Public hearing of the Draft Royal Decree on biocides in Spain

Regulation (EU) No 528/2012 of the European Parliament and of the Council of May 22, 2012 concerning the making available on the market and use of biocidal products ("BPR"), is directly applicable in Spain since September 1, 2013. Notwithstading the foregoing, Royal Decree 1054/2002, of October 11, regulating the evaluation process for the registration, authorization, and commercialization of biocides is still applicable with regard to the distribution of competences between state and regional authorities, the regulation of specific national aspects such as the Official Registry of Biocides, the Official Book of Biocide Movements, and the training of applicators.

The Spanish Health Authorities have considered that it is necessary to establish an updated national legal framework to ensure the correct application of the BPR at a national level and to repeal the current national regulations on this matter. Therefore, last February 21, the Ministry of Health opened the public hearing process of the Draft Royal Decree regulating the registration and conditions for authorization, manufacture, marketing, and use of biocides.

The purpose of this process, regulated by general administrative regulations, is to gather the opinion of citizens who hold rights and legitimate interests affected by a drafted regulatory project, either directly or through the organizations or associations that represent them, as well as to obtain any additional contributions that other individuals or entities may provide.

Pursuant to the document made available by the Spanish Health Authorities, this new Royal Decree regulates the following:

• the specific conditions for authorization, manufacturing, packaging, storage, commercialization and use of biocides in Spain. The Royal Decree establishes that these conditions will be those set out in the BPR. Regarding the manufacture, packaging, storage, marketing, and use of biocides, reference is made to the need for registration in the Official Register of Biocidal Establishments and Services of each region, which is currently regulated in Royal Decree 1054/2002, of October 11.
• the operation of the Official Registry of Biocides. With respect to this Registry, the text analyzed indicates that the registration procedure will be subject to the procedure established in the BPR.
• the training to carry out treatments with biocides. The current regulations are updated to include recently emerged professional qualifications related to the control of harmful organisms. A new exception is also established regarding the training of operators in the application of biocides in facilities owned by or under the control of the Ministry of Defense.
• the establishment of the competencies derived from the national implementation of the BPR; and
• the sanctions applicable in case of violation of the provisions of the BPR and of the provisions contemplated in the proposed royal decree. These sanctions would range between 6,000€ and 1,200,000€ -higher than the ones currently in force which amount to a maximum of 601,012.10€- and can also entail the temporary or permanent closure of facilities either total or partial.

The deadline for the submission of any comments or opinions to the Draft Royal Decree made available is next March 13, 2025.