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Commission Implementing Regulation (EU) 2022/2048 of 24 October 2022 approving L-(+)-lactic acid as an existing active substance for use in biocidal products of product-type 6 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Implementing Regulation (EU) 2022/2048 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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L-(+)-lactic acid is approved as an active substance for use in biocidal products of product-type 6, subject to the conditions set out in the Annex.

Article 2

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

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions L-(+)-lactic acid IUPAC Name: (2S)-2-Hydroxypropanoic acid EC No: 201-196-2 CAS No: 79-33-4 ≥ 955 g/kg (dry weight) 1 November 2023 31 October 2033 6 The authorisation of biocidal products is subject to the following conditions: 1. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment ( 2 ) of the active substance. 2. In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: (a) industrial and professional users; (b) non-professional users. The placing on the market of treated articles is subject to the following conditions: 1) The person responsible for the placing on the market of a substance or mixture treated with or incorporating L-(+)-lactic acid at concentrations in the substance or mixture leading to classification for: (a) local effects concerning skin corrosion/irritation or eye damage/eye irritation, in accordance with Regulation (EC) No 1272/2008, shall ensure that exposure to the general public is minimised by appropriate risk mitigation measures. Those measures may include using a gel-like formulation, a packaging with dosing aid or a packaging with a self-dissolving shell; (b) acute toxicity regarding corrosivity to the respiratory tract, in accordance with Regulation (EC) No 1272/2008, shall ensure that airborne exposure to the general public is minimised by appropriate risk mitigation measures. Those measures may include a label to indicate: no entry in the treated area until dry, or no application in the presence of the/in proximity to general public. 2) The person responsible for the placing on the market of a treated article treated with or incorporating L-(+)-lactic acid shall ensure that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012. 3) Member States competent authorities or, in the case of a Union authorisation, the Commission shall specify in the summary of the biocidal product characteristics of a biocidal product containing L-(+)-lactic acid the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), point (e), of Regulation (EU) No 528/2012. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance. ( 2 ) Biocidal Products Committee Opinion on the application for approval of the active substance: L-(+)-lactic acid, Product type: 6; ECHA/BPC/280/2021, adopted on 15 June 2021.

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