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NSF International Protocol P155

NSF International, is a not for profit, non governmental organization. They are the leading global supplier of public health and safety based risk management services. NSF services include product certification and safety audits for the food and water industries. NSF is a World Health Organization Collaborating Center for Food and Water Safety and Indoor Environment. NSF was founded in 1944 and is headquartered in Ann Arbor, MI.

This protocol covers disposable single-task gloves typically used for food handling, preparation, and service tasks. This protocol establishes criteria for product quality in terms of toxicology (indirect food additive), physical properties (tensile strength, elongation), barrier resistance (leakage), and sanitation (bioburden). The criteria in the protocol are divided into general requirements for all gloves and material specific requirements that apply to the major material-types used in food contact gloves: polyethylene, vinyl, natural rubber latex, nitrile, and other synthetic blends. As new materials are developed in the industry, material-specific requirements may be added in subsequent revisions of the protocol. As new test methods and regulatory requirements (e.g. ASTM, FDA) are developed dealing with durability or other product quality parameters, they may be added as well, in consultation with an expert panel consisting of health officials, manufacturers, users and other stake-holders.

What You Should Know About DOP/DEHP

DEHP (di-2-ethylhexyl phthalate) sometimes known as DOP (di-octyl phthalate) is a commonly used plasticizer from the phthalate ester family and has been in use in flexible PVC (Poly Vinyl Chloride) products since the 1930’s. Flexible PVC products for building, automotive, medical and packaging applications usually contain phthalates.

As phthalates have been used for such a long time, they continue to be closely studied to ensure that their use is safe. It has been known for many years that small amounts of plasticizers can leach out of the products under certain circumstances. One such circumstance is medical tubing, blood and other intravenous (IV) fluid bags where phthalate plasticizer that may have migrated into the fluid during storage can enter the patient.

In 2000, the World Health Organization’s International Agency for Research on Cancer (IARC) reclassified DEHP, the most commonly used plasticizer in flexible PVC products as non-carcinogenic to humans. Previous to that, in 1982 they had classified these plasticizers as “possibly carcinogenic to humans”. In 1990 the European Commission established its own position that DEHP shall not be labeled or classified as a carcinogen based on studies which showed differences in how species respond to DEHP.

In reaching its 2000 decision to downgrade the classification of DEHP to “not classifiable as to carcinogenicity in humans” they reviewed more recent scientific studies that took into account the evidence that the mechanism by which DEHP induces liver tumors in rats and mice is not relevant to humans.

In 2003 the CDC released a report on phthalates that confirmed that median exposures to phthalates were well below levels that could be expected to cause health effects, based on exposure level study using blood and urine tests.

There is no evidence that anyone has been harmed by exposure to phthalate plasticizers. Nevertheless, scientific uncertainty about the potential for phthalates to disrupt the human endocrine system or reproductive development has led to significant ongoing debate about their safety. Eighty six hospitals and GPO’s in 12 states have pledged to reduce the use of PVC and/or DEHP.