Activities of Cristina GUTIÉRREZ-CORTINES related to 2012/0278(COD)

Proposal for a regulation
Article 3 a (new)

Article 3a Concept of traceability Genetic items have to be defined at the molecular level with enough resolution to allow the unequivocal identification of their origin and destiny. Although a protocol of traceability requires proper recording of sequences of events or usages for any item, the traceability of any genetic entity requires its fingerprinting at the DNA level.

2013/05/17
Committee: DEVE

Proposal for a regulation
Article 3 b (new)

Article 3b Definition of catalogue Genetic catalogues are made of individuals belonging to certain species. The next item of importance are local populations (landraces, ecotypes, endemisms, varieties, or even subspecies). Genetic catalogues require as for traceability an unbiased method of bar- coding that should be based on DNA sequencing technologies.

2013/05/17
Committee: DEVE

Pavel POC, Cristina GUTIÉRREZ-CORTINES

Proposal for a regulation
Article 4 – paragraph 2 – point a

(a) seek, keep and transfer to subsequent users information on: (1) the date and place of access of genetic resources and traditional knowledge associated with such resources; (2) the description of genetic resources or traditional knowledge associated with such resources used, including available unique identifiers; (3) the source from which the resources or the knowledge were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with such resources; (4) the presence or absence of rights and obligations related to access and benefit- sharing; (5) access decisions and mutually agreed terms, where applicable;the internationally recognised certificate of compliance, where genetic resources were accessed by Parties to the Nagoya Protocol which have exercised their sovereign rights as provided for in Article 6 of that Protocol; or, failing this:

2013/05/17
Committee: DEVE

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol ~~significantly expand~~further details the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 – point a a (new)

(aa) seek, keep and transfer to subsequent users information on: (1) the date and place of access of genetic resources and traditional knowledge associated with such resources; (2) the description of genetic resources or traditional knowledge associated with such resources used, including available unique identifiers; (3) the source from which the resources or the knowledge were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with such resources; (4) the presence or absence of rights and obligations related to access and benefit- sharing; (5) access decisions and mutually agreed terms, where applicable;

2013/05/17
Committee: DEVE

Proposal for a regulation
Article 9 – paragraph 2

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.deleted

2013/05/17
Committee: DEVE

Proposal for a regulation
Article 9 – paragraph 3

3. Checks ~~may~~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 non-compliance of a user with this Regulation.

2013/05/17
Committee: DEVE

Proposal for a regulation
Article 14 – paragraph 1 – point d a (new)

(da) compile a catalogue of available genetic resources originating in Member States, pursuant to Article 7 of the Convention on Biological Diversity, in order to establish their biological diversity. They shall, in addition, encourage third countries to produce catalogues of their genetic resources with a view to improving the transparency of user access.

2013/05/17
Committee: DEVE

Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 (new)

Once the fund to be set up under the Convention on Biological Diversity, or any other fund established for the same purpose, has entered into operation, they shall endeavour to ensure that such funds provide sources of financing for research and the compilation of genetic resource catalogues.

2013/05/17
Committee: DEVE

Proposal for a regulation
Recital 11

(11) It is important to define, in accordance with the Nagoya Protocol, that usetilization of genetic resources refers to research and development on the genetic or biochemical composition of ~~samples of genetic material, which includes research and development on isolated compounds extracted from genetic material that was accessed in a Party to the Nagoya Protocol~~genetic resources.

2013/05/30
Committee: ENVI

Pavel POC, Cristina GUTIÉRREZ-CORTINES

Proposal for a regulation
Recital 20

(20) Competent authorities of Member States should check whether users comply with their obligations. In that context, competent authorities should accept internationally recognised certificates of compliance as evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established. When an international certificate is not available, other legally acceptable forms of compliance should be considered evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established. Competent authorities should also keep records of the checks made and relevant information should be made available in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information.13

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1

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).

2013/05/30
Committee: ENVI

Pavel POC, Cristina GUTIÉRREZ-CORTINES

Proposal for a regulation
Article 3 – paragraph 1 –point 1 a (new)

(1a) Definition of catalogue: genetic catalogues are made of individuals belonging to certain species. The next items of importance are local populations (landraces, ecotypes, endemism's, varieties, or even subspecies). Genetic catalogues require as for traceability an unbiased method of bar-coding that should be based on DNA sequencing technologies.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 a (new)

(1a) "commercialisation" means the first making available of a product on the Community market.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 1 b (new)

(1b) Concept of traceability: genetic items have to be defined at the molecular level with enough resolution to allow the unequivocal identification of its origin and destiny. Although a protocol of traceability requires a proper pipe of events or usage for any item, the traceability of any genetic entity requires its fingerprinting at the DNA level.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 1 a (new)

(1a) The internationally recognised certificate of compliance, in the case of genetic resources acquired from Parties to the Nagoya Protocol that have regulated access to their genetic resources in compliance with Article 6 of the Nagoya Protocol, or,

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 5

Article 5 Union trusted collections 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. 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. 3. In order for a collection to be included in the Union register of trusted collections, a collection owner shall demonstrate its capacity to: (a) apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their use; (b) have samples of genetic resources and related information supplied to third persons for their use only with documentation providing evidence that the resources and the information were accessed in accordance with applicable legal requirements and, where relevant, mutually agreed terms for the fair and equitable sharing of benefits; (c) keep records of all samples of genetic resources and related information supplied to third persons for their use; (d) establish or use unique identifiers for samples of genetic resources supplied to third persons; (e) use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections. 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. 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. 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. 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. 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).deleted

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 1

1. ~~Member States and the Commission shall request a~~All recipients of public research funding involving ~~uses~~the utilization of genetic resources and or of traditional knowledge associated with genetic resources ~~to declare that they will exercise due diligence in accordance with~~shall, upon approval of such funding, declare to the funding authority that they will fulfil or have fulfilled their obligations under Article 4.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 2

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 request~~Member States and the Commission shall request users seeking market approval for a product developed onvia the ~~basis~~use of genetic resources or traditional knowledge associated with ~~such~~genetic resources~~, or at the time of commercialisation~~ to declare and provide evidence that they have fulfilled the obligations under Article 4. They shall equally request such information before the product is placed on the market where a market approval is not required.

2013/05/30
Committee: ENVI

Cristina GUTIÉRREZ-CORTINES, Pavel POC

Proposal for a regulation
Article 7 – paragraph 3

3. 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 HouseAccess and Benefit Sharing Clearing House Mechanism, to the Commission and/or the competent authorities of the State concerned the information received on the basis of paragraph 1 and 2.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 8

Article 8 Best practices 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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).deleted

2013/05/30
Committee: ENVI

Cristina GUTIÉRREZ-CORTINES, Santiago FISAS AYXELÀ, Julie GIRLING

Proposal for a regulation
Article 9 – paragraph 2

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.deleted

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 3

3. Checks ~~may~~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 of a user with this Regulation.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 5

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 should be considered enough evidence that the genetic resources covered were legally obtained and that mutually agreed terms were established.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 6

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~~.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2

~~Additionally, d~~Depending on the nature of the shortcomings detected, Member States may take immediate appropriate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 11 – paragraph 1 a (new)

1 a. Member States shall allow the parties to make allegations or to appeal the decisions taken under Articles 7 and 9 in cases of alleged infringements.

2013/05/30
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 1 –point a a (new)

(aa). Create a catalogue of the available and original genetic resources from each Member State in accordance with Article 7 of the Convention on Biodiversity. The objective will be to have a better knowledge of biodiversity. At the same time they will support third countries in developing a catalogue of their genetic resources with the aim of improving transparency in the access to genetic resources.

2013/05/30
Committee: ENVI