Regulatory Testing from Start to Certificate

    Welcome to 360 Compliance
    REACH Candidate Update

    New Substance Added to REACH Candidate List

    On November 7, 2024, the European Chemicals Agency (ECHA) announced an update to the REACH Candidate List under the REACH Regulation (EC) 1907/2006. The addition of a new Substance of Very High Concern (SVHC) highlights the EU’s commitment to ensuring chemical safety and protecting human health and the environment.

    What Is the REACH Candidate List?

    The REACH Candidate List is a critical tool within the REACH Regulation, identifying substances that pose significant risks. These substances, designated as Substances of Very High Concern (SVHC), are closely monitored due to their hazardous properties, such as being:

    • Carcinogenic
    • Mutagenic
    • Toxic to Reproduction (CMR)
    • Persistent, Bioaccumulative, and Toxic (PBT)

    Once a substance is added to the REACH Candidate List, businesses using or supplying it face additional obligations to ensure safe usage and explore alternatives.

    What the Update Means

    The addition of a new substance imposes specific responsibilities for businesses using or distributing it. Companies must:

    • Report its presence in articles if above a concentration of 0.1% by weight.
    • Communicate its use and risks throughout the supply chain.
    • Submit notifications to the SCIP database for articles containing the SVHC.

    For detailed information, access the official ECHA Candidate List.

    Implications for Businesses

    The inclusion of a new substance in the REACH Candidate List introduces additional compliance responsibilities for manufacturers, importers, and downstream users. Companies must ensure they:

    1. Update Safety Data Sheets (SDS): Ensure all products containing the SVHC include accurate hazard information.
    2. Notify ECHA: If the SVHC is present in articles exceeding the 0.1% threshold, notification to ECHA is mandatory.
    3. Inform Customers and Supply Chains: Provide clear information about safe use and potential risks.
    4. Assess Safer Alternatives: Begin exploring substitutes to phase out the use of listed SVHCs where possible.

    Steps to Achieve Compliance with the REACH Candidate List

    To meet the requirements of the Candidate List, businesses should:

    1. Identify Affected Products: Review product portfolios to determine whether the new SVHC is present.
    2. Collaborate with Suppliers: Obtain detailed material composition data and communicate requirements for compliance.
    3. Fulfill SCIP Database Obligations: Submit required data to the database for all products containing the SVHC.
    4. Prepare Internal Processes: Ensure your compliance team is informed about the new requirements and is ready to act.

    Conclusion

    The addition of a new substance to the REACH Candidate List underscores the importance of staying updated with EU chemical regulations. Proactive compliance helps businesses maintain market access while fostering safer practices. Contact our team for expert support in navigating REACH requirements and ensuring your products meet the latest standards.

    Share this:

    You may also be interested

    Cambodia-TRC
    Cambodia TRC Regulatory Updates
    March 21, 2024
    On December 11th, 2023, the head leader of Cambodia's Telecommunication Regulator of Cambodia (TRC) issued a notification to all officers regarding the review of type approval documents, emphasizing the importance of consistency between the information provided in test reports and that submitted by clients. This notification clarified that previously accepted practices, such as using the product name and country of origin as claimed by the client, should now align precisely with the details presented in the test report. Following discussions and confirmations, TRC officers reaffirmed on December 27th, 2023, that this new rule must be adhered to for all future projects seeking type approval. For submissions with one country of origin, the test report must indicate the CoO. In cases where a product has more than one country of origin, the report should display one CoO, with any additional CoOs declared in a separate declaration letter. Moreover, TRC explicitly stated that reports lacking any indication of country of origin will not be accepted under these new guidelines. This adjustment aims to enhance accuracy and consistency in reviewing type approval submissions. Streamlining TRC Type Approval with Support from 360Compliance 360Compliance specializes in navigating TRC's type approval process, ensuring documents precisely reflect the country of origin per the latest guidelines. Our team offers expert advice and comprehensive services, including preparing test reports and submitting declaration letters. Partner with us to meet TRC's stringent criteria, minimize delays, and effectively secure type approval for your products. Let 360Compliance handle the complexities of compliance, allowing you to focus on your core business activities with peace of mind. Contact us today to learn more about our services and how we can help you achieve regulatory compliance in Cambodia.
    SIRIM_MCMC_Certification
    Malaysia SIRIM-MCMC Regulatory Updates
    March 21, 2024
    The Malaysia SIRIM CMCS Department, responsible for MCMC certification, recently implemented a significant update regarding Intellectual Property (IP) Forms for Type Approval applications. These forms replace the trademark authorization letter to improve efficiency and accuracy in approvals. The new IP Forms categorize trademark declarations based on whether the applicant has obtained authorization from the trademark/brand owner. For applicants who have been authorized, the required documents include evidence of a registration certificate issued by the Intellectual Property Corporation of Malaysia (MyIPO). Or an equivalent foreign organization, along with an Intellectual Property (IP) Authorization Letter (eTAC/FOR/01-8). On the other hand, if the applicant has not obtained written consent and authorization to use the trademark/brand, they must submit the Intellectual Property (IP) Undertaking form issued by the applicant (eTAC/FOR/01-9). Importantly, these new forms are effective immediately and will be used for all new projects. They mark a significant shift in SIRIM's approach. The organization can now accept brands/trademarks that have not been officially authorized by the brand owner. However, in such cases, the importer must provide a written declaration accepting responsibility. Furthermore, the new Brand name authorization process requires both the Brand owner and the Importer to co-sign the Brand name authorization letter. This updated procedure aims to enhance transparency and accountability in the approval process for Type Approval applications, ultimately benefiting both applicants and consumers in Malaysia. Simplifying SIRIM Certification with 360Compliance Navigating the latest SIRIM and MCMC certification requirements can be complex, especially when introducing new Intellectual Property (IP) Forms. 360Compliance is here to simplify this process for you. Our team knows the latest SIRIM updates, including the new eTAC/FOR/01-8 and eTAC/FOR/01-9 forms. We provide comprehensive support, ensuring your Type Approval applications are complete, accurate, and compliant with the latest regulations. From obtaining the necessary authorizations to submitting the correct IP Forms, we manage every step of the process efficiently. Partner with 360Compliance to streamline your SIRIM certification journey, minimize delays, and maximize compliance. Contact us today to ensure your products easily meet Malaysia's certification standards.
    india
    India Regulatory Updates
    March 21, 2024
    India TEC issued a notification in January 2024 regarding generic exemptions for products without available test labs.  In January 2024, India's Telecommunications Engineering Centre (TEC) issued a significant notification regarding generic exemptions due to the absence of available test laboratories within the country. These exemptions represent a crucial development, indicating that specific parameters no longer require the submission of test reports if customers cannot provide them. It's important to note that while these exemptions are in place, ILAC reports for CE/FCC are still subject to regulations based on the specific product category. This means that evaluation criteria for these reports vary depending on the nature of the product. Furthermore, TEC has specified product categories that continue to accept ILAC reports. Notably, the validation for these exemptions has been extended until June 30, 2024, with the potential for further extensions based on the evolving circumstances. These updates underscore TEC's commitment to adapting regulations to facilitate market access while maintaining stringent quality standards in the telecommunications sector. TEC approves testing exemptions for several product categories under their mandatory testing and certification program The Telecommunications Engineering Centre (TEC), under the Ministry of Communications, recently issued a notification regarding the approval of test requirements exemptions for certain product categories that necessitate mandatory testing and certification. This development signifies a significant step towards streamlining regulatory processes and promoting efficiency in the telecommunications sector. By exempting certain products from rigorous testing requirements, TEC aims to facilitate faster market access for manufacturers while maintaining high standards of quality and safety. This initiative aims to reduce costs and accelerate the introduction of innovative products to benefit industry stakeholders and consumers. How 360Compliance Can Streamline TEC Certification? 360Compliance offers expert guidance for navigating TEC certification complexities, especially with recent updates. We're adept in TEC requirements and ILAC report evaluations, ensuring compliance. Our understanding of exemption criteria and certification process management aids manufacturers and distributors in adjusting smoothly. Partnering with us secures strategic advantages for quicker market access, keeping with India's telecom quality standards. We simplify compliance, focusing on your innovation and growth in a changing regulatory landscape.

    Get in touch to take the next step with 360Compliance

    Contact us