11.2 REACH regulations

REACH regulations are a comprehensive EU framework for chemical safety, implemented in 2007. They aim to protect human health and the environment by shifting the burden of proof for chemical safety to industry, promoting responsible production and use of chemicals in green manufacturing.

REACH ensures comprehensive information on chemical hazards, promotes safer alternatives, enhances innovation in green chemistry, and improves transparency in supply chains. It affects various industries, including chemical manufacturing, automotive, electronics, and textiles, with global impact beyond the EU.

Overview of REACH regulations

• REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) represents a comprehensive EU regulatory framework for chemical safety
• Implemented in 2007 to protect human health and the environment from hazardous substances used in manufacturing processes
• Shifts the burden of proof for chemical safety from regulatory authorities to industry, promoting responsible production and use of chemicals in green manufacturing

Key objectives of REACH

• Ensures comprehensive information on hazards and risks of chemicals used in EU markets
• Promotes the development and use of safer alternatives to hazardous substances in manufacturing processes
• Enhances innovation and competitiveness in the EU chemicals industry by encouraging green chemistry practices
• Improves transparency in chemical supply chains, fostering better communication between manufacturers, importers, and downstream users

Scope and applicability

Industries affected

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Top images from around the web for Industries affected

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• Chemical manufacturing sector faces the most significant impact due to extensive testing and registration requirements
• Automotive industry must adapt to restrictions on certain substances used in vehicle components
• Electronics manufacturers need to find alternatives for restricted substances in circuit boards and other components
• Textile industry must phase out certain dyes and treatments containing hazardous chemicals

Geographical coverage

• Applies to all 27 EU member states, creating a unified chemical regulation across the European single market
• Impacts non-EU companies exporting to the EU market, requiring them to comply with REACH regulations
• European Economic Area (EEA) countries (Norway, Iceland, Liechtenstein) have also adopted REACH principles
• Influences global chemical regulations as other countries develop similar frameworks (South Korea's K-REACH)

Registration process

Pre-registration requirements

• Manufacturers and importers must submit basic information about substances produced or imported in quantities over 1 tonne per year
• Includes substance identification, company details, and intended registration deadline
• Allows companies to benefit from extended registration deadlines and participate in Substance Information Exchange Forums (SIEFs)
• Helps identify potential registrants for the same substance, facilitating data sharing and cost reduction

Full registration steps

• Gather comprehensive information on the substance's properties, hazards, and safe use
• Conduct Chemical Safety Assessment (CSA) for substances manufactured or imported in quantities over 10 tonnes per year
• Prepare and submit a technical dossier to the European Chemicals Agency (ECHA) via the REACH-IT portal
• Pay registration fees based on company size and tonnage band of the substance
• Await confirmation of registration completion from ECHA before manufacturing or importing can commence

Evaluation of chemicals

Dossier evaluation

• ECHA reviews all testing proposals submitted by registrants to ensure animal testing is minimized
• Compliance checks conducted on at least 5% of registration dossiers in each tonnage band
• Focuses on the quality and completeness of information provided in registration dossiers
• May result in requests for additional information or testing if gaps or inconsistencies are identified

Substance evaluation

• Member State Competent Authorities evaluate selected substances of potential concern
• Assesses risks to human health and the environment based on all available information
• Can lead to requests for further information from registrants to clarify concerns
• May result in recommendations for risk management measures or further regulatory actions (authorization, restriction)

Authorization procedure

Substances of very high concern

• Identified based on specific hazard criteria (carcinogenic, mutagenic, toxic for reproduction, persistent, bioaccumulative)
• Placed on the Candidate List for potential inclusion in Annex XIV (Authorization List)
• Subject to communication requirements throughout the supply chain
• Gradual phase-out unless specifically authorized for particular uses

Application for authorization

• Companies must apply for authorization to continue using Annex XIV substances after the sunset date
• Applications must include a Chemical Safety Report and analysis of possible alternatives
• Socio-economic analysis required to justify continued use if no suitable alternatives exist
• Authorization granted for a limited time period, subject to review and potential withdrawal

Restriction mechanism

Banned substances

• Substances listed in Annex XVII cannot be manufactured, placed on the market, or used unless they meet specific conditions
• Includes well-known hazardous substances (asbestos, mercury compounds)
• Restrictions may apply to all uses or specific applications of a substance
• Regular updates to Annex XVII as new risks are identified and evaluated

Conditions of use

• Some substances may be restricted only for certain uses or concentration limits
• Specific labeling or packaging requirements may be imposed as conditions for use
• Time-limited derogations may be granted for essential uses while alternatives are developed
• Conditions aim to balance risk management with socio-economic considerations

Roles and responsibilities

Manufacturers vs importers

• Manufacturers produce substances within the EU and are responsible for registration and safety assessments
• Importers bring substances into the EU from non-EU countries and have similar obligations to manufacturers
• Both must ensure compliance with REACH requirements before placing substances on the EU market
• Responsible for communicating safety information down the supply chain

Downstream users

• Companies that use chemicals in their industrial or professional activities
• Must implement risk management measures communicated by suppliers
• Can provide information on uses to suppliers to ensure they are covered in registration dossiers
• May need to conduct their own Chemical Safety Assessment for uses not covered by suppliers

Distributors

• Store and place substances on the market for third parties
• Responsible for passing information both up and down the supply chain
• Must retain and provide certain information for at least 10 years after the last supply
• Play a crucial role in ensuring traceability of chemicals throughout the supply chain

Information requirements

Safety data sheets

• Standardized document providing comprehensive safety information for hazardous substances
• Must be provided free of charge to downstream users and distributors
• Includes 16 sections covering identification, hazards, composition, handling, and regulatory information
• Updated when new information on hazards or risk management measures becomes available

Supply chain communication

• Two-way flow of information between suppliers and customers about substance properties and safe use
• Upstream communication of uses and exposure scenarios from downstream users
• Downstream communication of extended Safety Data Sheets for registered substances
• Specific communication requirements for Substances of Very High Concern in articles

Compliance and enforcement

Penalties for non-compliance

• Member States determine and impose penalties for REACH violations
• Fines can range from thousands to millions of euros depending on the severity of the infringement
• Possible criminal prosecution for serious violations in some jurisdictions
• Potential market withdrawal of non-compliant products and reputational damage

Inspection procedures

• National enforcement authorities conduct regular inspections of companies
• REACH-EN-FORCE projects coordinate EU-wide enforcement actions on specific aspects of REACH
• Inspections may involve document checks, site visits, and product sampling
• Cooperation between customs authorities and REACH enforcers to monitor imports

Impact on green manufacturing

Promotion of safer alternatives

• Encourages research and development of less hazardous substances and greener production processes
• Substitution principle requires companies to replace SVHCs with safer alternatives when available
• Drives innovation in green chemistry and sustainable product design
• Creates market opportunities for companies developing eco-friendly alternatives

Waste reduction strategies

• Improved knowledge of chemical properties leads to more efficient use and reduced waste generation
• Enhanced communication in the supply chain facilitates better waste management practices
• Restrictions on hazardous substances result in cleaner waste streams and improved recyclability
• Promotes circular economy principles by considering the entire lifecycle of chemicals

REACH vs other regulations

Comparison with RoHS

• RoHS (Restriction of Hazardous Substances) focuses specifically on electrical and electronic equipment
• REACH has a broader scope covering all chemical substances in various industries
• RoHS sets maximum concentration values for specific substances, while REACH uses various regulatory tools
• Both regulations complement each other in promoting safer products and manufacturing processes

Global chemical regulations

• REACH has influenced the development of similar regulations worldwide (South Korea's K-REACH, China's MEP Order No. 7)
• US Toxic Substances Control Act (TSCA) reformed in 2016 to align more closely with REACH principles
• Differences in implementation and scope create challenges for global companies
• Efforts towards international harmonization of chemical regulations (UN Globally Harmonized System)

Future developments

Potential amendments

• Ongoing review process to assess the effectiveness of REACH and identify areas for improvement
• Consideration of extending REACH to cover polymers, currently exempt from registration
• Proposals to strengthen requirements for nanomaterials and endocrine disruptors
• Potential simplification of registration process for low-volume substances to reduce burden on SMEs

Emerging concerns

• Increasing focus on mixture toxicity and combined effects of multiple chemicals
• Growing attention to microplastics and their potential regulation under REACH
• Addressing challenges of regulating chemicals in recycled materials to support circular economy
• Adapting REACH to cover new technologies and materials (3D printing, advanced materials)