New Royal Decree 952/2026 on biocides
📅 Published: 6 November 2026 · In force from: 1 July 2027
📢 The Spanish Official Gazette (BOE) has published Royal Decree 952/2026, which regulates the registration, manufacture, marketing and use of biocides in Spain. It complements Regulation (EU) 528/2012 and replaces, among others, Royal Decree 1054/2002.
⚖️ Biocide, medicinal product or medical device?
- 💊 Medicinal product: antiseptics for the pre-operative surgical field and the injection site are outside the scope of the decree.
- 🏥 Medical device: disinfectants intended for medical devices need CE marking under the MDR (class IIa or IIb).
- 🧴 Biocide: disinfectants for surfaces, equipment and furniture that are not medical devices. The AEMPS reports on their efficacy.
What decides is the intended purpose declared by the manufacturer, not the formula.
⚠️ Watch your claims
- The terms «higienizante» and «sanitizante» (sanitising) are considered biocidal claims.
- Labelling must be at least in Spanish.
🗓️ Other changes
- Mandatory transaction register for the most hazardous biocides, six months after entry into force.
- Six years for application staff to obtain the new training.
✅ At MeDev Consulting we help you review the intended purpose and claims of your disinfection products and, when they are medical devices, obtain their CE marking. Contact us.