Welcome to the third of four articles in our 2024 blog series, “Regulations to watch.” In this blog, we’re unpacking all you need to know about EU CLP, PFAS and PCN.
Countries around the world are taking aggressive steps to restrict PFAS, with proposals for widespread phase-outs and limitations on use. While PCN compliance has moved more into ongoing compliance mode, changes to other parts of the CLP regulation will continue to impact PCN submissions. The focus on PFAS and CLP continues to dominate the regulatory landscape, posing challenges and opportunities for businesses operating within the EU.
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WHAT YOU NEED TO KNOW
In the ever-evolving landscape of regulatory compliance, staying informed about the latest updates is crucial for businesses to ensure adherence and maintain consumer safety. This blog delves into the significant developments within the EU Classification, Labelling and Packaging (CLP) regulation, Poison Centre Notification (PCN) and the global regulations surrounding per- and polyfluoroalkyl substances (PFAS).
Understanding the Poison Centre Notification (PCN)
Compliance with the Poison Centre Notification (PCN) is an integral part of the EU CLP regulation, specifically outlined in Annex VIII. Importers and downstream users or duty holders under Article 45 must submit a set of harmonized information about hazardous mixtures to the European Chemicals Agency (ECHA) portal. This measure aims to enhance consumer safety and provide vital information for emergency health interventions. Key requirements include:
- Detailed submission data. Companies must provide comprehensive information, including market placement details, product categories (EuPCS codes), packaging information, unique formula identifier (UFI) and hazards, toxicological information, physical/chemical properties and composition.
- Submission format. The required format for submissions under the regulation comes from the International Uniform Chemical Information Database (IUCLID) and is an I6Z file. IUCLID serves many purposes and the changes to IUCLID can cause changes to the required format even when there has been no change to the regulation.
- Compliance tools. To prepare the necessary dossiers, compliance can be achieved using IUCLID or third-party software, with submissions possible either manually or through automated systems.
- Mandatory updates. Updates to PCN submissions are mandated in cases of changes to the mixture’s composition, classification for health or physical hazards name or when new toxicological information becomes available. Even though there hasn’t been any change to Annex VIII, other changes to the CLP regulation, like the addition of the new endocrine disruptor for human health hazard class, will drive necessary updates for some PCN submissions.
EU CLP updates: New hazard classes and digital labeling
The EU CLP is under revision again with 2022/0432(COD). While this is still making its way through the regulatory process, it is important to prepare for it. Key updates include:
- Label font size. Additional requirements are being implemented to ensure the readability of the label.
- Digital labeling provisions. Provisions for digital labeling have been incorporated to facilitate compliance and enhance the accessibility of hazard information. It shall be prohibited to track, analyze or use any usage information for purposes beyond what is necessary for the provision of digital labeling.
- Additional scrutiny of online or distance sales. Many products sold online from suppliers outside the EU are not complying with the regulations. For this reason, language is being added to specify that the supplier must have an entity within the EU and that entity’s address must be included on the label
PFAS: Addressing a global concern
PFAS have garnered significant regulatory attention due to their widespread use and adverse impact on human health. Both the United States and the European Union have taken decisive action to regulate the use of these substances.
United States regulations
Beginning in 2016, the Food and Drug Administration (FDA) banned the use of long-chain PFAS in food contact materials, and a review of short-chain substitutes is currently underway for other consumer product applications under the New Chemicals Program of the Toxic Substances Control Act (TSCA), overseen by the EPA. Several states have enacted bans on PFAS in specific consumer goods, reflecting a growing trend toward stricter regulations.
European Union regulations
The EU has restricted PFAS through several regulatory frameworks, including the Persistent Organic Pollutants (POPs) regulation, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and the Drinking Water Directive.
WHAT YOU NEED TO DO
Taking proactive steps will ensure you remain ahead in the compliance landscape
Take proactive steps to stay on top of compliance
A comprehensive compliance program is essential for safeguarding your organization’s reputation and mitigating risks. This involves a multi-faceted approach that encompasses several key steps.
- Assess and strategize: Begin by conducting a thorough compliance audit to pinpoint areas of strength and weakness. This evaluation serves as the foundation for developing a tailored compliance strategy that aligns with your organization’s objectives and adheres to all relevant regulations.
- Leverage technology: Streamline your compliance efforts by investing in technology solutions that automate data collection, reporting and submission processes. This not only saves time and resources but also enhances accuracy and efficiency.
- Foster a culture of compliance: Compliance should be ingrained in every aspect of your organization. Encourage employee involvement by fostering a culture where compliance is valued and prioritized.
- Seek expert guidance: For complex regulatory challenges or unique compliance needs, consider consulting with experts who can provide tailored solutions and support.
By following these steps, you can establish a robust compliance framework that protects your organization, minimizes risks and ensures long-term success.
HOW SPHERA CAN HELP
Partner with Sphera for a suite of solutions designed to simplify compliance
Navigating the complex regulatory landscape is a formidable challenge. Our tailored software solutions are designed to streamline your compliance processes, ensure compliance to industry standards and optimize operational efficiency.
Leveraging the expertise of our industry veterans, we provide unparalleled guidance on interpreting and applying regulations. Our regular updates and webinars keep you informed about the latest regulatory changes and empower you to stay ahead of the curve. Generate detailed compliance reports with our customizable reporting tools, which facilitate internal audits and external reporting requirements.
To further enhance your team’s capabilities, we offer comprehensive training programs that equip your staff with the necessary skills and knowledge to excel in a regulated environment. Let Sphera be your trusted partner in achieving regulatory excellence.
Legal disclaimer: The information provided in this blog is for general information purposes only, may not be updated in real time and does not constitute legal advice. Please consult with your legal and other advisors to discuss your particular needs and circumstances.
