Convention on Biological Diversity and the ABS Regulation
The cosmetics industry is very innovative and uses many ingredients derived from genetic resources from plants, animals or microbes. The use of these raw materials triggers the requirements of Access and Benefit Sharing Regulations across the world. These requirements implement the principles of the “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) from the Convention on Biological Diversity”, commonly referred to as the Nagoya Protocol.
The Convention on Biological Diversity (CBD), which entered into force on 29th December 1993, is inspired by the world community’s growing commitment to sustainable development. It is a multilateral treaty and has three main objectives;
- the conservation of biological diversity;
- the sustainable use of its components; and
- the fair and equitable sharing of benefits arising out of the utilisation of genetic resources.
To date the CBD has been either ratified, acceded to, approved or accepted by 196 parties. Further information on the convention can be found at: www.cbd.int/convention.
The Nagoya Protocol is an international agreement on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation (ABS). It is a supplementary agreement to the CBD and aims to ensure fair and equitable sharing of benefits arising from the utilisation of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.
The Nagoya Protocol was adopted on 29 October 2010, during the Biodiversity Summit which took place in Nagoya, Japan. The protocol came into force on 12 October 2014, 90 days after the signature by the fiftieth country, State or organisation. It was signed by the European Council on behalf of the European Union in June 2011.
Implementation of ABS into UK and EU law
Signing a treaty does not mean that a country, State or organisation is legally bound to the treaty. For a treaty to become legally binding, a further step of ratification must be taken. The term 'Party' is only used when the treaty is legally binding.
The Nagoya Protocol has, so far, been ratified by 129 countries and has 92 signatures. Companies can visit this site to check the parties signed up to the Nagoya Protocol.
The UK has signed and ratified the Treaty. However, the UK has chosen not to exercise sovereign rights for accessing its genetic resources under the Nagoya Protocol. Companies may need to comply with other UK legislation, which should be considered prior to any collection of sovereign UK genetic resources.
The UK ABS Regulations apply to any company, organisation or individual conducting research and development on genetic resources and/or associated traditional knowledge where the genetic resource and/or associated traditional knowledge;
- was accessed on or after 12th October 2015;
- was accessed from a country that is party to the Nagoya Protocol and has ABS legislation; and
- is not already covered by a specialised international instrument.
More information on the UK requirements can be found here.
The EU ratified the Treaty through the process of 'approval' on 16 May 2014 and became a Party on 12 October 2014. A Regulation on Access to Genetic Resources (ABS Regulation) was adopted on 16 April 2014 ((EU) No 511/2014) and applies to products placed on the EU market which contain genetic resources and/or are based on traditional knowledge associated with the genetic resources.
This Regulation, which implements the Nagoya Protocol in the EU, entered into force on 9 June 2014 and has been applicable since 12 October 2014. Commission Implementing Regulation (EU) 2015/1866 lays down detailed rules for the implementation of the ABS Regulation in regard to the register of collections, monitoring of user compliance and best practices. This Implementing Regulation is supplementary to the principal ABS Regulation.
Members can access further information in the CTPA Biodiversity Reference Zone. Publicly available guidance is available from the EU Commission and UK Government. The EU Commission also published updated advice as part of a Commission Notice and two Annexes, Annex I giving an overview of the conditions for the applicability of the EU ABS Regulation, and Annex II providing additional details on the concept of utilisation (R&D) covering specific sectorial aspects.
The UK Government provides a self-assessment tool, which is aimed at helping users to understand their requirements and record information relating to compliance, this tool can be downloaded from here.
The Nagoya Protocol applies to genetic resources and to the benefits arising from their utilisation. It also covers traditional knowledge associated with genetic resources and the benefits arising from its utilisation.
- A 'genetic resource' is defined as any material of plant, animal, microbial or other origin containing ‘functional units of heredity’ (genes) which is of actual or potential value.
- 'Associated traditional knowledge' is defined as traditional knowledge held by an indigenous or local community that is relevant for the utilisation of a genetic resource.
- 'Utilisation' means to conduct research and development (R&D) on genetic resource and/or the biochemical composition of genetic resource, including through the application of biotechnology - it is the process of researching new properties by a 'user'.
If a provider country of a genetic resource or associated traditional knowledge, is a Party to the Nagoya Protocol and has implemented national legislation, then a user must comply with the legislation in the provider country.
- The user must acquire Prior Informed Consent (PIC) from the provider country prior to beginning utilisation.
- The user and the provider country must establish Mutually Accepted Terms (MAT). These can take the form of monetary benefits (e.g., access fee per sample, up front or milestone payment, royalties) or non-monetary benefits (e.g., sharing of R&D results, scientific collaboration, contribution to local economy, cooperation in education or training).
Scope for cosmetic ingredients
Many of the naturally derived ingredients used in the cosmetics industry have been available for many years and as such are not subject to these regulations, because they were accessed before 12th October 2015.
The Nagoya Protocol defines "derivative" as "a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity."
New ingredients could well be within scope of these regulations therefore companies should conduct due diligence before proceeding with their use. Making a due diligence declaration is a requirement of compliance. Details of when this is required, how it is done, and the due diligence declaration form is available here.