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Requirements for cosmetic products on the EU market are regulated by Regulation No. 1223/2009
According to the Regulation, cosmetic products containing certain substances are prohibited from placing on the EU market, namely:
Colouring substances, preservatives and UV filters permitted for use as ingredients in cosmetic products are listed in Annex IV, Annex V and Annex VI to the Regulation respectively.
The use of substances that are carcinogenic, mutagenic or toxic to reproductive health is prohibited, except in exceptional cases.
The Regulation prohibits the placing on the EU market of cosmetic products whose final composition or ingredients have been subject to animal testing, except in exceptional circumstances.
Cosmetic products may only be sold on the EU market if the following information is provided on the cosmetic container and packaging in indelible, legible and clearly visible type:
1. Name and address of the responsible person. For imported cosmetics, the country of origin must be indicated.
2. Nominal content at the time of packaging, expressed by weight or volume
3. The minimum use-by date indicated after the symbol specified in point 3 of Annex VII or the phrase “Best used before the end of”. This requirement is not mandatory for products with a minimum shelf life of more than 30 months, for which the period after opening during which the product can be used without risk to the consumer must be indicated. This information should be indicated by the symbol given in point 2 of Annex VII, preceding the period.
4. Special precautions for use
5. Production batch number or reference information for product identification. If the size of the products is too small, this information may be placed only on the secondary packaging
6. Purpose of the product.
7. List of ingredients that may be indicated on the packaging under the heading “Ingredients”. For this purpose, the European Commission adopted the International Nomenclature for Cosmetic Ingredients by its Decision No. 96/335/EC.
If it is not possible to place the required information from points 4 and 7 on the packaging due to its size or shape, it may be provided on a leaflet, label, tape or card attached to the product. In such a case, the abbreviation or symbol specified in paragraph 1 of Annex VII shall be used to refer to the information.
Prior to placing imported cosmetic products on the EU market, the responsible person must notify the European Commission via the EU Cosmetic Products Notification Portal (CPNP) of the following information
See the requirements for cosmetics in the USA on the website – The Food and Drug Administration
Registration / re-registration of medicinal products
Certification, declaration of medical devices
Certification of Ukrainian medical devices in Europe
Registration/legalization of cosmetic products
Registration/legalization of Ukrainian cosmetics in Europe and the USA
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