Commission Implementing Regulation (EU) 2023/402 of 22 February 2023 granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/402of 22 February 2023granting a Union authorisation for the biocidal product family CMIT/MIT SOLVENT BASED in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 14 June 2017, Dow Europe GmbH ("the applicant") submitted an application to the European Chemicals Agency ("the Agency") in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named "CMIT/MIT SOLVENT BASED" of product-type 6, as described in Annex V to that Regulation, for preservation of aviation fuel, crude oil and middle distillate fuel, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-NN032576-24 in the Register for Biocidal Products. On 16 April 2020, the applicant withdrew the application as regards use of "CMIT/MIT SOLVENT BASED" in aviation fuels. On 31 October 2020, the application was transferred by the applicant to Nutrition & Biosciences Netherlands B.V.(2)The biocidal product family "CMIT/MIT SOLVENT BASED" comprises products for preservation of de-watered crude oil and refined products (middle and light distillate fuels) containing 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one ("C(M)IT/MIT") as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.(3)On 28 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the Agency.(4)On 7 April 2020, the Agency submitted an opinionECHA opinion of 5 March 2020 on the Union authorisation of the biocidal product family "CMIT-MIT Solvent Based" (ECHA/BPC/246/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "CMIT/MIT SOLVENT BASED" and the final assessment report on the biocidal product family to the Commission in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "CMIT/MIT SOLVENT BASED" is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. The opinion included a minority position expressed by the member appointed by Germany, which concluded that the use of "CMIT/MIT SOLVENT BASED" as a preservative in fuels conflicts with the national legislation of that Member State (10th Federal Emission Control Ordinance §2 (1) and (2)), which forbids that fuels for on-road motor vehicles contain additives with chlorine or bromine compounds and which forbids the placing on the market of additives that contain chlorine or bromine as these compounds cause formation of dioxins during the fuel combustion.(6)On 15 January 2021, the Agency transmitted the draft SPC to the Commission in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(7)To address the concerns on dioxin formation expressed in the minority position to the opinion, on 24 July 2020, the Commission requested an opinion from the Agency under Article 75(1), point (g), of Regulation (EU) No 528/2012 to estimate the amount of formation of dioxins and the overall contribution to the emissions of dioxins due to the use of the biocidal product family "CMIT/MIT SOLVENT BASED" in fuels used for road and water transport. The Commission also requested the Agency to clarify the level of the risks to the environment and human health due to the exposure to dioxins via the environment from the use of the biocidal product family "CMIT/MIT SOLVENT BASED".(8)On 5 July 2021, the Agency submitted the requested opinion to the CommissionBiocidal Products Committee (BPC) Opinion on a request according to Article 75(1)(g) of Regulation (EU) No 528/2012 on the evaluation of dioxins emissions from the use of the biocidal product family (BPF) "CMIT/MIT SOLVENT BASED" in fuels used in road and ship transport (ECHA/BPC/283/2021). concluding that although the potential consequences of the use of C(M)IT/MIT as a preservative in oil and fuel cannot be neglected, it is not possible to draw any conclusions on the magnitude of the potential contribution of the use of C(M)IT/MIT in fuels with respect to dioxin exposure, nor on the potential consequences of chlorine additives such as C(M)IT/MIT in fuels on human health and on the environment.(9)The objectives of the Stockholm Convention on Persistent Organic Pollutants ("Stockholm Convention")Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 3). and Regulation (EU) 2019/1021 of the European Parliament and of the CouncilRegulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45). are to protect human health and the environment from persistent organic pollutants (POPs), which include dioxins. The Commission considers that refusing the Union authorisation for the biocidal product family "CMIT/MIT SOLVENT BASED" would not lead to a significant decrease of dioxin emissions compared to granting it, as the same or similar chlorine-containing additives are currently allowed to be placed on the market under transitional measures of Regulation (EU) No 528/2012 by the Member States or could be authorised under national authorisations granted in accordance with Regulation (EU) No 528/2012. Furthermore, as a consequence of the ambitions of the European Green DealA European Green Deal | European Commission (europa.eu). and Regulation (EU) 2021/1119 of the European Parliament and of the CouncilRegulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (OJ L 243, 9.7.2021, p. 1). (the European Climate LawEuropean Climate Law (europa.eu).) to achieve climate neutrality by 2050, the overall amount of fuel that may potentially be treated with the biocidal product family and combusted in motors or heating systems is expected to decline significantly in the coming decades. Consequently, the possible formation of dioxins associated with the use of the biocidal product family "CMIT/MIT SOLVENT BASED" will decrease accordingly, thus contributing to achieve the objectives of the Stockholm Convention and Regulation (EU) 2019/1021.(10)On 16 November 2021, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, Denmark made a request to the Commission for the Union authorisation of the biocidal product family "CMIT/MIT SOLVENT BASED" not to apply in its territory, based on the grounds provided in Article 37(1), points (a) and (c), of that Regulation, as the presence of halogenated organic compounds such as C(M)IT/MIT in fuel may result in the formation of dioxins during fuel combustion, alternatives for fuel preservation without halogenated compounds are available and preservatives for fuels are not used by refineries or at service stations in Denmark.(11)On 12 December 2021, Germany requested that the Commission adjusts the conditions of the Union authorisation of the biocidal product family "CMIT/MIT SOLVENT BASED" in its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, based on the grounds referred to in Article 37(1) points (a) and (c), of that Regulation so as not to allow its use for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis in line with national legislation as set out in the 10th Federal Emission Control OrdinanceZehnte Verordnung zur Durchführung des Bundes-Immissionsschutzgesetzes. in combination with the German Road Traffic Act (Straßenverkehrsgesetz)Straßenverkehrsgesetz..(12)On 15 July 2022, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, Belgium made a request to the Commission for the Union authorisation of the biocidal product family "CMIT/MIT SOLVENT BASED" not to apply in its territory, based on the grounds provided in Article 37(1), points (a) and (c), of that Regulation, as it considers that the presence of halogenated organic compounds such as C(M)IT/MIT in fuel may result in the formation of dioxins during fuel combustion, that the formation of dioxins should be minimised and, where feasible, fully eliminated in Belgium, and that alternatives for fuel preservation without halogenated compounds are available.(13)The Commission considers that the requests made by Germany to adjust the conditions and the requests made by Denmark and Belgium not to apply the Union authorisation of the biocidal product family "CMIT/MIT SOLVENT BASED" in the respective territories of those Member States in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 can be considered justified on the grounds of the protection of the environment and the protection of health and life of humans pursuant to Article 37(1), points (a) and (c), of that Regulation as the presence of halogenated organic compounds, such as C(M)IT/MIT, in fuel may result in the formation of dioxins during fuel combustion.(14)Therefore, the biocidal product family "CMIT/MIT SOLVENT BASED" should not be authorised for use in Denmark and Belgium and should be not be used in Germany for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis.(15)Therefore, the Commission concurs with the opinion of the Agency and considers it appropriate to grant a Union authorisation for "CMIT/MIT SOLVENT BASED" with the adjustments for Germany, Denmark and Belgium requested in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012.(16)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: