requirement, such audits shall include a health impact assessment.
source: PE-475.932
2011/11/22
ITRE
1 amendments...
Amendment 1585 #
Proposal for a directive Annex III – point a a) where a product is covered by a delegated act adopted under Directive 2010/30/EU or Commission Directive implementing Directive 92/75/EEC, purchase only the products that comply with the criterion of belonging to the highest energy efficiency class while taking into account cost-effectiveness, health impact, economical feasibility and technical suitability, as well as sufficient competition;
source: PE-475.997
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| 43 |
2011/0401(COD) Horizon 2020 - Framework Programme for Research and Innovation 2014-2020
2012/02/07
ITRE
9 amendments...
Amendment 1050 #
Proposal for a regulation Annex 1 – Part 2 – point 1 – point 1.2 – point 1.2.1 – paragraph 1 The specific objective of nanotechnologies research and innovation is to
Amendment 1051 #
Proposal for a regulation Annex 1 – Part 2 – point 1 – point 1.2 – point 1.2.1 – paragraph 2 By 2015, the Commission will review all relevant legislation to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle. By 2020, nanotechnologies will be mainstreamed, that is seamlessly integrated with most technologies and applications, driven by consumer benefits, quality of life, sustainable development and the strong industrial potential for achieving previously unavailable solutions for productivity and resource efficiency
Amendment 1060 #
Proposal for a regulation Annex 1 – Part 2 – point 1 – point 1.2 – point 1.2.3 – point a – paragraph 1 Aiming at fundamentally new products enabling sustainable solutions in a wide range of sectors, particularly electronics, medicine and new energies and materials.
Amendment 1063 #
Proposal for a regulation Annex 1 – Part 2 – point 1 – point 1.2 – point 1.2.3 – point b – introductory part (b) Ensuring the safe development and application of nanotechnologies, particularly when they are used in the manufacture of products that will come into direct contact with the human body
Amendment 1249 #
Proposal for a regulation Annex 1 – Part 2 – point 3 – point 3.3 – point a – paragraph 2 All of the specific objectives on societal challenges and on leadership in enabling and industrial technologies will apply the dedicated SME instrument and will allocate
Amendment 1251 #
Proposal for a regulation Annex 1 – Part 2 – point 3 – point 3.3 – point a – paragraph 2 a (new) The dedicated SME instrument should be centrally managed in order to ensure coherent application of rules, visibility of the Instrument, and a single entry point, facilitating participation of SMEs. The SME instrument should contribute to the specific objectives of the Leadership in Enabling and Industrial Technologies and Societal Challenges.
Amendment 1254 #
Proposal for a regulation Annex 1 – Part 2 – point 3 – point 3.3 – point a – paragraph 2 b (new) This instrument shall create the necessary flexibility to allow for the integration of SMEs at project runtime and for limited shorter-than-project timeframes into research projects. It shall also allow the creation of a new category of smaller (micro) projects for SMEs that can be created independently or as spin-offs from larger research projects.
Amendment 1255 #
Proposal for a regulation Annex 1 – Part 2 – point 3 – point 3.3 – point a – paragraph 2 c (new) The SME instrument shall be subjected to an in-depth mid-term review. If the absorption objectives of the SME instrument are not met, the remaining funds shall be reallocated to the pillars of industrial leadership and societal challenges.
Amendment 1275 #
Proposal for a regulation Annex 1 – Part 3 – point 1 – point 1.1 – paragraph 3 The cost of Union health and social care systems is rising with care and prevention measures in all ages increasingly expensive, the number of Europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060, and those over 80 to rise from 22 to 61 million in the same period. Reducing or containing these costs such that they do not become unsustainable depends in part on
source: PE-492.765
2012/03/07
ITRE
1 amendments...
Amendment 1368 #
Proposal for a regulation Annex 1 – Part 3 – point 2 – point 2.1 – paragraph 2 Over the coming decades, Europe will be challenged by increased competition for limited and finite natural resources, by the effects of climate change, in particular on primary production systems (agriculture, forestry, fisheries and aquaculture) and by the need to provide a sustainable, safe and secure food supply for the European and an increasing global population. A 70 % increase of the world food supply is estimated to be required to feed the 9 billion global population by 2050. This food emergency does not justify the current imbalance between often surplus national production levels and the steady rise in food imports, nor does it provide a reason for the increasing complexity of the global food network. Hence the importance of the European Union having better control of the supply circuits, taking into account, as a matter of priority, seasonal cycles, the origin of products and the ability to track food. Agriculture accounts for about 10 % of Union greenhouse gases emissions, and while declining in Europe, global emissions from agriculture are projected to increase up to 20 % by 2030. Furthermore, Europe will need to ensure sufficient supplies of raw materials, energy and industrial products, under conditions of decreasing fossil carbon resources (oil and liquid gas production expected to decrease by about 60 % by 2050), while maintaining its competitiveness. Bio-waste (estimated at up to 138 million tonnes per year in the Union, of which up to 40 % is land-filled) represents a huge problem and cost, despite its high potential added value. For example, an estimated 30 % of all food produced in developed countries is discarded. Major changes are needed to reduce this amount by 50 % in the Union by 203026 . In addition, national borders are irrelevant in the spread of animal and plant pests and diseases, including zoonotic diseases, and food borne pathogens. While effective national prevention measures are needed, action at Union level is essential for ultimate control and the effective running of the single market. The challenge is complex, affects a broad range of interconnected sectors and requires a plurality of approaches.
source: PE-492.789
2012/06/25
ENVI
19 amendments...
Amendment 44 #
Proposal for a regulation Recital 22 a (new) (22a) Horizon 2020 should also help persuade European researchers to remain in Europe, attract researchers from the whole world to Europe and make Europe a more attractive destination for the best researchers. Consideration should therefore be given at European level to establishing attractive, coordinated tax arrangements for researchers.
Amendment 48 #
Proposal for a regulation Recital 24 (24) Research and innovation activities supported by Horizon 2020 should respect fundamental ethical principles. The reasoned, regularly updated opinions of the European Group on Ethics in Science and New Technologies should be taken into account, which entails, as a prerequisite, a transparent method of selection underpinned by the independence and scientific expertise of the members of the European Group on Ethics in Science and New Technologies (EGE). Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU.
Amendment 52 #
Proposal for a regulation Recital 25 (25) The European Commission
Amendment 58 #
Proposal for a regulation Recital 25 a (new) (25a) The Commission must take better account in the framework programme of research on cells extracted from umbilical cord blood (capacity for differentiation, proliferation and for autologous or allogeneic use, absence of immunological reaction in the patient receiving the cells), which have already been successfully used to treat certain conditions.
Amendment 60 #
Proposal for a regulation Recital 25 b (new) (25b) The recent discovery of induced pluripotent stem cells (iPSCs) has opened up a new avenue for research, over and beyond the opportunities for research on adult and embryonic stem cells that have existed for several years, and has thus offered new hope to patients awaiting treatment. The European Union should therefore take action according to the following recommendations – it must: – take account of the scientific community’s interest in all types of research; – strike a balance between these different ways of researching stem cells, without favouring any one over the others; – consider the ethical problems raised by each category of stem cells without prejudice.
Amendment 62 #
Proposal for a regulation Recital 27 (27) SMEs constitute a
Amendment 86 #
Proposal for a regulation Article 6 – paragraph 2 – subparagraph 1 – point b (b) Industrial and post-industrial leadership, EUR 2
Amendment 89 #
Proposal for a regulation Article 6 – paragraph 2 – subparagraph 1 – point c (c) Societal challenges, EUR 3
Amendment 97 #
Proposal for a regulation Article 7 – paragraph 1 – point b – point iii (iii) have close political, economic and geographical links to the Union;
Amendment 132 #
Proposal for a regulation Article 16 – paragraph 4 4. Research on human stem cells,
Amendment 182 #
Proposal for a regulation Annex I – part II – point 1.2.1. – introductory paragraph The specific objective of nanotechnologies research and innovation is to
Amendment 184 #
Proposal for a regulation Annex I – part II – point 1.2.1. – paragraph 1 By 2015, the Commission will review all relevant legislation to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle. By 2020, nanotechnologies will be mainstreamed, that is seamlessly integrated with most technologies and applications, driven by consumer benefits, quality of life, sustainable development and the strong industrial potential for achieving previously unavailable solutions for productivity and resource efficiency.
Amendment 190 #
Proposal for a regulation Annex I – part II – point 1.2.3. – point a – paragraph 1 Aiming at fundamentally new products enabling sustainable solutions in a wide range of sectors, in particular electronics, medicine, new energy sources and materials.
Amendment 191 #
Proposal for a regulation Annex I – part II – point 1.2.3. – point b (b) Ensuring the safe development and application of nanotechnologies, particularly when they are used to make products which will come into direct contact with the human body.
Amendment 221 #
Proposal for a regulation Annex I – part II – point 3.1 – paragraph 2 However, SMEs have – despite their important economic and employment share and significant innovation potential – size- related problems to become more innovative and more competitive. Although Europe produces a similar number of start- up companies than the United States of America, European SMEs are finding it much harder to grow into large companies than their US counterparts. The internationalised business environment with increasingly interlinked value chains puts further pressure on them. SMEs need to enhance their innovation capacity and to have ready access to different forms of financial support (loans, guarantees, venture capital). They need to generate, take up and commercialise new knowledge and business ideas faster and to a greater extent to compete successfully on fast evolving global markets. The challenge is to stimulate more innovation in SMEs, thereby enhancing their competitiveness and growth.
Amendment 235 #
Proposal for a regulation Annex I – part III – point 1.1 – paragraph 2 The cost of Union health and social care systems is rising with care and prevention measures in all ages increasingly expensive, the number of Europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060, and those over 80 to rise from 22 to 61 million in the same period. Reducing or containing these costs such that they do not become unsustainable depends in part on
Amendment 305 #
Proposal for a regulation Annex I – part III – point 2.1 – introductory paragraph The specific objective is to secure sufficient supplies of safe and high quality food and other bio-based products, by developing productive and resource- efficient primary production systems,
Amendment 307 #
Proposal for a regulation Annex I – part III – point 2.1 – paragraph 1 Over the coming decades, Europe will be challenged by increased competition for limited and finite natural resources, by the effects of climate change, in particular on primary production systems (agriculture, forestry, fisheries and aquaculture) and by the need to provide a sustainable, safe and secure food supply for the European and an increasing global population. A 70 % increase of the world food supply is estimated to be required to feed the 9 billion global population by 2050. This food emergency does not justify the current imbalance between often surplus national production levels and the steady rise in food imports, nor does it provide a reason for the increasing complexity of the global food network. Hence the importance of the European Union having better control of the supply circuits, taking into account, as a matter of priority, seasonal cycles, the origin of products and the ability to track food. Agriculture accounts for about 10 % of Union greenhouse gases emissions, and while declining in Europe, global emissions from agriculture are projected to increase up to 20 % by 2030. Furthermore, Europe will need to ensure sufficient supplies of raw materials, energy and industrial products, under conditions of decreasing fossil carbon resources (oil and liquid gas production expected to decrease by about 60 % by 2050), while maintaining its competitiveness. Bio-waste (estimated at up to 138 million tonnes per year in the Union, of which up to 40 % is land-filled) represents a huge problem and cost, despite its high potential added value. For example, an estimated 30 % of all food produced in developed countries is discarded. Major changes are needed to reduce this amount by 50 % in the Union by 2030. In addition, national borders are irrelevant in the spread of animal and plant pests and diseases, including zoonotic diseases, and food borne pathogens. While effective national prevention measures are needed, action at Union level is essential for ultimate control and the effective running of the single market. The challenge is complex, affects a broad range of interconnected sectors and requires a plurality of approaches.
Amendment 326 #
Proposal for a regulation Annex I – part III – point 2.3 – point c a (new) (c a) Another objective is to fight against the homogenisation of species present in inland seas and rivers, which has a significant impact on the functioning of ecosystems, particularly as a result of increased resistance to disturbances.
source: PE-492.556
2012/06/29
ITRE
14 amendments...
Amendment 287 #
Proposal for a regulation Recital 21 a (new) (21a) Industry and SMEs are essential in bringing research results into the markets. Horizon 2020 should leverage investment from the private sector in RDI in order to bring combined public and private R&D investment to 3% of GDP, of which the private sector should be expected to contribute with two thirds.
Amendment 293 #
Proposal for a regulation Recital 22 a (new) (22a) Horizon 2020 should also help persuade European researchers to remain in Europe, attract researchers from the whole world to Europe and make Europe a more attractive destination for the best researchers. Consideration should therefore be given at EU level to establishing attractive, coordinated tax arrangements for researchers.
Amendment 308 #
Proposal for a regulation Recital 24 (24) Research and innovation activities supported by Horizon 2020 should respect fundamental ethical principles. The reasoned, regularly updated opinions of the European Group on Ethics in Science and New Technologies (EGE) should be taken into account, which entails, as a prerequisite, a transparent method of selection underpinned by the independence and scientific expertise of the EGE members. Research activities should also take into account Article 13
Amendment 322 #
Proposal for a regulation Recital 25 (25) The European Commission
Amendment 331 #
Proposal for a regulation Recital 25 a (new) (25a) The Commission should take better account in the framework programme of research on cells extracted from umbilical cord blood (capacity for differentiation, for proliferation and for autologous or allogeneic use, absence of immunological reaction in the patient receiving the cells), which have already been successfully used to treat certain conditions.
Amendment 333 #
Proposal for a regulation Recital 25 b (new) (25b) The recent discovery of induced pluripotent stem cells (iPSCs) has opened up a new avenue for research, over and beyond the opportunities for research on adult and embryonic stem cells that have existed for several years, and has thus offered new hope to patients awaiting treatment. The Union should therefore take action, bearing in mind the following: - the scientific community’s interest in all types of research; - the need to strike a balance between the various ways of researching stem cells, without favouring any one over the others; - the importance of unprejudiced consideration of the ethical problems raised by each category of stem cells.
Amendment 350 #
Proposal for a regulation Recital 27 (27) SMEs constitute a
Amendment 448 #
Proposal for a regulation Article 7 – paragraph 1 – point b – point iii (iii) have close political, economic and geographical links to the Union;
Amendment 485 #
Proposal for a regulation Article 13 – paragraph 1 1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to climate change and sustainable development, to fostering the functioning and achievement of the ERA, to cooperation with third countries, to responsible research and innovation including a gender perspective, to SME involvement in research and innovation and the broader private sector participation, and to enhancing the attractiveness of the research profession and to facilitating cross-border and cross- sector mobility of researchers.
Amendment 576 #
Proposal for a regulation Article 16 – paragraph 4 4. Research on human stem cells,
Amendment 593 #
Proposal for a regulation Article 17 – paragraph 1 Horizon 2020 shall be implemented in a way which is complementary to other Union funding programmes, including the Structural Funds, the Programme for the Competitiveness of Enterprises and SMEs (COSME), and Erasmus for all.
Amendment 608 #
Proposal for a regulation Article 18 – paragraph 2 2. Specific actions shall be undertaken within the specific objective ‘Leadership in enabling and industrial technologies’ set out in Point 1 of Part II of Annex I and each of the specific objectives under the priority ‘Societal challenges’ set out in Points 1 to 6 of Part III of Annex I. These specific actions shall take the form of a dedicated SME instrument that is targeted at all types of SMEs with an innovation potential and shall be implemented in a consistent manner and tailored to the needs of SMEs as set out under the specific objective ‘Innovation in SMEs’ in Point 3.3.(a) of Part II of Annex I. It is essential that SMEs are integrated within the full value chain in order to get access to all opportunities in Horizon 2020.
Amendment 630 #
Proposal for a regulation Article 18 – paragraph 3 3. The integrated approach set out in paragraphs 1 and 2
Amendment 633 #
Proposal for a regulation Article 18 – paragraph 3 a (new) 3 a. Furthermore, at least 10% of the budget of pillar 2 and 3 should be earmarked for the dedicated SME instrument.
source: PE-492.656
|
| 2 |
2011/0402(CNS) Horizon 2020 - Framework Programme for Research and Innovation 2014-2020: specific programme implementing Horizon 2020
2012/05/07
ITRE
2 amendments...
Amendment 622 #
Proposal for a decision Annex 1 – section 3 – point 1 – point 1.6 – paragraph 1 An improved understanding of health, disease and disease processes at all ages is needed to develop new and more effective diagnostics. Innovative and existing technologies will be developed with the goal of significantly improving disease outcomes through earlier, more accurate diagnosis and by allowing for more patient-adapted treatment. Mutations causing genetic diseases will be identified and the availability of diagnostic tests will be significantly increased.
Amendment 636 #
Proposal for a decision Annex 1 – section 3 – point 1 – point 1.9 – paragraph 1 Clinical trials are the means to transfer biomedical knowledge to application in patients and support for these will be provided, as well as for the improvement of their practice. Examples include the development of better methodologies to allow trials to focus on relevant population groups, including those suffering from rare diseases, other concomitant diseases and/or already undergoing treatment, the determination of comparative effectiveness of interventions and solutions, as well as enhancing the use of databases and electronic health records as data sources for trials and knowledge transfer. Specific support should be ensured for the preclinical and/or clinical development of substances with a clear potential to address largely unmet medical needs, such as designated orphan drugs. Similarly, support for the transfer of other types of interventions such as those related to independent living into real world environments will be provided.
source: PE-492.814
|
| 5 |
2011/0421(COD) Serious cross-border threats to health
2012/09/17
ENVI
5 amendments...
Amendment 38 #
Proposal for a decision Recital 10 (10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure
Amendment 45 #
Proposal for a decision Recital 17 (17) The applicability of some specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, depends on the recognition at Union level in the framework of Decision 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza. Those provisions allow for the accelerated marketing of certain medicinal products in case of urgent needs, by means, respectively, of a conditional marketing authorisation and of the temporary possibility to grant a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non- clinical or clinical data are missing. However, in spite of the utility of such provisions in the event of a crisis, there is to date no specific procedure for issuing such recognitions at Union level. It is therefore appropriate to provide for such a procedure as part of the standards of quality and safety for medicinal products. The declaration of an emergency situation at Union level should be without prejudice to the effects of a decision taken by the World Health Organisation to trigger the production of vaccines from seasonal to pandemic
Amendment 70 #
Proposal for a decision Article 4 – paragraph 2 – point iii a (new) (iiia) specific mechanisms to monitor and report on vaccines coverage in respect of those listed in the Annex to Decision 2119/98/EC.
Amendment 80 #
Proposal for a decision Article 8 – paragraph 1 a (new) 1a. The actors in the Early Warning and Response System shall perform their duties independently and in the public interest. Prior to taking up their duties, they shall make available a declaration of interests, setting out any activities or roles which may compromise their integrity. Those declarations should be updated when significant changes occur, or at least once a year
Amendment 91 #
Proposal for a decision Article 10 – paragraph 2 – point c a (new) (ca) on the assessment of the World Health Organisation, when provided, in the case of an international public health emergency.
source: PE-496.383
|
| 1 |
2011/2087(INI) European dimension in sport
2011/07/18
ENVI
1 amendments...
Amendment 36 #
Draft opinion Paragraph 7 7. Calls on the Commission to
source: PE-469.809
|
| 1 |
2011/2095(INI) Roadmap for moving to a competitive low carbon economy in 2050
2011/12/12
ENVI
1 amendments...
Amendment 277 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission to propose a phasing out on the use within the European Union of fuel made from sources that can also provide food products.
source: PE-478.426
|
| 12 |
2011/2193(INI) Voluntary and unpaid donation of tissues and cells
2012/05/14
ENVI
12 amendments...
Amendment 8 #
Motion for a resolution Recital H H. whereas targeted public awareness and opinion, particularly among the patient’s immediate circle, play a very important role in increasing tissues and cells donation rates;
Amendment 11 #
Motion for a resolution Recital I I. whereas
Amendment 25 #
Motion for a resolution Paragraph 1 a (new) 1a. Notes with concern that half of Member States state that they regularly face a lack of human tissues and cells, particularly spinal marrow, gametes and tissues such as the cornea and the skin; believes that the policies and laws in force should therefore be reviewed, as they are not adequate to meet the challenge of self- sufficiency in the European Union;
Amendment 27 #
Motion for a resolution Paragraph 2 2. Stresses that donation should be voluntary and unpaid, a
Amendment 34 #
Motion for a resolution Paragraph 4 4.
Amendment 39 #
Motion for a resolution Paragraph 5 Amendment 51 #
Motion for a resolution Paragraph 9 9.
Amendment 61 #
Motion for a resolution Paragraph 14 b (new) 14b. Is concerned that, currently, clinical trials using umbilical cord blood stem cells in therapy of non-hematological disorders are mostly taking place outside the European Union (i.e. USA and Asian countries). Therefore, calls upon the European Commission and the Member States to take appropriate measures to avoid risk for the EU of lagging behind in this field, including by creating a regulatory framework which stimulates increased availability of umbilical cord blood stem cells;
Amendment 64 #
Motion for a resolution Paragraph 15 15. Underlines the importance of mothers donating cord blood and tissue at birth either into public or private banks, which adhere to common operational and ethical standards, to help treat illnesses and further research in the field;
Amendment 73 #
Motion for a resolution 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 antenatal classes; stresses that objective information should be provided about the advantages and disadvantages of cord blood blanks, and in the case of autologous cord blood banks, the promotion material provided to families must be accurate;
Amendment 78 #
Motion for a resolution Paragraph 16 b (new) 16b. Calls on Member States to ensure at the same time better protection of parents right to informed consent and freedom of choice regarding cord blood stem cell preservation practices;
Amendment 90 #
Motion for a resolution Paragraph 18 18.
source: PE-489.459
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| 7 |
2012/0192(COD) Clinical trials on medicinal products for human use
2013/03/01
ENVI
4 amendments...
Amendment 101 #
Proposal for a regulation Recital 9 a (new) (9a) In case of an urgent situation as well as for rare and ultra-rare diseases which are life-threatening and for which therapeutic options and expertise are limited and geographically spread across the world, Member-States should have the possibility to assess and authorise clinical trial applications in priority.
Amendment 116 #
Proposal for a regulation Recital 12 a (new) (12a) Whereas most clinical trials are conducted for the assessment of therapies, targeted at large patient populations, and involving a large sample of patient populations, the present regulation should not discriminate against patients suffering from rare and ultra-rare diseases, and should integrate the specificities of low- prevalence conditions into the assessment of a trial.
Amendment 169 #
Proposal for a regulation Recital 52 a (new) (52a) Commercially confidential information should be identified and protected in order to avoid harming the interests of patients and/or the competitive position of the sponsors.
Amendment 539 #
Proposal for a regulation Article 34 – paragraph 3 – subparagraph 2 a (new) In order to protect personal data and commercially confidential information, and subject to the provisions of Article 78(3), the summary of the results of a clinical trial intended to obtain a marketing authorisation shall be made public 30 days after the date of the marketing authorisation, or one year after the end of the clinical trial in case of the discontinuation of the product development.
source: PE-506.158
2013/03/06
ENVI
3 amendments...
Amendment 293 #
Proposal for a regulation Article 6 – paragraph 1 – point a – point i – indent 3 – the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial
Amendment 300 #
Proposal for a regulation Article 6 – paragraph 1 – point a – point ii – indent 4 a (new) - the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options;
Amendment 335 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point a a (new) (a a) compliance with national legislative provisions related to ethics;
source: PE-506.160
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2012/0266(COD) Medical devices
2013/05/14
ENVI
3 amendments...
Amendment 748 #
Proposal for a regulation Article 83 – paragraph 1 The Commission and the Member States shall take all appropriate measures to encourage the establishment of coordinated and harmonized registers for specific types of devices to gather post- market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices.
Amendment 845 #
Proposal for a regulation Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 2 – are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in class III, with the exception of sutures and staples.
Amendment 847 #
Proposal for a regulation Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8 – are spinal disc replacement implants and implantable devices that come into contact with the spinal co
source: PE-510.767
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2012/0366(COD) Tobacco and related products: manufacture, presentation and sale. Approximation of Member States legislation
2013/05/14
ENVI
31 amendments...
Amendment 58 #
Proposal for a directive Citation 1 Amendment 71 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people
Amendment 87 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received.
Amendment 90 #
Proposal for a directive Recital 13 a (new) (13a) Whereas a mandatory list of ingredients must be compiled as a matter of urgency, since, according to the 2010 report of the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)1, an increasing proportion of the ingredients in cigarettes – an average of 10% of their weight – are additives whose sole purpose is to make smoke more palatable by changing properties such as colour, acridity, odour and taste. __________________ 1 Almost 600 different additives were identified.
Amendment 114 #
Proposal for a directive Recital 17 (17) Certain additives are used to create the impression that tobacco products have health benefits, present reduced health hazards or increase mental alertness and physical performance.
Amendment 117 #
Proposal for a directive Recital 17 b (new) (17 b) The Commission should carefully monitor the addition of sugar substances which constitutes more than 10% of the total amount of additives in cigarettes. The Commission should, in particular, ask the industry to reformulate tobacco products in order to manufacture new products free of inverted sugar (fructose and glucose) which have hazardous effects on health.
Amendment 124 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The Commission should carefully monitor the use of water-pipe tobacco by young people as there is increasing evidence of their use beyond the traditional, older market. In this regard, articles 6 and 10 should apply to those products and health warnings be placed on packets of chicha tobacco which often do not comply with the European legislation.
Amendment 125 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco, water- pipe tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.
Amendment 130 #
Proposal for a directive Recital 19 (19) Disparities still exist between national provisions regarding the labelling of tobacco products, in particular with regard to the use of combined health warnings consisting of a picture and a text, which only 10 Member States had brought in by 2013, information on cessation services and promotional elements in and on packets.
Amendment 193 #
Proposal for a directive Recital 33 (33) Nicotine-containing products are being sold on the Union market in increasing quantities, Electronic cigarettes, which come in many different varieties with varying technical characteristics, are proving especially popular. This diversity makes them difficult to define in law, and means that several different European legal regimes apply to them depending on whether or not their purpose is to help people stop smoking and whether they contain addictive substances such as nicotine or toxic chemicals. The different regulatory approaches taken by Member States to address possible health and safety concerns associated with these new products
Amendment 197 #
Proposal for a directive Recital 33 a (new) (33a) Before their products can be authorised for marketing, electronic cigarette producers and distributors must provide the supervisory authorities with an exact statement of their products’ essential ingredients (in terms of purity, impurities and stability), which must be visible on the packaging in accordance with Directive 2001/95/EC on general product safety; reliable scientific data concerning the non-toxicity of electronic cigarettes is also essential in the interests of both the consumer and the manufacturer or distributor; the Commission will, therefore, request an opinion from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) within 24 months of the entry into force of the Directive;
Amendment 202 #
Proposal for a directive Recital 34 (34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use provides a legal framework to assess the quality, safety and efficacy of medicinal products including certain nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question.
Amendment 245 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17). The obligations imposed on manufacturers, importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in Articles 35 and 38 of the Charter of Fundamental Rights of the European Union. The application of this Directive should respect the EU law and relevant international obligations. Member States should respect the right to clean air in the spirit of Articles 7 (b) and 12 of the International Covenant on Economic, Social and Cultural Rights providing for rights for safe and healthy working conditions and the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This is within the aim of article 37 of the Charter of Fundamental rights where a high level of environmental protection and the improvement of the quality of the environment must be integrated into the policies of the Union.
Amendment 252 #
Proposal for a directive Article 1 – paragraph 1 – point d (d)
Amendment 257 #
Proposal for a directive Article 1 – paragraph 1 – point f (f) the placing on the market and the labelling of certain products, which are related to tobacco products, namely tobacco-free nicotine-containing products and herbal products for smoking;
Amendment 259 #
Proposal for a directive Article 1 – paragraph 1 – subparagraph 2 in order to facilitate the functioning of the internal market in tobacco and related tobacco-free products, taking as a basis a high level of health protection, particularly for young people. This directive also seeks to keep the public informed about harmful effects on smokers without in effect rejecting the risk reduction policies that consist in encouraging smokers to turn to lower-risk products.
Amendment 275 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means an aroma or taste distinguishable
Amendment 285 #
Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) (4a) ‘menthol flavour’ means a characterising flavour based on mint and present in a large number of manufactured cigarettes which, at levels in excess of 0.3%, is tasted with each puff of smoke inhaled.
Amendment 328 #
Proposal for a directive Article 2 – paragraph 1 – point 26 a (new) (26a)‘water pipe tobacco’ means tobacco intended solely for use in a water pipe such as a hookah (shisha), consisting of a moist mixture of tobacco, preservatives and flavours, often with a binding agent such as molasses or honey;
Amendment 329 #
Proposal for a directive Article 2 – paragraph 1 – point 28 (28) ‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers
Amendment 334 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least
Amendment 346 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) ‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco or some products containing nicotine, whether genetically modified or not;
Amendment 351 #
Proposal for a directive Article 2 – paragraph 1 – point 36 b (new) (36b) ‘passive smoking’ means the involuntary inhalation of smoke from the combustion of cigarettes or cigars or from the exhalation of one or more smokers.
Amendment 419 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields. Manufacturers or importers shall test and report to the competent authorities of the Member States quantities of Harmful and Potentially Harmful Constituents (HPHCs) based on the list established in Annex Ia. However, within the timeframes described in Article 25 for transposition, manufacturers or importers shall test and report for each of the constituents present in the abbreviated list set out in Annex Ib. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 473 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising flavour. On the other hand, Member States shall undertake to reduce as far as possible the presence of flavours said to be essential, such as certain sugars with adverse effects on health such as fructose and glucose.
Amendment 578 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco, water-pipe 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 on the basis of data supplied by competent authorities in Member States.
Amendment 593 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet. The same safety considerations justify the retention of the provision in Directive 2001/37/EC permitting warnings to be affixed to cigar boxes by means of removable stickers.
Amendment 1028 #
Proposal for a directive Title 2 – chapter 4 – title Amendment 1030 #
Proposal for a directive Article 16 – title Amendment 1038 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1.
Amendment 1081 #
Proposal for a directive Article 16 – paragraph 2 2.
source: PE-510.711
2013/05/21
ENVI
2 amendments...
Amendment 725 #
Proposal for a directive Article 9 – paragraph 2 2. The combined health warnings shall be divided into three sets rotating on an annual basis.
Amendment 759 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes
source: PE-510.717
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Frédérique RIES on
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Term 7 14.07.2009 / ...
Term 6 20.07.2004 - 13.07.2009
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