Product Safety

No heavy metals in TDPA™

The term “heavy metals” has no scientific meaning and should not be used. Since it is frequently used by those who are not scientists it will be used here to mean lead, arsenic, mercury, cadmium, selenium, barium, chromium, nickel and antimony. None of these elements is found in any of EPI’s TDPA™ additives. These are analyzed on a regular basis by certified independent laboratories in Europe and North America whose reports consistently confirm the absence of “heavy metals” in TDPA™.

The UK Food Standards Agency’s Expert Group on Vitamins and Minerals has carried out a risk assessment on trace elements and has shown that all the transition metal salts used in TDPA™- plastics are in fact trace elements necessary for healthy plant and human growth (ref. 1).

None of the active ingredients or the additives in EPI’s TDPA™ is classified as a carcinogen by the International Agency for Research on Cancer (IARC). California has some of the most aggressive environmental and public health legislation in the world. TDPA™ additives do not contain materials presently known by the State of California to cause cancer or reproductive toxicity at a level of exposure subject to the requirements of the California Safe Drinking Water and Toxic Enforcement Act of 1996 (California Proposition 95) nor do they contain any substance that would require a warning notice under the Proposition 65 regulations.

Manufacturing Safety

To assess any potential workplace hazards associated with the manufacture of products utilizing TDPA™ additives, EPI commissioned an independent laboratory (Levelton Consultants Ltd.) to determine worker exposure to TDPA™ additive during the manufacture of both the additives and products containing them. Results from this study showed that neither the air nor process water were contaminated with the components of TDPA™ and that factory exposure levels were several orders of magnitude below the allowable exposure limits. Furthermore, the concentration of airborne metal ions was extremely low, well below the NIOSH (National Institute for Occupational Safety and Health) and WCB (Worker’s Compensation Board) legislated levels.

Food Contact Compliance

Keller and Heckman LLP, an international law firm with expertise in regulatory law, provided an opinion that the TDPA™ additives they reviewed comply with food packaging safety requirements as regulated by the United States Food and Drug Administration (FDA) and the European Union’s Safety Committee for Food (EFSA).

TDPA™ additives are either listed in the FDA’s food additive regulations as GRAS (Generally Recognized as Safe) or have been tested to ensure that they are within acceptable limits for rate of migration from plastic packaging into foods with which they are in contact. These additives have been deemed to comply with the US Federal Food Drug and Cosmetic Act and all applicable food additive regulations.

TDPA™ additives comply with the relevant European Union (EFSA) and Member State legislation applicable to food contact materials and may be used in plastic food packaging in Europe. Most of the components of TDPA™ additives may be used in contact with food without restrictions. Some are subjected to specific migration limits, and tests have shown that these comply with the requirements of the Frame Work Directive (89/109/EEC) and the Plastics Directive (2002/72/EC).

Individual products sold in Canada for direct food contact applications have to be approved by the Canadian Food Inspection Agency (CFIA). For example, for each application incorporating TDPA™, end-product manufacturers are required to obtain approval from CFIA before the product can be used for food contact. A number of applications to date have been approved for products containing TDPA™ including polystyrene food trays for meat packaging and polypropylene cutlery.

References

1. UK Food Standards Agency (2003) “Expert Group on Vitamins and Minerals, Part 3, Trace Elements, Risk Assessment.