Plastics are one of the most commonly used materials in food contact products. As we move towards circular economies, what regulations should manufacturers consider when operating in the European Union (EU) and US?

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 2021 Q4_CC Plastics Container 

Why Use Plastics? 

Food contact materials (FCM) and articles are a broad category of consumer goods that are either intended to be brought into contact with food or are already in contact with food. Broadly speaking, this means containers, kitchen appliances and kitchenware, machinery for food preparation and serving, packaging materials and tableware. In order to protect human health, the materials used in these products must not transfer their constituents into the food or drink in quantities that could endanger human health. They must also not bring about an unacceptable change in food composition or lead to a deterioration in the organoleptic characteristic of the food. Plastics are a popular FCM because they are durable, lightweight, versatile, cost-effective, food-safe, and can be recycled.

Recyclability is becoming ever more relevant for manufacturers. Consumers now demand sustainability in the products and packaging they buy. At the same time, governments are starting to address the problems of the linear economy, and this means food contact plastics will need to be reusable and recyclable, if we are to achieve a true circular economy.

In the case of beverage bottles, the requirement to use post-consumer recycled (PCR) plastics will become mandatory in some territories. Industry is already responding. For example, the American Beverage Association (ABA) is aiming at full recyclability, so that every bottle will become a new bottle.1

However, safety remains a vital concern. Many jurisdictions enforce strict regulations and standards on FCM, which includes PCR. This can create a problem. As we detailed in a previous Consumer Compact article on the circular economy, there are issues surrounding the identification of plastics and contamination by non-intentionally added substances (NIAS). These can result from impurities, reaction intermediates formed during the manufacturing process, or a decomposition or reaction product, or legacy substances introduced during the former use of a recycled plastic. Difficulties in identifying and removing NIAS can result in a potential health hazard. 

European Union

In the EU, PCR plastics used as FCM must be recycled in accordance with Regulation (EC) 282/2008 (Food Contact Recycled Plastics) and the process must be managed under an appropriate assurance system for Good Manufacturing Practice (GMP) to Regulation (EC) 2023/2006. This applies whether the new FCM contains 100% PCR or partial PCR. 

Regulation (EC) 282/2008 was originally established with a primary focus on recycling polyethylene terephthalate (rPET). It does not apply to, among other things, the use of recycled plastics behind a plastic functional barrier as determined in Regulation (EU) 10/2011 (Food Contact Plastics Regulation). 

Meanwhile there is a wealth of recycling processes and demand for other recycled plastic FCMs and, on December 6, 2021, the European Commission announced a draft act that will update the EU legislative framework to simplify the processes around the development, certification, and use of recycled plastic FCMs. The draft regulation is open for public comment until January 10, 2022, and is intended to be published in the first quarter of 2022.

Whether food contact plastics contain recycled materials or not, they must always respect the overall migration and specific migration limits under Regulation (EU) 10/2011. This comprehensive piece of legislation includes an authorized list (Union List) of substances for the manufacture of food contact plastics. It also contains certain derogations, including for the use of substances that are not in the Union List for a plastic layer that is not in direct contact with food and is separated by a functional barrier in a multi-material, multi-layer material or article, and the presence of NIAS. 

The European Food Safety Agency (EFSA) has issued guidance to assist stakeholders when manufacturing FCM and articles from recycled plastics.2 This details the administrative and technical data requisites for safety assessments. 

Since its publication in 2008, the EFSA’s Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) has received multiple applications for the evaluation of processes producing rPET, recycled high density polyethylene (rHDPE) and recycled polypropylene (rPP) plastics for use in FCM and articles. These contain scientific opinions on their suitability as FCM and articles.

The EFSA recently provided further information about acknowledged recycling technologies with a scientific opinion that forms the basis for safety assessed rPET, rPP, or rHDPE production processes.3 Additionally, there are more than 140 favorable opinions published on rPET.4 rPET, rPP, and rHDPE are currently the only recycled plastics for which recycling technologies and processes are safety assessed by EFSA for use as FCM. However, no official authorization has yet been granted for any of the assessed materials. 

The demand for high quality and food safe rPET is partly triggered by Directive (EU) 2019/904 (Single-use plastic Directive). This contains Article 6 No. 5 (a) and (b), which provides specific enforcement dates and PET blend requirements for beverage bottles with a capacity of up to three liters. 

More specifically:

  1. From 2025 – beverage bottles which are manufactured from PET as the major component (‘PET bottles’) contain at least 25% recycled plastic, calculated as an average for all PET bottles placed on the market on the territory of that Member State
  2. From 2030 – beverage bottles must contain at least 30% recycled plastic, calculated as an average for all such beverage bottles placed on the market on the territory of that Member State

United States

The US Food and Drug Administration (FDA) has voiced multiple concerns relating to the use of PCR in FCM and articles. These include:

  1. Contaminants from recycled plastics
  2. Incorporation of non-food contact regulated PCR plastics
  3. Noncompliance with food contact regulations of additives in recycled plastics

To help the industry, the FDA has published guidance on chemistry considerations to help stakeholders.5 Applications for the use of recycled plastics are considered on a case-specific basis, with the FDA issuing informal advice about process suitability. 

The FDA also maintains a list of companies where favorable opinions have been issued for the suitability of specific processes, the scope and conditions of use for recycled plastics, the date of the No Objection Letter (NOL), and whether the recycling process is physical or chemical.6 It should be noted, a large number of the submissions with favorable opinions are related to polyethylene terephthalate (PET).

In addition, the Plastics Industry Association (PLASTICS) Food, Drug and Cosmetic Packaging Materials Committee (FDCPMC) has issued an industry guide entitled ‘General Information for Industry on Supply Chain Communication for Recycled Plastics in Food-Contact Applications’. This aims to help manufacturers ensure recycled plastic packaging meet FDA regulations on FCM and articles.7

Consumers, governments and industry are all looking for more sustainable FCM solutions. As the world shifts towards a circular economy, manufacturers need to lead the way in ensuring their processes will deliver safe and compliant PCR plastics for global markets. 

SGS Solution

We provide a range of services to support manufacturers, brands, retailers and other stakeholders in delivering safe and compliant FCM and articles to target markets around the world. Solutions include comparative testing between recycled and virgin resins/plastics and chemical testing in accordance with REACH and other relevant legislation. In addition, we can provide food contact safety assessments, covering testing for bisphenol A (BPA), overall migration/extractive tests, specific migration, sensory tests, NIAS, etc., and we offer auditing to ISO 14021 for the verification of rPET content.

Learn more about SGS Food Contact Materials Services.

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For more information, please contact:  

Hing Wo Tsang
Global Information and Innovation Manager
Connectivity & Products, SGS 
t: +852 2774 7420

Udo Krischke
Global Technical Manager RSTS & Operational Integrity Manager
Connectivity & Products, SGS 
t: +49 (0)6128 - 744 235

References

1 Every Bottle Back Initiative For Plastic Bottle Recycling | American Beverage Association
2 Plastics and plastic recycling | EFSA (europa.eu)
3 Plastics and plastic recycling | EFSA (europa.eu)
4 Lebensmittelechtes Post-Consumer-Rezyklat (kunststoffe.de)
5 Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations) | FDA
6 Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles (fda.gov)
7 FDCPM Committee | Plastics Industry Association