The European Federation for Cosmetic Ingredients (EFfCI) and Cosmetics Europe (CE) have jointly released a comprehensive guidance document detailing the implications and requirements of the EU's REACH Annex XVII Restriction on Synthetic Polymer Microparticles (SPM). The guidance aims to assist industry stakeholders in understanding and complying with the new regulatory framework designed to mitigate the environmental impact of microplastics.
Key Elements of the REACH Restriction
The guidance document outlines several crucial aspects of the restriction that are particularly relevant to the cosmetics industry:
- Definition of Synthetic Polymer Microparticles (SPM):
- SPMs are defined as polymers that are solid and either contained in particles constituting at least 1% by weight of those particles or forming a continuous surface coating on particles where at least 1% by weight of those particles fulfill specific size conditions.
- Substances Not in Scope:
- Natural polymers, biodegradable polymers, water-soluble polymers, and polymers without carbon atoms in their structure are excluded from the restriction.
- Derogated Uses:
- Certain uses of SPMs are permitted under specific conditions, such as use at industrial sites or when SPMs are permanently modified during end use.
- Transition Periods:
- The guidance provides a detailed timeline for the transition periods allowed for various applications, ranging from immediate bans on microbeads to extended periods up to 2035 for makeup, lip, and nail products.
Detailed Guidance on Compliance
The document offers a step-by-step approach to determine if a polymer falls within the scope of the restriction and how to comply with the new requirements:
- Assessment Template:
- An intuitive assessment template is provided to help companies record decisions made throughout the SPM assessment process. This template facilitates collaboration between SPM manufacturers and users.
- Test Methods:
- The guidance emphasizes the importance of using scientifically credible methodologies to determine the physical state, particle size, and biodegradability of polymers. Specific test methods and criteria are detailed for various assessments.
- Labelling and Reporting Obligations:
- Companies must adhere to strict labelling and reporting obligations, including providing Instructions for Use and Disposal (IFUD) and submitting annual reports to the European Chemicals Agency (ECHA).
Frequently Asked Questions
The document includes a comprehensive FAQ section addressing common concerns and ambiguities, such as the determination of SPM status, applicability of derogations, and specifics of labelling and reporting requirements.
Areas for Further Work
The guidance identifies several areas that require further deliberation and industry collaboration, such as:
- Test methods for polymers in suspensions or mixtures.
- Common interpretation of the term "natural polymers".
- Methodologies to demonstrate compliance with derogations.
The new guidance document released by EFfCI and CE is a critical resource for the cosmetics industry, providing clear and detailed instructions on how to navigate the complexities of the Annex XVII Restriction on SPM. By adhering to these guidelines, companies can ensure compliance while contributing to the reduction of microplastic pollution.
For more detailed information, stakeholders are encouraged to review the complete guidance document available on the EFfCI and Cosmetics Europe websites.
