Presentation
This directive is a specific directive provided for in Regulation n°1935/2004 of October 27, 2004 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs.
This directive is a specific directive provided for in Regulation n°1935/2004 of October 27, 2004 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs.
This directive lays down the basic rules for testing the quantity of nitrosamines and n-nitrosatable substances released by pacifiers in reconstituted saliva. Analyses must be carried out using a validated method, and the permitted limits are as follows:
- nitrosamines: 0.01 mg/kg of teat or pacifier parts
- n-nitrosatable substances: 0.1 mg/kg of pacifier parts
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The migration test is carried out with a solution simulating saliva: material samples taken from an appropriate quantity of teats or soothers are immersed in the liquid for 24 hours at a temperature of 40°C. The result of the migration of the substances investigated in the simulant is related to the material (mg/kg of material) to be compared with the specific migration limits expressed in mg/kg of material, the appropriate unit for assessing this particular risk linked to oral contact.