Regulatory Setback for Symrise: Animal Testing Ordered for Sunscreen Ingredients
Symrise, a German cosmetics manufacturer, faces a regulatory setback as the General Court, the first level of the European Court of Justice, ruled that animal testing must be conducted on homosalate and 2-ethylhexyl salicylate. These ingredients are already approved and exclusively used in sunscreens.
Background:
Symrise appealed against a decision by the European Chemicals Agency (ECHA) that mandated animal testing under REACH, the EU's primary chemicals legislation, when no non-animal alternatives are available. The ruling emphasizes Article 25 of REACH, requiring manufacturers to seek information and data through non-animal methods and resort to animal testing only as a last resort.
Criticisms and Concerns:
Cruelty Free Europe (CFE), representing Symrise in the appeals, expressed "anger and disbelief" over the decision. PETA also opposed the ruling, emphasizing advancements in non-animal testing methods such as three-dimensional tissue models and computer simulations.
Impact on Cosmetic Testing Bans:
The ruling raises concerns about the impact on existing EU and UK bans on animal testing in cosmetics. CFE argues that ECHA's enforcement of animal testing requirements takes precedence over these bans, potentially undermining long-standing regulations.
Chemical Sunscreen Ingredients in Focus:
Homosalate and 2-ethylhexyl salicylate, both chemical ultraviolet light filters used in sunscreens, are the focus of regulatory attention. CFE claims that the toxicity testing required by ECHA would affect over 5,500 animals, including rats, rabbits, and fish.
Setback for Animal Welfare:
The decision represents a setback in the ongoing battle against animal testing in the cosmetics industry. CFE's director of science and regulatory affairs, Dr. Emma Grange, expresses concern that the case sets a damaging precedent for toxicity testing, even for ingredients approved as safe for many years.
Long Standing Legal Battle:
The regulatory dispute dates back to 2018 when ECHA first notified Symrise of the need for animal testing. Despite Symrise's appeals, the Board of Appeal upheld ECHA's decision in 2021. The recent ruling is perceived as a significant step backward in efforts to eliminate animal testing in the cosmetics sector.
Biocidal Products Efficacy Workshop on January 22-23, 2024
HSE regulatory specialists are hosting a workshop to help attendees improve the quality of their submissions and understand how these will be reviewed by the GB regulator.
This workshop aims to provide a comprehensive understanding of the regulatory approach to evaluating the efficacy of disinfectant products falling under Main Group 1. The GB BPR will be explored in detail, offering insights into efficacy requirements and specific advice for the five product types within this group.
Workshop Details:
Title: Biocides Disinfectants Efficacy Workshop
Date: January 22-23, 2024
Duration: 2 Half-Days
Key Topics:
- General considerations affecting the labelling, testing, and assessment of efficacy for disinfectant products.
- Specific outlines of the standard testing required for surface disinfectants in product types 2, 3, and 4.
- Standard testing outlines for product type 1.
- Advice for generating adapted or novel methods for less standard products in product types 2, 3, and 4.
- Guidance on testing for product type 5, where limited standard methods are available.
- Common issues and problems faced in these product types.
Who Should Attend:
This workshop is tailored for individuals involved in creating and submitting efficacy data packages for disinfectant biocidal product applications. Whether you're from a test house, an applicant, a consultant, or related fields, this workshop is designed to enhance the quality of your submissions.
Registration:
To secure your spot at this valuable workshop, find out more details and register here. The closing date for registration is January 15, 2024.
Octocrylene Faces Potential Ban - Call for Evidence
Regulatory authorities in Europe, led by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), are increasing efforts to potentially ban the use of octocrylene. Octocrylene, known for its water-resistant properties, is a common ingredient in cosmetic formulations, especially sunscreens.
The European Chemicals Agency (ECHA) has initiated a call for evidence to gather essential information for France's proposal to restrict octocrylene.
FDA Position: The US FDA, in its 2021 evaluation, identified only zinc oxide and titanium dioxide as safe and effective sunscreen ingredients. Octocrylene, among others, faced classification challenges due to insufficient data.
Contamination Concerns: Octocrylene is often found to be contaminated with benzophenone, a known carcinogen, raising serious safety concerns.
Environmental Impact: The UV filter is linked to aquatic toxicity and potential harm to coral reefs, although conflicting evidence exists regarding its environmental impact.
Current Initiatives:
ECHA's call for scientific evidence to assess octocrylene's safety is open until January 10, 2024.
ANSES is preparing a REACH "restriction dossier" to address environmental risks, with a formal proposal anticipated in October 2024.
Implications for the Industry:
Industry Response:
As discussions unfold, the market is witnessing a surge in "reef-safe" alternatives. Companies like Advance ZincTek and Reef Relief have introduced products designed to not only protect coral reefs but also contribute positively to aquatic ecosystems.
New York Moves on Menstrual Rights
In a significant move towards gender inclusivity and health equity, Governor Kathy Hochul of New York has signed a comprehensive Health Equity and Opportunity legislative package into law. The legislation spans from destigmatising language around feminine hygiene products to fostering inclusivity in cosmetology education.
Key Components of the Legislative Package:
- Gender-Neutral Language for Menstrual Products: S.1522/A.1296 introduces inclusive language by replacing the terms "Feminine Hygiene Products" and "Sanitary Napkins" with the gender-neutral term "Menstrual Products." This change aims to eliminate stigma and promote open conversations about menstruation.
- Free Menstrual Products in Schools: Legislation S.5913A/A.113A mandates middle and high schools, including non-public schools, to provide free menstrual products in student restrooms. This initiative addresses menstrual equity, acknowledging that access to these products is a basic necessity.
State Senator Roxanne Persaud notes: "Outdated terminology perpetuates the stigma surrounding menstruation. This bill recognizes the simple reality that menstruation is not dirty but rather a natural bodily function."
This legislative stride aligns with global efforts for menstrual equity. Last year, Scotland made menstrual products legally free, and New York's progressive approach is expected to set a precedent for other states and nations.
China Finalises Toothpaste Dossier Requirements
China's National Medical Products Administration (NMPA) has introduced the final edition of the Provisions for Management of Toothpaste Notification Dossiers, to be enforced from December 1, 2023. The comprehensive set of guidelines, shaped through public consultations and comprising 3 chapters, 32 articles, and 3 annexes, outlines the responsibilities and obligations of toothpaste notifiers, user-information-related dossiers, and necessary documentation for initial toothpaste notification.
Key Requirements for Toothpaste Notification:
- Overview of the quality management system and adverse reaction monitoring of the notifier.
- Chinese domestic responsible person’s information form for overseas notifiers.
- Manufacturer information form and GMP certification for overseas manufacturers.
- Product testing report, safety assessment documents, and product label sample.
Increased Testing Requirements for Toothpaste Safety and Efficacy
Toothpaste safety and efficacy testing now involve a more comprehensive set of criteria. Notifiers must submit testing reports covering microbiological and physicochemical tests, toxicological tests, and efficacy evaluations.
Testing Items and Requirements:
- Microbiological and physicochemical tests expanded to include heavy metals like mercury and cadmium, and detection of hazardous substances.
- Oral mucosa irritation tests for specific types of toothpaste, including those for children.
- Varied efficacy evaluations based on claims.
Safety Assessment Requirements for Toothpastes
Safety assessment requirements for toothpaste are somewhat more relaxed compared to cosmetics. The safety assessment report should be conducted with reference to the Technical Guidelines for Cosmetic Safety Assessment, considering the specific characteristics of toothpaste.
Specific Requirements for Children's Toothpaste
Children's toothpaste comes with specific guidelines, definitions, permitted claims, and labelling warnings. Products targeting children under 12 years old are subject to unique considerations.
Children's Toothpaste Guidelines:
- Limited efficacy claims to cleaning and caries prevention.
- Inclusion of cautionary terms and warnings on packaging.
- Labelling indicating single-use limit for children's toothpaste containing fluoride.
As these regulations come into effect, cosmetic manufacturers involved in toothpaste production or distribution in China should carefully review and align their practices to ensure compliance and successful product notifications.
Thailand Revises Notification Review Standard for Mouth Spray Cosmetics
The Thai Food and Drug Administration (Thai FDA) has released a comprehensive update to the Criteria for Reviewing Notification of Mouth Spray Products in October 2023. This revision, an augmentation of the existing "Notification Standard for Mouth Spray and MouthWash Products in Cosmetics'' under the Cosmetic Notification Review Standard (2021 Edition), brings new regulations concerning claims, container characteristics, naming rules, and notification documentation requirements for mouth spray cosmetics.
Key Highlights:
Definition:
The updated standard expressly defines mouth spray products with a focus on their exclusive use for "breath freshening."
Prohibited Claims:
Products in this category face restrictions on claims beyond cosmetic scope, including assertions related to healing, relief, sterilisation, or treatment. Claims about moisturising effects on mouth and throat are also prohibited.
Container Characteristics:
Containers with spray connecting pipes are prohibited to prevent potential contact with the throat.
Product Naming:
Mouth spray products containing herbal plants with medicinal properties, such as Galangal and Andrographis Paniculata, are allowed to include the plant's name in the cosmetic name, provided the plant is a cosmetic ingredient and the product is solely for freshening breath (e.g., GALANGAL REFRESHING MOUTH SPRAY).
The term "KID/KIDS" is permissible in the product name under specific conditions, such as being intended for children aged 6 years and above. Formula composition considerations, including alcohol content, apply, and the label must state "Not for use by children under 6 years old."
Terms like "Baby," "Infant," "Newborn," etc., are not allowed in the product name.
Documentation Requirements:
Enterprises must furnish supporting documents during the notification process, including images of actual products for sale, labels, and a company-director-signed certificate ensuring compliance with cosmetic scope and claim restrictions.
These meticulous refinements in standards establish a robust regulatory framework, providing businesses with clarity as they navigate the notification process.
