Health Supplements Safety Test
In accordance with the requirements of Article 2 of the Health Food Management Act, in order to ensure the safety of health food in human consumption, it is necessary to prove that health food is safe and has definite and stable health efficacy. Different toxicological evaluations are conducted based on the ingredients of the health food. Here, we provide different toxicological test suggestions according to your product’s characteristics.
Safety Tests
Acute oral toxicity
The objective of the oral acute toxicity test is to understand the acute toxicity of food/healthy food by single dose administration infor experimental animals. Under the Safety Assessment Guideline of Health Food and the Redbook guidelines, the experimental animals are either rats or mice (please contact us for other species). The study design includes 3-6 dose groups. The test article is administration of a single dose (or multiple doses) in a period not exceeding 24 hours. Acute toxicology symptoms are recorded for 14 consecutive days. The results are used to assess the toxicity effects and the target organs for the test article and to help select doses for repeated-dose toxicity tests.
References:
Redbook II Chapter IV C 2. Acute Oral Toxicity Tests
Safety Assessment Guideline of Health Food, Department of Health, the Executive Yuan, Taiwan, 1999.
GB 15193.3-2014
Sub-acute Toxicity Study
The aim of the sub-acute toxicity test is to assess the toxicity dose effect of food/healthy food based on the information of acute toxicity test in experimental animals. Under the Safety Assessment Guideline of Health Food and the Redbook guidelines, for the sub-acute toxicity test a test article is administered orally in rodents for 28 days by gavage or through the diet or drinking water. The experimental animals are mainly rats or mice (please contact us for other species). Generally, at least three test groups are used, and the highest dose should be 100 times higher than the human expected intake. Test items include clinical observation, hematological examination, clinical biochemistry, urine examination, organ examination, and histopathological examination (detailed below).
The results are used to determine the LOAEL (lowest observed adverse effect level) or NOAEL (no observed adverse level) of the test article and to assess its safety for human intake. In addition, they provide an important reference for dosage design, observation indicator, and toxicity endpoint for long-term or chronic toxicity testing.
Test items:
- Clinical observation: ophthalmological examination, general clinical observation, body weight, food consumption, feed efficiency analysis, and water consumption.*
- Hematological examination: haematocrit, heamoglobin concentrations, erythrocyte count, reticulocytes*, total and differential leucocyte count, platelet count and a measure of blood clotting time/potential.
- Clinical biochemistry: Glucose, total cholesterol*, triglycerides*, blood urea nitrogen, creatinine, total protein, albumin, globulin*, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyltranspeptidase, sodium, potassium, calcium, phosphorus, chloride, thyroid hormones*, bile acids*.
- Urine examination: urinalysis and urinary sediments examination.
- Organ examination: organ gross observation, organ weight (male: 10 items, female: 9 items), histopathological examination.
*Depends on testing requirements
References:
Redbook II, Redbook 2000: IV.C.3.a Short-Term Toxicity Studies with Rodents
Safety Assessment Guideline of Health Food, Department of Health, the Executive Yuan, Taiwan, 1999.
GB 15193.22-2014
Subchronic Toxicity Study
Food/health food in human life involves long-term and repetitive consumption. Subchronic studies evaluate the toxicity effects of continuous or repeated daily exposure over a portion of the average life span of experimental animals (no more than 10% of a lifetime). They provide information on target-organ toxicity and bioaccumulation potential, as well as an important reference for the chronic toxicity test. Following the Safety Assessment Guideline of Health Food and the Redbook guidelines, the dose of the test article should consider the human expected intake, at least 100 times, and oral administration for 90 days by gavage or through the diet or drinking water. The experimental animals are mainly rats or mice (please contact us for other species). Generally, at least three test groups are used, and the highest dose should be 100 times higher than human expected intake.
Test items included clinical observation, hematological examination, clinical biochemistry, urine examination, organ examination, and histopathological examination (detailed below). The results are used to determine the LOAEL (lowest observed adverse effect level) or NOAEL (no observed adverse level) of the test article and provide an important reference for the safety of human intake.
Test items
- Clinical observation: ophthalmological examination, general clinical observation, body weight, food consumption, feed efficiency analysis, and water consumption.*
- Hematological examination (15 items): haematocrit, heamoglobin concentrations, erythrocyte count, reticulocytes*, total and differential leucocyte count, platelet count and a measure of blood clotting time/potential.
- Clinical biochemistry (18 items): Glucose, total cholesterol, triglyceride*, blood urea nitrogen, creatinine, total protein, albumin, globulin*, total bilirubin*, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyltranspeptidase, sodium, potassium, calcium*, phosphorus*, chloride*, thyroid hormones*.
- Urine examination (16 items): urinalysis and urinary sediments examination.
- Organ examination: organ gross observation, organ weight (male: 10 items, female: 9 items), histopathological examination.
*Depends on testing requirements
References:
Redbook 2000: IV.C.4.a Subchronic Toxicity Studies with Rodents
Safety Assessment Guideline of Health Food, Department of Health, the Executive Yuan, Taiwan, 1999.
GB 15193.13-2014
EFSA Guidance on Repeated-Dose 90-Day Oral Toxicity Study of Whole Food/Feed in Rodents
VICHGL31 Safety Studies for Veterinary Drug Residues in Human Food: Repeat-Dose (90) Toxicity Testing
Reproduction /Developmental Toxicity
Food/health food intake of pregnant women should assess whether it has an impact on maternal, fetal, and offspring development. Following the Redbook guidelines, reproductive/developmental toxicity includes:
(1) Prenatal Development Toxicity Study
(2) One-Generation Reproduction Toxicity Study
The experimental animals are mainly rats or mice (please contact us for other species). The dosage design is based on the information of sub-acute and subchronic toxicity trials and considers the human expected intake. Test article are assigned to three dose groups and orally administered by gavage or through the diet or drinking water. The results are used to evaluate the adverse effects, including fetal teratogenesis, maternal gestation, and offspring development, and provide an important reference for the safety of human consumption.
Prenatal Development Toxicity Study
The purpose of the prenatal development toxicity study is to evaluate the toxicity effects on maternal physiology and fetal development following the test article’s oral exposure during the development stage of embryonic organs. The test items include female uterus and ovarian examination, fetal appearance examination, and visceral and skeletal examination.
References:
Redbook 2000: IV.C.9.b Guidelines for Developmental Toxicity Studies
Safety Assessment Guideline of Health Food, Department of Health, the Executive Yuan, Taiwan, 1999.
GB 15193.27-2014
One-Generation Reproduction Toxicity Study
The purpose of the one-generation reproduction toxicity study is to evaluate the toxicity effects on maternal physiology and offspring development following the test article’s oral exposure during the pregnancy and lactation stages. The test items include genital examination, endocrine system changes, physiological cycle change, fertility analysis, pregnancy cycle, and offspring appearance and development.
References:
Redbook 2000: IV.C.9.a Guidelines for Reproduction Studies
GB 15193.14-2014
GB 15193.15-2014
GB 15193.27-2014
Genotoxicity
SuperLab implements the genotoxicity study of food/health food according to various laws and guidelines, completing at least 5 per year. The Introduction of the Gene Toxicology Study.
Test items
Bacterial Reverse Mutation Test (Salmonella typhimurium)
In vitro Mammalian Cell Chromosomal Aberration Test
Rodent Peripheral Blood Micronucleus Test
In vitro Mammalian Cell Gene Mutation Test Using the Hprt Gene
You must be logged in to post a comment.