All food contact articles fall into the category of high-risk products – and it’s our job to keep consumers’ safe, and yours too.

Every retailer, importer and distributor of food containers and food contact articles, as well as manufacturers, should use reliable quality assurance and laboratory testing services to protect the market’s interest.

Reach out to our FCM testing labroatory now, leverage our experience in food contact materials testing, to ensure your products meet the required standards and regulations:

European Regulations

The EU does have a harmonized legal framework, Regulation (EC) No. 1935/2004, which sets out general principles of good manufacturing practice (GMP), safety and inertness for food contact materials, but this is not the whole story. Different forms of food contact materials and specific substances are also subject to their own harmonized regulations, such as:

        • Directive 84/500/EEC, 2005/31/EC – Ceramics
        • Regulation (EU) 10/2011 – Plastics
        • Regulation (EU) 2018/213 – Bisphenol A (BPA) in varnishes and coatings
        • Regulation (EU) 2022/1616 – Recycled plastics

Despite EU efforts to further harmonize regulations for food contact materials (FCMs), there are still many important materials for which there are no specific requirements at EU level, and the European Council has developed resolutions to fill this gap.

While these resolutions are not legally binding, they are widely accepted by member states as guidance documents in the absence of EU or national legislation. These resolutions cover coatings, silicones, paper and paperboard, cork, glass, metals and alloys, ion exchange resins, rubber and packaging inks.

Food Contact MaterialCitation
CoatingsResolution ResAP (2004) 1
Cork stoppers and other cork materialsResolution ResAP (2004) 2
GlassGuidelines for Lead Leaching from Glass Tableware
Inks applied to non-food contact surfacesResolution ResAP (2005) 2
Ion exchange and adsorbent resinsResolution ResAP (2004) 3
Metals and alloysResolution CM/ResAP (2013) 9
Paper and boardEQDM Guidelines “Paper and Board”
Plastic colorantsResolution AP (89) 1
Plastic polymerization aidsResolution AP (92) 2
RubberResolution ResAP (2004) 4
SiliconesResolution ResAP (2004) 5
General requirementsResolution CM/Res (2020) 9

The U.S. Food and Drug Administration (FDA)

Regulations regarding FCMs are primarily found in Title 21 of the Code of Federal Regulations (CFR). Most regulated food contact materials can be found in 21 CFR Chapters 174 through 179:

        • 174 – General
        • 175 – Adhesives and components of coatings
        • 176 – Paper and paperboard components
        • 177 – Polymers
        • 178 – Adjuvants, production aids and sanitizers
        • 179 – Irradiation in the production, processing and handling of food

To support manufacturers of FCM, 21 CFR also contains:

        • 180 – Food additives permitted in food or in contact with food on an interim basis pending additional study
        • 182 – Substances recognized as safe
        • 184 – Direct food substances affirmed as generally recognized as safe
        • 186 – Indirect food substances affirmed as generally recognized as safe

To support manufacturers of pottery and silver-plated hollowware, the FDA has also published compliance policy guides in relation to leachable cadmium and/or lead:

        • CPG Sec 545.400: Pottery (ceramics) for cadmium
        • CPG Sec 545.450: Pottery (ceramics) for lead
        • CPG Sec 545.500: Silver-plated hollowware for lead

 

Federal Laws on BPA and Polycarbonate Resins

Finally, the FDA also has regulations affecting the use of BPA in FCM. Under 21 CFR 175.300 – Resinous and Polymeric Coatings, epoxy resins derived from BPA and epichlorohydrin are prohibited from being used in packaging for powdered and liquid infant formula. In 21 CFR.1580 – Polycarbonate resins, these materials are prohibited in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).