Division (b) Impurities in the substances and raw materials

United Kingdom

Impurities can have a major impact on the overall toxicity of any substance. It is important to check the impurities profile of a substance to avoid, or at least assess, any additional risk from the impurities. In the absence of safety data from toxicological studies, the threshold of toxicological concern (TTC)^f1 might be a useful tool for assessing the safety of certain impurities.

When toxicological studies are used to characterise the toxicological profile of a substance, the purity and impurities profile of the substance used in the toxicological studies should be described. If the batches actually used in the formulation of the cosmetic product do not have a comparable impurity profile, the differences need to be assessed.

Annotations

Footnotes

f1: R. Kroes, A. G. Renwick, V. Feron, C. L. Galli, M. Gibney, H. Greim, R. H. Guy, J. C. Lhuguenot, J. J. M. van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), pp. 2533–2562.

Notes on Division 3

Footnotes

f1: The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8^th Revision, SCCS/1501/12, and its subsequent updates.

Notes on Division 3.8

Footnotes

f1: M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), p. 261.
f2: Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final.