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Royal Decree 191/2013, 15 March, Amending Royal Decree 178/2004, Of 30 January, Which Approves The General Regulation For The Development And Execution Of Law 9/2003, Of 25 April, Which Establishes The J Diet...

Original Language Title: Real Decreto 191/2013, de 15 de marzo, por el que se modifica el Real Decreto 178/2004, de 30 de enero, por el que se aprueba el Reglamento general para el desarrollo y ejecución de la Ley 9/2003, de 25 de abril, por la que se establece el régimen j...

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TEXT

Law 9/2003 of 25 April establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms, incorporated into Spanish law the substantive rules of Council Directive 98 /81/EC of 26 October 1998 amending Directive 90 /219/EEC on the contained use of genetically modified micro-organisms (repealed by Directive 2009 /41/EC) of the European Parliament and of the Council of 6 May 2009 on the use of contained in genetically modified micro-organisms, and Directive 2001 /18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and by which Council Directive 90 /220/EEC is repealed.

The principles that inspired such a law were those of prevention and caution, which involves taking appropriate measures to avoid potential adverse effects on human health and the environment, that of on a case by case basis, that is, the assessment of the risks associated with the genetically modified organisms for each of them, the one in step by step, which assumes that only the release of genetically modified organisms will proceed when the evaluation of the earlier stages reveal that it can be passed to the next without existence of risks, the information and public participation, ensuring consultation of the public before authorising certain contained use activities, as well as all voluntary release activities and the placing on the market of genetically modified organisms; or products containing them, and the access of citizens to information on authorised releases or marketing.

Royal Decree 178/2004 of 30 January 2004 approved the general regulation for the development and implementation of the aforementioned Law 9/2003 of 25 April and was subsequently amended by Royal Decree 367/2010 of 26 March 2010. amendment of various environmental regulations for their adaptation to Law 17/2009 of 23 November on the free access to services activities and their exercise, for the purpose of achieving the complete adaptation of the law the principles of the Services Directive, as a complement to the one operated in the standards of the by Law 25/2009 of 22 December, amending various laws for their adaptation to the Law on free access to services and their exercise.

The purpose of this royal decree is the modification of Royal Decree 178/2004 of January 30, in order to adapt the composition of the Inter-Ministerial Council of Genetically Modified Organisms and the National Biosafety Commission. replace the references to the previous bodies by those currently competent in the field of genetically modified organisms. It also introduces a change in the designation of the National Focal Point and the National Competent Authority for the Cartagena Protocol on Biosafety, and changes in the jurisdiction of sanctions.

In the elaboration of this royal decree, the autonomous communities have been heard, as well as the ministerial departments concerned.

Under the proposal of the Minister for Agriculture, Food and the Environment, the Minister for Economic Affairs and Competitiveness and the Minister for Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on March 15, 2013,

DISPONGO:

Article first. Amendment of Royal Decree 178/2004 of 30 January 2004 adopting the general regulation for the development and implementation of Law 9/2003 of 25 April establishing the legal regime for the contained use, release voluntary and marketing of genetically modified organisms.

Royal Decree 178/2004 of 30 January 2004 approving the general regulation for the development and implementation of Law 9/2003 of 25 April establishing the legal regime for the contained use, release voluntary and marketing of genetically modified organisms, is amended as follows:

One. The first paragraph of the first provision is worded as follows:

" In accordance with the provisions of the third provision of Law 9/2003 of 25 April 2003 establishing the legal regime for the contained use, voluntary release and placing on the market of organisms genetically modified, the central register of genetically modified organisms is created, under the Ministry of Agriculture, Food and Environment, whose management corresponds to the General Secretariat of Agriculture and Food in coordination with the General Directorate of Quality and Environmental Assessment and the Secretary of State for the Environment. "

Two. The final first provision is worded as follows:

" Final Disposition first. Implementation of the Cartagena Protocol on Biosafety.

as National Focal Point and National Competent Authority, according to the instrument of ratification of the Cartagena Protocol on Biosafety, of 10 December 2001, the Directorate General of Agricultural Productions and Markets of the Secretary-General of Agriculture and Food in coordination with the Directorate-General for Quality and Environmental Assessment and Natural Environment of the Secretariat of State of the Environment " will assume the functions set out in Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on movement transboundary of genetically modified organisms. "

Three. The third final provision is worded as follows:

" Final Disposition Third. Development enablement.

The Ministers of the Interior, Education, Culture and Sport, Health, Social Services and Equality, Agriculture, Food and the Environment and the Economy and the Economy and Competitiveness are empowered to dictate, in the field of respective powers, how many provisions are necessary for the implementation and development of what is established in this royal decree. "

Article 2. Amendment of the general regulation for the development and implementation of Law 9/2003 of 25 April establishing the legal regime for the contained use, voluntary release and placing on the market of modified organisms genetically, approved by Royal Decree 178/2004, of January 30.

One. Article 6 is worded as follows:

" Article 6. Composition of the Council.

1. The Inter-Ministerial Council of Genetically Modified Organisms shall be composed of the following members:

(a) President: the Secretary General of Agriculture and Food of the Ministry of Agriculture, Food and Environment.

b) Vice President: the Director General of Agricultural Productions and Markets

c) Vocals:

1. Two representatives of the Ministry of Agriculture, Food and Environment, one of the Directorate General of the Food Industry and one of the Directorate General of Health for Agricultural Production.

2. A representative of the Ministry of the Interior of the Directorate General for Civil Protection and Emergencies

3. Three representatives of the Ministry of Economy and Competitiveness, one of them from the Directorate General for Trade and Investment, another from the Directorate-General for Scientific and Technical Research and the third from the Directorate General of Innovation and Competitiveness.

4. A representative of the Ministry of Education, Culture and Sport.

5. Three representatives of the Ministry of Health, Social Services and Equality, one representing the Directorate General of Public Health, Quality and Innovation, another of the Spanish Agency for Food Safety and Nutrition and the third of the Spanish Agency for Medicines and Health Products.

6. The President of the National Biosafety Commission will also be part of the Council, with a voice but without a vote.

d) Act as secretary, with voice but no vote: an official from the General Directorate of Agricultural Productions and Markets, at least level 28.

2. The vowels, with the rank of Director General, will be proposed by the corresponding ministers and appointed by the Minister of Agriculture, Food and Environment.

Subject to the procedure laid down in the preceding paragraph, alternate members may be appointed to replace the vowels in the cases of vacancy, absence or sickness of such persons, provided that the appointment is Level 30 officials.

3. Without prejudice to the above paragraphs, where the nature or the importance of the matters to be dealt with so requires, they may attend the meetings of the Interministerial Council of Genetically Modified Organisms, with a voice, but without a vote, the holders of other management bodies whose management is related to the subject matter to be dealt with.

4. The Council shall meet as many times as necessary for the performance of its tasks.

Without prejudice to the holding of such face-to-face meetings, in accordance with the authorization contained in the additional provision of Law 11/2007, of June 22, of electronic access of citizens to the Services Public, the council is empowered to carry out the functions assigned to it by electronic means, by vote in writing and without in-person session.

In this case, all the members of the committee will be sent electronically and with a deadline of at least eight days in advance, which, for reasons of urgency, may be lowered to five, the request for a report, the order of the day to be treated, and the corresponding documentation. In case of no longer-term answer, the vote will not be counted. The minutes to be held for the record of these meetings shall incorporate the communications that have taken place, both for the convocation and for the deliberations and the adoption of decisions. The members of the Board may record in the minutes their particular vote on the agreements reached.

The electronic procedure shall be the ordinary procedure, without prejudice to any face-to-face meetings deemed necessary by the President.

5. Within the framework of the Council, a Participation Committee is set up, which is attached to the Committee, in which the sectors concerned will be represented, the agricultural professional organizations at national level, the agri-food cooperatives, the consumer and user organisations, conservation organisations, in total, up to a maximum of 15 members, all of whom are appointed by the Minister for Agriculture, Food and the Environment, on a proposal from the respective entities. Its composition and functioning are regulated in Order ARM/2616/2010, of October 5.

The Participation Committee will be the organ of dialogue and information between the citizens and the General Administration of the State, in the field of genetically modified organisms. The members of the committee shall be duly informed of the agreements and reports adopted in order to enable them to make the judgment which is appropriate in each case.

Their functions will be to advise the Inter-Ministerial Council on how many issues are requested by the Council, to raise to the consideration of the same number of issues as appropriate, to ensure participation and information The Commission is also responsible for the implementation of the Council Directive on the protection of the environment and the protection of the environment. In cases where matters affecting a specific sector are to be dealt with in the committee for participation, the assistance of the main associations or national representative organisations of the respective sector may be requested, as well as of those experts of recognized prestige who, by reason of the matter, are justified. "

Two. Article 7 (3) and (4) shall be worded as

:

" 3. If the authorisations were intended to carry out activities for the contained use and voluntary release of genetically modified organisms, in the cases referred to in Law 14/2011 of 1 June of Science, Technology and Innovation, and in the framework of research programmes carried out by organs or agencies dependent on the General Administration of the State, the granting of the authorization is subject to the conformity of the representation of the Ministry Economics and Competitiveness, and the Ministry of Education, Culture and Sport.

4. For authorizations relating to the technical examination for the registration of commercial varieties referred to in Article 3.2.c of Law 9/2003 of 25 April, the conformity of the representation of the Ministry of Agriculture shall be required, Food and the Environment. "

Three. Article 8 (2) is worded as follows:

" 2. The National Biosafety Commission shall be composed of the following members:

a) President: the Director General of Quality and Environmental Assessment and Natural Environment.

b) A designated Vice President from among the vowels representing the General Administration of the State by agreement of the plenary of the Commission, to be appointed by the Minister of Agriculture, Food and Environment.

c) Vocals.

1. On behalf of the General Administration of the State:

An official representative of the Directorate General for Civil and Emergency Protection, Ministry of the Interior.

An official representative of the General Directorate of University Policy of the Ministry of Education, Culture and Sports.

Six officials representing the Ministry of Agriculture, Food and Environment, four of them from the General Secretariat of Agriculture and Food and two from the Secretary of State for the Environment, experts in food technology, agriculture, livestock, plant and animal health, biodiversity and biosecurity.

Five officials representing the Ministry of Health, Social Services and Equality, food safety experts, medicines for human use, veterinary medicines, public health and analytical techniques.

Five officials representing the Ministry of Economy and Competitiveness, one of them expert in foreign trade and the other four experts, in technological development and innovation, projects and activities of scientific research in biotechnology, biomedicine and in agro-food technologies.

The vowels will be appointed by the respective ministries and appointed by the Minister of Agriculture, Food and Environment.

2. A vocal for each of the autonomous communities, prior to communication to the Ministry of Agriculture, Food and Environment.

d) Act as secretary, with voice but no vote, an official from the Environmental and Environmental Quality and Evaluation Directorate General, at least, level 28. "

Four. Article 60 (3), (4), (5) and (6) are replaced by the following:

" 3. The imposition of penalties by the Commission for infringements related to the activities covered by Article 3.2.a of Law 9/2003 of 25 April, as well as those relating to the import and export of modified organisms genetically and of the products containing them, where the commission of the offences involves a risk to human health or to the health control of the environment, it shall be:

a) The Director General of Public Health, Quality and Innovation, in the case of minor infractions.

(b) to the Secretary-General for Health and Consumer Affairs, in the case of serious infringements.

c) To the Minister of Health, Social Services and Equality, in the case of very serious infringements.

4. The jurisdiction for the imposition of penalties by the commission of infringements related to the conduct of the research programmes referred to in Article 3.2.b of Law 9/2003 of 25 April shall be:

(a) to the Director-General for Scientific and Technical Research in respect of minor infractions.

(b) The Secretary of State for Research, Development and Innovation in respect of serious infringements.

c) The Minister of Economy and Competitiveness, in respect of very serious infringements.

5. The imposition of the penalties for the conduct of infringements committed in the case of technical examination referred to in Article 3.2.c of the abovementioned law, as well as those carried out in respect of imports and exports of Seed and nursery plants incorporating or containing genetically modified organisms, without prejudice to the provisions of paragraph 3 of this Article, shall be:

(a) to the Director General of Agricultural Productions and Markets, for the commission of minor infractions.

(b) to the Secretary-General for Agriculture and Food, in respect of serious infringements.

c) The Minister of Agriculture, Food and the Environment, the sanction of very serious infractions.

6. Infringements committed in connection with the import and export of genetically modified organisms and the products containing them for use in bioremediation or other activities other than those referred to in the paragraphs 3, 4 and 5 of this Article, provided that they do not pose a risk to human health or to the health control of the environment, shall be sanctioned by:

(a) The Director General of Agricultural Productions and Markets, in the event of minor infractions.

(b) The Secretary-General of Agriculture and Food in the case of serious infringements.

c) The Minister of Agriculture, Food and the Environment, in very serious infractions. "

Single additional disposition. References.

Mentions that are contained in the Director General of Quality and Environmental Assessment in articles 12.4, 15, 20, 21, 24, 25, 26, 27, 28, 32.5, 33, 40, 46.1 and 51 of Royal Decree 178/2004, of January 30, will be understood as all cases to the Secretary-General of Agriculture and Food, as Chairman of the Inter-Ministerial Council of Genetically Modified Organisms.

Single end disposition. Entry into force.

This rule shall enter into force on the day following that of its publication in the "Official State Gazette".

Given in Madrid, on March 15, 2013.

JOHN CARLOS R.

The Vice President of the Government and Minister of the Presidency,

SORAYA SAENZ DE SANTAMARIA ANTON