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:

 

safetytable 4

 

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).

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).

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.

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