There are five main requirements for placing a cosmetic product on the EU and UK markets.
- There must be an EU based “Responsible Person” for the product to be sold in an EU member state.
- There must be a UK based “Responsible Person” for the product to be sold in a UK constituent country.
- The “Responsible Person” must hold a “Product Information File” (PIF) for that product which demonstrates that the product conforms to the requirements of the Cosmetic Regulations 1223/2009 and which is available for inspection by the competent authorities.
- The “Responsible Person” must notify the product to the Cosmetic Product Notification Portal (CPNP) for products sold in the EU.
- The “Responsible Person” must notify the product to the Submit Cosmetic Product Notification Portal (SCPN) for products sold in the UK.
The “Responsible Person” is a legal term and does not necessarily refer to an individual person but rather to the legal entity or company who accepts responsibility for placing the product on the market. A company outside the EU cannot act as the Responsible Person and so a properly mandated EU based distributor usually undertakes this.
The PIF file consists, in general, of 5 sections:
- A). Description of the cosmetic product including details of the raw materials used,
- B). Cosmetic Product Safety Report,
- C). Description of the method of manufacturing and a statement on compliance with good manufacturing practice.
- D). Proof of the effect claimed for the cosmetic product (where justified by the nature or the effect of the cosmetic product)
- E). Data on any animal testing performed by the manufacturer, the agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients (the latter is usually a statement that no animal testing has taken place, as the testing of cosmetic products and ingredients on animals is forbidden in the EU).
By far the most complex section of the PIF is the Cosmetic Product Safety Report (CPSR) which must be undertaken by a suitably qualified person (a Toxicologist for example) and must conform to the requirements of the regulations.
This requires considerable information on the product including the results of various product tests (Stability Testing and perhaps others depending on the type of product), the formulation, and certification for certain ingredients (for instance, fragrances require an IFRA Certificate and an allergen list).
Lastly, the product must be notified to the CPNP and SCPN, both can be accessed online. The first time this is done an account must be created and authorised by ECAS. Following this each product must be notified by uploading various information to the portal including formulation information, a copy of the label (which must conform to EU and UK regulations) and a photograph of the product. The main purpose of the CPNP and SCPN is to act as a central repository of product information for the use of various national poison centres.
To support you with mandatory and current regulatory guidance, ADSL is competent and proficient in all areas of Global compliance.
ADSL provides several services which can help you bring your product to market.
Please note: the above pricing is based on per product, exclusive of VAT and work can only commence when ADSL is in receipt of all necessary information.
In the case of companies outside the EU or the UK we can act as the Responsible Person for their products. Please ask for more details.
We also have a number of other services such as helping with PIF creation, providing Safety Data Sheets, and providing User Trials and clinical testing for claim substantiation.
Take the next steps
We hope this is helpful to you. If you have any further questions or require any clarification please don’t hesitate to please speak to our compliance team today. Please call +44 (0) 1803 520 048 or book a free video consultation with us using the Get Started link.