Explanatory note

These Regulations implement Commission Directive No. 93/11/EEC concerning the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers (OJ No. L93, 17.4.1993, p.37). This Directive is a specific Directive adopted pursuant to the provisions of Article 3 of Council Directive No. 89/109/EEC on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (OJ No. L40, 11.2.1989, p.38) (the Council Directive). The Council Directive provides that such materials and articles must be manufactured in compliance with good manufacturing practices. This general duty is implemented by the provisions of regulation 4 of the Materials and Articles in Contact with Food Regulations 1987 (S.I. 1987/1528) which applies to teats and soothers within the scope of these Regulations.

These Regulations apply to teats and soothers (referred to as “dummies” in these Regulations) intended to be (or which are) brought into contact with foodstuffs (regulation 3).

The Regulations provide that the supply of a teat or dummy not complying with their requirements is prohibited (regulation 4).

Basic rules and criteria applicable to determining the release of substances are provided by these Regulations (regulation 5 and Schedule 1, and 2).

A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies can also be obtained from the Consumer Affairs Division of the Department of Trade and Industry, Room 315, 10 – 18 Victoria Street, London SW1H 0NN.