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European Commission Approves New Compound for Type 18 Biocidal Products

Enteral nutrition diet

On October 2, 2024, the European Commission issued Regulation EU 2024/2576, approving the compound 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate for use in Type 18 biocidal products under EU Regulation No. 528/2012. Details are provided in the table below.

spray bottles

Common NameIUPAC NameIdentification NumbersMinimum degree of purity of the active substanceDate of approvalExpiry date of approvalProduct type
prallethrinIUPAC name: 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylateEC No: 245-387-9
CAS No: 23031-36-9
92,0 % weight per weight (w/w)Note: 1R-trans, S isomer are present at > 80 % (w/w)1 March 202629 February 203618
Prallethrin is considered a candidate for substitution in accordance with Article 10(1), point (d), of Regulation (EU) No 528/2012.
The authorisation of biocidal products containing prallethrin as an active substance 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 of the active substance;(2) the product assessment shall pay particular attention to:
a. children (toddlers);
b. surface water, sediment, soil and groundwater for products applied indoors by non-professional users by residual spraying (barrier treatment) in private households;
(3) for products that may lead to residues in food or feed, it shall be assessed whether new maximum residue levels (‘MRLs’) need to be set or the existing MRLs need to be amended in accordance with Regulations (EC) No 470/2009 (2) or (EC) No 396/2005 (3) of the European Parliament and of the Council, and any appropriate risk mitigation measures shall be taken to ensure that such MRLs are not exceeded.
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 treated article treated with or incorporating prallethrin 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;
(2)  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 prallethrin 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.

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Source from CIRS

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