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Guidance: Utilizing genetic resources (Nagoya protocol) - Swedish Environmental Protection Agency

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 Guidance: Utilizing genetic resources (Nagoya protocol) - Swedish Environmental Protection Agency The website uses cookies to largest meet your needs. I accept  read increasingly It appears as if you are using an old web browser. For the weightier wits of swedishepa.se, please download a new browser, and make sure that JavaScript is enabled.  Swedish EPA Go to page content Go to sub menu SearchWell-nighus Contact News and printing Svenska Enjoying natureProtected areas & Hunting State of the environmentStatistics & Facts CooperationObjectives & Responsibilities GuidanceLaws & RegulationsGuidance in environmental workSpecies ProtectionWasteNoiseEnvironmentally hazardous activitiesEnvironmental quality standards Open dataGrantsInnovations for sustainable citiesLaws and regulationsThe Swedish Environmental CodeFor applicants and reviewers, Environmental researchInstructions for applicants – research projectsReporting resultsInstructions for reviewersCallsClosed Calls Utilizing genetic resources Guidance on the utilization of genetic resources in research and product development. svenska Share Contact Listen Guidance To you who:  self-mastery research or product minutiae on biological material (genetic resources), legitimatize applications for research funding, work for public agencies involved in product approval, are custodians of collections of biological material. The Nagoya Protocol and the EUWangleand Benefit-Sharing (ABS) Regulation, No. 511/2014, wield both to commercial and non-commercial researchers. Researchers conducting vital research and unromantic research on biological material and/or associated traditional knowledge shall comply with these regulations. Guidance and information on how to comply can be found in the navigations menu. The pursuit is a step-by-step guide aimed to provide you with practical steps on how to comply with the EU ABS Regulation.IncreasinglyinformationWell-nighGenetic resourses Environmental objective A Rich Diversity of Plant andUnprepossessingLife How do I comply with the EU ABS Regulation? BASIC OBLIGATIONS Steps to determine whether you need to file a declaration. 1. Find out whether the EU ABS Regulation is relevant for your research. Who is in telescopic of the Nagoya Protocol? 2. If your research is within telescopic of by the EU ABS Regulation, go to the ABS Clearing-House to: a) Determine whether the provider country is party to the Nagoya Protocol and whether there is any ABS legislation for genetic resources and/or associated traditional knowledge. b) Obtain the contact information for the national focal point (NFP) and competent national authorities (CNA) in the country that holds the genetic resource and/or the associated traditional knowledge. The ABS Clearing-House should have information on how to wield for wangle – such as a spritz orchestration or a where you can find increasingly information on how to wield for access. If not, proceed to step 3. Using the ABS Clearing-HouseABS Clearing-House website 3. Contact the national focal point in your provider country and seek translating as to: a) How to wield for Prior Informed Consent (PIC) and MutuallyWell-setTerms (MAT) and if there are any specific requirements or conditions tying to these permits. b) Other specific and relevant national legislation that requires remoter permits. Using ABS Clearing-House 4.Wieldfor PIC and establish MAT if required. During the research period, the conditions stated in the MAT and other relevant legislation must be fulfilled. 5. During the period of your research you shall declare due diligence to the Swedish Environmental Protection Agency. User Manual (pdf 1 MB) 6. If you launch a product in the market as a result of this research, you shall, surpassing the product is introduced in the market or at the time of the product approval, submit a second declaration to the Swedish Environmental Protection Agency. User Manual (pdf 1 MB) OTHER OBLIGATIONS Other obligations under the EU ABS Regulation. 7. Keep your permits (PIC AND MAT) and any other information relevant to wangle and benefit-sharing for 20 years without the research is concluded. 8. Inform subsequent users of the conditions as described in PIC and MAT. Laws/Regulations Laws and regulations EU and konventions Nagoyaprotokollet ABS-förordningen (EU) 511/2014  Genomförandeförordningen (EU) 2015/1866  EU:s förordning om genomförandet av CITES-konventionen  Det internationella fördraget om växtgenetiska resurser Swedish laws Ordinance on wangle to Genetic resources and Traditional Knowledge associated with Genetic Resources Artskyddsförordningen (2007:845) Brottsbalken (1962:700) Jaktlag (1987:259) Fiskelag (1993:787) Guidance Guidance document on the telescopic of using and cadre obligations of the ABS regulation The Right of PublicWangleDefinitions Definitions For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the pursuit definitions apply: access  ways the vanquishment of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol undertone of users  ways an organisation, established in vibrations with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the weightier practices referred to in Article 8 of this Regulation collection means a set of placid samples of genetic resources and related information that is piled and stored, whether held by public or private entities genetic material  means any material of plant, animal, microbial or other origin containing functional units of heredity genetic resources  ways genetic material of very or potential value illegally accessed genetic resources  ways genetic resources and traditional knowledge associated with genetic resources which were not accessed in vibrations with the national wangle and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent internationally recognised document of compliance means a permit or its equivalent issued at the time of wangle as vestige that the genetic resource it covers has been accessed in vibrations with the visualization to grant prior informed consent, and that mutually well-set terms have been established for the user and the utilisation specified therein by a competent validity in vibrations with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made misogynist to theWangleand Benefit-sharing Clearing House established under Article 14(1) of that Protocol traditional knowledge associated with genetic resources  ways traditional knowledge held by an ethnic or local polity that is relevant for the utilisation of genetic resources and that is as such described in the mutually well-set terms applying to the utilisation of genetic resources user means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources utilisation of genetic resources  ways to self-mastery research and minutiae on the genetic and/or biochemical sonnet of genetic resources, including through the using of biotechnology as specified in Article 2 of the Convention prior informed consent (PIC) a permit or an equivalent document that has been issued at the time of wangle as proof of the compliance of workable laws and regulations mutually well-set terms (MAT): a contract between a provider of genetic resources or associated traditional knowledge and a user, within which the obligations are described that ensures that any potential goody is shared fairly and equitably. Additional requirements may exist for subsequent users or at the time of product release to market Background Background The aims of the UN Convention on Biological Diversity (CBD) are the conservation of biological diversity, the sustainable use of its components and the pearly and equitable sharing of the benefits welling out of the utilization of genetic resources. At the Conference of the Parties to the Convention on Biological Diversity (CBD) in 2010, the Nagoya Protocol governing wangle to genetic resources and pearly and equitable sharing of their use was adopted. In the EU, the Nagoya Protocol is implemented by Regulation (EU) No 511/2014 of the European Parliament and of the Council on compliance measures for users from the Nagoya Protocol onWangleto Genetic Resources and thePearlyand Equitable Sharing of BenefitsWellingfrom their Utilization in the Union (also tabbed the ABS Regulation). This Regulation entered into gravity in October 2014. On 12 October 2015, one year without its entry into force, the Regulation’s provisions on the obligations of users of genetic resources began to wield within the EU. Sweden is a signatory to the Nagoya Protocol, but has not yet ratified it. According to the Government Offices of Sweden, Sweden plans to ratify the Nagoya Protocol at the latest 90 days surpassing the first meeting of the Parties to the Nagoya Protocol onWangleand Benefit-Sharing in December 2016, in order to be a full member at this meeting.Surpassingit can ratify the Protocol however, Sweden must have penalty provisions in place and a regulatory framework for wangle to traditional knowledge that is not uninventive in the context of wangle to genetic resources. These provisions are likely to be decided on surpassing the summer of 2016. Tasked with the implementation of the ABS Regulation In February 2015, the Swedish Environmental Protection Agency was tasked by the Government of Sweden with preparing for the implementation of the EU Regulation 511/2014 (ABS Regulation) on the implementation of the Nagoya Protocol. This task entailed: Suggesting how weightier to organize and exercise national supervision of the ABS Regulation cost-effectively Setting up a national focal point in the Internet-basedWangleand Benefit-Sharing Clearing House (ABS Clearing House) that has been established to provide information well-nigh wangle to genetic resources and benefit-sharing from the utilization of these resources Initiating dialogue with representatives of users of genetic resources in both private and public sector activities in order to materially squire the implementation and facilitate compliance with the ABS Regulation. How the Swedish EPA has been working on this task In June 2015, the Swedish Environmental Protection Agency submitted a proposal to the Government concerning the supervision organization. This proposal suggested that both the Swedish Environmental Protection Agency and the Swedish Board of Agriculture should be competent authorities and share supervisory responsibility for the implementation. However, in January 2016 it became well-spoken that the Swedish EPA needed to shoulder the unshortened responsibility for supervision, and therefore remains the only competent validity in Sweden. Since January, the Swedish EPA has been preparing in various ways to take on this responsibility, for example by developing a risk-based supervision plan and Guides for users. The Swedish EPA has set up a national focal point by publishing Guides and other information on the Web. The Swedish EPA now moreover has an organization for dealing with questions from stakeholders, and is ready to winnow declarations from users. Dialogue has been initiated through a hearing in the spring of 2015, and via e-mail communications with users of genetic resources. On 22 April 2016, a seminar will be held to communicate the using of the ABS Regulation to variegated categories of users. A report on this task was presented on 31 March 2016, at which time the Guides were moreover published. Report  (Only in Swedish, pdf 223 kB) Last updated: 14 May 2018Content editor: Karolina Åsman Related pages Managing the landscapePolicy instruments for a largest environmentCallsCall for research funding: Indicators of biological diversity at landscape levelCall for research funding: DNA methods in environmental monitoring Species Protection All guidance Species Protection Ordinance Genetic resourses Who is in telescopic of the Nagoya Protocol? Frequently asked Questions (FAQ) Using the ABS Clearing-House Declaring utilisation Using Swedish genetic resources Using traditional knowledge Using genetic resources from other countries Granting research funding and approving products Being a hodgepodge holder StartGuidanceGuidance in environmen...Species ProtectionGenetic resourses Search Contact us well-nigh this web page Your message will be sent to Registrar's Office at the Swedish Environmental Protection Agency. We read everything and respond as soon as possible. I have a question I want to requite feedback Your name Your e-mail Subject Message Share this page Share in social media Facebook Twitter LinkedIn Share with e-mail To e-mail From e-mail Message (optional) Postal address: SE-106 48 Stockholm Telephone: +46 10 698 10 00Well-nighthe website Cookies