REACH regulation

• Data on chemicals informs their classification which in turn informs decisions on risk management under REACH and other parallel legislation
• For example, if your chemical is designated a substance of very high concern (SVHC) based on its classification or properties, it will be a candidate for authorisation and substitution. However, this aspect of REACH is expected to change under the revisions set to be published at the end of 2025
• Achieving a robust understanding of chemicals, and interpreting associated data, has never been more important to support product use

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• Under REACH, any substance manufactured or imported at 1 or more tonnes per year must be registered, unless an exemption applies. Substances that have not been registered in accordance with REACH must not be manufactured, imported or supplied
• Registration dossiers must include supporting information related to substance properties, as specified by the authority. The amount of information required is proportional to volume and hazard classification
• Sagentia Regulatory offers bespoke registration services for markets with REACH regulations. We can prepare full or partial registration dossiers for your submission, or submit them on your behalf. We also provide Only Representative (OR) services for many global manufacturers under EU and UK REACH, ensuring seamless market access and full regulatory compliance

• Your chemical substance registration may be selected for detailed evaluation – either to check the information meets requirements under REACH or to investigate specific concerns for human health or the environment
• Assessors will evaluate your dossier for data quality and information gaps, determining whether further testing is required
• Sagentia Regulatory can support you through this process, identifying and performing necessary actions to give your substance the best chance of an appropriate REACH evaluation

• Authorisation is one of the REACH processes for managing the risks of very hazardous substances and promoting their replacement with safer alternatives
• SVHC lists differ across the EU, UK, and other markets, but core requirements for substances with this designation are similar
• Unless an exemption applies or authorisation is granted, it is illegal to sell or use an SVHC in the applicable market after its ‘sunset date’ has passed
• If you need to apply for authorisation, Sagentia Regulatory can devise an application strategy and assist with necessary reports, analyses (e.g. viable alternatives to the SVHC, socio-economic impacts of discontinued use), and data gathering. We can also manage stakeholder communications to set clear expectations
• If authorisation is granted, a time limitation will apply. Sagentia Regulatory can support the creation of review reports if you require longer use of the substance

• Restriction is a direct and unambiguous means of controlling the risks associated with hazardous substances. Under REACH, a substance which has been restricted must not be manufactured, imported, supplied or used on its own, in a mixture or in an article, unless it complies with the conditions of that restriction
• Some restrictions represent outright (or near-outright) bans on a substance, whereas other restrictions are far more targeted, prohibiting certain uses of a chemical but allowing others to continue
• Restrictions often include complex technical conditions and exemptions, so it is important to understand how the rules apply to your products. We can provide expert interpretation to help you stay on the right side of the law
• Sagentia Regulatory can evaluate and advise on your use of restricted substances, offering clear guidance on compliance requirements across relevant markets. We can also support robust submissions to inform policy development

• If you are a non-EU/UK manufacturer or formulator, appointing an Only Representative (OR) in target markets relieves your customers of importer responsibilities and facilitates trade in the EU/UK
• The OR handles REACH registrations and ongoing compliance management according to the relevant jurisdiction’s requirements. Customers are considered ‘downstream users’ and are therefore exempt from registration obligations
• This approach enables manufacturers and formulators of chemical substances to retain full visibility and control of the supply chain, and ensures they are not commercially disadvantaged
• Sagentia Regulatory offers end-to-end OR services in the EU and UK, from initial guidance to registration submissions, ongoing dossier management, regulatory support and advice, and downstream user communications

• When it became law in the EU in 2006, REACH was the largest ever piece of EU regulation, stretching to many hundreds of pages detailing complex obligations for businesses that manufacture, import, supply or use chemicals and articles
• Figuring out what applies to your business and interpreting the requirements is not straightforward. This puts companies at risk of missing key obligations or taking an overly cautious approach that goes beyond what is required
• At Sagentia Regulatory, our expert consultants have years of experience cutting through the complexity of REACH. We can help your team identify which specific requirements are relevant to your business, then devise and support practical strategies for compliance