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Directive concerning the release of the N-nitrosamines and N-nitrosatable substances – 93/11/EEC – EU Directive concerning the release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers

 

Requirments of the Directive

 

In accordance with the EU Directive 93/11/EEC, Nitrosamines are not allowed in rubber teats and soothers.

 

Toxicity

 

Nitrosamines can cause cancers in a wide variety of animal species, a feature that suggests that they may also be carcinogenic in humans. Epidemiological data suggest that nitrosamines in preserved food cause stomach cancer.

 

Additional information on Nitrosamines

 

Nitrosamines are found in many foodstuffs, especially beer, fish, and fish byproducts, and also in meat and cheese products preserved with nitrite pickling salt. The U.S. government established limits on the amount of nitrites used in meat products in order to decrease cancer risk in the population. There are also rules about adding ascorbic acid or related compounds to meat, because they inhibit nitrosamine formation.

 

Nitrosamines can be found in tobacco smoke and latex products. A test of party balloons and condoms indicated that many of them release small amounts of nitrosamines. However, nitrosamines from condoms are not expected to be of toxicological significance

 

In United States, for rubber teats and soothers, Nitrosamine content should not be greater than 100ppb.

 

 

 

 

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