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Nitrosamines are a class of chemical compounds with the generic chemical structure R2NN=O, produced under certain conditions (acidic pH, high temperature, presence of certain reducing agents) and can be found in products, biological systems, air, etc., where nitrites react with nitrosatable substances, mainly secondary amines.
Several nitrosamines are classified as carcinogenic by the International Agency for Research on Cancer. They can contribute to the development of tumors in several organs and can cause cancer of the penis, stomach, cervix, urinary bladder, and vagina. Nitrosamines are also linked to endocrine disruption and organ system toxicity. The two most common nitrosamines are
and
.
While there is no evidence that nitrosamines are intentionally added to consumer products, they have been detected as contaminants in a number of products including food, beer, tobacco, rubber products, and cosmetics. [*]
In the early 90’s, the EU established specific limits on the presence and release of nitrosamines from rubber teats (Directive 93/11/EEC). In 2002, the German Federal Institute for Health Protection of Consumers (BgVV) conducted a study on rubber balloons and in its scientific opinion, concluded that, on the assumption that children would mouth balloons for a standard average time, the release of nitrosamines does not pose specific health concerns, provided that the released amounts are low. BgVB suggested that the migratable levels of nitrosamines be regulated and minimised. In response, the public administrations in Germany and in the Netherlands proceeded with precautionary measures.
On the basis of these findings, in 2007 the European Commission requested the Scientific Committee on Consumer Products to provide a scientific opinion on the presence and release of nitrosamines from rubber balloons. Although the health concerns for exposure to children were found to be negligible, the Commission suggested to set a limit for nitrosamine levels in balloons as it found that minimisation of nitrosamine formation in the production process of balloons was possible using state-of-the-art technology, hence exposure to nitrosamines via balloons was largely avoidable. The use of vulcanisation accelerators which result in non-carcinogenic nitrosamines was encouraged.
In 2009 the new European Toy Safety Directive 2009/48/EC was published. Among the new safety requirements, the Directive stated that nitrosamines and nitrosable substances shall be prohibited in toys intended for use by children under 36 months, or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosable substances.
In 2010 the World Health Organization (WHO) set specific limits for the levels of nitrosamines in condoms, indicating that responsible manufacturers should keep nitrosamine levels as low as possible, with target levels of about 0,02 mg/kg.
A more recent study conducted in the U.S. aimed at identifying releases of nitrosamines from condoms. According to The Campaign for Safe Cosmetics (CSS), a broad-based coalition housed at the Breast Cancer Fund, one-third of 23 condoms tested exceeded the European leaching standards for nitrosamines in toys. Considering that no scientific body or world government, including the U.S. Food and Drug Administration (FDA), has set limits for safety standards on condoms, the CSS launched a petition to urge FDA to issue an industry safety standard that eliminates detectable levels of nitrosamines.
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“I don’t want even small amounts of a carcinogenic chemical in condoms given their close proximity to some of the most sensitive and permeable parts of my body. Some companies are already making condoms without nitrosamines, proving it’s possible. But without an FDA-mandated industry safety standard, industry laggards will continue to sell condoms that include these toxic chemicals!” (CSS petition letter template) |
Are governments planning to conduct specific studies to assess the risk posed by the presence of nitrosamines in condoms? Should you have any additional information or you would like to share your opinion, feel free to contact My Chemical Monitoring at: info@mychemicalmonitoring.com
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