The Israeli Ministry of Health has consulted on a draft amendment to the Pharmacists’ Notice on cosmetics, proposing updates to align national requirements with recent changes to the EU cosmetics framework set out in Regulation (EC) No 1223/2009.
The draft amendment, titled Pharmacists' Notice (Application of Changes to the Annex to the European Union Directives) (Regulation 1223/2009 – Cosmetics) (Amendment), expands the scope of existing rules and incorporates updates affecting cosmetic ingredients, safety limits, and labelling requirements.
The proposed notice formally extends the application of EU cosmetic standards in Israel, now explicitly covering Annexes II to V of the EU regulation, which govern prohibited substances, restricted ingredients, and approved preservatives.
Key Substance Updates
The draft introduces changes reflecting a draft EU amendment, which sets stricter controls on several widely used cosmetic ingredients.
The most significant changes of these is the complete prohibition of triphenyl phosphate (CAS No. 115-86-6), which has been added to the list of banned substances in Annex II. Additionally, the substance silver zinc zeolite (CAS No. 130328-20-0) will remain generally prohibited, but will be permitted under tightly controlled conditions as a preservative in specific product categories.
The amendment also imposes new restrictions on ingredients under Annex III, including fragrance allergens such as benzyl salicylate (CAS No. 118-58-1) and citral (CAS No. 5392-40-5). These substances will now be subject to stricter concentration limits and enhanced labelling requirements. Water-soluble zinc salts will be subject to different rules depending on the product type, particularly for oral care products and children’s use.
Furthermore, the regulation introduces maximum allowable concentrations for aluminum-containing compounds, which vary by product category such as sprays, leave-on cosmetics, and makeup products. Acetylated Vetiver Oil (CAS No. 84082-84-2) will also be restricted, with requirements for stabilization and controlled usage levels.
Several new substances in the hair dye category, including HC Blue 18, HC Yellow 16, HC Red 18, and hydroxypropyl-p-phenylenediamine (CAS No. 73793-79-0), are now regulated with clearly defined safety limits, usage conditions, and mandatory warnings.
The amendment also updates Annex V by allowing the use of a specific silver-based preservative (ammonium silver zinc aluminum silicate, CAS No. 130328-20-0) in limited applications such as spray deodorants and makeup powders, capped at a maximum concentration of 1%.
Additionally, updates to Annex VI introduce impurity limits for UV filter ingredients, including a cap on contamination levels in diethylamino hydroxybenzoyl hexyl benzoate (DHHB, CAS No. 302776-68-7).
Entry into Force and Transitional Measures
The EU amendment referenced in this draft will enter into force 20 days after its publication in the Official Journal of the European Union. However, transitional provisions provide phased compliance deadlines:
Notably, Israel imposes a stricter approach: once the update takes effect locally, non-compliant cosmetics cannot continue to be marketed, even during the transitional periods allowed for in the EU.
Conclusion
The draft reflects Israel’s approach of aligning with EU cosmetic safety standards, while,applying stricter enforcement timelines in some cases. Manufacturers, importers, and distributors will need to review product formulations, labelling, and compliance strategies in order to meet the new requirements ahead of the 2027–2028 deadlines.
