Regulation and safety of packaging

Regulation (EC) No 1935/2004 (or ‘Framework Regulation’) of 27 October 2004 sets general requirements applying to materials and articles intended to come into direct or indirect contact with foodstuffs, food products or beverages placed on the market in the European Union to ensure a high level of consumer protection.

It states that materials and articles intended to come into contact directly or indirectly with food must be sufficiently inert towards the foodstuffs.

This principle of inertness form the basis of the food contact legislation and manufacturers of plastic and flexible packaging pay particular attention to it.

Regarding the safety of plastic packaging, materials and articles must comply with Regulation (EU) No 10/2011 which lays down:

  • Only the substances included in the Union list may be intentionally used;
  • Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits set out in the Union list;
  • Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm2 of food contact surface (mg/dm2);
  • basic rules for compliance testing etc.

The compliance of the final plastic material and article with EU provisions can only be ensured if along the supply chain relevant information exchange takes place between the supplier and the customer and vice versa. The DoC is a document delivered by the supplier to his customer at marketing stages up to but excluding the retailer.
It has two main aims:
– It confirms to the customer the compliance of the product with the relevant requirements of the Plastics Regulation and the Framework Regulation.
– It provides the customer with relevant information necessary to establish or check the compliance of
the product
with relevant legislation.

In France, this obligation to complete a declaration of conformity has been extended to all types of materials (Article 6 of Decree No 2007-766 of 10 May 2007 amended).

For more information on French provisions, please consult the note of the DGCCRF n ° 2014-108.

Regulation of food contact materials does not apply to packaging used for cosmetic products and medicinal products. Regulation (EC) No 1223/2009, Public Health Code, and Pharmacopoeia are the regulatory basis for these two sectors. However, on the specific request of the customer or in order to widen the scope of his investigation, the packaging manufacturer may have to take account of the regulation of materials intended to come into contact with food.

Elipso supports its members in the implementation of the regulations applicable to food contact materials (food, cosmetics…), as well as in the assessment and management of risks associated with contact materials. The association is also involved in standardization with AFNOR and CEN.