Comments on the proposed Implementing Act on Regulation (EU) No 511/2014

This statement, issued by The Berne Declaration and Natural Justice on January 15, 2015, provides critical feedback on the draft Implementing Act for Regulation (EU) No 511/2014, which implements the Nagoya Protocol in the European Union. The authors identify significant gaps in the monitoring of user compliance, particularly when users and commercializers are different entities or operate outside the Union, and express concerns over blanket confidentiality clauses that could shield fraudulent access to genetic resources and traditional knowledge from public scrutiny.

• The authors argue that the draft Implementing Act fails to effectively monitor compliance when the 'user' of genetic resources (GR) and associated traditional knowledge (ATK) is not the same entity as the 'commercializer'. While the draft includes a checkpoint for when results are transferred to another person in the Union for market activities, the authors claim this event is "nearly impossible to monitor" because it is not a regulatory requirement or a publicly visible event.
• A compliance gap exists when both the user and the commercializer are located outside the European Union, and a person within the Union simply sources the resulting product. The authors propose a solution where the person within the Union who carries out market activities must submit the user's declaration of compliance to the Competent Authority.
• The authors identify a loophole regarding products based on GR and ATK sold via the Internet, which are "‘virtually’ placed in the Union’s market". They request greater clarity on which entity—such as the utilizer, vendor, or courier—is responsible for presenting the declaration of compliance to the Member State through which the product enters the Union.
• The draft Implementing Act's Annexes allow entities to request that information regarding the legitimacy of access be kept confidential based on subjective justifications. The authors argue this violates Article 7.5 of the Regulation, which limits confidentiality to cases where Union or national law protects a "legitimate economic interest". They suggest that without public scrutiny, fraudulent declarations may go undetected.
• Regarding the register of collections, the authors suggest that documents demonstrating a collection's capacity to comply with Article 5.3 should be publicly accessible to encourage best practices. They also criticize the three-year verification cycle as too infrequent and propose a specific timeframe (e.g., 2 months) for additional verifications when non-compliance is suspected.
• The authors call for the Implementing Act to define remedial steps for providers and subsequent users in two scenarios: when a registered collection is later declared non-compliant, and when a 'best practice' mechanism is later deemed to have failed its requirements.

APA

Natural Justice (2015). Comments on the proposed Implementing Act on Regulation (EU) No 511/2014. https://naturaljustice.org/wp-content/uploads/2015/01/EU-Draft-Nagoya-Protocol.pdf

Chicago

Natural Justice. Comments on the proposed Implementing Act on Regulation (EU) No 511/2014. 2015. https://naturaljustice.org/wp-content/uploads/2015/01/EU-Draft-Nagoya-Protocol.pdf.

Wikipedia

{{cite press release |author=Natural Justice |title=Comments on the proposed Implementing Act on Regulation (EU) No 511/2014 |date=15 January 2015 |url=https://naturaljustice.org/wp-content/uploads/2015/01/EU-Draft-Nagoya-Protocol.pdf |access-date=17 August 2026 |via=Climate Insights Directory}}

BibTeX

@misc{naturaljustice2015comments, author = {{Natural Justice}}, title = {{Comments on the proposed Implementing Act on Regulation (EU) No 511/2014}}, publisher = {Natural Justice}, year = {2015}, month = jan, url = {https://naturaljustice.org/wp-content/uploads/2015/01/EU-Draft-Nagoya-Protocol.pdf}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }