Approval & Notification
Approval and notification of your cosmetic product on the national and international market
Cosmetics generally do not require the approval procedure, which is necessary for medical devices and pharmaceuticals.
Notification of cosmetics
The surveillance authority in accordance with article 13 of Regulation (EC) No. 1223/2009 on cosmetic products (EU Cosmetics Regulation), must be notified about all cosmetics to be placed on the market in the European Union. The notification must be made before the product is placed on the market or imported. The regulation also applies to companies that are not a responsible person in the sense of the EU Cosmetics Regulation, i.e., those that do not have their name on the products, such as contract manufacturers.
Another requirement of the EU Cosmetics Regulation is that the EU Commission must be notified about all cosmetic products and their formulations before they are placed on the market. The corresponding internet portal, the Cosmetic Products Notification Portal (CPNP), is operated by the EU Commission and enables uniform and central notification in all member states of the European Union. The CPNP system is a direct result from the EU Cosmetics Regulation. The notification is explained in articles 13 and 16.
The US market requires compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FP&L Act), and the regulations published under the authority of these laws. The regulations related to cosmetics are stated at 21 CFR, parts 700 to 740. The color additive regulations that apply to cosmetics are found at 21 CFR 73, 74, 81 and 82.
Placing cosmetics on the market
On the EU market: when the cosmetic product is placed on the market, the responsible person must maintain a Product Information File (PIF), in accordance with Article 11 of the EU Cosmetics Regulation 1223/2009.
The PIF must include the description of the cosmetic product: Formulation, manufacturing instructions, specifications, printing material, safety report, description of manufacturing methods, Good Manufacturing Practice (GMP) evidence, evidence of claimed efficacy (detectability/efficacy testing,if applicable), and animal testing data.
According to article 10 of the EU Cosmetics Regulation, the PIF must include a safety report (exact contents in Annex I), e.g., information on impurities in the raw materials or properties of the packaging material.
We can help you with the approval and notification of your cosmetic product. Feel free to contact us!