Non-traditional Food Ingredients

According to Taiwan FDA, with the development of technology and the increasing international trade, more and more non-traditional food ingredients are available. In addition, the compositions and properties of many traditional foods have been changed due to non-traditional cultivation, reproduction, or new processing technology. These are all considered non-traditional food ingredients, which must undergo safety assessments to confirm that they do not constitute a health hazard.

Under the definition of non-traditional food ingredients defined by the Taiwan FDA, safety assessments requested for the application of non-traditional food ingredients are as follows:

 

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Medgaea provides GLP toxicity studies and registration consultants to assist our clients in addressing the regulatory requirements for applying non-traditional food ingredients. Welcome to contact us.

Salmonella Reverse Mutation Test
  • Guideline

    Health Food Safety Assessment Method

    OECD 471: Bacterial Reverse Mutation Test

  • Test system

    Salmonella typhimurium

  • Aim

    To evaluate the mutagenic potential of the test substance by using bacteria in the presence or absence of rat liver enzyme metabolic system (S9 mix).

In Vitro Mammalian Chromosomal Aberration Test


    • Guideline

      Health Food Safety Assessment Method


      OECD 473: In Vitro Mammalian Chromosomal Aberration Test


    • Test system

      Chinese hamster ovary cells


    • Aim

      To assess genotoxicity of the test substance in mammalian cells in the presence or absence of rat liver metabolic enzyme (S9 mix).



Rodent Micronucleus Test in Peripheral Blood
  • Guideline

    Health Food Safety Assessment Method

    OECD 474: Mammalian Erythrocyte Micronucleus Test

  • Test system

    ICR mice

  • Aim

    To evaluate the cytogenetic damage of the test substance which results in the formation of micronuclei.

Acute Oral Toxicity Test
  • Guideline

    OECD 423: Acute Oral toxicity - Acute Toxic Class Method

  • Test system

    SD rats

  • Aim

    To observe the adverse effects that occurred within a short time following oral administration of the test article and evaluate the LD50 value (median lethal oral dose) of the test article.

Repeated Dose 28-Day Oral Toxicity Study in Rodents
  • Guideline

    Health Food Safety Assessment Method

    OECD 407: Repeated Dose 28-day Oral Toxicity Study in Rodents

  • Test system

    SD rats

  • Aim

    To investigate the potential systemic toxicity of the test article on mammals after repeated feeding for 28 days, and to assess the No-Observed-Adverse-Effect Level (NOAEL).

Repeated Dose 90-Day Oral Toxicity Study in Rodents
  • Guideline

    Health Food Safety Assessment Method

    OECD 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents

  • Test system

    SD rats

  • Aim

    To investigate the potential systemic toxicity of the test article on mammals after repeated feeding for 90 days, and to assess the No-Observed-Adverse-Effect Level (NOAEL).

Teratogenicity Study
  • Guideline

    Health Food Safety Assessment Method

    OECD 414: Prenatal developmental toxicity study

  • Test system

    Pregnant female SD rats

  • Aim

    To assess the effects of test substances on embryonic development