EU to Increase Quality Control Over Plastic Food Contact Materials

As revealed by an initiative issued on March 13, 2024, EU is amending Commission Regulation (EU) No 10/2011 on plastic FCM and Commission Regulation (EC) No 2023/2006 on good manufacturing practice (GMP) for FCM regarding the quality control rules for plastic food contact materials. Any feedback can be sent to this webpage prior to April 10, 2024.

Table 1 Regulations supervising plastic FCMs in the EU

Key Revisions

1. Amendment to Commission Regulation (EU) No 10/2011 on plastic FCM

• Definitions and expressions are amended and clarified.

The definition of “additive” is revised. The draft Amendment clarifies that solid materials that are chemically bonded to the polymer to which they are added should be considered additives. The purpose is to address the uncertainty surrounding the inclusion of certain particles, fibers, and other solid materials in plastic, where such solid materials are coupled to the polymer by means of chemical bond to ensure the material's integrity. At present, such solid materials have no clear categorization, as it is hard to determine whether they are additives or starting substances.

The phrase “plastic layers” is deleted in some provisions of this draft. The current regulation specifies that only authorized substances listed in the Union list can be intentionally used “in the manufacture of plastic layers in plastic materials and articles”. However, in many situations, plastic materials and articles do not conform to a layer structure but consist of a single homogenous material with a complex shape. Therefore, this draft revises the above expression to “in the manufacture of plastic materials and articles”. The phrases “plastic layers” are deleted in certain provisions of this draft due to the same reason.

• More regulations are cited in this draft to ensure the alignment.

This draft includes a reference to Commission Regulation (EU) 2022/1616 for recycled plastic FCMs to be compliant with.

In terms of the derogations for substances not included in the Union list, this draft includes the legal basis regarding the use of biocidal products containing active substance in plastic FCM, i.e., Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.

• General requirements on substances are detailed.

To ensure a high protection level for human health, the draft requires substances used in the manufacture of plastic materials and articles to have high purity and of a technical quality suitable for the intended and foreseeable use of the materials or articles. Notably, Article 3a of this draft clarifies the situation when a substance used in the manufacture of plastic materials and article shall be considered as having a high degree of purity. Rules for the purity of substances of natural origin are also settled down. Moreover, this draft clarifies that substances manufactured from waste can also be used in the manufacture of plastic materials and articles, and such substances are also required to be with a high degree of purity. This supplements the blank of the current regulation in the source of substance.

Additionally, this draft adds requirements to better supervise each stage of the manufacturing process. For example, not only plastic materials and articles, but also substances and products from intermediate stages shall be subject to the sampling conducted by competent authorities to verify their degree of purity and their composition.

• General restrictions on plastic materials and articles are updated.

As per the draft, reprocessed plastic can be contained in plastic materials and articles after meeting several conditions according to Article 10. For example, the reprocessed plastic shall originate only from off-cuts and scraps from plastic materials and articles collected as per section B and C of the annex to Regulation (EC) No 2023/2006, etc. The definition of “reprocessing of plastic” is given accordingly in this draft.

Besides the requirements for reprocessed plastic, the requirements for plastic materials intended for repeated use in contacting with food are also stipulated.

• Labeling requirements are introduced into Chapter IV.

Since more and more plastic materials and articles in food contact are designed for repeated use, therefore, the draft requires the manufacturer or other operator, whoever is responsible for placing the plastic material or article on the market, shall provide information about the maximum life span of the material to its users by means of labelling or instructions, including appropriate instructions about slowing down the deterioration of the material or article, etc.

New labeling requirements are also stipulated for plastic materials and articles intended to be brought into contact with food but are not yet in contact with food when placed on the market.

• “Annex III Food simulants”, “Annex IV Declaration of compliance” and “Annex V Compliance testing” are revised.

The revision to Annex III is regarding the description and simulant assignment of cheese. Annex IV newly requires the Declaration of Compliance (DoC) of plastic material intended for reprocessing, plastic material manufactured with authorized substances from waste materials, etc.

Rules on the verification of compliance testing in Annex V are further specified. This draft revises the introduction part of compliance testing, “2.1.6 Repeated use materials and articles” and 2.1.7 Analysis of migrating substances” in Chapter 2 of Annex V, as well as “3.3.2 Repeated use articles and materials” in Chapter 3 of Annex V.

2. Amendment to Annex of Commission Regulation (EC) No 2023/2006 on good manufacturing practice (GMP) for FCM

• Commission Regulation (EU) 2022/1616 for recycled plastic FCMs is cited as the minimum requirement for recyclers to implement the quality assurance system.

• The quality assurance system is newly required to include specific operations in the recycling process. Recyclers shall assess the quality of each batch of material directly originating from a manufacturing stage. Items to be verified during the assessment are also detailed.

• Additionally, this draft adds the requirement for quality assurance system regarding the reprocessing of plastics within the scope of Regulation (EU) No 10/2011, to supervise the suitable use of plastic by-product and prevent the contamination of plastic by-product during different stages.

ChemLinked Solutions

FCM team of REACH24H Consulting Group, the founder of ChemLinked, is professional in regulatory compliance services in the U.S., EU, China, Canada, MERCOSUR, Switzerland, etc. With successful experience, we have helped numerous customers solve their food contact material compliance problems in the above-mentioned countries and regions, including but not limited to ESFA/FDA Post-Consumer Recycled (PCR) Plastic for FCMs Registration Service, Declaration of Compliance (DoC) Editing/Checking, U.S. FCN Application, and China/EU New Food Contact Substance Application. For any assistance, please feel free to contact [email protected].