- REACH Regulation (Registration, Evaluation, Authorisation, and Restriction of Chemicals)
Purpose and Scope:
REACH is the European Union’s regulatory framework for the production, marketing, and use of chemicals, primarily aimed at protecting human health and the environment from the adverse effects of chemicals. Implemented on June 1, 2007, it applies to companies manufacturing or importing at least 1 ton of chemical substances annually within the EU.
The regulation operates on the precautionary principle, requiring companies to demonstrate the safety of chemicals before placing them on the market. Manufacturers and importers must register detailed information about the safe use of chemicals with the European Chemicals Agency (ECHA).
Key Obligations:
- Registration: Every chemical must be registered with ECHA, including detailed information on its physical, chemical, toxicological, and ecotoxicological properties, as well as its uses and safety measures.
- Evaluation: ECHA assesses registered chemicals for risks to human health and the environment, ensuring the accuracy of submitted data and identifying hazardous substances.
- Authorisation: Substances of Very High Concern (SVHC) require special authorisation for use. The SVHC list is regularly updated to restrict harmful substances further.
- Restriction: REACH can limit or prohibit the use of certain chemicals, especially those posing significant risks to health or the environment.
Role of the OECD:
REACH aligns with the chemical safety standards established by the OECD. Its guidelines for testing and evaluating chemicals provide the scientific foundation for REACH’s risk assessment and authorisation processes. The OECD’s harmonisation of chemical testing protocols globally supports the scientific and regulatory framework of REACH.
- RoHS Directive (Restriction of Hazardous Substances)
Purpose and Scope:
RoHS is an EU regulation limiting the use of hazardous substances in electrical and electronic equipment (EEE). Initially implemented in 2003, it aims to mitigate the environmental and health risks of chemicals such as mercury, lead, cadmium, and hexavalent chromium, while improving recyclability and reducing e-waste.
Key Obligations:
- Scope: RoHS restricts the use of 10 hazardous substances in EEE and mandates compliance with CE marking requirements.
- Declaration of Conformity: Manufacturers must issue a Declaration of Conformity, certifying that their products comply with RoHS.
- CE Marking: Only RoHS-compliant products may bear the CE mark, a prerequisite for access to the EU internal market.
- Conflict Minerals Regulations: U.S. and EU
U.S. Regulation: Dodd-Frank Act Section 1502
Purpose and Scope:
The U.S. conflict minerals regulation, established under Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (2010), targets the prevention of armed groups’ financing in the Democratic Republic of Congo (DRC) and neighboring countries. The rule focuses on the sourcing of tin, tantalum, tungsten, and gold (3TG) in supply chains.
Key Obligations:
- Reporting: Publicly traded companies must file annual reports on the origin of 3TG minerals used in their supply chains, ensuring transparency and preventing the use of minerals from conflict zones.
- Auditing: Independent third-party audits are required to verify the source of minerals and enhance supply chain accountability.
EU Regulation: Regulation (EU) 2017/821
Purpose and Scope:
The EU adopted the Conflict Minerals Regulation in 2017, mandating responsible sourcing practices for importers and aligning with the OECD’s Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas.
Key Obligations:
- OECD Guidance: The regulation ensures ethical, transparent, and sustainable trade in conflict minerals, requiring compliance with the OECD’s international due diligence standards.
- Mandatory Reporting: As of 2021, all importers in the EU must report on their conflict minerals sourcing practices, ensuring better risk management within supply chains.
Conclusion
REACH, RoHS, and conflict minerals regulations are vital frameworks in the EU and U.S., aimed at safeguarding human health, protecting the environment, and promoting transparency and accountability in supply chains. Supported by OECD guidelines, these regulations ensure compliance with global standards for responsible production, trade, and sustainability.