New Israel Cosmetic Regulation & Import Policy

New Israel Cosmetic Regulations

On 18 October 2021, Israel Economics Committee has held a meeting that discussed and approved a new regulatory and importing policy for cosmetic products. A new cosmetic regulation is part of the government’s overall import reform defined in the Arrangements Bill, which includes importing consumer goods and food products. The change in the registration process and import may have a far-reaching implication for the cosmetic market in Israel. The lawgiver intended to reduce the existing regulatory burden during the cosmetic registration process, shorten registration timelines, and encourage more cosmetics to enter the Israeli market.

The registration of cosmetics is necessary for anyone who intends to import and market cosmetic products in Israel. Now, according to a new Israeli law which is expected to be implemented by the end of 2022, the registration process will now be significantly simplified. The product license (approval), managed by the Israel Ministry of Health (MoH), will now be replaced by the notification process so that the product registration becomes immediate. The responsible representative representing the manufacturer or importer in front of the MoH will register a cosmetic license or renewal online. 

What is a Cosmetic Product?

A cosmetic is “a product used or intended to be used for the treatment, beautification, cleansing, coloring, alteration or improvement of facial skin, body skin, hair, oral cavity, nails or teeth, including products such as these.”

The cosmetic products in Israel are expected to meet European requirements for quality and safety as per Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009 on Cosmetic Products. A person must not attribute to the cosmetic a virtue of healing the body or one of its organs or systems or of preventing disease, its healing, relief, or assistance in dealing with it or its symptoms nor it will attribute to the product characteristics or features which it does not have, by way of marking or advertising.

Responsible Representative

As the first step in a new cosmetic regulatory process, a manufacturer or importer of the cosmetic product must appoint in writing a Responsible Representative in Israel.  A Responsible Representative must have relevant experience and the knowledge of new cosmetic regulations and product claims, quality, and safety requirements to perform this function as expected. According to the new cosmetic regulation in Israel, a responsible representative has a central role in registration and therefore a proper selection of this person is crucial for successful cosmetic registration in Israel.

Cosmetic Dossier

According to new Israel cosmetic regulations, a cosmetic product could be marketed in Israel only if the responsible representative has available all the product-related documentation listed below, in Hebrew or English:

• Evidence-based support for the marketing claims attributed to cosmetics on the cosmetics label
• The cosmetics manufacturer declaration that no animal experiments were performed during the product development process; if such experiments were performed – data on the experiments should be available
• A photo of the cosmetic packaging in a way that will allow identification of the cosmetic
• Cosmetic safety assessment report
• Description of the stages of the cosmetic production process

The responsible representative will hold the cosmetics dossier electronically or in a hard copy at his address in Israel for ten years from the marketing date of the last product batch. The cosmetic dossier will be available for inspection by the MoH to supervise and control the cosmetics.

Marketing Notification Procedure 

Under a new regulatory regime, a product registration approval process and a manufacturer product license are replaced by the notification procedure. As a result, the product registration fee for the Ministry of Health will be canceled.

As for now, the new reform only deals with the products such as soap, shampoo, body lotion, and deodorant (non-sensitive cosmetics). Sensitive cosmetics such as products for babies and children (up to the age of 12), sunscreen, products for the mouth and eyes, cosmetics that contain a nano-component, and those for use by pregnant women are not included in the notification procedure the initial stage of implementation. These products will still need product approval issued by the MoH as before. However, if a new process is successful, more product types will be gradually added to the new procedure.

A marketing notification will be delivered online by the responsible representative and will contain all of the following info:

• Manufacturer name
• The full name of the cosmetic in Hebrew and English
• The cosmetic type
• Name of the responsible representative, his address, and contact details;
• Addresses of cosmetic production site(s)
• The common name of each of the cosmetic ingredients
• The purpose of use of the cosmetic as defined by the manufacturer
• Instructions for the use of cosmetics as defined by the manufacturer
• The target population for cosmetic use as defined by the manufacturer
• The texture of the cosmetics
• A photo of the cosmetic packaging in a way that will allow identification of the cosmetic
• The details appearing on the cosmetic label and a photo thereof
• Dimensions of cosmetics

Immediately following notification, a marketing notice will be issued to the responsible representative via an automatic online system established by MoH. A receipt of the marketing notification in the online system shall be deemed to be an import permit for customs purposes. A marketing notice for some products containing nano components shall be given by the MoH within six months from the date of submission of the marketing notification. During this period, MoH may also refuse to register such products. 

Parallel Import – New Cosmetic Import Policy

The cosmetics market in Israel is assessed to be NIS 4 billion a year. Utilizing parallel import, the public in Israel is expected to save NIS 600 million a year, which reflects a discount of about 15% on cosmetics.

According to the new Israel cosmetic importing policy, an importer will be eligible to import cosmetic products through a “parallel import” process except for sensitive cosmetics. 

Parallel import means – an import that is not within a direct relationship between the importer and the manufacturer. That is an import made by a non-importer who imports the cosmetics under an agreement with the manufacturer based on similarity to the reference cosmetic product issued by the approved laboratory. A reference cosmetic is a product that is already marketed in Israel and whose name has been published on the official Israel Ministry of Health website.

Products Included in the Parallel Import 

There are 15 types of cosmetics currently included in the parallel import route: 

• Aftershave
• Roll-on deodorant without aluminum
• Deodorant stick without aluminum
• Compressed powder
• Compressed blush (rouge)
• Compressed shimmer
• Hair softener
• Body soap
• Body cream
• Hand cream
• Hair cream
• Foot cream without salicylic acid
• Nail polish (other than gel)
• Foot wax
• Shampoo

MoH could expand this list n the future.

 

Testing Requirements for the Parallel Import

To confirm safety and prove the similarity of the imported cosmetics and the reference product, the importer must perform the following tests with the Standards Institute of Israel (SII) or another certified laboratory that is a member of the ILAC – International Laboratory Accreditation Cooperation:

• Microbial load, per the limits set in the standard ISO 17516 (Cosmetics — Microbiology — Microbiological limits)
• Absence of yeast and molds per the limits outlined in the ISO 17516
• Absence of pathogenic bacteria: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans according to the limits outlined in the ISO 17516
• Comparison between the value of the pH in the imported cosmetics and the value stated in the reference cosmetics
• Absence of salicylic acid in a concentration exceeding 2%
• Absence of formaldehyde
• In cosmetics packaged from any pressure or any aerosol – closure tightness test
• In cosmetics containing alcohol – the methanol concentration must not exceed 0.2%
• In cosmetics, which is a makeup product – the lead concentration must not exceed 5 PPM

Comparison Between the Importer & Reference Product Labeling 

Besides the laboratory testing, the approved laboratory must compare the imported and reference product labeling to establish similarity in all of the following:

• Manufacturer’s cosmetic name and cosmetic name
• Cosmetic ingredients, both in the names of the ingredients and in the order in which they appear on the label
• The texture and color of the cosmetics
• Type of packaging and instructions for the use of cosmetics
• The period of product use after opening, insofar as it is stated on the reference cosmetic or its packaging
• The purpose of using the cosmetics, insofar as it is stated on the reference cosmetics or its packaging
• The imported cosmetics are manufactured at most 24 months before the purchase (import)

Further, the following statement must be available:

• The importer purchased the cosmetics from a supplier in Europe whose primary business is marketing cosmetics or consumer products; In such a declaration, the importer shall declare the name and address of the supplier;
• That the imported cosmetic is manufactured at most 24 months before purchase
• The cosmetic is safe to use and the batch of that cosmetic has not been taken off the shelves or proactively returned from marketing
• There is an identity between the reference cosmetics and the imported cosmetics;

In addition, one of those must be available:

• Free Sale Certificate in a recognized country;
• Sales invoice to a retailer in a known country or a retailer in a known country;
• Certificate of delivery to a retailer in a recognized country;

The responsible representative shall keep all documents and details submitted to the approved laboratory to obtain a certificate of conformity by the laboratory. All documentation should be kept for a period not less than seven years from the date of release of the last shipment of cosmetics imported under the parallel import from customs.

Parallel Import Labelling

According to the new Israel Cosmetic Regulation, cosmetics imported via the parallel import pathway shall be marked with the special labeling, which shall be displayed prominently on the cosmetic packaging: “Cosmetic in parallel import which has been inspected by the Standards Institute or another approved laboratory.”

Marketing Notification Procedure 

The certified laboratory will submit the notice of receipt of a conformity certificate to the MoH online. Upon submission, the importer (its responsible representative) will automatically receive a receipt notice in the online system. A certificate of receipt of notice shall be deemed to be an import permit for the matter to the customs.

BioReg Services

BioReg Services is fully prepared to guide your company through new Israel cosmetic regulations and act as your responsible representative. We will accompany you throughout the entire registration process to ensure your cosmetic products will reach the Israeli market in expedited time. In addition to regulatory service, we can perform import and storage for your products. 

To visit our company website and inquire about additional regulatory services – Click here

For any questions, don’t hesitate to contact me directly: daniel.albahari@bioregservices.com

BioRegards,

Daniel