IPEC Federation: Taiwan Phthalate Contamination Incident
Impact on Safety of Excipients
June 15, 2011
Recent events in Taiwan have raised the possibility of Di-Ethyl Hexyl Phthalate (DEHP) and Di-isononyl phthalate (DINP) being added to certain nutritional supplements, vitamins, foods and beverages imported from Taiwan. This has resulted in some recalls of certain Taiwanese products. The IPEC Federation has developed this statement and frequently asked questions (FAQs) to address this specific situation in Taiwan.
This issue has raised significant public concern regarding the safety of both raw materials and excipients and pharmaceutical products. IPEC Federation members are using science-based risk management practices to ensure the safety and supply of safe excipient products to customers around the world.
The products of concern were produced with emulsifiers (clouding agents) manufactured by the Yu Shen Chemical Co. or the Pin Han Perfumery Co. that are contaminated with a prohibited ingredient, DEHP and/or DINP .
These chemicals are commonly used as plasticizers for polyvinyl chloride type plastics. While minute quantities of DEHP may be detected in certain food products as a result of migration from plastic containers, the Taiwanese authorities detected DEHP in various beverages at levels up to 600 ppm. It is believed to have been added as a form of Economically Motivated Adulteration as a low-cost replacement for the more expensive palm oil.
There are many other phthalates which are approved for use in pharmaceuticals such as Di-Ethyl Phthalate (DEP) and Di-Butyl Phthalate (DBP). These phthalates can be legally used as plasticizers in drug applications in many countries and they do not pose safety concerns in these applications.
It is important to stress that the Taiwan incident was limited to only DEHP and DINP and the emulsifier products of concern were only produced by the two companies listed above to the best of our knowledge.
At this time, only materials originating from the specifically identified manufacturers in Taiwan are at risk. Drug manufacturers should review their supply chains to determine if they are sourcing emulsifiers that may be implicated in the Taiwanese recalls. To facilitate communication between drug manufacturers and their suppliers the supply chain reviews should focus only on the two phthalates of concern, DEHP and DINP.
Two questions can adequately address the potential risk from the Taiwan incident, as explained in the Rx-360 Alert found on www.rx-360.org. The following questions should form the basis for the communications that drug manufacturers should have with their suppliers.
1) Are you confident that your supply chain security measures ensure that your products are not contaminated with DEHP or DINP?
2) Are your ingredients supplied by Yu Shen Chemical Company, Pin Han Perfumery Company, or their known distributors?
The IPEC Federation member companies will be monitoring the situation as it develops, and will be taking appropriate actions to comply with all international safety requirements for the safety and purity of excipient substances. Should additional developments occur, the IPEC Federation will update this information accordingly.
Frequently Asked Questions (FAQs)
Based on the scientific evidence available at this time, we have provided answers, which, in our opinion, may address most Frequently Asked Questions
What is the concern with DHEP and DINP?
It is recognized that DEHP can have significant reproductive and other negative health effects associated with chronic exposure. DEHP is also identified as a toxic substance. DINP is not classified as a carcinogen, reproductive, or developmental toxicant, however, is not approved for use as an ingredient in food or drug products as apparently was done in the Taiwan adulteration incident. There are many other phthalates, however, that are allowable in drug products and packaging materials which are not implicated by the incident in Taiwan.
What products are affected?
Emulsifiers or clouding agents from the Yu Shen Chemical Co. or the Pin Han Perfumery Co. and certain vitamins, nutritional supplements, food and beverages, particularly juices, sport and energy beverages and jams, imported from Taiwan. The Taiwan authorities have initiated recalls of certain brands of these products. DEHP-tainted products have been shipped to the United States, mainland China, Hong Kong, the Philippines and Vietnam.
Have the recent recalls in Taiwan affected IPEC member companies’ ability to supply products to customers?
IPEC members are all assessing the risk and taking appropriate actions to ensure a safe and secure supply of excipients so that there will be minimal, if any, supply chain disruptions
Are raw materials, processing aids and excipients from Taiwan safe for use?
All materials from Taiwan should be evaluated to confirm they are not from the affected materials or companies involved in the contamination events
What about the same materials from the surrounding Asian countries?
No other companies have been implicated at this time, but all companies in the supply chain need to confirm there are no materials originating from the identified suppliers in the supply chain.
Are packaging materials from the affected areas safe?
Some packaging materials may contain plastics with some phthalate content that has been approved for food contact based on migration criteria. These are not affected.
What kind of testing can be done to ensure no contamination with phthalates has occurred?
Analytical testing can be done to screen for multiple phthalates. This type of testing should only be necessary if chemicals from the identified sources are specifically involved. General testing for phthalates should not be required due to this incident.