Cosmetic Product Assessment at GCS

We provide Safety Reports to cosmetics business owners so they can legally and safely sell their products.  Read on to find out how cosmetic products are assessed and how to get a safety report from GCS.

How all cosmetic products are assessed

Is your proposed product is a cosmetic. ‘Cosmetic product’ means any “substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

The safety of a cosmetic product is determined from a consideration of the ingredients. An assessor does not need samples in order to do this. The approach to carrying out safety assessments of cosmetics in Europe is summarised by the European trade body: Cosmetics Europe.

Before a product can be assessed some additional testing may be required (depending on the product type), such as preservative efficacy (PET – otherwise know as challenge testing) and stability testing. GCS does not provide this testing, but we can give you details of testing companies.

The safety assessment results in a final report, called a Cosmetic Product Safety Report (CPSR).

What is a CPSR?

CPSRs have two parts.

Part A
  • Description of your product including the formulation / recipe.
  • What testing has been carried out on your product (such as stability and microbiological testing).
  • Packaging.
  • Expected exposure.
  • Calculations for individual ingredients’ exposures to determine the daily systemic exposure dose (SED) and the margins of safety (MOS) or equivalent (required for all ingredients).
  • Comparison with legal limits found in the Annexes to Regulation 1223/2009 and with other limits for specific ingredients.
Part B
  • Safety Assessor’s summary of your product, taking into account all the information contained in Part A

How to get a CPSR at GCS

  • All relevant information needs to be submitted via an Microsoft Excel template (use the contact form to request the template)
  • The template contains prompts for all the information needed in order to produce Part A of the CPSR.
  • The safety assessor then reviews all the submitted data, considers the intended use of the product, and the likely exposure to individuals, and is able to provide a summary of the safety assessment, in the form of Part B of the CPSR.
  • A pdf of the signed report is submitted to you, belongs to you and is accessible and ready in case a regulating authority needs to look at it.

Once completed, a CPSR contains much of the information needed to fulfill the requirements of a PIF (product information file) with regards to the finished product.

Legislation

EU Regulation 1223/2009 along with guidelines for Annex I

EU Scientific Committee on Consumer Safety (SCCS) notes of guidance for the testing of cosmetic substances

Assumptions

GCS can provide you with a safety assessment for your product or product range, which will allow you to sell your product in the EU, after completion of the CPNP notification portal. The validity of your CPSR is based on a number of assumptions:

a) the CPSR is filed in the Product Information File (PIF) together with the Sales Specification for each ingredient (or a Certificate of Analysis of a single batch) and a (Material) Safety Data Sheet for each ingredient (where applicable).

b) the product label is legally compliant and any claims are substantiated.

c) safety assessments and ingredient lists will be based on the products and recipes that you have sent us and that we have quoted for. The CPSR is only applicable to the formulation submitted.

d) all products are manufactured to suitable standards of hygiene and data recording, equivalent to the standards of GMP ISO 22716:2007

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