Regulation CE 1935/2004 for objects that come into contact with food

The ordinance regulates the basic requirements, terms and regulations that must be met in order to make objects and materials safe for contact with food. Compliance with regulation 1935/2004 forms the basis for a proper CE declaration of conformity

General requirements

All materials and objects are to be manufactured in accordance with good manufacturing practice (GMP) in such a way that, under normal or foreseeable conditions of use, they do not release any components on foods that are suitable:

  • endanger human health, or
  • bring about an unacceptable change in the composition of the food, or
  • cause a deterioration in the organoleptic properties of the food.
 
Furthermore, the labeling, advertising and presentation of the materials and objects must not mislead the consumer.

Individual measures for groups of objects

The ordinance also regulates how special groups of items such as: recycled materials or combinations can be issued.

This includes, among other things:

  • A list of substances approved for manufacture
  • One or more lists of materials and articles and substances permitted as constituents of active or intelligent materials
  • Purity criteria for the above substances
  • Special conditions for the use of the above substances
  • specific migration values ​​as well as total migration values
  • Regulations for the protection of human health from the dangers of oral contact with the materials and objects
  • Rules for taking samples
  • Rules to ensure traceability, including rules on how long records are kept
  • and more…
 
Furthermore, the regulation does not prevent individual member states from maintaining or enacting national regulations

Labelling

Without prejudice to any individual measures, materials and objects (such as gloves) must be labeled as follows, among other things, when they are placed on the market:

  • With the information "For food contact" or with a special reference to your reference such as the coffee machine, wine bottle or soup spoon or with the symbol shown below
  • At most with special instructions for safe and proper use
  • with the name or business name and, in any case, the address or registered office of the manufacturer, the processor or a seller established in the Community who is responsible for placing on the market
  • adequate marking or identification that allows traceability

Additional

The ordinance also defines important points such as public access, confidentiality, committee procedures, protective procedures, sanctions and transitional regulations.

Individual measures such as 10/2011 for plastics or AP (4) 2004 for rubber and Regulation 2023/2006 for good manufacturing practice GMP are specific to gloves.

References:

Original text of regulation 1935/2004: https://eur-lex.europa.eu/legal-content/de/ALL/?uri=CELEX%3A32004R1935
Original text Regulation (EU) 10/2011: https://eur-lex.europa.eu/legal-content/de/TXT/?uri=CELEX%3A32011R0010
Original text of regulation GMP 2023/2006: https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=celex%3A32006R2023

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