regulatory consultancy

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EASY AND CAREFREE IN COSMETIC INDUSTRY

we present to you

5 small steps for one big success

in cosmetic industry

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.

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.

Would like to add value to your product?

Many cosmetic companies now days are eager to not just sell in the local supermarkets or boutiques but also would like to start selling in the pharmacies or online. Customers are becoming more and more informed and if the cosmetic products are supported by opinions, certifications and standards from experts like dermatologists, pharmacists etc., the credibility of products raises incredibly. We have the power to help you obtain and maintain standards and certificates.

Need some more information?

CONSULTANCY SERVICES

We provide consultancy services in the cosmetic industry in regulation 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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RESPONSIBLE PERSON?

If you leave it to us...

Regulation 1223/2009 has already in 2013 determined a need to have a responsible person inside the European Union. We as RP will ensure that your products are produced according to the relevant GMP standard, assess your formula and see if it complies with EU standards and norms. We will create the Product Information File, containing safety assessment and all requested information. After label and claim check we perform the notification to the CPNP.

...you can go across the rapids carefree!

office@burstein-eu.com

+386 40 133 266