Allergens grouping names on packaging: Are the substances similar enough to ensure safety? The worst case scenarios question this

IF 2.7 4区医学 Q2 DERMATOLOGY International Journal of Cosmetic Science Pub Date : 2024-05-31 DOI:10.1111/ics.12979

C. Vandamme, M. Guillaume, S. Pirnay

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Abstract

Objective

European Commission Regulation (EU) n°2023/1545 introduced the concept of grouping names in the cosmetics sector in July 2023. These groups bring together allergenic substances with the same level of skin sensitization. Their purpose is to lighten the list of ingredients on cosmetic packaging, by grouping together substances deemed to be similar under the same name. As this classification is based on a single toxic effect − skin sensitization − the present study aims to analyse the relevance of these groupings with regard to other toxic effects of substances in the same group.

Methods

This study was carried out by consulting an available database, various reports from 5 committees, 2 books and 5 articles in order to complete the toxicological profile of each substance. Then, in order to highlight any discrepancies within the classification, the worst cases were identified. For this purpose, the data for each substance in a group were compared, and in the event of greater criticality for a toxic effect, this was qualified as a worst case. In addition, similar toxic effects between several substances within the same group were also recorded. The aim of this additional research was to validate the definition of the grouping name and the similarities between substances in the same group.

Results

From the 17 grouping names, 5 presented worst cases. Two groups had 2 worst cases and the others only one. In total, from the 7 worst cases detected, 3 were due to the toxic effect “skin irritation”. In most cases, the substances in the groupings shared the presence or absence of risk. Only the degree of risk criticality varied.

Conclusion

Classification by grouping names appears justified regarding the similarities between substances, particularly in terms of skin sensitization. However, the presence of worst cases qualifies it and highlights the importance of being vigilant when assessing the risk of cosmetic products including these grouping names in their list of ingredients.

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包装上的过敏原分组名称：物质是否足够相似以确保安全？最坏的情况也会产生这样的疑问。

目的：欧盟委员会条例 (EU) n°2023/1545 于 2023 年 7 月在化妆品行业引入了分组名称的概念。这些分组将皮肤过敏程度相同的致敏物质集中在一起。其目的是通过将被认为相似的物质归类到同一名称下，简化化妆品包装上的成分清单。由于这种分类是基于单一的毒性效应（皮肤过敏），本研究旨在分析这些分组与同组物质的其他毒性效应之间的相关性：本研究参考了现有数据库、5 个委员会的各种报告、2 本书和 5 篇文章，以完成每种物质的毒理学概况。然后，为了突出分类中的任何差异，确定了最严重的情况。为此，对一组物质中每种物质的数据进行了比较，如果某种毒性效应的临界程度较高，则将其定为最坏情况。此外，还记录了同一组中几种物质之间的类似毒性效应。这项额外研究的目的是验证分组名称的定义和同组物质之间的相似性：结果：在 17 个分组名称中，有 5 个出现了最严重的情况。结果：在 17 个分组名称中，有 5 个出现了最差情况。在检测到的 7 个最严重病例中，有 3 个是由于 "皮肤刺激 "这一毒性效应引起的。在大多数情况下，分组中的物质都存在或不存在风险。结论：结论：根据物质之间的相似性，尤其是在皮肤过敏方面，按分组名称进行分类似乎是合理的。然而，最坏情况的存在使其受到限制，并强调了在评估成分列表中包含这些分组名称的化妆品的风险时保持警惕的重要性。

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来源期刊

International Journal of Cosmetic Science DERMATOLOGY-

CiteScore

4.60

自引率

4.30%

发文量

期刊介绍： The Journal publishes original refereed papers, review papers and correspondence in the fields of cosmetic research. It is read by practising cosmetic scientists and dermatologists, as well as specialists in more diverse disciplines that are developing new products which contact the skin, hair, nails or mucous membranes. The aim of the Journal is to present current scientific research, both pure and applied, in: cosmetics, toiletries, perfumery and allied fields. Areas that are of particular interest include: studies in skin physiology and interactions with cosmetic ingredients, innovation in claim substantiation methods (in silico, in vitro, ex vivo, in vivo), human and in vitro safety testing of cosmetic ingredients and products, physical chemistry and technology of emulsion and dispersed systems, theory and application of surfactants, new developments in olfactive research, aerosol technology and selected aspects of analytical chemistry.