CTFA Annual Report 2022

Group (JWG) topics were discussed at the meeting: • Consumer Communications – ICCR SC endorsed the “Frequently Asked Questions (FAQ) for Allergens. The Allergens FAQs covers 5 messages, namely: cosmetic products/ingredients that can be a source of allergens; symptoms to watch for as a potential indicator of an allergic reaction; what to do if one believes they are experiencing an allergic reaction to a cosmetic product/ ingredient; how to avoid substances that one is allergic to in a cosmetic products/ingredient, and that cosmetic safety is a shared responsibility. In 2022 the JWG conducted a survey to find the best way to optimise access and use of deliverables for interested external parties. The group will present/discuss the survey outcomes and recommendations made to ICCR-17 SC in the year ahead. • Integrated Strategies for Safety Assessment of Cosmetic Ingredients - ICCR SC endorsed the approach proposed by the JWG. The JWG agreed on the best practices for using and reporting data when leveraging New Approach Methods (NAMs), to support safety assessments and updated risk assessment workflows for the integration of NAMs into the safety assessment of cosmetic ingredients. • Microbiome and Cosmetics - ICCR SC endorsed the “Microbiome and Cosmetics: Working Definitions & Microbiological Assessment Considerations” report. The first task was to work on the definitions including the vocabulary based on state-of-the-art scientific literature, description from the perspective of their use in the cosmetic sector, and guidance for future ICCR discussions to support a clear understanding of skin microbiome related terms for Regulators and other stakeholders in the cosmetic field. The second task, was to work on microbiological limits for products containing intentionally added live or viable microorganisms and investigate whether additional considerations would be appropriate. As current microbiological limits are intended to address microorganisms unintentionally introduced (i.e., contaminants), applying the current microbiological limits for probiotics, which are deliberately and intentionally added to products, would not be appropriate nor fit for purpose. Instead, when addressing the introduction of probiotics into cosmetic products, it is proposed that the determination of safe concentrations of such ingredients be established on a case-by-case basis. The SC endorsed the deliverable of the Microbiome and Cosmetics JWG II with minor edits. As the group has concluded the tasks described by the Terms of Reference (ToR), it will be disbanded after the endorsement of the deliverable. • Updates from Observers’ Regulations - Chinese Cosmetic Administration and Regulation by National Medical Products Administration (NMPA), People's Republic of China, provided a presentation about the Chinese administration system, cosmetics regulations, and conclusions. The NMPA summarised the overall conclusions: - Stringent Regulation (by life-cycle supervision/pre-market/post- market, 4-level illegal behavior, strictest punishment, and responsibility requirement for the company/Industry), - Streamline Administration (to decrease the scope of licensing, classify the products and ingredients based on the risk, and enhance the service level by informatisation), - Encourage Innovations (with new technical, ingredients, low-risk new ingredients notification and encouragement of the rules). SCIENTIFIC COMMITTEE ON CONSUMER SAFETY (SCCS) Technical information and opinions that were finalised and adopted by the Scientific Committee on Consumer Safety (SCCS) with the latest key technical information relevant to our local brands include: 17 March 2022, the SCCS issued a final assessment draft SCCS/1637/21 on Kojic acid, a whitening ingredient in cosmetics. It concluded that Kojic acid has potential endocrine-disrupting properties and a maximum concentration of 1% allowed for use in cosmetics in the European Union is no longer considered safe. At the same time, SCCS gave a maximum safe concentration of 0.7% for Kojic acid when it is used as a cosmetic whitening agent. 10 May 2022, the SCCS issued an opinion SCCS/1640/21 on the safety of 4-Methylbenzylidene camphor (4-MBC). The conclusions are as follows: The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity. Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the androgen system are not so evident, as only in vitro evidence is available. Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe. It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded. The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment. The African continent is still a huge focus for the CTFA, to ensure that members are aware of the regulatory requirements when they want to export to various African countries. BOTSWANA MEDICINES REGULATORY AUTHORITY (BOMRA) On the 18th of November 2022 BoMRA held a meeting with stakeholders to update on the developments and current state of cosmetic regulations AFRICA COSMETIC TOILETRY AND FRAGRANCE ASSOCIATION OF SOUTH AFRICA 10

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