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[For the Dutch version, see the ABS Focal Point website.] Welcome to the tenth ABS Focal Point newsletter. In this newsletter we are taking a closer look at collections: how can users of genetic resources minimise their administrative burden through making use of collections registered under the EU ABS Regulation and what do you need to know about ABS when storing and managing a collection? We also present the updated interactive ABS help tool and keep you informed about current international developments regarding digital sequence information (DSI).
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Interactive ABS help tool updatedTo help you determine if your activities are in scope of the EU ABS Regulation, the ABS Focal Point has developed an interactive help tool. The tool was recently updated to include information provided in the revised EU Guidance document. The European Commission published a revised EU Guidance document in 2021, providing more detailed information and practical examples on the scope and user obligations of the EU ABS Regulation (Regulation (EU) 511/2014). The ABS Focal Point has now incorporated this additional information into the ABS help tool. Questions were added on whether the genetic resource is utilised in the sense of the EU ABS Regulation (‘research and development’) and whether the genetic resource is obtained as a commodity without (subsequent) research and development. Some categories of genetic resources or activities with genetic resources may not be in scope of the EU ABS Regulation. The updated help tool highlights these categories and refers to relevant sections of the revised EU Guidance document. For more information on new content in the EU Guidance, see: ‘Revised EU Guidance document officially published’. In addition to helping you determine whether your activities with genetic resources are in scope of the EU ABS Regulation, the help tool provides a short overview of your obligations under the Regulation if your activities are within scope. The page also contains a printable flowchart that is to be used in combination with the information on the page, and a list which explains important terms used in the tool. You can find the updated help tool on the page ‘Tool to help you comply with the EU ABS Regulation’. |
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Invitation to submit views on Digital Sequence Information (DSI)How to deal with access to and benefit-sharing from the use of digital sequence information (DSI)? Important decisions on this topic will probably be taken in August-September 2022. You are invited to share your views on DSI and proposed policy options, so that these can be taken aboard by the EU in the preparations for the upcoming meetings. DSI discussions during the Geneva meeting in March 2022 From 14-29 March 2022, various previously postponed meetings in the framework of the Convention on Biological Diversity (CBD) and the Nagoya Protocol were held in Geneva, Switzerland. The meetings included the resumed session of the Third Meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework (OEWG-3), in which further discussions took place on how to deal with access to and benefit-sharing from the use of digital sequence information (DSI). It was agreed that an independent assessment will be made of the consequences of the proposed policy options, using a range of formulated criteria. It was also agreed that representatives from databases, the scientific research community, the private sector and civil society organizations would be included in the Informal Advisory Group which has been discussing DSI. As for the follow-up steps, it was agreed that updates on the independent assessment of the policy options and the work of the Informal Advisory Group will be given during an additional meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework (OEWG-4), to be held in Nairobi, Kenya, from 21-26 June 2022. The final results of both processes will be reported in the Fifteenth meeting of the Conference of the Parties to the CBD (COP-15), which will probably take place in August-September 2022. It is expected that important decisions on DSI will be taken be taken during COP-15. Policy options Concerning DSI, the following policy options are currently under consideration, also keeping open the possibility to combine various options (e.g. Option 4 with another option).
For more information, see the previous articles Policy options for Access and Benefit-Sharing (ABS) and Digital Sequence Information, Progress on Digital Sequence Information (DSI) and CBD meetings (including on DSI) to be held in March. Assessment of policy options To assess the different policy options, a multi-criteria framework has been developed, with the criteria focusing on effectiveness, efficiency, good governance and coherence. A performance matrix was developed to assess to what extent the policy options fulfill the criteria. More information can be found in this CBD document, with its annex I describing the policy options, its annex II mentioning the criteria and subcriteria to assess these options, and its annex III presenting the performance matrix. An assessment of the consequences of the proposed policy options, using the multi-criteria framework, will be made by an independent consultant. Your input is useful! As it is expected that important decisions will be taken be taken during COP-15 in August-September, and the EU position will be discussed during the coming months, now is the time to make your views known to the Dutch ABS Competent National Authority (Ms Kim van Seeters; k.vanseeters@minlnv.nl). It would be very helpful if you could share your assessment of the policy options, especially by filling in the performance matrix in annex III of the above-mentioned CBD document. Thank you in advance for your contribution. |
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Minimising your administrative burden: EU registered collectionsAs a user of genetic resources, it can be difficult to gather information on the ABS conditions that apply when accessing and using genetic resources. When using material from a collection registered under the EU ABS Regulation, you can minimise the administrative burden while still complying with ABS rules. The European Commission keeps a list of collections registered under Article 5 of the EU ABS Regulation (Regulation (EU) 511/2014): the EU Register of Collections. These collections apply standardised procedures for supplying genetic resources and related information. The procedures ensure that, along with the genetic resource, all relevant ABS information is provided to third parties and with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable ABS legislation or regulatory requirements and, where relevant, under mutually agreed terms (MAT). Obtaining genetic resources from a registered collection makes it easier for users to comply with ABS legislation. If you have obtained a genetic resource from a collection included in the EU Register of Collections you are considered to have exercised your due diligence obligations with regards to collecting information (the information listed in Article 4(3) of the Regulation). However, you may still need to submit a due diligence declaration. More information on due diligence declarations: ‘To DECLARE or not to DECLARE: when to submit a due diligence declaration’. Be aware that when the intended use changes, there might be a need to seek new or updated prior informed consent (PIC) from the provider country and establish MAT for the new use, if it is not covered by the PIC and MAT obtained and relied upon by the registered collection. Where to find the EU Register of Collections The EU Register of Collections is available on the ABS webpage of the European Commission under the heading ‘Register of collections’. It currently includes collections from the Leibniz-Institut DSMZ, the French Collection for Plant-associated Bacteria (CIRM-CFBP) and the Pierre Fabre Research Institute. More information on the registered collections and how to obtain their genetic resources is found on the European Commission’s website under Register of Collections. |
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EU ABS Regulation on storage and collection managementWhen storing and managing collections of genetic resources, it is important to know which activities may or may not be in scope of the EU ABS Regulation. We take a look at what the EU ABS Regulation and EU Guidance document say about storage and collection management. Activities with genetic resources may be in scope of the EU ABS Regulation (Regulation (EU) 511/2014) when they are considered to be ‘utilisation of genetic resources’. This is defined by the Nagoya Protocol and EU ABS Regulation as: “to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology”. Many activities that are related to storage and collection management are not considered to be utilisation and are therefore out of scope of the EU ABS Regulation. For example, the following activities do not involve research and development on the genetic and/or biochemical composition of genetic resources, are thus not considered utilisation and are therefore out of scope of the EU ABS Regulation:
For more information, see section 2.3.3.1 and Annex 2, section 3 of the EU Guidance document. Good practices for collection holders To help potential users of collection material, the EU Guidance document recommends some good practices for collection holders:
EU Register of Collections The European Commission keeps a list of collections registered under Article 5 of the EU ABS Regulation: the EU Register of Collections. These collections apply standardised procedures for supplying genetic resources and related information. Obtaining genetic resources from a registered collection makes it easier for users to comply with ABS legislation, as users of this material are considered to have exercised due diligence as regards the seeking of information. Collection holders in the EU may register their collection, or part of it, by applying to their country’s competent national authority (CNA). To qualify for inclusion in the EU Register of Collections, collection holders are obliged to supply genetic resources and related information only with appropriate documentation (PIC and MAT where applicable) and to keep records of all samples of genetic resources and related information supplied to third persons for their utilisation. If the provider country of genetic resources cannot be identified, a collection is advised to keep this material apart in its unregistered part. Further conditions are set up in Article 5(3) of the EU ABS Regulation. For more information on EU registered collections, see the article: ‘Minimising your administrative burden: EU registered collections’ above. |
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