The REACH Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) is one of the most extensive and complex pieces of legislation adopted by the European Union. Adopted in 2006 and in effect since 2007, it applies to any company that manufactures, imports, distributes, or uses chemicals in the EU. And that includes many industrial companies that do not consider themselves to be «part of the chemical industry»: From a painting company to a manufacturer of metal components that uses solvents in its production process.
Lack of knowledge about REACH does not exempt one from compliance. And in a supply chain where obligations are passed from one link to the next, not knowing about it can pose a serious problem, as regulatory compliance specialists themselves acknowledge.
What is the REACH Regulation, and what is its purpose?
REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. Its objective is to to improve the protection of human health and the environment against risks associated with the use of chemicals in the EU, shifting the burden of proof from regulatory authorities to the companies themselves: it is up to the companies to demonstrate that their substances can be used safely, not up to the authorities to prove that they are hazardous.
The body that manages the system is the ECHA (European Chemicals Agency, based in Helsinki), although enforcement and the authority to impose penalties rest with the competent authorities in each Member State.
Which companies are affected? Manufacturers, importers, and intermediate users
The Regulation establishes different obligations depending on each company’s role in the supply chain. Manufacturers and importers who produce or introduce substances into the EU in quantities exceeding one metric ton per year must register them with ECHA, submitting a technical dossier that includes toxicological, environmental, and exposure information. The intermediate users These are companies that use chemical substances or mixtures in their industrial or professional activities without being the manufacturer or importer. Their primary obligation is to implement the risk management measures specified in the safety data sheets and to verify that their uses are included in their suppliers’ registration dossiers. The distributors They pass the information along the chain without creating new record-keeping obligations, but they must ensure that the documentation they transmit is accurate and up-to-date.
What are my company's obligations under REACH?
Responsibilities vary depending on the role, but there are three that are common to all. Safety Data Sheets (SDS): All suppliers of hazardous substances or mixtures must provide their customers with an up-to-date SDS. Labeling in accordance with the CLP Regulation: As a supplement to REACH, it requires the proper classification, labeling, and packaging of hazardous substances and mixtures. And communication in the supply chain: both upstream (informing the supplier about the uses of the substance) and downstream (informing the customer about the risks and control measures).
For Substances of Very High Concern (SVHC), the ECHA Candidate List currently includes more than 235 substances. If a product contains an SVHC in a concentration of 0.1% or more by weight, the company must notify its customers and inform the consumer upon request.
REACH and PRL: Relationship to Substance Safety
REACH and occupational safety and health regulations are not separate frameworks: they are directly linked. The occupational risk assessment required by the Occupational Risk Prevention Act It must take into account the risks associated with the chemicals used in the production process, and that assessment is based precisely on the information contained in the safety data sheets required by REACH. A worker exposed to an SVHC without adequate control measures constitutes a simultaneous violation of both REACH and occupational safety and health regulations.
What penalties are imposed for noncompliance with REACH?
In Spain, the penalty system is established by Law 8/2010. The consequences of noncompliance have two aspects. The legal: financial penalties imposed by national authorities, recall of noncompliant products from the market, and customs holds on imports that do not meet registration or labeling requirements. The commercial: loss of customers who require REACH documentation as a prerequisite for supplier approval, exclusion from public tenders, and reputational damage in markets where chemical sustainability is a selection criterion.
How to Train Your Teams in the Safe Handling of Chemicals
REACH compliance is not a one-time task: It is an ongoing process that requires individuals within the organization to have specific knowledge of substance classification and labeling, the preparation and interpretation of safety data sheets, the management of SVHC substances, and communication within the supply chain. Specialized training in this area reduces the risk of noncompliance and positions the technical team to respond quickly to changes in the Candidate List or new restrictions under Annex XVII.
