Technical Benchmark of Administrative Procedures
Access to the SMA procedure (according to Articles 25 to 28 of the BPR) offers substantial advantages in terms of costs and timelines, subject to strict compliance with the eligibility criteria of Annex I.
| Performance Indicators | Simplified Authorization (SMA) | Marketing Authorization (MA) |
| Time-to-Market (Theoretical) | 3 months | 3 years |
| Administrative Costs (Estimated) | + (min. €10,000) | +++ (min. €150,000) |
| Formulation Requirements | Strict criteria (Art. 25): Expertise in Annex I active substances | Standard criteria: Conventional chemistry |
| Validity Period | 10 years | 5 to 10 years |
| SAME Process | Possible via SBP (Same Biocidal Product) | Possible via SBP (Same Biocidal Product) |
Geographical Deployment Dynamics and Notifications
The SMA procedure radically simplifies territorial expansion by replacing mutual recognition (sequential or parallel) with a direct notification procedure to national competent authorities.
Accessible Market Scope: An initial SMA registration grants direct access to 31 countries, covering the 27 EU Member States, the 3 EEA countries (Iceland, Liechtenstein, Norway), as well as Northern Ireland.
Notification Control: Notification is the final administrative step in each country. This process ensures the submission of dossiers without technical reservations, preventing requests for additional information (RFI) that hinder market launch (compared to mutual recognition, which grants countries the right to review the evaluation).
Costs and timelines are significantly more favorable for simplified marketing authorization notifications compared to mutual recognition (the geographical development approach in the conventional procedure). Approximate notification costs range from €0 to €3,100 with timelines of around 30 days. In comparison, mutual recognition costs range between €500 and €30,000 for certain countries, with long timelines spanning from 150 to 485 days.
Technological Lever: Formulation as a Barrier to Entry
While the administrative burden of the SMA is reduced, formulation complexity is inversely proportional. Eligibility relies on the systematic exclusion of substances of concern (SoC), nanomaterials, and any corrosive or irritant toxicological classification.
Our laboratory’s expertise overcomes this hurdle by formulating solutions from Annex I active substances (e.g., Lactic Acid) whose biocidal performance is optimized through molecular synergy. This know-how guarantees efficacy that meets industrial standards while securing access to the shortest and most sustainable regulatory pathway.
Mastering SMA and SBP procedures allows companies to transform a regulatory constraint into a lever for commercial agility. By prioritizing ECHA-validated dossiers and optimized cost structures, manufacturers secure the sustainable exploitation of their biocidal assets on a European scale.
Key Takeaways for Portfolio Audits:
A 10-fold reduction in theoretical time-to-market.
Securing assets for 10 years with geographical coverage of 31 countries.
Validation of efficacy equivalence by ECHA as a prerequisite for notification.
Advantageous costs and timelines for geographical expansion.
Salveco supports you through all administrative and regulatory procedures. Get in touch with our experts.
