This legal instrument was completed in the regulatory area by Royal Decree 178/2004 of January 30, which approved the general regulation for the development and implementation of the Law 9/2003 of 25 April. In this way, the requirements for the implementation of contained use activities, voluntary release for purposes other than the placing on the market and marketing of genetically modified organisms, are developed.

It is necessary to amend this royal decree to incorporate the provisions contained in Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 on the measures to be taken to prevent the the accidental presence of GMOs in other products and, more specifically, the actions to be carried out in border areas with other neighbouring Member States which have banned cultivation in order to avoid possible cross-border contamination. Whereas the principle of 'case by case', which is based on Law 9/2003 of 25 April, and since the adoption of those measures, it is necessary to take into account many factors, such as the type of crop, the plant species, the The Commission will be responsible for the implementation of the programme for the implementation of the programme for the implementation of the programme for the development of the European Community in the framework of the European Community's action programme. In each situation, taking into account the factors mentioned above and any other aspect it could influence possible cross-border contamination to neighbouring Member States where the cultivation of such GMOs is prohibited.

In accordance with Article 26 a) a) of Directive 2001 /18/EC of the European Parliament and of the Council of 12 March 2001 on the prevention of transboundary pollution to the Member States of the European Union, neighbouring members where the cultivation of those GMOs is prohibited will not be taken if they are unnecessary due to specific geographical conditions. Therefore, prior to its adoption, a mandatory risk assessment report will be requested from the National Biosafety Commission. Such a report shall determine whether it is necessary to adopt it and, if so, recommend the most appropriate and effective actions in accordance with the principle of prevention and caution and the principle of case by case. Scientific publications, as well as the documents published by the European Joint Research Centre on this subject, may be considered for this purpose.

If according to the risk assessment report it is determined that these measures are necessary, the corresponding order or orders will only take effect once the authorization or renewal of their authorization has been granted for cultivation in the EU and the prohibition of cultivation in the neighbouring Member State or Member States.

Finally, this royal decree is issued without prejudice to the future update of the Annexes to Directive 2001 /18/EC, as Article 3 of Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015, provides that by 3 April 2017, the Commission shall update them as regards the risk assessment for the environment, in order to include and develop the enhanced guidelines of the European Safety Authority. Food (EFSA) of 2010 on the environmental risk assessment of plants genetically modified. At the moment such an update is in the process of being worked out, so the approval of this royal decree cannot be delayed. Without prejudice to the above, if necessary, on the basis of the update which may be made, the corresponding amendment of the provisions of Annex I to the General Regulation for the Development and Implementation of Law 9/2003 of 25 May be adopted. April, establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms.

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

Under the proposal of the Minister for Agriculture and Fisheries, Food and the Environment, the Minister for Economic Affairs, Industry and Competitiveness, and the Minister for Health, Social Services and Equality, according to the Council of the State and after deliberation by the Council of Ministers at its meeting on 7 April 2017,

DISPONGO:

Single Article. Amendment of the General Regulation for the Development and Enforcement of Law 9/2003 of 25 April establishing the legal regime for the contained use, voluntary release and the placing on the market of genetically modified organisms, approved by Royal Decree 178/2004 of 30 January 2004.

An additional new provision is added in 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 the placing on the market of genetically modified organisms, approved by Royal Decree 178/2004 of 30 January 2004, with the following content:

" Single additional disposition. Measures to prevent transboundary pollution arising from the cultivation of GMOs to neighbouring Member States where the cultivation of those GMOs is prohibited.

1. Where GMOs are grown on land border with another Member State or other Member State where this activity is prohibited, appropriate measures shall be taken to prevent possible transboundary contamination.

2. The measures shall be adopted by order or orders of the person holding the Ministry of Agriculture and Fisheries, Food and the Environment, with the prior provision of a risk assessment report from the National Commission of Biosecurity, and