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Mutagenicity & In-vivo Toxicology Services for GRAS & Food Additives

"GRAS" is an acronym for the phrase "Generally Recognized As Safe". Under sections 201(s) and 409 of the US Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, which is subject to premarket review and approval by the US FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food. Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.

Under 21 CFR 170.30(c) and 170.3(f), the general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.

Safety evaluation for a direct food additive or color additive used in food involves assigning the additive to a Concern Level (i.e., low (I), intermediate (II) or high (III)) based on information on the additive's toxicological potential predicted from its chemical structure (i.e., low (A), intermediate (B), or high (C)) and an estimation of cumulative human exposure.

Vanta Bioscience services offered:
Invitro Studies
Test for gene mutations in bacteria (Ames test)
In vitro test with cytogenetic evaluation of chromosomal damage using mammalian cells
In vitro mouse lymphoma thymidine kinase+/- gene mutation assay
In vivo test for chromosomal damage using mammalian hematopoietic cells

Invivo Studies
Short term toxicity with rodents (28 days)
Sub-chronic toxicity studies with rodents (90 days)
Chronic toxicity studies with rodents (1 year)
Carcinogenicity
2-Generation Reproduction and Teratology Study


Recommended Toxicological Testing Summary Table for Additives Used in Food
Toxicity Tests Concern
Level
Low
(I)
Concern Level
Intermediate
(II)
Concern
Level
High
(III)
Genetic toxicity tests X X X
Short-term toxicity tests with rodents X Xa,c Xa,c
Subchronic toxicity studies with rodents   Xc Xa,c
Subchronic toxicity studies with non-rodents   Xc Xa,c
One-year toxicity studies with non-rodents     Xc
Chronic toxicity or combined chronic toxicity/carcinogenicity studies with rodents     Xc
Carcinogenicity studies with rodents     X
Reproduction studies   Xc Xc
Developmental toxicity studies   Xb,c Xb,c
Metabolism and Pharmacokinetic studies   Xb Xb
Human studies     Xb

a : If needed as preliminary to further study
b : If indicated by available data or information
c : Including screens for neurotoxicity and immunotoxicity
The source of tables above is from http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/FoodIngredientsandPackaging/ucm054658.htm and we gratefully thank the US FDA for posting this information in public domain for the benefit of scientific community at large.