where appropriate, to the European Commission and national authorities. competent, as set out in Article 14.5.

Additionally, it requires the competent authorities to carry out checks in order to verify whether the users comply with the obligations imposed under Articles 4 and 7 of Regulation (EU) No 511/2014 of the European Parliament. European Union and the Council of 16 April 2014. Such checks shall be carried out whenever there are indications of non-compliance and also on the basis of a plan to be drawn up applying risk criteria.

Finally, internal procedures are established at the national level concerning the application of Spanish collections to be part of the collection register in the European Union.

In short, through this standard, Spanish biodiversity is valued as a source of innovation in our economy, so that the use of Spanish genetic resources is an incentive and a new source of innovative financing for the conservation of biodiversity in our country and in terms of potential opportunities and benefits for Spanish research institutions.

III

The royal decree is structured in seven chapters.

Chapter I contains the general provisions relating to the object, definitions and scope of application of the rule.

Chapter II, for its part, regulates the procedure for access to Spanish genetic resources from wild taxa and the distribution of their benefits.

Chapter III establishes the state system of information on access and use of genetic resources and associated traditional knowledge in Spain. This system constitutes the nerve centre of information, both of the access to genetic resources in Spain and of the measures of compliance with the use of genetic resources in our country, whether they be the last Spanish or third countries Part of the Nagoya Protocol.

Chapter IV regulates measures to monitor the use of genetic resources and traditional knowledge associated with genetic resources in Spain.

Chapter V establishes the procedure for the inclusion of Spanish collections in the register of collections in the European Union.

Chapter VI regulates cooperation and collaboration between competent public administrations, through the establishment of the Committee on Access and Use of Genetic Resources and Traditional Knowledge associated with the genetic resources in Spain, which is attached to the State Commission of Natural Heritage and Biodiversity.

And finally, Chapter VII refers to the sanctioning regime. The breaches of the royal decree shall constitute an infringement and shall be punished in accordance with Articles 80 and 81 of Law 42/2007 of 13 December 2007.

The article is complemented by four additional provisions, two transitional provisions, three endings and four anexes.

This royal decree is issued under Article 149.1.23 of the Spanish Constitution, which gives the State exclusive competence over basic legislation on environmental protection, without prejudice to the laws of the Member States. powers of the autonomous communities to establish additional standards of protection.

In the elaboration of this royal decree have participated both the autonomous communities, through the State Commission of Natural Heritage and Biodiversity, as the economic and social agents, through the State Council of Natural Heritage and Biodiversity.

Likewise, the royal decree has been submitted to public information and consultation, in accordance with the procedure for public participation provided for in Law 27/2006 of July 18, which regulates the rights of access to the information, public participation and access to justice in the field of the environment.

In its virtue, on the proposal of the Minister of Agriculture and Fisheries, Food and Environment, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council and after deliberation of the Council of Ministers at its meeting on 24 February 2017,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

1. This royal decree aims to develop Articles 71, 72, 74, 80 and 81 of Law 42/2007, of 13 December, of Natural Heritage and Biodiversity, as well as to ensure the correct use of genetic resources in accordance with Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on measures for the compliance of users of the Nagoya Protocol in the Union and with Implementing Regulation (EU) 2015/1866 of the European Parliament and of the Council Commission of the European Parliament of 13 October 2015 laying down detailed rules for the application of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014, and in particular:

a) Promote the conservation of Spanish biodiversity and the sustainable use of its components, as well as its value, in particular its genetic resources through the fair and equitable participation of the benefits which are derived from their use.

b) Regular access to Spanish genetic resources from wild taxa.

c) Ensure control and traceability in access to and use of Spanish genetic resources from wild taxa, in and out of Spain, in accordance with the rights and obligations of the Parties to the United Nations Convention on Biological Diversity and the Nagoya Protocol.

d) Ensure the use in the Kingdom of Spain of genetic resources, both Spanish and third countries, part of the Nagoya Protocol, obtained legally in compliance with the obligations arising from the Regulation (EU) No. 511/2014 of the European Parliament and of the Council of 16 April 2014 and of the Nagoya Protocol.

e) Ensuring the use in the Kingdom of Spain of traditional knowledge associated with genetic resources of third countries Parties to the Nagoya Protocol legally obtained in compliance with the obligations arising from the Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and of the Nagoya Protocol.

f) Promote research related to access to Spanish genetic resources from wild taxa.

g) Encourage the participation of researchers and Spanish research institutions in research related to the access and use of Spanish genetic resources from wild taxa.

h) Designate the competent Spanish authorities for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and identify the distribution of functions between them.

2. This royal decree additionally establishes the state system of information 2014 of the European Parliament and of the Council of 16 April 2014. In turn, specific procedures for the application and collection of the due diligence statements by users of genetic resources and traditional knowledge associated with these resources, when those users are beneficiaries of research funds or are in the final stage of the development of a product developed through the use of genetic resources or traditional knowledge of such resources.

To these two verification points provided for in the Community regulation, the application and collection of the due diligence declarations of the users applying for a patent, in accordance with the requirement, are added to Spain. introduced by Article 23.2 of Law 24/2015, of July 24, of Patents.

The information on due diligence statements will be sent to the Information Exchange Centre on Access and Participation in Benefits, and,em on access and use of the associated genetic resources and traditional knowledge in Spain, as provided for in Article 11.

Article 6. Procedure for access to Spanish genetic resources from wild taxa when their use is for non-commercial research purposes.

1. The person concerned to access the Spanish genetic resources from wild taxa must have, prior to access, the relevant access authorisation.

2. The request for access shall be addressed to the competent authority of access, in accordance with the provisions of the previous Article, and shall be accompanied by a declaration signed by the applicant himself committing at least the following:

a) That you do not intend to use for commercial purposes the genetic resources whose access you request.

(b) To request a new access authorisation for the use for commercial purposes where, in the course of the investigation, a possible use is made for commercial purposes.

(c) That it shall not facilitate the genetic resource to any unauthorised person and that, in any event, the transmission of the genetic resource to third parties shall be carried out under the same conditions as its responsible declaration.

d) To inform in writing of the final results of the investigation to the competent authority granting access to the genetic resources.

This application may be filed in any of the forms provided for in Article 16.4 of Law 39/2015 of 1 October of the Common Administrative Procedure of the Public Administrations or through the seat The Ministry of Agriculture and Fisheries, Food and Environment.

3. Annex I includes the minimum content of this request.

4. The body that negotiates with the applicant the establishment of mutually agreed conditions may require additional specifications for the distribution of benefits reflected in the previous paragraph, such as the deduplication of the material which you access in some existing ex situ collection in the Kingdom of Spain. In the event that the user concerned is a researcher, research institute or foreign company, the authorisation of access to the collaboration or participation of a Spanish research institution may be conditional.

5. The competent access authority, after the application and the declaration signed by the applicant, have been reviewed, and after the report of the body providing the prior informed consent and negotiates the mutually agreed conditions in each case, grant the access authorisation within a maximum of two months. Should the authorisation not be granted within this period, the request shall be deemed to have been estimated.

6. The minimum content of the access authorisation, which shall be in accordance with the Nagoya Protocol and its development mechanisms and which shall include the terms of the distribution of benefits, shall be the same for the entire national territory. Annex II includes the minimum content of the access authorisation to Spanish genetic resources from wild taxa when their use is for non-commercial research purposes.

7. In the event that the applicant for access to the genetic resource is not interested in the mode of profit distribution set forth in this article, you can choose the path of the access authorization with commercial end use in which the profit sharing is negotiated.

8. In the field of the General Administration of the State, the resolution of authorization of access may be brought before the Secretary of State of the Environment within one month in accordance with the provisions of the Articles 121 and 122 of Law 39/2015 of 1 October.

Article 7. Procedure for access to Spanish genetic resources from wild taxa when their use is for commercial purposes.

1. The person concerned to access the Spanish genetic resources from wild taxa must have, prior to access, the relevant access authorisation.

2. The request for access shall be addressed to the competent authority of access, in accordance with Article 5, and may be submitted directly in any of the forms provided for in Article 16.4 of Law 39/2015 of 1 October, or through the electronic headquarters of the Ministry of Agriculture and Fisheries, Food and Environment.

This application shall be accompanied by the prior informed consent and mutually agreed conditions established with the competent body in accordance with the provisions of Article 5.

3. Annex III includes the minimum content of this request.

4. The Environmental Sector Conference will adopt guidelines for the establishment of mutually agreed conditions, including the distribution of benefits arising from the use of genetic resources.

5. The competent access authority may collect additional information from the applicant throughout the procedure and provided that it considers that the request is not complete.

6. The competent authority of access shall grant the authorisation within a maximum period of six months from the receipt of the application. Should the authorisation not be granted within this period, the request shall be deemed to have been estimated.

7. The minimum content of the access authorisation, in accordance with Annex IV, shall be in accordance with the provisions of the Nagoya Protocol and its development mechanisms and shall include the terms of the distribution of benefits.

8. The transmission of the genetic resource to third parties shall be carried out under the same conditions as those imposed in the authorisation and in accordance with mutually agreed conditions. The user, as well as the following possible users, must always indicate the Spanish origin of the genetic resource used and inform the competent authority of access when there is any commercial activity arising from the use of that genetic resource. The competent authorities shall take into account the provisions of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 on the with the confidential information provided by the user in these cases.

9. In the field of the General Administration of the State, against the resolution of authorization of access, an appeal may be brought before the Secretary of State of the Environment within one month in accordance with the provisions of the articles 121 and 122 of Law 39/2015 of 1 October.

Article 8. Access to genetic resources in emergency situations.

The declaration of alert or emergency situations, in particular health, may lead to an exceptional, provisional and immediate authorisation of access to the genetic resource, even with the effects provided for in Article 4.2 of Law 42/2007, of 13 December.

This provisional authorisation will be conditional on the subsequent negotiation of mutually agreed terms and on the acquisition within six months of the final authorisation of access, as established in this Agreement. royal decree.

In of Quality, Environmental Assessment and Natural Environment of the Ministry of Agriculture and Fisheries, Food and Environment of the competent authorities of access.

4. The Ministry of Agriculture and Fisheries, Food and Environment, as a national focal point, will provide information on the competent authorities of access to Spanish genetic resources to the Protocol's Information Exchange Center. of Nagoya, as well as the users interested in accessing those resources. This information shall be incorporated into the state information syst/2014 of the European Parliament and of the Council of 16 April 2014, the following bodies of administrations are the competent Spanish authorities public:

1. The Ministry of Agriculture and Fisheries, Food and Environment's Environmental and Environmental Quality and Environmental Assessment Directorate, which, as the national focal point of the Nagoya Protocol, will be the competent authority responsible for:

(a) to coordinate, through the state system of information on access and use of the genetic resources and traditional knowledge associated in Spain, the reception and the sending of the information provided in the articles 7.1, 7.2 and 7.3 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015;

(b) cooperate with the Information Exchange Center on Access and Participation in Benefits to carry out the exchange of information referred to in Article 17 of the Nagoya Protocol;

(c) cooperate with the other competent authorities at the level of the European Union in accordance with Article 12 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014;

d) to analyse the best practice applications submitted to the European Commission pursuant to Article 8 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014, and, where appropriate, to forward comments to the European Commission as provided for in Article 8 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2014 2015;

e) to carry out checks only on those users who are public institutions of a state or a State ownership, in order to verify that they comply with the obligations laid down in Articles 4 and 7 of the Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and, in the event of the detection of inadequacies, notify those users of the rectification measures to be taken or to take the appropriate provisional measures where the nature of the the inadequacies so require;

(f) to penalise users who are public institutions of a state or a State ownership where breaches of the obligations of Articles 4 and 7 of Regulation (EU) No 511/2014 of the European Parliament and of the European Parliament are observed. Council, 16 April 2014;

(g) the referral of the implementation reports of Article 16 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014;

(h) those other functions which may be derived from Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and its secondary legislation.

2. The competent bodies designated by the Autonomous Communities in the field of their competences to which the following tasks correspond:

(a) carry out checks on users who have registered offices in the territory of the respective autonomous community, provided that they are not public institutions of a state or state ownership, in order to verify they comply with the obligations set out in Articles 4 and 7 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and, in the event of the detection of weaknesses, to notify those users of the the right to adopt or, depending on the nature of the inadequacies, provisional measures;

(b) to penalise users other than public institutions of a state or state ownership, where breaches of the obligations of Articles 4 and 7 of Regulation (EU) No 511/2014 of the European Parliament are observed; and of the Council of 16 April 2014.

Article 14. Exercise of due diligence by users.

1. The exercise of due diligence by natural or legal persons who are beneficiaries of research funds using genetic resources in Spain, Spanish or foreign, and traditional knowledge associated with genetic resources, will be subject to the following conditions:

(a) The due diligence declaration shall be submitted by the users of genetic resources or traditional knowledge associated with genetic resources, through the electronic headquarters of the Ministry of Agriculture and Fisheries, Food and the Environment or in any of the forms provided for in Article 16.4 of Law 39/2015 of 1 October, so that they are included in the state information system on access and use of genetic resources and associated traditional knowledge in Spain.

(b) In accordance with Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015, the due diligence statement shall be made after receipt of the first payment of the financing associated with the call for tenders. research and to obtain all the genetic resources and traditional knowledge associated with the genetic resources used in the research financed, but, in no case, later in the final report or, in the absence of such a report, of the project completion.

(c) Financial institutions for research projects using genetic resources and traditional knowledge associated with genetic resources shall verify the information that justifies the presentation of the a statement of due diligence in accordance with subparagraph (a) through the application of this information in its procedures and forms and, in no case, shall make the final payment without having verified that the user has complied with the exercise of the due diligence.

d) The use of genetic resources or traditional knowledge associated with genetic resources obtained without the observance of the current regulations regarding access and distribution of benefits of the supplier country, may (a) the withdrawal or return, in whole or in part, of the funding received.

2. The exercise of due diligence by users in the final stage of production of a product developed through the use of genetic resources and traditional knowledge associated with such resources shall be subject to the following: conditions:

(a) Users of genetic resources or traditional knowledge associated with such resources shall make the due diligence declaration through the electronic headquarters of the Ministry of Agriculture and Fisheries, Food and the Environment or in any of the forms provided for in Article 16.4 of Law 39/2015 of 1 October, in such a way as to be incorporated in the state information system prior to the first of any of the following situations:

1. Approval or authorization for the marketing of a product developed through the use of genetic resources and traditional knowledge associated with genetic resources;

2. When the first placing on the market of a product developed through the use of genetic resources and traditional knowledge associated with such resources in the Union requires a notification;

3. When the first placing on the market of a product developed through the use of genetic resources and traditional knowledge associated with such resources in the Union does not require any authorisation, approval or notification;

Article 13. Designation of the competent Spanish authorities for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014.

For the purposes of Article 6 of Regulation (EU) No 511borated in collaboration with the competent regional bodies and with other organs of the General Administration of the State with powers in this field, through the committee on access and use of resources. genetic resources and traditional knowledge associated with the genetic resources in Spain of the State Commission for Heritage and Biodiversity, which is regulated in Article 18. The proposal will also be submitted to the public information procedure and will take into account the views of the representatives of the various sectors and other interested groups.

4. The Plan will be approved by the Council of Ministers Agreement.

5. The validity of the Plan will be five years, proceeding to its review and update after the end of this period.

CHAPTER V

Inclusion of Spanish collections in the collections register in the European Union

Article 17. Inclusion of Spanish collections in the register of collections in the European Union.

1. The procedure for the inclusion of Spanish collections in the register of collections in the Union shall be governed by the provisions of Article 5 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and in the Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015.

2. The application for inclusion, which shall be in accordance with Annex I to Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015, shall be submitted to the competent authority. In the case of collections belonging to state institutions or state ownership, the application shall be submitted to the state competent authority.

3. The competent authority receiving the application shall be in charge of reviewing it and carrying out the verifications of the criteria of Article 5.3 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014, as the provisions of Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015.

4. In cases where the competent authority determines that the collection complies with the provisions of Article 5 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Implementing Regulation (EU) 2015/1866, the Commission, of 13 October 2015, shall communicate it to the national focal point which shall notify the European Commission for the inclusion of the collection in the European Register of Collections.

5. The competent authorities shall carry out the supervision and control of the collections registered in the register of collections in the European Union as provided for in Commission Implementing Regulation (EU) 2015/1866 of 13 October 2009. 2015. Where, through the supervisory actions, breaches of any of the criteria provided for in Article 5.3 of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014, the competent authority are detected, notify the necessary rectification measures or actions to the collection. If the competent authority concludes that a collection or part of a collection under its competence no longer meets the above criteria, it shall inform the national focal point, which shall inform the European Commission of the collection or remove the collection or part of the collection in question from the registry.

CHAPTER VI

Cooperation and collaboration between competent public administrations

Article 18. Committee on access and utilization of genetic resources and traditional knowledge associated with genetic resources in Spain.

1. The competent public authorities shall cooperate and cooperate in the implementation and monitoring of this royal decree, establishing for this purpose the Committee on Access and Use of Genetic Resources and Traditional Knowledge associated with genetic resources in Spain.

2. This committee will be attached to the State Natural Heritage and Biodiversity Commission.

3. The Committee on Access to and use of genetic resources and traditional knowledge associated with genetic resources in Spain shall be responsible for at least the following functions:

(a) Cooperation and collaboration for the coherent application in the national territory and follow-up of the present royal decree.

b) The elaboration of the State Plan for the control of the legality of the use of genetic resources and associated traditional knowledge in Spain.

4. The Committee on Access to and use of genetic resources and traditional knowledge associated with genetic resources in Spain shall be composed of:

(a) a representative of each of the competent access authorities designated pursuant to Article 5, which in the case of the General Administration of the State shall be appointed by the Director General of Quality and Evaluation Environmental and Natural Environment,

(b) a representative of each of the autonomic competent bodies referred to in Article 13.2,

(c) five representatives of the Ministry of Agriculture and Fisheries, Food and the Environment, to be appointed by the Directors-General with competence in the field of genetic resources, exercising the presidency by the Director General of Quality and Environmental Assessment and Natural Environment,

d) two representatives from the Ministry of Economy, Industry and Competitiveness,

e) a representative of the Ministry of Health, Social Services and Equality,

f) a representative of the Spanish Patent and Trademark Office of the Ministry of Energy, Tourism and Digital Agenda.

The Secretary of the Committee will be an official of the Environmental and Environmental Quality and Evaluation Directorate General who will act with voice and without a vote.

5. On the basis of the content of the matters to be dealt with, representatives of other bodies of the General Administration of the State or the Autonomous Administration and experts in such matters may be invited to the Committee at the invitation of the Presidency. so that, with a voice but no vote, they will collaborate and advise the Committees. The number of invited representatives or experts shall be the same as the number of designated vowels held by the committee.

6. The legal system of the Committee on Access to and Use of Genetic Resources and Traditional Knowledge Associated with Genetic Resources in Spain will be in line with the provisions of the legislation on the system of the system. State public sector legal.

CHAPTER VII

Sanctioning Regime

Article 19. Sanctioning regime.

Failure to comply with the provisions of this royal decree shall constitute an infringement and shall be sanctioned in accordance with the provisions of Articles 80, in particular paragraphs 1 (1) and (v), and 81 of Law 42/2007, of 13 of December.

Additional disposition first. Designation of the competent authorities for access knowledge associated with genetic resources obtained illegally, both in Spain and in third countries Countries Parties to the Nagoya Protocol.

2. This Plan will be developed using risk criteria and will take into account the information contained in the state information system on access and use of genetic resources and associated traditional knowledge in Spain. The plan shall comply with the provisions laid down in the European Union legislation resulting from implementation.

3. The proposal for a plan will be elase must be requested for commercial purposes. Always indicate the origin of the genetic resource used as Spanish.

11. Conditions for transferring the genetic resource to third parties: Failure to provide the genetic resource to any unauthorised person and, in any event, the transmission of the genetic resource to third parties shall be carried out under the same conditions as those imposed in the authorisation and in accordance with the responsible declaration made by the user concerned.

ANNEX III

Minimum content of the application in relation to access to Spanish genetic resources from wild taxa when their use is for commercial purposes

Part 1. Applicant information.

1. Name and Surname:

2. D.N.I. /N.I.F., passport or equivalent document in case of foreigners:

3. Full address:

4. Telephone, fax, e-mail:

5. The applicant is (point one): Individual: Company: Public Body:

6. If it is a company or an Agency, you must also complete:

a) Name:

b) CIF-NIF:

c) Full address:

Part 2. Usage information.

1. Short description of the use (Purpose, justification and objectives):

2. Intended program of use:

3. Participating institutions:

4. Expected benefits of the use for conservation and sustainable use of biodiversity in Spain:

Part 3. Access to genetic resources.

1. Description of the genetic resources to be collected.

2. Location where the ex-site collection or collection is to be collected or collected:

3. Expected dates of access:

4. Are you planning to deposit a copy of the material in any Spanish collection? (If yes, please enter the name of the collection.)

Part 4. Prior informed consent and mutually agreed conditions (Attach)

In case any of the above information should have a confidential character, please indicate and justify it.

Place, date, and signature:

ANNEX IV

Minimum content of the authorization of access to Spanish genetic resources when their use is for commercial purposes

1. Competent authority of access:

2. Body providing the prior informed consent and establishing mutually agreed conditions:

3. Reference number of the authorisation, if applicable:

4. Date the authorization is granted:

5. Date of expiry of the authorisation, if applicable:

6. Data of the natural person/research institution/user undertaking concerned to which the authorisation is granted:

7. This access authorisation is granted as a sample of the prior informed consent and agreed upon mutually agreed conditions for the commercial use of the genetic resources specified below for the following usage (indicate type and purpose of use).

8. Genetic resources covered by the authorisation:

9. Description of the genetic resources covered by the authorisation:

10. Use for which authorization and limitations are granted:

11. Commercial purposes.

12. Compliance with mutually agreed conditions.

a) Always indicate the origin of the genetic resource used as Spanish.

(b) Inform the competent authority of access to when there is any commercial activity arising from the use of the genetic resource (patent application, registration and/or marketing of products, etc.)

(c) Reporting of the net profits made with such products for the calculation and annual settlement of profits while the patent is valid or the product is available on the market.

13. Conditions for transferring the genetic resource to third parties: Transmission of the genetic resource to third parties shall be carried out under the same conditions as those imposed in this authorisation and on mutually agreed terms.