All Materials and objects intended to come into Contact directly or indirectly with Food (FCM) must comply with European Regulation EC 1935/2004. The Regulation aims to guarantee and protect human health and consumer interests. The Regulation 2023/2006 (GMP) currently in use, establishes the rules relating to good manufacturing practices for materials and objects intended for contact with food and applies to all stages of production, processing and distribution.
What do European Regulations say?
According to the a.m. European Regulations, the object or material for food contact must not:
- Representing a risk for health
- Change the composition of the food
- Unfavorably modify the organoleptic characteristics of the food
The traceability of the entire supply chain must be guaranteed at every stage of the process, from production to distribution.
Quality and safety
Based on these principles, all the FCMs must comply with Good Manufacturing Practices, be managed by adequate quality procedures, control system and correct documentation management. All FCMs are therefore based on two fundamentals that are general principles of safety:
Regulations on use of rubber
Nowadays, for rubber, there is no specific European Regulations that can provide a list of polymers and ingredients suitable for the production of objects and materials suitable for contact with food.
Therefore, the following National Regulations and official national guidelines are currently still in force:
- DM (Ministerial Decree) of 03/21/1973 for Italy
- BfR (Bundestamt fü Risikobewertung) Recommendations for Germany
- Arrêté du 9 November 1994 for France
- FDA (Food and Drugs Administration) for USA
Each National Regulation draws up their own list of substances which can be used for the preparation of materials and objects suitable for contact with food. Each manufacturer must strictly observe the list and the use of substances that are not listed is not allowed. The use of substances not included in each Regulation results in administrative and criminal sanctions.
The principles of MTG on GMPs
MTG has been working with this philosophy for 40 years, focusing its activities in the choice of raw materials, definition of correct processes from year to year in order to comply with the requirements of the several existing regulations.