SG 57/24
The EU has initiated a consultation over its proposed revision to the food contact plastic and GMP regulations. Comments are being accepted until April 15, 2024.
In March 2024, the European Commission (EC) announced a four-week consultation over its draft regulation to revise two pieces of legislation on food contact materials and articles:
The draft regulation aims to strengthen quality control rules for food contact plastics by:
- Ensuring consistency with Regulation (EU) 2022/1616 on recycled plastics and Regulation (EU) No. 528/2012 on biocidal products
- Requiring substance purity requirements if these are obtained from waste and natural materials
- Adopting migration testing of multi-layer materials and repeat testing
The proposal also adds quality control rules for good manufacturing practice
Highlight of the draft regulation are summarized in Table 1
| Unless stated, amendment to Regulation (EU) No. 10/2011 | Highlights |
|---|
| Article 3a ‘High degree of purity’ | - A substance is considered as having a high degree of purity if all of its constituents form part of its identity, and it otherwise only contains a minor quantity of contaminants and non-intentionally added substances (NIAS) that meet one of several conditions, including but not limited to:
- They have undergone a risk assessment in accordance with internationally recognized scientific principles (Article 19) and considered compliant
- ≤ 0.05 mg/kg if they are not genotoxic after an individual toxicological assessment
- ≤ 0.00015 mg/kg for an individual migration if they are unknowns or have not undergone an assessment in one of the two sub-bullet points above
|
| Article 8 ‘General requirements on substances’ | - Substances used in the production of plastic materials and articles, including those from waste, must be of a high degree of purity
- Manufacturers of plastic materials, components and finished goods must provide the substance composition to the authorities if requested
- Manufacturers of plastic materials, components and finished goods are obliged to permit authorities to take samples to verify their purity and composition, including substances and materials used for their manufacture
|
| Article 10 ‘General restrictions and requirements concerning the composition of plastic materials and articles’ | - Plastic materials and articles may contain reprocessed plastic if such plastic meets certain conditions
- The composition of food contact plastics for repeated use must guarantee that there is no increase in the migration of constituents of the material or article to food during that maximum life span when subjected to subsequent use cycles (Article 10(3))
|
| Chapter IV ‘Declaration of compliance and documentation’ | - Replaces title with ‘LABELING, DECLARATION OF COMPLIANCE AND DOCUMENTATION’
- Adds New Article 4a:
- Manufacturer or other economic operator responsible for placing a repeated use material or article on the market must furnish information on its maximum life span to users by means of labeling or instructions, including appropriate instructions to slow down deterioration, and a description of observable changes that may indicate deterioration of the material or article and that it has reached its maximum life span
- Food contact plastics that are not yet in contact with food must be labeled with instructions of use at the point of sale or supply to consumers, if they are produced with substances on the positive list with one or more of the following specifications in Annex I Table 1 Column 10:
- Specific foods or groups of foods
- Contact time and/or temperature
- To heating conditions such as oven and microwave use
- The labeling mentioned above must be indelibly affixed to the repeated use material or article, unless it is not possible for technical reasons. At least font size 9 pt (3 mm) is required
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| Annex III ‘Food simulants’ | - Revises language and food simulants for ‘cheeses’ (reference no 07.04, Table 2)
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| Annex IV ‘Declaration of compliance (DoC)’ | - Adds ‘maximum lifespan of the material or article based on a report evaluation by taking into account the elements in Article 10(3)’ for one of the specifications on the use of the material or article
- New requirements for a batch of plastic materials for reprocessing and the use of substances on the positive list that have been produced from waste
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| Annex V ‘Compliance testing’ | - Revises introductory section indicating that the analytical method for migration testing compliance is in accordance with Article 34 of Regulation (EU) 2017/625 by applying specific performance criteria
- Replaces point 2.1.6 ‘Repeated use materials and articles’
- New indicators for non-compliance on migration tests
- New specific performance criteria for compliance with specific migration levels
- Replaces point 3.3.2 ‘Repeated use materials and articles’ with new language
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| Amendments to Regulation (EC) No. 2023/2006 ‘GMP’ | - Revises citation to Regulation (EU) 2022/1616
- Mandates recyclers to implement specific requirements for quality assurance systems
- New requirements for reprocessing of plastics falling under Regulation (EU) No. 10/2011
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Table 1
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