PharmaLex | Regulations for the Cosmetic Products Industry

Regulation (EC) No. 1223/2009 is the primary legislation governing the cosmetics products industry in Europe. First published in the Official Journal of the European Union, Volume 52, on the 22 December 2009, it has been applied in full since 11 July 2013. The purpose of this cosmetics Regulation is to safeguard public health, with due regard to animal welfare, and to harmonise the rules in the European Economic Area (EEA) in order to achieve a single market for cosmetic products.

A ‘cosmetic product’ is any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Only cosmetic products for which a legal or natural person is designated within the Community as ‘Responsible Person’ (RP), shall be placed on the market as per Article 4 of Regulation (EC) No. 1223/2009. The RP may be the manufacturer, importer or person to whose order a cosmetic product is manufactured. The RP can be an individual or a legally registered company, must be based within the EEA and is responsible for the safety of the product which includes ensuring the product has undergone a safety assessment. The address of the RP should appear on the cosmetic labelling and would normally be the manufacturer or, where the manufacturer is based outside the EEA, the importer. The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept the responsibility in writing.

The RP must review all the requirements outlined in Regulation No. 1223/2009 against their procedures and amend them accordingly. Before placing a cosmetic product on the market in the EEA, the RP must ensure that the cosmetic product is safe for use and meets the requirements of Regulation (EC) No. 1223/2009. The name and address of the RP must be on the label of the cosmetic product and in the Product Information File (PIF). A cosmetic product does not require approval or a licence before being placed on the market, and the PIF must be available at the address on the label.

For each cosmetic product placed on the market, the responsible person must ensure compliance with the following as set out in Regulation (EC) No. 1223/2009:

Adherence to the RP requirements as stipulated in per Article 4.
Notification to CPNP (Cosmetic Product Notification Portal) as per Article 13.
Include a Cosmetic Product Safety Report (CPSR) ensuring that the cosmetic product has undergone a safety assessment and a cosmetic product safety report is available.
Provision of the Product Information File (PIF) as per Article 11. This file must be available by the RP at the address displayed on the label of the cosmetic product.
Labelling as per Article 19.
Adherence to Claims as per Regulation (EU) 655/2013.

A distributor is a natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.

The obligations of the distributors as per Regulation (EC) No. 1223/2009 are as follows:

Ensure labelling requirements as per Article 19.
Confirm traceability within the supply chain.
Ensure the date of minimum durability specified, where applicable under Article 19(1), has not passed.
Take corrective action on non-compliant products and prevent non-conforming product entering the market.
Confirm storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.
Co-operate with the Competent Authorities as required.

The national competent authorities conduct regular inspections of manufacturers of cosmetic products to ensure compliance with GMP. Article 8 of Regulation (EC) No. 1223/2009 requires the manufacture of cosmetic products to comply with GMP standards as per ISO 27716.2007.

If you would like further information or wish to discuss how PharmaLex can support you with cosmetic product’s regulation or compliance, please connect with us on +353 1 846 4742 or email us at contactirl@pharmalex.com.

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