2021-05-25T09:52:03+00:00March 14th, 2021|

Guidelines for the process of cosmetics registration/submission in Israel

The Department that is responsible to assure the safety and quality of cosmetics products for the Israeli market is the Cosmetics and Toiletries department of the Israeli Ministry of Health. It is a sub-department in the pharmacy department and the Institute for Standardization (IFS). It is the department licensing cosmetics and certifying products in Israel.


The Israeli Ministry of Health is based on the European directive for registration of cosmetics and importers and manufacturers of cosmetics must follow the Israeli Ministry of Health’s current regulatory guidelines.


Cosmetics product registration and submission in Israel

Our services

Cosmetics product registration and submission in Israel - Bio Chem
Cosmetics product registration and submission in Israel - Bio Chem
Cosmetics product registration and submission in Israel - Bio Chem
Cosmetics product registration and submission in Israel - Bio Chem
Cosmetics product registration and submission in Israel - Bio Chem
Cosmetics product registration and submission in Israel - Bio Chem


Steps, challenges, and requirements for cosmetics registration in Israel

Part of the regulatory requirements for cosmetics products submission in Israel is listed below:

  • After the exact order of activity was determined as required by the Israeli Ministry of Health, a request must be submitted for a license of a new cosmetic product
  • Obtain a general license for cosmetic products
  • Obtain a license for marketing a new cosmetic product or renew the licenses of a pre-marketed cosmetics product in another country
  • The text and graphics for the label and package of the cosmetics products should be arranged and submitted for printing. In the case the products are intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic. In the case the product is intended for professional use only within health facilities, the labeling and instructions for use may only be in English.
  • Determine what kind of laboratory tests are required and complete the relevant tests by certified laboratories
  • Obtain a certificate of free sale for exporting the cosmetic product
  • Obtain a BSE certificate if required by the products
  • Side effects must be continuously reported
  • Maintain the cosmetics licenses and keep track of the process
  • Update the Israeli Ministry of Health of any changes of the licenses or a licensed product

    לפרטים נוספים

    For further details

    Research and development

    Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.

    read more

    Design and engineering

    Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.

    read more

    Manufacture and packaging

    Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.

    read more

    GxP, quality and validation

    Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until  a successful audit outcome is obtained.

    read more

    Regulation and registration

    Regulatory consulting and drug registration,  medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval  (marketing authorization) is received.

    read more

    Software and systems

    Digital healthcare consulting, software development and medical applications in accordance with US  FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.

    read more

    Eran Yona Bio-Chem Founder and CEO

    Bio-Chem has been advising biomedical companies for more than 15 years.

    Contact us for cosmetics registration consulting
    To get in touch, Click here Or email us: [email protected]


    Articles we wrote for your use

    Validation for ERP Priority and SAP systems at Pharma and Medical companies

    מהי ולידציה למערכות ERP פריוריטי? מערכת ERP היא מערכת ממוחשבת לתכנון משאבי הארגון והיא נמצאת בשימוש כמעט בכל העסקים והארגונים הבינוניים והגדולים בעולם, אך גם בשימוש של חברות קטנות Read More >>>

    More articles for you

    Contact us