News Brief
The Spanish government has recently published a Draft Royal Decree on the registration, manufacture, marketing, and use of biocides, aiming to repeal outdated national rules and fully align with the EU Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012).
The draft strengthens the Official Registry of Biocidal Establishments and Services (ROESB) registration system, introduces a Declaration of Responsibility mechanism, and enhances electronic traceability for high-risk products and professional qualification requirements.
Why Spain Is Updating Its Biocide Framework?
Although biocide regulation is highly harmonized at the EU level, Spain still applies parts of older national legislation. With the progress of the EU active substance review programme and updated professional qualification systems, existing rules no longer meet regulatory needs.
The new Decree seeks to close these gaps by clarifying national implementation requirements and improving supply chain safety and transparency.
Key Changes Under the Draft Royal Decree
The draft focuses on five main areas:
1. Clear User Classification
Users are classified as professional personnel, specialized professionals, and the general public. Product authorizations must specify the target user group.
2. Enhanced ROESB Registration
All companies involved in manufacturing, packaging, storage, distribution, and application services must be registered with ROESB in their respective Autonomous Communities.
3. Declaration of Responsibility for Sales
For products intended for professional use, distributors must obtain a signed Declaration of Responsibility at first supply and provide updated SDS and authorization documents. This also applies to online sales.
4. Electronic Transaction Traceability System
High-risk biocides (e.g. Acute Toxicity Categories 1–3, CMR, endocrine disruptors) must be recorded in an electronic transaction registry, with records retained for at least five years.
5. Updated Training and Qualification Requirements
The Decree specifies required professional certificates for different Product Types (TPs), such as Legionella control, wood preservation, and disinfection.
Compliance Recommendations from REACH24H
Given that the Draft Royal Decree is approaching implementation, it is recommended that relevant companies take the following measures:
Reviewing product hazard classifications and upgrading IT systems for batch and customer traceability;
Preparing standard Declaration of Responsibility templates and training sales teams;
Verifying ROESB registration status across all operating regions;
Checking that staff qualifications cover all relevant Product Types.
For more information or compliance support, please feel free to contact us at customer@reach24h.com.
