Food Contact Materials
During production, transport, and consumption, food comes into contact with all kinds of materials. For example, think of conveyor belts, filters, all kinds of (plastic) packaging materials and the coffee machine at your office. Overall, these materials are called: Food Contact Materials (FCMs).
The responsibility for the food safety of materials falls to the business operators who are putting them on the market. Specifically, the safety of materials relies on ensuring that there is no migration of unsafe levels of chemical substances from material (packaging) to food. Therefore, producers and importers must check and document that their food contact materials meet this and other legislative requirements.
As a result, the European Food Safety Authority (EFSA) regulates the safety of food contact materials. At EFSA’s website, you can search for opinions on substances to be used in food contact materials.
Overall, the Regulation 1935/2004/EC is applicable for all food contact materials in the EU. In short, this framework of regulations states the following:
“Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable condition of use, they do not transfer their constituents to food in quantities which could:
- Endanger human health
- Bring about a large change in composition
- Bring about deterioration of the organoleptic characteristics”
17 materials for FCM have been identified. However, Harmonised EU legislation only exists for 4 of them. The most well-known set of harmonised EU legislation is Regulation (EU) No 10/2011 on Plastic Materials and Articles. For other materials such as coatings, adhesives, and paper, national legislation applies (i.e. the Dutch Packaging and Consumer Items (Commodities Act) Regulation).
In the EU, a declaration of compliance (DOC) is mandatory for food contact plastics (including recycled plastics), active and intelligent materials, ceramics and regenerated cellulose film. For other types of food contact materials (i.e, paper, inks), a DOC is currently not mandatory. However, it is common for actors up the value chain to request one.
FDA -21 CFR part 170 to 186
When introducing your product to the US market, the regulatory rules of the US Food and Drug authority apply. Therefore, substances used in food-contact articles are considered “indirect” food additives.
The following regulatory chapters of FDA -21 CFR part 170 to 186 describe the US regulations for packaging and other FCM.
174 – General
175 – Adhesives and coatings
176 – Paper and Paperboard
177 – Polymers
178 – Adjuvants, Production aids and sanitizers
181 – Prior- Sanctioned substances
182, 184, 186 – GRAS substances
Recycled, Biobased and Bio-degradable products
The packaging market is under the influence of strong market and consumer-driven preferences. For example, the increasingly bad reputation of single-use plastics forces manufacturers to consider more biodegradable, bio-based and/or recyclable alternatives. However, despite these alternatives having a beneficial effect on the natural environment, they do not necessarily guarantee food safety. As a result, in some cases, the biodegradable properties or recycled content can even be at odds with the principle of inertness and traceability requirements stipulated in the EU framework regulation.
For more information, please contact us on how to make sure your product meets all relevant food contact regulations. Ecomatters can assist your company in the screening and evaluation of your food contact materials specified for its intended use.
At Ecomatters, we are experts in supporting the following activities:
- Compliance evaluation of recipes / formulations / products
- Safety evaluation of non-listed substances
- Migration modelling
- Migration tests
- Declaration of Compliance in accordance with relevant legislation