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No specific harmonised regulation at EU level exists that specifies the requirements for rubber materials and articles for food contact. However, there are two European guidelines for rubber materials and articles intended to come into contact with food. The guidelines are of help to ensure that manufacturers and importers comply with Regulation 1935/2004/EC.
The European Council has issued Resolution ResAP (2004) 4, which lists a number of basic substances that are usually allowed in the manufacture of rubber. The list is not a positive list of authorised substances, but it can be used to lean on during an actual assessment of the precautions to be taken when the substances are used. The guideline also helps with calculation examples that can be used to assess whether testing is required. These calculations are based on:
- Contact area between food and rubber material
- Contact duration
- Contact temperature
- Number of repeated contacts
In its guideline no. XXI, the German Federal Institute for Risk Assessment also identifies a number of substances that may be used in the manufacture of rubber – as well as recommendations on which tests should be conducted with the materials and articles.
Soothers and rubber teats are the only food related products that are regulated by a specific directive at EU level – the Commission Directive 93/11/EC. These products are usually in prolonged contact with the mucosa in the mouth cavity. It was, therefore, decided that they should be regulated by a specific directive that sets limits for the release of N-nitrosamines and N-nitrosatable substances.