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Details
- European Union
REACH is a binding EU regulation directly applicable as mandatory in all Member States.
Criteria:
Applies to all companies manufacturing or importing chemical substances into the EU market in quantities of ≥ 1 tonne/year.
Also applies to formulators, downstream users, and distributors of chemicals.
Articles (finished products) containing SVHCs above 0.1 % weight by weight must communicate this information to ECHA and recipients.
Exemptions:
Certain substances are partially or fully exempt, including:
Radioactive substances (covered by other legislation).
Non-isolated intermediates.
Waste (not considered a substance under REACH).
Substances used in defense (can be exempted by Member States).
Medicinal, food, and cosmetic products (regulated under sector-specific laws).
Polymers are currently exempt from registration but may become subject to future requirements.
Deep dive
What’s Required
The REACH Regulation (EC No. 1907/2006) is the European Union’s primary chemical safety law, designed to ensure a high level of protection for human health and the environment from the risks posed by chemicals. It governs how substances are manufactured, imported, and used within the EU and requires industry to take responsibility for managing chemical risks.
Key Requirements:
Registration: All chemical substances manufactured or imported into the EU in quantities of 1 tonne or more per year must be registered with the European Chemicals Agency (ECHA).
Evaluation: ECHA and EU Member States assess registration dossiers and testing proposals to ensure compliance and data quality.
Authorisation: Substances of very high concern (SVHCs) require specific authorisation before being placed on the market or used.
Restriction: Certain hazardous substances may be banned or restricted under Annex XVII.
Communication duties: Companies must inform customers and consumers about hazardous substances in products (articles).
Safety data sheets (SDS): Mandatory for hazardous substances and mixtures.
Important Deadlines
June 1, 2007: REACH entered into force.
2010–2018: Phased registration deadlines based on tonnage and hazard level.
Ongoing: Continuous evaluation and updates to the Candidate List and Annexes XIV (Authorisation) and XVII (Restriction).
Current Status
Legal instrument: Regulation (EC) No 1907/2006.
Adopted by: European Parliament and the Council of the European Union.
In force since: June 1, 2007.
Managed by: European Chemicals Agency (ECHA) in Helsinki.
Applies to: All EU and EEA Member States (and Northern Ireland under the NI Protocol).
Objective: Improve protection of human health and the environment while enhancing innovation and competitiveness of the EU chemicals industry.
Revisions: Ongoing under the EU Chemicals Strategy for Sustainability (CSS) to strengthen hazard assessment and data transparency (2025+).
Penalties for Non-Compliance
REACH is enforceable by national authorities in each EU Member State.
Penalties may include:
Fines (can reach several million euros depending on the country).
Product withdrawal or sales bans.
Criminal liability in severe cases (e.g., intentional concealment of hazards).
Example: National enforcement bodies regularly publish cases of non-compliance for missing registration, mislabeling, or unapproved use of SVHCs.
Examples of Known Violations
Germany (2021): A manufacturer was fined €500,000 for failure to register an imported solvent.
France (2022): Retailers sanctioned for selling articles containing SVHCs without disclosure.
ECHA (2023): Publicized enforcement actions under the REACH-EN-FORCE (REF) campaigns; many companies penalized for incomplete safety data sheets and unregistered imports.
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