Since July 2013 the manufacture and supply of cosmetic products in the EU has been covered by the Cosmetic Regulation (EC) No. 1223/2009.
Its aim is to harmonize the rules in the Community to create a common market whilst ensuring a high level of protection of human health.
The Regulation covers all cosmetic products whether manufactured in or imported into the European Union and whether sold, given away or used in professional treatments.
We realise that this legislation places an enormous burden on your organisation so in answer to this need we have created the Allingham Beck Compliance Division (ABCD).
We have invested in developing a new web based system to speed up the compliance process and keep costs to the minimum.
Contact us today for an informal chat or further information on how we can assit you with your cosmetic safety assessment.
To comply with this legislation and to be able to retail your products in any EU Member State you will need to:
- Generate a Product Information File (PIF) for each and every cosmetic/toiletry product. Included in this file will be a Cosmetic Product Safety Report (CPSR). To produce this you will require the following:
o The Formulation
o The Manufacturing Method
o A GMP certificate
o The Product Specifications and parameters
o MSDS and Specifications for each of the raw materials
o A microbiological challenge test report (where applicable)
o Stability test data for the finished product
o Compatibility test data for the finished product
o Toxicological data for all raw material and packaging materials
o A fragrance allergen listing
o Specifications of the finished product
- Using the information listed above and other risk analyses provided by the ingredient suppliers where required a safety assessment can be made that takes account of all toxicological issues and possible synergistic reactions between the various ingredients and packaging components.
- The Safety Assessment must be carried out by a suitably “European qualified” professional such as a Toxicologist, Chartered Chemist, Chartered Microbiologist or other suitably qualified person with at least 5 years’ experience of the cosmetic industry.
- You will also need an example of the labelling and if possible a photographic example of the packaging (that conforms to current EU legislation).
- Armed with the above information, details for each product can, and must, be entered electronically through the Cosmetic Products Notification Portal (CPNP). This has been a requirement since 11th July 2013.
The following information needs to be notified:
o Product category
o Product name
o Responsible person – name address
o Country of origin (import only)
o Member State where product is placed on the market
o Details of physical contact person in case of emergency
o Nanomaterials – identification, exposure conditions
o CMRs identification (Carcinogenic, Mutagenic or Toxic for Reproduction)
o Frame formulation, a banded formulation or the exact formulation
o Original labelling
o Photograph of packaging (if reasonably legible)
All products that are currently on sale, all new products intended for immediate sale and any discontinued products that were on the market in 2009 must be notified.
Any new products containing nanomaterials must be notified 6 months before entering the market.
Notification is the responsibility of the manufacturer (brand owner) or importer. Under this legislation the manufacturer is the person who causes the product to be made.
The Regulation requires that each product on the market be linked to this ‘Responsible Person’ who must be EU based and who will hold a Product Information File which includes appropriate defence of claims made about the product, evidence that the product was manufactured to a recognised quality system (GMP), records of reports and
appropriate action on Serious Undesirable Effects of the product and a Cosmetic Product Safety Report.
Allingham Beck Associates can assist and advise on any or all aspects of compliance with the EU Regulation, including preparing Cosmetic Product Safety Reports and undertaking Microbiological Challenge and Stability/Compatibility testing as well as assessing labels for mandatory information and any potentially contentious claims.
We can also act on your behalf to manage your information on the EU CPNP online database.
Allingham Beck Associates’ international client base means we also have extensive experience of non EU regulatory requirements and are happy to advise on the extra obligations cosmetic manufacturers and suppliers face in global markets.
We are here to help,
Allingham Beck Compliance Division