The New EU Regulation 1223/2009

The cosmetic regulation 1223/2009 was established to strengthen the safety of all cosmetic products, and it provides guidelines for all the operators in the sector. The regulation 1223/2009 repeals Directive 76/768/EC, which was established in 1976 and has been subject to numerous revisions. The regulation takes into consideration, modern technological advancements such as the use of nanomaterials while reinforcing product safety. However, the subsisting ban on animal testing was not modified.

Some of the significant changes introduced by Regulation 1223/2009 are;

Enhanced safety requirements for all cosmetic products

The manufacturers of cosmetic products must follow the requirements and also provide a safety report on the product before placing the product on the market.

The introduction of the term “responsible person.”

The cosmetic responsible person is designated as a Legal or natural person from the EU to ensure that all the laid down procedure is followed carefully before the cosmetic product can be put on the EU market. This cosmetic responsible person must be identified, and their obligations are explicitly stated.

Centralized and compulsory notification of any cosmetic product to be introduced into the EU market

All manufacturers of cosmetic products must notify the EU of their product and such notification must be passed through the cosmetic products notification portal.

Reporting of any serious undesirable effects

The cosmetic responsible person must monitor cosmetic products which have already been introduced into the market for any reports of undesirable side effects. This report must be directed to the national authorities, who will, in turn, collect more information from users of the cosmetic product and other health professionals and then this information will be passed to other EU countries.

Rules relating to the use of nanomaterials in all cosmetic products.

Regulation 1223/2009 provides new rules relating to the use of nanomaterials in all cosmetic products. Nanomaterials such as preservatives, colorants and UV-filters cannot be used in cosmetic products unless they are authorized. Other nanomaterials which are not on the restriction list may be used after a full safety assessment from the EU. Also, nanomaterial must be explicitly stated on the product with the exact words “Nano” in a bracket following the name of the Nano substance. For example, “Titanium dioxide” (Nano).

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The duties of the responsible person

The cosmetic responsible person is usually mandated by the manufacturer of the product within the community or the manufacturer of the product. The responsible person can also be the importer or a person appointed by the importer or the distributor of the cosmetic products.

The cosmetic responsible person is responsible for the safety assessment to ensure that the cosmetic product is safe for use on humans. The responsible person also has the duty of presenting the product, labeling the product, preparing the instructions on how to use and dispose of the product.

The responsible person must also monitor the cosmetic products after their entry into the market and take all necessary measures to withdraw the cosmetic product from the market if it is defective or produces undesirable results on the users of the product.

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