EU adopts the 12th Revision of the SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation
On May 16, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the 12th Revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (the Notes of Guidance). Compared to its predecessor, the newly released Notes of Guidance provides updates on animal-free alternative testing methods, emphasizes aggregate exposure and children’s exposure in specific ingredients’ assessments, and gives instructions on assessing children’s exposure to cosmetics.
The Notes of Guidance
SCCS is an independent advisory body that offers opinions on the health and safety risks of non-food consumer products. One of its responsibilities is to recommend a set of guidelines for developing adequate studies used in the safety evaluation of cosmetic ingredients. This is done through the Notes of Guidance, a document that introduces different aspects of the testing and safety evaluation of cosmetic ingredients. While its emphasis is on ingredients, it also gives indirect guidance for the safety assessment of finished products.
To incorporate new knowledge as well as scientific and regulatory advances, the Notes of Guidance is regularly updated. Its most recent revision, SCCS/1628/21, was carried out in 2021. After that, several new addenda, opinions and memoranda that are important to the guidance’s content were adopted. On this basis, the 12th revision of Notes of Guidance is formed.
Highlights of the 12th Revision
Compared to the 11th revision, the new revision makes the following main changes:
- Updating Animal-free Alternative Testing Methods
Regarding cosmetics and their ingredients, testing and marketing bans are in place to prohibit the use of animals. Additionally, there is an obligation to use only validated replacement alternatives. This is why for validated animal-free alternative methods for chemical hazard assessment, it is much harder to achieve compliance to Regulation (EC) No 1223/2009 (the Cosmetics Regulation) than with other regulatory frameworks in Europe.
Given the testing and marketing bans imposed by the Cosmetics Regulation, SCCS pays special attention to alternative methods that are suitable for the safety testing of cosmetic ingredients, and regularly updates the Notes of Guidance. In the 12th revision, SCCS provides updates on alternative methods to reflect the changes in this area, introducing changes for acute inhalation toxicity testing, skin irritation testing, defined approaches for eye irritation testing and skin sensitisation, as well as new in vitro methods for genotoxicity testing.
- Emphasizing Aggregate Exposure and Children’s Exposure in the Assessment for Specific Ingredients
Endocrine disruptor (ED) refers to a substance or a mixture that alters one or more functions of the endocrine system, and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. On March 31, 2023, the Commission Delegated Regulation (EU) 2023/707 formally introduced endocrine disruptor as a new hazard category. Following this formal introduction, the 12th revision underlines that when a cosmetic ingredient is suspected of having potential endocrine properties, SCCS will assess its risk for children according to age, taking into consideration the relevant cosmetic categories to which children of different ages are commonly exposed.
CMR substances are those classified as carcinogenic, mutagenic, or toxic for reproduction. Depending on properties, they are grouped under Category 1A, Category 1B and Category 2. As a general principle, CMR substances are banned for use in cosmetics. Exceptionally, they may be used in cosmetic under specific conditions where they have been evaluated safe by SCCS.
For CMR substances of Category 1A and 1B, the aggregate exposure from all sources shall be taken into consideration during the safety evaluation. This means that, as clarified by the 12th revision, not only the amount of the ingredient used in all cosmetic categories, but also the amounts coming from other sources (e.g., food, pesticides, industrial chemicals, etc.) should be considered. Moreover, the new revision adds that, since children are vulnerable, the safety assessment shall also take into consideration the exposure of children of different age groups.
- Giving Instructions on Assessing Children’s Exposure to Cosmetics
To give a useful reference for safety assessors and agencies, Appendix 7 to the Notes of Guidance includes a literature overview of recent consumer exposure data of cosmetics, including different categories of cosmetics, frequency of use, amount per application, and amount per day. The data covers consumers from one or more particular countries and, in some cases, are stratified by age, gender, and cosmetic formulation. However, there is a lack of exposure data of cosmetic products for children of different age groups.
As mentioned above, the 12th revision draws attention to the exposure of children of different age groups when assessing the safety of EDs and CMR substances. In line with this focus, the 12th revision introduces recent studies and available data for calculating children’s exposure. Based on this, it further provides an example of different cosmetic categories to which children of different ages may be exposed.
|
Children between 6 months and 1 year old |
Children between 1 and 3 years old | Children between 3 and 6 years old | Children between 6 and 10 years old | Children between 10 and 14 years old and between 14 and 18 years old |
|
Shower gel Hand soap Shampoo Body lotion Face cream Hand cream |
Shower gel
Hand soap Shampoo Body lotion Face cream Hand cream Hair conditioner |
Shower gel Hand soap Shampoo Body lotion Face cream Hand cream Hair conditioner |
Shower gel Hand soap Shampoo Body lotion Face cream Hand cream Hair conditioner Mouthwash |
Same as Adults |
| Toothpaste
(Retention Factor 40%) |
Toothpaste
(RF 40%) |
Toothpaste
(RF 40%) |
Toothpaste
(RF 5%) Mouthwash (RF 10%) |
Same as Adults |
In addition to these main changes, the 12th revision of the Notes of Guidance explains the rationale behind the exposure data used to evaluate sunscreen’s sun protection, stresses the importance of systematic literature review and the potential of in silico prediction, as well as introduces templates for describing Physiologically Based ToxicoKinetics (PBTK) models, parameter verification and analysis. Details of these changes can be found here.
Further Reading
- Cosmetics Regulation Focus: What Are the Impacts of the EU Chemicals Strategy for Sustainability?
- EU SCCS Releases Preliminary Opinion on Children’s Exposure to Methyl Salicylate
- EU SCCS Updates the Scientific Advice on HC Blue 18
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