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UE zatwierdza 2 istniejące substancje czynne stosowane w produktach biobójczych

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Stycznia 16, 2024, trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (CAS: 70693-62-8) was approved for use in biocidal products of product-types 2, 3, 4, and 5, in accordance with Regulation (EC) No 528/2012 of the European Parliament and the Council. 

Earlier on 15 January, Alkyl (C12-16) dimethylbenzyl ammonium chloride (CAS: 68424-85-1) was approved as an existing active substance for use as product-type 2, subject to the specifications in Table 2.

Table 1: Information of Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)

Minimum Degree of Purity of the Active SubstanceData zatwierdzeniaExpiry Date of ApprovalRodzaj produktuWarunki szczególne
≥ 890 g/kg (≥ 89 % w/w)

dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)
1 lipca 202530 czerwca 2035PT2

(disinfectants and algaecides not intended for direct application to humans or animals)
The authorisation of biocidal products 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: 
● professional users;
● non-professional users; and
● surface water due to chronic emissions following private swimming pool disinfection.
PT3

(veterinary hygiene)
The authorisation of biocidal products 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 professional users.
PT4

(food and feed area)
The authorisation of biocidal products 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 professional users.
PT5

(drinking water)
The authorisation of biocidal products 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 professional users.

Table 2: Information of Alkyl (C12-16) dimethylbenzyl ammonium chloride

Minimum Degree of Purity of the Active SubstanceData zatwierdzeniaExpiry Date of ApprovalRodzaj produktuSzczególne warunki
972 g/kg dry weight1 lipca 202530 czerwca 2035PT2

(disinfectants and algaecides not intended for direct application to humans or animals)
The authorisation of biocidal products using Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) 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 professional users.

Uwaga: 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.

In summary, enterprises shall guarantee that biocidal products containing specific active ingredients meet EU regulations.

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