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Official Journal EN
of the European Union L series
2024/2635 4.10.2024
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 89(1), third subparagraph,
thereof,
Whereas:
(1) Commission Delegated Regulation (EU) No 1062/2014(2) establishes a list of existing active substances to be
evaluated for their possible approval for use in biocidal products. That list includes silver zinc zeolite (CAS No:
130328-20-0) for product-types 2, 7 and 9.
(2) Silver zinc zeolite has been evaluated for use in biocidal products of product-types 2 (private area and public health
area disinfectants and other biocidal products), 7 (film preservatives) and 9 (fibre, leather, rubber and polymerised
materials preservatives), as described in Annex V to Directive 98/8/EC of the European Parliament and of the
Council(3), which correspond respectively to product-types 2 (disinfectants and algaecides not intended for direct
application to humans or animals), 7 (film preservatives) and 9 (fibre, leather, rubber and polymerised materials
preservatives), as described in Annex V to Regulation (EU) No 528/2012.
(3) Sweden was designated as the rapporteur Member State and its evaluating competent authority submitted the
assessment report together with its conclusions to the Commission on 7 May 2012. After the submission of the
assessment report, discussions took place in technical meetings organised by the European Chemicals Agency (‘the
Agency’).
(4) It follows from Article 90(2), first subparagraph, of Regulation (EU) No 528/2012 that substances for which the
Member States’ evaluation has been completed by 1 September 2013 are to be evaluated in accordance with the
substantive conditions for approval laid down in Directive 98/8/EC.
(5) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal
Products Committee prepares the opinion of the Agency regarding the applications for approval of active
substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with
Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinions of
the Agency on 29 February 2024(4),(5),(6), having regard to the conclusions of the evaluating competent authority.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of
all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament
and of the Council (OJ L 294, 10.10.2014, p. 1, ELI: http://data.europa.eu/eli/reg_del/2014/1062/oj).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/8/oj).
(4) Biocidal Products Committee Opinion on the application for approval of the active substance Silver zinc zeolite; Product-type: 2;
ECHA/BPC/414/2024, adopted on 29 February 2024.
(5) Biocidal Products Committee Opinion on the application for approval of the active substance Silver zinc zeolite; Product-type: 7;
ECHA/BPC/415/2024, adopted on 29 February 2024.
(6) Biocidal Products Committee Opinion on the application for approval of the active substance Silver zinc zeolite; Product-type: 9;
ECHA/BPC/416/2024, adopted on 29 February 2024.
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OJ L, 4.10.2024
(6) Taking into account the opinions of the Agency, it can be concluded that biocidal products of product-types 2, 7
and 9 containing silver zinc zeolite may be expected to satisfy the requirements laid down in Article 5(1), points (b),
(c) and (d), read in conjunction with Article 10(1) of Directive 98/8/EC, provided that certain requirements
concerning their use are complied with. It is therefore appropriate to approve silver zinc zeolite as an active
substance for use in biocidal products of product-types 2, 7 and 9 subject to compliance with certain conditions,
including certain conditions for placing on the market of treated articles treated with or incorporating silver zinc
zeolite.
(7) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested
parties to take the preparatory measures necessary to meet the new requirements.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS REGULATION:
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 October 2024.
For the Commission
The President
Ursula VON DER LEYEN
2/7 ELI: http://data.europa.eu/eli/reg_impl/2024/2635/ojANNEX
IUPAC Name Minimum degree of purity Date of Expiry date Product
Common Name Specific conditions
Identification Numbers of the active substance(1) approval of approval type
Silver zinc zeolite IUPAC name: Silver 990 g/kg dry weight 1 March 29 2 (1) The authorisation of biocidal products containing silver zinc zeolite
zinc zeolite (zeolite, with the following 2026 February as an active substance is subject to the following conditions:
LTA(2)framework relevant impurities: 2036
(a) the product assessment shall pay particular attention to the
type, surface-modified arsenic and chromium,
exposures, the risks and the efficacy linked to any uses covered
with silver, zinc and each with a maximum
by an application for authorisation, but not addressed in the
ammonium ions) content of 40 mg/kg dry
Union level risk assessment of the active substance;
EC No: not assigned weight.
CAS No: (b) products shall not be authorised for treatment of non-textile
130328-20-0(3) 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.
ELI:
http://data.europa.eu/eli/reg_impl/2024/2635/oj
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ENIUPAC Name Minimum degree of purity Date of Expiry date Product
Common Name Specific conditions
Identification Numbers of the active substance(1) approval of approval type
(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.
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 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);
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4.10.2024IUPAC Name Minimum degree of purity Date of Expiry date Product
Common Name Specific conditions Identification Numbers of the active substance(1) approval of approval type
(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 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) 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.
ELI:
http://data.europa.eu/eli/reg_impl/2024/2635/oj
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ENIUPAC Name Minimum degree of purity Date of Expiry date Product
Common Name Specific conditions
Identification Numbers of the active substance(1) approval of approval type
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 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) 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.
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http://data.europa.eu/eli/reg_impl/2024/2635/oj
EN
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4.10.2024IUPAC Name Minimum degree of purity Date of Expiry date Product
Common Name Specific conditions Identification Numbers of the active substance(1) approval of approval type
(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;
(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.
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