Health Food

According to the Health Food Safety Assessment Method of Taiwan FDA, the safety category of the final product could be divided into four levels depending on the ingredient used:

 

safetytable 2

○：Required

 

Medgaea offers full service, including safety category evaluation and toxicity studies, to assess your products' safety, allowing our clients to address the regulatory requirements for Taiwan Health Food registration. (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