The N-nitrosamines and N-nitrosatable Substances in Elastomer or Rubber Teats and Dummies (Safety) Regulations 1995

• Citation: S.I. 1995/1012
• Sections: 9

Section 1 Citation and Commencement

These Regulations may be cited as the N-nitrosamines and N-nitrosatable Substances in Elastomer or Rubber Teats and Dummies (Safety) Regulations 1995 and shall come into force on 28th April 1995.

Section 2 Interpretation

In these Regulations –

“N-nitrosatable substances” means any substances capable of being converted into N-nitrosamines;

“dummy” means a soother and includes an article made of elastomer or rubber used to satisfy sucking needs and to pacify infants;

“supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply; and

“teat” includes a substitute nipple made of elastomer or rubber that when attached to a container holding a fluid permits a baby to obtain the fluid from the container by sucking.

Section 3 Application

These Regulations apply to teats and dummies which are intended to be, or are, brought into contact with foodstuffs.

Section 4 Supply

No person shall supply a teat or dummy unless the teat or dummy complies with the provisions of regulation 5 below.

Section 5 Basic Rules and Criteria Applicable to the Method of Determining Release

A teat or dummy shall not pass on to release-test liquid (saliva test solution) under the conditions specified in Schedule 1 to these Regulations any N-nitrosamine and N-nitrosatable substance detectable by a method which complies with the criteria laid down in Schedule 2 to these Regulations and which can detect the following quantities –

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

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

Section 1 Release-test liquid (saliva test solution)

To obtain the release-test liquid, dissolve 4,2g of sodium bicarbonate (NaHCO3), 0,5g of sodium chloride (NaCl), 0,2g 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.

Section 2 Test conditions

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

Section 1

The release of N-nitrosamines is determined in one aliquot of each solution obtained according to Schedule 1. The N-nitrosamines are extracted from the aliquot with nitrosamine-free dichloromethane ( DCM ) and determined by gas chromatography.

Section 2

The release of N-nitrosatable substances is determined in another aliquot of each solution obtained according to Schedule 1. 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.