Standar Korea Selatan - Obat Herbal   

Korea Selatan memberlakukan standard nasional yang disebut Korean Standards (KS).Namun, ada beberapa Standard Internasional yang dapat menjadi acuan untuk produk impor di Korea Selatan. Adapun standard internasional yang dapat menjadi acuan adalah:

  • ISO(International Standardization Organization)
  • IEC(International Electrotechnical Commission)
  • ASTM(American Society of Testing Materials)
  • EN(European Norm)
  • DIN(Deusche Industrie Norm)
  • NF(Normes Francaises)

Requirement for Health Functional Foods

Classification of Health Functional Foods

Without Pre-approval
Functional ingredients / products which risk assessment has been conducted by KFDA
When this type of product is imported, it goes to Lab test whether it conforms with stadards
Required for Preapproval
Functional ingredients / products which risk assessment has not been conducted by KFDA are required for pre-approval

☞ Please contect Health Functional Food Standard Division

Comparison between functional ingredients and product

Ingredients
Packed in bulk or in large volume of units for further processing / manufacture
Semi-products can be included which are mixed with minor ingredients such as fructose, starch, glucose or seasoning
Products
goods which consumer can have in retail and which have appearance of tablet, capsule, powder, liquid, granule, flake, paste, syrup, gel, jelly or bar
Every ingredients, Health claim(functionality), Daily dose/intake, caution(allergy, side effects etc.) are labelled on the package for consumer
 
Documents related to Genetically Modified Organisms

Scope of GMO labelling

  • Foods contained soybean, corn, cottonseed, rapeseed, sugar beet or it’s sprouts as main ingredients(up to the 5th largest ingredients in contents)
Scope of GM Labelling Scope of GM Labelling Exempt from GM Labelling
Agricultural products LMOs which KFDA approves to import IP Handling or Export Certificate has been submitted to prove
※ unintentional adulteration : not more than 3%
Processed Foods Processed foods which contained GMO as ingredients o    Isolated agricultural produce from GM which attached with IP Handling or Export Certificate
※ unintentional adulteration : not more than 3%
o    Including GM ingredients, but
§  contents of GM ingredient is less than the 5th largest ingredients
§  analysis certificate ca prove that any GM ingredients do not exist in final good
※ soysauce, oil, sugar, alcoholic beverages, etc

Organic Certificate

  • Scope : imported foods labelled "organic"
  • A copy of organic certificate is required to submit which can be issued by organic certification bodies accredited by IFOAM or by exporting country

Transaction certificate or Ingredient list can be required to confirm from 2011, any product labelled "organic" will be required to be certified according to ‘Food Industry Promotion Act’ (for details of organic certification, please contact National Agriculture Products Quality Management Service).

Analysis Certificate / Organic Certificate

Laboratory Analysis Certificate

  • KFDA commissioner approves overseas laboratories after on-site inspection
  • Certificate of analysis issued by overseas laboratories can be substituted for inspection at the border

☞ For Information of Approved Overseas Laboratories
☞ ENGLISH (an enhanced button at the top of the page)
※ Please check an operating country and scope of analysis for each laboratory

Organic Certificate

  • Scope : imported foods labelled "organic"
  • A copy of organic certificate is required to submit which can be issued by organic certification bodies accredited by IFOAM or by exporting country
  • Transaction certificate or Ingredient list can be required to confirm

※ From 2011, any product labelled "organic" will be required to be certified according to ‘Food Industry Promotion Act’ (for details of organic certification, please contact National Agriculture Products Quality Management Service)

Details on Inspection of Imported Foods

Same Product

Factors determining the same product from the same company

  • Processed foods, food additives : importer·country of origin· manufacturer·product name·processing flow and every ingredients are identical
  • Agricultural products : importer·country of origin·manufacturer· category of produce·exporter and packer are identical
  • Utensils, containers & packages : importer·country of origin· manufacturer·food-contact material and color are identical

Type of Inspection

  • Document Review (2 days)
  • Once the product conforms with standard as a result of laboratory test, the next consignment of the same product goes to document review
  • Ingredients for processing
  • Flavour(food grade) and utensils·containers made with woods or stones
  • Sensory Test (3 days)
  • Once agricultural produce conforms with standard as a result of lab analysis, the next consignment of the same produce goes to sensory test
  • Any product which is required for checking characteristics(flavor, taste, color), storage, labelling and/or package
  • Laboratory Test (10 days, 14 days for canned or retort foods) 
  • The first import of a product
  • The product with rejection record or risk information from various sources
  • In case that standards or specification has been changed<>/
  • Random Sampling Test (5 days)
  • Products are chosen by KFDA system according to annual random sampling plan

Category of Foods

  • Agricultural Products : fresh, chilled, dehydrated, frozen or minimally processed products
  • Processed Foods
  • Food Additives
  • Utensils, Containers & Packages : in contact with foods or food additives
  • Health Functional Foods

Purpose of Import

  • For sale : registered importer can import foods for sale
  • For processing : registered food manufacturer can import foods for processing

Address of Manufacturer / Processor

  • It is required to state address of place where the product is actually manufactured or processed
  • It is not admitted to state address of headquarter or distribution office

Ingredients, Components, Materials

  • Foods : Name of every ingredients or components has to be stated.
  • Quantity of food additives has to be stated when the food additives have limitation in use in Korea Food Additive Code.
  • Utensils, Containers & Packages : Every food-contact materials has to be stated

Processing flow

  • Processing flow and solvent / enzyme used have to be stated

 
For pharmaceutical product
The Republic of Korea has legally adopted two medicare systems, Western medicine and oriental medicine.Traditional medicine in Korea is based on both traditional Chinese medicine and Korean folk medicine. The empirical folk medicine has passed on from generation to generation and is not prescribed by Korean oriental physicians.


Legal Status
The Composite Pharmacy Law governs all activities concerning pharmacies, pharmaceutical industries, and suppliers of medicines including herbal raw materials. The two official drug compendia are the fifth edition of the Korean Pharmacopoeia and the Korean Natural Drug Standards [Chang, 1989]. In addition, there is a specific law for pharmaceutical.

In 1969, the Ministry of Public Health and Social Affairs published a notification which acknowledged that aherbal preparation could be prepared by a pharmaceutical company without submitting any clinical ortoxicological data, provided that the formula is described in the eleven classic books on traditional Korean and Chinese medicines [Chang, 1989].

Since 1983, the government has been working on standardization of 530 medicinal plants, including 145which were already listed in the Korean Pharmacopoeia. Since 1993, only standardized medicinal plants canlegally be distributed. For herbal medicines produced by domestic pharmaceutical companies, thegovernment imposes strict regulations on these companies, so that they follow the GMP standard inmanufacturing herbal medicines.

For the production of well controlled herbal raw materials, the Ministry of Public Health and Social Affairs haspublished a notification under which a new licence will be issued to the manufacturer of standardized herbs.
Herbal drugs and preparations thereof have to be standardized and controlled according to the requirementsof the Korean Pharmacopoeia, the National Institute of Health and the Ministry of Public Health and Social Affairs. The information required for these products includes taxonomic status, parts of plants, morphology, qualitative examination, purity, content of essential oil or extract, and grade of quality.

A single herb used in traditional medicine may contain hundreds of constituents. In the case of a combinationof several herbs, hundreds of natural constituents would have to be assayed in quality control. For this reasonthe National Institute of Health employs approximate assay methods within which an active natural product oran indicative substance may be analyzed in quality control [Chang, 1989].

The Medical Act and the Drug Administrative Act stipulate that only certified oriental medical doctors orpharmacies with oriental medical doctors' prescriptions can provide patients with any of the herbal medicines listed in the Korean Pharmacopoeia.

An example of standard for pharmaceutical specifications:

  1. General standard
    1. Pharmaceutical ingredients: not less than 99.0%
    2. Single preparations: 95.0-105.0% (for externally applied preparations, 90.0-110.0%)
    3. Multiple preparation : 90.0-110.0%
  2. Antibiotic preparations: 90.0-120.0%
  3. Vitamins
    1. Vitamin multiple preparation (except injections) and vitamins and metal elements added in the vitamin multiple preparation:90.0-150.0%
    2. Vitamin single preparations and vitamin injections:90.0-130.0%
    3. Vitamin derivatives preparations: 90.0-130.0%
  4. Volatile substances of the pharmaceutical: 90.0-130.0% (e.g., menthol, thymol, camphor, ethanol, etc.)
  5. Single and multi nucleic acids: 90.0-130.0%
  6. Enzyme preparations
    1. Pharmaceutical ingredients: not less than 100.0%
    2. igestive enzyme preparations: not less than 90.0%
    3. Anti-inflammatory enzyme preparations: 90.0-130.0%
  7. Single or multi amino acids and their derivatives preparations: 90.0-130.0%
  8. Lactic acid bacteria preparations and other probiotics: not less than 90.0%
  9. Disinfectants: 90.0-110.0%
  10. Protein organ extracts (hydrolysis) preparations ∙
    1. Pharmaceutical ingredients: not less than 100.0%
    2. rug products: not less than 90.0%
  11. If it is impossible or unnecessary to determine the content of active pharmaceutical ingredients and so, the specification of content is not established, the efficacy test, performance test, or pharmaceutical test may be conducted instead (e.g., medicinal carbon: absorption capacity test).

 Test standard for other quality control for pharmaceutical:

  1. pH: ± 1.0 as for actual statistical values
  2. Specific gravity: ± 0.05 as for actual statistical values
  3. Residue on evaporation: Upper limit shall be established on the basis of actual statistical values.
  4. Alcohol number: This test shall be established for oral preparations containing not less than 4% of ethanol and the limit shall be not less than 90.0% of the labeled value.
  5. Preservatives test: This test shall be established for drug products containing preservatives. In this case, the preservative shall be identified and the content shall be not more than the labeled value. As for all preparations except oral solutions, the amount of the content shall be 80.0-120.0% of the labeled value. If necessary, other appropriate ranges may be established separately.
  6. Uniformity of dosage units: Korean Pharmacopoeia and Specification & Test Methods for Mass (Volume) Variation of Pharmaceuticals, etc. (KFDA's Notification) shall be applied.
  7. Microbial limit test: Specification & Test Methods for Microbial Limit Test of Pharmaceuticals, etc. (KFDA's Notification) shall be applied.
  8. Adhesive strength: When tested according to the Adhesive strength method described in the adhesive plaster of the Korean Pharmacopoeia, plasters and pressure sensitive adhesives, and cataplasmas shall have the adhesive strength of not less than 42 g per 12 mm wide.
  9. Texture (length and width): When tested according to the Texture described in the adhesive plaster of the Korean Pharmacopoeia, the length and width shall be not less than 98.0% of the labeled values.