If you want to sell cosmetic products in the EU or US, there are certain compliance requirements you must achieve. In the EU and the US, you will need to ensure your product complies with labelling and ingredient requirements specific to each region. In addition for the EU, you will need to have a ‘PIF’ – a comprehensive Product Information File which is held by a ‘Responsible Person’ within the EU and entered into their Cosmetic Product Notification Portal.
The information requirements can seem exhaustive to the un-initiated and conducting ingredient searches seem daunting if you don’t know where to look!
Products are required to have suitable ‘proof of effect’ – this means having suitable evidence to support all claims made in relation to the product. This means not only complying with labelling requirements and claims, but having suitable evidence to support all claims made in your labelling and marketing. This is especially relevant for cosmeceutical products and products with claims of SPF.
A Cosmetic Product Safety Report (CPSR) must be provided for each product that you wish to sell in the EU. The CPSR must be provided by a suitably qualified person who has been trained in Pharmacy, Toxicology or Chemistry and has appropriate experience to undertake the safety assessment. The CPSR takes into consideration:
- MSDS of the finished product
- Safety calculations – extensive calculations performed based on the No Observed Adverse Effect Level (NO(A)EL), Low Observed Adverse Effect Level (LO(A)EL) or LD50 of individual raw materials based on the amount of exposure, daily application levels and method of use
- Required warnings and directions for use provided on the product label and limits/restrictions imposed as part of the EU Cosmetic Regulations
Once a CPSR has been finalised, all required warnings and directions for use are then cross checked against provided label information and again, all information MUST match.
Belinda Pilmore will be presenting ‘Regulations in the West (Europe and USA)’ as part of in-cosmetic Asia’s Marketing Trends programme at 12:00 – 13:00 on Thursday, 6th November. She will also be presenting ‘Brand Management – How R&D/Formulators Need To Collaborate With Marketing’ at 15:00 –15:45 on the same day of the exhibition.