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The Nagoya Protocol (Compliance) Regulations 2015

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Due diligence obligations of the EU Regulation which are subject to civil sanctions

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8.—(1) Subject to paragraphs (2) and (3), civil sanctions may be imposed in relation to a failure to comply with any of the following provisions—

(a)Article 4(1) of the EU Regulation (obligation to exercise due diligence);

(b)Article 4(3) of the EU Regulation (obligation to seek, keep and transfer information and documentation to subsequent users);

(c)Article 7(2) of the EU Regulation (obligation to make a declaration of due diligence).

(2) There is no failure to comply with the provisions referred to in paragraph (1) if the Secretary of State is satisfied that the user has shown that they have effectively implemented best practice recognised under Article 8(2) of the EU Regulation.

(3) There is no failure to comply with Article 4(3) of the EU Regulation if the Secretary of State is satisfied that—

(a)the user is considered to have exercised due diligence under Article 4(4) of the EU Regulation (use of the Plant Treaty’s Standard Material Transfer Agreement for material not listed in Annex 1 to that Treaty);

(b)the user is considered to have exercised due diligence under Article 4(7) of the EU Regulation (users obtaining material from a registered collection); or

(c)the use is in accordance with Article 4(8) of the EU Regulation (use of pathogen for the purpose of public health emergency preparedness).

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