Cosmetics Product Registration and Submission in Israel

Strategic Guide to Cosmetics Registration and Notification in Israel

The Bottom Line for Cosmetics Manufacturers and Importers:
The Israeli cosmetics regulatory landscape underwent a historic shift on January 1, 2025. The traditional “Cosmetic Product License” system has been discontinued and replaced by the “What’s Good for Europe” reform. To market products in 2026 you must transition to the Notification Track, which requires the appointment of a Responsible Person (RP) based in Israel. This RP is legally accountable for the Product Information File (PIF) and safety assessments. While this reform accelerates market entry for EU-compliant products it places a significantly higher burden of liability and documentation on the local importer. Expert oversight is essential to ensure your PIF meets the rigorous post-market audit standards of the Ministry of Health.

The Department responsible for the safety and quality of cosmetics in the Israeli market is the Cosmetics and Toiletries Department of the Israeli Ministry of Health (IMOH). As a sub-department of the Pharmacy Department it oversees the licensing of businesses and the certification of products. Following the adoption of the European Directive (EC 1223/2009) the IMOH now operates a digitalized notification system.

Key Steps for Cosmetics Submission in 2026

Importers and manufacturers must follow a specific sequence of regulatory activities to ensure their products reach the shelves without legal delay:

Registration on the Dealers Registry — Every manufacturer, importer, and wholesaler must be registered as an authorized cosmetic dealer via the government identification system.
Appointment of a Responsible Person (RP) — You must appoint an Israeli resident to act as the RP. This individual is responsible for the safety, quality, and efficacy of the product and maintains the Product Information File (PIF).
Establishing a Qualified Importer Status — Importers seeking the “European Track” must manage an acceptable risk-management plan and assume full responsibility for the product’s safety.
Digital Marketing Notification — Instead of waiting months for a license the RP submits a digital notification. Marketing can often begin immediately after receiving the system confirmation.

Technical Requirements and Documentation

Under the new 2026 guidelines a “state of control” must be demonstrated through a comprehensive technical dossier. This dossier must be available for inspection at the RP’s address at all times.

Requirement	Details and Compliance Standards
Product Information File (PIF)	Must include the safety assessment, qualitative and quantitative formula, and GMP evidence.
Safety Assessment	Conducted by a qualified professional (Toxicologist/Pharmacist) proving the product is safe for human use.
GMP Certification	Self-declaration or certification of compliance with ISO 22716 standards.
Lab Testing	Microbiological, stability, and challenge tests must be performed by certified laboratories.
BSE/TSE Certificate	Required for products containing ingredients of animal origin to ensure they are free from bovine spongiform encephalopathy.

Labeling and Multi-Lingual Packaging

The text and graphics for the label and package must comply with strict Israeli standards.

While the reform allows for more flexibility the following language rules still apply:

Domestic Use — Labels and instructions must be provided in Hebrew, English, and Arabic.
Professional Use — Products intended for use solely within health facilities or professional salons may provide labeling in English only.

Exclusions and Sensitive Cosmetics

The simplified European Track does not apply to “Designated” or sensitive cosmetics. These products still require intensive review and specific licensing from the Ministry of Health. These categories include the following items:

Sun protection (SPF) products and sunless tanners
Products for infants and children up to age 12
Hair straightening products (specifically those formerly containing banned ingredients like Glyoxylic Acid)
Products for pregnant or breastfeeding women

Ongoing Post-Market Compliance

Registration is not a one-time event. The RP must continuously monitor and report any serious side effects to the Ministry of Health. Any changes to the product formulation, manufacturing site, or commercial name require an immediate update to the portal. Failure to maintain an accurate and active PIF can result in immediate market withdrawal and revocation of the dealer’s license.

Frequently Asked Questions

Is the old Cosmetic Product License still valid?
No. The licensing track was discontinued on December 31, 2024. All existing products must have been transitioned to the Notification Track by early 2025 to remain legally on the market.

What is a Certificate of Free Sale (CFS)?
A CFS is an official document from the country of origin stating the product is sold freely there. It is often required for exporting Israeli cosmetics to international markets or for certain import categories.

Can I act as my own Responsible Person?
If you are an Israeli resident or a corporation registered in Israel you can act as the RP. However many companies choose to outsource this role to regulatory experts to ensure the technical PIF and toxicological assessments are professionally managed.

Contact Eran Yona for Cosmetics Regulatory Support in Israel

Bio-Chem Ltd. provides end-to-end support for the new 2026 cosmetics reform.

From acting as your Responsible Person to preparing your PIF and managing notifications we ensure your brand enters the Israeli market safely and swiftly.