Commission Implementing Regulation (EU) 2024/2964 of 29 November 2024 approving reaction products of boric acid with didecylamine and ethylene oxide (polymeric betaine) as an existing active substance for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Article 1

Reaction products of boric acid with didecylamine and ethylene oxide (polymeric betaine) is approved as an active substance for use in biocidal products of product-type 8, subject to the conditions set out in the Annex.

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 .

ANNEX

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
Polymeric betaine
IUPAC name: reaction products of boric acid with didecylamine and ethylene oxide
EC No: not available
CAS No: 214710-34-6
100 % weight per weight.
Polymeric betaine is an unknown or variable composition, complex reaction products or of biological materials (UVCB) substance.
1 June 2026
31 May 2036
8
(1)
Reaction products of boric acid with didecylamine and ethylene oxide (‘polymeric betaine’) is considered a candidate for substitution in accordance with Article 10(1), point (d), of Regulation (EU) No 528/2012.
(2)
The authorisation of biocidal products containing polymeric betaine as an active substance is subject to the following conditions:
(a)
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;
(b)
the product assessment shall pay particular attention to:
(i)
industrial and professional users;
(ii)
sewage treatment plant, surface water, sediment, soil and groundwater for Use Class  ( 2 ) 1 (situation in which the wood or wood-based product is inside a construction, not exposed to the weather and wetting) and Use Class 2 (situation in which the wood or wood-based product is under cover and not exposed to the weather, particularly rain and driven rain, but where occasional, but not persistent, wetting can occur);
(c)
in view of the risks identified for surface water, sediment, soil and groundwater during industrial impregnation and storage of wood intended for Use Class 1 and Use Class 2, labels and, where provided, safety data sheets of products authorised shall indicate the following:
(i)
all industrial application processes shall be conducted within a contained area situated on impermeable hard standing with bunding to prevent run-off, and a recovery system shall be in place (e.g. sump);
(ii)
measures are in place to prevent any release of cleaning water (after cleaning of floors, tanks, containers) to the environment (sewer, soil, water) during the application phase;
(iii)
freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer or water, and that any losses from the application of the product, including any contaminated water / soil, shall be collected for reuse or disposal;
(d)
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 polymeric betaine 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;
(e)
for products that may lead to residues in food or feed, it shall be assessed whether new maximum residue levels or maximum residue limits need to be set or the existing maximum residue levels or maximum residue limits need to be amended in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council  ( 3 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( 4 ) , and any appropriate risk mitigation measures shall be taken to ensure that such maximum residue levels or maximum residue limits are not exceeded.
(3)
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 polymeric betaine 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.
( 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 )   The use classes described in EN 335:2013 are defined in terms of service conditions, with reference to the generalised moisture content and the prevailing biological agents of deterioration (ECHA Guidance on the Biocidal Products Regulation, Volume II: Efficacy, Parts B + C: Assessment and Evaluation, Version 5.0, November 2022).
( 3 )   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 ).
( 4 )   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 ).

Schedules & Appendices

Cite this act