The Israeli Ministry of Health has announced new drafts of regulations called “Pharmacists’ Regulations (Cosmetics)” that mirror the European Regulation on cosmetics.
The alignment process began in 2013, when Israel first notified the WTO of its intention to adjust its cosmetics marketing legislation with the European model for the purpose of lowering trade barriers in the country.
The new regulations brought significant changes on control of cosmetics in Israel in the past. The points below present the major novelties which appear to be closely related to the EC Regulation No. 1223/2009:
- Each cosmetic product should be linked to a responsible person who will be the legal entity responsible for the product;
- It becomes mandatory to perform a safety assessment from a suitable professional that covers all safety aspects of the cosmetic product;
- Prior to placing the cosmetic product on the market, the responsible person shall provide the Ministry of Health electronically the general information required for the basic control.
- A product information file (PIF) should be made readily accessible to the competent authority and should include data about the safety of the product;
- Cosmetic products placed on the market should be produced in accordance with Good Manufacturing Practice (GMP);
- The establishment of a National Cosmetics Poison Center which will hold full information about
- the cosmetic ingredients, including dosages;
- No person shall import into Israel a cosmetic unless the product has been granted a Certificate of Free Sale by a recognized country.
However, despite the mentioned similarities to the EU legislation, certain differences remain. These include the concept of parallel imports (Israeli companies can import same origin products without having the full product information file) as well as manufacturers of cosmetics with nanomaterial components who need to obtain marketing approval from an expert commission.