Cosmetics Registration

Before starting to market regular or dedicated cosmetics in Israel, there is a need to undergo a registration process at the Ministry of health to check its safety and quality. At the end of the evaluation process of the cosmetic product at the Ministry of health an approval is obtained from the Ministry of health for its marketing. The registration activities accompany the cosmetic product also after the Ministry of health approval (License) for its marketing has been obtained and actually during its entire marketing period (life cycle) in Israel.

Our main goal is to verify that your cosmetics comply with the Ministry of health standards to ensure that a license for the regular or dedicated cosmetic is received quickly.

Blau Pharmaceutical Services will contribute to successfully marketing of your cosmetics by giving a comprehensive response to a variety of regulatory challenges during the lifecycle of your cosmetics.

Registration requirements of importers and manufacturers of cosmetics

The Ministry of Health is planning to start using the European directive for registration of cosmetics in the near future.
At this stage, importers and local manufacturers of cosmetics are required to act according to the Ministry of Health guidelines such as “Obtaining a license for cosmetics”, guidelines that were approved a long time ago.
The pharmacy department in the Ministry of Health and the Institute for Standardization and control of pharmaceuticals are central bodies of the Ministry of Health that deal with registration of cosmetics in Israel.
It is important to know what the regulatory challenges you will be required to comply with are in order to market a cosmetic in Israel:
  • Determining the order of the activities required for submitting a request for a license for a new cosmetic product
  • Obtaining a general license for cosmetics
  • Obtaining a license for marketing a new cosmetic
  • Renewal of a license of a regular cosmetic as opposed to a dedicated cosmetic
  • Manner of conduct when dealing with the Ministry of Health when adding a commercial name or variation for a cosmetic product
  • Preparation of text for the label / package of the cosmetic product, graphic preparation and printing of the label / package
  • Types of laboratory tests required for registration of a cosmetic product and authorised laboratories for conducting these tests
  • Obtaining a certificate for free sale for exporting the cosmetic product
  • Obtaining a BSE certificate
  • Ongoing reporting of side effects as a result of the cosmetics
  • Organized maintenance of cosmetics licenses including regular contact with the manufacturer and updating the Ministry of Health of any changes in the license

Our services for Registration of regular and dedicated cosmetics

Peter Blau, a graduate of the department of drug registration at the Ministry of Health and his devoted staff of Blau Pharmaceutical Services offer you the following solutions in order to comply with the complex requirements of the Ministry of Health.
Blau Pharmaceutical Services obtain licenses that will enable you to quickly market your cosmetics, and to handle the maintenance of marketing approvals (licenses) in the best manner:
  • Regularly or temporarily handling of the registration of cosmetics
  • Handling the request for registration to receive a general cosmetics license
  • Analytical testing at a recognized laboratory before submission of the request for registration of a cosmetic
  • Submitting requests for registration of a new regular or dedicated cosmetic
  • Submitting requests for parallel import of cosmetics
  • Submitting requests for variations/updates in the registration of regular or dedicated cosmetics
  • Keeping track in an efficient and professional manner after the progress of the above mentioned activities up to obtaining the approval from the Ministry of Health
  • Preparation of labels, packages and leaflets, including ongoing handling of updates
  • Consultation regarding classification of products for registration purposes such as regular cosmetic vs dedicated cosmetic, cosmetic verus medicine
  • Obtaining a certificate for free sale (CFS) and a BSE certificate
  • Translation and graphic design of promotional materials and marketing materials including printing
  • Reporting and monitoring side effects due to use of the cosmetic
  • Ongoing updates regarding regulatory changes in Israel and internationally

In conclusion, due to the professionalism, the profound familiarity with the requirements of the Ministry of Health, the close working relationship with authorities and proven management that enables dealing with many regulatory projects in parallel, customers of our company have increased the amount of cosmetics sold.

Cosmetic – Basic terms

Regular cosmetic – A product intended for treatment, beauty, cleaning, coloring, change or improvement of the facial skin, body skin, hair, mouth, nails or teeth. According to the law in the state of Israel, manufacturing, importing or marketing of a cosmetic is prohibited unless licensed by the Ministry of health. The license is obtained following the relevant test and according to the relevant procedure of the Ministry of health.
Dedicated cosmetic – A cosmetic that is one of the following:
    a.Intended for highlighting the skin, protection against the sun radiation, prevention of sweating, treatment of wrinkles, slowing of skin aging or dandruff treatment
    b.Comes in contact with external genitals, body mucus or the mouth
    c.Hypoallergenic cosmetic or cosmetic for use on sensitive skin
    d.Non- comedogenic cosmetic: does not cause blockage of the skin pores and creation of blackheads
    e.No-tears cosmetic
    f.Cosmetic containing ingredients derived from animals, microorganisms or using a bio-technology process
CFS – Certificate of free sale – An approval from the official authorities declaring that the cosmetic is imported and sold freely in the manufacturing country of origin.
This approval is also given by the Ministry of Health for products exported abroad. A company that designates its products for export requires a CFS since the country that will receive the products is interested to know that these products have an Israeli license from the Ministry of Health that are sold freely in Israel.
BSE certificate (Bovine Spongiform Encephalopathy) –
Countries that require a declaration that the cosmetic does not contain animal derived ingredients require a BSE/TSE certificate in addition to the certificate of free sale.
BSE or in its common name Mad cow disease, is a cattle disease that when transferred to humans causes Creutzfeldt–Jakob disease (CJD). This is one of the only diseases caused by proteins that due to a defect in their conformation create amyloid residue. This is a toxic residue that causes neuron mortality and as a result forms voids in the brain tissue until it is spongy. This is an incurable disease that causes death within a few months from the appearance of the first symptoms.
Variation in the license of a cosmetic – Every variation in the conditions of which the Ministry of Health approved a license such as:
– Change in the text on the label
– Change of packaging
– Change of the composition of the product
– Additional claim
– Additional toning
– Additional name