Plasticizer haze spread to the medical industry there is risk of disease

Business Club on June 8th June 3rd, a notice from the State Food and Drug Administration made the public further aware of the threat of "plasticizers."

According to the notification from the Food and Drug Administration, production and sales of two kinds of health food products containing “phthalate esters” were suspended and sold throughout the country. These products were various amino acid tablets of the Concordia spore powder and the US-China Qingsu brand, which were sold on the market. Both of these products should be immediately removed.

The "butyl phthalate" and "diethyl phthalate" (DEP) contained in the two health care products mentioned above are all illegal food additives named in the Ministry of Health's announcement No. 16 of 2010. Although it is slightly different from the plasticizer (DEHP) detected in Taiwan, it belongs to the category of plasticizers. This is also the first time in mainland China that the composition of plasticizers has been detected in local products.

The State Food and Drug Administration requires that “health foods containing phthalates in formulas should be immediately suspended by relevant health food production enterprises, and immediately recalled products being sold on the market, and immediately report to the local food and drug regulatory authority. ".

However, the shadow of “plasticizers” does not only exist in health foods, but may also exist in medicines. On June 6, Dr. Wang Yuedan, Ph.D., Department of Immunology, Peking University Medical College, said: “The most abused plasticizers should be drug manufacturers.” He cited a variety of DEP-containing drugs, including calcium tablets, aspirin and other commonly used drugs. .

For regulators, this is obviously a bigger challenge.

Allowed DEP

Plasticizer DEP is one of the pharmaceutical excipients allowed in the 2010 edition of pharmacopoeia

The two health care products that were discontinued and put off were all marked with ingredients of plasticizers in their ingredients.

As a plastic softening chemical, plasticizers are widely used in hundreds of products such as toys, food packaging materials, medical hoses, vinyl flooring, cleaning agents, lubricating oils, nail polishes, and shampoos. Multinational studies have confirmed that plasticizers affect the body's endocrine system, interfere with normal human hormone secretion, and affect the normal development of the fetus and children.

The sound of protest against plasticizers has been long overdue. As early as 1999, the European Union decided to strictly limit the content of plasticizers in children's toys and supplies. The reason why the problem of plasticizers that began in Taiwan has caused widespread concern is because it is directly added to foods.

Wu Yixiu, director of the pollution prevention program at an NGO, said: “Plasticizers, including DEHP, are potentially toxic environmental hormones and should never appear in foods and toys.”

In February of this year, the European Union had included DEHP on the list of chemical eliminations and was preparing to stop its production and use in Europe within three to five years. However, China has not yet explicitly eliminated or banned this timetable.

In fact, diethyl phthalate (DEP) is one of the pharmaceutical excipients specified in the 2010 edition of the Pharmacopoeia and is mainly used as a plasticizer for tablet coatings. Therefore, the above two products will be clearly listed in the composition of "plasticizer ingredients." A punished company also claimed that "most of the medicines and health products are widely used in the coating."

The Ministry of Health announced on June 5 that accidental consumption of a small amount of food contaminated with DEHP would not cause any health hazards. However, Wang Yuedan thought: "If the pharmaceutical and food production companies do not publicize how much plasticizer is used, the public cannot define what is accidental and small."

Ningbo Duomei Product Certification Co., Ltd. is one of the domestic certification companies with plasticizer testing capabilities. However, one of the company’s personnel said: “We only check the content of plasticizers in plastic products and do not involve drugs and foods. So far, no one has asked for testing of plasticizers in foods and medicines.”

Risk in medicines

In the production of pharmaceuticals, plasticizers are also commonly used ingredients

So far, relevant departments have focused their attention on plasticizers in the food sector.

However, Wang Yuedan said: "At least in the specifications of the two drugs, you can find plasticizers." He pointed to two drugs, respectively, Zhuhai Biochemical Pharmaceutical calcium products Gaishutai and Wichita Pharmaceutical produced Aspirin vitamin C enteric-coated tablets. Both drugs are listed in the instructions and contain "diethyl phthalate" in their chemical composition.

In Wang Yuedan's view, "Can not think that medicines are accidentally taken without paying attention, and calcium, aspirin and other commonly used drugs, the actual amount is very large, the same risk of disease."

According to insiders, “Dip phthalate (DEP) and dibutyl phthalate (DBP) are commonly used formula ingredients for tablet film coatings and enteric-coated hollow capsules. As long as the professionals who study pharmaceuticals are aware of this knowledge, they can also find relevant contents in the university's pharmacy teaching materials." Plasticizers are mainly used to control the release time of drugs in the intestine and to act as a sustained release.

Although mainland pharmaceutical companies have yet to raise concerns. However, in Taiwan, Macao, Hong Kong and other regions, many drugs have been taken off the shelves. The Hong Kong government has explicitly requested that plasticizers be included in the routine testing of foods and drugs.

Wang Yuedan stated: "If there is no way to thoroughly revise the pharmacopoeia specification, at least it will be possible to give appropriate tips on the use of drugs for pregnant women and children so as not to endanger the health of the next generation. In addition, it is hoped that companies can disclose the content of plasticizers in packaging materials and consume them. The person can judge whether it will pose a hazard to the human body."

And more people in the industry are urging that if plasticizers cannot be used for foods and medicines, then the Ministry of Health and the State Food and Drug Administration should expand the product range of recalls to protect public safety.