The European Commission has resolved an ongoing dispute between France and Germany, approving the biocidal product Phenogen for use in livestock facilities across the EU, effective from 23 October 2024. The decision follows objections from Germany over consumer safety concerns regarding the residue levels of chlorocresol, a key ingredient in the disinfectant, despite approval recommendations from the European Chemicals Agency (ECHA).
Background on the Phenogen Approval
Phenogen, produced by Synthèse élevage SARL, is designed for disinfecting animal housing and transportation vehicles, targeting livestock sectors. Initially evaluated by France, the product contains chlorocresol and lactic acid as active ingredients. Under Regulation (EU) No 528/2012, the European Union mandates strict evaluation of biocidal products to protect human and animal health, and Phenogen’s approval faced scrutiny over compliance with Article 19 requirements for biocidal product safety.
Germany’s Safety Objections
Germany’s primary concern focused on chlorocresol residue potentially exceeding the 0.01 mg/kg maximum residue limit (MRL) established under EU regulation. German authorities argued that the residue risk assessment conducted by France was inadequate, as only partial experimental data on chlorocresol in livestock tissues were available, and they proposed mandatory rinsing of treated surfaces as a mitigation measure. Germany also questioned the use of a 50% dermal absorption rate—meant for human skin—for assessing livestock exposure, suggesting instead the use of livestock-specific data.
ECHA’s Evaluation and Commission’s Decision
ECHA reviewed the objections and determined that France's residue assessment approach was suitable, stating that while rinsing could reduce residue levels by an estimated 90%, Phenogen’s application without rinsing still posed no dietary risk to consumers. Furthermore, ECHA confirmed that chlorocresol, under current regulations, does not necessitate an MRL due to its rapid metabolism and minimal residue in edible animal tissues. Consequently, the European Commission deemed Phenogen compliant with Articles 19(1)(b)(iii) and (e) of Regulation (EU) No 528/2012, validating France's assessment and authorising the product without mandatory rinsing instructions.
Implications for Biocidal Product Regulation
This decision reflects the EU’s ongoing efforts to balance safety standards with agricultural product efficacy. The outcome underscores the European Commission's trust in scientific bodies like ECHA for independent risk assessment and may set a precedent for similar disputes over biocidal product authorisations in the future.
The Commission's decision, led by Commissioner Stella Kyriakides, reaffirms Phenogen’s compliance with EU biocidal regulations, offering a pathway for its use within livestock management while upholding food safety assurances. This resolution may influence future biocidal product evaluations, especially in areas with contested safety standards and residue management.
