Text proposed by the Commission Amendment

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.

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).

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.

4. The checks referred to in paragraph 1 shall include at least: 4. The checks referred to in paragraph 1 shall include at least:

(a) examination of the measures taken by a user to exercise due diligence in accordance with Article 4; (a) examination of the measures taken by a user to exercise due diligence in accordance with Article 4;

(b) examination of documentation and records that demonstrate the exercise of due diligence in accordance with Article 4 in relation to specific use activities; (b) examination of documentation and records that demonstrate the exercise of due diligence in accordance with Article 4 in relation to specific use activities;

(c) on the spot checks, including field audits; (c) on the spot checks, including field audits;

(d) examination of instances where a user was obliged to make declarations under Article 7. (d) examination of instances where a user was obliged to make declarations under Article 7.

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.

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.

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.

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.