Commission Implementing Regulation (EU) 2024/2635 of 3 October 2024 approving silver zinc zeolite as an existing active substance for use in biocidal products of product-types 2, 7 and 9 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Article 1

Silver zinc zeolite is approved as an active substance for use in biocidal products of product-types 2, 7 and 9, 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
Silver zinc zeolite
IUPAC name: Silver zinc zeolite (zeolite, LTA  ( 2 ) framework type, surface-modified with silver, zinc and ammonium ions)
EC No: not assigned
CAS No: 130328-20-0  ( 3 )
990 g/kg dry weight with the following relevant impurities: arsenic and chromium, each with a maximum content of 40 mg/kg dry weight.
1 March 2026
29 February 2036
2
(1)
The authorisation of biocidal products containing silver zinc zeolite 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)
products shall not be authorised for treatment of non-textile polymers that may come into direct contact with skin with contact area of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old);
(c)
products shall not be authorised for treatment of textiles that, used by themselves or incorporated in other articles, satisfy any of the following conditions:
(1)
may come into contact with human skin, including indirectly via body fluids;
(2)
may be handled under wet conditions;
(3)
may be mouthed by children under the age of 2 years.
(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 silver zinc zeolite 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.
(2)
The placing on the market of treated articles is subject to the following conditions:
(a)
non-textile polymer articles treated with or incorporating silver zinc zeolite that may come into direct contact with skin of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old), shall not be placed on the market;
(b)
textiles treated with or incorporating silver zinc zeolite shall not be placed on the market if they, used by themselves or incorporated in other articles, satisfy any of the following conditions:
(1)
may come into contact with human skin, including indirectly via body fluids;
(2)
may be handled under wet conditions;
(3)
may be mouthed by children under the age of 2 years;
(c)
the person responsible for the placing on the market of a treated article treated with or incorporating silver zinc zeolite 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.
7
(1)
The authorisation of biocidal products containing silver zinc zeolite 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)
products shall not be authorised for treatment of non-textile polymers that may come into direct contact with skin with contact area of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old);
(c)
products shall not be authorised for use in paints or coatings which are intended to be used on outdoor infrastructures, such as houses, façades or noise barriers, or structures above water, such as bridges;
(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 silver zinc zeolite 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.
(2)
The placing on the market of treated articles is subject to the following conditions:
(a)
non-textile polymer articles treated with or incorporating silver zinc zeolite that may come into direct contact with skin of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old), shall not be placed on the market;
(b)
the person responsible for the placing on the market of a paint or coating treated with or incorporating silver zinc zeolite shall ensure that the label of that paint or coating indicates that it shall not be used on outdoor infrastructures, such as houses, façades or noise barriers, or structures above water, such as bridges;
(c)
the person responsible for the placing on the market of a treated article treated with or incorporating silver zinc zeolite 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.
9
(1)
The authorisation of biocidal products containing silver zinc zeolite 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)
products shall not be authorised for treatment of non-textile polymers that may come into direct contact with skin with contact area of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old);
(c)
products shall not be authorised for treatment of textiles that, used by themselves or incorporated in other articles, satisfy any of the following conditions:
(1)
may come into contact with human skin, including indirectly via body fluids;
(2)
may be handled under wet conditions;
(3)
may be mouthed by children under the age of 2 years;
(4)
may be used outdoors;
(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 silver zinc zeolite 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.
(2)
The placing on the market of treated articles is subject to the following conditions:
(a)
non-textile polymer articles treated with or incorporating silver zinc zeolite that may come into direct contact with skin of more than 300 cm 2 for adults and children (> 2 years old), and of more than 200 cm 2 for toddlers (1-2 years old) and infants (< 1 year old), shall not be placed on the market;
(b)
textiles treated with or incorporating silver zinc zeolite shall not be placed on the market if they, used by themselves or incorporated in other articles, satisfy any of the following conditions:
(1)
may come into contact with human skin, including indirectly via body fluids;
(2)
may be handled under wet conditions;
(3)
may be mouthed by children under the age of 2 years;
(4)
may be used outdoors;
(c)
the person responsible for the placing on the market of a treated article treated with or incorporating silver zinc zeolite 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 may be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
( 2 )   Linde Type A (framework type of the zeolite). The framework type is a crucial part of the identity. A silver zinc zeolite with a different framework-type shall not be considered the same substance.
( 3 )   The CAS-name is zeolites, synthetic, Ag. The entry in the CAS inventory is broader than the specified chemical name.

Commission Implementing Regulation (EU) 2024/2635 of 3 October 2024 approving silver zinc zeolite as an existing active substance for use in biocidal products of product-types 2, 7 and 9 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Schedules & Appendices

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