In the European Union (EU), manufacturers, producers, assemblers, importers, and other actors in the supply chain are required to comply with the EU Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. EU REACH is managed and enforced by the European Chemicals Agency (ECHA). The regulation is intended to protect human health and the environment from risks and effects posed by potentially harmful substances by encouraging the use of safer alternatives.
To achieve this goal, companies within the scope of the regulation must register all substances manufactured in or imported into the European Union in quantities exceeding 1 tonne per year. This process requires companies to investigate their supply chain and collect data on all articles included in their products.
This five-step guide to EU REACH compliance will help you navigate the process and reduce risk in your supply chain.
EU REACH Compliance Requirements
Step 1: Product Information Collection and Analysis
The first step to complying with EU REACH is to collect information on the properties and uses of the substances in the scope of the regulation that are manufactured in or imported into the EU above one tonne a year. There is no standard reporting template for REACH—Full Materials Declarations (FMDs), certificates, safety data sheets, and test reports are all examples of valid information that can be collected from suppliers.
After data collection, companies must assess the hazards and potential risks posed by any in-scope substances. This information is then shared with ECHA in the second step.
Step 2: Registration of Substances
The second step of EU REACH compliance is registering substances via a registration dossier. Registration dossiers contain substance hazard information, an assessment of the risks associated with those substances, and an indication of how the risks are managed.
The registration step applies to individual substances, substances in mixtures, and (in some cases) substances in articles. Already-regulated chemical substances are partially or completely exempt from REACH reporting requirements.
REACH registration follows a "one substance, one registration” principle, which requires manufacturers and importers of the same substance to submit their registration jointly.
Step 3: ECHA Registration Evaluation
After submission of a REACH registration dossier, ECHA evaluates whether the registration follows the requirements of the regulation. ECHA and the EU member states assess the quality of the registration dossiers, as well as the testing proposals, to clarify if a substance poses a risk to human health or the environment. After the evaluation is completed, companies may be required to submit additional information on certain substances.
Step 4: Ruling on Substances by ECHA
If ECHA discovers risks associated with the use of certain substances, those substances can be restricted, banned, or made reportable as Substances of Very High Concern (SVHCs). SVHCs that are not restricted, banned, or authorized for specific purposes must be reported before being used in products.
Per REACH Article 33, companies must declare the presence of SVHCs at a concentration above 0.1% weight by weight (w/w) at the article level. Companies are required to provide the names of any SVHCs present in their products, along with any safe use information for those substances. After companies complete this process, they are permitted to use the declared SVHCs.
While REACH is intended to remove SVHCs from the EU market, ECHA grants certain substances authorization to be used for a specific purpose after it has otherwise been restricted via the Authorization List. Once a substance is moved to the Authorization List, it is assigned a sunset date. After that date, the substance can no longer be used to manufacture a product or be imported into the EU.
Step 5: REACH Certification
The final step of EU REACH compliance is receiving certification. Once a REACH registration dossier is evaluated and approved by ECHA and the appropriate EU member states, ECHA issues a REACH certificate that displays a REACH registration number to prove compliance with the regulation.
Simplify EU REACH Compliance with Source Intelligence
EU REACH is a complex and ever-changing regulation, which can make compliance confusing and difficult. Manually conducting supplier outreach and gathering product data at the article level can be inefficient, costing your team valuable resources. It also leaves plenty of room for error.
Reduce risk in your supply chain and simplify EU REACH compliance with Source Intelligence. Our REACH platform facilitates data collection from suppliers, validates the documentation for accuracy, and rolls up the data for easy reporting. Whether you need a solution with a team of experts to manage your REACH compliance or a solution that simply provides the software to support your compliance initiatives, we can find the right mix of services and software to fit your needs.
