On 18 March 2026, the EU Official Journal published Commission Implementing Decision (EU) 2026/578 of 17 March 2026, extending the approval of alphachloralose as an active substance in biocidal products of product type 14 (rodenticides). This measure, adopted under Regulation (EU) No 528/2012, has direct implications for manufacturers, distributors and pest control companies operating in Spain and across all other EU Member States.
What does this regulation establish?
The European Commission has decided to delay the expiry date of the approval of alphachloralose for use in biocidal products classified as product type 14, namely rodenticides: products intended for the control of rodents such as rats and mice.
This extension occurs because the regulatory evaluation process for the substance has not been completed within the originally planned timeframes. This is a common practice within the European biocides regulatory framework: when administrative review procedures take longer than expected, the Commission may temporarily extend the current approval to avoid a legal gap.
The practical effect is clear: biocidal products containing alphachloralose may continue to be placed on the market and legally used in Member States during the extension period, without their regulatory status being left in limbo.
- Legal basis: Regulation (EU) No 528/2012 of the European Parliament and of the Council.
- Affected substance: alphachloralose.
- Product type: PT14 – Rodenticides.
- Official publication date: 18 March 2026.
- Date of entry into force: refer to the original regulation for specific details.
Who is affected and how?
This decision has a direct impact on several actors in the biocides and pest control sector in Spain and across the EU:
- Manufacturers of rodenticide biocidal products: companies that produce formulations with alphachloralose as an active substance may continue their operations without interruption, provided their national product authorisations remain valid.
- Distributors of biocidal products: the extension ensures that products on the market do not suddenly lose their legal status, providing legal certainty throughout the distribution chain.
- Pest control companies: professionals using rodenticides containing alphachloralose in their services must verify that the national authorisations of the products they use remain valid during the extension period and that they comply with any additional conditions that may be established.
It is important to note that the extension of approval at European level does not replace the national authorisations of individual products. Each Member State manages its own marketing authorisations, so companies must check the specific status of each product in Spain with the competent authorities.
What should you do to adapt?
If your company manufactures, distributes or uses rodenticide biocidal products containing alphachloralose, the following are the recommended action steps:
- Verify national authorisations: check that the specific products you market or use hold a valid national authorisation in Spain. The European extension does not automatically guarantee the validity of each product authorisation at national level.
- Review conditions of use: during the extension period, specific conditions of use or marketing may be established. Consult the original regulation and stay informed of any updates published by the competent authorities.
- Keep documentation up to date: ensure that all technical and regulatory documentation for your products reflects the current status of the alphachloralose approval.
- Consult a specialist adviser: since the regulatory evaluation process is ongoing, the situation may evolve. It is advisable to seek specialised legal or technical advice on biocides to anticipate potential changes.
- Monitor the progress of the dossier: the evaluation of alphachloralose will continue its course. Upon completion, new approval conditions, restrictions or, where applicable, non-renewal of the substance may be established. Monitor publications in the EU Official Journal and from the European Chemicals Agency (ECHA).
In summary, the extension provides continuity and legal certainty in the short term, but does not eliminate the need to remain attentive to the progress of the evaluation process and the obligations arising from national authorisations.
Official source
View full regulation at official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For decisions specific to your situation, please consult a qualified professional. Original source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202600578
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