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The 11th revision of the SCCS Notes of Guidance

The 11th revision of the SCCS Notes of Guidance introduces a number of important changes for the safety assessment of cosmetic ingredients. The EU Scientific Committee on Consumer Safety (SCCS) has recently issued a new document that significantly clarifies the guidance for the testing and authorization of cosmetic ingredients. The 11th revision of the SCCS Notes of Guidance, adopted in late March 2021 at a plenary meeting, includes a number of very important changes to the procedure of safety assessment of cosmetic ingredients.  The document includes a key set of guidance for public authorities and the cosmetics industry (including safety assessors). Its purpose is to harmonise SCCS requirements with European legislation. Iwona Białas, Eng.D., Safety Assessor, owner of CosmetoSAFE Consulting, explains how these new regulations will affect the industry. 

SCCS safeguards consumer safety

The EU Scientific Committee on Consumer Safety (SCCS) is an advisory body of the European Commission responsible for the development of safety assessment methodology for cosmetic ingredients. SCCS’s requirements in terms of testing and the preparation of dossiers must be met by all authorized cosmetic ingredients (those substances that are subject to restrictions on use, in accordance with Annexes II to VI of Regulation (EC) no. 1223/2009 on cosmetic products). SCCS, basing on the ingredient submitted dossier, perform a risk assessment. The Committee conclusions on ingredient safety are transferred into its authorization in the EU. 

The SCCS Notes of Guidance are also a basic requirements for the industry, in order to meet the requirements of Article 3 of the Regulation on cosmetic products. Every cosmetic product must undergo a safety assessment procedure before placing on the market. A professional (safety assessor) must evaluate whether a relevant cosmetic (under the foreseeable conditions of use) poses a significant risk to consumer health.

Importantly, the SCCS Notes of Guidance are not set in stone: they evolve with progress of scientific knowledge related to individual ingredients and testing methods. What changes have been introduced in this revision?

Alternative methods finally acceptable

One of the key problems we have been facing in recent years in the European cosmetic market has been the limited number of new authorised cosmetic ingredients, such as UV filters, preservatives, colouring agents. On the one hand, animal testing of cosmetic ingredients and products has been banned in the EU for more than 16 years, yet on the other hand, in accordance with SCCS’s requirements, it has been necessary to submit a complete safety dossier for the ingredients assessed by the Committee. Therefore, there has been a certain legislative impasse because even though animal testing has been prohibited, the information obtained with alternative methods has not been accepted by SCCSexplains Iwona Białas, Eng.D., owner of CosmetoSAFE.

For the last few decades, we have seen significant progress in the alternatives to animal testing. For some time, selected methods have been accepted (under certain conditions, of course) as reliable and used for regulatory purposes in some areas (e.g. REACH/CLP). Until very recently, however, SCCS had a very conservative and restrictive approach to requirements to testing methods. Committee members aware of the shortcomings of the methodology (SCCS in a 2020 paper published in the journal Toxicology stated that no substance used exclusively for cosmetic purposes had been regulated after 2013) began work on adapting the requirements to the currently available legislative and research space. 

The current knowledge regarding alternative methods is not perfect: we still do not have alternatives (without animal tests) for a number of endpoints, e.g. systemic repeated dose toxicity or carcinogenicity. Therefore, the EU, as a regulator, is face with a dilemma on how to combine animal protection with the priority being the protection of human health. This is the reason why SCCS has been watching developments in this area very closely in recent yearsconcludes Iwona Białas.

The 11th revision of the SCCS Notes of Guidance has been developed to provide assistance in the complex process of testing and safety assessment of cosmetic ingredients in the EU. What is completely new in this latest revision? There is a shift from results of animal testing (treated in previous revisions as the only reliable and valid ones) to the use of alternative methods, in particular validated methods of 3R (Refinement, Reduction and Replacement)strategies and the so-called New Approach Methodologies (NAMs). 

Therefore, the risk assessment of cosmetics and their ingredients is shifting towards a strategic combination of NAMs and new technologies with historical animal data in the dossiersexplains the expert of CosmetoSAFE Consulting.

What does this mean for the industry?

The difference in the approach to the safety assessment is enormous: when preparing the dossiers to be evaluated by SCCS and gathering data to ensure Article 3 compliance (finished product safety), the industry can compile scientific arguments based on the weight of evidence (WoE) approach. 

Why is it important? In accordance with the conservative, historical approach to the safety evaluation, it was necessary to submit the animal tests data for a relevant ingredient. In the absence of such information, SCCS would conclude that it could not assess the safety of the ingredient, which in practice could result in a ban on its use. Currently, based on the new guidance, we can collect information from all possible sources, both for the analysed substance and its analogues. We can also use in vitro and ex vivo methods, and properly justified results from in silico methods (toxicity prediction using computational tools).

This is a huge change, and we hope that, in the near future, the lists of authorised substances (Annexes III to VI) will finally start to become longer, rather than becoming progressively smaller, as has been the case for a decade. Interestingly, this has not always resulted from an identified health risk. Sometimes, legislative decisions resulted from the fact that it was impossible to submit required data (ban on animal testing and simultaneously absence of alternative methods acceptable to SCCS)explains Iwona Białas.

What other issues important from the safety assessment viewpoint are included in the Notes of Guidance?

As far as significant technical changes (important for safety assessors) are concerned, after a very long waiting period SCCS presented a risk evaluation methodology for products with inhalation exposure. 

This issue has been a very big problem in practical terms. From one hand, it is clear that certain cosmetics may results in secondary inhalative exposure, and there are methods to assess the health risks (used in other industry sectors). On the other hand, in the absence of an accepted evaluation method, in most cases SCCS has excluded inhalation exposure from the safety assessment opinions. Consequently, the absence of SCCS addressing this issue has led to a ban on the use of the ingredient in products of a relevant category, adds the expert.

Another very important issue is the so-called TTC (Threshold of Toxicological Concern) approach, derived from the food safety evaluation. 

The basis of toxicological knowledge is the distinction between hazard and risk. A hazardous substance may be used under conditions of minimum exposure where no health risk is expected. In other words, there is a certain level of exposure below which harmful effects are unlikely. This concept is also detailed in the revised SCCS Notes of Guidance. This is a very convenient method of argumentation. Certainly, it has its limitations, but its potential use improves the decision-making process in the safety assessment of cosmetics. 

There are many other changes in the 11th revision of the SCCS Notes of Guidance, which are important for safety assessors. For the industry as a whole, the opportunity for innovation results mainly from change in perception – shifting from the animal tests results as the primary toxicological information on cosmetic ingredients. 

Nitrosamines are chemical compounds classified as potential carcinogens. Nitrosamines are formed when nitrosating agents react with secondary or tertiary amines. Examples of nitrosating agents include
The 11th revision of the SCCS Notes of Guidance introduces a number of important changes for the safety assessment of cosmetic ingredients.