The most popular plasticizer used as auxiliary mat

2022-07-23
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On the 27th, the State Food and Drug Administration issued the notice on the substitution of excipients related to health food containing phthalates (hereinafter referred to as the notice), The notice quoted the Announcement No. 16 of the Ministry of health in 2011 as saying: "within three months from the date of issuance of this notice, for the health food formula containing phthalates, the applicant shall apply for the use of triethyl citrate, glyceryl triacetate or other substances that meet relevant regulations, (1) optimize and upgrade the traditional industry to replace phthalates, or apply for the removal of phthalates from the formula."

the food and Drug Administration's call to stop the use of plasticizers as auxiliary materials for health products can be seen as a continuation of the call to stop plasticizers on June 3. At the beginning of last month, the food and Drug Administration issued a document to publicly request to stop the sales of two kinds of health care products containing diethyl phthalate - Xiehe brand ganoderma spore powder tablets (guoshijian Zi g) and Meizhong Qingsu brand multi amino acid tablets (guoshijian Zi g)

the notice requires: "The applicant shall provide the specific ingredients of the coating formula, the basis for the use and dosage of the coating raw materials, the daily safe dosage, as well as the product production process, quality standards, research data, stability test report, three batches of pilot production verification data and product self inspection report. If the requirements are considered to be met through technical review and administrative approval, the State Food and drug administration shall prepare and issue a new approval certificate for health food, and withdraw the original batch of health food from Certificate at constant temperature. The relevant time limit requirements shall refer to the relevant provisions on the registration of new products in the administrative measures for the registration of health food (for Trial Implementation). "

as for the application of plasticizers in domestic health food, Zhang Dachao, chairman of the Advisory Service Committee of China Health Association, said in a media interview earlier that phthalates are mainly used to improve the taste of liquid preparations in health food, but now most health products are in the form of solid tablets and soft capsules, so there are few opportunities to use phthalates

"the national suspension of phthalates as health product excipients has a major impact on domestic health product manufacturers in terms of production costs. However, since there are already a variety of phthalate substitutes in the market, and such products are only used as health product excipients in small quantities, the suspension has a limited impact on many domestic health product manufacturers." CIC checks whether the up and down travel switches of the mobile station are normal one by one. Guofanli, a consultant researcher in the pharmaceutical industry, told the daily economy

guofanli believes that since triethyl citrate, glycerin triacetate or other substances that comply with relevant regulations mentioned by the food and drug administration have long existed, "said Walter ripple, vice president and general manager of PolyOne thermoplastic elastomer department, the enterprise does not need to reset the production line when replacing phthalates as auxiliary materials. "In terms of use cost, although the price of substitutes is higher than that of phthalates, because these products are only used as auxiliary materials for health products, the increased cost does not account for a large proportion in the whole production cost of health products, and has a limited impact on the cost of relevant health product manufacturers. In terms of safety, as phthalates are unsafe substances, the use of phthalates as substitutes for health products is safer Much higher. "

it is reported that phthalic acid esters have been listed as the fourth grade poison in some foreign markets because they have the effect similar to female hormones, and are strictly prohibited to be used as unsafe substances

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