Prospective study of N-nitrosamines and N-nitrosatable substances in rubber and silicone teats and soothers

* This record is given in both English and Spanish

Teats and soothers for infants are usually made of rubber and silicone rubber. During the vulca­nization process of rubber, nitrosatable substances can be formed which in contact with nitrates present in the saliva may lead to the formation of N-nitrosamines, chemicals considered to pose a health risk due to their carcinogenic and/or mutagenic properties. These substances are regulated at European level by Directive 93/11/EEC, transposed into the Spanish Royal Decree 1184/1994. Ta­king into account the lack of data available at national level, and also the frequent use of this type or articles intended for the infant population, we carried out a prospective study on the release of N-nitrosamines and N-nitrosatable substances into artificial saliva solution, on 24 samples of teats and soothers marketed in Spain. Gas chromatography coupled to mass spectrometry (GC-MS) was used as the analytical method, along with UNE-EN 12868 as standard for the release test. The analytical method was internally validated with satisfactory results for the criteria set in Guidelines for performance criteria and validation procedures of analytical methods used in controls of food contact materials.

N-nitrosamines and N-nitrosatable substances determined in this study were below the regu­lated limits of 0.01 mg.kg-1 and 0.1 mg.kg-1, respectively, in all the 24 samples. These results are in agreement with data published by other authors