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Document 52013AP0373
Amendments adopted by the European Parliament on 12 September 2013 on the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (COM(2012)0576 — C7-0322/2012 — 2012/0278(COD))
Amendments adopted by the European Parliament on 12 September 2013 on the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (COM(2012)0576 — C7-0322/2012 — 2012/0278(COD))
Amendments adopted by the European Parliament on 12 September 2013 on the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (COM(2012)0576 — C7-0322/2012 — 2012/0278(COD))
OJ C 93, 9.3.2016, pp. 419–453
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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9.3.2016 |
EN |
Official Journal of the European Union |
C 93/419 |
P7_TA(2013)0373
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union ***I
Amendments adopted by the European Parliament on 12 September 2013 on the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (COM(2012)0576 — C7-0322/2012 — 2012/0278(COD)) (1)
(Ordinary legislative procedure: first reading)
(2016/C 093/55)
Amendment 1
Proposal for a regulation
Citation - 1 (new)
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Text proposed by the Commission |
Amendment |
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Having regard to the Convention on Biological Diversity and to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization , |
Amendment 2
Proposal for a regulation
Recital - 1 (new)
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Text proposed by the Commission |
Amendment |
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Amendment 3
Proposal for a regulation
Recital 1
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Text proposed by the Commission |
Amendment |
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Amendment 4
Proposal for a regulation
Recital 2
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Text proposed by the Commission |
Amendment |
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Amendment 5
Proposal for a regulation
Recital 2 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 6
Proposal for a regulation
Recital 2 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 7
Proposal for a regulation
Recital 2 c (new)
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Text proposed by the Commission |
Amendment |
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Amendment 8
Proposal for a regulation
Recital 3
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Text proposed by the Commission |
Amendment |
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Amendment 9
Proposal for a regulation
Recital 3 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 10
Proposal for a regulation
Recital 3 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 11
Proposal for a regulation
Recital 4 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 12
Proposal for a regulation
Recital 4 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 13
Proposal for a regulation
Recital 4 c (new)
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Text proposed by the Commission |
Amendment |
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Amendment 14
Proposal for a regulation
Recital 4 d (new)
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Text proposed by the Commission |
Amendment |
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Amendment 15
Proposal for a regulation
Recital 5
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Text proposed by the Commission |
Amendment |
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Amendment 16
Proposal for a regulation
Recital 6
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Text proposed by the Commission |
Amendment |
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Amendment 17
Proposal for a regulation
Recital 7 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 18
Proposal for a regulation
Recital 8
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Text proposed by the Commission |
Amendment |
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Amendment 19
Proposal for a regulation
Recital 8 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 20
Proposal for a regulation
Recital 8 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 21
Proposal for a regulation
Recital 9
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Text proposed by the Commission |
Amendment |
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Amendment 22
Proposal for a regulation
Recital 11
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Text proposed by the Commission |
Amendment |
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Amendment 23
Proposal for a regulation
Recital 14
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Text proposed by the Commission |
Amendment |
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Amendment 24
Proposal for a regulation
Recital 14 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 25
Proposal for a regulation
Recital 16
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Text proposed by the Commission |
Amendment |
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deleted |
Amendment 26
Proposal for a regulation
Recital 17
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Text proposed by the Commission |
Amendment |
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Amendment 27
Proposal for a regulation
Recital 18
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Text proposed by the Commission |
Amendment |
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Amendment 28
Proposal for a regulation
Recital 19
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Text proposed by the Commission |
Amendment |
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Amendment 29
Proposal for a regulation
Recital 19 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 30
Proposal for a regulation
Recital 20
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Text proposed by the Commission |
Amendment |
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Amendment 31
Proposal for a regulation
Recital 22 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 33
Proposal for a regulation
Recital 23
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Text proposed by the Commission |
Amendment |
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Amendment 34
Proposal for a regulation
Article 1 — paragraph 1
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Text proposed by the Commission |
Amendment |
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This Regulation establishes rules governing access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol). |
This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol). |
Amendment 35
Proposal for a regulation
Article 1 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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The objective of this Regulation is the fair and equitable sharing of the benefits arising from the utilisation of genetic resources, thereby contributing to the conservation of biological diversity and the sustainable use of its components, in accordance with the objectives of the Convention on Biological Diversity (‘the Convention’). |
Amendment 36
Proposal for a regulation
Article 1 — paragraph 1 b (new)
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Text proposed by the Commission |
Amendment |
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This Regulation lays down obligations for users of genetic resources and traditional knowledge associated with genetic resources. The system for implementing the Nagoya Protocol established by this Regulation also includes arrangements for facilitating user compliance with their obligations and a framework for monitoring and control arrangements to be drawn up and put in place by the Member States of the Union. This Regulation also includes provisions encouraging activities by relevant actors to raise awareness of the importance of genetic resources and traditional knowledge associated with genetic resources and related access and benefit-sharing issues, as well as activities contributing to capacity-building in developing countries, in line with the Nagoya Protocol's provisions. |
Amendment 37
Proposal for a regulation
Article 2
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Text proposed by the Commission |
Amendment |
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This Regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use of such genetic resources and to traditional knowledge associated with genetic resources. |
This Regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the utilisation of such genetic resources and to traditional knowledge associated with genetic resources. |
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This Regulation does not apply to genetic resources for which access and benefit-sharing is governed by a specialised international instrument to which the Union is a Party. |
This Regulation does not apply to genetic resources for which access and benefit-sharing is governed by a specialised international instrument to which the Union is a Party. |
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This Regulation does not apply to genetic resources from a country of origin which decided not to adopt domestic access rules in conformity with the requirements of the Nagoya Protocol in place or to commodity trade in general. Due regard should be paid to useful and relevant ongoing work or practices under other international organisations. |
Amendment 38
Proposal for a regulation
Article 3 — point 3
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Text proposed by the Commission |
Amendment |
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Amendment 39
Proposal for a regulation
Article 3 — point 3 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 40
Proposal for a regulation
Article 3 — point 5
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Text proposed by the Commission |
Amendment |
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Amendment 41
Proposal for a regulation
Article 3 — point 6
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Text proposed by the Commission |
Amendment |
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Amendment 42
Proposal for a regulation
Article 3 — point 6 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 43
Proposal for a regulation
Article 3 — point 6 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 44
Proposal for a regulation
Article 3 — point 8 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 45
Proposal for a regulation
Article 3 — point 11
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Text proposed by the Commission |
Amendment |
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Amendment 46
Proposal for a regulation
Article 3 — point 12
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Text proposed by the Commission |
Amendment |
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Amendment 47
Proposal for a regulation
Article 4 — paragraph - 1 (new)
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Text proposed by the Commission |
Amendment |
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-1. Utilisation of illegally acquired genetic resources shall be prohibited in the Union. |
Amendment 48
Proposal for a regulation
Article 4 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that, where relevant , benefits are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users information relevant for access and benefit-sharing. |
1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed with prior informed consent and based on mutually agreed terms as defined by applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon those agreed terms. Users shall seek, keep, and transfer to subsequent users all information and documents relevant for access and benefit-sharing and for compliance with the provisions of this Regulation. |
Amendment 49
Proposal for a regulation
Article 4 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. Genetic resources and associated traditional knowledge shall only be transferred to other users in accordance with the internationally recognised certificate of compliance and mutually agreed terms, or prior informed consent and mutually agreed terms. In the absence of mutually agreed terms or if subsequent users envisage utilising such genetic resources or traditional knowledge under conditions that are not included in the prior terms, those users shall be required to seek mutually agreed terms from the country of origin. |
Amendment 51
Proposal for a regulation
Article 4 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Users shall: |
2. Users shall: |
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Amendment 52
Proposal for a regulation
Article 4 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Users shall keep the information relevant for access and benefit-sharing for twenty years after the end of the period of use. |
3. Users shall keep the information relevant for access and benefit-sharing for twenty years after the end of the period of utilisation or subsequent commercialisation. |
Amendment 53
Proposal for a regulation
Article 4 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. The Commission shall be empowered to adopt delegated acts in accordance with Article 14a in order to establish the rules for benefit-sharing in accordance with paragraph 4a by … (2) . Those rules shall require benefit-sharing at least at the level of best practice in the sector concerned and establish conditions for the sharing of non-monetary benefits. |
Amendment 54
Proposal for a regulation
Article 4 — paragraph 4 b (new)
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Text proposed by the Commission |
Amendment |
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4b. Users, when negotiating mutually agreed terms with providers of genetic resources or of traditional knowledge associated with genetic resources, shall seek to ensure that such terms contribute to the conservation of biological diversity and the sustainable use of its components and to technology transfer to developing countries. |
Amendment 55
Proposal for a regulation
Article 5
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Text proposed by the Commission |
Amendment |
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Article 5 |
deleted |
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Union trusted collections |
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1. The Commission shall establish and maintain a Union register of trusted collections. That register shall be internet-based, easily accessible to users, and shall include the collections of genetic resources identified as meeting the criteria of Union trusted collection. |
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2. Each Member State shall, upon request by a collection under its jurisdiction, consider the inclusion of this collection in the Union register of trusted collections. After verifying that the collection meets the criteria set out in paragraph 3, the Member State shall notify the Commission without delay of that collection's name, contact details, and type. The Commission shall without delay include the information thus received into the Union register of trusted collections. |
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3. In order for a collection to be included in the Union register of trusted collections, a collection owner shall demonstrate its capacity to: |
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4. Member States shall regularly verify that each collection under their jurisdiction included in the Union register of trusted collections effectively applies the measures set out in paragraph 3. |
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Member States shall inform the Commission without delay if a collection under their jurisdiction included in the Union register no longer complies with paragraph 3. |
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5. Where there is evidence that a collection included in the Union register of trusted collections does not apply the measures set out in paragraph 3, the Member State concerned shall without delay identify remedial actions in dialogue with the owner of the collection concerned. |
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The Commission shall remove a collection from the Union register of trusted collections when, in particular on the basis of information provided pursuant to paragraph 4, it has determined that a collection included in the Union register of trusted collections faces important or persistent difficulties to comply with paragraph 3. |
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6. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). |
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Amendment 56
Proposal for a regulation
Article 6 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The Commission shall make public, including on the internet, a list of the competent authorities. The Commission shall keep the list up to date. |
2. The Commission shall make public, including on the internet, a list of the competent authorities. The Commission shall keep the list up to date ; particular attention shall be paid to the outermost regions, bearing in mind the significance and fragility of the genetic resources found on their territories, and with a view to preventing any abusive exploitation . |
Amendment 57
Proposal for a regulation
Article 6 — paragraph 3 a (new)
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Text proposed by the Commission |
Amendment |
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(3a) The focal point designated by the Commission pursuant to paragraph 3, shall ensure consultation with the relevant Union bodies established under, and national authorities implementing, Council Regulation (EC) No 338/97 (3) . |
Amendment 58
Proposal for a regulation
Article 6 — paragraph 3 b (new)
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Text proposed by the Commission |
Amendment |
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3b. The competent authorities and the focal point on access and benefit-sharing shall provide advice to the public and potential users seeking information on the implementation of this Regulation and of the relevant provisions of the Convention and the Nagoya Protocol in the Union. |
Amendment 59
Proposal for a regulation
Article 7 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States and the Commission shall request all recipients of public research funding involving uses of genetic resources and traditional knowledge associated with genetic resources to declare that they will exercise due diligence in accordance with Article 4. |
deleted |
Amendment 60
Proposal for a regulation
Article 7 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Users shall declare to the competent authorities established under Article 6(1) that they exercised due diligence in accordance with Article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or at the time of commercialisation where a market approval is not required. |
2. Users shall declare to the competent authorities established under Article 6(1) that they have fulfilled the obligations under Article 4 and shall submit the related information on the occasion of: |
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Amendment 61
Proposal for a regulation
Article 7 — paragraph 3
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Text proposed by the Commission |
Amendment |
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Competent authorities shall transmit to the Commission every two years the information received on the basis of paragraphs 1 and 2. The Commission shall summarise the information received and make it available to the Access and Benefit-sharing Clearing House. |
Competent authorities shall verify the information provided under points (b) to (e) of paragraph 2 and transmit to the Access and Benefit Sharing Clearing House Mechanism, to the Commission and if appropriate to the competent authorities of the State concerned within three months the information received pursuant to this Article. The Commission shall within three months summarise the information received and make it public in an easily accessible, open, internet-based format . |
Amendment 62
Proposal for a regulation
Article 8
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Text proposed by the Commission |
Amendment |
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Best practices |
deleted |
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Any association of users may submit an application to the Commission for recognising as best practice a combination of procedures, tools or mechanisms developed and overseen by it. The application shall be supported by evidence and information. |
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Where, on the basis of information and evidence supplied to it by an association of users, the Commission determines that the specific combination of procedures, tools or mechanisms, when effectively implemented by a user, enables the user to comply with its obligations set out in Articles 4 and 7, it shall grant recognition as best practice. |
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An association of users shall inform the Commission of any changes or updates made to a recognised best practice for which it was granted recognition in accordance with paragraph 2. |
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If evidence from competent authorities of the Member States or other sources indicates repeated cases where users implementing a best practice fail to comply with their obligations under this Regulation, the Commission shall examine in dialogue with the relevant association of users whether the repeated cases of non-compliance indicate possible deficiencies in the best practice. |
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The Commission shall withdraw the recognition of a best practice, when it has determined that changes to the best practice compromise a user's ability to meet the conditions set out in Articles 4 and 7, or when repeated cases of non-compliance by users relate to deficiencies in the practice. |
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The Commission shall establish and keep up to date an internet-based register of recognised best practices. That register shall list in one section best practices recognised by the Commission in accordance with paragraph 2 of this Article and display in another section best practices adopted on the basis of Article 20(2) Nagoya Protocol. |
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The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). |
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Amendment 63
Proposal for a regulation
Article 9
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Text proposed by the Commission |
Amendment |
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1. The competent authorities shall carry out checks to verify if users comply with the requirements set out in Articles 4 and 7. |
1. The competent authorities shall carry out checks to verify if users comply with the requirements set out in Articles 4 and 7. |
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2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, Member States shall consider that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance. |
2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach of which the key principles shall be laid down by the Commission in accordance with the procedure referred to in Article 15(2). |
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3. Checks may be conducted when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning non-compliance of a user with this Regulation. |
3. Additional checks shall be conducted when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning a user's non-compliance with this Regulation. |
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4. The checks referred to in paragraph 1 shall include at least: |
4. The checks referred to in paragraph 1 shall include at least: |
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5. Competent authorities shall accept an internationally recognised certificate of compliance as evidence that the genetic resource it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the Party to the Nagoya Protocol providing the prior informed consent. |
5. Competent authorities shall accept an internationally recognised certificate of compliance as evidence that the genetic resource it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the Party to the Nagoya Protocol providing the prior informed consent. In the event that an internationally recognised certificate is not available, other legally acceptable forms of compliance shall be considered sufficient evidence that the genetic resources covered were legally obtained and that mutually agreed terms were established. |
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6. Users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1, notably as regards access to premises and the presentation of documentation or records. |
6. Users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1, notably as regards access to premises and the presentation of documentation or records. |
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7. Without prejudice to Article 11, where, following the checks referred to in paragraph 1 of this Article, shortcomings have been detected, the competent authority shall issue a notice of remedial actions to be taken by the user. |
7. Without prejudice to Article 11, where, following the checks referred to in paragraphs 1 and 3 of this Article, or following verification under Article 7(2) , shortcomings have been detected, the competent authority shall issue a notice of remedial actions to be taken by the user. |
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Additionally, depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities. |
If no positive or satisfactory response is given by the user, and depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge. Such interim measures shall be effective, proportionate and dissuasive. |
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8. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 7 of this Article. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). |
8. The Commission shall be empowered to adopt delegated acts in accordance with Article 14a to establish the procedures for implementing paragraphs 1 to 7 of this Article and to define procedural safeguards, such as a right to appeal, with respect to the provisions under Article 7 and Articles 9 to 11 . |
Amendment 64
Proposal for a regulation
Article 10 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC. |
2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC in an easily accessible, open, internet-based format . |
Amendment 65
Proposal for a regulation
Article 11 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The penalties provided for must be effective, proportionate and dissuasive. Those penalties may include: |
2. The penalties provided for must be effective, proportionate and dissuasive. Those penalties may include: |
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Amendment 66
Proposal for a regulation
Article 12 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. The competent authorities shall cooperate with each other, with the administrative authorities of third countries and with the Commission sin order to ensure compliance of users with this Regulation. |
1. The competent authorities shall cooperate with each other, with the administrative authorities of third countries and with the Commission in order to reinforce effective coordination and ensure compliance of users with this Regulation. Cooperation shall also take place with other relevant actors, including collections, non-governmental organisations and representatives of indigenous and local communities when this is important for the correct implementation of the Nagoya Protocol and this Regulation. |
Amendment 67
Proposal for a regulation
Article 12 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The competent authorities shall exchange information on serious shortcomings detected through checks referred to in Article 9(1) and on the types of penalties imposed in accordance with Article 11 with the competent authorities of other Member States and with the Commission. |
2. The competent authorities shall exchange information on the organisation of their checking system for monitoring user compliance with this Regulation, on serious shortcomings detected through checks referred to in Article 9(4) and Article 10(1), and on the types of penalties imposed in accordance with Article 11 with the competent authorities of other Member States and with the Commission. |
Amendment 68
Proposal for a regulation
Article 12 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. The Commission shall seek arrangements with the European Patent Office and with the World Intellectual Property Organization to ensure that references to genetic resources and their origin are included in patent registrations. |
Amendment 69
Proposal for a regulation
Article 13 — title
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Text proposed by the Commission |
Amendment |
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Union platform on access |
Union platform on access and benefit-sharing |
Amendment 70
Proposal for a regulation
Article 13 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established. |
1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources and on fair and equitable benefit-sharing is hereby established. Member States that plan to adopt rules governing access to their genetic resources shall first conduct an assessment of the impact of those rules and submit the results to the Union platform for consideration under the procedure laid down in paragraph 5 of this Article. |
Amendment 71
Proposal for a regulation
Article 13 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The Union platform shall contribute to the streamlining of access conditions at Union level by discussing related issues, including the design and performances of access regimes established in Member States, simplified access for non-commercial research, access practices of collections in the Union, access of Union stakeholders in third countries and the sharing of best practices. |
2. The Union platform shall contribute to the streamlining of access conditions at Union level by discussing related issues, including the design and performances of access regimes established in Member States, the promotion of research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including simplified access for non-commercial research, access practices of collections in the Union, access of Union stakeholders in third countries on mutually agreed terms after obtaining prior informed consent, benefit-sharing practices, the implementation and further development of best practices, and the functioning of dispute settlement arrangements. . |
Amendment 72
Proposal for a regulation
Article 13 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. The Union platform may provide non-binding advice, guidance or opinions on issues under its mandate. |
3. The Union platform may provide non-binding advice, guidance or opinions on issues under its mandate. Any such advice, guidance or opinions provided shall have due regard for the requirement to involve the relevant indigenous and local communities concerned. |
Amendment 73
Proposal for a regulation
Article 14 — points da, db, dc, dd, de and df (new)
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Text proposed by the Commission |
Amendment |
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Amendment 74
Proposal for a regulation
Article 14 a (new)
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Text proposed by the Commission |
Amendment |
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Article 14a |
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Exercise of the delegation |
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1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. |
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2. The power to adopt delegated acts referred to in Article 4(4b) and Article 9(8) shall be conferred on the Commission for a period of five years from … (4) . The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. |
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3. The delegation of power referred to in Article 4(4a) and Article 9(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |
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4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. |
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5. A delegated act adopted pursuant to Article 4(4a) and Article 9(8) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. |
Amendment 75
Proposal for a regulation
Article 15 a (new)
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Text proposed by the Commission |
Amendment |
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Article 15a |
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Consultation Forum |
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The Commission shall ensure a balanced participation of Member States’ representatives and relevant provider organisations, user associations, inter-governmental and non-governmental organisations as well as representatives of indigenous and local communities in the implementation of this Regulation. Those parties shall contribute, in particular, to defining and reviewing delegated acts pursuant to Article 4(4a) and Article 9(8), and to the implementation of Articles 5, 7 and 8, and any guidelines for establishing mutually agreed terms. The parties shall meet in a consultation forum. The rules of procedure of that forum shall be established by the Commission. |
Amendment 76
Proposal for a regulation
Article 16 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Every ten years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider the administrative consequences for public research institutions, small or medium-sized enterprises and micro-enterprises. It shall also consider the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources. |
3. Every five years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider the administrative consequences for specific sectors, public research institutions, small or medium-sized enterprises and micro-enterprises. It shall also consider the need to review the implementation of the provisions of this Regulation concerning traditional knowledge associated with genetic resources in light of developments in other relevant international organizations and the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources with the view to implementing Article 5.2, Article 6.2, Article 7 and Article 12 of the Nagoya Protocol and respecting the rights of indigenous and local communities. |
Amendment 77
Proposal for a regulation
Article 16 a (new)
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Text proposed by the Commission |
Amendment |
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Article 16 a |
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Amendment to Directive 2008/99/EC |
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Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (5) is hereby amended, with effect from … (6) , as follows:
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Amendment 78
Proposal for a regulation
Article 17 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Articles 4, 7, and 9 shall apply one year after the date of entry into force of this Regulation |
2. Article 4 (1) to (4) , Article 7, and Article 9 shall apply one year after the date of entry into force of this Regulation. |
(1) The matter was referred back to the committee responsible for reconsideration pursuant to Rule 57(2), second subparagraph (A7-0263/2013).
(2) Six months after the entry into force of this Regulation.
(4) Date referred to in Article 17(1)
(5) OJ L 328, 6.12.2008, p. 28.
(6) One year after the date of entry into force of this Regulation.