Israel: New regulation for cosmetics

 

The Israeli Ministry of Health announced New draft regulations called “Pharmacists’ Regulations (Cosmetics), 5783-2022.  The proposed regulations aim to establish requirements and instructions for cosmetic products, while setting high and professional requirements for the production, marketing, and import that will ensure the safety, quality, and efficiency of and the protection of public health.

The draft regulation is to be read jointly with the existing Pharmacists Order [New Version], 5741-1981.

The draft regulation deals among others with banned ingredients in cosmetics, restricted ingredients in cosmetics, colour additives permitted for use in cosmetics, preservatives permitted in cosmetics and UV filters permitted in cosmetics.

The regulations put forth a variety of guidelines and demands for those involved in the production, importation, and promotion of perfumes. This encompasses defining terms such as “batch” and “serious side effect,” outlining the necessary paperwork and details for registration with the perfumer registry, and specifying the processes related to production, storage, and distribution.

As per the suggested regulations, a qualified individual holding a medical license, a pharmacist license, or a degree in chemistry, toxicology, or life sciences must conduct a professional safety evaluation. These regulations also introduce extra prerequisites for the selection of a responsible representative.

Furthermore, the proposed rules recommend establishing a presumption of normalcy for test results regarding microbial content, yeasts, molds, and the absence of harmful bacteria in perfumes. Additionally, the regulations suggest enhancing the information provided in notices regarding the marketing of products containing nano components.

The text of the regulation can be accessed HERE.