What falls under cosmetic products regulation?
‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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.
Who can be a responsible person?
Since July 11, 2013, Regulation EC No 1223/2009 requires designation of a responsible person (RP) for each cosmetic product marketed within the European territory.
A Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the EU market with relevant obligations as set forth in Regulation EC 1223/2009. It can be the EU manufacturer, the importer, the distributor or a third party located in the EU who has been designated by a written mandate.
What are the obligations of the responsible person?
The Responsible Person is in charge of ensuring that the cosmetic product comply with Regulation on cosmetic products.
Which means it has to provide, among other things:
- compliance with good manufacturing practice (GMP),
- product safety for human health,
- performance of safety assessment and production of a Cosmetic Product Safety Report (CPSR),
- compliance of labelling,
- maintenance of the Product Information File (PIF),
- notification in the Cosmetic Product Notification Portal (CPNP),
- identification of nanomaterials,
- monitoring of the product (reporting of any undesirable or serious effects).
What does CPNP stand for?
Before a cosmetic product is launched on the market, the responsible person must electronically register the cosmetic product with the European Commission. Electronic notification of a cosmetic product is performed via the Cosmetic Products Notification Portal or CPNP.
What should a cosmetic product safety report include?
According to Annex I of Regulation EC 1223/2009 the cosmetic product safety report shall, as a minimum, contain the following:
PART A - Cosmetic product safety information
1. Quantitative and qualitative composition of the cosmetic product;
2. Physical/chemical characteristics and stability of the cosmetic product;
3. Microbiological quality;
4. Impurities, traces, information about the packaging material;
5. Normal and reasonably foreseeable use;
6. Exposure to the cosmetic product;
7. Exposure to the substances;
8. Toxicological profile of the substances;
9. Undesirable effects and serious undesirable effects;
10. Information on the cosmetic product.
PART B – Cosmetic product safety assessment
1. Assessment conclusion;
2. Labelled warnings and instructions of use;
4. Assessor's credentials and approval of part B.
Who can perform a cosmetic product safety assessment?
Person with an appropriate education. A person must hold a university degree in pharmacy, toxicology, medicine or similar field which is recognised as equivalent in a member state.
COSMETIC PRODUCT CONSULTING SERVICES
preparation of a Cosmetic Product Safety Report (CPSR),
notification in the Cosmetic Product Notification Portal (CPNP),
preparation of the Product Information File (PIF),
identification of nanomaterials,
reporting of undesirable or serious effects.
Our properly trained team of experts will be happy to arrange the documentation of the cosmetic product for you.
If you are looking for a competent team, please don't hesitate to contact us for further advice.