Product certification mark SEK

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Product certification mark SEK

THE CERTIFICATION STANDARDS OF ANTIBACTERIAL FINISHED TEXTILE PRODUCTS

CHAPTER ONE: General Provisions

1. Scope

(1)The certification standards are applied to certify antibacterial finished textile products to be labeled as SEK mark. The production of labeled products is applicable for domestic and overseas production (including OEM production).

(2)An applicant for certification shall be a company who holds the corporate veil in Japan. Where an overseas company wishes to apply for the certification, an overseas company can apply for the certification either by setting up a Japanese corporation, or by joining with a Japanese company through which an application will be made.

 

2. Objective

(1)The aim of this marking system is to provide antibacterial finished products “ensuring to prevent the growth of bacteria on fibers” on the basis of proper labelingas well as the criterion for certification and safety tests to improve the environment of consumers’ life and care.

CHAPTER TWO: Labeling Procedure and Target Products

3. Mark

(1)The following SEK Mark is used and labeled as follows:

4.Target Product

(1)Target products exclude those of infants less than 24 months after birth.

(2)Target products exclude those of applicable to Pharmaceutical Affairs Act (Law No. 145, 1960)

 

5. Labeling and compliance rules of description

(1)The antibacterial finishing appeals only for prevention of the growth of bacteria on fibers. The labeling is prohibited to represent, expressly or suggestively, “the use for the healing or prevention of human diseases as well as the effect on the construction or performance of the human body”. The labeling is also prohibited to represent, expressly or suggestively, “secondary control or sterilizing effect on bacteria”, “effect in combination with other performances” or other similar descriptions.

CHAPTER THREE: Antibacterial Effect

6. Test Method

(1)The antibacterial test is conducted on both the unwashed samples and the washed samples.

(2) The test method shall be a quantitative test (absorption method) according to JIS L 1902 (Testing for antibacterial activity and efficacy on textile products). (Reference standard is ISO 20743.)

(3) The count method shall be either Plate count method or Luminescence method (ATP method).

 

7. Strain for Test

(1)The following strain shall be used : No other strain shall be used.

Type of bacterial strain: Staphylococcus aureus

Strain number : NBRC 12732

 

8. Criterion for Certification)

(1)The criterion for certification shall be as follows: S (antibacterial activity value) = (Mb – Ma) – (Mc – Mo) ≧2.2

Mb: The average common logarithm for the number of bacteria, or the average amount of ATP, obtained from three test samples of control fabric after 18 h incubation.

Ma: The average common logarithm for the number of bacteria, or the average amount of ATP, obtained from three test samples of control fabric immediately after inoculation.

Mc: The average common logarithm for the number of bacteria, or the average amount of ATP, obtained from three antibacterial treated test samples after 18 h incubation.

Mo: The average common logarithm for the number of bacteria, or the average amount of ATP, obtained from three antibacterial treated test samples immediately after inoculation.

(Note: The growth value on the control fabric : Mb – Ma ≧1.0 (number of bacteria) or 0.5 (amount of ATP )

 

9. Washing Procedure and Recycle Number of Washings

(1)A washing procedure and washing times for durability of antibacterial finished textiles shall be as follows: Washing procedure: A standard washing procedure specified by Japan Textile Evaluation Technology Council (JTETC) using JAFET standard detergent. The details of a washing procedure is specified in JEC 326 “The Washing Manual for 4 Textiles for SEK Labeling”

washing times: 0 and predetermined times

CHAPTER FOUR: Safety

10. Banned Chemical Substances

(1)For antibacterial finishing, the use shall be banned of specified chemical substances of classⅠandⅡas well as monitoring chemical substances of classⅠ,Ⅱand Ⅲ specified in the Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. Law No. 117, 1973).

(2) In addition to the substances listed above, usage-banned chemical substances may be included considering examples in reports on endocrine disruptor (environmental disrupting chemicals), dioxin, allergic contact dermatitis and other similar toxic substances.

 

11. Laws to be Respected

(1)To manufacture/process antibacterial finished textile products, following laws should, be respected, and care should be taken for “product safety”, “work safety” and “environmental impact”.

 1) “Poisonous and Deleterious Substances Control Act” (Act No.303, 1950)

 2) “Cannabis Control Act” (Act No.124, 1948), “Stimulants Control Act” (Act No.252, 1951) and “Narcotics and Psychotropic Control Act” (Act No.14, 1958)

 3) “Atomic Energy Basic Act” (Act No.186, 1955)

 4) “Act on Control of Household Products Containing Harmful Substances” (Act No.112, 1973)

 5) “Industrial Safety and Health Act” (Act No. 57, 1972)

 6) “Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof” (Act No. 86, 1999); Act on Pollutant Release and Transfer Register (PRTR) as well as Material Safety Data Sheet(MSDS), hereinafter referred to as “Act on PRTR” )

 

12. Safety Test for Finishing Agents

(1)Safety data should be submitted of main ingredient of finishing agents for all items The safety test method of finishing agents may be conducted according to the guideline specified by OECD.

(2) The test laboratory shall be those approved by GLP accreditation authority or corresponding laboratories. (3) The safety test method and assessment standard shall be as follows:

 1) Acute oral toxicity test Test Method: Tests according to “Guideline of Revised Toxicologic Test of Medicines” Assessment Standard: Median lethal dose, LD50 shall be 2,000mg/kg or more.

 2) Mutagenicity tests

Test Method: Tests according to “Pre-incubation Method or Plate Method of Mutagenicity Tests in Industrial Safety and Health Act” (Test should be conducted by using total five strains of base-pair substitution mutation type1 and frameshift mutation type2)

Assessment Standard: Negative

 3) Skin irritation tests

Test Method: Tests on the basis of “ASTM F 719-81-1996 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation” Assessment Standard: PII (Primary skin Irritation Index) shall be less than 2.00 (mild irritant). If PII is not less than 2.00 but less than 4.0, PII of more than double the maximum concentration of finishing agents shall be less than 2.00 (mild irritant)

 4) Skin sensitization test Test Method: Test method for biological safety assessment of medical devices (Ministry of Health, Labor and Welfare, Medical Devices Evaluation No.36) A maximization test method shall be applied. If not applicable, “ Adjuvant Patch Test”shall be applied. Assessment Standard: Negative (0% in sensitization rate)

 

13. Safety Test for Products

(1) For those products which need a skin-patch test, finished products, fabrics or raw material shall be tested by a skin patch test.

(2) Finished products, fabrics or raw material to be skin-patch tested shall be finished with higher concentration than the maximum finishing concentration of agents.

(3) The test method and assessment standard of a skin-patch test are any of the following tests.

□ Closed patch test

Assessment standard: No reaction (Negative)

□Semi-open patch test

Assessment standard: Negative or qauasi-negative

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