Published on 21/12/2025
How to Manage Substances of Very High Concern (SVHCs) in Pharma
As regulatory frameworks evolve, understanding how to manage Substances of Very High Concern (SVHCs) under EU regulations—specifically REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)—has become imperative for pharmaceutical companies operating in the United States. This step-by-step tutorial provides practical insights for compliance, documenting requirements, and establishing a robust framework for managing SVHCs in the global supply chain.
Step 1: Understanding SVHCs and Their Regulatory Implications
Before embarking on compliance efforts, it is crucial to have a clear understanding of what constitutes an SVHC as outlined in the REACH regulation. SVHCs are chemicals that may have serious effects on human health and the environment. The European Chemicals Agency (ECHA) maintains a candidate list of these substances, which is regularly updated.
The identification of SVHCs triggers specific regulatory requirements. These include, but are not limited to, the obligation to notify ECHA if a substance is present in articles above a certain concentration (0.1% w/w) and the need to provide adequate safety data
Key Actions:
- Review the current candidate list of SVHCs on the ECHA website to determine any that may be relevant to your products.
- Assess potential risks associated with these substances in the context of your operations and products.
- Establish an internal compliance team responsible for tracking changes in regulations regarding SVHCs.
Step 2: Conducting a Comprehensive Inventory of Chemicals
Once you understand what SVHCs are, you need to perform a thorough inventory of the chemicals used in your products and processes. This step is foundational, as it will inform all subsequent compliance actions.
The inventory should consider all raw materials, intermediates, and finished products. This task may seem daunting; however, using software tools designed for inventory management can facilitate the process. Look for tools that are specifically meant for compliance with REACH and RoHS regulations.
Documentation Requirements:
- Create a master inventory list that includes product names, Chemical Abstracts Service (CAS) numbers, relevant CAS number information, and their corresponding regulatory status concerning REACH.
- Document the quantities and forms in which these substances are used (solid, liquid, gas).
- Ensure traceability by recording the source of each chemical to help with future supplier communications.
Step 3: Assessing Risks and Compliance Obligations
Once your inventory is complete, the next critical step involves assessing the risks associated with identified SVHCs. Conduct a risk assessment to evaluate potential exposure pathways and the likelihood of adverse effects.
This assessment does not only involve evaluating the inherent toxicity of the substances but also considering usage patterns within your supply chain. Different products may have varying degrees of risk associated with the same substance due to differences in exposure levels and regulatory controls.
Compliance Checklist:
- For each SVHC identified, determine if the substance is present in concentrations that exceed 0.1% w/w.
- Evaluate the need for registration under REACH for substances manufactured or imported in volumes above 1 ton per year.
- Consult ECHA’s guidelines on assessing the exposure and safety of chemicals.
Step 4: Engaging with Suppliers and Supply Chain Compliance
Effective management of SVHCs requires collaboration across the supply chain. Engage with your suppliers to ensure that they are transparent regarding the presence of SVHCs in their materials. A proactive approach may involve creating a Supplier Declaration form that aligns with REACH requirements, where suppliers must confirm the compliance status of their products.
Key Actions:
- Develop a questionnaire to assess your suppliers’ compliance with REACH and RoHS regulations.
- Establish a communication plan to facilitate ongoing discussions about SVHC presence and alternatives that comply with regulations.
- Implement a system for documenting supplier feedback and compliance declarations.
- Consider conducting audits of suppliers for compliance verification.
Step 5: Documentation and Safety Data Sheets (SDS) Management
Under REACH, maintaining accurate and up-to-date Safety Data Sheets (SDS) for all substances containing SVHC is mandatory. The SDS serves as the primary source of information for the safe handling, storage, and transport of hazardous substances.
SDS must be prepared in accordance with Annex II of REACH, which includes specific formatting requirements. Furthermore, all SCIP (Substances of Concern In articles as such or in complex objects (Products)) notifications must be submitted for products containing SVHCs.
SDS Management Best Practices:
- Regularly update SDS to reflect any changes in regulatory status or product formulations that may occur.
- Ensure that copies of SDS are easily accessible to all relevant employees across the organization.
- Train staff on the importance of understanding and implementing the information contained in the SDS.
- Track and document SDS expiry dates to ensure continuous compliance.
Step 6: Reporting and Notification Requirements to ECHA
Reporting requirements are pivotal in your compliance journey. If your company manufactures or imports any SVHC above the threshold concentration, you must notify ECHA under Article 7(2) of REACH. This procedure involves submitting an official notification using the REACH-IT platform, which will require detailed information regarding the substance, its uses, and exposure scenarios.
Steps to Follow for Notification:
- Gather detailed information about the SVHC, including tonnage, types of uses, and potential exposure scenarios.
- Prepare your notification in REACH-IT by entering the required substance-specific information.
- Submit the notification electronically and retain proof of submission for your records.
Step 7: Post-Approval Monitoring and Continuous Compliance
Once you have successfully notified ECHA, you need to establish a post-approval monitoring framework to ensure ongoing compliance with REACH requirements. This includes keeping abreast of updates to the candidate list and being responsive to changes in your supply chain.
Additionally, organizations should consider implementing a compliance management system (CMS) that includes mechanisms for tracking regulatory changes and responding proactively.
Ongoing Compliance Strategies:
- Designate a compliance officer or team responsible for monitoring changes in SVHC regulations.
- Schedule regular reviews of your compliance status concerning SVHCs and update necessary documentation.
- Engage in continuous training for all employees regarding changes in regulations affecting SVHCs and waste management practices.
Conclusion: Embracing EU REACH Compliance
Managing Substances of Very High Concern is a multifaceted challenge that requires dedication and attention to evolving regulatory frameworks. Compliance with EU REACH regulations is vital not only to avoid legal penalties but to promote safety, sustainability, and corporate responsibility.
By following the outlined steps—understanding SVHCs, conducting thorough inventories, assessing risks, engaging with suppliers, managing SDS documentation, meeting reporting obligations, and continuously monitoring compliance—your organization can establish a successful framework for sustainable chemical management.
For further information on compliance guidelines, refer to the official resources on the ECHA website.