First, the scope The Green Industry Standard for Import and Export of Medicinal Plants and Preparations (referred to as the "Standard") stipulates the green quality standards for medicinal plants and preparations, including the quality standards and test methods for medicinal plant raw materials, decoction pieces, extracts and preparations thereof. . This standard applies to the import and export quality inspection of medicinal plant raw materials and preparations. Second, the term (1) Green medicinal plants and preparations Means medicinal plants and their preparations that have been tested to meet specific criteria. The green mark is licensed for use by a specialized agency. (2) botanical drugs Refers to plant materials and plant extracts for medical and health purposes. (3) Botanical preparations Refers to a preparation that has been initially processed and extracted and purified from plant material. Third, the reference standard The provisions contained in the following standards constitute provisions of the Standard by reference in the Standards. The editions shown are valid at the time of publication of the Standard. All Standards will be revised and parties using the Standards should explore the possibility of using the latest versions below. 1. The Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix IXE Heavy Metal Detection Method 2. GB/T 5009.12-1996 Determination of lead in foods (Atomic absorption spectroscopy) Fourth, the limit indicator (1) Heavy metals and arsenic salts 1. Total heavy metal ≤ 20.0mg/kg (2) Aflatoxin content Aflatoxin B1 (Aflatoxin) ≤ 5μg / kg (tentative) (3) Pesticide residues 1. Six six six (BHC) ≤ 0.1mg/kg (4) Microbial limits Executed in accordance with the regulations of the Pharmacopoeia of the People's Republic of China (except for injection) Five, testing methods (1) Indicator inspection 1. Total amount of heavy metals: Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix IXE Heavy Metal Detection Method 2. Lead: GB/T 5009.12-1996 Method for determination of lead in foods (Atomic absorption spectrometry) (2) Other physical and chemical tests Execution according to the regulations of the People's Republic of China Pharmacopoeia (2000 edition) Six, testing rules (1) Import and export products are required to pass the inspection of the designated inspection agency in accordance with this standard before they can apply for the green sign of import and export of medicinal plants and preparations. (2) Settlement inspection 1. The sampling method and sampling amount of the settlement inspection shall be carried out in accordance with the relevant provisions of the Pharmacopoeia of the People's Republic of China (2000 edition). (3) Type inspection 1. The products and real estate botanicals imported and exported by the company are tested by designated inspection agencies, and the quality of the drugs is stable and standardized in the prescribed time. The type inspection is carried out once every half (壹) year, one of the following Should be re-examined. A. Change the origin of the raw materials; 2. Type inspection items and sampling and settlement inspection (4) Judging principle If the test results are all in line with this standard, it is a green standard product. Otherwise, two samples are taken in the batch and retested once. If one of the retest results still does not meet the requirements of this standard, it is determined that the batch of products is not in compliance with the green standard products. (5) Inspection arbitration If there is any dispute over the test results, the China Import and Export Commodity Inspection Technology Research Institute or the China National Institute for the Control of Pharmaceutical and Biological Products will conduct inspection and arbitration. 7. Packaging, marking, transportation and storage (1) Packaging Packaging containers should be made of materials that are dry, clean, odor-free, and do not affect quality. The packaging should be firm, sealed and moisture-proof to protect the quality. Packaging materials should be easy to recycle and easily degrade. (2) Signs The product label uses the green label for the import and export of Chinese medicinal plants and preparations. The specific implementation shall comply with the relevant regulations of the China Chamber of Commerce for Import and Export of Medicines and Health Products. (3) Transportation Transportation tools must be clean, dry, odor-free, non-polluting, and should be protected from rain, moisture, sun, and pollution during transportation. It is strictly forbidden to mix and transport goods that may contaminate their quality. (4) Storage The product should be stored in a dedicated warehouse that is clean, dry, cool, ventilated, and smell-free. Handmade Apron Kitchen Sink,Kitchen Sink,Stainless Handmade Apron Farmhouse,Handmade Apron Farmhouse Kitchen Sink Guangdong Huayou Hardware Products Co.,Ltd , https://www.gudsink.com
3. GB/T 5009.15-1996 Determination of cadmium in foods (Atomic absorption spectroscopy)
4. GB/T 5009.17-1996 Determination of total mercury in foods (cold atomic absorption spectrometry)
5. GB/T 5009.13-1996 Determination of copper in foods (Atomic absorption spectroscopy)
6. GB/T 5009.11-1996 Determination of total arsenic in foods 7. SN 0339-95 Test method for aflatoxin B1 in tea leaves. The Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix IX Q Determination of Organochlorine Pesticides Residues (Appendix 60)
9. The Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix X III C Microbial Limit Test
2. Lead (Pb) ≤ 5.0mg/kg
3. Cadmium (Cd) ≤ 0.3mg/kg
4. Mercury (Hg) ≤ 0.2mg/kg
5. Copper (Cu) ≤ 20.0mg / kg
6. Arsenic (As) ≤ 2.0mg/kg
2. DDT≤0.1mg/kg
3. Pentachloronitrobenzene (PCNB) ≤ 0.1mg/kg
4. Aldrin (≤ 0.02mg/kg)
(5) In addition to the above standards, other qualities shall comply with the regulations of the Pharmacopoeia of the People's Republic of China (2000).
3. Cadmium: GB/T 5009.15-1996 Method for determination of cadmium in foods (Atomic absorption spectroscopy)
4. Total mercury: GB/T 5009.17-1996 Method for determination of total mercury in foods (cold atomic absorption spectrometry)
5. Copper: GB/T 5009.13-1996 Method for determination of copper in foods (Atomic absorption spectroscopy)
6. Total arsenic: GB/T 5009.11-1996 Method for determination of total arsenic in foods 7. Aflatoxin B1 (tentative): SN 0339-95 Aflatoxin B1 test method for exporting tea. The Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix IXQ Determination of Organochlorine Pesticides Residues (Appendix 60)
9. The Pharmacopoeia of the People's Republic of China 2000 Edition: Appendix XIIIC Microbial Limit Test
2. For the settlement inspection project, in addition to the above standard indicators, physical and chemical indicators (if required) should also be tested.
B. When there are major changes in the formulation and process;
C. When the product is discontinued or stopped for a long time, when production or export is resumed;