Non-approval of silver zeolite for use in biocidal products
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The EU has not approved silver zeolite as an active substance for use in biocidal products
Commission Implementing Decision (EU) 2023/2648 of 27 November 2023 not approving silver zeolite as an existing active substance for use in biocidal products of product-type 4 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Update
Following an assessment by the European Chemicals Agency (ECHA), the EU has not approved silver zeolite for use in biocidal products. This substance is found in disinfectants used by food companies, and in food packaging. Suppliers of packaged food should avoid using products containing silver zeolite.
Impacted Products
disinfectants, food contact materials, food packaging
What is changing?
An application for the approval of silver zeolite in type-4 biocidal products has been rejected by the EU. Silver zeolite is used in food and feed area disinfectants, and incorporated into polymers used in food contact materials to reduce cross-contamination of pathogens. It will no longer be permitted in these products.
Why?
According to the ECHA, there is insufficient evidence of efficacy when incorporating silver zeolite into polymers used in food contact materials. There are concerns about potential risks to human health from eating food that has been in contact with these treated polymers.
Timeline
Silver zeolite is not approved as an active substance for use in type-4 biocidal products as from 17 December 2023.
Recommended Actions
To ensure compliant packaging and avoid risks of residues, suppliers of packaged food to the EU market must ensure that silver zeolite is not used in food processing or in food contact materials. If this substance is currently being used, alternative solutions should be explored.
The approval status of substances used in biocidal products can be checked on the ECHA Biocides database.
Suppliers must ensure that any residues in food comply with the maximum residue levels (MRLs) established for pesticides. These can be found in the EU Pesticide Residues database.
Background
Biocides are substances or mixtures that are used to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action.
Biocides are typically classified into four groups based on their intended use:
- disinfectants
- protective products
- products for the control of so-called "harmful" species
- other biocidal products.
Regulation (EU) 1062/2014 established a work programme for the systematic review of active substances contained in biocidal products and used at the time of the Regulation. Silver zeolite was one of those substances.
For further information on the EU’s regulation of biocides, see Biocides explained.
Resources
Regulation (EU) 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products
Joint EFSA-ECHA (2020) Comparison of the evaluations performed on silver compounds used as biocidal active substances in food contact materials.
European Chemicals Agency (ECHA) Biocides database.
EFSA (2020) The 2018 European Union report on pesticide residues in food. EFSA Journal 18(4): e06057.
Sources
Commission Implementing Decision (EU) 2023/2648 not approving silver zeolite as an existing active substance for use in biocidal products of product-type 4