Framework regulation 1935/2004
Materials must not transfer substances to food that endanger health, change composition, or impair organoleptic properties. The requirement applies to all materials — also where no material-specific regulation exists.
The plastics regulation EU 10/2011
The most important material-specific regulation. A positive list of authorised starting substances: what is not on the list may not be used in food-contact plastics. A prohibition principle with exceptions — not a list of bans, but a list of permissions.
Migration — the transfer of substances from packaging to food — is the decisive technical metric. Overall Migration Limit OML: 10 mg/dm². Substance-specific Migration Limits SML for individual compounds. Testing uses standardised food simulants.
For plastics materials, a written declaration of compliance to every downstream customer is mandatory. Manufacturers must retain test reports and documents for five years.
Swiss specifics
Switzerland applies its food law, which has taken over EU 10/2011 in substance. Declarations for the Swiss market reference Swiss legal bases — not EU regulations. A supply chain that runs from an EU production site via a Swiss distributor to Swiss food manufacturers must have Swiss-compliant documents at each step.
For other materials — ceramics, paper and board, metals, glass, silicones — there is partial EU harmonisation, partial national regulation, partial reliance on the general 1935/2004 requirements only. Each market must be analysed separately.
Case: supplier change, CHF 420,000
A Swiss food-packaging manufacturer changes polypropylene supplier for cost reasons. Nominally identical material. New supplier: cheaper, better lead time. Compliance check of the new material: skipped.
Three months after the switch: a Migros in-house lab analysis of a yoghurt-cup batch shows OML breach. The new material contains different additives — outside the EU 10/2011 positive list. Migros delists the line. Total damage: new lab testing CHF 18,000, production stoppage and reformulation CHF 402,000.
Red flag: every raw-material supplier change is a compliance event. No exception.