Table 1.

Fish acute toxicity data requirements by sector and global region, based on the Fish Toxicity Testing Framework (Organisation for Economic Co‐operation and Development 2014) and Maynard et al. (2017) ^a

Industry sector	Region	Example legislation	Acute in vivo test required for active substances (yes/no)	Species required/recommended, and product/formulation testing requirements
Plant protection products	EU	European Commission (2013)	Yes	Always required for rainbow trout (Oncorhynchus mykiss, cold‐freshwater species) Testing of products and ingredients, where it cannot be predicted based on ingredients, per Regulation 284/2013
	North America	US Federal Insecticide, Fungicide and Rodenticide Act, Canadian Plant Protection Product Active Substances (Pest Management Regulatory Agency)	Yes	Cold‐ and warm‐water freshwater species; 1 saltwater fish species, dependent on use Testing of ingredients only
	Latin America	Brazil (IBAMA): Portaria Normativa IBAMA no. 84, de 15 de outubro de 1996	Yes	Cold freshwater, warm freshwater dependent on country Testing of products and ingredients
	Asia Pacific	Japanese Agricultural Chemicals Regulation; China, Ministry of Agriculture and Rural Affairs: e.g., Measures on the Management of Pesticide Registration and Measures for the Administration of Pesticide Labels and Manuals, and the Data Requirements on Pesticide Registration (defines data required for submissions); Republic of Korea, Ministry of Agriculture, Food and Rural Affairs: Pesticide Control Act Enforcement Decree of the Pesticide Control Act	Yes	In‐country testing may be required. For example, only test reports obtained from qualified testing facilities can be recognized for registration review in China. Unilateral acceptance of data generated following OECD TGs to GLP from overseas laboratories is not possible unless there is a multilateral acceptance of data agreement with China. Local fish species may be required to be tested; e.g., in Bangladesh 2 local species are required to be tested in‐country for formulations. Some countries require testing of specific species for specific uses; e.g., in South Korea loach is required for paddy uses. Testing of products and ingredients can be required
	Notes	Estimated total number of different species tested in practice for global registration of an active substance = 4 (rainbow trout in the European Union, fathead minnow and sheepshead minnow in the United States, and carp in Japan). Can be higher if multiple Asian countries require specific native species. Multiple additional studies may be required, depending on the number of products requiring formulation testing.
Industrial chemicals	EU	European Commission (2006)	Yes, if manufactured or imported at >10 tonnes/yr	Not specified; includes reference to species included in OECD TG 203.
	North America	US industrial chemicals Toxic Substances Control Act for New Substances (premanufacture notices) and Existing Substances	Can be requested following modeling outcome; can be requested following data review and risk determination	Cold‐ and warm‐freshwater species; if a marine or estuarine system may be affected, saltwater species also generally required.
	Asia Pacific	Japanese Chemical Substances Control Law; Australian Industrial Chemicals (Notification and Assessment) Act 1989; China New Substance Registration—China REACH—required by China's Ministry of Ecology and Environment	Yes	Cold freshwater or warm freshwater, dependent on country; in‐country testing may be required (e.g. China). State Environmental Protection Administration, China, Guidelines for the testing of chemicals, no. 203 fish acute toxicity test (2004) requires freshwater zebrafish (Brachydanio rerio)
Biocides	EU	EU Biocidal Products Regulation (Regulation EU 528/2012)	Yes	One freshwater (+marine species, if relevant) Testing of products and ingredients may be required in some circumstances depending on the use pattern, relative sensitivity of other taxa compared to fish, and if the risk cannot be predicted/resolved based on the ingredients. Exemptions can apply to active substance data, if 1) valid chronic (long‐term) fish toxicity data are available or 2) in some rare cases, if negligible exposure is expected (attributable to the use pattern or properties of the active substance)
	North America		Yes	Cold freshwater, warm freshwater, marine; requirements can potentially be reduced dependent on use or expected exposure Testing of ingredients
	Asia Pacific		Yes	Cold freshwater; requirements can potentially be reduced dependent on use or expected exposure or country Testing of products and ingredients
	Notes	For some product categories the data are already available from plant protection product registrations (e.g., certain fungicides and insecticides).
Human pharmaceuticals	EU	EU Human Pharmaceuticals (Regulation EC 726/2004)	No; considered not relevant because of long‐term, low‐level exposure	n/a
	North America	US Food and Drug Administration Center for Drug Evaluation and Research	Yes; action limit at expected environmental concentration >100 ng/L (if not an endocrine‐disrupting compound), then a tiered approach if Daphnia or algae risk quotient <1000	Not specified
	Notes	For most global submissions, chronic testing conducted for EU submissions enables skipping of acute tiers of US requirements; see Supplemental Data 1.
Cosmetics	EU		No, although information on fish may be required on ingredients covered under REACH (>10 tonnes/yr); see Notes
	Rest of world		Country‐specific	Dependent on country; requirement in China for ingredients imported >1 tonne/yr to test with a native species
	Notes	Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products sets out a testing ban—prohibition on testing finished cosmetic products and cosmetic ingredients on animals and a marketing ban, prohibition on marketing finished cosmetic products and ingredients in the European Union which were tested on animals.

^aNotably, testing in multiple species is required to register an agrochemical globally, whereas for human pharmaceuticals and cosmetics, minimal or no testing is required.

GLP = good laboratory practice; IBAMA = Brazilian Institute of the Environment and Renewable Natural Resources; n/a = not applicable; OECD = Organisation for Economic Co‐operation and Development; TG = test guideline.