Proposition 65 warnings may soon be carried on an unlikely personal care product according to recent pre-suit notice filed by the Oakland-based Center for Environmental Health (CEH) on October 6.
In its notice CEH alleges condoms expose users to an obscure carcinogen known as N-Nitrosodiethyl-amine (NDEA) (CAS No. 1116-54-7).
According to the U.S. Environmental Protection Agency, individuals are most likely to be exposed to NDEA in occupational settings such as in the rubber, tannery, fish processing, dye, and surfactant industries.
The chemical is also used as an additive for lubricants, and softener for co-polymers. It has also been used as an ingredient in rocket fuels.
The EPA notes humans are also exposed to low levels of NDEA from cured meats, smoked fish and tobacco smoke.
N-Nitrosodiethylamine was listed as a Proposition 65 carcinogen on January 1, 1988.
CEH told Prop 65 News that it tested several brands of condoms, finding that only a few of the samples registered measurable levels of NDEA. CEH research director, Caroline Cox said that levels of the chemicals were significantly higher in the Playboy Premium Latex Condom, Lubricated, brand manufactured by the Los Angeles-based United Medical Devices, LLC than in any of the other condoms tested.
She said that while CEH is sensitive to its role in promoting public health, including the use of condoms, however the test results for the Playboy brand showed substantially higher levels of NDEA requiring action.
Concerns about NDEA in condoms were raised in July 2012 by researchers at the Chemical and Veterinary Investigation Institute in Stuttgart which reported that harmful levels of nitrosamines were released by 29 of 32 condom brands tested when they came into contact with bodily fluids. The researchers urged manufacturers to address the problem and seek alternative, non-carcinogenic chemicals for use in place of nitrosamines, which are added to improve elasticity.
The study authors said “N-nitrosamine is one of the most carcinogenic substances. There is a pressing need for manufacturers to tackle this problem.”
Condom producers Durex were quick to dispute the Institute’s findings. “This is completely unsupported by medical and scientific evidence and no regulatory body has ever called for limits to be set on levels of nitrosamines in condoms,” said a company spokes-person the day the test data was released.
The European standards authority sets limits for nitrosamines or nitrosable substances in latex products likely to come into contact with very young children and relatively large volumes of saliva, such as baby bottles, but the agency has not established limits for condoms.
But Germany’s Federal Institute for Risk Assess-ment has said that daily condom use exposed users to N-Nitrosamine levels up to three times higher than levels naturally present in food.
Werner Altkofer, head of the Chemical and Veterinary Investigation Institute said that though the production of rubber usually uses chemicals that can exclude N-Nitrosamine, condom manufacturers could avoid it by using more expensive alternative substances available on the market that don’t form the carcinogen.
CEH is the only citizen enforcement group to target condoms in a 60-day notice.
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