Cosmetic Products Registration in Israel in order to Obtain Ministry of Health Licenses and Preparation of Product Information Files for the European Market

Indeed, the new law was approved and published at the end of 2016 and is apparently scheduled to take effect in late June 2016 or no later than late September 2016. You will not have to submit applications for pre-market registration and will not have to wait long for licenses, but you will definitely have to appoint a Responsible Person. This representative will prepare and maintain detailed and accurate Product Information Files and will notify the authorities when the products are ready to be placed on the market. Of course, you will be expected to audits of your files and products by the health authorities at all times.

The Ministry Of Health website has a search page for registered cosmetic products; it is possible to search by name (in English or Hebrew) and also by the importer/producer of the product. Information on the license number and expiration date is available.

Any business that imports, stores and markets cosmetics in Israel requires a General Cosmetic License. This license is given by the county pharmacist on the basis of the business license that is given by the city council.

You can register cosmetic products only after obtaining a general cosmetic license.

It is possible to use a general cosmetic license to a third party, but in this case the license will be listed in the name of the third party.

There is also a general cosmetic license for production. All details are available in the Ministry of Health website.

It is allowed to import few samples of every product, as long as it is not a commercial quantity. It is important to make sure that the shipment and the bill is addressed to the company or someone in possession, as indicated in the general cosmetic license for import so the samples would be released from customs.

A GMP is a certificate of Good Manufacturing Practice that approves certain conditions at the production site and the compliance with certain quality standards. When registering an imported product from a new production site that has not been approved in Israel – a GMP is required.

Also, when registering a designated product (with a claim) – a GMP is required.

The ISO 22716: GMP is accepted by the Ministry of Health and it is required that the GMP be issued by the Ministry of Health in the country of origin or by organizations that are approved by the Israeli Ministry of Health.

A self-stated GMP or a GMP issued by private organizations or by the Chamber of Commerce are not acceptable in Israel.

Initially the following documents are required:

  • A formula containing the exact percentage of every INCI ingredient; this formula must bear the company logo and be signed by the manufacturer.

  • Name of manufacturer; In case it is an imported product a GMP is required, the GMP should state the name and address of the manufacturer.

  •  A declaration of no animal testing.

  • The rest of the documents are required while preparing the Product File for the Ministry of Health.

It is also required to send 2 samples of each product intended for licensing.

A re-formulation request should be submitted to the Ministry of Health. It is a new registration request, the formula will be compared to the old formula and in some cases a new lab test would be required. There is no fee for re-formulation requests.

If the base formulation is the same except the Color/Aroma/Fragrance, the shades can be included in the same license. In some cases the shades differ greatly in their composition – in which case they will not be allowed to be registered under one license.

The chemical formulation must be identical, and the manufacturer must provide a Private Label statement in one of the following ways:

  • A general statement, signed by one of the governmental bodies approved by the Israeli Ministry of Health that stated that the products are manufactured in the same production site, under the same production conditions and are sold in the country of origin.

  • A specific statement concerning the products of interest, signed by the manufacturer and listing already-marketed-products with the same formula.

At this point there is no need to register perfumes as cosmetics.

Most licenses have a 5 year validity. In some cases the Ministry of Health will provide a license for a different time period, such as one year, and toward the end of this period, a request for prolonging the expiry date should be submitted, without additional payment.

  • Special unique products that have no similarities (name, formula or claims) in the Ministry of Health database.

  • Nail building, Hair straightening, Hair fiber products.

  • Baby products.

  • Products that have an ingredient that is not listed in the Ministry of Health database of ingredients or that its concentration is above the approved concentration that is indicated in the database based on a previous Safety Assessment Report.

A product that has a claim, such as: SPF, hypo-allergenic, optomologically tested, for sensitive skin,

tear-less, skin whitening. Other products, such as products for babies are considered designated as well. The registration process is similar to a regular product but certain additional documents are required: a GMP, Free sale certificate, Product specification, Encoding system and in some cases a test report to support the product’s claim.

It is forbidden to write descriptions that indicate a physiological intervention of the product (such as “Regenerates Collagen”), names of diseases and any phrasing that gives the product a medical property.

For example, the following cannot be written on a product: anti-inflammatory or anti-microbial, Psoriasis and Acne.

Marketing of the product, or production (if it’s Israeli) is forbidden until a license is obtained from the Ministry of Health.

It is not recommended to do so, since with the submission of the product for registration we make an offer for a label. While granting the license, the Ministry of Health approves the label, but it is susceptible to changes (some claims may be removed or added). Only upon receiving the license and approval of the label is it recommended to produce the packaging or the stickers.

The label will contain the following details:

  • The name of the product in English and Hebrew.

  •  Free style text that should be pre-approved by the Ministry of Health.

  • Purpose of use – if not clear from the product name.

  • Instruction of use.

  • Name of the Manufacturer/Importer/Marketer and the address.

  • Listing of the ingredients by INCI name in descending order of percentage in the formula.

  • Warnings and restrictions.

  • Period After Opening or Expiration Date.

  • Content (gr or ml)

Pre-Market
Cosmetics Registration
 to Receive Ministry
of Health Licenses

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Preparation of
Product Information Files
for the 
European Market
 

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