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

• CELEX: Directive 93/11/EEC
• Articles: 5

Article 1

This Directive is a specific directive within the meaning of Article 3 of Directive 89/109/EEC.

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.

Article 2

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:

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

- 0,1 mg in total of N-nitrosatable substances/kg (of the parts of teat or soother made of elastomer or rubber).

Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 April 1994. They shall immediately inform the Commission thereof.

Member States shall:

- permit, as from 1 April 1994, the trade in and use of teats and soothers complying with this Directive,

- prohibit, as from 1 April 1995, the trade in and use of teats and soothers which do not comply with this Directive.

2. When Member States adopt the measures referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 15 March 1993.

For the Commission Martin BANGEMANN Member of the Commission

Schedules & Appendices

ANNEX I

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

1. Release-test liquid (saliva test solution) To obtain the release-test liquid, dissolve 4,2 g of sodium bicarbonate (NaHCO3), 0,5 g of sodium chloride (NaCl), 0,2 g of potassium carbonate (K2CO3) and 30,0 mg of sodium nitrite (NaNO2) in one litre of distilled water or water of equivalent quality. The solution must have a pH value of 9.

2. Test conditions Samples of material obtained from an appropriate number of teats or soothers are immersed in the test-release liquid for 24 hours at a temperature of 40 ± 2 °C.

ANNEX II

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

1. 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.

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