Food contact materials regulations around the world
Food contact materials (FCMs) regulations in the United States, Asia-Pacific, and Europe, the Middle East and Africa
In the sixth instalment of our expert 101-level series, Global Product Compliance Manager, Stacey Bowers, details the trending regulations in food contact materials (FCMs) in the US, APAC, and EMEA.
Here, we summarize some of the emerging requirements across various products, including utensils, ceramicware, glassware, and kettles, which are set to impact manufacturers of food packaging and other articles across these regions.
Click here for a quick, interactive summary of the regulations in each region, or read on for deeper expert insights and analysis following our webinar Food Contact Materials 101.
Utensils
In the US, the FDA’s Food Code is a reference document to ensure food safety across food service establishments, retail food stores, and other institutions such as childcare centers and nursing homes.
Chapter 4 of the Food Code specifically establishes requirements for utensils used in these environments.
[A utensil is] defined to mean a food contact implement or container used in the storage, preparation, transportation, dispensing, sale or service of food, including kitchenware and tableware.
FDA The Food Code Chapter 4The requirements laid out in Chapter 4 state that materials used in the construction of utensils:
- Mustn’t allow the migration of harmful substances or impart colors, odors, or tastes to food
- Must be safe
- Must be durable
- Must be resistant to corrosion
- Mustn’t be absorbent
- Must be sufficient in weight and thickness to withstand repeated washing
- Must have a smooth, easily cleanable surface
- Must be resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition
The FDA Code further establishes limitations for the use of certain materials in multiuse, ceramic, china, and crystal utensils, including:
- Cast iron
- Copper
- Galvanized metal
- Lead
Ceramicware and glassware
Ceramic and glass products are regulated under several policies in both the US and Canada.
Compliance Policy Guides
The FDA’s Compliance Policy Guides (CPGs) features restrictions on the use of lead and cadmium in ceramicware and silver-plated hollowware, which applies to cups, mugs, flatware, large hollowware, pitchers, and small hollowware used in the preparation, serving, or storage of food.
- CPG 7117.06 restricts extractable cadmium from imported and domestic ceramicware
- CPG 7117.07 restricts extractable lead from imported and domestic ceramicware
The FDA will evaluate the ceramicware based on multiple standards (ASTM C738, AOAC 973.32 and AOAC 973.82). There’s a risk of legal action for exceeding the lead and cadmium limits in ceramicware articles, but non-compliant items may avoid fines or detention if they bear a label claiming “Not for Food Use – Article May Poison Food”.
Glazed Ceramics and Glassware Regulations
The Glazed Ceramics and Glassware Regulations in Canada establish leachability limits for lead and cadmium in flatware, small and large hollowware, cups and mugs, and pitchers. The Regulations also limit lead and cadmium in any drinking vessel with a distinctive exterior decorative pattern within 20mm of the rim.
Products must be tested to a method based on ISO 6486-1:2019 to determine if they release lead or cadmium. Similarly, drinking vessels must be tested based on the American Society for Testing and Materials standard ASTM C927-80 (2019)e1.
Products that aren’t intended for food use, but still have excess lead or cadmium, have to be identified by a design feature, a hole, or a label specifying it isn’t for food use.
MERCOSUR
Among many other regulations, MERCOSUR/GMC/RES No. 55/92 establishes requirements for glass and ceramic containers, along with other equipment intended as food contact materials. This is applicable to the Southern Common Market, such as Argentina, Brazil, Paraguay, Uruguay and Bolivia.
MERCOSUR has a series of technical regulations or resolutions that talk about food contact — many of which are based on what’s happening in the EU.
Stacey Bowers Global Product Compliance ManagerThe Resolution mandates that only specified glass, such as borosilicate and sodium-lime, may be used for food contact.
Any ceramic, glass, or metal container that has been enameled or vitrified on the food contact surfaces must comply with a specified total migration limit and limits for lead and cadmium, based on their size and capacity.
Food Sanitation Act
In Japan, the Food Sanitation Act provides specifications for various materials present in apparatus, containers, and food packaging, mandating cleanliness and sanitation.
The Act establishes specifications for the following FCMs:
- Synthetic resins
- Metal cans
- Apparatus, containers, and packages made of glass, ceramic, enamel, or rubber
By 1 June 2025, the country intends to publish its positive list of raw materials allowed for use in apparatus, containers, and packaging.
Directive 84/500/EEC
This European Directive establishes the following limits for cadmium and lead present in ceramicware:
Category 1: Articles which can and cannot be filled without exceeding 25mm internal depth.
Lead: 0.8mg/dm2
Cadmium: 0.07mg/dm2
Category 2: All other articles which can be filled.
Lead: 4.0mg/l
Cadmium: 0.3mg/l
Category 3: Cooking ware and packaging and storage vessels with a capacity of over three liters.
Lead: 1.5mg/l
Cadmium: 0.1mg/l
Kettles
In Canada, the Kettles Regulations restrict the use of lead present in kettles for household use, a concern that arose in the 1970s.
Under these Regulations, a kettle mustn’t release more than 0.01ppm of lead, which is tested via heating and boiling distilled and deionized water for 15 minutes.
Global FCM regulations
Catch up on our webinar recording, where Global Product Compliance Manager, Stacey Bowers, takes a deep dive into the existing and emerging FCM regulations in the United States, Canada, Europe, Mexico, New Zealand, China, Japan, India, the United Kingdom, and more.
Attend our live demonstration showcasing how businesses can leverage Product Intelligence solutions to manage chemical and product compliance regulations for FCMs.
