The EU Chemicals Legislation
The European Union has developed a comprehensive and integrated system of chemicals legislation to ensure the safe use of chemicals across all sectors.
While REACH and CLP are central pillars, they are part of a much wider legislative landscape that includes sector-specific and horizontal regulations.
Key legislative instruments
- REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals): it ensures that industry is responsible for assessing and managing the risks posed by chemicals.
- CLP (Classification, Labelling and Packaging): it aligns EU hazard communication with the UN’s Globally Harmonised System (GHS).
- BPR (Biocidal Products Regulation): it regulates the use of biocides to protect humans, animals, and materials from harmful organisms.
- Detergents Regulation: it covers labelling and biodegradability of surfactants in cleaning products.
- Fertilising Products Regulation: it ensures safety and environmental compatibility of fertilisers.
Other relevant Regulations are the Explosives Precursors Regulation, the Drug Precursors Regulation and the Good Laboratory Practice (GLP).
REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals
REACH is the cornerstone of EU chemicals policy. It was adopted in 2006 and came into force in 2007, replacing a fragmented system of over 40 laws with a single, coherent framework.
The main goal of REACH is to protect human health and the environment from potential risks posed by chemical substances. It also encourages the use of alternative testing methods that avoid animal testing, supports innovation, and helps maintain a competitive chemicals market within the EU.
Under REACH, the responsibility lies with companies to make sure the chemicals they produce, import, or use do not pose unacceptable risks. This means businesses must gather data on the substances they deal with, assess their safety, and take appropriate measures to manage any risks.
The regulation sets out clear procedures for collecting information about the properties of chemicals. It also gives authorities the power to limit or ban the use of substances that are found to be particularly hazardous, or to require special permission before they can be used or sold.
Key Objectives:
- Protect human health and the environment
- Promote alternative methods for hazard assessment
- Enhance innovation and competitiveness in the EU chemical industry
Core Elements:
- Registration: companies must register substances they manufacture or import in quantities equal to or over 1 tonne per year via submitting their registration dossiers to the European Chemicals Agency (ECHA).
- Evaluation: ECHA and Member States assess the quality of registration dossiers, testing proposals and can select substances for further investigations.
- Authorisation: it ensures that substances of Very High Concern (SVHCs) are allowed on the market only after being granted an authorisation for the specific use from the European Commission.
- Restriction: to limit or ban the manufacture, placing on the market or use of substances.
HERA’s approach aligns closely with these topics, particularly in its emphasis on:
- Industry responsibility for safety
- Risk-based assessments (hazard + exposure)
- Transparent communication
- Collaboration across the supply chain
- Compatibility with international frameworks
EU Chemicals Legislation Timeline (1967-2025)
Directive 67/548/EEC (Directive)
Initial Dangerous Substances Directive: classification, packaging, and labelling rules.
Directive 79/831/EEC (Directive)
Sixth Amendment: introduced notification of new substances and EINECS.
Seveso Directive (Directive)
Major accident prevention for dangerous substances.
Directive 88/379/EEC (Directive)
Dangerous Preparations Directive: classification and labelling of mixtures.
Directive 92/32/EEC (Directive)
Seventh Amendment: strengthened notification and added environmental hazard classification.
Regulation 793/93/EEC (Regulation)
Risk assessment of existing substances based on priority lists.
Directive 98/8/EC (Directive)
Biocidal Products Directive: regulation of biocidal products and active substances.
Directive 1999/45/EC (Directive)
Recast Dangerous Preparations Directive: updated rules for mixtures.
Regulation 648/2004/EC (Regulation)
Detergents Regulation: biodegradability and labelling requirements.
REACH Regulation 1907/2006/EC (Regulation)
Registration, Evaluation, Authorisation and Restriction of Chemicals.
CLP Regulation 1272/2008/EC (Regulation)
Classification, Labelling and Packaging aligned with GHS.
Regulation 528/2012/EU (Regulation)
Biocidal Products Regulation: harmonised authorisation and data sharing.
Chemicals Strategy for Sustainability (Policy)
Part of EU Green Deal aiming for a toxic-free environment.
CLP Revision (Regulation)
New hazard classes including endocrine disruptors.
REACH Revision (Regulation)
Expected update to broaden scope and strengthen restrictions