Will Your Plastic Food Contact Products Make It in the EU?
The European Union (EU) has gone much further than other authorities around the globe in establishing regulations on food contact materials (FCM) and in particular, plastic food contact materials. There are strict limits on what substances manufacturers can use to make food contact materials, as well as limits on how much of a substance can leach into foods that come into contact with the materials. And there are requirements for manufacture, traceability and labeling that apply to every business that places food contact materials on the market in EU countries.Violations can keep your products off the market in EU countries and lead to costly recalls, fines and other penalties. Read on to make sure your products meet all necessary requirements!
What are food contact materials?
Food contact materials include anything and everything that is likely or intended to come into contact with food, or is already in contact with food.
This includes: Packaging materials that are sold with a food or beverage already in themTableware for serving food and drinks (forks, spoons, plates, bowls, glasses, cups, mugs, bottles, etc.)Cutlery and kitchen tools (knives, peelers, slicers, choppers, etc.)Cookware for preparing food (pots, pans, microwave-safe dishes, etc.)Containers intended for food storage or transport (lunch boxes, etc.)Film, wraps and bags intended for use with food productsKitchen electronics (blenders, food processors, mixers, etc.)Kitchen appliances (microwaves, refrigerators, etc.)Furthermore, rules that apply to FCMs can extend to other products that warrant special consideration. This includes baby toys and other products for infants, children or pets, personal hygiene products like toothbrushes, containers for pills and any product intended to be placed in the mouth or body such as a thermometer, whistle you blow into, mouth guard, mouth held stylus/controller, etc.
What are the rules?
EU regulations identify a few basic requirements for all food contact materials:
Manufacture must follow good manufacturing practices (GMP) – Ingredients are known, raw materials are traceable, and products are produced with consistent quality.
The FCM cannot change the food – The quality, color, smell, and taste of foods cannot be changed by contact with the FCM (with the exception of active/intelligent materials).
Health must not be endangered – Only authorized substances may be used to make plastic FCMs. Toxic substances and chemicals such as primary aromatic amines, some kinds of phthalates, heavy metals and monomers, or other starting substances cannot migrate into foods (beyond acceptable levels). A new proposal would also ban the use of per- and poly-fluoroalkyl substances (PFAS).
Beyond these basics, and especially for plastic FCMs, there are very specific requirements for the ingredients allowed, the amount of substance (if any) allowed to migrate to foods, the tests that must be performed on FCMs, labelling and declarations of compliance.
For plastic food contact materials, the main EU regulations are:
EC No 1935/2004 – Framework, materials and articles intended to come into contact with food
EC 2023/2006 – Good Manufacturing Practices Regulation
EU Regulation No. 10/2011, Plastic Materials in Contact with Food, and all related amendments
A plastic FCM may be subject to additional requirements depending on its intended use and specific composition. Some related regulations and directives are:
EU 2018/213 – BPA in FCM coatings
EC 282/2008 – Recycled Plastic Materials
EN 14350 and 14372 – Child Use and Care Articles
EU 321/2011 – BPA in Plastic Infant Feeding Bottles
EC 94/62/EC – Packaging and Packaging Waste
EC 2007/42/EC – Regenerated Cellulose Film
EC 1895/2005 – Epoxy Derivatives in FCM
EC No 450/2009 – Active/Intelligent Materials
EU 284/2011 – Products Originating or Consigned from China or Hong Kong
Various REACH requirements
What do all these regulations mean?
What they all boil down to is that if you intend to place food contact materials on the market in the EU, you need to know exactly what is in your product, how the product is tested, whether or not the product is compliant and how to demonstrate compliance.
Manufacturers, importers and retailers must:
Identify ingredients – whether you make plastics or source them, know their composition.
Adhere to GMP – quality control processes, traceability records for supply chain and labeling.
Know (and be able to trust) your sources – evaluate your supply chain and suppliers’ test results.
Meet the testing requirements with specified food simulant(s), temperatures, test durations, and detection limits for each FCM ingredient – per kg and total volume migration limits may apply.
Know the labeling requirements – FCMs that are not already in contact with food must have the EU food contact symbol or state “for food contact”; FCMs for use under specific temperature ranges should be labeled accordingly, and cooking instructions can impact testing.
Whether you’re making plastic FCMs, making products to be used in the manufacture of FCMs, or using FCMs to package food products, a declaration of compliance and supporting documents are required. The steps above can help you ensure that you have everything you need to prove a product’s compliance.
Constant change
The EU safety standards for FCMs have been updated through numerous amendments. The next is expected in 2022. EU regulations allow individual countries to set limits for substances not yet addressed in harmonized EU standards. In some cases, these will become part of the EU regulations in future amendments. For example, the German Federal Institute for Risk Assessment (BfR) makes food safety recommendations continuously as science evolves, and Switzerland regulates printing inks for food packaging.
Sustainability efforts and new technology are also driving change in the FCM industry. New plastics and ingredients can pose new threats or introduce safer alternatives. Biodegradable packaging, materials with greater recycling potential and nanotechnology are all at the forefront of changes in the food contact industry.
How QIMA can help
QIMA’s rich industry experience and full team of experts can help you take charge of your product compliance for FCM products. As a leading provider of quality control, lab testing and audit services for EU markets, we are always keeping up with the current state of regulations and can help you navigate complex and evolving requirements. We offer:
Supply chain intelligence: get supplier and quality stats in real time
Industry leading turnaround time for audits, testing and inspections
Online and mobile: manage your orders and access your data anywhere, any time
All-inclusive pricing: flat rates for inspections and audits; instant quotes for testing
Contact us today and we’ll be happy to help you make sure your plastic FCMs will be accepted on the EU market.
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