Commission Implementing Regulation (EU) 2026/400 of 18 February 2026 granting a Union authorisation for the biocidal product family CHLOROCRESOL BASED PRODUCTS-CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 25 July 2018, CID LINES NV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ of product-types 2 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-RF039183-42 in the Register for Biocidal Products.

(2) ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ contains chlorocresol 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 for product-types 2 and 3.

(3) On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 18 November 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concluded that for the biocidal product family ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ the conditions of Article 19(6) of Regulation (EU) No 528/2012 are met and proposed the biocidal product family to be authorised, for the uses described under section 2.1 of the opinion, subject to compliance with the proposed SPC. For one of the uses (use # 7.7 as listed in the Agency opinion) as a concentrated animal skin disinfectant (product type 3) used by spraying by professional users, the Agency opinion did not provide a conclusion due to an ongoing discussion at regulatory level about the consequences of the exceedance of maximum residue limits.

(6) On 7 December 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 establishes as a condition for authorisation that a biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects. In accordance with Article 19(1), point (e), of Regulation (EU) No 528/2012, biocidal products are to be authorised provided that, where appropriate, maximum residue limits (MRLs) for food and feed or specific migration limits or limits for the residual content in food contact materials have been established in accordance with relevant Union legislation.

(8) Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) sets a default MRL of 0,01 mg/kg for pesticide residues for products for which no specific MRL is set out in Annexes II or III to that Regulation. However, in accordance with Article 3(2), point (c), of Regulation (EC) No 396/2005, pesticide residues are residues, including active substances, metabolites and/or breakdown or reaction products of active substances currently or formerly used in plant protection products as defined in Article 2, point 1, of Council Directive 91/414/EEC (4), which are present in or on the products covered by Annex I to Regulation (EC) No 396/2005, including in particular those which may arise as a result of use in plant protection, in veterinary medicine and as a biocide. After analysis, it appears that chlorocresol was never used as an active substance in plant protection products under Directive 91/414/EEC or Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5). As there is no evidence that chlorocresol is currently or was formerly used in plant protection products, the Commission concludes that chlorocresol does not fall within the scope of Regulation (EC) No 396/2005 and that the default MRL value of 0,01 mg/kg set out in Article 18(1), point (b), of that Regulation does not apply to the biocidal active substance chlorocresol.

(9) For the use #7.7 of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’, the opinion provided by the Agency identified a case where residues of chlorocresol in products of animal origin would exceed the level of 0,01 mg/kg but specified no risks for human health. Specifically, no immediate or delayed unacceptable effects of chlorocresol as such, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects were identified.

(10) The active substance chlorocresol has also been evaluated by the Committee for Veterinary Medicinal Products under Council Regulation (EEC) No 2377/90 (6) which was replaced by Regulation (EC) 470/2009 of the European Parliament and of the Council (7) and it concluded that there is no need to establish a MRL for chlorocresol in all food-producing species as chlorocresol is considered to have low toxicity, is rapidly metabolised and excreted, with no potential to accumulate in tissues, and has been safely used in human medicine for many years (8).

(11) The Commission therefore considers that for the use #7.7 the conditions of Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 are fulfilled, taking into account, that there is no dietary risk for the consumer arising from the use of the product and that consumer exposure does not exceed the acceptable daily intake. The Commission also considers that the condition of Article 19(1), point (e), of Regulation (EU) No 528/2012 is met as chlorocresol is classified as a substance for which no MRL is required pursuant to Commission Regulation (EU) No 37/2010 (9) and it is not within the scope of Regulation (EC) No 396/2005.

(12) As the draft SPC provided to the Commission by the Agency did not include the use #7.7, on 22 August 2024 the Commission requested the Agency to provide a revised draft SPC including use #7.7 and its use conditions and an updated version of the product assessment report and a revised Agency opinion in accordance with Article 75(1), point (g), of Regulation (EU) No 528/2012.

(13) On 6 March 2025 the Agency provided its revised opinion (10) (‘revised Agency opinion’) and an updated product assessment report to the Commission. The revised draft SPC included additional editorial changes, and a correction, namely that use #7.4 (as listed in the revised Agency opinion), as concentrated disinfectants for use on instruments/equipment by veterinarians (PT2) by spraying or immersion, is not proposed for authorisation due to risks to human health and the environment that were already identified during the initial assessment.

(14) The Commission concurs with the revised Agency opinion and considers it therefore appropriate to grant a Union authorisation for ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’, for the uses proposed in the overall conclusions of the revised Agency opinion, in accordance with the revised SPC.

(15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0029989-0000 is hereby granted to CID LINES NV for the making available on the market and use of the biocidal product family ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 19 March 2026 to 29 February 2036.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 February 2026.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2) ECHA Biocidal Products Committee opinion of 16 September 2022 on the Union authorisation of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ (ECHA/BPC/362/2022).

(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj).

(4) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, (OJ L 230, 19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).

(5) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).

(6) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1, ELI: http://data.europa.eu/eli/reg/1990/2377/oj).

(7) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj).

(8) Committee for Veterinary Medicinal Products of the European Agency for the Evaluation of Medicinal Products Summary report Chlorocresol EMEA/MRL/074/96-FINAL of March 1996, https://www.ema.europa.eu/en/documents/mrl-report/chlorocresol-4-chloro-3-methylphenol-summary-report-committee-veterinary-medicinal-products_en.pdf.

(9) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/37(1)/oj).

(10) ECHA Biocidal Products Committee opinion of 28 February 2025 on the Union authorisation of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’,

https://echa.europa.eu/de/opinions-on-union-authorisation.