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III. Regulations and implementation of the use of phthalates in China

1. National standard situation in the current national standards of food containers, packaging materials, GB9685-2003 "food containers, packaging materials for the use of additives sanitary standards" specified the permitted use of plasticizers, stabilizers, fillers, anti-aging agent, such as 20 kinds of 64 kinds of additives. Among them, the plasticizer has DBP, DOP, DIOP and other 10 kinds, but there is no DEHP. This means that DEHP cannot be used in food containers or packaging materials. Other standards, such as GB9685-2003 "sanitary standards for the use of additives for food containers and packaging materials", GB4803-1994 "sanitary standards for PVC resins for food containers and packaging materials", GB9681-1988 "sanitary standards for PVC molded products for food packaging", GB15204-1994 "sanitary standard for vinyl chloride-vinyl chloride copolymer resin for food packaging", GB14944-1994 "PVC bottle cap gasket for food packaging and sanitary standard for granules", etc., only specify the residue of vinyl chloride monomer, and do not make any provision for DEHP. There are two standards involved in DEHP in the national standards for medical devices. GB14232.1-2004 "human blood and blood composition bag plastic container part 1th: traditional blood bag" is applicable to the use of DEHP plasticizer PVC mainly blood bags, the nominal capacity of blood bags in 300ml~500ml alcohol (DEHP) is not greater than 10mg/100ml, not greater than 13mg/100ml at 150ml~300ml, not greater than 14mg/100ml when less than 150ml. The standard also provides that vinyl chloride monomer residues not greater than 1ppm: ethylene oxide residues are not greater than 10mg. GB15593-1995 "Blood transfusion (liquid) blow molding film bag with soft polyvinyl chloride plastic" stipulates that blood transfusion (liquid) blow molding film bags with soft polyvinyl chloride plastic alcohol dissolution (DEHP) is not more than 10MG/ML, the standard also stipulates that vinyl chloride monomer residue is not greater than 1ppm. Other standards, such as GB10010-1988 "Medical soft PVC pipe" and so on only specify heavy metals, vinyl chloride monomer residues and other indicators, there is no DEHP requirements.


2. The Regulations on sanitary management of plastic products and raw materials for food, issued by the Ministry of Health in November 1990, stipulate that "synthetic resins and processed plastic products shall conform to their respective hygiene standards" and that "the additives used in the production of plastic tableware, containers and packaging materials shall conform to the food containers, Sanitary requirements for the use of additives for packaging materials ". National standard GB9685-2003 "food containers, packaging materials for the use of additives sanitary standards" stipulates that food containers, packaging materials can not use DEHP, containing DEHP PVC and its products can not be used for food packaging. State Food and Drug Administration National Medicine Supervision (2000) No. 516 requires pharmaceutical production enterprises and medical institutions in the preparation room of new or modified projects, it is not appropriate to use PVC bags filling infusion. After that, the state Drug Administration did not approve the use of PVC bags of infusion products. The General administration of quality Supervision, inspection and quarantine, in response to the EU directive on the prohibition of the sale of PVC soft plastic toys and children's supplies (1999/815/EC), issued in 2002 a notice on the EU ban on the sale of toys for children under the age of three in the manufacture of PVC, requiring organizations of relevant foreign trade import and export companies to organize and implement Each directly under the Inspection and Quarantine Bureau to do a good job of pre-export inspection work to reduce unnecessary losses.