Legislation in the UK

From January 1st 2021:

Following departure from the EU, the UK has independent ABS legislation, although almost identical to the legislation applying before that date.

The UK ABS Regulation comprises:
Nagoya Protocol (Compliance) Regulations 2015 (SI 2015/821)
as amended by The Nagoya Protocol (Compliance) (Amendment) Regulations 2015 Statutory Instrument No 1691 (October 2015),

as amended by the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (SI 2018/1393) 
and retained EU direct legislation Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 
and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 
as amended by the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (SI 2018/1393)
and the Environment and Wildlife (Legislative Function) (EU Exit) Regulations 2019 (SI 2019/473)

There is currently no single document including all of the amendments, although Government guidance can be found here.

Defra has now published a Guidance Document to the UK Legislation. This replaces Guidance Document. published by the European Commission in 2020 for UK users.

There are several important processes applying to users that are in the in the legislation: Making a declaration of Due Diligence; Applying for recognition of Best practices; Seeking to Register a Collection. Instructions on how to carry out these processes will be made available at the beginning of January, since the current modalities will not apply.

The UK the Policy Lead is Defra (National Focal Point).

The UK Competent National Authority (& Checkpoint) is the Office for Product Safety and Standards (OPSS) – part of  BEIS. Further information is available here.

The Regulation requires making a Declaration of Due Diligence at two points in the project workflow. Taxonomic research that makes use of DNA or RNA sequences (and does not examine the properties of genes) is out of scope of the legislation and a declaration is not required, but the Guidance Document should be consulted to be certain of this. If a declaration is rquired this is likely to be at the stage when utilization takes place (of GR accessed from a country that was a Party to the Nagoya Protocol at the time of access) funded by a grant (Article 7(1) of the retained EU Regulation). This declaration must be made after the first instalment of funding has been received and all the GR and TKaGR that are utilised in the funded research have been obtained, but no later than at the time of the final project report (or if there is no such report, at the project end). Submissions must be made according to the guidance on Gov.UK here.

The OPSS has a LinkedIn group on the Nagoya Protocol, which can be found here

Situation prior to January 1st 2021

The EU ABS Regulation applied in the UK from 14 October 2014, and its Implementing Regulation from October 12 2015. In March 2015 the UK implemented the Nagoya Protocol (Compliance) Regulations 2015 Statutory Instrument 2015 No. 821 (March 2015).

This was slightly amended by The Nagoya Protocol (Compliance) (Amendment) Regulations 2015 Statutory Instrument No 1691 (October 2015),  The amendment is only to add a very short phrase ["In   regulation   16(2)   of   the   Nagoya   Protocol   (Compliance)   Regulations   2015(c), after “regulation 13”, insert “, or regulation 14,"]; the main text is in the first of these Statutory Instruments.

The Statutory Instrument puts in place measures to implement:
• the EU Regulation;
• the Commission’s Implementing Regulation;
• elements of the Nagoya Protocol not covered by the EU Regulation.
It does not include Access requirements; the UK does not require to give PIC to anyone collecting. It applies to all of the UK.

Scratchpads developed and conceived by (alphabetical): Ed Baker, Katherine Bouton Alice Heaton Dimitris Koureas, Laurence Livermore, Dave Roberts, Simon Rycroft, Ben Scott, Vince Smith