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Yes
No difficulties and challenges encountered.
Yes
EU ABS Regulation - REGULATION (EU) No 511/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union;
Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices;
Commission notice — Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union;
Biological Diversity Act (State Gazette No. 77/9.08.2002, last amended, SG No. 76/19.09.2017.
Ministry of Environment and Water (MOEW) – CA for GR from wild species (Coordinating authority);
Ministry of Agriculture Food and Forests (MAFF) – CA for agricultural and forest GR ;
Ministry of economics (ME) – CA for industrial microbiological GR.
MAFF and ME can be contacted through the NFP.
To establish effective checkpoints without creating unnecessary administrative burden.
The competent authorities designated under Regulation (EU) No 511/2014CAs are also functioning as checkpoints under article 17 as follows:
Ministry of Environment and Water (MOEW);
Ministry of Agriculture Food and Forests (MAFF);
Ministry of economics (ME).
In accordance with their competences the CAs:
1. receive due diligence declarations from researchers; all recipients of research funding, where such research involves utilization of genetic resources and traditional knowledge associated with genetic resources, are requested either by the European Commission or by the Member State as providers of funding, to declare that they exercised due diligence; the template for this declaration is contained in the Commission Implementing Regulation in Annex II;
2. gather due diligence declarations at the final stage of a product development from all users; the template for this declaration is contained in the Commission Implementing Regulation in Annex III; specific events triggering submission of the declaration are defined in Article 6 of the Commission Implementing Regulation;
3. transfer the information to ABS Clearing House, provided it is not confidential; alternatively, in case crucial information for publishing of checkpoint communique (CPC) is indicated as confidential and CPC cannot be published, the authorities contact the competent national authorities of the country providing genetic resources.
Further work is to be done for the improvement of the process of gathering and analyzing information within the Bulgarian CAs as well as the rate and quality of information exchange process between the CAs in their function as a checkpoints.
In accordance with article 66 (6) of the BDA the detailed terms and procedures for provision of access to genetic resources shall be established by a regulation adopted by the Council of Ministers. The document is in advanced drafting stage.
Yes
A written permission for access and use is issued by the CA after a filed request from the applicant.
Yes
The CA will provide the user with a written permission and will notify ABSCH accordingly.
Detailed rules and procedures for requiring and negotiating MAT will be established by a Ordinance adopted by the Council of Ministers. The document is advanced drafting stage. Prior the adoption of the Regulation adopted MAT are established on case by case basis also with reference to the Bonn guidelines.
No selection made
No benefits have been received.
No additional information provided
Yes
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilize have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”.
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilize have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”.
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilize have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”.
Regulation (EU) 511/2014 on compliance measures for the users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union entered into force on 9 June 2014 and into application on 12 October 2014. Some provisions has entered into force on 12 October 2015;
Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards the register of collections, monitoring user compliance and best practices entered into force on 9 November 2015;
Biological Diversity Act (State Gazette No. 77/9.08.2002, last amended, SG No. 76 /19.09.2017.
The legal framework for addressing the issues of non-compliance is provided by the EU ABS Regulation (511/2014), Commission Implementing Regulation (2015/1866) and the Bulgarian Biodiversity Act.
In accordance with Article 7(1) and (2) of Regulation (EU) No 511/2014, users need to provide information as required by Article 17(1) of the Nagoya Protocol to designated competent authorities in Bulgaria. Annex II and III to the Commission Implementing Regulation provide for a list of information requested from researchers and end-users respectively; this includes information related to PIC, to the source of genetic resource, to the establishment of MAT and to utilization of genetic resources.
Yes
Following the country's obligation under Article 9 of Regulation 511/2014, the Bulgarian CNAs are prepared to perform checks on user compliance in accordance with periodically revised risk-based plan.
Article 13 of Regulation 511/2014 obliges both the European Commission and EU Member States, as appropriate, to promote the development and use of cost-effective communication tools and systems in support of monitoring and tracking the utilization of genetic resources and associated traditional knowledge by collections and users. An EU-wide web-based application called DECLARE is being developed for gathering due diligence declarations and their conversion into checkpoint communiques. The DECLARE system will be used by the Bulgarian competent national authorities in their roles as a checkpoints.
No additional information provided
Not applicable, since no access requirements are in place
Yes
Detailed rules and procedures for establishing MAT are to be introduced with special Ordinance issued under Article 66 (6) of the Biodiversity Act. The document will contain the minimum provisions in MAT including dispute resolution clauses.
The document is in advanced drafting stage. Until the adoption of the document MAT are established on case by case basis also with reference to the Bonn guidelines.
Yes
There are legal opportunities for recourse in case of dispute arising from MAT. In such cases the parties are advised to contact the NFP for further guidance.
Existing mechanisms in the Bulgarian legal system.
No additional information provided
Yes
Article 66 (4) of the Biological Diversity Act provides for gratuitous provision of genetic resources if the said resources are intended for non-commercial purposes: scientific research, education, conservation of biological diversity, or public health. Before any other use not mentioned in the permit the possible new terms of use of samples and new benefit sharing provisions shall be negotiated.
Article 66 (4) of the Biological Diversity Act provides for gratuitous provision of genetic resources if the said resources are intended for non-commercial purposes: scientific research, education, conservation of biological diversity, or public health.
Regulation 511/2014 recognizes ITPGRFA аs a specialised instrument within the meaning of Article 4(4) of the Protocol. Furthermore the Regulation also recognizes that where Parties have decided to use standard material transfer agreements for plant genetic resources for food and agriculture (PGRFA) which are not covered by ITPGRFA, but which are under their control and in the public domain, no due diligence declaration is required.
As a party to ITPGRFA Bulgaria has recognized the importance of PGRFA and their special role in food security.
No additional information provided
No
Not applicable
No selection made
No selection made
Not applicable
Not applicable
Not applicable
Not applicable
No selection made
No selection made
No selection made
Not applicable
Not applicable
No additional information provided.
Yes
The designated CNAs have the responsibility to encourage users and providers to direct benefits from the utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components, in conformity with the country’s obligations under Article 13 of Regulation 511/2014.
Not applicable since there are no indigenous and local communities.
Not applicable, since there are no indigenous and local communities in my country
No selection made
No additional information provided
Yes
In line with Article 13 of Regulation 511/2014, the Commission and the EU Member States shall encourage development of codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, university and non-commercial researchers and small and medium-sized enterprises.
In line with Article 13 of Regulation 511/2014 the Commission and the Member States shall encourage development of codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, university and non-commercial researchers and small and medium-sized enterprises.
Bulgarian CNA representatives have participated in a number of conferences, workshops and seminars attended by national authorities, politicians, regional administration, NGOs, business and academia where the ABS was discussed as a main topic or as part of wider agenda.
Representatives from academia and universities are members of Multilateral working group on ABS to the minister of environment and water. The group meets at regular basis.
At EU level European Commission has organized a series of awareness rising workshops for academia and non-commercial researchers.
No
No
No
Yes
Bulgaria did not provide external support for capacity building protects in other countries. However, EU provides support to many ABS related projects.
No additional information provided
At this time the country’s efforts are directed towards the completion of the national ABS system. Remaining challenge is to establish better communication between national CAs, business, and academia.
Yes
Bulgaria did not provide external support for building and developing capacity for the implementation of the Nagoya Protocol independently. However, EU provides support to many research and development programs contributing thus to technology transfer and collaborating in technical and scientific research and development programs.
No additional information provided
No selection made
No selection made
No information provided
No information provided
Yes
Less than 5
Due to budgetary restrictions the administrative functions were allocated to the existing personnel. At present in the Bulgarian CAs the administrative tasks are allocated to one to tree internal experts per CA, in addition to their other duties. The extra responsibilities are creating extra work load for the staff. For most of the experts usually there is not enough time to engage at a full extent in the ABS issues. This creates difficulties in communication between CAs and the policy making and implementation.
