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Release of N-nitrosamines from rubber teats

Community legislation is harmonising the provisions relating to the release of N-nitrosamines and N-nitrosable substances from elastomer or rubber teats and soothers.

ACT

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

SUMMARY

This Directive is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

Elastomer or rubber teats and soothers are capable of releasing N-nitrosamines and N-nitrosable substances (substances likely to be transformed into N-nitrosamines) which, by virtue of their toxicity, pose a threat to human health.

Accordingly, the migration of substances must not exceed the following limits:

  • 0.01 mg of the total quantity of N-nitrosamines released per kg (parts of elastomer or rubber teats and soothers)
  • 0.1 mg of the total quantity of N-nitrosatable substances (parts of elastomer or rubber teats and soothers).

These limits must be checked by means of a test, subject to the conditions set out in the annex to this Directive. The analytical method to be employed is also laid down in this annex.

Teats and soothers which do not comply with this Directive are prohibited from 1 April 1995.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 93/11/EEC

24.3.1993

1.4.1994

OJ L 93 of 17.4.1993

Last updated: 19.11.2009

See also

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