Dr. BursteiN & waymore

EU REGULATIONS

in cosmetic industry

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Every cosmetic product sold in the European Union have 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 open to the competent authorities. The PIF has 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.

In Europe Cosmetic claims, which are usually used to market purposes, are highly regulated as to avoid any misleading advertising and are mentioned in article 20 of Regulation 1223/2009: “In the labeling, 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.”​

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 then made available to the EU member states’ competent authorities and poison centres. Cosmetic Regulation no. 1223/2009 demands to that any organization wishing to place a cosmetic product on the European market must notify it online via CPNP portal before doing so. The CPNP is making this information available electronically to the Competent Authorities.

Safety assessment is a paper 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. Based on the information and tests compiled in part A of the CPSR, safety assessment contains the safety assessor’s conclusion on the safety of the cosmetic product.

Before entering European market you should make sure that products that you want to place on the market are fully compliant with the Annexes of the Regulation. As these annexes are updated several times a year, it is important to note that this work must be done on a regular basis.

Dr. Burstein & Waymore can also provide labelling guidance for products which includes advice on ingredient labelling and regulatory labelling requirements.
DR. Burstein & Waymore will review your cosmetic label and packaging, and introduce you with 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 EU market.

RESPONSIBLE PERSON?

If you leave it to us...

The regulation of having to have a responsible person inside the European Union, came into force in the year 2013 and is written in the annexes of European Regulation (EC) No. 1223/2009. As a RP we will ensure that your products are produced according to the relevant GMP standard, assess your formula and see if it complies with EU norms and create the Product Information File, containing the CPSR-A (all the documents related to the product) and the CPSR-B (Safety Assessment signed by a certified Safety Assessor). After labels and claim check we perform the notification to the CPNP

...you can go across the rapids carefree!

assessed products
different countries
notified products

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CONSULTANCY SERVICES

We provide consultancy services in the cosmetics industry on regulatory affairs and the EU legislations compliance. Dr. Burstein and Waymore team can advise and support you in ensuring the compliance of your cosmetic products, as per Regulation (EC) No.1223/2009 and in your development activities.

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office@burstein-eu.com

+386 40 133 266