SCCS Issues Final Opinion on Silver Safety in Cosmetics.
The Scientific Committee on Consumer Safety (SCCS) has released its final opinion on the safety of silver and its compounds in cosmetics. This follows a review requested by the European Commission to clarify the safety of both ionic and nanoparticle forms of silver in consumer products.
Conclusion of the opinion:
(1) In light of the data provided and taking under consideration the classification as toxic for reproduction Cat. 2, does the SCCS consider micron-sized particulate Silver safe when used up to a maximum concentration of 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products?
In light of the data provided and taking under consideration the classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination.
However, the use of micron-sized particulate Silver in eye shadow and oral exposure products (lip balm, toothpaste and mouthwash) at concentrations mentioned in Section 3.5 is considered safe, either used alone or in combination.
(2) Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of micron-sized particulate Silver in cosmetic products?
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(3) Does the SCCS have any further scientific concerns with regard to the use of micron-sized particulate Silver in cosmetic products
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Full details available here.
Updates to the ASEAN Cosmetic Directive (ACD) Regulation.
The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) recently revised the ACD annexes. This update aims to harmonise cosmetic regulations across the region, further reducing technical trade barriers.
Updates include:
- Acid Yellow 3 (CAS No 8004-92-0) - added to restricted list of substances with a max usage of 0.5% in non-oxidative hair dyes only.
- Salicylic acid (CAS No 69-72-7) is now restricted for use of up to 0.5% in nail polishes.
- Pyrithione Zinc (CAS No 13463-41-7) can be used in concentrations of up to 1.0% (2% for the Philippines).
Australia Seeks Feedback on Proposed Exposure Models for Sunscreen Ingredient Safety.
Australia is taking steps to enhance the safety of sunscreen products through a consultation on proposed exposure models for assessing sunscreen ingredients. Led by the Australian Therapeutic Goods Administration (TGA), this initiative aims to gather input from stakeholders to ensure a thorough evaluation of sunscreen ingredients, balancing efficacy and safety for consumers. The TGA’s consultation period opened on 2nd July 2024 and will close on the 13th August 2024.
Sunscreens are crucial for protecting against UV radiation, which can cause skin cancer and premature ageing. However, concerns have arisen regarding the safety of certain ingredients, particularly with long-term exposure and potential systemic absorption.
Traditional safety assessments have focused on acute toxicity and irritation. Emerging scientific evidence suggests some sunscreen ingredients might have endocrine-disrupting properties or other long-term health effects, prompting a re-evaluation of safety assessment protocols worldwide.
The three different models being considered, each with its own approach to assessing sunscreen exposure are detailed below:
Option 1: Australian Sunscreen Exposure Model (ASEM)
The ASEM offers a model specifically designed for Australia, calculating the highest expected daily exposure to sunscreen by considering local application practices and Australian research. This approach focuses on how sunscreen is used in Australia rather than relying on international models. ASEM aims to ensure safety for both high and low users of sunscreen by basing risk assessments on local usage patterns.
Option 2: Scientific Committee on Consumer Safety (SCCS) Exposure Model
The SCCS model is a widely recognised framework used in various international regions, such as Europe, where sunscreens are regulated as cosmetics. This model uses established methods to estimate sunscreen exposure, but the TGA is concerned that its assumptions may not fully reflect Australian usage practices. Therefore, there is a question of whether this model would provide accurate and relevant risk assessments for Australians.
Option 3: Status Quo
The status quo involves continuing the current practice of evaluating sunscreen ingredients individually without adopting a specific exposure model. This method uses various approaches for each evaluation, offering flexibility but potentially lacking consistency and coherence in measuring and assessing sunscreen exposure.
Manufacturers may need to conduct more detailed safety evaluations, potentially increasing research and development costs. However, adhering to a rigorous safety framework can help brands build consumer trust and differentiate themselves in the market. Products meeting enhanced safety standards may also gain a competitive edge internationally. A more comprehensive exposure model promises greater assurance of sunscreen safety, accounting for long-term and cumulative exposure. This initiative aligns with growing consumer demand for transparency and safety in personal care products, fostering greater confidence in the market.
Japan Proposes Revision to GHS Classification List for Cosmetic Ingredients
On 21st June 2024, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) informed the World Trade Organization (WTO) about the designation of NPE (polyoxyethylene nonylphenyl ether) as a Class II Specified Chemical Substance under the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (the Act).
Class II Specified Chemical Substances are those identified by Cabinet Order (Order for enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.) as posing a potential risk to humans or causing environmental damage, with significant residual presence over large areas, or where such situations are likely to arise soon.
This designation imposes several regulatory requirements:
- Manufacturers and importers of NPE must notify the intended quantity of NPE to be produced or imported, as outlined in Article 35, paragraphs 1 and 6 of the Act.
- The handling of NPE and NPE-containing water-based cleaning agents must follow the measures specified in the technical guidelines, in accordance with Article 36, paragraph 1 of the Act.
- Containers and packaging of NPE and NPE-containing water-based cleaning agents must have labels indicating compliance with the prescribed measures, as stated in Article 37, paragraph 1 of the Act.
The main objective of this designation is to protect animal and plant life, public health, and the environment. This action underscores Japan's commitment to environmental protection and public health. Proposed dates include the date of adoption in October 2024 and the date of entry into force in April 2025, with a deadline for comments 60 days from notification.
