Applicable legislation

Cosmetics sold in Israel are regulated by the Ministry of Health (MoH), which controls production and distribution. Cosmetic products placed in the Israeli market are pre-market registered and must comply with Pharmacists Provisions and the Ministry of Health Standards for registration and licensing.

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What type of products are cosmetics?

The definition of cosmetic products in Israel is the same as the EU definition: “cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.

Cosmetic products are divided into two categories:

  1. Regular product– which includes most products.
  2. Designated product – which includes products with specific claims such as antiperspirants, Anti-Dandruff, Oral care, Skin bleaching, Sun protectors, Hypoallergenic, Ophthalmologically tested, Non-Comedogenic, products for sensitive skin, No tears.

** Baby products although considered as regular products will require extra documentation.

Requirements

In Israel, cosmetic products can be placed in the Israeli market only after being granted a license by the Ministry of Health. A product license is valid for 5 years.

For the registration process, an electronic file is submitted to MoH. In addition, a hard copy of formula, product specification, GMP certificate, Certificate of Free Sale, lab analyses and clinical test report, some relevant declarations, such as non-animal testing, conformity of packaging etc. as well as the product itself are submitted.  Safety Assessment report is required for unique products such as hair straighteners, artificial nail building products, baby products and whenever new ingredients are found in the formula. After 2-3 months the license is reviewed, and if approved, a license is granted.

Approved ingredients, prohibited substances, restricted substances, allowed dyes/pigments, preservatives an UV filters in use in the formulas are quite similar to the EU Regulation. However, the lists are not exactly the same and not every ingredient that is approved for use in the EU is approved in the Israeli market.

Cosmetic product labels must conform to the approved license label, and any claim which does not comply with the definition of cosmetics is not allowed.

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Services offered

  • Product classification
  • Formula review to ensure compliance with the Israeli legislation
  • Labelling review
  • Safety assessment (CPSR)
  • Pre-market product registration
  • Label translation to Hebrew

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