Apr 23 • 4 min read
REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a European Union regulation that ensures the safe use of chemicals to protect human health and the environment. This guide explains REACH, its importance, Substances of Very High Concern (SVHCs), and the steps to achieve compliance.
REACH, established under Regulation (EC) No 1907/2006, is an EU framework for managing chemical substances in products. It requires companies to assess and control risks from chemicals, promoting safer alternatives and sustainability.
Protect Health and Environment: Minimize risks from hazardous chemicals.
Ensure Safe Use: Require companies to demonstrate chemical safety.
Promote Innovation: Encourage development of safer chemical alternatives.
Restrict Harmful Substances: Ban or limit substances posing unacceptable risks.
REACH shifts the burden of proof to companies to ensure chemical safety, reducing environmental and health risks. It:
Enhances product safety for consumers and workers.
Drives innovation in eco-friendly materials.
Facilitates global trade by aligning with international standards.
Inspires similar regulations worldwide (e.g., UK REACH, China REACH).
REACH applies to chemical substances in:
Industrial Materials: Paints, solvents, construction materials.
Consumer Goods: Textiles, electronics, toys, furniture.
Mixtures and Articles: Products containing chemicals (e.g., plastic additives).
Regulatory Thresholds: Compliance is required for substances manufactured or imported in quantities of 1 tonne or more per year per company.
REACH compliance involves:
Registration: Submit substance data to the European Chemicals Agency (ECHA) for quantities ≥1 tonne/year.
Evaluation: ECHA assesses dossiers for compliance and risk.
Authorization: Obtain approval for using Substances of Very High Concern (SVHCs).
Restriction: Comply with bans or limits on certain substances.
Documentation: Maintain Safety Data Sheets (SDS) and supply chain communication.
Reporting: Notify ECHA of SVHCs in articles (>0.1% w/w).
While REACH is EU-specific, other regions have adopted similar frameworks:
EU REACH: Managed by ECHA, requires registration for substances ≥1 tonne/year.
UK REACH: Post-Brexit, administered by the Health and Safety Executive (HSE), with separate registration requirements.
China REACH: Overseen by the Ministry of Ecology and Environment, focuses on new chemical substances and labeling.
Other Regions: Countries like South Korea (K-REACH) and Turkey (KKDIK) have REACH-like regulations.
Note: Each framework has unique requirements, so businesses must research local rules.
Gather data on substance properties, uses, and supply chain (e.g., via Safety Data Sheets, supplier declarations).
Assess hazards and risks of substances.
Identify substances requiring registration (≥1 tonne/year).
Prepare a registration dossier with substance data, risk assessments, and safety measures.
Submit to ECHA via REACH-IT portal for substances, mixtures, or articles.
Pay registration fees based on company size and substance volume.
ECHA reviews dossiers for completeness and compliance.
Evaluates testing proposals and substance risks.
May request additional data if needed.
Identify if substances are on the SVHC Candidate List or subject to restrictions.
Report SVHCs in articles (>0.1% w/w) to ECHA via SCIP database.
Apply for authorisation to use SVHCs, if necessary.
Receive a registration number upon successful submission (not a certificate).
Update dossiers for changes (e.g., new uses, increased volumes).
Maintain records for at least 10 years and ensure supply chain communication.
Note: REACH does not issue certificates; compliance is proven through registration numbers and documentation.
SVHCs are substances with severe health or environmental risks, such as:
Carcinogenic, mutagenic, or toxic to reproduction (CMR).
Persistent, bioaccumulative, and toxic (PBT).
Very persistent and very bioaccumulative (vPvB).
Other substances of equivalent concern (e.g., endocrine disruptors).
The SVHC Candidate List, managed by ECHA, identifies substances requiring reporting or authorisation. As of January 2025, it contains 240 entries, covering over 300 individual substances (some entries are groups).
Under Article 33, companies must:
Declare SVHCs in articles (>0.1% w/w) to customers and ECHA (via SCIP database).
Provide safe-use information within 45 days of a request.
Frequency: Updated twice yearly (typically June and December/January).
Recent Additions (January 2025): Two substances added, including Diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide (reprotoxic) and Bis(4-chlorophenyl) sulphone (persistent, bioaccumulative).
Proposal Submission: ECHA, EU member states, or national authorities submit an Annex XV dossier proposing a substance.
Public Consultation: ECHA publishes the proposal for a 45-day comment period.
Decision-Making: If unchallenged, the substance is added to the Candidate List. Challenges extend the review.
Authorisation List: SVHCs may be recommended for the Authorisation List, requiring companies to seek approval for continued use.
Non-compliance with REACH can lead to:
Fines and Penalties: Vary by EU member state, potentially in thousands of euros.
Market Restrictions: Bans on selling non-compliant products.
Product Recalls: Mandatory withdrawal of non-compliant goods.
Reputation Damage: Loss of consumer and partner trust.
Legal Action: Lawsuits from authorities or affected parties.
REACH (Regulation (EC) No 1907/2006) is a cornerstone of chemical safety in the EU, ensuring substances are safe for humans and the environment. By following its registration, evaluation, authorisation, and restriction processes, companies can achieve compliance, avoid penalties, and promote sustainability. Stay informed about SVHC updates and global variations to navigate REACH effectively.
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