Testpage modifications help-tool Share: Twitter Whatsapp Email Linkedin LET OP: Dit is een tijdelijke testpagina tbv de wijzigingen aan de help-tool. Deze pagina wordt verwijderd zodra de aanpassingen akkoord zijn. 1. What genetic resource are you working with? Non-human genetic resource (e.g. material from plants, animals, micro-organisms or viruses) Human genetic resource This genetic resource falls outside the scope of the CBD, the Nagoya Protocol and the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the CBD, the Nagoya Protocol and the EU ABS Regulation . 2. Is the genetic resource utilised in the sense of the EU ABS Regulation (‘research and development’)?See section 2.3.3 of the EU Guidance document for more information on what constitutes utilisation in the sense of the EU ABS Regulation. Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 3. Is the genetic resource utilised either partly or entirely within the European Union? Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 4. When was the genetic resource accessed? On or after 12 October 2014 Before 12 October 2014 This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 5. When the genetic resource was accessed, was the provider country a Party to the Nagoya Protocol?See the ABS Clearing-House to determine whether the provider country is a Party to the Nagoya Protocol. Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. It is recommended to keep information relevant to the genetic resource to show that the genetic resource has been obtained from this country. More information can be found on the ABS Focal Point website. 6. Has the provider country established applicable access measures on genetic resources?See the ABS Clearing-House and contact the National Focal Point of the provider country to determine whether the provider country has established applicable access measures. Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. It is recommended to keep information relevant to the genetic resource to show that the genetic resource has been obtained from this country. More information can be found on the ABS Focal Point website. 7. Is the genetic resource obtained as a commodity without (subsequent) research and development?See section 2.3.1.3 of the EU Guidance document for more information on traded commodities. Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 8. Is the utilisation of the genetic resource covered by a specialised international ABS instrument that has been recognised in the EU ABS Regulation? More information on specialised international ABS instruments can be found on the ABS Focal Point website. Yes, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) Yes, the Pandemic Influenza Preparedness Framework (PIP) No This genetic resource falls outside the scope of the EU ABS Regulation when used under the conditions specified in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). When obtaining and using this genetic resource in accordance with the ITPGRFA, there are no obligations related to the EU ABS Regulation. Access to plant genetic resources (PGRFA) within the Multilateral System (MLS) is provided under the conditions specified in Article 12.3 of the ITPGRFA. If the genetic resource is used for purposes other than those set out in the ITPGRFA ("research, breeding and training for food and agriculture"), use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue. More information can be found on the ABS Focal Point website. This genetic resource falls outside the scope of the EU ABS Regulation when used under the conditions specified in the Pandemic Influenza Preparedness (PIP) Framework. When obtaining and using this genetic resource in accordance with the PIP Framework, there are no obligations related to the EU ABS Regulation. Article 3 of the PIP Framework states: 3.1 This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits.3.2 This Framework does not apply to seasonal influenza viruses or other noninfluenza pathogens or biological substances that may be contained in clinical specimens shared under this Framework.If the PIP Framework does not apply, use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue. More information can be found on the ABS Focal Point website. 9. Consider whether the genetic resource falls into one or more of the following categories.Before clicking ‘Yes’ or ‘No’ below, see the indicated sections in the EU Guidance document to determine whether the genetic resource falls into these categories and to find more information on the scope of the EU ABS Regulation.Alien or invasive alien species (2.1.4);Released biocontrol organisms (2.1.5);Pathogenic genetic resources or pests introduced unintentionally in the EU (2.3.1.5);Associated organisms brought to the EU on an (accessed) genetic resource (2.3.1.6);Human microbiota (2.3.1.7);Traditional knowledge associated with genetic resources (2.3.2);Derivatives (2.3.4);Testing or reference tools (Annex II 7.1, 7.2);Laboratory strains (Annex II 7.5);Commercial plant varieties (Annex II 8.4);Forest reproductive material (Annex II 8.5);Animals for breeding (Annex II 8.6).Based on the information provided about these categories in the indicated sections of the EU Guidance document, is the genetic resource in scope of the EU ABS Regulation? Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 10. Consider whether the activities with the genetic resource fall into one or more of the following categories.Before clicking ‘Yes’ or ‘No’ below, see the indicated sections in the EU Guidance document to determine whether the activities with the genetic resource fall into these categories and to find more information on what constitutes utilisation in the sense of the EU ABS Regulation.(Taxonomic) identification of a genetic resource (2.3.3.1, Annex II 6.1);Storage and collection management (Annex II 3);Rearing and multiplication (Annex II 4);Characterisation (Annex II 6.2);Phylogenetic analysis (Annex II 6.3);Identification of derivatives (Annex II 6.4);Large-scale screening (Annex II 6.5);Behavioural studies (Annex II 6.6);Breeding (Annex II 8);Product development, processing and product formulation (Annex II 9);Product testing, including regulatory tests and clinical trials (Annex II 10).Based on the information provided about these categories in the indicated sections of the EU Guidance document, are the activities with the genetic resource in scope of the EU ABS Regulation? Yes No This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation. However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you should respect the national rules and regulations of the provider country. More information can be found on the ABS Focal Point website. 11. Has the genetic resource been accessed under the standard material transfer agreement (SMTA) of the ITPGRFA? More information on the SMTA can be found in the FAQ - Important terms on the ABS Focal Point website. Yes No When you access plant genetic resources from countries that issue their plant-genetic resources for food and agriculture under the conditions of the SMTA, including those not listed in Annex I of the ITPGRFA, you are considered to have exercised due diligence. It is not necessary to submit a due diligence declaration. Use and transfer the genetic resources obtained only in accordance with the conditions as stated in the SMTA. If the situation above does not apply, use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue. More information can be found on the ABS Focal Point website. 12. Is the genetic resource obtained from a collection registered under the EU ABS Regulation? An overview of the registered collections can be found in the European Commission's Register of Collections. Yes, from a collection registered under the EU ABS Regulation No, it was obtained from a collection, but not from a collection registered under the EU ABS Regulation No, not from a collection 13. Were prior informed consent (PIC) and mutually agreed terms (MAT) obtained? More information on PIC and MAT can be found in the FAQ - Important terms on the ABS Focal Point website. Yes, PIC has been obtained from the country's competent national authority (CNA). MAT were established with the provider No, PIC and MAT are required by the country, but were not obtained Users of this material are considered to have exercised due diligence regarding the collection of information. You may need to submit a due diligence declaration. Keep relevant information and documents for at least 20 years, and transfer this information to any subsequent users. Use and transfer the genetic resources obtained only in accordance with the conditions agreed with the provider country, and carefully document the use you make of them. Relevant information. Relevant information includes an internationally recognised certificate of compliance (IRCC), as well as information on the content of the mutually agreed terms relevant for subsequent users. If an IRCC is not available, this constitutes information and relevant documents on: the date and place of access to genetic resources or traditional knowledge associated with genetic resourcesthe description of the genetic resources or of traditional knowledge associated with genetic resources utilisedthe source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resourcesthe presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisationaccess permits, where applicablemutually agreed terms, including benefit-sharing arrangements, where applicableMore information can be found on the ABS Focal Point website. Due diligence requirements are not fulfilled. You are required to obtain prior informed consent (PIC) and establish mutually agreed terms (MAT) or discontinue utilisation of the genetic resource. More information can be found on the ABS Focal Point website.