Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment

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doi:10.2903/j.efsa.2009.1052

Cited by 6 publications

(6 citation statements)

References 63 publications

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“…EFSA has been proactive in reducing animal testing and implementing reliable NAMs. For example, in 2009, EFSA published a scientific opinion covering the key data requirements for evaluation of pesticide toxicity that were amendable to NAMs ( EFSA, 2009 ). In 2012, EFSA initiated a series of scientific conferences to create a regular opportunity to engage with partners and stakeholders.…”

Section: Pesticides and Plant Protection Productsmentioning

confidence: 99%

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Stucki¹,

Barton-Maclaren

Bhuller

et al. 2022

Front. Toxicol.

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New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies’ guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.

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Section: Pesticides and Plant Protection Productsmentioning

confidence: 99%

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Stucki¹,

Barton-Maclaren

Bhuller

et al. 2022

Front. Toxicol.

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“…This tiered approach to the safety assessment of new food ingredients, used by regulatory agencies, limits the amount of data initially generated for a risk assessment, establishes the types of evidence to be considered, and potentially reduces the extent of animal research conducted by applying the 3-R approach: replace, refine, and reduce (26,27). The initial tier includes requirements for minimal testing and data, including determination of absorption by the gastrointestinal tract of the compound and the metabolic or manufacturing degradation products of a compound via in vitro, in vivo, and ex vivo models of absorption and bioavailability.…”

Section: Methods Of Data Acquisitionmentioning

confidence: 99%

“…Diets are carefully produced and constructed to minimize any potential effects that could confound data interpretation; the conditions and density of animal housing are specified and require a testing environment that supports good animal health; and data collection within the different types of core research studies to be conducted is rigorously standardized in terms of both extent and frequency (24,25). Modification of statistical methodology has enabled interpretation of data that may need to take into account a plethora of information (a Bayesian approach) (26,27). …”

Section: Introductionmentioning

confidence: 99%

Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale

Berry

Brusick²,

Cohen

et al. 2016

Nutrition and Cancer

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Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.

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“…The U.S. EPA also developed a series of in vitro and in silico NAMs to streamline the toxicity tests . According to reports, the EU and Japan also adopt NAMs in pesticide registration, while NAMs are only applied to the cosmetics industry in China. , If the applicants and registrants are permitted to use the NAMs, there would be great potential to decrease the number of animals needed and costs by over 20 000 per year . Thus, it is greatly beneficial for China to develop and adopt the NAMs for pesticide registration.…”

Section: Introductionmentioning

confidence: 99%

Toxicity Tests for Chemical Pesticide Registration: Requirement Differences among the United States, the European Union, Japan, and China?

Chen

Huang

et al. 2023

J. Agric. Food Chem.

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Pesticide registration is a scientific, legal, and administrative process that checks if a pesticide is safe and effective for its intended use before it can be used. The toxicity test is a key part of pesticide registration, which includes human health and ecological effect testing. Different countries adopt their own toxicity test criteria for pesticide registration guidelines. However, these differences, which may help accelerate the progress of pesticide registration and reduce the number of animals used, are yet to be explored and compared. Herein, we outlined the details and compared the differences between the toxicity tests in the United States, the European Union, Japan, and China. Some differences lie in the types and waiver policy, while others are in new approach methodologies (NAMs). On the basis of these differences, there is great potential for the optimization of NAMs during the toxicity tests. It is expected that this perspective can contribute to developing and adopting NAMs.

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Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment

Cited by 6 publications

References 63 publications

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale

Toxicity Tests for Chemical Pesticide Registration: Requirement Differences among the United States, the European Union, Japan, and China?

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