TAGS: Perfumes & Fragrances Decorative Cosmetic
The European Commission has asked the SCCS (Scientific Committee on Consumer Safety) to carry out a safety assessment on Silver Zinc Zeolite when used as a preservative in cosmetic products.
Used for Antimicrobial Effects
Silver Zinc Zeolite (SZZ) (CAS No. 130328-20-0, EC No. 603-404-0) with INCI name ‘Ammonium Silver Zinc Aluminium Silicate’ is included in the European database for information on cosmetic substances and ingredients (CosIng) with the reported functions of ‘absorbent’, ‘deodorant’ and ‘preservative’.
SZZ is used for the antimicrobial effects exerted by the silver ions released. Silver ions may interact with the cell membrane of microorganisms and the electron transport processes, bind to nucleic acids, inhibit enzymes and catalyze the formation of free radical oxygen species (ROS). Generally, the antimicrobial effect depends on how much of the silver is released.
In December 2015, the Risk Assessment Committee (RAC) of ECHA issued an Opinion recommending a ‘Toxic for reproduction Category 2’ classification (i.e., suspected of damaging the unborn) for Silver Zinc Zeolite.
In May 2017, the Commission Regulation No. 2017/776 was amended for the purposes of its adaptation to technical and scientific progress- Regulation No. 1272/2008 of the European Parliament and of the Council on classification, labeling, and packaging of substances and mixtures (CLP Regulation).
In particular, a new entry in Annex VI to the CLP Regulation was added for ‘Silver Zinc Zeolite (Zeolite, LTA framework type, surface-modified with silver and zinc ions) [This entry covers LTA (Linde Type A) framework type zeolite which has been surface-modified with both silver and zinc ions at contents Ag+ 0,5 %-6 %, Zn2 + 5 %-16 %, and potentially with phosphorus, NH4+, Mg2+ and/or Ca2+ each at level < 3 %]’.
Raised Concerns to Human Health & Environment
In May 2019, the Commission Regulation No. 2019/831 amended Annexes II, III, and V to Regulation (EC) No. 1223/2009 (Cosmetics Regulation) following the provisions of Article 15 on CMR substances, and the substance Silver Zinc Zeolite was added in entry 1597 of Annex II as a prohibited substance in cosmetic products.
In August 2020, the Commission services received a dossier submitted by the industry to support the safety assessment of SZZ as a preservative in cosmetic products, in particular in spray deodorant and powder foundation. A positive outcome of this assessment may support the delisting of SZZ from Annex II and its inclusion under Annex V to the Cosmetics Regulation as an authorized preservative.
In March 2021, the Biocidal Products Committee (BPC) published their Opinion on the application for approval of the active substance Silver zinc zeolite. The overall conclusion of the BPC was that SZZ in product type (PT) 4 may not be approved. More specifically, according to the Committee, the criteria laid down in point (b)(iii) of Article 19(1) of Regulation No. 528/2012 were not met. The active substance did not fulfill the criteria according to Article 28(2) to enable inclusion in Annex I of Regulation No. 528/2012. SZZ raised concerns for human health and the environment (Repr. 2, Skin Irrit. 2, Eye Dam. 1 and as Aquatic acute 1).
In light of the information provided, the Commission requested the SCCS to carry out a safety assessment on Silver Zinc Zeolite when used as a preservative in cosmetic products.
Source: European Commission
