EU Approves Silver Zinc Zeolite for PT2, PT7, PT9 Biocides

In October 2024, the European Commission approved silver zinc zeolite (SZZ, CAS number: 130328-20-0) for use in biocides including disinfectants and preservatives for fibers, leather, rubber, and polymers. Compliance with specific regulations is mandatory. A transition period has been established to support industry adaptation, with details provided in the following table.

EU,Biocides,BPR,Substance,Approval,Chemical

Common Name

CAS Num.

Minimum degree of purity of the active substance

Date of approval

Expiry date of approval

Product type

Specific conditions

Silver zinc zeolite

130328-20-0

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

(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 cm2 for adults and children (> 2 years old), and of more than 200 cm2 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 cm2 for adults and children (> 2 years old), and of more than 200 cm2 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.

(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 cm2 for adults and children (> 2 years old), and of more than 200 cm2 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)

(2)

The placing on the market of treated articles is subject to the following conditions:

(a)

(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.

(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 cm2 for adults and children (> 2 years old), and of more than 200 cm2 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)

(2)

The placing on the market of treated articles is subject to the following conditions:

(a)

(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.

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