Health-EU newsletter 254 - Focus
The Scientific Committee on Consumer Safety continues its search for reliable alternatives to animal testing
by Prof. Vera Rogiers, Vice-Chair of the Scientific Committee on Consumer Safety (SCCS) and Chair of the SCCS Working Group on Methodology, Vrije Universiteit, Brussels, Belgium.
The Methodology Working Group of the Scientific Committee on Consumer Safety published a review in the 30 April 2020 edition of Toxicology on ‘The way forward for assessing the human health safety of cosmetics in the EU - Workshop proceedings’.
This ongoing work is the result of the EU Cosmetics Directive, which provided the regulatory framework for the phasing out of animal testing for cosmetics. The Cosmetic Directive established both a testing ban, which prohibits testing finished cosmetic products and cosmetic ingredients on animals, and a marketing ban, which prohibits marketing finished cosmetic products and ingredients in the EU that were tested on animals.
While this is very good news for animals and animal lovers, it poses challenges to the cosmetic industry and to scientists responsible for ensuring that cosmetic products are safe for consumers. Testing on animals provided a reliable way of knowing that finished products and their ingredients could be used safely. As animal-testing is no longer permitted, there is an ongoing search for reliable non-animal alternatives for testing the safety of cosmetic ingredients and adhering to ‘New Approach Methodology’. Now, necessary safety data for both the ingredients and the finished product is drawn from validated (or scientifically valid) replacement methods.
The review published in Toxicology summarises the outcomes of a workshop organised by the committee’s Methodology Working Group in February 2019 to discuss animal-free alternative methods for the safety evaluation of cosmetic ingredients and issues related to their identification and use.
The key points were that:
- In the EU, only animal-free methods may be used for safety assessment of cosmetics.
- Next Generation Risk Assessment offers a suitable framework for safety assessment.
- Next Generation Risk Assessment makes use of animal-free New Approach Methodologies.
- New Approach Methodologies consist of in chemico, in silico, in vitro and ex vivo methods.
In its conclusions, the Scientific Committee on Consumer Safety stated that the workshop provided an up-to-date overview of selected New Approach Methodologies and strategies for the safety assessment of cosmetic ingredients. The workshop was also timely, since the safety assessment of new cosmetic ingredients will have to rely on new non-animal concepts. These may include Next Generation Risk Assessment and Weight of Evidence approaches in which New Approach Methodologies concepts such as Threshold of Toxicological Concern and/or internal Threshold of Toxicological Concern and read-across are combined with historical animal data. Animal data that are generated for regulatory purposes other than cosmetics may also be included in the safety assessments, but some companies choose not to use any post-ban animal test data.
Progress has clearly been made, but more examples are needed to create confidence that performing Next Generation Risk Assessment, also for new compounds, continues to provide consumer protection. There are concerns about testing for more complex issues – not just that an ingredient or product is non-irritant, but that it is safe and non-carcinogenic when used repeatedly, used for prolonged periods, and when used in combination with other cosmetic products. Yet, with growing experience, an increasing number of case studies and the development of practical workflows, solutions for complex endpoints are also being found.
Concerns have also been raised that methods that are available in the Organisation for Economic Co-operation and Development test guidelines program are validated for a limited set of standard chemicals and not for a sufficiently large chemical space e.g. nanomaterials, which complicates the safety assessment of cosmetic ingredients that are used in the nanoform.
The Next Generation Risk Assessment concept may offer an interesting platform for dealing with the safety assessment of cosmetics and their ingredients. During the SCCS’s plenary discussion, it was recommended that practical solutions be shared more widely, for example, by using case studies in practical exercises or courses. This will facilitate learning by doing and hands-on experience with new methods and approaches.
It was further stressed that the development process of New Approach Methodologies and their application should be monitored closely, preferably by a multidisciplinary supervisory group of experts. Close interaction between the different actors in this field is essential to get a common understanding of the novel approach. This also allows regulators to give feedback on their specific needs and expectations. The case studies of data-rich substances presented during the workshop were especially illustrative of the process followed. To further evaluate the usefulness of this approach, more detailed information on the case studies is needed, including an assessment of the underlying confidence.
It was also suggested that the cosmetic industry pro-actively take up the challenge and develop a complete dossier of a new compound based on the emerging Next Generation Risk Assessment concept. This would help identify potential knowledge gaps and provide experience in the topic to risk assessors from both industry and the regulatory side.
Negligible anaerobic biodegradation of Linear Alkylbenzene Sulphonates in fresh and marine waters may pose environmental concerns
The European Commission asked its independent Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to evaluate whether Linear Alkylbenzene Sulphonates show potential for anaerobic biodegradation in both marine and freshwater environments. Linear Alkylbenzene Sulphonate is the most widely used synthetic surfactant in the world, and includes the various salts of sulfonated alkylbenzenes that are used in household detergents as well as in various industrial applications. Anaerobic biodegradation is the degradation of compounds by microorganisms in the absence of oxygen.
The European Commission made this request for a new scientific opinion in light of some recent data, particularly a University of Cadiz study that describes the results of four anaerobic biodegradation experiments performed with Linear Alkylbenzene Sulphonates in different environmental conditions. When fulfilling this request, the Scientific Committee was asked to take into consideration additional reports and references from the open literature published in the period 2009 – 2019 to support or refute the conclusions of the University of Cadiz study.
After careful examination of these materials, the Committee agreed with the conclusions of the University of Cadiz study that anaerobic degradation is negligible in fresh water but possible in seawater under specific conditions. The Committee stated that the university’s experiments had been performed in agreement with The Organisation for Economic Co-operation and Development Test Guideline 308 and concluded that the results of these experiments may be considered reliable, albeit with some restrictions in view of a number of weaknesses, in particular regarding the statistical analysis performed and the reporting of the results.
It is therefore the opinion of the Scientific Committee on Health, Environmental and Emerging Risks that there is moderate evidence that:
- in marine waters anaerobic degradation of Linear Alkylbenzene Sulphonate may occur only under particular conditions (e.g.: sandy sediment and low organic carbon content);
- the potential for anaerobic degradation of Linear Alkylbenzene Sulphonate is negligible in freshwater;
- the conditions in which some anaerobic degradation has been observed (sandy sediments with low organic carbon contents) may be atypical for sites impacted by waste water, where muddy and organic sediments may be encountered more frequently.
The Scientific Committee is also of the opinion that the absence of degradation may lead to accumulation of Linear Alkylbenzene Sulphonates in anaerobic sediments and thus may present a relevant environmental concern.