Anna ROSBACH
Constituencies
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Denmark
Løsgænger
2009/07/14 - 9999/12/31
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Denmark
Dansk Folkeparti
2009/07/14 - 9999/12/31
Groups
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ECR
Member of the Bureau
European Conservatives and Reformists Group
2011/03/09 - 9999/12/31
Show earlier groups...
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 Transport and Tourism | 2012/01/19 | 9999/12/31 |
| Substitute of | Committee on Fisheries | 2012/01/19 | 9999/12/31 |
Show earlier commitees...
Delegations
| Role | Delegation | Start | End |
|---|---|---|---|
| Vice-Chair of | Delegation for relations with the Korean Peninsula | 2009/09/17 | 9999/12/31 |
| Substitute of | Delegation for relations with the countries of Southeast Asia and the Association of Southeast Asian Nations (ASEAN) | 2012/03/19 | 9999/12/31 |
Show earlier delegations...
| Role | Delegation | Start | End |
|---|---|---|---|
| Substitute of | Delegation for relations with Canada | 2011/03/28 | 2012/03/18 |
| Substitute of | Delegation for relations with Iran | 2009/09/16 | 2011/03/07 |
| Substitute of | Delegation for relations with Canada | 2009/09/16 | 2011/03/07 |
| Substitute of | Delegation for relations with the People's Republic of China | 2009/09/22 | 2011/03/07 |
| Substitute of | Delegation for relations with India | 2009/09/22 | 2011/03/07 |
| Member of | Delegation for relations with the Korean Peninsula | 2009/09/16 | 2009/09/16 |
Contact
Online
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Brussels
- Phone
- +322 28 45746
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- +322 28 49746
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- Bât. Willy Brandt 05M097
- Full Address
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- City
- Bruxelles/Brussel
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Strasbourg
- Phone
- +333 88 1 75746
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- +333 88 1 79746
- Office
- Bât. Louise Weiss T11020
- Full Address
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- City
- Strasbourg
- Zip
- CS 91024 - F-67070
- Street
- 1, avenue du Président Robert Schuman
Postal
- Europa-Parlamentet
- Rue Wiertz
- Willy Brandt 05M097
- B-1047 Bruxelles
Rapporteur
| Shadow | 2012/2104(INI) | Improving the delivery of benefits from EU environment measures: building confidence through better knowledge and responsiveness |
| Opinion | 2012/2100(INI) | Regional strategies for industrial areas in the European Union |
| Responsible | 2012/2041(INI) | Microbial challenge - rising threats from antimicrobial resistance |
| Shadow | 2012/0337(COD) | General Union Environment Action Programme to 2020: 'Living well, within the limits of our planet' |
| Shadow | 2012/0278(COD) | Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol): Union implementation and ratification |
| Shadow | 2012/0196(COD) | Protection of species of wild fauna and flora by regulating trade therein. Recast |
| Shadow | 2012/0186(COD) | Technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Union. 'Roadworthiness package' |
| Shadow | 2012/0184(COD) | Periodic roadworthiness tests for motor vehicles and their trailers. 'Roadworthiness package' |
| Opinion | 2012/0179(COD) | Fishing in the North-East Atlantic: specific conditions to fishing for deep-sea stocks, provisions for fishing in international waters |
| Shadow | 2012/0179(COD) | Fishing in the North-East Atlantic: specific conditions to fishing for deep-sea stocks, provisions for fishing in international waters |
| Shadow | 2012/0120(NLE) | Biosafety: liability and redress. Nagoya - Kuala Lumpur Supplementary Protocol to the Cartagena Protocol |
| Shadow | 2012/0074(NLE) | Protection of public health: radioactive substances in water intended for human consumption |
| Shadow | 2012/0062(COD) | Port State control: aligning the Directive to the Maritime Labour Convention requirements |
| Shadow | 2011/2318(INI) | External dimension of the Common Fisheries Policy |
| Shadow | 2011/2290(INI) | Reform of the Common Fisheries Policy - overarching communication |
| Opinion | 2011/2175(INI) | How to avoid food wastage: strategies for a more efficient food chain in the EU |
| Shadow | 2011/0461(COD) | Union Civil Protection Mechanism 2014-2020 |
| Shadow | 2011/0327(COD) | Driving licences with the functionalities of a driver card |
| Responsible | 2011/0304(NLE) | Protection of the Mediterranean Sea against pollution resulting from exploration and exploitation of the continental shelf and the seabed and its subsoil. Accession to the Offshore Protocol of the Barcelona Convention |
| Shadow | 2011/0239(COD) | Maritime safety: minimum level of training of seafarers |
| Shadow | 2011/0231(COD) | Aromatised wine products: definition, description, presentation, labelling, and protection of geographical indications |
| Responsible | 2011/0218(COD) | Sustainable exploitation of fishery resources in the Mediterranean Sea: alignment of the Regulation with the TFEU (Commission delegated powers) |
| Opinion | 2010/2210(INI) | Combating illegal fishing at the global level - the role of the EU |
| Opinion | 2010/2158(INI) | European Urban Agenda and its Future in Cohesion Policy |
| Responsible | 2010/2088(INI) | GDP and beyond - Measuring progress in a changing world |
| Opinion | 2009/2230(INI) | European Union strategy for the Baltic Sea Region and the role of macro-regions in the future cohesion policy |
| Opinion | 2009/0169(COD) | Joint Baltic Sea Research and Development Programme (BONUS) |
| Responsible | 2009/0120(NLE) | Cooperation Agreement for the Protection of the Coasts and Waters of the North-East Atlantic against Pollution. Additional Protocol to the Lisbon Agreement |
| Responsible | 2009/0071(CNS) | Protection of the marine environment of the North-East Atlantic, OSPAR Convention 1997: storage of carbon dioxide streams in geological formations (amend. Annexes II and III) |
Born
1947/02/02 GladsaxeAmendments
| Amendments | Dossier |
| 6 |
2008/0028(COD) Provision of food information to consumers (amend. Regulations (EC) No 1924/2006 and (EC) No 1925/2006; repeal. Directives 90/496/EEC and 2000/13/EC)
2009/12/22
ENVI
6 amendments...
Amendment 421 #
Proposal for a regulation Article 31 – paragraph 2 2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml
Amendment 433 #
Proposal for a regulation Article 31 – paragraph 3 3.
Amendment 446 #
Proposal for a regulation Article 32 – paragraph 1 Amendment 447 #
Proposal for a regulation Article 32 – paragraph 2 Amendment 450 #
Proposal for a regulation Article 32 – paragraph 3 3.
Amendment 571 #
Proposal for a regulation Annex XI – part B – table – row 6 a (new) Added sugar 1 45 g __________________________________ 1If refined sugars have been added to a food the content and percent of reference values thereof shall also be specified.
source: PE-431.137
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| 8 |
2010/0377(COD) Control of major-accident hazards involving dangerous substances
2011/06/28
ENVI
8 amendments...
Amendment 49 #
Proposal for a directive Recital 2 (2) Major accidents
Amendment 71 #
Proposal for a directive Article 2 – paragraph 2 – point a (a) military establishments, installations or storage facilities used solely for military purposes;
Amendment 75 #
Proposal for a directive Article 2 – paragraph 2 – point c (c) the transport of dangerous substances and intermediate temporary storage by road, rail, internal waterways, sea or air, outside the establishments covered by this Directive, including loading and unloading and transport to and from another means of transport at docks, wharves or marshalling yards; areas used for such storage purposes shall not be exempted from this Directive if hazardous substances are stored in the area on a regular basis or for long consecutive periods;
Amendment 77 #
Proposal for a directive Article 2 – paragraph 2 – point d Amendment 89 #
Proposal for a directive Article 2 – paragraph 2 – point f Amendment 92 #
Proposal for a directive Article 3 – paragraph 1 – point 3 a (new) 3a. 'neighbouring establishment' or 'neighbouring site' means an establishment or site that is operating within the impact zone of an establishment;
Amendment 130 #
Proposal for a directive Article 6 – paragraph 2 – point b (b) for existing establishments,
Amendment 131 #
Proposal for a directive Article 6 – paragraph 2 – point c (c) for subsequent establishments,
source: PE-467.297
|
| 2 |
2010/2158(INI) European Urban Agenda and its Future in Cohesion Policy
2010/11/11
TRAN
2 amendments...
Amendment 16 #
Draft opinion Paragraph 2 2. Strongly supports the use and promotion of integrated urban mobility plans (urban travel plans) and regular connections to surrounding and rural areas;
Amendment 39 #
Draft opinion Paragraph 5 5. Underlines the vital importance of transport infrastructure to the regions and cities of Europe and calls on the Commission to provide innovative financing solutions for its development without disadvantaging the connections to the rural districts;
source: PE-452.758
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| 59 |
2011/0195(COD) Common Fisheries Policy
2012/06/25
PECH
44 amendments...
Amendment 578 #
Proposal for a regulation Part 1 – article 1 – paragraph 1 – point a (a) conservation, management and
Amendment 599 #
Proposal for a regulation Part 1 – article 1 – paragraph 2 a (new) 2 a. Contribute to a fair standard of living for those who depend on fishing activities within and outside the Union.
Amendment 671 #
Proposal for a regulation Part 1 – article 2 – paragraph 4 a (new) 4 a. The Common Fisheries Policy shall promote a shift towards low-impact fishing methods and ensure that the fishing capacity of the fleets is aligned with exploitation levels that comply with paragraph 2.
Amendment 797 #
Proposal for a regulation Part 1 – article 4 – paragraph 1 – point b (b) establishment of fishing opportunities and other measures in accordance with the best available scientific advice;
Amendment 819 #
Proposal for a regulation Part 1 – article 4 – paragraph 1 – point f (f) consistence with the integrated maritime policy, and
Amendment 872 #
Proposal for a regulation Part 1 – article 5 – paragraph 1 – indent 8 – ‘ecosystem-based approach to fisheries management’ means an approach ensuring that benefits from living aquatic resources are high while the direct and indirect impacts of human activities, including fishing operations on marine ecosystems, are
Amendment 895 #
Proposal for a regulation Part 1 – article 5 – paragraph 1 – indent 12 – ‘
Amendment 942 #
Proposal for a regulation Part 1 – article 5 – paragraph 1 – indent 19 – ‘fishing capacity’ means a vessel's tonnage in GT (Gross Tonnage) and its power in kW (Kilowatt) as defined in Articles 4 and 5 of Council Regulation (EEC) No 2930/8635 in addition to characteristics of onboard equipments;
Amendment 1066 #
Proposal for a regulation Part 3 – article 7 – paragraph 1 – point c a (new) (ca) adopting measures to meet requirements under environmental legislation;
Amendment 1143 #
Proposal for a regulation Part 3 – article 8 – paragraph 1 – point e (e) requirements for fishing vessels to cease operating in an area for a defined minimum period in order to protect
Amendment 1183 #
Proposal for a regulation Part 3 – article 9 – paragraph 2 – point a (a) the basis for fixing fishing opportunities for the fish stocks concerned on the basis of predefined
Amendment 1186 #
Proposal for a regulation Part 3 – article 9 – paragraph 2 – point b (b) measures capable of effectively preventing
Amendment 1208 #
Proposal for a regulation Part 3 – article 9 – paragraph 3 3. Multiannual plans shall, where possible, cover either fisheries exploiting single fish stocks or fisheries exploiting a mixture of stocks, taking due account of interactions between stocks
Amendment 1218 #
Proposal for a regulation Part 3 – article 9 – paragraph 4 4. Multiannual plans shall comply with the objectives in Articles 2 and 3, be based on the precautionary approach to fisheries management
Amendment 1252 #
Proposal for a regulation Part 3 – article 10 – paragraph 1 1. Multiannual plans shall provide for adaptations of the fishing mortality rate, resulting in
Amendment 1282 #
Proposal for a regulation Part 3 – article 11 – paragraph 1 – point a (a) the geographical scope, in terms of stocks, fishery and the marine ecosystem to which the multiannual plan shall be applied;
Amendment 1373 #
Proposal for a regulation Part 3 – article 11 – paragraph 1 – point j a (new) (ja) New point (k) a description of the role, abundance and diversity of fish in relation to biodiversity and marine food webs and measures to restore and maintain the functionality of such food webs, where they are impacted on by fishing activities;
Amendment 1377 #
Proposal for a regulation Part 3 – article 11 – paragraph 1 – point j b (new) (jb) measures to protect species listed in Annex IV of Directive 92/43/EEC and Directive 2009/147/EC from the impacts of fishing.
Amendment 1433 #
Proposal for a regulation Part 3 – article 14 – paragraph 1 – introductory part Technical measures frameworks to ensure the protection of marine biological resources and the reduction of the impact of fishing activities on fish stocks and on marine eco-systems shall be established in relation to fishing activities in and outside of EU waters. Technical measures frameworks shall:
Amendment 1442 #
Proposal for a regulation Part 3 – article 14 – paragraph 1 – point a (a) contribute to maintaining or restoring
Amendment 1448 #
Proposal for a regulation Part 3 – article 14 – paragraph 1 – point b (b) reduce catches of
Amendment 1485 #
Proposal for a regulation Part 3 – article 15 – paragraph 1 – introductory part 1. All catches of
Amendment 1544 #
Proposal for a regulation Part 3 – article 15 – paragraph 2 2. Minimum conservation reference sizes based on the best available scientific advice shall be established for the fish stocks
Amendment 1569 #
Proposal for a regulation Part 3 – article 15 – paragraph 4 4. Member States shall ensure that Union fishing vessels flying their flag are equipped to
Amendment 1613 #
Proposal for a regulation Part 3 – article 16 – paragraph 3 3. Fishing opportunities shall not exceed the level specified in the scientific advice and shall comply with quantifiable targets, time frames and margins established in accordance with Article 9(2) and 11(b), (c) and (h).
Amendment 1620 #
Proposal for a regulation Part 3 – article 16 – paragraph 3 a (new) 3a. If no corresponding multiannual plan has been adopted for a commercially used fish stock in EU waters, an exploitation rate shall be established at the latest by 2015 in order to restore and maintain the population well above levels capable of producing the maximum sutainable yield by 2020 at the latest.
Amendment 1625 #
Proposal for a regulation Part 3 – article 16 – paragraph 4 a (new) 4 a. The Commission shall present to the European Parliament and to the Council an annual report assessing whether current fishing opportunities are proving effective in restoring and maintaining populations of harvested species at levels above those which can produce the target laid down in Article 2.2.
Amendment 1696 #
Proposal for a regulation Part 3 – article 19 – paragraph 1 – subparagraph 1 (new) The Commission shall assess whether the measures are consistent with the multiannual plans and comply with the provisions set out in Article 17 and the objectives set out in Articles 2 and 3.
Amendment 1745 #
Proposal for a regulation Part 3 – article 21 – paragraph 1 – point d a (new) (d a) measures to protect species listed in Annex IV of Directive 92/43/EEC and Directive 2009/147/EC from the impact of fishing;
Amendment 1809 #
Proposal for a regulation Part 4 – article 27 – paragraph 1 – introductory part 1. Each Member State
Amendment 2051 #
Proposal for a regulation Part 5 – article 34 – paragraph 4 4. Member States shall ensure that
Amendment 2054 #
Proposal for a regulation Part 5 – article 34 – paragraph 4 a (new) 4 a. The Commission shall be empowered to adopt delegated acts in accordance with Article 55 concerning the re-calculation of the fishing capacity ceilings as referred to in paragraphs 1 and 2.
Amendment 2266 #
Proposal for a regulation Part 8 – article 43 – paragraph 1 – point a (a) improving the quality, competitiveness and ecological sustainability of the aquaculture industry
Amendment 2292 #
Proposal for a regulation Part 8 – article 43 – paragraph 1 – point d a (new) (d a) phasing-out of unsustainable feed, especially those obtained from wild capture fisheries.
Amendment 2320 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point b Amendment 2332 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d a (new) (d a) Requirements for coherent management of capture based aquaculture and the related wild stocks ensuring sustainability in both phases of the production aiming at a progressive phasing out of this type of activity.
Amendment 2335 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d b (new) (d b) provisions for the use of sustainable feeds;
Amendment 2338 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d c (new) (d c) food safety, animal health and welfare, sustainable environment;
Amendment 2340 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d d (new) (d d) the requirement to use sustainable feeds, the potential to use animal by- products and the development of alternatives to fish meal and oil;
Amendment 2341 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d e (new) (d e) standardisation and consistency of Environmental Impact Assessment (EIA) Directive in order to reduce environmental impacts and the effects of climate change
Amendment 2442 #
Proposal for a regulation Part 11 – article 50 – paragraph 2 a (new) The Union shall ensure that detailed and timely information on the objectives and administration of financial assistance, including relevant budgets and evaluations, are publicly available.
Amendment 2505 #
Proposal for a regulation Part 12 – article 54 – paragraph 1 1. Advisory Councils shall be composed of organizations representing the fisheries operators and other interest groups affected by the Common Fisheries Policy as well as scientists and representative of relevant national and regional administrations.
Amendment 2538 #
Proposal for a regulation Part 14 – article 57 – paragraph 4 Amendment 2544 #
Proposal for a regulation Part 14 – article 58 – paragraph 1 a (new) The Commission shall report to the European Parliament and the Council on the operation of the Common Fisheries Policy by the end of 2022.
source: PE-491.358
2012/12/03
ENVI
15 amendments...
Amendment 109 #
Proposal for a regulation Recital 3 (3) The Common Fisheries Policy should ensure that fishing and aquaculture activities contribute to long-term sustainable environmental, economic, and social conditions.
Amendment 118 #
Proposal for a regulation Recital 7 (7) Sustainable
Amendment 129 #
Proposal for a regulation Recital 22 (22) In view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing activities, it is necessary to ensure the relative stability of
Amendment 134 #
Proposal for a regulation Recital 38 (38) The Union should promote the objectives of the Common Fisheries Policy internationally. To this end, the Union should strive to improve the performance of regional and international organisations in conservation and sustainable management of international fish stocks, by promoting decision-making based on science and improved compliance, increased transparency and stakeholder participation, and by combating illegal, unreported and unregulated (IUU) fishing activities.
Amendment 138 #
Proposal for a regulation Recital 42 (42) Aquaculture should contribute to the preservation of the food production potential on a sustainable basis throughout the Union so as to guarantee long-term food security for European citizens and to contribute to the growing world aquatic food demand. Aquaculture should not increase the fishing pressure on wild stocks and should be subjected to environmental impact assessment prior to any expansion.
Amendment 145 #
Proposal for a regulation Part 1 – article 1 – paragraph 1 – point a (a) conservation, management and
Amendment 162 #
Proposal for a regulation Part 1 – article 2 – paragraph 3 3. The Common Fisheries Policy shall implement the ecosystem-based approach to fisheries and aquaculture management to ensure that the impacts of fishing activities on the marine ecosystem are limited.
Amendment 323 #
Proposal for a regulation Part 3 – article 11 – paragraph 1 a (new) 1a. a description of the role, abundance and diversity of fish in relation to biodiversity and marine food webs and measures to restore and maintain the functionality of such food webs, where they are impacted on by fishing activities;
Amendment 344 #
Proposal for a regulation Part 3 – article 14 – paragraph 1 – point a (a) contribute to maintaining or restoring
Amendment 345 #
Proposal for a regulation Part 3 – article 14 – paragraph 1 – point b (b) reduce catches of
Amendment 411 #
Proposal for a regulation Part 4 – article 27 – paragraph 1 – introductory part 1. Each Member State
Amendment 512 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point c (c) indicators for environmental, economic and social sustainability, food safety, animal health and welfare, sustainable environment;
Amendment 515 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 – point d (d) assessment of other possible cross- bordering effects on neighbouring Member States, standardisation and consistency of Environmental Impact Assessment (EIA) Directive in order to reduce environmental impacts and the effects of climate change.
Amendment 522 #
Proposal for a regulation Part 8 – article 43 – paragraph 4 -point d a (new) (da) the requirement to use sustainable feeds, the potential to use animal by- products and the development of alternatives to fish meal and oil;
Amendment 532 #
Proposal for a regulation Part 11 – article 51 – paragraph 3 3. Member States shall ensure that Union financial assistance is granted only if no
source: PE-483.857
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| 10 |
2011/0196(COD) Road transport: tachograph system
2012/03/29
TRAN
10 amendments...
Amendment 146 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 2 – paragraph 2 – j Amendment 158 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 3 a (new) Article 3a Essential requirements 1. Tacographs, tachograph cards and record sheets must comply with stringent technical, functional and other requirements so as to ensure that they fulfil the essential requirements set out in paragraph 2 and that they achieve the objectives of this Regulation. 2. To allow for efficient control of compliance with the applicable social legislation the tachograph shall comply with the following essential requirements: (a) to record accurate and reliable data related to the driver activity and the vehicle; (b) to be secure, in order to guarantee the integrity and the origin of the source of data recorded by and retrieved from vehicle units, motion sensors and tachograph cards; (c) to be interoperable; (d) to be user friendly; 3. Tachographs must be designed and used in such a way as to ensure privacy and personal data protection. 4. Tachographs shall be positioned in the vehicle at the driver's field of vision and in such a way as to allow the driver to access the necessary functions from his seat. 5. Downloading of data shall be performed with the minimum delay to transport undertakings or drivers. 6. Downloading of data may not alter or delete stored data. The downloading of the detailed speed file may not be necessary to ensure compliance with Regulation (EC) No 561/2006, but may be used for other purposes, such as accident investigation.
Amendment 172 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 4 – Title Recording of
Amendment 176 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 4 – paragraph 1 Amendment 185 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 4 – paragraph 2 a (new) 2 a. The specifications shall establish the type of events that may trigger an automatic record of position and the situation for which a manual record should remain possible. They shall confirm the location data format, including the UTC data format (legal time). The specification shall specify how to correlate GNSS with other vehicle motion data.
Amendment 190 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 5 – paragraph 1 1. In order to facilitate targeted (roadside) checks by the competent control authorities, the
Amendment 193 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 5 – paragraph 2 2.
Amendment 204 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 5 – paragraph 8 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 39 concerning the
Amendment 208 #
Proposal for a regulation Article 1 – point 1 Council Regulation (EEC) No 3821/85 Article 6 – paragraph 2 2. For the purpose of paragraph 1, vehicles put into service for the first time
Amendment 326 #
Proposal for a regulation Article 2 – paragraph 2 Council Regulation (EEC) No 561/2006 Article 13(1) – (d), (f), (p) The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘1
source: PE-485.915
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| 4 |
2011/0206(COD) Fish stock conservation: multiannual plan for the Baltic salmon stock
2012/04/16
ENVI
4 amendments...
Amendment 22 #
Proposal for a regulation Title 1 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a multiannual plan for the Baltic salmon stock and the fisheries
Amendment 36 #
Proposal for a regulation Article 4 – paragraph 1 – point a a) the Baltic salmon stock is
Amendment 45 #
Proposal for a regulation Article 7 – paragraph 1 1. The annual TAC for the salmon stocks at sea shall not exceed the level corresponding to a fishing mortality rate of 0.1. Harvesting of salmon that takes place in rivers and at sea within the baselines shall be reduced within six years of the entry into force of this Regulation and evaluated within eight years of the entry into force of this Regulation. In order to allow the wild salmon populations to grow beyond levels of maximum sustainable yields the harvesting of salmons in the spawning period should be prohibited in the natural spawning areas.
Amendment 69 #
Proposal for a regulation Annex 3 – paragraph 1 – introductory part source: PE-486.132
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| 2 |
2011/0218(COD) Sustainable exploitation of fishery resources in the Mediterranean Sea: alignment of the Regulation with the TFEU (Commission delegated powers)
2012/07/05
PECH
2 amendments...
Amendment 28 #
Proposal for a regulation Article 1 – point 1 b (new) Regulation (EC) No 1967/2006 Article 7 − paragraphs 4 and 5 (1b) Article 7 is amended as follows: (a) Paragraph 4 is replaced by the following: "4. If the Commission considers that the fisheries management measures notified pursuant to paragraph 3 are not sufficient to ensure a high level of protection of resources and the environment, it may, after consulting the Member State concerned, request it to amend the measure within three months from the date of notification of the request. If the Commission considers that the Member State's fisheries management measures have not been changed, or have been amended inappropriately, and are still not sufficient to ensure a high level of protection of resources and of the environment, it shall be empowered to adopt delegated acts, in accordance with Article 30a, designating a fishing protected area or laying down fisheries management measures in respect of the waters concerned." (b) Paragraph 5 is replaced by the following: "5. Where a Member State proposes to designate a fishing protected area within its territorial waters that is liable to affect the vessels of another Member State, it shall notify the Commission, that other Member State and the Regional Advisory Council concerned, before adopting that designation. The Member States and Regional Advisory Council concerned may submit their written comments to the Commission on the proposed designation within 30 working days from the date of notification of the proposed designation. After considering any such comments submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 30a, that confirm, cancel or amend the designation within 60 working days from that date of notification of the proposed designation."
Amendment 29 #
Proposal for a regulation Article 1 – point 2 c (new) Regulation (EC) No 1967/2006 Article 19 − paragraphs 8 and 9 source: PE-489.340
|
| 1 |
2011/0280(COD) Common agricultural policy (CAP): direct payments to farmers under support schemes 2014-2020
2012/05/22
ENVI
1 amendments...
Amendment 64 #
Proposal for a regulation Recital 43 (43) With a view to strengthening their rural development policy, Member States should be given the possibility to transfer funds from their direct payments ceiling to their support assigned for rural development.
source: PE-489.554
|
| 29 |
2011/0380(COD) European Maritime and Fisheries Fund (EMFF) 2014-2020
2013/01/17
PECH
29 amendments...
Amendment 189 #
Proposal for a regulation Recital 9 (9) It is paramount to better integrate environmental concerns into the CFP which should deliver on the objectives and targets of the Union's environmental policy and the Europe 2020 Strategy. The CFP is aimed at a
Amendment 219 #
Proposal for a regulation Recital 31 (31) In order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship. Therefore the EMFF should support innovative operations and business development which add value to the industry and food production and offer adequate environmental protection. All such operations should be economically viable.
Amendment 262 #
Proposal for a regulation Recital 37 (37)
Amendment 286 #
Proposal for a regulation Recital 39 (39)
Amendment 345 #
Proposal for a regulation Recital 48 (48) New forms of income combined with aquaculture activities have already shown their added value for business development. Therefore the EMFF should support these complementary activities outside aquaculture such as angling- tourism, educational or environmental activities. In particular innovations that contribute to the use of waste materials including dissolved nutrients, the production of renewable energy and the integration of different trophic levels (IMTA) such as fish alongside shellfish and algae should be supported.
Amendment 349 #
Proposal for a regulation Recital 49 (49) Another important form of increasing the income of aquaculture enterprises is adding value to their products by processing and marketing their own production, as well as introducing new species with good market and environmental prospects and thus diversifying their production.
Amendment 371 #
Proposal for a regulation Recital 54 Amendment 391 #
Proposal for a regulation Recital 62 Amendment 531 #
Proposal for a regulation Article 5 – paragraph 1 – point a (a) promoting
Amendment 641 #
Proposal for a regulation Article 6 – paragraph 1 – point 3 – introductory part (3) Fostering sustainable, innovative, competitive and knowledge based aquaculture through the focus on the following areas:
Amendment 833 #
Proposal for a regulation Article 15 – paragraph 6 Amendment 940 #
Proposal for a regulation Article 20 – paragraph 1 – point o – point i – indent 3 – an evaluation of the effects of the fishing and aquaculture sectors on the ecosystem.
Amendment 1204 #
Proposal for a regulation Article 34 – title Support to systems of
Amendment 1212 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 1.
Amendment 1218 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) the design and development of technical and administrative means necessary for the creation or functioning of a
Amendment 1227 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) stakeholder participation in designing and developing
Amendment 1232 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) the monitoring and evaluation of
Amendment 1236 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d) the management of
Amendment 1241 #
Proposal for a regulation Article 34 – paragraph 2 2. Support under paragraph 1
Amendment 1276 #
Proposal for a regulation Article 36 – paragraph 1 – introductory part 1. In order to reduce the impact of fishing on the marine environment, foster the elimination of discards and facilitate the transition to the exploitation of living marine biological resources
Amendment 1278 #
Proposal for a regulation Article 36 – paragraph 1 – point a a (new) (a a) changing of fishing gear and the related vessel modification, necessary know-how and training, provided that the new gear has demonstrably better size and species selectivity, a limited impact on the marine environment and vulnerable marine ecosystems and does not increase the ability of the fishing vessel to catch fish;
Amendment 1523 #
Proposal for a regulation Article 44 – paragraph 1 1. Support under this Chapter shall be limited to aquaculture enterprises
Amendment 1612 #
Proposal for a regulation Article 47 – paragraph 1 – point b (b) diversification of the income of aquaculture enterprises through the development of new aquaculture species with good market and environmental prospects;
Amendment 1700 #
Proposal for a regulation Article 51 – paragraph 2 – point c (c) submit an economically and environmentally viable business plan for the development of their aquaculture activities.
Amendment 1719 #
Proposal for a regulation Article 52 – paragraph 1 - point e a (new) (e a) that promote the research of aquaculture techniques with low environmental impact.
Amendment 1736 #
Proposal for a regulation Article 54 – paragraph 1 – point a (a) aquaculture methods that use existing structures like natural ponds, and aim to create an activity that is semi-natural and compatible with specific environmental needs
Amendment 1779 #
Proposal for a regulation Article 57 A
Amendment 1984 #
Proposal for a regulation Article 71 – paragraph 1 – point f (f) conducting regional, national or transnational promotional campaigns for environmentally sustainable fishery and aquaculture products.
Amendment 2206 #
Proposal for a regulation Article 94 – paragraph 3 – point a source: PE-496.422
|
| 2 |
2011/0421(COD) Serious cross-border threats to health
2012/09/17
ENVI
2 amendments...
Amendment 34 #
Proposal for a decision Recital 3 (3) Apart from communicable diseases, a number of other
Amendment 40 #
Proposal for a decision Recital 11 (11) Contrary to communicable diseases, whose surveillance at the Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health, with perhaps the exception of antimicrobial resistance, do not currently necessitate a systematic monitoring. A risk-based approach, whereby monitoring networks are set up ad hoc and on a temporary basis, is therefore more appropriate to those other threats.
source: PE-496.383
|
| 48 |
2011/0461(COD) Union Civil Protection Mechanism 2014-2020
2012/10/18
ENVI
48 amendments...
Amendment 65 #
Proposal for a decision Article 1 – paragraph 1 1. The Union Civil Protection Mechanism (hereinafter referred to as ‘the Mechanism’) shall aim to s
Amendment 69 #
Proposal for a decision Article 1 – paragraph 2 2. The protection to be ensured by the Mechanism shall cover primarily people, but also the environment and property, including cultural heritage, against all natural and man-made disasters, including
Amendment 72 #
Proposal for a decision Article 1 – paragraph 3 3. The Union intervention enhances prevention, preparedness and response capacity of Member States to face major disasters minimising human and material loss where appropriate. The objective of this Decision cannot always be sufficiently achieved by Member States operating alone and can sometimes be better achieved at Union level by reason of the scale or effects of the proposed action.
Amendment 81 #
Proposal for a decision Article 2 – paragraph 2 2. This Decision shall apply to actions to assist with the response to immediate adverse consequences of a major disaster regardless of its nature, inside or outside the Union, where a request is made for assistance
Amendment 85 #
Proposal for a decision Article 3 – paragraph 1 – introductory part 1. The Mechanism shall support
Amendment 87 #
Proposal for a decision Article 3 – paragraph 1 – point b (b) to enhance the Member States' and the European Union's state of preparedness to respond to disasters;
Amendment 90 #
Proposal for a decision Article 3 – paragraph 1 – point c (c) to facilitate rapid and efficient
Amendment 94 #
Proposal for a decision Article 3 – paragraph 2 – subparagraph 1 – point a (a) progress in implementing the disaster prevention framework
Amendment 108 #
Proposal for a decision Article 4 – point 4 4. ‘preparedness’ means a state of readiness and capability of human and material means enabling them to ensure an effective rapid response to a
Amendment 110 #
Proposal for a decision Article 4 – point 6 6. ‘early warning’ means the timely and effective provision of information that allows action to be taken to avoid or reduce risks and
Amendment 112 #
Proposal for a decision Article 4 – point 9 9. ‘risk management plan’ means planning instrument prepared by a Member State
Amendment 116 #
Proposal for a decision Article 5 – point c (c) establish and regularly update an overview of natural and man-made
Amendment 121 #
Proposal for a decision Article 5 – point d (d) promote and support the development
Amendment 127 #
Proposal for a decision Article 6 – paragraph 1 1. In order to ensure an effective cooperation within the Mechanism, Members States shall communicate to the Commission a description of their risk management
Amendment 131 #
Proposal for a decision Article 6 – paragraph 2 2. The description of their risk management
Amendment 139 #
Proposal for a decision Article 6 – paragraph 3 3. Member States shall ensure by the end of 2016 at the latest that descriptions of their risk management
Amendment 145 #
Proposal for a decision Article 7 – point a (a) establish and manage the
Amendment 147 #
Proposal for a decision Article 7 – point b (b) manage a Common
Amendment 149 #
Proposal for a decision Article 7 – point d – indent 2 – facilitating, when necessary, the coordination of
Amendment 151 #
Proposal for a decision Article 7 – point e (e) establish and maintain a capability to provide logistical support and assistance for expert teams, modules and other response capacities deployed under the Mechanism,
Amendment 152 #
Proposal for a decision Article 7 – point f Amendment 157 #
Proposal for a decision Article 7 – point g Amendment 166 #
Proposal for a decision Article 9 – paragraph 6 6. Member States shall designate
Amendment 168 #
Proposal for a decision Article 10 – paragraph 1 – introductory part 1. The Commission and Member States shall work together to improve the planning of disaster response operations under the Mechanism. For this purpose:
Amendment 169 #
Proposal for a decision Article 10 – paragraph 1 – point a (a) the Commission, in cooperation with Member States, shall
Amendment 172 #
Proposal for a decision Article 10 – paragraph 2 2. The Commission and the Member States shall identify and
Amendment 173 #
Proposal for a decision Article 11 – title European
Amendment 174 #
Proposal for a decision Article 11 – paragraph 1 1. A European
Amendment 186 #
Proposal for a decision Article 12 – paragraph 2 – introductory part 2. The Commission shall support Member States in addressing the capacity gaps and, if desired by the Member States, in filling these gaps in the most appropriate and cost-effective way, including by:
Amendment 187 #
Proposal for a decision Article 12 – paragraph 2 – point b (b) facilitating access to or developing response capacities at Union level, whe
Amendment 192 #
Proposal for a decision Article 13 – paragraph 1 – introductory part 1. The Commission, in cooperation with the Member States, shall carry out the following tasks in the field of training, exercises, lessons learnt and knowledge dissemination:
Amendment 194 #
Proposal for a decision Article 14 – paragraph 2 2. In the event of a major disaster within the Union, or of the imminence thereof, which may result in a call for assistance from one or more Member States, the Member State in which the
Amendment 197 #
Proposal for a decision Article 15 – paragraph 1 1. Where a major disaster occurs within the Union, or in the imminence thereof, affected Member States may request assistance through the ERC. The request shall be as specific as possible.
Amendment 199 #
Proposal for a decision Article 15 – paragraph 2 2.
Amendment 202 #
Proposal for a decision Article 15 – paragraph 3 – point c (c) together with the requesting Member State(s) propose a response plan based on the needs on the ground and pre-developed contingency plans, and invite Member States to deploy specific capacities from the European Emergency Response Capacity in accordance with the plan;
Amendment 213 #
Proposal for a decision Article 16 – paragraph 2 – point a – introductory part (a) maintaining a continuous dialogue with Member States‘ contact points in order to ensure an effective and coherent European
Amendment 226 #
Proposal for a decision Article 17 – paragraph 5 Amendment 238 #
Proposal for a decision Article 21 – point c (c) developing and maintaining a
Amendment 240 #
Proposal for a decision Article 21 – point g – subparagraph 2 The Union financial contribution for actions under this point shall take the form of unit costs determined per type of capacity and shall not exceed
Amendment 242 #
Proposal for a decision Article 21 – point h – sub-paragraph 2 Actions taken in accordance with this point shall be based on a thorough needs and cost-benefit analysis per type of capacity, taking into account the probability and impact of the relevant risks. The Union financial contribution for the actions under this point shall not exceed
Amendment 244 #
Proposal for a decision Article 21 – point i (i) ensuring the availability of
Amendment 245 #
Proposal for a decision Article 21 – point j (j) assisting Member States in prepositioning
Amendment 246 #
Proposal for a decision Article 22 – point b (b) deploying the capacities referred to in points (g), (h) and (i) of Article 21 in the event of major disasters,
Amendment 250 #
Proposal for a decision Article 23 – paragraph 1 – point a (a) providing and sharing information on equipment and transport resources that
Amendment 252 #
Proposal for a decision Article 23 – paragraph 2 – introductory part 2. The amount of Union financial support for transport resources and related logistics shall not exceed
Amendment 253 #
Proposal for a decision Article 23 – paragraph 2 – point a Amendment 254 #
Proposal for a decision Article 23 – paragraph 2 – point b Amendment 255 #
Proposal for a decision Article 23 – paragraph 2 – point c source: PE-496.667
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| 8 |
2011/2175(INI) How to avoid food wastage: strategies for a more efficient food chain in the EU
2011/10/21
ENVI
8 amendments...
Amendment 19 #
Draft opinion Paragraph 1 a (new) 1a. Stresses that (food-) waste should be recognised as a resource. If it under no circumstances can be used as foods, the opportunities to use waste in biogas plants should be improved and biogas production should be further supported.
Amendment 30 #
Draft opinion Paragraph 2 a (new) 2a. Is of the opinion that packaging must be optimised and reduced. Research and innovation in the field of intelligent packaging should be promoted to explore good solutions for the actual use by date for individual products.
Amendment 34 #
Draft opinion Paragraph 2 b (new) 2b. Believes that sales by loose weight and in customised portions in supermarkets should be encouraged to delimit that customers purchase excess food.
Amendment 35 #
Draft opinion Paragraph 2 c (new) 2c. Stresses that clearly indicated 'sell by' and 'use by' dates on foods should be introduced on food packaging in order to guide consumers regarding the shelf life of a product, before and after purchase.
Amendment 36 #
Draft opinion Paragraph 2 d (new) 2d. Calls for investigation into whether previously issued regulations cause unnecessary rules that forces supermarkets and food shops to throw away perfectly usable food.
Amendment 37 #
Draft opinion Paragraph 2 e (new) 2e. Considers that, where possible, the regulation should be adjusted, to ease food banks, charity organisations', public institutions etc. possibilities for collecting and redistributing leftover food to the needy, without compromising food security.
Amendment 51 #
Draft opinion Paragraph 3 a (new) 3a. Underlines that concrete initiatives for more and better consumer information and education should be introduced, in order to raise awareness and knowledge among the public about sound food handling and how to delimit food waste to a minimum.
Amendment 54 #
Draft opinion Paragraph 3 b (new) 3b. Is of the opinion that education and awareness raising about food as a precious resource should be introduced from early age.
source: PE-474.043
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| 4 |
2011/2217(DEC) 2010 discharge: European Environment Agency (EEA)
2012/08/31
ENVI
4 amendments...
Amendment 4 #
Draft opinion Paragraph 5 5. Has taken careful note of the extensive and detailed correspondence between the different decision taking levels in the EEA, i.e. the Management Board and the Executive Director, and the CONT rapporteur both before and after the plenary decision to
Amendment 7 #
Draft opinion Paragraph 10 10. Welcomes, in a general context, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up;
Amendment 8 #
Draft opinion Paragraph 11 11. Believes that the discharge decision for the EEA
Amendment 10 #
Draft opinion Paragraph 12 12.
source: PE-494.703
|
| 5 |
2011/2220(DEC) 2010 discharge: European Medicines Agency (EMA)
2012/08/31
ENVI
5 amendments...
Amendment 3 #
Draft opinion Paragraph 5 5.
Amendment 8 #
Draft opinion Paragraph 6 6. Points out again that the Court of Auditors made observations on carryovers, IT contracts and the payment system for services provided by national authorities but despite these inconsistencies, considered the Agency's accounts of 2010 reliable, legal and regular;
Amendment 9 #
Draft opinion Paragraph 8 8. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up;
Amendment 11 #
Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA
Amendment 13 #
Draft opinion Paragraph 10 10. Is of the opinion that, on the basis of the information available, discharge
source: PE-494.704
|
| 5 |
2011/2226(DEC) 2010 discharge: European Food Safety Authority (EFSA)
2012/08/31
ENVI
5 amendments...
Amendment 2 #
Draft opinion Paragraph 2 2.
Amendment 12 #
Draft opinion Paragraph 7 7. Is informed about the detailed correspondence between the administration level of the EFSA and the CONT rapporteur both before and after the plenary decision to
Amendment 14 #
Draft opinion Paragraph 9 9. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up;
Amendment 16 #
Draft opinion Paragraph 10 10. Believes
Amendment 18 #
Draft opinion Paragraph 11 11. Is
source: PE-494.706
|
| 1 |
2012/0055(COD) Ship recycling
2012/12/20
ENVI
1 amendments...
Amendment 141 #
Proposal for a regulation Recital 14 (14) Since the objective to prevent, reduce or eliminate adverse effects on human health and the environment caused by the recycling, operation and maintenance of ships flying the flag of a Member State cannot always be sufficiently achieved by the Member States alone due to the international character of shipping and ship recycling, and can therefore in some cases be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
source: PE-502.035
|
| 2 |
2012/0179(COD) Fishing in the North-East Atlantic: specific conditions to fishing for deep-sea stocks, provisions for fishing in international waters
2013/02/25
ENVI
2 amendments...
Amendment 16 #
Proposal for a regulation Recital 2 (2) The Union is committed to implementing the Resolutions adopted by the General Assembly of the United Nations, in particular Resolutions 61/105 and 64/72, which call on States and Regional Fisheries Management Organisations to ensure the protection of vulnerable deep-sea marine ecosystems from the destructive impact of bottom fishing gears, as well as the sustainable exploitation of deep-sea fish stocks. Furthermore the Union should act as a leader in the establishment and implementation of good governance measures for the sustainable management of deep-sea fisheries within international fora in line with the UNGA and FAO resolutions adopted in this Regulation.
Amendment 36 #
Proposal for a regulation Article 10 – paragraph 2 – point b a (new) ba) There shall be no fishing opportunities allocated for targeted fishing or by-catch of those deep-sea species identified in accordance with Article 3(e) as being most vulnerable.
source: PE-506.073
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| 6 |
2012/0184(COD) Periodic roadworthiness tests for motor vehicles and their trailers. 'Roadworthiness package'
2013/03/28
TRAN
6 amendments...
Amendment 139 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 – indent 2 –
Amendment 142 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 – indent 3 Amendment 148 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 – indent 4 Amendment 191 #
Proposal for a regulation Article 5 – paragraph 1 – indent 1 – Vehicles of categories L1e, L2e, L3e, L4e
Amendment 202 #
Proposal for a regulation Article 5 – paragraph 1 – indent 2 – Vehicles of category M1, N1, O2, L5e, L6e and
Amendment 214 #
Proposal for a regulation Article 5 – paragraph 2 source: PE-507.994
|
| 10 |
2012/0186(COD) Technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Union. 'Roadworthiness package'
2013/03/28
TRAN
10 amendments...
Amendment 34 #
Proposal for a regulation Recital 3 (3) Roadworthiness testing is a part of a wider regime ensuring that vehicles are kept in a condition which complies with the existing safety and environmental
Amendment 37 #
Proposal for a regulation Recital 6 Amendment 44 #
Proposal for a regulation Recital 10 Amendment 48 #
Proposal for a regulation Recital 17 (17) In order to allow a monitoring of the roadside inspection regime implemented in the Union Member States should communicate
Amendment 84 #
Proposal for a regulation Article 5 – paragraph 1 Each Member State shall carry out in every calendar year a total number of initial roadside inspections, corresponding to at least
Amendment 89 #
Proposal for a regulation Article 6 – paragraph 1 Amendment 91 #
Proposal for a regulation Article 6 – paragraph 2 Amendment 92 #
Proposal for a regulation Article 6 – paragraph 3 Amendment 103 #
Proposal for a regulation Article 9 – paragraph 1 Amendment 128 #
Proposal for a regulation Article 11 – paragraph 1 1. A more detailed roadside inspection shall be carried out using a mobile inspection unit, or in a testing centre as referred to in Regulation (EU) NO XXX/XXX of the European Parliament and of the Council of [date] on roadworthiness tests for motor vehicles and for their trailers. In the case of an inspection carried out in a testing centre, controllers shall book in advance a free capacity in the centre so that periodic inspections already scheduled will not be affected.
source: PE-508.051
|
| 51 |
2012/0192(COD) Clinical trials on medicinal products for human use
2013/03/01
ENVI
24 amendments...
Amendment 76 #
Proposal for a regulation Recital 1 (1) In a clinical trial the safety
Amendment 79 #
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 it should be ensured that those granting the authorisation do not have conflicts of interest and are independent of the sponsor, the institution of the trial site and the investigators involved.
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 121 #
Proposal for a regulation Recital 21 (21) It should be left to Member States to establish the language requirements for the application dossier. To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should
Amendment 129 #
Proposal for a regulation Recital 24 (24) In accordance with international guidelines, the free and informed consent of the subject should be in writing, save in exceptional situations. It should be based on information which is clear, relevant and understandable to the subject, and should be in the subject's own language.
Amendment 132 #
Proposal for a regulation Recital 26 (26) In order for the sponsor to assess all potentially relevant safety information, the investigator should report to him all serious adverse events and all suspected serious adverse events.
Amendment 134 #
Proposal for a regulation Recital 28 (28) The Agency should as soon as possible forward this information to the Member States for them to assess this information.
Amendment 142 #
Proposal for a regulation Recital 33 (33) During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial. This should be reported to the Member States concerned, as well as to the Agency, in order for action to be taken by those Member States, where necessary.
Amendment 176 #
Proposal for a regulation Recital 64 a (new) (64a) As stated in the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era-Putting Competitiveness and Sustainability at Centre Stage", systematic evaluations of legislation should become an integral part of smart regulation. To ensure that this Regulation keeps pace with scientific and technological progress with regard to the organization and conduct of clinical trials and that it interfaces with other legal provisions, the Commission should periodically report on the experience with and functioning of the Regulation, and present its conclusions thereof.
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 507 #
Proposal for a regulation Article 32 – paragraph 1 – point a (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, it is impossible to obtain prior informed consent from the subject or its legal representative (parent or guardian) and it is impossible to supply prior information to the subject or its legal representative (parent or guardian);
Amendment 509 #
Proposal for a regulation Article 32 – paragraph 1 – point c (c) the subject or legal representative has not previously expressed objections known to the investigator;
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 564 #
Proposal for a regulation Article 39 – paragraph 1 a (new) 1a. Where the sponsor does not have access to certain information and, therefore, is not able to submit a complete report, this shall be stated in the report. In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may submit a single safety report on all investigational medicinal products used in the trial. The sponsor shall provide the reasons for this decision in the report.
Amendment 565 #
Proposal for a regulation Article 39 – paragraph 2 2. The obligation for a particular sponsor referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation for that sponsor. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product. The annual reporting obligation shall not apply when a sponsor is not currently conducting any clinical trials with the investigational medicinal product.
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
27 amendments...
Amendment 205 #
Proposal for a regulation Article 2 – paragraph 2 – point 3 – point a (a) the investigational medicinal products, or the placebos, are authorised;
Amendment 222 #
Proposal for a regulation Article 2 – paragraph 2 – point 11 a (new) (11 a) 'Reporting Member State': the Member State coordinating and documenting the assessment of an application for authorisation or of a substantial modification, which involves three or more Member States, and which has been submitted under Chapters II and III of this Regulation.
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 265 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 3 Where the proposed reporting Member State does not wish to be the reporting Member State, it shall agree with another Member State concerned that the latter will be the reporting Member State. If no Member State concerned accepts to be the reporting Member State, the proposed reporting Member State shall be the reporting Member State, unless the proposed reporting Member State can justify that it does not have sufficient capacity to fulfil the task in a satisfactory manner.
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 307 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph -1 (new) and sub-paragraph 1 – introductory part 4. The assessment date shall, for the purposes of this Chapter, be the date on which the assessment report is submitted to the other Member States concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other Member States concerned. The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods, which shall include periods for initial assessment, for joint assessment and for consolidation of the final report:
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 324 #
Proposal for a regulation Article 6 – paragraph 6 – subparagraph 2 For the purpose of obtaining those additional explanations, the reporting Member State may
Amendment 327 #
Proposal for a regulation Article 6 – paragraph 6 – subparagraph 3 Amendment 328 #
Proposal for a regulation Article 6 – paragraph 6 – subparagraph 5 a (new) The reporting Member State may also extend the time referred to in paragraphs 4 and 6 with a further 60 days for trials involving Advanced Therapy Medicinal Products or other novel therapies, for the purpose of consulting with expert committees.
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 370 #
Proposal for a regulation Article 9 – paragraph 1 1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. Where possible, the persons validating the applications shall therefore publish in the EU database a declaration of their interests, or a statement that they have none.
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 377 #
Proposal for a regulation Article 9 – paragraph 3 3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. An independent Ethics Committee, as referred to in the Declaration of Helsinki and the ICH-GCP, shall be involved in the assessment of each clinical trial.
Amendment 396 #
Proposal for a regulation Article 14 – paragraph 2 2.
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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| 2 |
2012/0216(COD) Incidental catches of cetaceans in fisheries; alignment of the Regulation with the TFEU (Commission delegated and implementing powers)
2013/01/29
PECH
2 amendments...
Amendment 4 #
Proposal for a regulation - amending act Recital 6 a (new) (6 a) With regard to the shortcomings of the Regulation (EC) No 812/2004 and the failures in implementation as indicated in COM(2009)0368 and the related 2010 ICES scientific advice and the lacking of integration of the Habitats Directive 92/43/EEC and the requirement by Member States to take the requisite measures to establish a system of strict protection for cetaceans, the Commission should no later than 31 December 2015 assess the shortcomings of Regulation (EC) No 812/2004 and make a legislative proposal for a coherent, overarching legislative framework for ensuring the effective protection of cetaceans from all threats.
Amendment 5 #
Proposal for a regulation Article 1 – point 1 a (new) Regulation (EC) No 812/2004 Article 7 – paragraph 3 (new)) (1a) In Article 7, the following paragraph is added: "3. The Commission shall no later than 31 December 2015 review the effectiveness of the measures laid down in this Regulation and accompany this review with an overarching legislative proposal for ensuring the effective protection of cetaceans."
source: PE-504.110
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| 47 |
2012/0266(COD) Medical devices
2013/05/14
ENVI
47 amendments...
Amendment 166 #
Proposal for a regulation Recital 25 a (new) (25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices, manufacturers shall be obliged to take liability insurance with appropriate coverage.
Amendment 174 #
Proposal for a regulation Recital 32 (32) Patients who are implanted with a device should be given where possible in advance essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
Amendment 181 #
Proposal for a regulation Recital 35 (35) Transparency and
Amendment 189 #
Proposal for a regulation Recital 42 (42) For high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body.
Amendment 197 #
Proposal for a regulation Recital 47 (47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent
Amendment 198 #
Proposal for a regulation Recital 48 (48) An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database, as well as the www.clinicaltrials.gov database of the USA FDA to be set up for clinical trials on medicinal products for human use.
Amendment 201 #
Proposal for a regulation Recital 50 (50) Sponsors should report certain adverse events, including Serious adverse Device Effects, device effects and device deficiencies occurring during clinical investigations to the Member States concerned, which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should be communicated to the other Member States.
Amendment 227 #
Proposal for a regulation Article 1 – paragraph 2 – point f a (new) (fa) To devices that are composed of substances or combination of substances intended to be ingested and that are absorbed by or dispersed in the human body that based on robust scientific evidence pose no adverse health implications to patient safety.
Amendment 240 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 2 (2)
Amendment 258 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 24 (24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients
Amendment 259 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part (27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition;
Amendment 267 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii (iii) hospitalisation or
Amendment 275 #
Proposal for a regulation Article 3 – paragraph 1 1. The Commission may, at the request of a Member State, or after consultation wit
Amendment 279 #
Proposal for a regulation Article 3 – paragraph 2 2. The Commission shall ensure the sharing of expertise between Member States and relevant stakeholders including patient groups in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products.
Amendment 282 #
Proposal for a regulation Article 4 – paragraph 4 4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23
Amendment 288 #
Proposal for a regulation Article 7 – paragraph 1 1. Where no harmonised standards exist
Amendment 306 #
Proposal for a regulation Article 8 – paragraph 6 – subparagraph 2 If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including the immediate reporting to the European databank on medical devices (Eudamed)set up by the Commission Decision 2010/227/EU.
Amendment 310 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers shall, in response to a reasoned request from a competent authority, or from a legitimate health institution or association, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 317 #
Proposal for a regulation Article 8 – paragraph 10 a (new) 10a. Manufacturers shall have an appropriate liability insurance covering any damages that may be caused by their medical devices to patients, users or third parties. That insurance shall at least cover damage in the following cases: (a) in the event of the death of or injury to a patient, user or a third party; or, (b) in the event of the death of or injury to multiple patients or users or other third parties due to the use of the same medical device.
Amendment 347 #
Proposal for a regulation Article 13 – paragraph 1 – subparagraph 1 – point a (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least
Amendment 352 #
Proposal for a regulation Article 13 – paragraph 1 – subparagraph 1 – point b (b)
Amendment 364 #
Proposal for a regulation Article 13 – paragraph 2 – point c (c) that the reporting obligations in accordance with Articles 59 and 61 to 66 are fulfilled;
Amendment 367 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued and the obligations on Serious Adverse Events reporting are fulfilled.
Amendment 372 #
Proposal for a regulation Article 13 – paragraph 4 – point a (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least
Amendment 374 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b)
Amendment 376 #
Proposal for a regulation Article 14 – paragraph 1 – subparagraph 1 – point c (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected; this includes the reuse of a device outside of the specifications set out in the manufacturer's instructions for use.
Amendment 385 #
Proposal for a regulation Article 15 – paragraph 1 1. Any natural or legal person, including health institutions as specified at Art. 4.4, who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 388 #
Proposal for a regulation Article 15 – paragraph 2 2. Only single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed, and only if this allowed under national legislation as well as can be proved by the reprocessor to be safe for the patient.
Amendment 394 #
Proposal for a regulation Article 15 – paragraph 3 a (new) 3a. In case of reprocessing of single-use medical devices the legal or natural person referred to in paragraph 1 shall ensure the traceability of each reprocessed device, including clear indications for how many times the device has already been reprocessed.
Amendment 395 #
Proposal for a regulation Article 15 – paragraph 3 b (new) 3b. The legal or natural person referred to in paragraph 1 shall establish a maximum number of times a single-use device can be reprocessed and shall ensure that the device is not reprocessed more times than this level.
Amendment 401 #
Proposal for a regulation Article 15 – paragraph 6 a (new) 6a. Patients shall always be informed when reprocessed single-use devices are used.
Amendment 459 #
Proposal for a regulation Article 26 – paragraph 1 1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall
Amendment 468 #
Proposal for a regulation Article 27 – paragraph 1 – point a (a) to enable the public to be adequately informed via a central information point where patients can ask, seek and find information about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; The Commission should develop guidelines in consultation with stakeholders, including Member State competent authorities, the research community and patient and consumer organisations, and to specify the exact content and format of the information that should be published.
Amendment 477 #
Proposal for a regulation Article 27 – paragraph 4 4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, healthcare professionals, sponsors and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 481 #
Proposal for a regulation Article 28 – paragraph 1 – point 1 (new) (1) Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 492 #
Proposal for a regulation Article 31 – paragraph 2 – subparagraph 1 The application shall
Amendment 506 #
Proposal for a regulation Article 33 – paragraph 9 9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. Details of the notification, such as the class and the typology of devices shall be made publicly available.
Amendment 527 #
Proposal for a regulation Article 37 – paragraph 3 – subparagraph 1 Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. A report with the opinions of Member States should be made publicly available by the European Commission after the assessment.
Amendment 533 #
Proposal for a regulation Article 40 – paragraph 1 1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. The fees shall be transparent and proportionate in nature and be subject to member state labour markets.
Amendment 623 #
Proposal for a regulation Article 53 – paragraph 1 – point b (b) the exchange of information between the Member States and between them and the Commission in accordance with Article 56; All relevant updates to the information concerning an investigation should be posted on the database, such as measures taken by Member States to terminate, suspend or modify an investigation, as well as updated information on the benefit-risk balance or any urgent safety measures taken.
Amendment 631 #
Proposal for a regulation Article 59 – paragraph 1 – point d (d) new findings in relation to any event referred to in points (a) to (c). Information regarding incidents that are caused by user errors should also be collected, as they are a major source of incidents with medical devices. This information can contribute to improve the safety and knowledge of the device. The Regulation should also provide for Member States to put in place non- electronic formats of reporting to ensure that patients who do not have online access are able to report.
Amendment 675 #
Proposal for a regulation Article 67 – paragraph 2 2. The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every
Amendment 717 #
Proposal for a regulation Article 80 – paragraph 1 – point b Amendment 895 #
Proposal for a regulation Annex 13 – point 5 a (new) 5 a. All clinical data collected by the manufacturer as part of a PMCF should be made accessible to health professionals.
Amendment 897 #
Proposal for a regulation Annex 14 – part I – point 1 – paragraph 1 Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and
source: PE-510.765
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| 30 |
2012/0267(COD) In vitro diagnostic medical devices
2013/05/13
ENVI
30 amendments...
Amendment 86 #
Proposal for a regulation Recital 27 (27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
Proposal for a regulation Article 1 – paragraph 6 6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 115 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 4 (4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services;
Amendment 120 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new) (12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 3 – point 21 (21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients
Amendment 131 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 5 – point 47 – indent 2 – point iii (iii) hospitalisation or
Amendment 144 #
Proposal for a regulation Article 4 a (new) Amendment 148 #
Proposal for a regulation Article 7 – paragraph 1 1.
Amendment 149 #
Proposal for a regulation Article 7 – paragraph 3 a (new) 3a. The relevant scientific experts from the various interested parties shall be involved in the drafting of the common technical specifications.
Amendment 174 #
Proposal for a regulation Article 12 – paragraph 4 4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 176 #
Proposal for a regulation Article 13 – paragraph 1 – point a (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least
Amendment 178 #
Proposal for a regulation Article 13 – paragraph 1 – point b (b)
Amendment 180 #
Proposal for a regulation Article 13 – paragraph 4 – point a (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least
Amendment 181 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b)
Amendment 189 #
Proposal for a regulation Article 22 – paragraph 8 – point e a (new) (ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 195 #
Proposal for a regulation Article 26 – paragraph 1 – subparagraph 2 (new) Member States may decide that the assessment and monitoring referred to in the first subparagraph shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 208 #
Proposal for a regulation Article 29 – paragraph 2 – subparagraph 1 The application shall
Amendment 259 #
Proposal for a regulation Article 40 – paragraph 2 – subparagraph 2 In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS,
Amendment 260 #
Proposal for a regulation Article 40 – paragraph 2 – subparagraph 3 For companion diagnostics
Amendment 262 #
Proposal for a regulation Article 40 – paragraph 3 – subparagraph 3 For companion diagnostic
Amendment 282 #
Proposal for a regulation Article 49 – paragraph 2 – subparagraph 1 a (new) In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA.
Amendment 309 #
Proposal for a regulation Article 59 – paragraph 3 – subparagraph 1 The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 322 #
Proposal for a regulation Article 77 – paragraph 1 – point b Amendment 332 #
Proposal for a regulation Article 78 – paragraph 2 – point b (b) to carry out appropriate tests on samples of manufactured class D devices o
Amendment 391 #
Proposal for a regulation Annex 8 – section 2 – point 6 – point 6.2 – point c (c)
Amendment 392 #
Proposal for a regulation Annex 8 – section 2 – point 6 – point 6.2 – point c a (new) (c a) Changes to the approved design shall receive further approval from the notified body which issued the EU design- examination certificate, wherever the changes could affect conformity with the general safety and performance requirements of this Regulation or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EU design- examination certificate of any planned changes to the approved design. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU design-examination report. Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU design examination certificate, the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The reference laboratory shall provide a scientific opinion within 30 days. The approval of any change to the approved design shall take the form of a supplement to the EU design-examination certificate.
Amendment 394 #
Proposal for a regulation Annex 9 – point 3 – paragraph 1 – point 3.5 3.5. in the case of devices classified as class D, or for companion diagnostics, request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The reference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable;
Amendment 395 #
Proposal for a regulation Annex 9 – point 3 – paragraph 1 – point 3.6 Amendment 396 #
Proposal for a regulation Annex 9 – point 5 – point 5.4 source: PE-510.740
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| 33 |
2012/0337(COD) General Union Environment Action Programme to 2020: 'Living well, within the limits of our planet'
2013/03/27
ENVI
33 amendments...
Amendment 76 #
Draft legislative resolution Citation 5 a (new) - having regard to its resolution of 19 January 2012 on how to avoid food wastage: strategies for a more efficient food chain in the EU1 (2011/2175(INI), __________________ 1 Texts adopted, P7_TA(2012)0014.
Amendment 84 #
Proposal for a decision Recital 19 (19) Action to deliver the priority objectives should be taken at different levels of governance, in line with the principle of subsidiarity and the latest scientific developments.
Amendment 86 #
Proposal for a decision Recital 20 (20)
Amendment 88 #
Proposal for a decision Recital 21 (21) Biodiversity loss and the degradation of ecosystems in the Union have not only important implications for the environment and are costly for society as a whole, particularly for economic actors in sectors that depend directly on ecosystem services, but also for future generations.
Amendment 90 #
Proposal for a decision Recital 22 (22) There is significant scope for reducing greenhouse gas emissions and enhancing energy and resource efficiency in the Union. This will ease pressures on the environment and bring increased competitiveness and new sources of growth and jobs through cost savings from improved efficiency, commercialisation of innovations and better management of resources over their whole life cycle.
Amendment 92 #
Proposal for a decision Recital 23 (23) Environmental problems and impacts
Amendment 95 #
Proposal for a decision Recital 24 (24) The full and even implementation of the environment acquis across the Union is a sound investment for the environment and human health,
Amendment 99 #
Proposal for a decision Recital 25 (25) Union environment policy should continue to draw on a sound evidence base and therefore savings on the Union budget should, where possible, not be taken from research funds.
Amendment 102 #
Proposal for a decision Recital 26 (26) Environmental objectives should be supported by adequate investments
Amendment 103 #
Proposal for a decision Recital 27 (27) Environmental integration in all policy areas is essential to reduce pressures on the environment resulting from the policies and activities of other sectors and to meet environment and climate-related targets.
Amendment 109 #
Proposal for a decision Article 2 – paragraph 1 – point b (b) to turn the Union into a resource- efficient, green, innovative and competitive low-
Amendment 113 #
Proposal for a decision Article 2 – paragraph 1 – point f (f) to secure private and public investment for environment and climate policy and get the prices right;
Amendment 119 #
Proposal for a decision Article 2 – paragraph 3 3. All measures, actions and targets set out in the programme shall be implemented in accordance with the principles of smart regulation, should be based on sound science and subject to comprehensive impact assessment where appropriate.
Amendment 121 #
Proposal for a decision Annex 1 – point 2 2. Emissions of pollutants to air, water and soil have been reduced significantly over the past decades, as have greenhouse gas (GHG) emissions in recent years. EU chemicals legislation has been modernised and the use of many toxic or hazardous substances such as lead, cadmium and mercury has been restricted in products found in most households. EU citizens enjoy some of the best water quality in the world, and over 18 % of the EU’s territory and 4 % of its seas have been designated as protected areas for nature. However there are still large problems with marine litter and pollution of the marine environment
Amendment 122 #
Proposal for a decision Annex 1 – point 3 3. The
Amendment 123 #
Proposal for a decision Annex 1 – point 4 4. Considerable headway has also been made in integrating environmental objectives into other Union policies and activities. The reformed Common Agricultural Policy (CAP) has, since 2003, linked direct payments to requirements for farmers to maintain land in good agricultural and environmental condition and to comply with relevant environmental legislation. However when it comes to greening of the CAP there is unfortunately still much room for improvement. Fighting climate change has become an integral part of energy policy and progress is being made on integrating resource efficiency, climate change and energy efficiency concerns into other key sectors, such as transport and buildings.
Amendment 131 #
Proposal for a decision Annex 1 – point 5 5. However, many environmental and biodiversity trends in the EU remain worrying, not least due to insufficient implementation of existing EU environment legislation. Only 17 % of species and habitats assessed under the Habitats Directive are in good status, and the degradation and loss of natural capital is jeopardising efforts to attain the EU’s biodiversity and climate change objectives. This has high associated costs which have not yet been properly valued in our economic or social system. Thirty per cent of the EU’s territory is highly fragmented, affecting the connectivity and health of ecosystems and their ability to provide services as well as viable habitats for species. While progress has been made in the EU to decouple growth from GHG emissions, resource use and environmental impacts, resource use is still largely unsustainable and inefficient, and waste is not yet properly managed. As a result, EU businesses are foregoing the significant opportunities that resource efficiency offers in terms of competitiveness, cost reductions, improved productivity and security of supply. Water quality and air pollution levels are still problematic in many parts of Europe, and EU citizens continue to be exposed to hazardous substances, potentially compromising their health and wellbeing. Unsustainable land use is consuming fertile soils, with impacts on food security and the achievement of biodiversity targets. Soil degradation continues largely unchecked.
Amendment 146 #
Proposal for a decision Annex 1 – point 15 15. In many cases, action to achieve these objectives will be required primarily at national, regional or local level, in line with the principle of subsidiarity. In others, additional measures at EU level will be needed. Since environment policy is a sphere of shared competence in the EU, one of the purposes of this programme is to create common ownership of shared goals and objectives and ensure a level playing field for businesses and public authorities. Clear goals and objectives and the exchange of Best Practice also provide policy makers and other stakeholders, including regions and cities, businesses and social partners, and individual citizens, with a sense of direction and a predictable framework for action.
Amendment 165 #
Proposal for a decision Annex 1 – point 20 20. In the case of the marine environment, while the maritime sector offers economic opportunities, from fishing, shipping and aquaculture to raw materials and offshore energy and marine biotechnology, care needs to be taken to ensure their exploitation is compatible with the conservation and sustainable management of marine and coastal ecosystems. Where possible the involved parties should be invited to come up with new ways to help protect the marine environment
Amendment 189 #
Proposal for a decision Annex 1 – point 26 – subparagraph 1 - point a (a) The loss of biodiversity and the degradation of ecosystem services are halted and ecosystems and their services
Amendment 191 #
Proposal for a decision Annex 1 – point 26 – subparagraph 1 – point b (b) The impacts of pressures on fresh, transitional and coastal waters are significantly reduced to achieve, maintain
Amendment 193 #
Proposal for a decision Annex 1 – point 26 – subparagraph 1 – point c (c) The impacts of pressures on marine waters are reduced to achieve or maintain good environmental status as required by the Marine Strategy Framework Directive. This will also help safeguard the biodiversity of the marine environment
Amendment 196 #
Proposal for a decision Annex 1 – point 26 – subparagraph 1 – point e (e) Land is managed sustainably in the EU, soil is adequately protected, farm land soil fertility is enhanced and the remediation of contaminated sites is well underway.
Amendment 204 #
Proposal for a decision Annex 1 – point 26 – subparagraph 2 – point c (c) Increasing efforts, inter alia, to ensure that healthy fish stocks are achieved by 2020 at the latest, starting by fishing at, or below, maximum sustainable yield levels as from 2015 in all fisheries,
Amendment 222 #
Proposal for a decision Annex 1 – point 27 27. The Europe 2020 Strategy's ‘Resource- efficient Europe’ Flagship Initiative aims to support the shift towards an economy that is efficient in the way it uses all resources, decouples absolutely economic growth from resource and energy use and its environmental impacts, reduces GHG emissions, enhances competitiveness through efficiency and innovation and promotes greater energy security. The Roadmap to Resource Efficient Europe
Amendment 256 #
Proposal for a decision Annex 1 – point 36 36. In addition to mandatory green public procurement requirements for certain product categories , most Member States have adopted voluntary action plans and many have set targets for specific product groups. There is, however, considerable scope for administrations at all levels to further reduce their environmental impact through their purchasing decisions. Member States and regions should take further steps to reach the target of applying European Union green procurement criteria to at least 50% of public tenders. The Commission will assess the possibility of introducing further sector-specific legislation to set mandatory green public procurement rules for additional product categories.
Amendment 360 #
Proposal for a decision Annex 1 – point 52 – subparagraph 2 – point d (d) Developing an EU strategy for a non- toxic environment, supported by a comprehensive chemical exposure and toxicity knowledge base built as much as possible through the use of alternative non-live animal test methods and testing strategies, and conducive to innovation of sustainable substitutes.
Amendment 361 #
Proposal for a decision Annex 1 – point 52 – subparagraph 2 – point d a (new) (da) Adopting an EU-wide strategy for the development, validation, acceptance and use of non-animal testing methods in the context of the revision of EU legislation and the setting up of rules for new technologies such as nanotechnologies.
Amendment 394 #
Proposal for a decision Annex 1 – point 68 68. Further implementation of the Shared Environmental Information System principle of ‘produce once, use often’ and the common approaches and standards on acquisition and collation of spatial information under the INSPIRE and
Amendment 401 #
Proposal for a decision Annex 1 – point 69 – indent 3 – There are still uncertainties surrounding the human health and environmental implications of endocrine disruptors, mixtures, chemicals in products and nanomaterials. Filling these gaps can accelerate decision-making and enable the further development of the chemicals acquis to better target areas of concern, while stimulating more sustainable use of chemicals. An improved understanding of the environmental factors affecting human health would allow preventive policy actions to be taken. This should be done as much as possible through the use of alternative methods of testing with the aim to reduce the number of animals used.
Amendment 407 #
Proposal for a decision Annex 1 – point 71 – subparagraph 1 - point a (a) Policy-makers and businesses have a better basis for developing and implementing environment and climate policies, including measuring costs and benefits of action or inaction.
Amendment 413 #
Proposal for a decision Annex 1 – point 71 – subparagraph 2 - point b (b) Adopting a systematic and integrated approach to risk management, based on the precautionary principle and preventive action, the polluter-pays principle, the principle of rectification of pollution at source as well as the principle of proportionality.
Amendment 417 #
Proposal for a decision Annex 1 – point 71 – subparagraph 2 – point c (c) Simplifying, streamlining and modernising environmental and climate change data and information collection, management and sharing – including the development and implementation of a European Shared Environmental Information System.
source: PE-508.007
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| 5 |
2012/0366(COD) Tobacco and related products: manufacture, presentation and sale. Approximation of Member States legislation
2013/05/14
ENVI
5 amendments...
Amendment 170 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition
Amendment 396 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 2 a (new) Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories monitored by the competent authorities of the Member States.
Amendment 456 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour as well as additives that are intended to be added to the tobacco product after its manufacture, for instance by the consumer.
Amendment 569 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 1018 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban should, however, not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States.
source: PE-510.712
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| 8 |
2012/2031(INI) Protection of animals during transport
2012/03/29
TRAN
2 amendments...
Amendment 5 #
Draft opinion Paragraph 1 a (new) 1a. Urges the Commission to ensure that veterinary controls of animals to be transported take place at the end of their transport.
Amendment 6 #
Draft opinion Paragraph 1 a (new) 1a. Calls on the European Commission to submit a proposal for amending Regulation (EC) No 1/2005 so as to limit the transport of live animals to 8 hours;
source: PE-486.182
2012/03/30
ENVI
6 amendments...
Amendment 7 #
Draft opinion Paragraph 3 3. Considers that reducing the volume of transport
Amendment 18 #
Draft opinion Paragraph 4 a (new) 4 a.(new) Calls for a reclassification of horses separately from other farm animals to reflect the specific physical, physiological and behavioural characteristics of horses as set out in the EFSA report1. Calls for a specific journey limit for horses (to slaughter) to have immediate effect. __________________ 1 EFSA Report on the Welfare of Animals during Transport (2011) pg. 86
Amendment 26 #
Draft opinion Paragraph 5 5. Recalls that Article 32 of the Regulation states that the Commission report shall take into account ‘scientific evidence on the welfare needs of animals’, and may be accompanied if necessary by appropriate legislative proposals concerning long journeys; calls on the Commission and the Council, therefore, to review Regulation 1/2005 in order to establish a maximum 8- hour limit for the journeys of animals transported for the purpose of being slaughtered
Amendment 35 #
Draft opinion Paragraph 6 6. Considers that the yearly reports submitted by
Amendment 42 #
Draft opinion Paragraph 7 7. Urges the Commission to take measures in order to increase cooperation and communication between competent authorities of different Member States; calls on the Commission to
Amendment 44 #
Draft opinion Paragraph 7 a (new) 7 a.(new) Urges the Commission to ensure that veterinary controls of animals to be transported take place at the end of their transport.
source: PE-486.155
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| 31 |
2012/2041(INI) Microbial challenge - rising threats from antimicrobial resistance
2012/09/19
ENVI
31 amendments...
Amendment 1 #
Motion for a resolution Citation 12 – having regard to 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 29 #
Motion for a resolution Recital H b (new) Hb. whereas the use of diagnostics have a vital role to play in combating AMR by encouraging more targeted approaches to treatment;
Amendment 31 #
Motion for a resolution Paragraph 1 1. Considers that, while almost all Member States have developed national AMR strategies in accordance with the Council Recommendation on prudent use of antimicrobial agents in human medicine, progress with regard to meeting set objectives has been slow and uneven; calls for firm governmental commitment to full and timely implementation at national level;
Amendment 32 #
Motion for a resolution Paragraph 1 a (new) 1a. Welcomes the Commission's five-year strategic Action Plan on tackling AMR, but expresses concern that many of the action points reiterate measures prescribed over a decade earlier in the Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine;
Amendment 35 #
Motion for a resolution Paragraph 2 2. Underlines that the key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly prescribed over a
Amendment 36 #
Motion for a resolution Paragraph 2 2. Underlines that the key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly prescribed over a limited time at the appropriate dosage, and reducing the use of antimicrobials in general and especially of Critically- Important Antimicrobials (CIAs) in human and veterinary medicine; we need to enhance surveillance of the use of antimicrobials in babies and young children, as well as in clinical treatment, where there is a need to control and measure antimicrobial use;
Amendment 37 #
Motion for a resolution Paragraph 2 – footnote 14 14. Report of the
Amendment 41 #
Motion for a resolution Paragraph 3 3. Stresses that more efforts are needed to control the use of antimicrobials in the veterinary sector; strongly disapproves of the uncontrolled prophylactic use of antimicrobials in animal husbandry; controls on, and the criteria for, imports of food from non-Member States should be enhanced, particularly owing to the potential that such imports may contain traces of antimicrobials;
Amendment 45 #
Motion for a resolution Paragraph 3 3. Stresses that more efforts are needed to control the use of antimicrobials in the human and veterinary
Amendment 53 #
Motion for a resolution Paragraph 4 4. Calls on the Commission to come up with a legislative proposal for the veterinary sector to limit the use of
Amendment 63 #
Motion for a resolution Paragraph 6 a (new) 6a. Underlines that the increased use of diagnostics is necessary to improve the accuracy of diagnoses, leading to a reduction in the use of antimicrobials;
Amendment 68 #
Motion for a resolution Paragraph 7 7. With a view to limiting the use and easy availability of antimicrobial agents, welcomes Member States’ initiatives to review the legal status of all oral, inhaled and parenteral antibiotics (namely antimalarial, antiviral and antifungal drugs) that remain available to patients without a prescription; antibiotics should not be available in EU Member States without a prescription, i.e. sold freely, as this encourages people to self-treat, often on the basis of inaccurate assumptions;
Amendment 69 #
Motion for a resolution Paragraph 7 7. With a view to limiting
Amendment 76 #
Motion for a resolution Paragraph 9 9. Calls on the Commission and Member States, in accordance with the competent EU Agencies, to devise and promote prudent use guidelines aimed at reducing non-essential and inappropriate exposure to antimicrobials in human and veterinary medicine, livestock farming, agriculture, aquaculture and horticulture;
Amendment 77 #
Motion for a resolution Paragraph 9 a (new) 9a. Welcomes moves by public authorities in the Member States to use vaccination as a key intervention in their AMR strategies but believes this should not replace good farm management and animal husbandry systems;
Amendment 83 #
Motion for a resolution Paragraph 9 b (new) 9b. Underlines that infection prevention and control is a vital cornerstone in the fight against AMR in human medicine; believes that research into the epidemiology of healthcare-associated infections (HAIs) due to MRSA and C. difficile and other emerging multidrug resistant organisms needs to be broadened out;
Amendment 85 #
Motion for a resolution Paragraph 9 c (new) 9c. Calls on the Commission and Member States to increase the exchange of best practice on preventing and reducing healthcare associated infections (HAIs);
Amendment 92 #
Motion for a resolution Paragraph 12 a (new) 12a. Notes the importance of access to rapid, reliable and affordable diagnostic tools in the development of new treatment strategies;
Amendment 95 #
Motion for a resolution Paragraph 12 b (new) 12b. Calls on the Commission and Member States to strengthen incentives for public and private sector cooperation to reinvigorate antimicrobial research and development (R&D); believes that sharing knowledge and pooling resources through innovative public-private partnerships (PPPs) will be critical to ensuring the clinical efficacy and availability of existing antimicrobials;
Amendment 96 #
Motion for a resolution Paragraph 12 c (new) 12c. Calls on the Commission to ensure that, as part of the EU 2020 strategy, farmers across all EU Member States can have access to smart, effective and alternative tools to cure their animals, including for minor uses and minor species (MUMS), which currently face a substantial lack of veterinary medicines;
Amendment 97 #
Motion for a resolution Paragraph 12 d (new) 12d. Calls on the Commission to ensure the development and availability of more on farm tools for early, rapid diagnosis and control of diseases, as well as a broad and effective diagnostic system at Member State level which can ensure the timely delivery of results in case bacteriological examinations are performed;
Amendment 101 #
Motion for a resolution Paragraph 14 14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-
Amendment 103 #
Motion for a resolution Paragraph 14 14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors, based on uniform standards for all Member States, in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-net), the ECDC European Antimicrobial Resistance Surveillance Network (EARS-net), and the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC);
Amendment 105 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on Member States to promote closer inter-sectoral collaboration between relevant authorities and sectors to encourage a more integrated veterinary-human health approach and monitor the implementation of national antimicrobial resistance strategies;
Amendment 108 #
Motion for a resolution Paragraph 14 b (new) 14b. Calls on the Commission and Member States to ensure that future measuring and reporting on the use of antimicrobials in both the human and veterinary sectors will be broadened out, showing not only the total amount of antimicrobials used but also types of antimicrobials, treatment times, etc.;
Amendment 110 #
Motion for a resolution Paragraph 15 15. Notes that the encouragement of appropriate antimicrobial use depends on a change of attitude and practice among patients, farmers
Amendment 113 #
Motion for a resolution Paragraph 15 15. Notes that the encouragement of appropriate antimicrobial use depends on a change of attitude
Amendment 116 #
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 strengthened political support at national and European levels, a broader approach which covers also animals, and coordinated, innovative and high-impact campaigns based on the experience derived from successful European and international initiatives;
Amendment 122 #
Motion for a resolution Paragraph 19 a (new) 19a. Calls on the Commission to build on the work of the TATFAR and promote similar multilateral and bilateral commitments for the prevention and control of AMR with other global partners;
Amendment 124 #
Motion for a resolution Paragraph 20 a (new) 20a. Urges Member States and the Commission to encourage and promote global risk management initiatives, such as the WHO list of CIAs for human medicine and the OIE List of Antimicrobials of Veterinary Importance;
source: PE-496.371
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| 2 |
2012/2056(INI) eCall: new 112 service for citizens
2012/09/05
IMCO, TRAN
2 amendments...
Amendment 110 #
Motion for a resolution Paragraph 11 11. Emphasises that consumers should be offered a realistic overview and comprehensive information regarding the additional functionalit
Amendment 121 #
Motion for a resolution Paragraph 15 15. Stresses that private eCall services should
source: PE-489.409
|
| 7 |
2012/2100(INI) Regional strategies for industrial areas in the European Union
2013/02/27
ENVI
7 amendments...
Amendment 10 #
Draft opinion Paragraph 2 a (new) 2a. Underlines that while restructuring of industrial areas can be expensive this should as far as possible be done in a budget-neutral manner, i.e. by focussing funds and support mechanisms already in place;
Amendment 14 #
Draft opinion Paragraph 3 3. Stresses that regional strategies for industrial areas should include, as a focus point, the cleaning-up of land and water, so that environmentally harmful substances do not continue to leak into nature; and that the regional strategies should therefore consider measures which support the aims and goals of the Waste Framework Directive and the Water Framework Directive;
Amendment 17 #
Draft opinion Paragraph 4 4. Believes it is important that strategies for industrial areas include an integrated focus on the transport possibilities to and from the areas, both in the form of raw materials, goods and personnel, and that this can help reduce the environmental footprint of industrial areas as well as positively contribute to public health;
Amendment 19 #
Draft opinion Paragraph 4 a (new) 4a. Believes that an increased focus on and the promotion of best practice regarding transport using internal waterways, ocean transport, railway goods transport and smart distribution centres and networks is essential for improving the environment of regional industrial areas;
Amendment 21 #
Draft opinion Paragraph 5 5. Underlines the importance of an effective transposition by Member States of the SEVESO III Directive, in order to ensure that possible risks to citizens close to the industrial regions concerned are minimised, that they have adequate information regarding any possible risk, and that they are better involved in land- use planning decisions
Amendment 23 #
Draft opinion Paragraph 5 a (new) 5a. Notes that many former and out-dated industrial areas hold great possibilities for increasing energy efficiency by applying modern technology and building standards and that this will benefit both the regional economies and the environment;
Amendment 24 #
Draft opinion Paragraph 5 b (new) 5b. Points to the possibility of acquiring funds for green investments by selling off former industrial properties in attractive locations, i.e. in port areas, along river banks, etc; and that this can reduce the need for public funding;
source: PE-506.100
|
| 14 |
2012/2104(INI) Improving the delivery of benefits from EU environment measures: building confidence through better knowledge and responsiveness
2012/12/18
ENVI
14 amendments...
Amendment 3 #
Motion for a resolution Citation 8 a (new) - having regard to the Interinstitutional Agreement on Better Lawmaking (2003/C 321/01),
Amendment 7 #
Motion for a resolution Subheading 1 General points:
Amendment 22 #
Motion for a resolution Recital C Amendment 33 #
Motion for a resolution Recital E E. whereas Article 11 TEU calls for the European institutions to engage more actively in dialogue and consultation;
Amendment 35 #
Motion for a resolution Recital F F. whereas the subsidiarity principle extends to the regional and local levels; whereas Article 5 of the Protocol on the application of the principles of subsidiarity and proportionality stipulates that draft legislative acts must include a financial impact assessment and set out the implications for the rules to be put in place by Member States
Amendment 41 #
Motion for a resolution Recital F a (new) Fa. whereas the 6th Environmental Action Plan was undermined by persistent implementation failures in mature policy sectors such as air pollution control, waste management, water and waste water treatment, and nature conservation;
Amendment 43 #
Motion for a resolution Paragraph 1 1. Welcomes the Commission communication entitled ‘Improving the delivery of benefits from EU environment measures: building confidence through better knowledge and responsiveness’ (COM(2012)0095), but
Amendment 58 #
Motion for a resolution Paragraph 2 2.
Amendment 68 #
Motion for a resolution Paragraph 4 4. Recognises that the implementation of environment legislation demands a considerable administrative and financial effort;
Amendment 69 #
Motion for a resolution Paragraph 4 – subparagraph 1 (new) Considers that full implementation and enforcement at all levels is critical, and may require, where appropriate, further strengthening; therefore emphasises the need for clear, consistent and non- duplicative environmental legislation;
Amendment 83 #
Motion for a resolution Paragraph 5 Amendment 89 #
Motion for a resolution Paragraph 6 – indent 1 Amendment 93 #
Motion for a resolution Paragraph 6 – indent 3 a (new) - Encourages the European Parliament's Environment, Public Health and Food Safety Committee to convene regular hearings to evaluate progress in implementing environmental legislation;
Amendment 98 #
Motion for a resolution Paragraph 7 source: PE-502.042
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| 3 |
2012/2167(DEC) 2011 discharge: EU general budget, Section III, Commission
2012/12/20
ENVI
3 amendments...
Amendment 1 #
Draft opinion Paragraph 2 2.
Amendment 3 #
Draft opinion Paragraph 6 6. Is aware that the payment rate of LIFE+ actions under the responsibility of DG CLIMA in the first year reached only 58,23%;
Amendment 4 #
Draft opinion Paragraph 13 13. Is of the opinion, on the basis of the data available and the implementation report, that discharge
source: PE-502.116
|
| 4 |
2012/2187(DEC) 2011 discharge: European Environment Agency (EEA)
2012/12/20
ENVI
4 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Reiterates that the European Court of Auditors (Court of Auditors) considers the transactions underlying the annual accounts of the European Environment Agency (EEA) for the financial year 2011 as legal and regular in all material respects; underlines again that the discharge procedure shall focus on the preceding year;
Amendment 4 #
Draft opinion Paragraph 2 b (new) 2b. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of EEA and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 6 #
Draft opinion Paragraph 3 3. Has been aware of the cooperation with Earthwatch since the discharge procedure 2010; has fully been informed by the EEA and its Executive Director on the collaboration; takes note that in future special attention
Amendment 10 #
Draft opinion Paragraph 5 a (new) 5a. Believes that the discharge decision for the EEA should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
source: PE-502.117
|
| 4 |
2012/2190(DEC) 2011 discharge: European Medicines Agency (EMA)
2012/12/20
ENVI
4 amendments...
Amendment 2 #
Draft opinion Paragraph 1 a (new) 1a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of the Agency and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 5 #
Draft opinion Paragraph 2 2. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes
Amendment 7 #
Draft opinion Paragraph 7 7. Acknowledges the efforts by the executive level of the Agency to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs;
Amendment 10 #
Draft opinion Paragraph 8 a (new) 8a. Believes that the discharge decision for the Agency should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
source: PE-502.119
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| 2 |
2012/2195(DEC) 2011 discharge: European Centre for Disease Prevention and Control (ECDC)
2012/12/20
ENVI
2 amendments...
Amendment 2 #
Draft opinion Paragraph 2 a (new) 2a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of ECDC and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 6 #
Draft opinion Paragraph 6 a (new) 6a. Believes that the discharge decision for the ECDC should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common rulebook for all European institutions and bodies;
source: PE-502.118
|
| 5 |
2012/2196(DEC) 2011 discharge: European Food Safety Authority (EFSA)
2012/12/20
ENVI
5 amendments...
Amendment 4 #
Draft opinion Paragraph 2 2. Thinks it is noteworthy in this context that
Amendment 6 #
Draft opinion Paragraph 2 b (new) 2b. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of the Authority and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 7 #
Draft opinion Paragraph 4 4. Reminds the Authority to respect in an improved way the principle of annuality;
Amendment 9 #
Draft opinion Paragraph 6 6.
Amendment 12 #
Draft opinion Paragraph 7 a (new) 7a. Believes that the discharge decision for the Authority should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
source: PE-502.122
|
| 3 |
2012/2203(DEC) 2011 discharge: European Chemicals Agency (ECHA)
2012/12/20
ENVI
3 amendments...
Amendment 2 #
Draft opinion Paragraph 1 a (new) 1a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of ECHA and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 3 #
Draft opinion Paragraph 5 5.
Amendment 6 #
Draft opinion Paragraph 7 a (new) 7a. Believes that the discharge decision for the ECHA should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
source: PE-502.120
|
| 2 |
2012/2214(DEC) 2011 discharge: performance, financial management and control of EU agencies
2012/12/20
ENVI
2 amendments...
Amendment 1 #
Draft opinion Paragraph 4 4.
Amendment 2 #
Draft opinion Paragraph 7 a (new) 7 a. Draws attention to the Health and Consumer Protection Commissioner's pledge to pursue an initiative for a common rulebook governing the auditing and management of EU agencies and to tackle the various instances of conflicts of interest, whilst examining the scope for cuts to its operating budget;
source: PE-502.128
|
| 7 |
2012/2259(INI) Current challenges and opportunities for renewable energy on the European internal energy market
2013/01/30
ENVI
7 amendments...
Amendment 8 #
Draft opinion Paragraph 1 1. Welcomes the fact that renewable energy is being developed in the Member States with a view to meeting the targets set for 2020, and to strengthen the competitiveness of Europe; calls on the Commission to propose r
Amendment 15 #
Draft opinion Paragraph 1 a (new) 1a. Points to the market potential for green technology; and underlines that green technologies should be seen as an opportunity to strengthen European industries, rather than something that necessarily requires public funding;
Amendment 24 #
Draft opinion Paragraph 2 2. Points out that renewable energy is not being developed separately, but as part of the overall energy system; reiterates that funding needs to be allocated under the Connecting Europe programme to finance the development of ICT-based smart grids so as to enable renewable energy to be incorporated more comprehensively and improve the stability of transfer systems; underlines that this funding should not lead to an increase in the overall EU- budget;
Amendment 34 #
Draft opinion Paragraph 3 3. Maintains that a transitional period is necessary in order to establish European support schemes; but underlines that these support schemes should come from diversion of existing funds rather than from budget increases; suggests that the Commission
Amendment 53 #
Draft opinion Paragraph 4 a (new) 4a. Points to the fact that the increased use of renewables and green technologies is not only an issue of meeting emissions targets but also improves energy security and reduces the need for imported fuels;
Amendment 57 #
Draft opinion Paragraph 5 5. Stresses that research and development focusing on the efficient use of waste, including food waste and debris recovered from the marine environment, to produce electricity, gas, and heat are important from the point of view of meeting energy efficiency targets;
Amendment 63 #
Draft opinion Paragraph 5 a (new) 5a. Points to the fact that a lot can be achieved by the use of existing technologies, simply by increasing energy efficiency as well as by replacing out- dated power generating technologies with newer and less polluting versions;
source: PE-504.183
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| 2 |
2012/2323(INI) Follow-up on the delegation of legislative powers and the control by Member States of the Commission's exercise of implementing powers
2013/05/06
ENVI
2 amendments...
Amendment 1 #
Draft opinion Paragraph 2 2. Emphasises that the delegation of power is a choice for Parliament as a co- legislator, which it should exercise with care on a case-by-case basis having regard to the need to
Amendment 8 #
Draft opinion Paragraph 6 6. Is of the opinion that
source: PE-510.673
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| 3 |
2013/2006(INI) Reindustrialising Europe to promote competitiveness and sustainability
2013/05/17
ENVI
3 amendments...
Amendment 11 #
Draft opinion Recital A A.
Amendment 52 #
Draft opinion Paragraph 2 Amendment 68 #
Draft opinion Paragraph 3 3. Notes that the industrial strategy should emphasise access to cheap
source: PE-510.791
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