EF Cosmetics Safety

Cosmetic product safety reports

Cosmetic product safety reports (CPSRs)

Our cosmetic product safety reports (CPSRs) are fully compliant with Annex 1 of Regulation 1223/2009 that came into force in July 2013. The assessment process is complex and requires a detailed knowledge of regulatory toxicology, a good chemical understanding of the ingredients used, how they are made, and their chemical structures, as well as experience of formulating and optimising cosmetic products. The EU Commission official guidelines to the interpretation of what exactly needs to go into the safety report were published in November 2013: see guidelines to Annex 1 2013/674/EU. This document is used by enforcement authorities in the EU to check for compliance with the regulations and we pride ourselves on following it to the fullest extent.

Many products we have assessed are sold in major UK retailers, including QVC, Boots, Harrods, and Debenhams, so you can be sure that the format and content of our assessments are of a high standard. Our safety assessments are also compliance certificates: not only do they confirm that the product is safe for use in the intended application but they confirm that the product complies with the EU cosmetics regulation and its various annexes.

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Not all safety assessments are of the same quality and many on the market do not meet the requirements of Annex I and its guidelines. However, the Responsible Person is legally responsible for the compliance of their CPSR - not the safety assessor!

Here are some examples of non-compliance we have seen in recent CPSRs from well-known suppliers in the UK and Europe:

  • some ingredients missing NOAEL (see below) or equivalent values and no margin of safety calculations, with no detailed reasoning to explain why they are otherwise safe
  • NOAEL values given but no reference or literature source to say where the figure has come from
  • no discussion of the combined effect of irritant ingredients in a shampoo to decide whether or not the product as a whole will irritate the eyes or not
  • spray tan booth product with calculations for just dermal exposure and no consideration of droplet particle sizes and inhalation exposure
  • formulations with no ingredient trade names
  • no discussion as to the purity of the individual ingredients or whether the actual trade name ingredient used is safe in terms of its purity profile
  • CPSRs that do not define a specific formulation but list a broad range of ingredients that can be used (so called flexible assessments)

Calculation of Margin of Safety (MoS)

The human toxicity of all substances can be described in terms of their toxicological end-points, which are divided into local effects such as skin sensitisation and irritancy; and systemic effects, which are potentially more serious and include liver or kidney toxicity, reproductive toxicity, neurotoxicity and carcinogenicity. The safety of each ingredient in terms of its potential systemic toxicity must be calculated under the EC1223/2009. The method involves researching a value in the literature for the NOAEL (No Observed Adverse Effect Level), which is the maximum safe daily level of the substance usually derived from animal chronic toxicity studies. If a reliable NOAEL value can not be found it may be possible to estimate it from related substances (termed read-across or structure-activity relationships). If a NOAEL or alternative safe daily dose figure can not be estimated then the ingredient should not be used. EF Cosmetic Safety does not carry out any actual toxicity studies on animal or human subjects - we reasearch the literature and carry out calculations. The margin of safety (MoS) is then calculated from a knowledge of the amount of the substance to which the customer will be exposed each day (including dermal, inhalation and oral exposure). The MoS must be greater than 100 to be deemed safe; lower values can not be accepted unless good reasons are given. As an example see MoS calculation for lavender oil. Calculations for local toxicity are done differently and must also be detailed on the report.