REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Union’s comprehensive chemical regulatory framework established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council, adopted on 18 December 2006. It governs the manufacture, import, placing on the market, and use of chemical substances within the EU to ensure a high level of protection for human health and the environment. REACH requires companies to register substances they manufacture or import in quantities of one tonne or more per year with the European Chemicals Agency (ECHA), conduct safety assessments, and communicate information throughout the supply chain.
REACH Regulation (REACH) Compliance Guide
The REACH Regulation (EC) No 1907/2006 is the cornerstone of the EU’s chemical safety policy, legally binding all manufacturers, importers, and downstream users of chemical substances in the European Economic Area (EEA). This guide provides a detailed overview of the regulation’s scope, key definitions, obligations, compliance timelines, penalties, and enforcement mechanisms to help compliance managers fully understand and meet their legal requirements.
Legal Basis and Scope of REACH
REACH Regulation is based on Article 95 of the Treaty establishing the European Community (now Article 114 TFEU), aiming to harmonize chemical legislation across Member States. It applies to all chemical substances manufactured, imported, or placed on the EU market in quantities of one tonne or more per year, including substances in preparations and articles.
The regulation covers:
- Manufacturers producing chemical substances within the EU.
- Importers bringing chemical substances into the EU market from outside.
- Downstream users who use substances in industrial or professional activities.
- Distributors who supply substances or mixtures to third parties.
Exemptions include radioactive substances, certain substances under customs supervision, and substances used in medicinal products regulated under other EU laws.
Key Definitions from REACH Regulation
| Term | Definition (Plain English) | Article Reference |
|---|---|---|
| Substance | A chemical element and its compounds in the natural state or obtained by any manufacturing process. | Article 3(1) |
| Preparation | A mixture or solution composed of two or more substances. | Article 3(2) |
| Article | An object with a specific shape or design which determines its function more than its chemical composition. | Article 3(3) |
| Manufacturer | A natural or legal person who manufactures a substance within the EU. | Article 3(9) |
| Importer | A natural or legal person established in the EU who imports a substance from outside the EU. | Article 3(10) |
| Downstream User | A natural or legal person using a substance, either on its own or in a preparation, in the course of industrial or professional activities. | Article 3(13) |
| Registration | The process of submitting information about a substance to ECHA to demonstrate safe use. | Article 10 |
Obligations Under REACH Regulation
Compliance with REACH Regulation involves several key obligations for companies:
- Registration: Manufacturers and importers must register substances manufactured or imported in quantities of one tonne or more per year with the European Chemicals Agency (ECHA). Registration dossiers must include information on properties, uses, and safe handling.
- Evaluation: ECHA and Member States evaluate registration dossiers and testing proposals to ensure compliance and assess risks.
- Authorisation: Substances of very high concern (SVHCs) listed in Annex XIV require authorisation before use or placing on the market.
- Restriction: Certain substances may be restricted or banned under Annex XVII due to unacceptable risks.
- Communication in the Supply Chain: Safety Data Sheets (SDS) must be provided to downstream users and consumers for hazardous substances and mixtures.
- Notification of Substances in Articles: If a substance of very high concern is present in articles above 0.1% weight by weight and exceeds one tonne per year per manufacturer or importer, notification to ECHA is required.
Plain English Summaries of Key Articles
Article 5 – Registration Requirement
Any manufacturer or importer producing or importing a substance in quantities of one tonne or more per year must register that substance with ECHA before placing it on the market. Registration includes submitting technical dossiers with safety data.
Article 7 – Duty to Communicate Information
Suppliers must provide safety information to customers and consumers, including Safety Data Sheets for hazardous substances and mixtures, ensuring safe use throughout the supply chain.
Article 31 – Safety Data Sheets
Manufacturers and importers must provide a Safety Data Sheet (SDS) for substances or mixtures classified as hazardous under the CLP Regulation (Regulation (EC) No 1272/2008), updated regularly with new information.
Article 33 – Notification of Substances in Articles
Producers or importers of articles containing substances of very high concern (SVHCs) above 0.1% w/w and exceeding one tonne per year must notify ECHA, enabling tracking and risk management.
Article 56 – Restriction of Dangerous Substances
The use or placing on the market of substances posing unacceptable risks can be restricted or banned by the European Commission following a risk assessment and consultation process.
REACH Compliance Timeline
The REACH Regulation (EC) No 1907/2006 established staggered deadlines for registration and compliance based on tonnage bands and substance hazard categories. The following table summarizes key deadlines:
| Deadline | Requirement | Applicable Substances | Reference |
|---|---|---|---|
| 1 December 2008 | Initial registration deadline | Substances ≥ 1000 tonnes/year; CMR substances ≥ 1 tonne/year; Substances ≥ 100 tonnes/year classified as dangerous | Article 23(1) |
| 1 June 2013 | Second registration deadline | Substances ≥ 100 tonnes/year not registered by 2008 deadline | Article 23(2) |
| 1 June 2018 | Third registration deadline | Substances ≥ 1 tonne/year not registered by previous deadlines | Article 23(3) |
| Ongoing | Authorisation and Restriction updates | SVHCs added periodically to Annex XIV and substances restricted under Annex XVII | Articles 56, 58 |
Penalties and Enforcement Mechanisms
Non-compliance with the REACH Regulation can result in significant penalties, enforced by national authorities in each Member State. Penalties vary but can include fines, product recalls, and bans on placing substances on the market.
| Type of Non-Compliance | Potential Penalty | Enforcement Authority | Reference |
|---|---|---|---|
| Failure to register substances | Fines up to €500,000 per infringement; prohibition on placing substance on market | National Competent Authorities | Article 126 |
| Failure to provide Safety Data Sheets | Fines up to €250,000; possible product withdrawal | National Competent Authorities | Article 126 |
| Non-notification of SVHCs in articles | Fines up to €300,000; mandatory corrective actions | National Competent Authorities | Article 126 |
| Use of restricted substances | Fines up to €1,000,000; criminal sanctions in severe cases | National Competent Authorities / Courts | Article 126 |
How to Achieve REACH Compliance
To comply with REACH Regulation (EC) No 1907/2006, companies should follow these steps:
- Identify substances: Determine which substances your company manufactures, imports, or uses and in what quantities.
- Check registration status: Verify if substances are already registered by you or other actors in the supply chain.
- Prepare registration dossiers: Collect and compile data on substance properties, uses, and risk management measures.
- Submit registration to ECHA: Use the ECHA REACH-IT portal to submit dossiers before applicable deadlines.
- Communicate safety information: Provide Safety Data Sheets and other relevant information downstream.
- Monitor updates: Stay informed about changes to the Candidate List of SVHCs, Annex XIV authorisation list, and Annex XVII restrictions.
- Implement risk management: Apply necessary controls and authorisations to ensure safe use.
Failure to comply can lead to enforcement actions and significant financial penalties as outlined above.
Truth anchor: The REACH Regulation (EC) No 1907/2006 entered into force on 1 June 2007 and established registration deadlines starting from 1 December 2008. Non-compliance penalties can reach up to €1,000,000 per infringement depending on the Member State’s enforcement framework (Article 126).
Frequently Asked Questions
What substances need to be registered under REACH?
Any chemical substance manufactured or imported into the EU in quantities of one tonne or more per year must be registered with ECHA. This includes substances on their own, in mixtures, or in articles if they are intended to be released.
Does REACH apply to imported articles?
REACH applies to substances contained in imported articles only if the substance is intended to be released during normal use or if it is a substance of very high concern (SVHC) present above 0.1% weight by weight and exceeds one tonne per year per importer.
What are the deadlines for registering substances under REACH?
Registration deadlines depend on tonnage and hazard classification. The main deadlines were 1 December 2008, 1 June 2013, and 1 June 2018. New substances must be registered before being placed on the market.
What penalties can my company face for non-compliance?
Penalties vary by Member State but can include fines up to €1,000,000, product recalls, and bans on placing substances on the market. Criminal sanctions may apply in severe cases.
How do I know if a substance is on the Candidate List of SVHCs?
The European Chemicals Agency (ECHA) publishes and regularly updates the Candidate List of substances of very high concern on its website. Companies must monitor this list to comply with authorisation and notification obligations.
What information must be included in a Safety Data Sheet (SDS)?
An SDS must include detailed information on the substance’s properties, hazards, safe handling, storage, and emergency measures, following the format specified in Annex II of REACH and aligned with the CLP Regulation.
Where can I submit my registration dossier?
Registration dossiers must be submitted electronically via the ECHA REACH-IT portal. The portal provides guidance and tools to prepare and upload dossiers.
Ready to ensure your company’s REACH Regulation compliance? Use our REACH Registration Compliance Tool to assess your obligations, prepare your dossier, and meet all deadlines. Clicking the link will take you to a step-by-step interactive tool that guides you through your registration requirements and helps avoid costly penalties.