The European Union has recently enacted Regulation (EU) 2024/1328, amending Annex XVII to Regulation (EC) No 1907/2006 (REACH). This new regulation, effective from June 6, 2024, imposes critical restrictions on the use of three chemical substances: octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6). Authorities have identified these substances as persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) chemicals, posing significant environmental risks.
Key Details of the New Regulation:
- New Restrictions:
- The regulation imposes stringent limits on D4, D5, and D6 concentration in non-wash-off cosmetic products, such as lotions, creams, and serums, to reduce their environmental persistence. This builds on the existing restrictions in entry 70 of Annex XVII to Regulation (EC) No 1907/2006, which previously targeted wash-off products.
- Transition Period:
- Manufacturers have three years to reformulate their products to meet the new standards and achieve complete compliance by 2027.
Environmental and Industry Implications:
The updated regulation, a necessary and logical extension of existing regulations, underscores the EU’s dedication to decreasing the environmental impact of cosmetic products. The Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) fully support this decision.
Why Immediate Action is Crucial:
- Regulatory Compliance: Ensuring your products comply with these new regulations is not just essential; it’s a legal requirement. Non-compliance can lead to severe penalties, including product recalls and damage to your brand’s reputation.
- Environmental Responsibility: Taking proactive steps to reformulate your products now ensures compliance and demonstrates your commitment to environmental sustainability and consumer safety, empowering you to lead the change.
- Market Advantage: Proactively addressing these changes positions your brand as a leader in sustainability, enhancing your reputation and consumer trust.
How CE. Way Can Help:
Navigating these regulatory changes can be complex. CE.way, with its extensive expertise in regulatory compliance, offers a comprehensive suite of services to support your compliance journey:
- Regulatory Consultation: Detailed analysis of how the new regulations impact your product range and actionable guidance on compliance steps.
- Compliance Audits: Thorough evaluations to ensure your products meet the new standards.
- Formulation Assistance: Expert advice on reformulating products to eliminate or reduce the restricted substances.
- Labeling and Documentation: To comply with new requirements, assistance is needed to update product labels and necessary documentation.
Ensure your products are ready for the future—partner with CE.way for expert guidance and seamless compliance with the new EU regulations. Contact us today to start your transition towards more sustainable and compliant products.
