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Commission Implementing Regulation (EU) 2015/1759 of 28 September 2015 approving glutaraldehyde as an existing active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 (Text with EEA relevance)

Implementing Regulation (EU) 2015/1759 · 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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Glutaraldehyde is approved as an active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12, 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 Glutaraldehyde IUPAC Name: 1,5-pentanedial EC No: 203-856-5 CAS No: 111-30-8 950 g/kg dry weight (95 %) 1 October 2016 30 September 2026 2 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) In view of the risks to professional users, products cannot be applied by wiping unless it can be demonstrated that risks can be reduced to an acceptable level. 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 glutaraldehyde 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. 3 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) Application by fogging shall be restricted to trained professionals. (3) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 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 glutaraldehyde 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. 4 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (3) Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of glutaraldehyde into food or it has been established pursuant to that Regulation that such limits are not necessary. 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 glutaraldehyde 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. 6 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) In view of the risks to human health, products intended for non-professional users shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment. (3) In view of the risks to the environment, products shall not be authorised for preservation of drilling and cementing fluids unless it can be demonstrated that risks can be reduced to an acceptable level. The placing on the market of treated articles is subject to the following conditions. (1) Mixtures treated with or incorporating glutaraldehyde shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment. (2) The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde 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. 11 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) In view of the risks to the soil and surface water, products shall not be authorised for use in small open recirculating cooling systems, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) In view of the risks to the environment, products shall not be authorised for preservation of hydrotesting water unless it can be demonstrated that risks can be reduced to an acceptable level. 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 glutaraldehyde 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. 12 Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) 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. The authorisations of biocidal products are subject to the following conditions. (1) For industrial or 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. (2) In view of the risks to the environment, products shall not be authorised for use in pulp or paper mills which are not connected to a wastewater treatment plant unless it can be demonstrated that risks can be reduced to an acceptable level. 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 glutaraldehyde 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. ( 2 ) 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 ). ( 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 ).

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