These Regulations implement, within the United Kingdom, compliance measures for users of genetic resources or traditional knowledge associated with genetic resources resulting from 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 Protocol”). The Protocol aims to promote the conservation and sustainable use of biodiversity by ensuring the benefits from the use of genetic resources and traditional knowledge associated with genetic resources are shared fairly. Regulation (EU) No 511/2014 of the European Parliament and of the Council on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union (OJ No L 150, 20.5.2014, p 59) (“the EU Regulation”) requires users to exercise due diligence that they only utilise genetic resources or traditional knowledge associated with genetic resources that have been accessed in accordance with the Protocol. Users are also required to make a declaration confirming due diligence at the final stage of development of a product.

Part 2 deals with the allocation of functions to the Secretary of State as competent authority for the EU Regulation and as member State under Articles 5, 7(1) and 13 of the EU Regulation. Regulation 6 provides that the Secretary of State must take any other administrative or policy measures that are necessary to provide that genetic resources or traditional knowledge associated with genetic resources are utilised in accordance with the Protocol.

Part 3 and the Schedule enable the Secretary of State to impose civil sanctions. Compliance with requirements to exercise due diligence under, or to fail to make a declaration of due diligence in accordance with, the EU Regulation is made subject to civil sanctions, but will not directly be made an offence. Variable monetary penalties may be imposed in relation to offences under the Regulations.

Part 4 deals with enforcement. Regulations 9, 10 and 11 confer entry, inspection and seizure powers on inspectors. Regulation 12 makes provision for documents which are the subject of legal professional privilege or its equivalent in Scotland.

Part 5 sets out offences and penalties. Regulation 13 provides for offences for failure to comply with compliance or stop notices, as well as requirements to keep information under the EU Regulation. Regulation 14 makes it an offence to obstruct an inspector.

Part 6 requires the Secretary of State to review the operation and effect of these Regulations and publish a report within five years of the enforcement and penalty provisions coming into force.

An impact assessment has not been produced for these Regulations as no significant impact on the costs of business or the voluntary sector is foreseen as a result of them. The Explanatory Memorandum is published alongside the instrument on www.legislation.gov.uk.