(1)

On 26 April 2018, the company European Registration Office B.V. (‘the applicant’) submitted to the competent authorities of Belgium, Denmark, France, Germany, Ireland, Italy, Luxembourg, Poland and Spain an application for an authorisation granted by mutual recognition in accordance with Article 34 of Regulation (EU) No 528/2012 of the biocidal product ERO MP (‘the product’). The product is a product for veterinary hygiene of product-type 3 in accordance with Annex V to Regulation (EU) No 528/2012, contains 24 % w/w of the active substance chlorocresol and is a disinfectant for professional use to be applied by low-pressure spraying of a diluted concentrate in non-porous surfaces and materials (use 1) and in floors and walls of animal housing (use 2). The product and its dilutions are classified as skin corrosive (H314) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). The Netherlands is the reference Member State responsible for the evaluation in accordance with Article 34(1) of Regulation (EU) No 528/2012.

(2)

On 4 July 2023, France referred objections to the coordination group pursuant to Article 35(2) of Regulation (EU) No 528/2012, indicating that the product does not meet the condition for authorisation laid down in Article 19(1), point (b)(iii), of that Regulation. According to France, a systemic exposure and risk assessment considering the acceptable exposure levels for chlorocresol should be performed. France considered that the use of the product by spraying does not meet the criteria for concluding qualitatively on the acceptability for professional exposure listed in Table 27 of Section 4.3.2.5.iv of the Guidance on the Biocidal Products Regulation Volume III Human Health – Assessment & Evaluation (Parts B+C), version 2.0; October 2015) (3) as the proposed risk mitigation measures and personal protective equipment are not sufficient to achieve a negligible exposure. France also considered that a combined systemic risk assessment should be carried out in accordance with Section 4.4.1 of that Guidance on the Biocidal Products Regulation as the product contains one active substance (chlorocresol) and the substance of concern propan-2-ol.

(3)

As no agreement was reached in the coordination group on whether the biocidal product complies with the conditions for authorisation, on 15 July 2024 the Netherlands referred the unresolved objection to the Commission and provided the Commission with a detailed statement of the matter on which Member States were unable to reach an agreement and the reasons for their disagreement in accordance with Article 36(1) of Regulation (EU) No 528/2012. That statement was forwarded to the Member States concerned and to the applicant.

(4)

On 21 January 2025, the Commission asked the European Chemicals Agency (the ‘Agency’) for an opinion in relation to the disagreement in accordance with Article 36(2) of Regulation (EU) No 528/2012. The Agency was asked to conclude on whether a systemic exposure and risk assessment is necessary and if so, the outcome of that risk assessment. The Agency was also asked to conclude on whether the local risk from the use of the product is acceptable considering appropriate risk mitigation measures and wearing of personal protective equipment. Furthermore, the Agency was asked if it is necessary to conduct a combined exposure and risk assessment for chlorocresol and the substance of concern, propan-2-ol, and if so, the outcome of that risk assessment. Finally, the Agency was asked to clarify, based on the answers to the first questions, if the condition in Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 is met for the product.

(5)

On 16 May 2025, the Biocidal Products Committee of the Agency adopted its opinion (4). According to the Agency, a systemic exposure and risk assessment for the active substance chlorocresol and a combined risk assessment for the active substance and substance of concern should be performed. The Agency concluded that the systemic exposure and risk assessment, the local risk assessment and the combined risk assessment result in no unacceptable risks from the use of the product when applying certain risk mitigation measures. The Agency concluded that the product meets the conditions of Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,