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Division 3.8 Toxicological profile of the substances

United Kingdom

Original text. Later amendments are not shown.

The aim of this section of the cosmetic product safety report is to describe the toxicological hazard of each of the substances in the finished product, determine the potential exposure, and draw up a risk characterisation. These aspects are of crucial importance in order to perform the risk assessment, as they are the three essential steps of the risk assessment process f1 .

The endpoints to be considered, as well as the necessary data, depend on a number of factors, including the routes of exposure, the conditions of use of the product, the physico/chemical characteristics and the possible absorption of the substance. The choice of relevant endpoints should be the responsibility of the safety assessor, who should justify their decisions.

The safety assessor should ensure that the experimental data comply with the requirements of Article 18 of Regulation (EC) No 1223/2009 concerning animal testing. Such requirements are clarified in the Commission Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics f2 .

Point 8 of Part A of Annex I to Regulation (EC) No 1223/2009 establishes the key requirements for the cosmetic product safety report as far as the toxicological profile of substances is concerned.

  1. 3.8.1General considerations concerning the toxicological profile as part of the safety assessment
  2. 3.8.2Toxicological profile of substances for all the relevant toxicological endpoints
  3. 3.8.3Consideration of all the significant routes of absorption
  4. 3.8.4Consideration of systemic effects and calculation of the margin of safety
  5. 3.8.5Impact on the toxicological profile of certain characteristics of the substances or the product
  6. 3.8.6Use of read-across should be substantiated and justified
  7. 3.8.7Identification of the sources of information

Annotations

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.

Notes on Division 3

Footnotes

f1

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