Horst SCHNELLHARDT
Constituencies
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Germany
Christlich Demokratische Union Deutschlands
2009/07/14 - 9999/12/31
Show earlier Constituencies...
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Germany
Christlich Demokratische Union Deutschlands
2004/07/20 - 2009/07/13
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Germany
Christlich Demokratische Union Deutschlands
1999/07/20 - 2004/07/19
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Germany
Christlich Demokratische Union Deutschlands
1994/07/19 - 1999/07/19
Groups
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PPE
Member
Group of the European People's Party (Christian Democrats)
2009/07/14 - 9999/12/31
Show earlier groups...
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PPE-DE
Member
Group of the European People's Party (Christian Democrats) and European Democrats
2004/07/20 - 2009/07/13
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PPE-DE
Member
Group of the European People's Party (Christian Democrats) and European Democrats
1999/07/20 - 2004/07/19
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PPE
Member
Group of the European People's Party (Christian-Democratic Group)
1994/07/19 - 1999/07/19
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 Development | 2012/01/19 | 9999/12/31 |
Show earlier commitees...
Delegations
| Role | Delegation | Start | End |
|---|---|---|---|
| Member of | Delegation to the ACP-EU Joint Parliamentary Assembly | 2009/09/16 | 9999/12/31 |
| Substitute of | Delegation for relations with the countries of South Asia | 2009/09/16 | 9999/12/31 |
Show earlier delegations...
| Role | Delegation | Start | End |
|---|---|---|---|
| Member of | Delegation to the ACP-EU Joint Parliamentary Assembly | 2004/09/15 | 2009/07/13 |
| Substitute of | Delegation to the EU-Kazakhstan, EU-Kyrgyzstan and EU-Uzbekistan Parliamentary Cooperation Committees, and for relations with Tajikistan, Turkmenistan and Mongolia | 2004/09/16 | 2009/07/13 |
| Substitute of | Delegation for relations with India | 2007/03/26 | 2009/07/13 |
| Substitute of | Delegation to the EU-Moldova Parliamentary Cooperation Committee | 2004/09/15 | 2007/03/25 |
| Member of | Members from the European Parliament to the Joint Parliamentary Assembly of the Agreement between the African, Caribbean and Pacific States and the European Union (ACP-EU) | 2002/02/06 | 2004/07/19 |
| Member of | Members from the European Parliament to the Joint Parliamentary Assembly of the Agreement between the African, Caribbean and Pacific States and the European Union (ACP-EU) | 1999/09/14 | 2002/01/14 |
| Vice-Chair of | Delegation for relations with Canada | 1999/02/24 | 1999/07/19 |
| Vice-Chair of | Delegation for relations with Canada | 1997/10/14 | 1999/02/23 |
| Vice-Chair of | Delegation for relations with Canada | 1997/01/30 | 1997/10/13 |
| Member of | Delegation for relations with Canada | 1997/01/16 | 1997/01/29 |
| Member of | Delegation for relations with Canada | 1995/07/12 | 1997/01/15 |
| Member of | Delegation for relations with Canada | 1994/11/17 | 1995/07/11 |
Contact
Online
- [javascript protected email address]
Brussels
- Phone
- +322 28 45618
- Fax
- +322 28 49618
- Office
- Bât. Altiero Spinelli 15E115
- Full Address
-
- City
- Bruxelles/Brussel
- Zip
- B-1047
- Street
- 60, rue Wiertz / Wiertzstraat 60
Strasbourg
- Phone
- +333 88 1 75618
- Fax
- +333 88 1 79618
- Office
- Bât. Louise Weiss T10025
- Full Address
-
- City
- Strasbourg
- Zip
- CS 91024 - F-67070
- Street
- 1, avenue du Président Robert Schuman
Postal
- Europäisches Parlament
- Rue Wiertz
- Altiero Spinelli 15E115
- B-1047 Brüssel
Rapporteur
| Responsible | 2012/0040(COD) | Animal health requirements: intra-Union trade in and imports of dogs, cats and ferrets |
| Responsible | 2012/0039(COD) | Non-commercial movement of pet animals |
| Shadow | 2010/2088(INI) | GDP and beyond - Measuring progress in a changing world |
| Shadow | 2009/0146(COD) | Animal and public health: third countries authorised to import certain animals and fresh meat, and the veterinary certification requirements (repeal. Decision 79/542/EEC) |
| Responsible | 2008/0110(COD) | Health rules: animal by-products and derived products not intended for human consumption (repeal. Regulation (EC) No 1774/2002) |
| Responsible | 2005/0028(COD) | Spirit drinks: definition, description, presentation and labelling |
| Responsible | 2002/0141(COD) | Products of animal origin, human consumption: safety, controls. Hygiene package |
| Responsible | 2000/0182(COD) | Products of animal origin, human consumption: health rules (amend. Directives 89/662/EEC, 91/67/EEC). Food hygiene package |
| Opinion | 2000/0181(CNS) | Products of animal origin intended for human consumption: animal-health rules |
| Responsible | 2000/0180(COD) | Products of animal origin intended for human consumption: organisation of official controls |
| Responsible | 2000/0179(COD) | Protection of human health: food of animal origin, specific hygiene rules |
| Responsible | 2000/0178(COD) | Protection of human health: hygiene of foodstuffs |
| Responsible | 1997/0027(COD) | Foodstuffs, alcoholic beverages: labelling, presentation and advertising (amend. Direct. 79/112/EEC) |
| Responsible | 1996/0312(COD) | Revised community eco-label award scheme (regul. 880/92/EEC) |
| Responsible | 1995/0269(CNS) | Animal health conditions: imports from third countries of fresh poultry meat (amend. direct. 91/494/EEC) |
| Responsible | 1995/0268(CNS) | Animal health conditions: imports from third countries of poultry and hatching eggs (amend. Directive 90/539/EEC) |
| Responsible | 1994/0176(CNS) | Fresh meat: health conditions for the production and marketing |
| Responsible | 1991/0380(COD) | Foodstuffs: labelling, presentation and advertising (amend. Directive 79/112/EEC) |
Born
1946/05/12 Rüdigershagen- Veterinary surgeon (1970). Doctor of veterinary medicine (1984). Veterinary surgeon specialising in food hygiene (1986). Vet in Halberstadt (1970-1990). District veterinary officer (1990). Head of Halberstadt veterinary agency (1990).
- CDU District Chairman (1992-1994). Member, Regional Executive (since 1993). Member, Regional Committee on European Affairs (since 1990). Member, Federal Committee on European Affairs (1990-2004 and since 2008).
- Chairman, CDU Group Federal and European Affairs Working Group, Saxony-Anhalt Regional Assembly (1992-1994). Member, CDU Group Executive (1992-1994).
- Member of the European Parliament (since 1994). Vice-President, EPP-ED Group Working Group. Substitute Member of the Executive of the European People's Party.
- Representative for Saxony-Anhalt on the Committee of the Regions (1994-1998). Vice-President of the European Movement in Saxony-Anhalt.
- Federal Cross of Merit with ribbon.
Amendments
| Amendments | Dossier |
| 1 |
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
1 amendments...
Amendment 267 #
Council position Article 46 – paragraph 2 – subparagraph 1 a (new) For waste co-incineration combustion plants that fire indigenous solid fuel and cannot comply with the emission limit values for sulphur dioxide referred to in Part 4 of Annex VI due to the characteristics of this fuel, Member States may apply instead the minimum rates of desulphurisation set out in Part 5 of Annex V, in accordance with the compliance rules set out in Part 6 of that Annex.
source: PE-439.995
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| 16 |
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
11 amendments...
Amendment 228 #
Proposal for a regulation Recital 34 (34)
Amendment 321 #
Proposal for a regulation Article 13 – paragraph 4 (4) In the case of non-prepacked food, the following provisions
Amendment 354 #
Proposal for a regulation Article 17 – paragraph 2 2. In the case of packaging or containers the largest printable surface of which has an area of less than 100 cm2 only the particulars listed in Article 9(1) (a), (c), (e) and (f) shall be mandatory on the package or on the label. The particulars referred to in Article 9(1)(b) shall be provided through other means or shall be available at the request of the consumer.
Amendment 363 #
Proposal for a regulation Article 20 – point d (d) cheese, butter, fermented milk and cream,
Amendment 396 #
Proposal for a regulation Article 29 – paragraph 1 – subparagraph 2 This paragraph shall not apply to
Amendment 408 #
Proposal for a regulation Article 29 – paragraph 2 – point d Amendment 455 #
Proposal for a regulation Article 33 – paragraph 2 2. Such additional forms of expression referred to in paragraph 1 shall be
Amendment 529 #
Proposal for a regulation Article 53 – subparagraph 3 Articles 29 to 34 shall apply from [the first day of the month 3 years after the entry into force] except in the case of foods labelled by food business operators with
Amendment 533 #
Proposal for a regulation Annex I - point 9 9. ‘polyols’ means
Amendment 564 #
Proposal for a regulation Annex VI – part C – listing – row 16 a (new) Cellulose extract 1 __________________________________ 1It is not necessary to indicate the specific name or the EC number.
Amendment 567 #
Proposal for a regulation Annex VIII – paragraph 1 1. The net quantity shall not be mandatory in the case of foods: (a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser; or
source: PE-431.051
2011/03/23
ENVI
5 amendments...
Amendment 181 #
Proposal for a regulation Article 13 – paragraph 3 a (new) 3a. Paragraph 2 of this Article shall not apply in the case of food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, provided that the information on the package is clearly legible.
Amendment 206 #
Proposal for a regulation Article 23 – paragraph 1 – point b a (new) (ba) in units of mass and/or volume in the case of semi liquid or viscous products
Amendment 301 #
Proposal for a regulation Article 33 – paragraph 2 a (new) (2a) The energy content, expressed in kcal per 100 g or 100 ml, shall be repeated in the bottom right-hand corner of the ‘front of pack’, in a font size of 3 mm and surrounded by a border. In the case of portion packs with a net quantity of less than 100 g/ 100 ml, the energy content may alternatively be indicated in kcal per portion.
Amendment 361 #
Proposal for a regulation Annex V – point 19 19. Food directly supplied by the manufacturer of small quantities of products, including handcrafted products produced by micro-enterprises and local retailers, to the final consumer or to local retail establishments directly supplying the final consumer.
Amendment 381 #
Proposal for a regulation Annex VI – point 2 a (new) Part Ba – SPECIFIC REQUIREMENTS CONCERNING THE DESIGNATION OF SAUSAGE CASINGS Sausage casings shall be indicated as follows in the list of ingredients: ‘natural casing’ if the casing used in sausage production is derived from the intestinal tract of even-toed ungulates; ‘artificial casing’ in all other cases. If an artificial casing is not edible, this must be indicated.
source: PE-460.950
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| 9 |
2008/0142(COD) Patients' rights in cross-border healthcare
2010/05/10
ENVI
9 amendments...
Amendment 138 #
Council position Article 1 – paragraph 3 – point c a (new) (ca) sales of medicinal products and medical devices over the Internet.
Amendment 141 #
Council position Article 3 – paragraph 1 – point a (a) "healthcare" means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices if these activities are performed in a Member State where the services are provided by members of the health professions under the appropriate professional title;
Amendment 150 #
Council position Article 4 – paragraph 2 – point f (f) patients who have received treatment are entitled to a written or electronic medical record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC, without prejudice to the exceptions applicable in the Member States.
Amendment 200 #
Council position Article 11 – paragraph 2 – introductory part (2)
Amendment 201 #
Council position Article 11 – paragraph 2 – point a (a)
Amendment 203 #
Council position Article 11 – paragraph 2 – point b (b)
Amendment 205 #
Council position Article 11 – paragraph 2 – point c (c)
Amendment 206 #
Council position Article 11 – paragraph 2 – point d (d)
Amendment 208 #
Council position Article 11 – paragraph 3 source: PE-450.566
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| 32 |
2008/0238(COD) Organ transplantation: standards of quality and safety of human organs intended for transplantation
2010/04/03
ENVI
32 amendments...
Amendment 61 #
Proposal for a directive Recital 2 (2) Risks however are associated with the use of organs in transplantation. The
Amendment 68 #
Proposal for a directive Recital 7 Amendment 87 #
Proposal for a directive Article 2 – paragraph 1 a (new) 1a. It shall apply also to parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and to complex tissues.
Amendment 89 #
Proposal for a directive Article 3 – point a (a) ‘authorisation‘ means a
Amendment 92 #
Proposal for a directive Article 3 – point c Amendment 95 #
Proposal for a directive Article 3 – point d (d) ‘donation’ means
Amendment 98 #
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 and complex tissues ;
Amendment 102 #
Proposal for a directive Article 3 – point i (i) ‘procurement’ means a coordinated process by which the donated organs become available
Amendment 103 #
Proposal for a directive Article 3 – point i a (new) ia)'making available' means the preparation, manipulation, preservation, packaging and transport of human organs;
Amendment 104 #
Proposal for a directive Article 3 –point j (j) "procurement organisation" means
Amendment 105 #
Proposal for a directive Article 3 – point j a (new) ja) 'competent authority' means one or more public or private non-profit making, competent body or bodies/organisation(s)/institution(s) particularly involved in the implementation of this Directive;
Amendment 106 #
Proposal for a directive Article 3 – point k (k) ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means
Amendment 107 #
Proposal for a directive Article 3 – point m (m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with
Amendment 108 #
Proposal for a directive Article 3 – point n (n) ) ‘serious adverse reaction’ means an unintended or unexpected serious response, including a communicable disease, in the donor or in the recipient associated with
Amendment 110 #
Proposal for a directive Article 3 – point p (p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring
Amendment 111 #
Proposal for a directive Article 3 – paragraph 1 – point r (r) ‘traceability’ means the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal
Amendment 130 #
Proposal for a directive Article 5 – paragraph 1 1. Member States shall ensure that the procurement
Amendment 154 #
Proposal for a directive Article 13 – paragraph 2 2. Member States shall prohibit
Amendment 155 #
Proposal for a directive Article 13 – paragraph 3 3. Member States shall ensure that the procurement of organs is
Amendment 162 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals. Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves. Member States shall also ensure that living donors are legally insured.
Amendment 172 #
Proposal for a directive Article 17 – title Amendment 174 #
Proposal for a directive Article 17 Member States shall take all necessary measures to ensure that all personal data of donors and recipients gathered and processed within the
Amendment 176 #
Proposal for a directive Article 18 – title Designation and tasks of the competent
Amendment 178 #
Proposal for a directive Article 18 – paragraph 1 Member States shall designate the competent
Amendment 180 #
Proposal for a directive Article 18 – paragraph 2 – introductory part The competent authorit
Amendment 186 #
Proposal for a directive Article 19 – paragraph 1 – introductory part 1. Member States shall ensure that the competent
Amendment 187 #
Proposal for a directive Article 19 – paragraph 1 – point c (c) establishes and maintains a register of
Amendment 188 #
Proposal for a directive Article 19 – paragraph 2 2. Member States shall, upon the request of the Commission or another Member State, provide information on the register of
Amendment 189 #
Proposal for a directive Article 20 – paragraph 1 1. The Commission shall set up a network of the competent
Amendment 190 #
Proposal for a directive Article 21 – paragraph 1 1. Member States shall ensure that
Amendment 193 #
Proposal for a directive Article 21 – paragraph 1 a (new) 1a. Responsibility for authorising organ exchanges with third countries may be transferred by Member States to European organ exchange organisations.
Amendment 203 #
Proposal for a directive Annex – Introduction For the purpose of Article 7 the following information shall be gathered by the procurement organisation or procurement team on the characteristics of the organ and of the donor,
source: PE-439.155
|
| 2 |
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
2 amendments...
Amendment 124 #
Proposal for a directive Article 2 - paragraph 3- point c a (new) (ca) photovoltaic modules intended for use in a system designed, assembled and installed for permanent operation for power generation for public, commercial and private purposes, provided it can safely be ruled out that the substances used present a risk to people and to the environment;
Amendment 336 #
Proposal for a directive Annex VI a (new) Annex VIa Applications exempted from the ban in Article 4(1) as regards Category 11 1. Cadmium in thin-film photovoltaic panels based on cadmium telluride
source: PE-439.865
|
| 4 |
2008/0241(COD) Waste electrical and electronic equipment (WEEE). Recast
2010/03/16
ENVI
2 amendments...
Amendment 224 #
Proposal for a directive Article 16 – paragraph 2 a (new) 2a. Producers shall be allowed to apply, through the register of one Member State for registration in all the other Member State registers.
Amendment 231 #
Proposal for a directive Article 16 – paragraph 4 source: PE-439.905
2010/11/03
ENVI
2 amendments...
Amendment 140 #
Proposal for a directive Article 7 – paragraph 1 a (new) 1a. Member States shall ensure that any distributor who cannot prove that the producer of an electrical or electronic appliance has fulfilled its financial or procedural and technical obligations in respect of that appliance shall himself/herself fulfil those obligations or ensure that they are fulfilled before selling the appliance on.
Amendment 143 #
Proposal for a directive Article 7 – paragraph 1 b (new) 1b. To establish that the minimum collection rate has been achieved, Member States shall ensure that information on WEEE which: - has been taken to collection facilities in accordance with Article 5(2)(a), - has been taken to distributors in accordance with Article 5(2)(b), - has been separately collected and treated or exported by producers or third parties acting on their behalf, - or has been separately collected and treated, refurbished or exported via any means by other WEEE actor is communicated to them free of charge on annual basis.
source: PE-439.856
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| 26 |
2008/0256(COD) Medicinal products for human use: information on products subject to medical prescription
2010/05/25
ENVI
26 amendments...
Amendment 34 #
Proposal for a directive - amending act Recital 2 (2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the
Amendment 42 #
Proposal for a directive - amending act Recital 4 (4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to
Amendment 46 #
Proposal for a directive - amending act Recital 7 (7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.
Amendment 49 #
Proposal for a directive - amending act Recital 8 (8) National competent authorities and health care professionals should remain
Amendment 53 #
Proposal for a directive - amending act Recital 8 a (new) (8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 54 #
Proposal for a directive - amending act Recital 9 (9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 58 #
Proposal for a directive - amending act Recital 10 (10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should
Amendment 64 #
Proposal for a directive - amending act Recital 11 (11) In order to further ensure that marketing authorisation holders
Amendment 67 #
Proposal for a directive - amending act Recital 11 (11) In order to further ensure that marketing authorisation holders disseminate only
Amendment 75 #
Proposal for a directive - amending act Recital 14 (14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its
Amendment 88 #
Proposal for a directive - amending act Article 1 – point 1 Directive 2001/83/EC Article 86 – paragraph 2 – indent 1a (new) – correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
Proposal for a directive - amending act Article 1 – point 1 Directive 2001/83/EC Article 86 – paragraph 2 – indent 4 - information
Amendment 108 #
Proposal for a directive - amending act Article 1 – point 2 Directive 2001/83/EC Article 88 – paragraph 4 4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns
Amendment 116 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 a - paragraph 1 1. Member States shall allow the marketing authorisation holder to
Amendment 129 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 b – introductory part and point a The
Amendment 146 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 b – point b b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities,
Amendment 162 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 b – point d d)
Amendment 165 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 c – introductory part Information on authorised medicinal products subject to medical prescription
Amendment 182 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 c – point b b) marketing authorisation holders' internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 190 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 d – paragraph 1 a (new) 1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 g – paragraph 1 – subparagraph 1 1. Member States shall ensure that
Amendment 248 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 h – paragraph 1 – subparagraph 1 1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Amendment 259 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 h – paragraph 2 – subparagraph 2 Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof.
Amendment 267 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 h – paragraph 2 a (new) 2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 h – paragraph 4 – point a (a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
Proposal for a directive - amending act Article 1 – point 5 Directive 2001/83/EC Article 100 h – paragraph 4 – point b (b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
source: PE-441.215
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| 8 |
2008/0260(COD) Medicinal products for human use: pharmacovigilance of products (amend. Directive 2001/83/EC, Community code)
2010/03/15
ENVI
8 amendments...
Amendment 44 #
Proposal for a directive – amending act Recital 10 (10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section
Amendment 77 #
Proposal for a directive – amending act Article 1 – point 1 – point a Directive 2001/83/EC Article 1 – point 11 Amendment 82 #
Proposal for a directive – amending act Article 1 – point 1 – point b Directive 2001/83/EC Article 1 – point 14 “(14) Suspected adverse reaction: An
Amendment 149 #
Proposal for a directive – amending act Article 1 – point 18 – point a Directive 2001/83/EC Article 59 – paragraph 1 – point aa “(aa) a
Amendment 220 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 – paragraphs 1 and 2 1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by
Amendment 234 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 a – paragraph 1 – subparagraph 2 Member States shall ensure that reports of such reactions
Amendment 236 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 a – paragraph 3 3. The Member States shall ensure that reports of medication errors, or of adverse reactions derived from uses outside the authorised summary of the product characteristics, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.
Amendment 263 #
Proposal for a directive – amending act Article 1 – point 23 Directive 2001/83/EC Article 116 – paragraph 1 The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it
source: PE-438.412
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| 5 |
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)
2010/12/03
ENVI
5 amendments...
Amendment 107 #
Proposal for a directive – amending act Recital 14 a (new) (14a) Counterfeit medicinal products are often found to have been supplied in response to orders placed over the Internet. In accordance with the provisions of the Treaty, particularly Article 168 of the TFEU, Member States are responsible for regulating the marketing of medicinal products at the last level of trade, particularly in pharmacies. This also includes regulating the marketing of medicinal products by mail order and over the Internet. The case law of the Court of Justice permits Member States to impose an absolute ban on the supply of prescription medicines by mail order, in accordance with the wide margin of discretion which they enjoy on account of the dangers associated with this method of marketing.
Amendment 110 #
Proposal for a directive – amending act Recital 15 a (new) (15a) It is necessary for the operation of the internal market to establish EU-wide harmonised safety features for medicinal products. The technical implementation of these features and the design of the test methods should, however, be left to the Member States in accordance with the principle of subsidiarity.
Amendment 232 #
Proposal for a directive – amending act Article 1 - point 9 Directive 2001/83/EC Article 54a – paragraph 2 – point b (b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23). To this effect, the manufacturing authorisation holder shall produce a new outer carton replicating all relevant product and trademark information and subject to carrying safety features as required by Article 54(o); original cartons shall be destroyed;
Amendment 285 #
Proposal for a directive – amending act Article 1 - point 9 Directive 2001/83/EC Article 54 a – paragraph 4 – subparagraph 5 The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights. It has to be ensured that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products supplied and the corresponding patients or pharmacies.’
Amendment 320 #
Proposal for a directive – amending act Article 1 – point 13 – point b Directive 2001/83/EC Article 80 – point i – paragraph 2 Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.
source: PE-439.406
|
| 1 |
2009/0076(COD) Placing on the market and use of biocidal products
2011/09/13
ENVI
1 amendments...
Amendment 117 #
Council position Article 2 – paragraph 8 (8) Member States may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence or of animal disease control.
source: PE-472.199
|
| 30 |
2009/0173(COD) Reduction of CO2 emissions from light-duty vehicles: emission performance standards for new light commercial vehicles
2010/05/21
ENVI
30 amendments...
Amendment 21 #
Proposal for a regulation Recital 3 a (new) (3a) To enhance the competitiveness of the European automotive industry, incentive schemes such as the offsetting of eco-innovations and the award of super-credits should be used in preference to prohibitions incurring criminal penalties.
Amendment 26 #
Proposal for a regulation Recital 10 a (new) (10a) In order to provide the purchasers of light commercial vehicles with the information necessary to take purchasing decisions, manufacturers should provide potential customers with information on these vehicles’ CO2 emissions and fuel consumption.
Amendment 34 #
Proposal for a regulation Recital 13 (13) Manufacturers should have flexibility to decide how to meet their targets under this Regulation and should be allowed to average emissions over their new vehicle fleet rather than having to respect CO2 targets for each individual vehicle. Manufacturers should therefore be required to ensure that the average specific emission for all the new light commercial vehicles registered in the Community for which they are responsible does not exceed the average of the emissions targets for those vehicles. This requirement should be phased in between 201
Amendment 35 #
Proposal for a regulation Recital 14 (14) In order to ensure that targets reflect the particularities of small and niche manufacturers and are consistent with the manufacturer's reduction potential, alternative emission reduction targets should be set for such manufacturers taking into account the technological potential of a given manufacturer's vehicles to reduce their specific emissions of CO2 and consistently with the characteristics of the market segments concerned. This derogation should be covered by the review of the specific emission targets in Annex I, to be completed by the beginning of 201
Amendment 38 #
Proposal for a regulation Recital 15 (15) The Community Strategy to reduce CO2 emissions from passenger cars and light commercial vehicles established an integrated approach with a view to reaching the Community target of 120 g CO2/km by 2012, while also presenting a longer-term vision of further emission reductions. Regulation (EC) No 443/2009 substantiates this longer-term view by setting a target of 95 g CO2/km as average emissions for the new car fleet. In order to ensure consistency with that approach and to provide planning certainty for the industry,
Amendment 41 #
Proposal for a regulation Recital 20 (20) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year from 1. January 201
Amendment 52 #
Proposal for a regulation Recital 24 (24) The speed of road vehicles
Amendment 65 #
Proposal for a regulation Article 1 – paragraph 2 2. From 2020, this Regulation sets a target of 1
Amendment 74 #
Proposal for a regulation Article 1 – paragraph 2 a (new) 2a. From 2025, this Regulation sets a target of 135 g CO2/km for the average emissions of new light commercial vehicles registered in the Union, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 97 #
Proposal for a regulation Article 4 – paragraph 1 For the calendar year commencing 1 January 201
Amendment 107 #
Proposal for a regulation Article 4 – paragraph 2 a (new) Manufacturers shall take the appropriate measures to gradually reduce the average CO2 emissions of new light commercial vehicles registered in the Union so as to reach the target of 135 g CO2/km in 2025, taking account – in order to promote continuing innovation – of the following non-binding targets: - 165 g CO2/km in 2019 - 145 g CO2/km in 2023.
Amendment 138 #
Proposal for a regulation Article 4 – paragraph 2 – indent 3 –100% from 201
Amendment 147 #
Proposal for a regulation Article 5 a (new) Article 5a Specific emission target for alternative fuel vehicles For the purpose of determining compliance by a manufacturer with its specific emissions target referred to in Article 4, the specified emissions of CO2 of each vehicle which is designed to be capable of running on a mixture of petrol with 85 % ethanol (‘E85’), and which meets relevant Union legislation or European technical standards, shall be reduced by 5 % by 31 December 2015 in recognition of the greater technological and emissions reduction capability when running on biofuels. This reduction shall apply only where at least 30 % of the filling stations in the Member State in which the vehicle is registered provide this type of alternative fuel complying with the sustainability criteria for biofuels set out in relevant Union legislation.
Amendment 152 #
Proposal for a regulation Article 5 – introductory part In calculating the average specific emissions of CO2, each new light commercial vehicle with specific emissions of CO2 of less than 50
Amendment 161 #
Proposal for a regulation Article 5 – indent 1 2
Amendment 165 #
Proposal for a regulation Article 5 – indent 2 Amendment 168 #
Proposal for a regulation Article 5 – indent 3 Amendment 172 #
Proposal for a regulation Article 7 a (new) Article 7a Information For the calendar year commencing 1 January 2014 and each subsequent calendar year, each manufacturer of light commercial vehicles shall ensure that customers are provided with information on the average specific CO2 emissions and fuel consumption of its vehicle models.
Amendment 195 #
Proposal for a regulation Article 8 – paragraph 1 1. In respect of the period 1 January 201
Amendment 201 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part (a) From 201
Amendment 240 #
Proposal for a regulation Article 9 – paragraph 2 2. From the 31 October 201
Amendment 242 #
Proposal for a regulation Article 11 – paragraph 1 1. Upon application by a supplier or a manufacturer, CO2 savings achieved through the use of innovative technologies shall be considered.
Amendment 245 #
Proposal for a regulation Article 11 – paragraph 2 – introductory part 2. The Commission shall by 31 December 2012, adopt detailed provisions for a procedure to approve such innovative technologies in accordance with the regulatory procedure referred to in Article 13(2). Those detailed provisions shall be in conformity with the provisions of Article 12(2) of Regulation (EC) No 443/2009 and shall be based on the following criteria for innovative technologies:
Amendment 246 #
Proposal for a regulation Article 11 – paragraph 2 – subparagraph 1 a (new) These detailed provisions shall respect the following principles: (a) the regularly updated European Union list of approved eco-innovations shall guarantee that eco-innovations are standardised within the European Union and ensure that these technologies are applied effectively by the authorities responsible for type-approval in the Member States; (b) the authorities responsible for type- approval in the Member States shall assess and approve the use of eco- innovations and the way in which their respective contributions to CO2 reduction are taken into account, so that every vehicle model can be assigned a specific eco-innovation pack; (c) the Commission shall decide on the application from the supplier or manufacturer within six months of receipt of the application; (d) a technology shall be approved as an eco-innovation where a maximum of 40% of its contributions to CO2 reduction are measurable in the type test cycle; (e) a technology shall be approved as an eco-innovation where its contributions to CO2 reduction amount to more than 0.2 g/km.
Amendment 255 #
Proposal for a regulation Article 12 – paragraph 4 – subparagraph 1 – indent 1 –
Amendment 272 #
Proposal for a regulation Article 12 – paragraph 4 – subparagraph 2 – indent 2 –
Amendment 284 #
Proposal for a regulation Article 12 – paragraph 6 – subparagraph 2 Amendment 292 #
Proposal for a regulation Annex 1 – point 1 – subpoint a – line 1 (a) From 201
source: PE-442.811
|
| 1 |
2009/2105(INI) Agricultural product quality policy: what strategy to follow?
2009/11/12
ENVI
1 amendments...
Amendment 13 #
Draft opinion Suggestion 12 source: PE-430.985
|
| 2 |
2009/2152(INI) Report on the Commission White Paper: 'Adapting to climate change: towards a European framework for action'
2010/02/22
ENVI
2 amendments...
Amendment 48 #
Motion for a resolution Paragraph 12 12. Emphasises the need to enhance resilience of the agricultural ecosystems by more sustainable use of natural resources
Amendment 69 #
Motion for a resolution Paragraph 14 14. Takes the view that
source: PE-439.124
|
| 20 |
2010/0195(COD) Air quality: provisions for engines placed on the market under the flexibility scheme
2011/02/23
ENVI
20 amendments...
Amendment 34 #
Proposal for a directive - amending act Recital 5 (5) During the
Amendment 38 #
Proposal for a directive - amending act Recital 6 (6) The rules applicable to the flexibility scheme should be adapted to extend
Amendment 44 #
Proposal for a directive - amending act Recital 7 (7) The measures provided in this Directive reflect a temporary difficulty faced by the manufacturing sector
Amendment 50 #
Proposal for a directive - amending act Article 1 – point -1 (new) Directive 97/68/CE Article 2 - last indent (-1) In Article 2, the last indent is replaced by the following: – flexibility scheme shall mean the exemption procedure whereby a Member State allows placing on the market of a limited quantity of engines according to Article 10.
Amendment 52 #
Proposal for a directive - amending act Article 1 – point -1 a (new) Directive 97/68/CE Article 2 - new indent (-1a) In Article 2 the following new indent is added: – engine category shall mean the engine classification combining the power range, the exhaust emission stage requirements and the engine classification according to Section I of Annex I.
Amendment 55 #
Proposal for a directive - amending act Article 1 – point 1 Directive 97/68/CE Article 4 - paragraph 6 Amendment 69 #
Proposal for a directive - amending act Article 1 – point 2 - point a Directive 97/68/CE Article 10 - paragraph 7 (7) Member States shall permit the placing on the market of engines, as defined in Section 1 of Annex I under A(i), A(ii), A(iv) and A(v), under the flexibility scheme in accordance with the provisions in Annex XIII. Spark ignited engines, as defined in Section 1 of Annex I under A(iii), and engines for propulsion of inland waterways vessels are excluded from this procedure. The flexibility scheme shall start when placing on the market of engines becomes compulsory for any given Stage and shall have the duration of any given stage, but not more than three years. The engines shall be type approved according to the Stage immediately preceding the one under consideration.
Amendment 72 #
Proposal for a directive - amending act Article 1 – point 2 – point b Directive 97/68/CE Article 10 – paragraph 8 Amendment 80 #
Proposal for a directive - amending act Annex - introductory part Directive 97/68/CE - Amendment 82 #
Proposal for a directive - amending act Annex Directive 97/68/CE Annex XIII - section 1 - point 1.1. 1.1.
Amendment 84 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.1.1. 1.1.1. The number of engines placed on the market under a flexibility scheme shall, in each engine category, not exceed 20 % of the OEM's annual
Amendment 86 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.1.2 1.1.2. As an optional alternative to section 1.1.1. and with the exception of engines for
Amendment 89 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.2. 1.2
Amendment 92 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.2.1. 1.2.1. The number of engines placed on the market under
Amendment 96 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.2.2. 1.2.2. As an optional alternative to section 1.2.1., the OEM may seek permission for
Amendment 99 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.3. Amendment 102 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.4. 1.4 As regards engines for
Amendment 111 #
Proposal for a directive - amending act Annex Directive 97/68/EC Annex XIII – section 1 - point 1.5. - introductory part 1.5. The OEM shall include in
Amendment 113 #
Proposal for a directive - amending act Annex Directive 97/68/CE Annex XIII - section 2 2. ACTIONS BY THE ENGINE MANUFACTURER 2.1. An engine manufacturer may place on the market engines under a flexible scheme covered by the permission granted in accordance with Section 1 and 3 of this Annex. 2.2. The engine manufacturer shall mark those engines with the following text: ‘Engine placed on the market under the flexibility scheme’ in conformity with the requirements of Section 3 of Annex I.
Amendment 114 #
Proposal for a directive - amending act Annex Directive 97/68/CE Annex XIII - section 3 3.
source: PE-458.785
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| 15 |
2010/0208(COD) Genetically modified organisms GMOs: possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
2011/03/17
ENVI
15 amendments...
Amendment 18 #
Proposal for a regulation - amending act Recital 2 (2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. In accordance with the conclusions of the Environment Council of 4 December 2008, this risk assessment should be enhanced, particularly by taking better account of regional and local circumstances in the context of the assessment by the European Food Safety Authority. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. The same high level of protection of health and the environment should be sought and maintained throughout the territory of the Union.
Amendment 25 #
Proposal for a regulation - amending act Recital 5 (5) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level.
Amendment 32 #
Proposal for a regulation - amending act Recital 6 (6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products. This freedom of action for Member States must not result in distortion of competition between farmers in different Member States of the Union and between the various methods of cultivation (organic, conventional, with GMOs and others).
Amendment 33 #
Proposal for a regulation - amending act Recital 6 (6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products. This freedom granted to Member States should not result in any distortion of competition between farmers in the various Member States.
Amendment 34 #
Proposal for a regulation - amending act Recital 7 (7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of
Amendment 40 #
Proposal for a regulation - amending act Recital 8 (8) According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the
Amendment 64 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – introductory part Member States may adopt measures restricting or prohibiting the cultivation of
Amendment 83 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a (a) those measures are scientifically based on grounds other than those related to the
Amendment 87 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a a (new) (aa) those measures ensure that the freedom of choice of farmers and consumers is duly respected;
Amendment 88 #
Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a b (new) (ab) those measures do not entail any distortion of competition between farmers in different Member States;
Amendment 94 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a a (new) (aa) those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months prior to the start of the growing season;
Amendment 99 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a c (new) (ac) those measures have been the subject of a prior impact assessment showing them to be necessary and proportionate;
Amendment 104 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point ad (new) (ad) those measures are adopted for a maximum of three years, and may where appropriate be renewed following the conclusion of a new impact assessment showing that they are necessary and proportionate;
Amendment 107 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point b (b) that they are in conformity with the Treaties and the Union's international obligations.
Amendment 109 #
Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 2 source: PE-460.799
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| 3 |
2010/0254(COD) Fruit juices and certain similar products intended for human consumption
2011/04/26
ENVI
3 amendments...
Amendment 47 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 1 – point a – paragraph 2 Flavour, pulp, and cells
Amendment 51 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 1 – point a – paragraph 2 The product obtained by re
Amendment 54 #
Proposal for a directive - amending act Annex Directive 2001/112/EC Annex I – part I – point 1 – point b – paragraph 5 Flavour and, if appropriate, pulp and cells shall be obtained by suitable physical means from the fruit juice in question or from fruit juices from the same species of fruit
source: PE-464.677
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| 10 |
2010/2088(INI) GDP and beyond - Measuring progress in a changing world
2010/09/11
ENVI
10 amendments...
Amendment 11 #
Motion for a resolution Recital B B. whereas the EU 2020 strategy should pave the way to a resource-efficient economy, serve economic growth and create jobs, in particular
Amendment 16 #
Motion for a resolution Recital C C. whereas the EU 2020 strategy also requires
Amendment 19 #
Motion for a resolution Paragraph 1 1. Stresses that GDP is an indicator of economic market activity and is widely used in policy analysis and debates; recalls that GDP, after its birth in the 1930s, was rapidly adopted as the best-recognised measure of economic performance in the world; underlines that GDP has become a standard benchmark used by policy-makers throughout the world; is concerned that GDP might
Amendment 26 #
Motion for a resolution Paragraph 2 2. Emphasises that GDP is based on a clear methodology which allows comparisons to be made over time and between countries and regions; stresses that it was, however, not intended to be an accurate measure to inform policy debates on all issues; underlines that
Amendment 37 #
Motion for a resolution Paragraph 4 a (new) 4a. Takes the view, in the light of the ever closer degree of interdependence between economic, social and environmental issues, that GDP is the only indicator which makes it possible to take proper account of differing socioeconomic characteristics at European level, but emphasises the need to take account of environmental and social factors at national and regional level and to determine suitable criteria for that purpose;
Amendment 44 #
Motion for a resolution Paragraph 7 a (new) 7a. Considers that GDP is the key indicator for measuring and comparing regional imbalances at European level; does, however, regard the newly-proposed environmental and social criteria for measuring regional prosperity (income distribution, degree to which a region is affected by climate-related problems, gender equality, unemployment, etc.) as a significant addition to the economic criteria;
Amendment 47 #
Motion for a resolution Paragraph 8 8.
Amendment 54 #
Motion for a resolution Paragraph 9 9. Underlines the need to keep costs at a reasonable and appropriate level and to also weigh the potential gains of Beyond GDP against the cost associated with it; stresses the importance of budgetary constraints and the necessity of timely impact assessment;
Amendment 77 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to
Amendment 80 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission to carry out an impact assessment before introducing new indicators, in order to estimate the costs and complexity of data collection for the competent authorities and businesses;
source: PE-452.675
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| 11 |
2010/2106(INI) Commission Green Paper "On forest protection and information in the EU: preparing forests for climate change"
2011/02/15
ENVI
11 amendments...
Amendment 48 #
Motion for a resolution Recital D D. whereas energy generation from
Amendment 53 #
Motion for a resolution Recital E E. whereas forest protection and protection of its functions should be mainstreamed in all EU policies affecting forests,
Amendment 79 #
Motion for a resolution Recital I I. whereas the EU FAP has four goals: improving long-term competitiveness, protecting the environment, contributing to quality of life and fostering coordination and whereas significant progress has been made
Amendment 89 #
Motion for a resolution Recital L L. whereas genetic selection should
Amendment 108 #
Motion for a resolution Paragraph 3 3. Is convinced that ecological, economic and social sustainability is the prerequisite for the continuation of the
Amendment 123 #
Motion for a resolution Paragraph 5 5. Calls on the Commission and Member States to intensify efforts to achieve the
Amendment 152 #
Motion for a resolution Paragraph 10 10.
Amendment 182 #
Motion for a resolution Paragraph 12 12. Calls on the
Amendment 205 #
Motion for a resolution Paragraph 14 14. Urges the Commission
Amendment 242 #
Motion for a resolution Paragraph 17 Amendment 275 #
Motion for a resolution Paragraph 25 25. Calls on the Commission to develop legally binding sustainability criteria for woody biomass and ILUC factors for all forms of biomass; states that there should first be an assessment of experience with certification of liquid biomass and, with regard to timber, existing certification systems (e.g. TEFC and FSC) should be built on;
source: PE-458.605
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| 4 |
2010/2111(INI) EU protein deficit: what solution for a long standing problem?
2010/08/12
ENVI
4 amendments...
Amendment 8 #
Draft opinion Paragraph 2 Amendment 11 #
Draft opinion Paragraph 2 a (new) 2a. Calls on the Commission to submit to Parliament a report on the current use of slaughter waste, swill and meat and bone meal in the Member States and propose options for their use as protein sources;
Amendment 12 #
Draft opinion Paragraph 2 b (new) 2b. Supports the Commission in its intention of reviewing the ban on feeding animal protein to non-ruminants subject to compliance with the ban on cannibalism (COM(2010)384 final); advocates the introduction of a tolerance threshold for processed animal proteins, expressly advocates full application of the precautionary principle with regard to the possible use of animal protein for animal feed;
Amendment 30 #
Draft opinion Paragraph 6 6. Emphasizes that the treatment of slaughter offal, swill, meat and bone meal shall meet the existing strict provisions on the protection of human health and environment
source: PE-454.536
|
| 14 |
2010/2249(INI) EU legislation on Transmissible Spongiform Encephalopathies (TSE) and on related feed and food controls - implementation and outlook
2011/04/05
ENVI
14 amendments...
Amendment 1 #
Motion for a resolution Citation 5 – having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
Amendment 2 #
Motion for a resolution Citation 7 – having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
Amendment 3 #
Motion for a resolution Recital B B. whereas the number of positive BSE cases in the EU has decreased from 2167 cases in 2001 to 67 cases in 2009 (excluding the UK); whereas, in the light of this decreasing number of cases, the legislation implemented during this period can be viewed as having contributed to the eradication of BSE and other TSEs in the EU and whereas, hand-in-hand with this declining epidemiological trend, the legislative provisions should be adapted in line with the actual situation in terms of risk,
Amendment 4 #
Motion for a resolution Recital C C. whereas, in view of the continuous declining number of BSE cases, the legislation on TSEs has been modified in recent years and consideration could be given to future changes while ensuring and maintaining the high level of animal and public health in the European Union; whereas these changes could include measures relating to SRM removal, review of the total feed ban provisions, eradication of scrapie, cohort culling and surveillance,
Amendment 7 #
Motion for a resolution Paragraph 4 4.
Amendment 8 #
Motion for a resolution Paragraph 5 5. Underlines that the surveillance mechanism is an important instrument in monitoring TSE in the EU;
Amendment 11 #
Motion for a resolution Paragraph 7 7. Supports - particularly in the light of the existing protein deficit in the EU - the Commission proposal to lift the
Amendment 15 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to investigate the need for
Amendment 20 #
Motion for a resolution Paragraph 12 12.
Amendment 26 #
Motion for a resolution Paragraph 18 18.
Amendment 27 #
Motion for a resolution Paragraph 18 18.
Amendment 32 #
Motion for a resolution Paragraph 20 20.
Amendment 34 #
Motion for a resolution Paragraph 21 Amendment 35 #
Motion for a resolution Paragraph 22 22.
source: PE-462.890
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| 1 |
2011/0196(COD) Road transport: tachograph system
2012/03/29
TRAN
1 amendments...
Amendment 327 #
Proposal for a regulation Article 2 – paragraph 2 Regulation (EC) No 561/2006 Article 13 – paragraph 1 – points d, f und p The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘
source: PE-485.915
|
| 6 |
2011/0229(COD) Food safety: electronic identification of bovine animals and beef labelling
2012/02/17
ENVI
6 amendments...
Amendment 23 #
Proposal for a regulation Recital 9 (9) Given the technological advances in EID, several Member States have decided to start to implement bovine EID on a voluntary basis. Those initiatives are likely to lead to different systems to be developed in individual Member States or by stakeholders. Such a development would impede later harmonisation of technical standards within the Union. It must be ensured at an early stage that the systems introduced in the Member States are interoperable.
Amendment 36 #
Proposal for a regulation Recital 17 a (new) (17a) In order to be able to apply identification systems in a harmonised manner in future, it is desirable that, after a transitional period, the use of electronic identifiers, which has previously been voluntary, should become compulsory in all Member States.
Amendment 59 #
Proposal for a regulation Article 1 – point 3 Regulation (EC) No 1760/2000 Article 4 – paragraph 2 – subparagraph 1 2. Member States may, within a transitional period of five years after the entry into force of this Regulation, introduce national provisions to make compulsory the use of an electronic identifier as one of the two means of identification provided for in paragraph 1. After the expiry of this transitional period, at the latest, the use of an electronic identifier as one of the two means of identification provided for in paragraph 1 shall be compulsory.
Amendment 60 #
Proposal for a regulation Article 1 – point 3 Regulation (EC) No 1760/2000 Article 4 – paragraph 2 – subparagraph 2 Amendment 63 #
Proposal for a regulation Article 1 – point 3 a (new) Regulation (EC) No 1760/2000 Article 4 – paragraph 5 a (new) 5a. The Commission shall ensure that the national identifiers used are interoperable.
Amendment 86 #
Proposal for a regulation Article 1 – point 14 Regulation (EC) No 1760/2000 Articles 16 - 18 source: PE-480.879
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| 3 |
2011/0280(COD) Common agricultural policy (CAP): direct payments to farmers under support schemes 2014-2020
2012/07/18
AGRI
2 amendments...
Amendment 154 #
Proposal for a regulation Recital 15 Amendment 173 #
Proposal for a regulation Recital 16 source: PE-491.238
2012/07/19
AGRI
1 amendments...
Amendment 706 #
Proposal for a regulation Article 11 source: PE-492.792
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| 3 |
2011/0428(COD) Programme for the Environment and Climate Action, LIFE 2014-2020
2012/10/07
ENVI
3 amendments...
Amendment 68 #
Proposal for a regulation Recital 12 (12) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions "Roadmap to a Resource Efficient Europe" (hereinafter the "Roadmap to a Resource Efficient Europe") has set forth the milestones and actions that
Amendment 129 #
Proposal for a regulation Article 12 – paragraph 1 – point c (c) to promote and contribute to a more effective compliance with and enforcement of existing Union environmental legislation in all Member States, in particular by promoting the development and dissemination of best practices and policy approaches;
Amendment 178 #
Proposal for a regulation Article 20 – paragraph 2 – subparagraph 1 source: PE-492.686
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| 19 |
2011/2051(INI) CAP towards 2020: meeting the food, natural resources and territorial challenges of the future
2011/03/22
ENVI
13 amendments...
Amendment 2 #
Draft opinion Paragraph 1 1. Calls for the post-2013 CAP to pursue food objectives which
Amendment 11 #
Draft opinion Paragraph 1 a (new) 1a. Points out that previous CAP reforms (the 1992 McSharry reform, the ‘Agenda 2000’ reform, the 2003 reform and the 2008 health check) were all aimed at ensuring that European farmers meet the highest standards in the world as far as environmental protection and animal welfare and traceability of foodstuffs are concerned; stresses in this connection that farmers are not compensated by the market for the costs entailed in meeting these standards; (This paragraph should be the new number 1 and therefore be put on the top.)
Amendment 18 #
Draft opinion Paragraph 2 2. Points out that the CAP
Amendment 23 #
Draft opinion Paragraph 3 3. Calls for CAP funding to be based on a model which
Amendment 32 #
Draft opinion Paragraph 4 4. Calls for a reinforcement of the concept of funding for both pillars subject to the fulfilment of a number of
Amendment 37 #
Draft opinion Paragraph 4 a (new) 4a. Stresses that the ‘greening’ of EU agricultural policy is, in reality, nothing new to farmers, as each successive reform has been geared towards strengthening this aspect of the CAP;
Amendment 38 #
Draft opinion Paragraph 4 b (new) 4b. Stresses the services which European farmers provide to European society, in particular maintaining a varied cultivated landscape and making an important contribution to the protection and stewardship of natural resources and to climate protection;
Amendment 47 #
Draft opinion Paragraph 5 5. Emphasises that
Amendment 65 #
Draft opinion Paragraph 7 Amendment 72 #
Draft opinion Paragraph 8 8.
Amendment 79 #
Draft opinion Paragraph 9 Amendment 82 #
Draft opinion Paragraph 9 9. Points out that a majority of Europeans currently oppose the use of GMOs in agriculture and food;
Amendment 91 #
Draft opinion Paragraph 10 10. Encourages more EU-funded and -coordinated projects in which farmers and researchers can work together to find innovative ways of
source: PE-460.983
2011/03/29
DEVE
6 amendments...
Amendment 17 #
Draft opinion Paragraph 2 2.
Amendment 21 #
Draft opinion Paragraph 2 a (new) 2a. Stresses that greater coherence is needed between the CAP, trade policy and development policy in order to ensure effective development cooperation; also notes that the EU needs to coordinate more effectively with non-state organisations, including the FAO, the United Nations and other international bodies;
Amendment 22 #
Draft opinion Paragraph 2 b (new) 2b. Considers that the CAP plays an important role in relation to development policy, particularly in the area of food security; points out that the CAP has a contribution to make to meeting increased world demand for food;
Amendment 30 #
Draft opinion Paragraph 3 3.
Amendment 41 #
Draft opinion Paragraph 5 5. Takes the view that, in the context of tackling international speculation in agricultural commodity prices, the new CAP should establish appropriate mechanisms and rules to govern trade in agricultural commodity derivatives and enhance transparency;
Amendment 46 #
Draft opinion Paragraph 6 6. Asks for a
source: PE-462.581
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| 12 |
2011/2068(INI) Resource-efficient Europe
2012/03/13
ENVI
12 amendments...
Amendment 13 #
Motion for a resolution Recital C C. whereas intense resource use and dramatically increased global consumption are pushing up prices of raw materials, with real commodity prices having increased by 147% since the turn of the century; whereas the EU is likely to face severe challenges in securing access to, and the uninterrupted supply of, key resources; whereas efficient use of raw materials in industry and at political level is recognised to be crucial to meeting these challenges;
Amendment 47 #
Motion for a resolution Paragraph 2 2. Calls on the Commission and Member States to
Amendment 65 #
Motion for a resolution Paragraph 3 3. Urges the Commission to boost research and technological innovation to speed up the transition to a green economy; underlines that the ‘Innovation Union’, especially the European innovation partnership on raw materials, is one of the engines for a resource-efficient Europe;
Amendment 84 #
Motion for a resolution Paragraph 5 5. Calls on the Commission, before taking any steps to extend the scope of the eco- design directive to non-
Amendment 124 #
Motion for a resolution Paragraph 10 a (new) 10a. Calls on the Commission, as regards the choice of means, to give preference to incentives and voluntary solutions over state regulation;
Amendment 176 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission and the Member States to increase the transparency of publicly financed research, remove the bureaucratic obstacles to participation in research programmes aimed at enhancing resource efficiency, and involve SMEs to more useful effect in innovation research;
Amendment 178 #
Motion for a resolution Paragraph 14 b (new) 14b. Calls on the Commission and the Member States, together with the business community and civil society, to devise strategies to foster continuing acceptance of technology and innovation;
Amendment 180 #
Motion for a resolution Paragraph 15 Amendment 200 #
Motion for a resolution Paragraph 16 16. Urges the Commission and Member States to present concrete plans for phasing out
Amendment 206 #
Motion for a resolution Paragraph 17 17. Calls on the Commission and Member States to
Amendment 219 #
Motion for a resolution Paragraph 19 19. Calls on the Commission to start pilot projects for several resources, e.g. phosphorous, to reach
Amendment 230 #
Motion for a resolution Paragraph 20 20. Highlights the importance of sustainable agriculture
source: PE-485.854
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| 1 |
2011/2071(INI) European semester for economic policy coordination
2011/06/21
ENVI
1 amendments...
Amendment 18 #
Draft opinion Paragraph 5 5. Calls on the Commission, therefore, to
source: PE-467.210
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| 14 |
2011/2194(INI) Review of the 6th Environment Action Programme and the setting of priorities for the 7th Environment Action Programme
2012/01/27
ENVI
14 amendments...
Amendment 22 #
Motion for a resolution Paragraph 4 4. Considers that the 7th EAP should be an overarching framework that makes it possible to deal with both persistent and emerging environmental challengeschallenges with due regard to existing and planned measures;
Amendment 39 #
Motion for a resolution Paragraph 8 8. Invites the Commission to
Amendment 56 #
Motion for a resolution Paragraph 13 13. Invites the Commission to already use – and improve – existing resource efficiency
Amendment 62 #
Motion for a resolution Paragraph 14 14. Takes the view that the
Amendment 69 #
Motion for a resolution Paragraph 15 15. Considers that the 7th EAP should provide for full attainment of the goals for sustainable and ecological consumption and production set in the Roadmap,
Amendment 78 #
Motion for a resolution Paragraph 16 16. Takes the view that the 7th EAP should provide for full implementation of waste legislation and, by paying particular attention to the 5-stage waste hierarchy, should set very ambitious targets, including a net decrease
Amendment 87 #
Motion for a resolution Paragraph 17 Amendment 114 #
Motion for a resolution Paragraph 20 – indent 3 – provide for the development of specific measures
Amendment 131 #
Motion for a resolution Paragraph 21 21. Considers it essential to strengthen the European Union Network for the Implementation and Enforcement of Environmental Law (IMPEL) and urges the Commission to report on possible ways of doing so
Amendment 143 #
Motion for a resolution Paragraph 23 23. Takes the view that
Amendment 148 #
Motion for a resolution Paragraph 24 24. Invites the Commission to
Amendment 149 #
Motion for a resolution Paragraph 25 25. Urges the Commission to include in its 7th EAP proposal
Amendment 153 #
Motion for a resolution Paragraph 26 26. Takes the view that the 7th EAP should
Amendment 165 #
Motion for a resolution Paragraph 30 30. Takes the view that the 7th EAP should aim at supporting the development of alternative models to measure growth and welfare
source: PE-480.650
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| 8 |
2011/2307(INI) Our life insurance, our natural capital: an EU biodiversity strategy to 2020
2012/01/02
ENVI
2 amendments...
Amendment 30 #
Motion for a resolution Paragraph 2 2. Welcomes and supports the EU biodiversity strategy to 2020, including its targets and actions; considers, nevertheless, that
Amendment 97 #
Motion for a resolution Paragraph 10 10. Notes the requirement under the CBD to restore 15 % of degraded ecosystems by 2020; considers, however, that this is a minimum and that the EU should have its own, more ambitious target and long-term vision; calls
source: PE-480.669
2012/02/14
ENVI
6 amendments...
Amendment 143 #
Motion for a resolution Paragraph 14 14. Calls for the greening of Pillar I in order to make income support for farmers legitimate by ensuring the conservation of the environment and therefore of biodiversity in the wider farmed landscape, improving connectivity and adapting to the effects of climate change;
Amendment 162 #
Motion for a resolution Paragraph 15 15. Calls for all CAP payments, to continue to be underpinned by robust cross-compliance rules
Amendment 173 #
Motion for a resolution Paragraph 16 16. Calls for a strengthening of Pillar II and for drastic improvements to the environmental focus of that pillar in all Member States and the effectiveness of its agro-environmental measures, including through minimum mandatory spending on environmental measures;
Amendment 187 #
Motion for a resolution Paragraph 17 Amendment 190 #
Motion for a resolution Paragraph 17 17. Requests the Commission and Member States to
Amendment 275 #
Motion for a resolution Paragraph 28 28. With a view to ensuring adequate financing of the Natura 2000 network, calls on the Commission and the Member States to ensure that a
source: PE-480.679
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| 3 |
2012/0035(COD) Medicinal products for human use: transparency of measures regulating the prices and their inclusion in the scope of public health insurance systems
2012/10/22
ENVI
2 amendments...
Amendment 52 #
Proposal for a directive Recital 8 (8) Due to diversity of national measures managing the consumption of medicines, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies.
Amendment 83 #
Proposal for a directive Article 1 – paragraph 2 – subparagraph 1 – point a (a) voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions, provided that such arrangements also meet the transparency requirements of Article 5, paragraph 3 a (new);
source: PE-497.983
2012/10/25
ENVI
1 amendments...
Amendment 172 #
Proposal for a directive Article 5 – paragraph 3 a (new) 3a. Member States shall ensure that dispensaries possess information about the sale price of the medicinal product applicable to the insured person in order to prevent possible distorting effects caused by a lack of transparency in prices displayed on the market.
source: PE-498.042
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| 2 |
2012/0039(COD) Non-commercial movement of pet animals
2012/09/27
ENVI
2 amendments...
Amendment 180 #
Proposal for a regulation Article 4 a (new) Article 4 a Maximum number of pet animals (1) The number of pet animals of the species listed in Part A of Annex I which may accompany the owner or an authorised person in the course of an individual movement may not exceed five. (2) By way of derogation from paragraph 1, the number of pet animals of the species listed in Part A of Annex I may exceed five if: a) the non-commercial movement of pet animals is for the purpose of participating in competitions, exhibitions or sporting events or in training for these events; and b) the owner or the authorised person is able to submit a written invitation and a written registration document to the event to be attended under point (a), or has written evidence to prove that the pets are registered with an association that organises events mentioned under point (a). (3) The Commission shall submit a report to the European Parliament and the Council on the implementation of this Regulation not later than 5 years after the entry into force of this Regulation. The Commission shall, where necessary, propose amendments to the Regulation on the basis of its report.
Amendment 194 #
Proposal for a regulation Article 17 (1) The implantation of a transponder shall be carried out by an approved veterinarian. (2) By way of derogation from paragraph 1, Member States
source: PE-496.565
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| 9 |
2012/0042(COD) Greenhouse gas emissions and removals resulting from activities related to land use, land use change and forestry (LULUCF): accounting rules and action plans
2012/07/20
ENVI
9 amendments...
Amendment 90 #
Proposal for a decision Recital 4 (4) (4) LULUCF accounting rules should reflect efforts made in the agriculture and forestry sectors to enhance the contribution of changes made to the use of land resources to the reduction of emissions. This Decision should provide for accounting rules applicable on a mandatory basis to the forestry activities of afforestation, reforestation, deforestation and forest management
Amendment 117 #
Proposal for a decision Recital 12 (12) Member State LULUCF Action Plans should set out measures to limit or reduce emissions and to maintain or increase removals from the LULUCF sector. Each LULUCF Action Plan should contain certain information as specified in this Decision. Moreover, to promote best practice, an indicative list of measures that may also be included in those plans should be set out in Annex to this Decision. The Commission should periodically evaluate the content and implementation of Member States’ LULUCF Action Plans and, where appropriate, provide practicable recommendations to enhance Member State action.
Amendment 169 #
Proposal for a decision Article 3 – paragraph 1 – subparagraph 1 – point e Amendment 178 #
Proposal for a decision Article 3 – paragraph 1 – subparagraph 1 – point f Amendment 186 #
Proposal for a decision Article 3 – paragraph 1 – subparagraph 2 Member States may also draw up and maintain accounts that accurately reflect emissions and removals resulting from cropland and grazing land management, revegetation, and wetland drainage and rewetting.
Amendment 249 #
Proposal for a decision Article 8 – paragraph 1 1.
Amendment 293 #
Proposal for a decision Article 10 – paragraph 3 – subparagraph 1 The Commission shall evaluate a Member State’s draft LULUCF Action Plan within three months of receiving all relevant information from that Member State. The Commission shall publish the results of that evaluation and may issue practicable recommendations, as appropriate, with a view to enhance Member States’ efforts to limit or reduce emissions and maintain or increase removals.
Amendment 301 #
Proposal for a decision Article 10 – paragraph 3 – subparagraph 2 Member States shall
Amendment 310 #
Proposal for a decision Article 10 – paragraph 5 – subparagraph 2 The Commission shall publish those reports and the results of that evaluation and may issue practicable recommendations, as appropriate, with a view to enhance Member States’ efforts to limit or reduce emissions and maintain or increase removals. Member States shall take due account of the Commission’s findings.
source: PE-492.911
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| 29 |
2012/0192(COD) Clinical trials on medicinal products for human use
2013/03/01
ENVI
12 amendments...
Amendment 80 #
Proposal for a regulation Recital 2 (2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 463 #
Proposal for a regulation Article 29 – paragraph 1 1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been
Amendment 474 #
Proposal for a regulation Article 30 – paragraph 1 – point a (a) the informed consent of the legal representative has been obtained
Amendment 478 #
Proposal for a regulation Article 30 – paragraph 1 – point c (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is
Amendment 481 #
Proposal for a regulation Article 30 – paragraph 1 – point h a (new) (ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
Proposal for a regulation Article 31 – paragraph 1 – point b (b) the minor has received all relevant information in a way adapted to his or her age and maturity, from
Amendment 491 #
Proposal for a regulation Article 31 – paragraph 1 – point c (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator
Amendment 496 #
Proposal for a regulation Article 31 – paragraph 1 – point h b (new) (hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
Proposal for a regulation Article 31 – paragraph 1 – point h d (new) (hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
Proposal for a regulation Article 32 – paragraph 1 – point e (e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 532 #
Proposal for a regulation Article 34 – paragraph 3 – subparagraph 1 3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 570 #
Proposal for a regulation Article 40 – paragraph 2 a (new) 2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
source: PE-506.158
2013/03/06
ENVI
17 amendments...
Amendment 253 #
Proposal for a regulation Article 4 a (new) Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 2 The
Amendment 264 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 3 Amendment 269 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. Within
Amendment 276 #
Proposal for a regulation Article 5 – paragraph 3 3. Where the proposed reporting Member State has not notified the sponsor within
Amendment 280 #
Proposal for a regulation Article 5 – paragraph 4 – subparagraph 3 Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within
Amendment 310 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point a (a) within
Amendment 313 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point b (b) within
Amendment 317 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point c (c) within
Amendment 321 #
Proposal for a regulation Article 6 – paragraph 5 5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 359 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 3 a (new) Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 375 #
Proposal for a regulation Article 9 – paragraph 2 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 409 #
Proposal for a regulation Article 15 A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
Proposal for a regulation Article 17 – paragraph 2 – introductory part 2. Within
Amendment 425 #
Proposal for a regulation Article 20 – paragraph 5 – subparagraph 2 Notification shall be done by way of one single decision within ten days from the
Amendment 454 #
Proposal for a regulation Article 28 – paragraph 1 – point d (d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
Proposal for a regulation Article 28 – paragraph 3 3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
source: PE-506.160
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| 12 |
2012/0266(COD) Medical devices
2013/05/14
ENVI
12 amendments...
Amendment 154 #
Proposal for a regulation Recital 8 (8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by- case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. In the interests of legal certainty, clear reasons should be given for such decisions and the manufacturers concerned should be consulted as part of the decision-making process. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU-
Amendment 273 #
Proposal for a regulation Article 3 – paragraph 1 1. The Commission may, at the request of a Member State or on its own initiative and following consultation with the manufacturer in question on the basis of concerns about patient safety or in the light of new scientific findings, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of 'medical device' or 'accessory to a medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 390 #
Proposal for a regulation Article 15 – paragraph 2 a (new) 2a. The Commission, by means of implementing acts, shall lay down guidelines on the reprocessing of medical devices, with stipulations on standardisable, reproducible and effective cleaning, disinfection and sterilisation processes in line with the risk assessment for the respective devices, as well as requirements in relation to systems for hygiene, infection-prevention, quality management and documentation applicable to the natural or legal persons reprocessing the medical devices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 398 #
Proposal for a regulation Article 15 – paragraph 4 4. The Commission, by means of implementing acts, shall establish
Amendment 400 #
Proposal for a regulation Article 15 – paragraph 6 Amendment 495 #
Proposal for a regulation Article 32 – paragraph 3 3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least t
Amendment 496 #
Proposal for a regulation Article 32 – paragraph 4 – subparagraph 2 Findings regarding non-compliance of a body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application.
Amendment 497 #
Proposal for a regulation Article 32 – paragraph 5 5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, this too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages.
Amendment 498 #
Proposal for a regulation Article 32 – paragraph 6 6. The joint assessment team shall provide its final opinion regarding the assessment report
Amendment 669 #
Proposal for a regulation Article 67 – paragraph 1 1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, and also without announcing their intention, enter the premises of economic operators and take the necessary samples of devices. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 674 #
Proposal for a regulation Article 67 – paragraph 2 2. The Member States shall periodically plan, review and assess the functioning of their surveillance activities.
source: PE-510.765
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| 9 |
2012/0288(COD) Fuels and energy from renewable sources: transition to biofuels to deliver greenhouse gas savings
2013/05/31
ENVI
5 amendments...
Amendment 107 #
Proposal for a directive Recital 5 (5) Based on forecasts of biofuel demand provided by the Member States and estimates of indirect land-use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant, and could negate some or all of the greenhouse gas savings of individual biofuels. This is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets.
Amendment 154 #
Proposal for a directive Recital 9 Amendment 178 #
Proposal for a directive Recital 11 Amendment 194 #
Proposal for a directive Recital 12 Amendment 215 #
Proposal for a directive Recital 19 (19) In order to permit adaptation to technical and scientific progress of Directive 2009/28/EC, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the list of biofuel feedstocks that are counted
source: PE-513.032
2013/06/03
ENVI
4 amendments...
Amendment 242 #
Proposal for a directive Article 1 – point 1 – point a Directive 98/70/EC Article 7a – paragraph 6 Amendment 326 #
Proposal for a directive Article 2 – point 2 – point b Directive 2009/28/EC Article 3 – paragraph 1 – subparagraph 2 Amendment 367 #
Proposal for a directive Article 2 – point 2 – point c – point iii Directive 2009/28/EC Article 3 – paragraph 4 – subparagraph 2 – point e Amendment 475 #
Proposal for a directive Article 3 The Commission shall, before 31 December 20
source: PE-513.033
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| 29 |
2012/0297(COD) Assessment of the effects of certain public and private projects on the environment: provisions concerning the quality of the EIA
2013/05/29
ENVI
29 amendments...
Amendment 106 #
Proposal for a directive Article 1 – point 1 – point a Directive 2011/92/EU Article 1 – paragraph 2 – point a – indent 1 Amendment 137 #
Proposal for a directive Article 1 – point 2 Directive 2011/92/EU Article 2 – paragraph 3 – subparagraph 1 3.
Amendment 151 #
Proposal for a directive Article 1 – point 2 Directive 2011/92/EU Article 2 – paragraph 3 – subparagraph 4 Amendment 166 #
Proposal for a directive Article 1 – point 3 Directive 2011/92/EU Article 3 – point a (a)
Amendment 171 #
Proposal for a directive Article 1 – point 3 2011/92/EG Article 3 – point b (b)
Amendment 180 #
Proposal for a directive Article 1 – point 3 Directive 2011/92/EU Article 3 – point c (c) material assets
Amendment 193 #
Proposal for a directive Article 1 – point 4 – point a Directive 2011/92/EU Article 4 – paragraph 3 3. For projects listed in Annex II, the developer shall, where necessary and appropriate, provide information on the characteristics of the project, its potential impact on the environment and the measures envisaged in order to avoid and reduce significant effects.
Amendment 207 #
Proposal for a directive Article 1 – point 4 – point a Directive 2011/92/EU Article 4 – paragraph 4 4. When a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the competent authority shall, where necessary, take account of selection criteria related to the characteristics and location of the project and its potential impact on the environment. The detailed list of selection criteria to be used is specified in Annex III.
Amendment 212 #
Proposal for a directive Article 1 – point 4 – point b Directive 2011/92/EU Article 4 – paragraph 5 – introductory part 5. The competent authority shall make its decision pursuant to paragraph 2, on the basis of the information provided by the developer and taking into account, where relevant, the results of studies with which it is familiar, preliminary verifications or assessments of the effects on the environment arising from other Union legislation. The decision pursuant to paragraph 2 shall:
Amendment 215 #
Proposal for a directive Article 1 – point 4 – point b Directive 2011/92/EU Article 4 – paragraph 5 – point a Amendment 242 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 1 1. Where an environmental impact assessment must be carried out in accordance with Articles 5 to 10, the developer shall prepare an environmental report. The environmental report shall be based on the determination pursuant to paragraph 2 of this Article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project, taking into account current knowledge and methods of assessment, the characteristics, technical capacity and location of the project, the characteristics of the potential impact, reasonable alternatives
Amendment 254 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 2 – subparagraph 1 – introductory part 2. The competent authority, after having consulted the authorities referred to in Article 6(1) and the developer, shall determine the scope and level of detail of the information to be included by the developer in the environmental report, in accordance with paragraph 1 of this Article, if the operator asks for this. In particular, it shall
Amendment 275 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 2 – subparagraph 1 – point d (d) reasonable alternatives relevant to the proposed project
Amendment 296 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 3 – subparagraph 1 – point a (a) the developer shall ensure that the environmental report is prepared by
Amendment 306 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 3 – subparagraph 1 – point b (b) if deemed necessary due to obvious technical deficiencies in the environmental report, the competent authority shall ensure that the environmental report is verified by
Amendment 322 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 3 – subparagraph 2 Where
Amendment 324 #
Proposal for a directive Article 1 – point 5 Directive 2011/92/EU Article 5 – paragraph 3 – subparagraph 3 Amendment 359 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 1 – point b (b) ) the main reasons for choosing the project as adopted, in the light of the other alternatives considered
Amendment 372 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 2 – subparagraph 1 1. If the consultations and the information gathered pursuant to Articles 5, 6 and 7 conclude that a project will have significant adverse environmental effects, the competent authority shall, as early as possible
Amendment 377 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 2 – subparagraph 2 If the competent authority decides to grant development consent, it shall, in accordance with the relevant legislation, ensure that the development consent includes measures to monitor the significant adverse environmental
Amendment 383 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 2 – subparagraph 3 Amendment 387 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 2 – subparagraph 4 Amendment 404 #
Proposal for a directive Article 1 – point 8 Directive 2011/92/EU Article 8 – paragraph 4 Amendment 436 #
Proposal for a directive Article 1 – point 11 Directive 2011/92/EU Articles 12 a and 12b Amendment 455 #
Proposal for a directive Article 3 Projects for which the request for development consent was introduced before the date referred to in the first subparagraph of Article 2(1) and for which the environmental impact assessment has not been concluded before that date shall be subject to the obligations referred to in Articles 3 to 11 of Directive 2011/92/EU
Amendment 478 #
Proposal for a directive Annex – point 1 Directive 2011/92/EU Annex II.A Amendment 507 #
Proposal for a directive Annex – point 2 Directive 2011/92/EU Annex III – paragraph 1 – point g (g) impacts of the project on
Amendment 555 #
Proposal for a directive Annex – point 2 Directive 2011/92/EU Annex IV – paragraph 2 2. A description, of the technical, locational or other aspects (e.g. in terms of project design, technical capacity, size and scale) of the alternatives considered
Amendment 560 #
Proposal for a directive Annex – point 2 Directive 2011/92/EU Annex IV – paragraph 3 3. A description of the relevant aspects of the existing state of the environment
source: PE-510.827
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| 4 |
2012/2031(INI) Protection of animals during transport
2012/03/30
ENVI
4 amendments...
Amendment 3 #
Draft opinion Paragraph 1 a (new) 1a. Regrets that Council Regulation (EC) No 1/2005 has not been adequately implemented in some Member States; calls on the Commission to seek to ensure swift and full implementation of the provision in all Member States.
Amendment 9 #
Draft opinion Paragraph 3 3. C
Amendment 30 #
Draft opinion Paragraph 5 a (new) 5a. Points out that other factors also have a major significance for the welfare of animals during transport, in particular appropriate speed and careful loading and unloading; calls on the Commission to ensure that the introduction of an 8-hour limit for the transport of animals for slaughter does not increase stress on animals during transport;
Amendment 34 #
Draft opinion Paragraph 5 b (new) 5b. Calls on the Commission to examine ways to introduce special training and testing for lorry drivers to qualify them to carry out animal transport under the most humane conditions possible;
source: PE-486.155
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| 10 |
2012/2041(INI) Microbial challenge - rising threats from antimicrobial resistance
2012/09/19
ENVI
10 amendments...
Amendment 1 #
Motion for a resolution Citation 12 – having regard to the
Amendment 14 #
Motion for a resolution Recital F F. whereas, given the lack of new antibacterial drug development, it is of paramount importance that the effective exploitation of existing antimicrobials is maintained for as long as possible via preventive measures to contain infection spread prevention, vaccinations, alternative treatments, prudent use and controlled antimicrobial dosage;
Amendment 20 #
Motion for a resolution Recital G G. whereas the
Amendment 23 #
Motion for a resolution Recital H a (new) Ha. whereas, despite farmers' primary objective to keep their livestock healthy and productive through good agricultural practices (hygiene, proper feed, appropriate husbandry and good animal management), animals can still become ill, and appropriate therapy and veterinary medicines should be available;
Amendment 24 #
Motion for a resolution Recital H a (new) Ha. whereas to date no standard definition of ‘preventive treatment’ has been adopted and disagreements are constantly arising from different interpretations thereof;
Amendment 28 #
Motion for a resolution Recital H b (new) Hb. whereas failure to respect basic rules of hygiene in a human environment, not only in hospitals but also in the home for example, is causing a further spread of antimicrobial pathogens;
Amendment 46 #
Motion for a resolution Paragraph 3 a (new) 3a. Calls on the European Medicines Agency to establish scientific criteria for the reliability and medical necessity of preventive antimicrobial treatment;
Amendment 71 #
Motion for a resolution Paragraph 8 8.
Amendment 115 #
Motion for a resolution Paragraph 16 16. Welcomes the annual European Antibiotic Awareness Day (18 November) instituted to promote the responsible use of antimicrobials; considers, however, that its visibility and potential could be more effectively maximised through coordinated, innovative and high-impact campaigns based on the experience derived from successful European and international initiatives; calls on the Commission to introduce year-round information concerning the correct dosage of prescribed antibiotics;
Amendment 119 #
Motion for a resolution Paragraph 17 a (new) 17a. Takes the view that effective information and awareness campaigns must be developed with a view to heightening awareness of the dangers of the unintentional spread of antimicrobial pathogens in hospitals and in the home and means of avoiding this;
source: PE-496.371
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| 6 |
2012/2043(INI) EU Strategy for the Protection and Welfare of Animals 2012-2015
2012/03/05
ENVI
6 amendments...
Amendment 6 #
Draft opinion Paragraph 1 – point 1 (new) 1a. Welcomes the European Union Animal Health Strategy 2012–2015, but notes with regret that the importance of healthy animals for public health, as promoted in the concept of ‘Animals + Humans = One Health’, or the link between animal health and animal welfare does not feature in that strategy;
Amendment 9 #
Draft opinion Paragraph 2 2. Welcomes the inclusion of a European Animal Welfare Framework Law in the Strategy, provided that such a legal framework is not allowed to dilute existing national provisions and that the principle of subsidiarity is carefully examined; reiterates that such a Framework Law should be based on up-to- date validated science and should cover all animals, whether domesticated or stray, as well as invasive alien species
Amendment 27 #
Draft opinion Paragraph 4 4. Stresses that the list of actions included in the Strategy
Amendment 41 #
Draft opinion Indent 3 – a legislative proposal
Amendment 62 #
Draft opinion Paragraph 6 – point 1 (new) (1) Acknowledges that the use of veterinary medicinal products, including antibiotics, serves to restore animal health and therefore to reduce the suffering of sick animals; points out that such treatment of disease in animals helps prevent zoonoses and thus protect public health;
Amendment 68 #
Draft opinion Paragraph 7 source: PE-488.001
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Horst SCHNELLHARDT on
Activities
Term 7 14.07.2009 / ...
Term 6 20.07.2004 - 13.07.2009
All references link to europarl.euHistory
(these mark the time of scraping, not the official date of the change)
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