Table 2.

Acute Systemic Toxicity Regulatory Agencies and Relevant Statutes and Regulations

Country	Chemical Sector	Regulatory Agencies	Statutes and Regulations
Brazil	Consumer Products (Antimicrobial/disinfect-tant)	National Health Surveillance Agency	Resolution RDC 14/2007 Approves the technical regulation for sanitizing products with antimicrobial action, harmonized within the scope of Mercosur and gives other arrangements of 28 February 2007. Resolution RDC 34/2010 Technical regulation for sanitizing disinfectant products of 16 August 2010. Resolution RDC 35/2010 Provides for the technical regulation for products with antimicrobial action used in critical articles and semi-critical of 15 August 2010. Resolution RDC 59/2010 Provides for the procedures and technical requirements for the notification and registration of sanitizing products and other provisions of 17 December 2010.
	Consumer Products (Toys/school supplies)	National Institute of Metrology, Quality and Technology	Law 9933/1 Ministry of Development Industry and Foreign Trade. (2010). Ordinance No. 481, of 07 December 2010 (toys). Ministry of Development Industry and Foreign Trade. (2016). Ordinance No. 563, of 29 December 2016 (school supplies).
	Cosmetics	National Health Surveillance Agency	Resolution RDC 7/2015. Technical requirements for the regularization of products from personal care, cosmetics and perfumes and other provisions. Resolution RDC 15/ 2015. Technical requirements for the pre-market approval of personal hygiene products, cosmetics and fragrances for children. Resolution RDC 409/2020. Technical Requirements for authorization of products to modify hair format by changing its chemical structure.
	Industrial Chemicals	Secretary of Labor and Employment, Ministry of Economy	Ministerial Ordinance nº 229 24th May 2011
	Medical Devices	National Health Surveillance Agency	RDC 56/2001, Technical Regulation: Essential requirements for safety and efficacy of medical devices
	Pesticides	Ministry of Health, Ministry of Environment, and Ministry of Agriculture	Pesticide Law 7802/1989 Resolution RDC 294/2019. Provides for the criteria for toxicological evaluation and classification, prioritization of analysis and comparison of the toxicological action of pesticides, components, the like and wood preservatives, and other measures. Resolution RDC 296/2019. Provides for toxicological information for labels and package inserts for pesticides, the like and wood preservatives.
	Pharmaceuticals	Ministry of Health	Resolution RDC 200/2017. Provides for the criteria for granting and renewing the registration of drugs with synthetic and semi-synthetic active principles, classified as new, generic and similar, and other provisions Resolution RDC 9/2015. Provides for the Regulation for conducting clinical trials with drugs in Brazil.
Canada	Consumer Products	Consumer and Hazardous Products Safety Directorate of Health Canada’s Healthy Environments and Consumer Safety Branch	Canada Consumer Product Safety Act Consumer Chemicals and Containers Regulations, 2001. (SOR/2001-269).
	Cosmetics	Consumer and Hazardous Products Safety Directorate of the Healthy Environments and Consumer Safety Branch of Health Canada	Food and Drugs Act Cosmetics Regulations. (C.R.C., c. 869) Consumer Packaging and Labelling Act (R.S.C., 1985, c. C-38) Consumer Packaging and Labelling Regulations (C.R.C., c. 417).
	Industrial Chemicals (not on Domestic Substances List)	Environment and Climate Change Canada and Health Canada	Canadian Environmental Protection Act, 1999
	Medical Devices	Therapeutic Products Directorate of the Health Products and Food Branch of Health Canada	Medical Devices Regulations
	Pesticides	Pest Management Regulatory Agency of Health Canada	Pest Control Products Act (S.C. 2002, c. 28) Pest Control Products Regulations (SOR/2006-124).
	Pharmaceuticals (Non-prescription)	Natural and Non-Prescription Health Products Directorate, Health Products and Food Branch of Health Canada	Consumer Chemicals and Containers Regulation, 2001
	Pharmaceuticals (Prescription)	Therapeutic Products Directorate, Health Products and Food Branch of Health Canada	Food and Drugs Act Food and Drugs Regulations
China	Consumer Products	State Administration for Market Regulation	Product Quality Law of the People’s Republic of China
	Cosmetics	National Medical Products Administration under the State Administration for Market Regulation	Cosmetics Supervision and Administration Regulation (2021)
	Industrial Chemicals	Ministry of Environmental Protection, the State Administration of Work Safety, and the General Administration of Quality Supervision, Inspection and Quarantine	Decree 591 Regulations on Safe Management of Hazardous Chemicals
	Medical Devices	National Medical Products Administration	Regulation on the Supervision and Administration of Medical Devices
	Pesticides	Ministry of Agriculture and Rural Affairs	Regulation on Administration of Pesticides Data Requirements on Pesticide Registration (Ministry of Agriculture and Rural Affairs, 2017) Accreditation on Testing Facilities for Pesticide Registration & GLP for the Experimentation of Pesticide Registration (Ministry of Agriculture and Rural Affairs, 2017)
	Pharmaceuticals	National Medical Product Administration	Drug Administration Law of the People’s Republic of China
European Uniona	Cosmetics	National authorities in the European Commission	Regulation (EC) No 1223/2009 on Cosmetic Products
	Industrial Chemicals (including those with consumer uses)	European Chemicals Agency	Classification Labelling and Packaging (CLP) Regulation (EU) No. 1272/2008 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation (EU) No. 1907/2006
	Medical Devices	European Medicines Agency	The Medical Device Regulation (EU) 2017/745
	Pesticides (biocidal products)	European Chemicals Agency	Regulation (EU) No. 528/2012
	Pesticides (plant protection products)	European Food Safety Agency	Regulation (EU) No. 283/2013. Data requirements for active substances. Commission Regulation (EU) No. 284/2013. Data requirements for plant protection products.
	Pharmaceuticals	European Medicines Agency	Directive 2001/83/EC of the European Parliament and the Council on the Community Code Relating to Medicinal Products for Human Use
Japan	Consumer Products	Ministry of Health, Labor, and Welfare	Act on the Control of Household Products Containing Harmful Substances
	Cosmetics	Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor, and Welfare and the Pharmaceuticals and Medical Devices Agency	Pharmaceutical and Medical Devices Law
	Industrial Chemicals (Toxic substances)	Ministry of the Environment; Ministry of Economy, Trade and Industry; Ministry of Health, Labor, and Welfare	Chemical Substances Control Law Poisonous and Deleterious Substances Control Law
	Medical Devices	Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labor, and Welfare	The Pharmaceutical and Medical Device Act
	Pesticides	Ministry of Agriculture, Forestry, and Fisheries	Agricultural Chemical Regulation Act
	Pharmaceuticals	Ministry of Health, Labor, and Welfare’s Pharmaceutical and Food Safety Bureau, the Pharmaceuticals and Medical Devices Agency	Pharmaceutical and Medical Device Act.
	Pharmaceuticals (Toxic medicines)	Pharmaceuticals and Medical Devices Agency	Poisonous and Deleterious Substances Control Law
South Korea	Consumer Products	Ministry of Environment	Act on Consumer Chemical Products and Biocides Safety
	Cosmetics	Ministry of Food and Drug Safety	Cosmetics Act (Act No. 17250)
	Industrial Chemicals	Ministry of Environment	Act on the Registration and Evaluation of Chemicals Substances (Act No. 13891)
	Medical Devices	Ministry of Food and Drug Safety	Medical Device Act
	Pesticides	Ministry of Agriculture, Food and Rural Affairs and Rural Development Administration	Pesticide Control Act No. 16964
	Pharmaceuticals	National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety	Enforcement Decree of the South Korean Pharmaceutical Affairs Act
Taiwan	Consumer Products (Biocides)	Environmental Protection Administration	Toxic and Concerned Chemical Substances Control Act
	Cosmetics	Food and Drug Administration, Ministry of Health and Welfare	Cosmetic Hygiene and Safety Act
	Industrial Chemicals	Environmental Protection Administration	The Toxic and Concerned Chemical Substances Control Act
	Medical Devices	Food and Drug Administration, Ministry of Health and Welfare	Pharmaceutical Affairs Act
	Pesticides	Council of Agriculture	Agro-pesticides Management Act
	Pharmaceuticals	Food and Drug Administration, Ministry of Health and Welfare	Pharmaceutical Affairs Act
United States	Consumer Products	Consumer Product Safety Commission	Federal Hazardous Substances Act of 1964
	Cosmetics	Food and Drug Administration Center for Food Safety and Applied Nutrition	Food, Drug and Cosmetic Act.
	Industrial Chemicals	Environmental Protection Agency Office of Pollution Prevention and Toxics	Toxic Substances Control Act
	Medical Devices	Food and Drug Administration Center for Devices and Radiological Health	Food, Drug and Cosmetic Act
	Pesticides	Environmental Protection Agency Office of Pesticide Programs	Federal Insecticide, Fungicide and Rodenticide Act
	Pharmaceuticals	Food and Drug Administration Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research	Federal Food, Drug, and Cosmetic Act

^aIn general, all provisions of REACH, including those of registration, evaluation, identification of Substances of Very High Concern, authorization and restrictions, apply to chemical substances used in other sectors for which specific legislation exists with references to REACH provisions, unless there is a specific exemption mentioned in REACH. REACH, the Regulation on Biocidal Products, the Regulation on Plant Protection Products, and the CLP Regulation are closely interlinked. The obligation to classify is based on the CLP Regulation (Article 4). The provisions of the CLP Regulation apply in full to any substance or mixture whose marketing and use are controlled by the Biocidal Product Regulation or the Plant Protection Products Regulation.