The following EU directives/regulations must be confirmed in the declaration of conformity:
- Regulation 1935/2004 Materials and articles intended to come into contact with food
- Regulation 2023/2006 Good manufacturing practice for materials and articles intended to come into contact with food
- List of CAS numbers for mixtures and approved substances
and the following confirmations depending on the material group:
Forplastics:
- Regulation 10/2011 Plastic materials and articles intended to come into contact with food
- Information on the simulants used (preferably: A, B, D2)
- Test conditions (temperature, time)
- Intended food contact
- Specification of the maximum duration of contact with food at a temperature of 70°C
- Ratio of contact surface to volume (usually 6 dm2/dm3)
- List of SML substances
- List of dual-use substances (substance name and CAS number)
- List of NIAS substances (not intentionally added substances)
For rubber:
- BfR Recommendation XXI
For silicone:
- BfR recommendation XV
For epoxy derivatives:
- Directive EC 1895/2005
For ceramic parts:
- Directive EC 84/500
The following US directives/regulations must be confirmed in the declaration of conformity:
- Compliance with the requirements of the Food and Drug Administration (FDA) in accordance with Code of Federal Regulation (CFR) Title 21