Regulation (EC) No. 1223/2009 (and subsequent amendments) establishes the requirements that every cosmetic product placed on the market must comply with to ensure consumer health protection and information. It defines restrictions on the substances contained in these products and clarifies the minimum requirements for product labeling.
What is considered a cosmetic product?
Any substance or mixture intended to be applied to the external surfaces of the human body (epidermis, hair system and hair, nails, lips, external genital organs) or to the teeth and mucous membranes of the mouth, exclusively or mainly for cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odors.
The application of Good Manufacturing Practices (GMP) in cosmetic product production drives companies toward proper management of production processes and facilities, quality control, etc., to ensure that only safe and high-quality cosmetics are distributed and marketed. Regulatory consulting is thus crucial from the preliminary stages.
At Flashpoint, our team of experts supports organizations at every stage before the marketing of a cosmetic product:
– Preparation of the Product Information File (PIF), including the safety assessment of the cosmetic product.
– Drafting and verification of the Label, which must include the INCI (International Nomenclature of Cosmetic Ingredients) and other key consumer transparency information.
– Notification to the Cosmetic Products Notification Portal (CPNP).
– Drafting of Safety Information Sheets (SIS) for the finished cosmetic product.
– Verification and support in selecting the Claims to feature on the label.
– Assistance with exporting cosmetic products to non-EU countries, including requesting Certificates of Free Sale (CLV) if needed.
In the post-market phase, we provide support in market surveillance, managing reports to health authorities regarding any adverse effects reported.