Spain Drafts New Royal Decree To Update Biocides Registration And Use Rules

The draft is framed as a complementary national layer to the EU Biocidal Products Regulation (Regulation (EU) No 528/2012). While the EU regulation applies directly, Spain’s draft explains that legacy national rules remain relevant for questions such as the division of responsibilities between state and regional authorities, national registers and certain operational controls.

What The Draft Covers

The proposal sets out conditions for authorisation, manufacture, packaging, storage, commercialisation and use of biocides in Spain. It also provides for a national, public Official Register of Biocides in which authorised products are to be recorded, and it ties registration obligations to whether active substances are on the EU list of approved substances for the relevant product type or remain in the EU review programme.

Communications relating to registration are described as being handled through the ECHA “Register for Biocidal Products” (R4BP) platform for the relevant biocides, reflecting the operational reality that many regulatory exchanges for biocides are routed via EU-level tools.

Competent Authorities And Market Controls

The draft allocates roles across multiple bodies. It describes responsibilities for the Ministry of Health, including authorisation and register management, while recognising input from other ministries and national bodies for areas such as environmental protection and animal health. It also sets out enforcement expectations for Spain’s autonomous communities and the cities of Ceuta and Melilla, including market surveillance and sanctioning powers within their territories.

On the operational side, the draft includes detailed conditions for manufacturing and storage. It describes expectations for secure and suitable storage areas, separation from food and feed, and access controls. It also prohibits storing biocides in homes and other inappropriate locations, reflecting a focus on preventing misuse and reducing exposure risks.

Summary

If adopted, Spain’s draft Royal Decree would refresh the national rules that sit alongside EU biocides requirements, bringing greater clarity to registration workflows, oversight responsibilities and practical storage and commercialisation conditions. Manufacturers, distributors and biocidal service providers operating in Spain should review how their current procedures map to the draft’s register, traceability and competency expectations.