In order to protect public health, in particular in view of the possible association with the formation of carcinogenic substances such as nitrosamines, the level of nitrate should be reduced to as low as reasonably achievable

The release of N-nitrosamines is determined in one aliquot of each solution obtained according to Annex I. The N-nitrosamines are extracted from the aliquot with nitrosamine-free dichloromethane (DCM) and determined by gas chromatography.

The teats and soothers referred to in Article 1 must not pass on to release-test liquid (saliva test solution) under the conditions specified in Annex I any N-nitrosamine and N-nitrosatable substance detectable by a validated method which complies with the criteria laid down in Annex II and which can detect the following quantities:

BASIC RULES FOR DETERMINING THE RELEASE OF N-NITROSAMINES AND N-NITROSATABLE SUBSTANCES

Whereas it has been shown that teats and soothers, made of elastomer or rubber, may release N-nitrosamines and substances capable of being converted into N-nitrosamines (N-nitrosatable substances);

It concerns the release of N-nitrosamines and of substances capable of being converted into N-nitrosamines, hereinafter called 'N-nitrosatable substances', from teats and soothers, made of elastomer or rubber.

Subsequently the nitrosamines are extracted from the solution with DCM and determined by gas chromatography.

CRITERIA APPLICABLE TO THE METHOD FOR DETERMINING THE RELEASE OF N-NITROSAMINES AND N-NITROSATABLE SUBSTANCES

0,01 mg in total of N-nitrosamines released/kg (of the parts of teat or soother made of elastomer or rubber),

concerning the release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers

Commission Directive 93/11/EEC of 15 March 1993 concerning the release of the N-nitrosamines and N- nitrosatable substances from elastomer or rubber teats and soothers

Whereas this Directive establishes the basic rules and general criteria for determining the release of N-nitrosamines and N-nitrosatable substances and postpones the definition of a detailed method of analysis;

The release of N-nitrosatable substances is determined in another aliquot of each solution obtained according to Annex I. The nitrosatable substances are converted into nitrosamines by acidification of the aliquot with hydrochloric acid.

It recommended, however, continuation of efforts to reduce exposure to nitrates via food and water since nitrates can be converted into nitrites and nitrosamines, and urged that good agricultural practices are adopted to ensure nitrate levels are as low as reasonably achievable.

Whereas the Scientific Committee for Food has given the opinion that N-nitrosamines and N-nitrosatable substances may endanger human health owing to their toxicity and has therefore recommended that migration of these substances from the abovementioned articles be kept below the detection limit of an appropriate sensitive method;

Whereas it is necessary to act immediately and therefore this Directive is limited to establishing specific rules regarding the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers, postponing to a more general directive regarding elastomers and rubber the solution of other problems concerning teats and soothers;

Nitrosamines:

Avoid formation of nitrosamines

The following N-Nitrosamines shall not be detected in rubber.

Smoke contains benzene, nitrosamines, formaldehyde and hydrogen cyanide.

The concentration of N-nitrosamines shall not exceed 0,001 mg/m3 as measured with the chamber test.

It concerns the release of N-nitrosamines and of substances capable of being converted into N-nitrosamines, hereinafter called 'N-nitrosatable substances`, from teats and soothers, made of elastomer or rubber.

COMMISSION DIRECTIVE 93/11/EEC of 15 March 1993 concerning the release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers

These substances belong to chemical classes that include short chain aliphatic nitrosamines, divalent metals, aldehydes, azo-dyes and diazo compounds, pyrollizidine alkaloids, allyl compounds and nitro compounds (3).

In order to protect public health, in particular in view of the possible association with the formation of carcinogenic substances such as nitrosamines, the level of nitrate should be reduced to as low as reasonably achievable

It is the opinion of the SCCNFP that the toxicological effects of the dialkanolamine salts, and, in particular, their readiness for nitrosamines' formation are similar to the respective properties of the dialkanolamines and that dialkylamines and their salts have very similar properties with the respective dialkanolamines' analogues with respect to nitrosamines' formation. The terms "dialkanolamines" and "dialkylamines" and synonymous with "secondary alkanolamines" and "secondary alkylamines" and the latter are less ambiguous.

Whereas, in order to protect public health, it is necessary to prohibit the use of 1,2-epoxybutane, CI 15585, strontium lactate, strontium nitrate, strontium polycarboxylate, pramocaine, 4-ethoxy-m-phenylenediamine and its salts, 2,4-diaminophenylethanol and its salts, catechol, pyrogallol, nitrosamines and dialkanolamines;