Evaluation of EU rules for users of genetic resources and the sharing of benefits arising from their utilization

Dear Madam or Sir, I would like to provide my opinion on implementation of Regulation (EU) No 511/2014 under the Nagoya Protocol. EU made a great effort to clarify the obligations resulting from the Nagoya Protocol and the procedures to be taken to comply with the Regulation.

The European regulation has succeeded in its objective in that it has made it possible to deconsolidate the need for compliance on the part of European users. It leads them to be more vigilant about the utilisation of genetic resources and compliance with national regulations of countries party to the Nagoya Protocol. The Regulation makes it essential to exercise due diligence in the context of a research project.

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CropLife International welcomes the ability to contribute to the European Commissions consultation on the EU Access and Benefit-Sharing (ABS) Regulation. Secured access to and use of genetic resources by CropLife member companies is of paramount importance to ensure the continued development of innovative technologies that enable farmers to sustainably increase productivity and safeguard food security.

/ The Society for Medicinal Plant and Natural Product Research (GA) is the leading international scientific society for the utilization of Genetic Resources (GRs) in its field globally. GA represents more than 1,900 researchers from almost 100 countries worldwide, with more than half based in the EU.

IBMA has shared the survey with its members, who will provide the requested information (deadline set by ENV: 28 February). Regarding the general Call for Evidence, IBMA understands that the implementation of the Nagoya Protocol and the respective EU legislation is primarily targeted at Member States.

The International Fragrance Association (IFRA) welcomes the European Commissions evaluation of Regulation (EU) No 511/2014 on Access and Benefit Sharing (ABS) and appreciates the opportunity to provide feedback to this important review.

The European Marine Biological Resource Centre (EMBRC-ERIC) is a European Research Infrastructure (RI) which promotes marine research in Europe, supporting ABS due diligence and the sustainable use of marine genetic resources (MGR).

EFfCI is the European Federation for Cosmetic Ingredients, a trade association that brings together European manufacturers of synthetic and natural ingredients for the cosmetics and personal care industry. EFfCI support the objectives of the Nagoya Protocol and the EUs compliance framework to ensure fair and equitable benefit sharing while enabling sustainable innovation.

COUSIN is a Horizon Europefunded research project (www.cousinproject.eu) focusing on the conservation, characterization, and use of Crop Wild Relatives (CWR) of five flagship crops (wheat, barley, pea, lettuce, and brassicas) for breeding new varieties or organic heterogeneous materials (OHM) for sustainable agriculture.

Synpa-les Ingredients Alimentaires de Specialité represents producers and distributors of specialty food ingredients in France. We welcome the European Commission’s initiative to consult stakeholders on the application of European Regulations (EU) No 511/2014 and No 2015/1866 in the Member States.

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EFPIA, representing the biopharmaceutical industry operating in Europe, welcomes the opportunity to contribute to the European Commission's open consultation on the EU Access and Benefit-Sharing (ABS) Regulation (EU No 511/2014).

This submission was elaborated by the GNP-HuB project in cooperation with the SKBV of the DFG and supported by the listed signatory institutions. It is based on three sources of evidence: an online survey, the GNP-HuBs experience with ABS compliance, and information from the ABS Clearing-House. The complete submission is attached.

The European Commission has launched an evaluation of the implementation of the EU Access and Benefit Sharing (ABS) Regulation and opened a call for evidence to gather stakeholders views. In this context, The Spanish National Research Council (Agencia Estatal Consejo Superior de Investigaciones Científicas, CSIC) submits the attached position paper, outlining its perspectives and considerations regarding the current…

Bayer's corporate mission Health for all - Hunger for none underscores the essential role that access to genetic resources plays in delivering innovations for health and food security. Bayer is fully committed to compliant access to genetic resources and supports the objectives of the Convention on Biological Diversity, the Nagoya Protocol, and Regulation (EU) 511/2014.

Stockholm University is grateful for this chance to contribute to the evaluation of the EU regulation No 511/2014. Our input is based on accumulated experiences at the research support office which supports researchers conducting non-commercial research involving the utilization of genetic resources from other countries than Sweden.

Christian Council International (CCI) appreciates this opportunity to provide input to the call for evidence for the evaluation of Regulation 511/2014. In the attached document, we provide feedback on the relation between the Nagoya Protocol and Regulation 511/2014, Digital sequence information (DSI) and member state sovereignty.

INRAE is a French public research institution which carries out, for the most part, basic research activities with no commercial objective in the field of agriculture, food and the environment, using public and private funding and national and international collaborations.

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The European Food and Fermentation Cultures Association (EFFCA) welcomes the opportunity to provide feedback on the evaluation of the EU ABS Regulation based on the outlined criteria of efficiency, effectiveness, coherence, relevance and EU added value. Effectiveness.

Strengthening the scientific basis of herbal medicinal products is the key objective of Kooperation Phytopharmaka GbR, Bonn (www.koop-phyto.org). This is achieved by scientific projects that address challenges relating to herbal medicinal products.

Submission on behalf of the Alliance of University and Non-University Biodiversity Research in Germany and the Consortium of European Taxonomic Facilities (CETAF). >>> Please find additional remarks and recommendations attached (pdf). EFFECTIVENESS Q1 The ABS Reg has supported compliance with the Nagoya Protocol (NP) and to clarify individual and institutional responsibilities.

PlantaRei Biotech is an innovative SME that addresses the growing demand for sustainable and effective ingredients, promoting a circular economy model through upcycling and the development of biosolutions. The company integrates its supply chain by recovering plant residues from carefully selected organic farms and collaborating with Italian partners to develop products with enhanced effectiveness compared to…

I am a lawyer and independent legal consultant with over ten years experience supporting academic institutions, public research centres and SMEs in the biotechnology sector in Italy on ABS matters. In my professional practice, most challenges faced by researchers and operators - in both the public and private sectors - stem from the implementation of national ABS measures worldwide rather than from the EU Regulation…

Pharma Deutschamd generally welcomes the ABS system and is aware of the need to respect and comply with ABS requirements. Preventing future cases of biopiracy is an important goal, and this is explicitly supported by the industry. The introduction of the EU regulation aims to create uniform and harmonised processes in Europe, which we expressly welcome.

Euroseeds, representing the European seed sector, welcomes the opportunity to contribute to the European Commissions open consultation on the EU Access and Benefit-Sharing (ABS) Regulation (EU No 511/2014). The European seed and plant breeding sector accesses genetic resources as a basis for innovation, competitiveness, and the development of improved plant varieties that contribute to sustainable agriculture, food…

The Union Française des Semenciers (UFS), representing almost 100 companies active in variety breeding, seed production and marketing in France, asked the lopportunit to contribute to the European Commission’s public consultation on EU Regulation 511/2014 on access and benefit-sharing (ABS).

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The implementation of the ABS rules in Ifremer is a major development, leading to a transformation of the operational approach to our life research. In this context, Ifremer has set up national ABS coordination, the aim of which is to ensure the regulatory compliance of the institute’s research activities, while accompanying and raising operational awareness of the issues involved in this regulation.

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JRU MIRRI-IT and National Node of MIRRI-IT Microorganisms are naturally ubiquitous and crossborder. The bilateral State of Origin logic fails when the same strain can be isolated in multiple jurisdictions, creating legal uncertainty and the risk of doubleclaiming. Distinguishing strains of the same species from different countries is scientifically challenging, further complicating any provenancebased ABS approach.

1. Practicality and bureaucracy The ABS rules are generally considered to be sensible, but in practice they are often very bureaucratic, lengthy, and costly to implement. A key problem is that the competent authorities in the countries of origin often do not sufficiently understand what information, permits, or evidence researchers actually need in order to analyze genetic resources in a legally compliant manner.

MIRRI-ERIC is a distributed European Research Infrastructure integrating microbial Biological Resource Centres that act as upstream users under Regulation (EU) No 511/2014. Based on operational experience since 2014, intra-EU implementation of the EU Access and Benefit-Sharing framework functions effectively for microbial collections.

FEFANA welcomes the opportunity provided by the European Commission to offer feedback on the use of genetic resources and the sharing of benefits arising from their utilization. For more information, please find attached our position paper on this matter.

As a French public research institution, the CNRS mainly carries out basic research activities without a commercial objective, covering all scientific disciplines and relying in particular on public and private funding and on national and international collaborations.

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As coordinator (or PI) of several EU funded projects in the frame of Horizon 2020 and Horizon Europe I welcome the opportunity to contribute evidence to the evaluation of Regulation (EU) No 511/2014. One of our projects was focused on fundamental and pre-competitive research on microorganisms with potential applications in cosmetics and biotechnology, fully aligned with EU priorities on innovation, sustainability…

FRUITDIV is a Horizon Europefunded research project focusing on the conservation, characterisation, and use of fruit tree Crop Wild Relatives (CWR) for climate-resilient and sustainable agriculture. Drawing on concrete, first-hand experience with implementing Access and Benefit-Sharing (ABS) obligations in a large, multinational, non-commercial research project, FRUITDIV wishes to contribute evidence on how…

The EU Access and Benefit Sharing Regulation puts in place compliance measures for users in the EU to implement the Nagoya Protocol on access to genetic resources and the sharing of benefits arising from their use. By 2027, the Commission will evaluate whether the Regulation is properly achieving the Protocol’s objectives, assessing its efficiency, effectiveness, coherence, relevance and EU added value.

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I shall respond to Given the EUs political priorities and objectives, the increased use of Digital sequence information on genetic resources (DSI), and relevant international developments, are the legislation, its objectives and measures still relevant?

Hello, the Nagoya Protocol starts from a good principle. But it chooses modes of action that kill this principle. First of all, it accepts the principle of patents on genetic elements in living conditions. As a result, some can capture them. And those who have the most will get the most. This reinforces the exploitation of the South by the North.

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Good governance depends not only on intent, but on whether policies achieve their stated aims in practice. I submit this comment as an author of a recent peer-reviewed Perspective published in the Proceedings of the National Academy of Sciences (PNAS): Reviving Vavilovs Vision: The Tragedy of Biodiversity Governance and Principles for Reform The article examines the real-world consequences of current frameworks…

We welcome the opportunity to contribute to the evaluation of Regulation (EU) No 511/2014 and fully support the objectives of the Nagoya Protocol. Based on long-term non-commercial biodiversity research conducted in close cooperation with partner institutions in biodiversity-rich developing countries, we observe that the current implementation of the EU ABS Regulation creates significant practical barriers to…

The “EU Access and Benefit-Sharing Regulation” works moderately in practice. It often leads to uncertainties, with the result that potential utilisation of genetic resources is limited by evasive behaviour. In practice, we only use material that was already available before 2014 and material from countries with easy regulations on the use of their genetic resources.

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The implementation of compliance with the Nagoya Protocol to the IRD has benefited from a gradual and tangible structuring. Increased awareness among staff and researchers has been achieved through the organisation of annual training courses, which have significantly increased the number of staff trained and harmonised practices.

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After I clicked the link to the "personal data protection provisions*" ate the end of this page, all my entries were gone. So I have to start all over again: Since Nagoya I stay away from projects involving tropical countries. I neither have the resources nor the time or motivation to study some legal documents to find out whether it gets me into trouble or perhaps not.