7 small steps for one big success
Before entering European market, you should make sure, that products you want to place on the market, are fully compliant with Regulation 1223/2009 and its annexes. Since these annexes are updated several times yearly, it is important to make check-ups on a regular basis. Cosmetic regulatory compliance services will ensure your formula is up to date.
Cosmetic products need to have specific tests made in order to confirm their safety. In our laboratory we can perform different testing protocols according to GLP standards, among which are microbiology, stability & compatibility, challenge, SPF and UVA testing, water resistance, patch, efficacy and preliminary testing, safety in use, effectiveness proving, clinical studies, etc.
Safety assessment is a document that ensures the safety of a product and includes all the necessary testing. Safety assessor which is required to have an official qualification recognized by a Member State checks whether the product is compliant with the EU cosmetics regulation and whether it is safe for use or not. Its aim is to prove that the cosmetic product does not pose a threat to human health. Cosmetic regulatory compliance services of Dr. Burstein & Waymore can support with performing the latest regulatory challenges.
The Cosmetic Regulation 1223/2009 & 655/2013 set up requirements for the labelling and claims of finished cosmetic products. Compliant claims and labels are the key steps for entering EU market.
Cosmetic claims, which are usually used for marketing purposes, are in EU highly regulated. Claims should be designed in a way to avoid any misleading advertising as mentioned in article 20 of Regulation 1223/2009: “In the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.” In addition, Regulation 655/2013 is editing claim support.
Dr. Burstein & Waymore can also provide labelling guidance for cosmetic products. Labelling guidelines include ingredient labelling and regulatory labelling requirements.
Our team will review your cosmetic label and packaging and introduce you mandatory information that must be printed on every product label and identify and correct any mistakes or enforcement risks before you place your products on the EU market.
Every cosmetic product sold in the European Union needs to have a Product Information File (PIF), containing all information about the product, such as product description, Cosmetic Product Safety Report, details of methods of manufacture (GMP), proof of the effect claimed, …
PIF is a legal requirement and the files must be available to the competent authorities. The PIF needs to be kept by the Responsible Person for ten years from the date when the last batch of the product was placed on the market.
Cosmetic Products Notification Portal (CPNP) is an EU online notification system, where responsible persons and, under certain circumstances, the distributors of cosmetic products, submit certain information about the cosmetic products that they place or make available on the EU market. This information is made available to the EU member states competent authorities and poison centres.
Cosmetic Regulation no. 1223/2009 demands that any organization wishing to place a cosmetic product on the European market must notify it via CPNP portal before starting with sales.
