Biocidal Registration in Spain
Biocide registration is the official authorisation a disinfectant or other biocide needs to be sold in Spain; its number must be on the label and data sheet.
The framework is Regulation (EU) 528/2012 on biocidal products (BPR): active substances are approved at European level and each product then needs its own authorisation, which may be national, by mutual recognition or at Union level. While an active substance is still under evaluation, the product may be placed on the market under the transitional national rules; in Spain, disinfectants for environmental use and for use in the food industry are entered in the Official Register of Biocides of the Spanish Ministry of Health. Disinfectants for use in livestock settings follow their own registration procedure.
To obtain authorisation, a dossier must be submitted with the composition, the efficacy tests (UNE-EN standards for each claimed activity), the risk assessment for people and the environment and the proposed label. The authorisation sets for which uses, at what doses, by which type of user (general public, professional or specialised professional) and with which application method the product may be used. An authorisation under the BPR is granted for a maximum of 10 years and must be renewed.
For the user, the practical check is simple: the registration number must appear on the label, and the use made of the product must match the authorised use. In entries for the food industry, the number carries the suffix HA.
Examples of registration numbers shown on Instaquim technical data sheets:
- eqo Bacter Desinfectante (registration 19-20/90-04313 HA): detergent-disinfectant for the food industry, for application by professional staff.
- InstaBact® 3000 Uso en entorno ganadero (registration 11551-P): disinfection of facilities and surfaces related to the housing and transport of animals.
- Bacter 200 (registration 21-100-04598): biocide for the treatment of legionella in cooling towers and evaporative condensers, for application by specialised professional staff.