Commission Implementing Regulation (EU) 2026/385 of 20 February 2026 approving formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) as an existing active substance for use in biocidal products of product-types 2, 6, 11, 12 and 13 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
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 ↗
Formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) is approved as an active substance for use in biocidal products of product-types 2, 6, 11, 12 and 13, subject to the conditions set out in the Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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 the reaction products of paraformaldehyde and 2- hydroxypropylamine (ratio 3:2) (‘RP 3:2’) IUPAC name: Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) EC No: not applicable CAS No: not applicable The active substance has to be considered as substance of Unknown or Variable composition or Complex reaction products or Biological materials (UVCB). Therefore the minimum purity is 1 000 g/kg (100% by weight). 1 June 2027 31 May 2032 2 RP 3:2 is a candidate for substitution in accordance with Article 10(1), point (a), of Regulation (EU) No 528/2012. The authorisation of biocidal products using RP 3:2 as an active substance is subject to the following conditions: (a) the product assessment pays 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 assessment of the active substance; (b) pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (c) products may only be authorised for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (d) the use of biocidal products containing RP 3:2 is subject to appropriate measures to ensure that exposure of humans, animals and the environment to RP 3:2 is minimised as far as possible; (e) products may only be authorised for industrial or professional use as system cleaner formulations for metal working systems; (f) the product assessment pays particular attention to: (i) professionals and industrial workers; (ii) sewage treatment plant, surface water and the terrestrial compartment; (g) Member States competent authorities shall specify in the summary of the biocidal product characteristics of a biocidal product containing RP 3:2 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. The placing on the market of treated articles treated with or incorporating RP 3:2 is subject to the following conditions: (a) only treated articles treated with or incorporating RP 3:2 may be placed on the market, where RP 3:2 has been used as system cleaner formulation for metal working systems; (b) the person responsible for the placing on the market of a treated article treated with or incorporating RP 3:2 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. 6 RP 3:2 is a candidate for substitution in accordance with Article 10(1), point (a), of Regulation (EU) No 528/2012. The authorisation of biocidal products using RP 3:2 as an active substance is subject to the following conditions: (a) the product assessment pays 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 assessment of the active substance; (b) pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (c) products may only be authorised for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (d) the use of biocidal products containing RP 3:2 is subject to appropriate measures to ensure that exposure of humans, animals and the environment to RP 3:2 is minimised as far as possible; (e) products may only be authorised for the preservation of fuels, handled by industrial or professional users; (f) the product assessment pays particular attention to: (i) professionals and industrial workers; (ii) sewage treatment plant, surface water and the terrestrial compartment; (g) Member States competent authorities specify in the summary of the biocidal product characteristics of a biocidal product containing RP 3:2 the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012. The placing on the market of treated articles treated with or incorporating RP 3:2 is subject to the following conditions: (a) only fuel treated with or incorporating RP 3:2 may be placed on the market, where RP 3:2 has been used as preservative of fuel; (b) the person responsible for the placing on the market of fuel treated with or incorporating RP 3:2 ensures that the label of that fuel provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012. 11 RP 3:2 is a candidate for substitution in accordance with Article 10(1), point (a), of Regulation (EU) No 528/2012. The authorisation of biocidal products using RP 3:2 as an active substance is subject to the following conditions: (a) the product assessment pays 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 assessment of the active substance; (b) pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (c) products may only be authorised for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (d) the use of biocidal products containing RP 3:2 is subject to appropriate measures to ensure that exposure of humans, animals and the environment to RP 3:2 is minimised as far as possible; (e) products may only be authorised for the preservation of liquid cooling and processing systems, only in closed systems, handled by industrial or professional users; (f) the product assessment pays particular attention to: (i) professionals and industrial workers; (ii) sewage treatment plant, surface water and the terrestrial compartment; (g) Member States competent authorities shall specify in the summary of the biocidal product characteristics of a biocidal product containing RP 3:2 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. The placing on the market of treated articles treated with or incorporating RP 3:2 is subject to the following conditions: (a) only treated articles treated with or incorporating RP 3:2 may be placed on the market, where RP 3:2 has been used for the preservation of liquid cooling and processing systems, only in closed systems; (b) the person responsible for the placing on the market of a treated article treated with or incorporating RP 3:2 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. 12 RP 3:2 is a candidate for substitution in accordance with Article 10(1), point (a), of Regulation (EU) No 528/2012. The authorisation of biocidal products using RP 3:2 as an active substance is subject to the following conditions: (a) the product assessment pays 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 assessment of the active substance; (b) pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (c) products may only be authorised for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (d) the use of biocidal products containing RP 3:2 is subject to appropriate measures to ensure that exposure of humans, animals and the environment to RP 3:2 is minimised as far as possible; (e) products may only be authorised for the prevention or control of slime growth on materials, equipment and structures in offshore oil industry installations in contact with drilling muds, handled by industrial or professional users; (f) the product assessment pays particular attention to: (i) professionals and industrial workers; (ii) sea water; (g) Member States competent authorities shall specify in the summary of the biocidal product characteristics of a biocidal product containing RP 3:2 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. The placing on the market of treated articles treated with or incorporating RP 3:2 is subject to the following conditions: (a) only treated articles treated with or incorporating RP 3:2 may be placed on the market, where RP 3:2 has been used for the prevention or control of slime growth on materials, equipment and structures in offshore oil industry installations in contact with drilling muds; (b) the person responsible for the placing on the market of a treated article treated with or incorporating RP 3:2 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. 13 RP 3:2 is a candidate for substitution in accordance with Article 10(1), point (a), of Regulation (EU) No 528/2012. The authorisation of biocidal products using RP 3:2 as an active substance is subject to the following conditions: (a) the product assessment pays 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 assessment of the active substance; (b) pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (c) products may only be authorised for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied; (d) the use of biocidal products containing RP 3:2 is subject to appropriate measures to ensure that exposure of humans, animals and the environment to RP 3:2 is minimised as far as possible; (e) products may only be authorised for the preservation of metal working or cutting fluids, handled by industrial or professional users; (f) the product assessment pays particular attention to: (i) professionals and industrial workers; (ii) sewage treatment plant, surface water and the terrestrial compartment; (g) Member States competent authorities specify in the summary of the biocidal product characteristics of a biocidal product containing RP 3:2 the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012. The placing on the market of treated articles treated with or incorporating RP 3:2 is subject to the following conditions: (a) only metal working or cutting fluids treated with or incorporating RP 3:2 may be placed on the market; (b) the person responsible for the placing on the market of a treated article treated with or incorporating RP 3:2 ensures that the label of that treated article provides the information listed in Article 58(3), second subparagraph, 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 made available on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
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