REACH Regulation

The four REACH processes

• Registration. Manufacturers and importers of substances in quantities equal to or greater than one tonne per year submit to ECHA a dossier with physicochemical, toxicological and ecotoxicological information, the identified uses and, from ten tonnes, a report on chemical safety with exposure scenarios; since 2020, specific information on nanoforms must be included.
• Assessment. ECHA checks the conformity of dossiers and test proposals, and Member States assess substances that may pose a risk in order to clarify information and propose measures.
• Authorization. Substances of very high concern are identified and included in the candidate list; those that are moved to Annex XIV can only be used with specific, temporary and conditional authorization, which encourages their substitution .
• Restriction. Annex XVII prohibits or limits the manufacture, marketing or use of substances, mixtures and articles when they pose an unacceptable risk, such as asbestos , certain phthalates, lead in some uses or diisocyanates without specific training.
• Communication in the supply chain. Safety data sheets with attached exposure scenarios, information on substances from the candidate list in articles, and flow of information on uses between suppliers and downstream users.
• Agency and authorities. ECHA manages the processes and public databases, and national authorities monitor compliance; in Spain, Law 8/2010 establishes the sanctions regime.

Obligations of companies according to their role

Manufacturers and importers must register substances, classify and label them according to CLP, prepare safety data sheets and exposure scenarios, and, where applicable, apply for authorization. Downstream users (formulators, industrial companies, and professionals who use substances and mixtures in their processes) must verify that their uses are covered by the supplier’s exposure scenarios, apply the operating conditions and risk management measures described, inform the supplier of any uncovered uses or prepare their own chemical safety report, comply with the restrictions and conditions of authorizations, and pass the information down the supply chain. Distributors must retain and transmit safety data sheets and information on substances on the candidate list.

Producers and importers of goods must notify ECHA of substances on the Candidate List present in concentrations exceeding 0.1 percent by weight and in quantities exceeding one tonne per year, inform their customers, and, since 2021, report articles containing these substances to the SCIP database. The Safety Data Sheet (SDS), whose updated format is established by Regulation (EU) 2020/878, is the key document linking REACH with occupational health and safety.

Relationship with occupational risk prevention

• Information for the assessment. The safety data sheet and exposure scenarios provide the classification, limit values, risk management measures and protective equipment that must be considered in the assessment in accordance with Royal Decree 374/2001.
• Substitution. The authorization regime and the list of candidates guide the substitution of the most dangerous substances, a priority obligation in Royal Decree 665/1997 and Royal Decree 374/2001.
• Restrictions with preventive content. Certain restrictions in Annex XVII, such as the one requiring specific training for the use of diisocyanates, have a direct effect on the organization of prevention.
• Consistency and limits. Exposure scenario measures do not replace occupational risk assessment, which must consider the actual conditions of the job and may require additional measures.
• Intermediate users. Companies must verify that their uses are covered and report those that are not, which requires an up-to-date inventory of products and uses.
• Records and traceability. Safety data sheets must be kept and updated, and their information must reach exposed persons in an understandable way.

Organizational application: how to comply with REACH through prevention

1. Determine the company’s role for each substance and mixture (manufacturer, importer, downstream user, distributor, producer of articles) and its specific obligations.
2. Maintain an up-to-date inventory of substances, mixtures, and articles with their safety data sheets, CLP classifications, uses, and exposure scenarios.
3. Verify that the company’s uses are covered by the exposure scenarios and apply the operating conditions and risk management measures, communicating the uncovered uses to the supplier.
4. Verify the presence of substances from the candidate list, Annex XIV and Annex XVII, and plan for substitution or application for authorization.
5. Integrate the information from the fact sheets and scenarios into the risk assessment for chemical and carcinogenic agents, and adapt the measures to the actual conditions of the job.
6. Inform and train exposed individuals with the information on the fact sheets and comply with the restrictions through training requirements.
7. Review the inventory and records with each supplier update and with changes to the candidate list and REACH annexes.

Preventive management software allows you to maintain an inventory of chemical products with their safety data sheets and exposure scenarios, control versions and updates, identify substances subject to authorization or restriction, link information with risk assessment and job positions, and record training and information provided to exposed individuals.

Limits and common mistakes

1. To assume that REACH only affects manufacturers and importers and to ignore the obligations of downstream users.
2. Using outdated safety data sheets or those without exposure scenarios and not checking the coverage of uses.
3. Confusing risk management measures for the exposure scenario with the occupational risk assessment of the job.
4. Do not check for the presence of substances from the candidate list and Annex XIV, nor plan for their replacement.
5. Ignorance of restrictions with a direct impact on prevention, such as mandatory training for diisocyanates.
6. Do not transmit the information from the fact sheets to the exposed persons in an understandable way.

REACH is a lengthy and evolving regulation; this fact sheet is for informational purposes and should be supplemented by consulting the ECHA and the current texts.

Regulatory and reference framework

• Regulation (EC) 1907/2006 (REACH) . Registration, evaluation, authorisation and restriction of chemical substances and mixtures.
• Regulation (EC) 1272/2008 (CLP) . Classification, labelling and packaging of substances and mixtures.
• Regulation (EU) 2020/878 . Amends Annex II to REACH; format and content of safety data sheets.
• Law 8/2010, of March 31. Sanctioning regime applicable in Spain to non-compliance with the REACH and CLP Regulations.
• ECHA. Understanding REACH . Institutional explanation from the European Chemicals Agency.
• Royal Decree 374/2001, of April 6. Protection against risks related to chemical agents during work.
• Royal Decree 665/1997, of May 12. Protection against exposure to carcinogenic agents during work.

The list of candidates and Annexes XIV and XVII of REACH are updated periodically; ECHA publishes their current versions and databases for consultation.