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- Practical Guide -
Page 121 of 153
ANNEX TO SECTION 7 OF CHAPTER I
NITROSAMINES AND N-NITROSATABLE SUBSTANCES
IN RUBBER TEATS AND SOOTHERS
1.
EU legislation: List of pertinent Directives
93/11/EEC [A16]
Commission
Limits of nitrosamines and N-nitrosatable
substances in teats and soothers
2.
Limits of nitrosamines and N-nitrosatable substances in rubber teats and
soothers
Researches carried out in Germany showed a possible release of nitrosamines and N-
nitrosatable substances in rubber teats and soothers. Therefore the Commission, after the
advice of the Scientific Committee on Food (SCF), drafted a proposal of Directive adopted as
Directive 93/11/EEC.
Nitrosamines are formed in rubber teats and soothers during their production, nitroso- or
NOx compounds reacting with secondary amines used as accelerators or stabilisers. Since
modifications of the manufacturing process did not sufficiently reduce the migration of
volatile nitrosamines, it seemed necessary to establish limits for the amides, amines and other
nitrosatable substances which are as low as technically achievable. Directive 93/11/EEC
(Article 2) limits the quantity of these substances in finished rubber teats and soothers.
3.
Control of N-nitrosamines and N-nitrosatable substances
Annexes I and II of Directive 93/11/EEC provide basic rules and criteria for the method of
analysis to be used to determine the release of these materials. A validated method is issued
as EN (see Chapter III).