Chemicals form the foundation of virtually every industrial and consumer product — from pharmaceuticals and paints to electronics, fuels, and food packaging. While chemical innovation drives economic growth, the inherent risks associated with toxic, flammable, corrosive, or environmentally persistent substances necessitate robust regulatory control.

Regulatory compliance for chemicals worldwide ensures that substances are manufactured, handled, transported, and used safely, protecting human health, the environment, and trade integrity.
This global compliance system spans chemical registration, classification, labeling, transport, and waste management, shaped by decades of scientific advancement and international cooperation.

1. Purpose and Scope of Chemical Regulation

The main objectives of chemical regulation are to:

• Safeguard human health from exposure to hazardous chemicals.

• Protect the environment by controlling releases of pollutants, persistent organic pollutants (POPs), and ozone-depleting substances.

• Promote safe manufacturing and handling across industries.

• Ensure transparent information flow through labeling, safety data sheets (SDS), and hazard communication systems.

• Facilitate global trade and innovation through harmonized standards and mutual recognition of data.

Chemical regulations cover raw substances, mixtures, and articles that release chemicals during use or disposal, spanning the full product lifecycle — from synthesis and importation to end-of-life treatment.

2. International Framework and Harmonization

Several international conventions and frameworks form the backbone of global chemical governance:

a. United Nations (UN) Initiatives

• Globally Harmonized System of Classification and Labelling of Chemicals (GHS):
  The UN GHS provides a unified system for hazard classification, labeling, and safety data sheets. It harmonizes terms like “flammable,” “toxic,” or “corrosive” and standardizes pictograms, signal words, and hazard statements.
  Nearly all major jurisdictions (EU, U.S., China, Japan, Korea, etc.) have implemented GHS-aligned regulations.

• Strategic Approach to International Chemicals Management (SAICM):
  A global policy framework under the UN Environment Programme (UNEP) aimed at ensuring the sound management of chemicals throughout their life cycle.

• Basel, Rotterdam, and Stockholm Conventions:

  • Basel Convention (1989): Controls transboundary movement of hazardous waste.

  • Rotterdam Convention (1998): Requires prior informed consent (PIC) for trade in certain hazardous chemicals and pesticides.

  • Stockholm Convention (2001): Bans or restricts persistent organic pollutants (POPs).

• Montreal Protocol (1987): Regulates ozone-depleting substances such as CFCs and halons.

These treaties establish the international legal foundation for national chemical control systems.

3. Major Regional Regulatory Frameworks

a. European Union (EU)

The European Union operates the most comprehensive chemical regulatory system in the world through REACH, CLP, and related regulations.

1. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) — Regulation (EC) No 1907/2006
REACH requires companies to:

• Register all chemical substances manufactured or imported in quantities of ≥1 tonne per year with the European Chemicals Agency (ECHA).

• Provide detailed toxicological, ecotoxicological, and physicochemical data.

• Conduct chemical safety assessments and prepare Safety Data Sheets (SDS).

• Identify and manage risks through risk management measures (RMMs).

• Comply with restrictions and authorization procedures for Substances of Very High Concern (SVHCs) such as carcinogens, mutagens, and reproductive toxins (CMRs).

2. CLP (Classification, Labelling and Packaging) — Regulation (EC) No 1272/2008
Implements the UN GHS within the EU, defining how substances and mixtures must be labeled.

• Standardizes pictograms, signal words (“Danger” / “Warning”), and hazard statements.

• Requires classification before placing products on the EU market.

• Obligates notification to the ECHA Classification and Labelling Inventory.

3. Biocidal Products Regulation (BPR) — Regulation (EU) No 528/2012
Regulates chemicals used to control harmful organisms (e.g., disinfectants, insecticides).

4. POPs Regulation — Regulation (EU) 2019/1021
Implements the Stockholm Convention on persistent organic pollutants.

5. PIC Regulation — Regulation (EU) 649/2012
Implements the Rotterdam Convention, requiring prior consent before exporting certain hazardous chemicals.

Together, these frameworks ensure the EU operates under a “no data, no market” principle — meaning substances cannot be sold without safety evidence.

b. United States (U.S.)

The United States has a long-established, sectoral system of chemical regulation governed primarily by the Environmental Protection Agency (EPA) and other federal agencies.

1. Toxic Substances Control Act (TSCA)

• Administered by the EPA, TSCA regulates chemical substances not covered by other laws (e.g., pesticides, drugs, food additives).

• The Lautenberg Chemical Safety Act (2016) modernized TSCA, requiring risk-based evaluations of existing chemicals, prioritization of high-risk substances, and greater transparency.

• Manufacturers and importers must submit Premanufacture Notices (PMNs) for new chemicals.

2. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

• Governs registration, distribution, and use of pesticides and antimicrobial chemicals.

3. Clean Air Act (CAA) & Clean Water Act (CWA):

• Regulate air and water emissions of hazardous substances.

4. Hazard Communication Standard (HCS) — OSHA 29 CFR 1910.1200

• Aligns U.S. workplace chemical labeling with the UN GHS.

• Requires standardized Safety Data Sheets (SDS) and hazard pictograms for all chemicals in the workplace.

5. Resource Conservation and Recovery Act (RCRA):

• Manages hazardous waste generation, transportation, and disposal.

The U.S. framework is risk-based and data-driven, emphasizing continuous review, public disclosure, and risk mitigation across the chemical supply chain.

c. Canada

Canada’s chemical compliance system is built around the Canadian Environmental Protection Act (CEPA) and the Chemicals Management Plan (CMP).

• CEPA (1999): Requires pre-market notification and risk assessment of new substances.

• Domestic Substances List (DSL): Identifies chemicals permitted in commerce; new substances must undergo New Substances Notification (NSN).

• Workplace Hazardous Materials Information System (WHMIS): Implements GHS-aligned classification and labeling requirements for workplace chemicals.

• Pest Control Products Act (PCPA): Regulates pesticides.

Canada’s system integrates health and environmental protection through coordinated assessments by Environment and Climate Change Canada (ECCC) and Health Canada.

d. Asia-Pacific Region

China

China’s chemical regulation framework has undergone significant modernization:

• MEE Order No. 12 (Measures for the Environmental Management Registration of New Chemical Substances) — replaced Order No. 7 in 2021.

• Requires registration of new substances and submission of safety data to the Ministry of Ecology and Environment (MEE).

• China GHS: Implemented via GB 30000 series standards for classification and labeling.

• Hazardous Chemicals Catalogue (2015) lists substances subject to stricter controls.

Japan

• Chemical Substances Control Law (CSCL): Regulates new and existing chemicals, requiring pre-market notification and risk evaluation.

• Industrial Safety and Health Law (ISHL): Addresses workplace exposure and labeling.

• Poisonous and Deleterious Substances Control Law (PDSCL): Controls highly hazardous substances.
  Japan aligns closely with GHS and emphasizes environmental risk management.

South Korea

• K-REACH (Act on Registration and Evaluation of Chemicals, 2015): Mirrors EU REACH, requiring registration of substances ≥1 tonne/year.

• KOSHA GHS Regulations: Mandate classification, labeling, and SDS for workplace safety.

• CCA (Chemicals Control Act): Governs management of hazardous substances and accident prevention.

Australia and New Zealand

• Australia: Administered by AICIS (Australian Industrial Chemicals Introduction Scheme) since 2020. Introducers must categorize chemicals and register them before use.

• New Zealand: Governed by the Hazardous Substances and New Organisms Act (HSNO) and EPA NZ, implementing GHS-aligned classification and labeling.

e. Latin America

Chemical management in Latin America is evolving rapidly, with several countries introducing REACH-like systems:

• Brazil: Developing a national chemicals management law (Proquimica) to create a centralized inventory.

• Mexico: Implements GHS under NOM-018-STPS-2015, and controls hazardous substances under SEMARNAT and COFEPRIS.

• Chile and Colombia: Introducing inventory and registration systems aligned with GHS and international conventions.

• Argentina: Follows the Mercosur GHS Technical Regulation for classification and labeling.

f. Middle East and Africa

• Turkey: Implemented KKDIK Regulation (2017) — Turkey’s version of REACH — requiring registration, evaluation, and authorization of chemicals.

• Gulf Cooperation Council (GCC): Developing harmonized GHS-based frameworks across member states.

• South Africa: Enforces the Hazardous Substances Act (15/1973) and GHS-aligned workplace labeling (2021) under the Department of Employment and Labour.

• Egypt and Morocco: Introduced GHS implementation roadmaps and chemical inventory programs.

4. Common Global Compliance Elements

Across jurisdictions, several recurring principles define chemical regulatory compliance:

5. Emerging Trends and Challenges

The global chemical regulatory landscape continues to evolve, driven by new technologies, sustainability goals, and public expectations:

• Convergence of REACH-like Systems: Countries including China, Turkey, South Korea, and Brazil are adopting REACH-inspired legislation, promoting global harmonization.

• Digitalization of Compliance: Electronic registration systems, online SDS databases, and digital product passports streamline compliance monitoring.

• Sustainable Chemistry & Circular Economy: Regulations now emphasize life-cycle management, recyclability, and substitution of hazardous substances with safer alternatives.

• Endocrine Disruptors and PFAS Regulation: Authorities worldwide are tightening controls on per- and polyfluoroalkyl substances (PFAS) and other persistent contaminants.

• Nanomaterials and Biotechnology: Emerging areas that challenge conventional testing and risk assessment methods.

• Data Transparency and AI: Machine learning is being applied to predict toxicity, while regulations demand open access to non-confidential data.

6. Conclusion

Regulatory compliance for chemicals is a vital component of global public health, environmental stewardship, and sustainable industrial development. From the EU’s REACH and CLP Regulations to the U.S. TSCA and Asia’s REACH-like frameworks, nations worldwide are converging toward a unified principle: “No safety, no market.”

For manufacturers and importers, compliance is no longer a static legal requirement but a continuous process — involving scientific evaluation, data sharing, transparency, and sustainability commitments.

As global supply chains grow increasingly interconnected and as new substances and technologies emerge, the future of chemical regulation will center on innovation that is inherently safe, traceable, and sustainable, ensuring that the benefits of chemistry continue to serve society without compromising health or the environment.

Do not hesitate to contact us directly to talk about your challenges regarding the global regulatory compliance for chemicals.