Five Considerations In Global Food Contact Material Compliance

Monday, May 6th, 2019

Food contact material compliance is an essential part of a risk management system. By Orsi Dézsi, Business Unit Manager of Food Equipment, Food Contact Material and New Services at NSF International.

Regulatory alphabet soup is a way of life for manufacturers in the food industry. Food packaging and the food contact materials of which it is made are no different. From EC, EU, FDA CFR, GB and BIS to Mercosur, each country or region has its own specific rules and regulations on packaging materials. To make it even more difficult, the regulations all vary enough to cause significant confusion in the industry.

Food contact material compliance is an essential part of a risk management system. In this article, I’ll address the five biggest questions related to global food contact material compliance that help ensure compliance and consumer safety.


Are Global Regulations Necessary?

When it comes to the FCM regulations, the reason for their existence is consistent across the board. First, legislation exists to keep humans safe by ensuring chemicals from packaging materials do not leach into the food in hazardous concentrations. Second, FCM should not adversely affect the sensory properties of food. Think about it—when opening cashews packaged in plastic, what should the consumer be tasting? If they’re tasting plastic, their experience has been compromised, and they will immediately question the safety of the food. Finally, a commonality among regulations is that FCM should be manufactured using Good Manufacturing Practices (GMPs). The GMPs tend to be broad (or general) in nature, but ultimately, the intent is to ensure that materials are manufactured in a quality-controlled environment with acceptable hygiene controls in place.


Is There A One-Size-Fits-All Approach?

The good news is that there are two fundamental systems globally that encompass the theories and processes behind most regulations: U.S. FDA 21 CFR and Regulation (EC) No 1935/2004. The bad news? Just because a material complies with one, doesn’t mean that it will comply with the other. In addition, globally, it’s common to see a mix of these two systems, which can also make navigation difficult. Occasionally, specific regional regulations will accept compliance with either, if it is present.

What’s The Deal With BPA?

Another common buzz word and phrase in the FCM industry is BPA and it has been getting a lot of attention in the last few years.  BPA, bisphenol A, is a chemical that is often found in plastic bottles and other plastic products.

Since the 1960s, BPA has been used in the manufacturing of many hard-plastic food containers, aluminium cans and plastic bottles. Contrary to popular belief, there is not an all-out ban on this substance in most countries. There are restrictions on how the substance can be used, but it is still allowed in many everyday products. However, because of consumer concerns, manufacturers are choosing to reformulate to exclude BPA. In addition, as research continues to develop, most regulations state that infant and children’s products must be free from this substance.


How Does The Testing Work?

Requirements for testing food packaging materials are different across the various regulations. But one thing is consistent: generally, real food is not used when testing for migration and extraction. Because it is impossible to create consistent and reproducible food from actual food, FCM testing globally depends on food simulants (substances that mimic food) to show accurate results. Common simulants include ethanol, acetic acid and vegetable oil. Regardless of which regulation materials are being tested to, the maximum food contact temperature and time in contact with the actual food are needed to test accurately. For example, packaging for ice cream should not be tested at boiling temperatures, as it is not intended for use in that environment.


Who Regulates FCM Anyway?

Another general commonality from regulation to regulation is that the burden of proof is really at the formulator level. Ideally, the material formulator has reviewed its compositions to the regulations and is able to tell its consumers whether or not it complies. How do formulators communicate this? Through a self-declaration, or a Declaration of Compliance (DoC), that may or may not also include some test data.

The final product manufacturer gathers up all these declarations and determines if further testing is necessary. Perhaps the material was never tested at the temperature of the intended food, or with the correct simulant. Either way, the final product manufacturer also ends up testing the material to ensure compliance for its end customer, the food manufacturer. The packaging manufacturer will then create its own DoC, accompanied by its own testing, to show compliance of the overall packaging material. Some countries may have registration requirements, or labelling requirements, but all the material testing and formulary review are done by the manufacturer and verified by customs, in the field or maybe not at all.

Food contact material compliance is an essential part of a risk management system. As you swim through the sea of alphabet soup and regulatory nuances, remember that although regulations are complex and adherence is often time consuming, the intent is the same across the board: keeping people safe.