EF Cosmetics Safety

The safety assessment procedure

Assessing new cosmetic formulations

The way we assess a new formulation is to study the recipe and research whether the individual ingredients are safe in line with the stated use of the product. The customer should complete our template for each product and send in other supporting documentation such as IFRA certificates and challenge test results. We do not physically test the finished product and we do not normally require samples. The final safety assessment (CPSR) is a pdf file and typically 20 pages long.

Information needed from the customer

All submissions must be made using our Excel template - please email us on edmund@efchemicalconsulting.co.uk for the latest version. The following is the usual minimum information requirements:

  • Name and address of the company and contact person
  • Product name and code
  • Manufacturer's name and address, if different
  • What the product is to be used for and what particular group of people it is aimed at
  • How the product is to be used (how often, which part of the body, washed-off or left on). A pdf of the artwork can help.
  • List of all the ingredients used with their INCI names
  • Manufacturer(s) and tradename(s) of each ingredient
  • CI index of any colour used
  • Code and manufacturer of any perfume being used
  • Percentage by weight of each ingredient (note that percentage bands are usually insufficient)
  • Percentage breakdown of tradenamed ingredients that are mixtures of INCI names
  • A recent IFRA certificate from the perfume manufacturer confirming that it complies with the IFRA (International Fragrance Association) regulations, and a list of the concentrations of the 26 allergens that must be declared in the EU. Note that the absence of an IFRA certificate is one of the most common reasons for holding up the assessment process. We also need a safety data sheet of the perfume.
  • For flavours, e.g. as used in lip balms, we also need confirmation that the flavour is food additive compliant, which in practice means all components are GRAS listed and have FEMA numbers or compliant with EU regulation 1334/2008.
  • Details of the packaging type (e.g. pump spray, tube, wide-mouthed jar), and the pack size(s), and preferably the name of the packaging supplier
  • The actual materials used in the contact parts of the packaging. If its a plastic we need to know the exact type. If its a laminate, what is the internal lamination layer? Getting this information is another major reason for holding up the assessment.
  • Microbial challenge tests where appropriate. This is another main reason for holding up assessments - it is a 40 day test.
  • Final product specifications, especially pH, appearance, colour, viscosity, microbial contamination
  • Brief summary of stability testing (including stability in the final packaging) that has been done
  • Details of any adverse effects, if any, reported during clinical testing or whilst on the market
  • When the product was first launched and in which country
  • Full reports of any dermatological or clinical testing done, if any