The European Commission has approved sulphur dioxide generated from sulphur by combustion as an active substance for use in biocidal products of product-type 4. This approval, detailed in Commission Implementing Regulation (EU) 2023/2620, marks a significant development in the regulatory landscape of biocidal products within the EU.
Understanding the Decision
Sulphur dioxide, now recognized for its biocidal properties, particularly in food and feed area disinfectants, underwent a rigorous evaluation process. Germany, as the rapporteur Member State, led this assessment, culminating in the European Chemicals Agency (ECHA) adopting a favourable opinion.
This approval aligns with Article 19(1), point (b), of Regulation (EU) No 528/2012, subject to specific conditions to ensure safety and efficacy. The decision reflects the EU's commitment to maintaining high standards in biocidal product regulation, balancing public health needs with environmental and safety considerations.
Implications for Stakeholders
- Compliance with Conditions: Biocidal products containing sulphur dioxide must adhere to the conditions set out in the Annex of the regulation. This includes particular attention to exposures, risks, and efficacy in product assessments, especially concerning professional and general public users.
- Residue Management: For products leading to residues in food or feed, stakeholders must assess the need for new or amended maximum residue levels (MRLs), in line with Regulations (EC) No 470/2009 and (EC) No 396/2005.
- Preparatory Measures: A transition period until October 1, 2024, allows entities to adapt to these new requirements, ensuring a smooth implementation of the regulation.
The approval of sulphur dioxide for biocidal use opens new avenues for product development in the EU. However, it brings a set of compliance obligations that require careful attention.
