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Commission Implementing Regulation (EU) 2015/1981 of 4 November 2015 approving Formaldehyde released from N,N-Methylenebismorpholine as an existing active substance for use in biocidal products for product-types 6 and 13 (Text with EEA relevance)

Implementing Regulation (EU) 2015/1981 · 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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Formaldehyde released from N,N-Methylenebismorpholine is approved as an active substance for use in biocidal products for product-types 6 and 13, subject to the specifications and 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 Formaldehyde released from N,N-Methylenebismorpholine (hereafter referred to as ‘MBM’) IUPAC Name: N,N-Methylenebismorpholine EC No: 227-062-3 CAS No: 5625-90-1 92,1 % w/w 1 April 2017 31 March 2022 6 MBM is considered a candidate for substitution in accordance with Article 10(1)(a) of Regulation (EU) No 528/2012. 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 of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied. The authorisations of biocidal products are subject to the following conditions: (1) Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (3) In view of the risks to professional users, mixing and loading of products to formulation vessels shall be automated, unless it can be demonstrated that potential exposure of skin, eye and respiratory tracts to MBM can be reduced to an acceptable level by other means. The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating MBM shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. 13 MBM is considered a candidate for substitution in accordance with Article 10(1)(a) of Regulation (EU) No 528/2012. 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 of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied. The authorisations of biocidal products are subject to the following conditions: (1) Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (3) In view of the risks to professional users, mixing and loading of products to formulation vessels shall be automated, unless it can be demonstrated that potential exposure of skin, eye and respiratory tracts to MBM can be reduced to an acceptable level by other means. The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating MBM shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

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