From Directive (EU) 2019/904 to Regulation (EU) 2025/351: plastics and materials intended to come into contact with food

By Benedetta Pisauro

(Master's student in Global Food Law: Sustainability Challenges and Innovation - University of Parma)

Directive (EU) 2019/904

In recent years, the European Union has intensified its regulatory work regarding plastics and recycling, promoting a more robust framework oriented towards sustainable development. The Directive(EU) 2019/904, known as the “SUP Directive” (Single-UsePlastics), aims to reduce the environmental impact of single-use plastic products (Article 2) to promote a valid circular economy model, optimizing environmental sustainability goals and encouraging recycling (Recital No. 36).

The obligations of the Directive can be summarized as follows:

1. Reduction of the consumption of single-use plastic products (Article 4),identified in Part A of the Annex to the same Directive (beverage cups,including their lids and covers; food containers, i.e., containers such as boxes with or without lids, used for food intended for immediate consumption,on-site or take-away, generally consumed directly from the container and ready for consumption without further preparation, for example, cooking, boiling, orheating, including food containers like fast food or other meals ready forimmediate consumption, except for beverage containers, plates, packages, andwrappers containing food).

2. Prohibition of placing on the market (Article 5) single-use plastic products listedin Part B of the Annex (cotton bud sticks, cutlery, plates, straws, beveragestirrers, sticks to attach to support balloons, except for balloons for industrial use or other professional uses and applications that are not distributed to consumers, and related mechanisms, food containers made of expanded polystyrene, i.e., containers such as boxes with or without lids, usedfor food, intended for immediate consumption, on-site or take-away, generally consumed directly from the container and ready for consumption without further preparation, for example, cooking, boiling, or heating, including fast food containers or other ready-to-eat meals, except for beverage containers, plates, packages, and wrappers containing food; beverage containers made of expanded polystyrene and their caps and lids; beverage cups made of expanded polystyreneand their caps and lids) and oxo-degradable plastic products.

3. Compliance with certain requirements (Article 6), in particular thenon-detachability of caps and lids for beverage containers with a capacity of up to three litres, that is, containers used to hold liquids (part C of theAnnex), the reduction of plastic content for beverage bottles with a capacity of up to three litres (part F of the Annex), starting from 2025, and the achievement of a minimum recycled plastic content in the same bottles starting from 2030.

4. Marking of single-use plastic products listed in part D of the Annex to the Directive, with indications that report the correct waste management methods, the forms of waste disposal to avoid, the presence of plastic in the product,and the consequent «negative impact of littering or other inappropriate means of waste disposal of the product on the environment.»

5. A regime of extended producer responsibility for the products listed in Part Eof the Annex, including, by way of example, food containers, that is, receptacles such as boxes with or without lids, used for food intended forimmediate consumption, on-site or take-away, generally consumed directly from the receptacle and ready for consumption without further preparation, such as cooking, boiling, or heating, including food containers like fast food or other meals ready for immediate consumption, except for beverage containers, plates, packages, and wrappings containing food; packages and wrappers made of flexible material containing food intended for immediate consumption directly from the package or wrapper without further preparation; containers for beverages with a capacity of up to three litres, that is, receptacles used to hold liquids, such as beverage bottles and their caps and lids, as well as composite beverage packaging and their caps and lids, but not glass or metal containers forbeverages with plastic caps and lids; cups for beverages and their respective lids and covers.

The national implementation of Directive (EU) 2019/904

However, the Italian implementation of the obligations imposed by the Directive, carriedout through LegislativeDecree 196/2021, has distorted its application. Article 5, paragraph 3, of the aforementioned Legislative Decree indeed provided forthe exclusion from the market ban on single-use products and oxodegradable plastic products of biodegradable and compostable materials, encouraging the substitution of plastic with bioplastic rather than aiming at its actual reduction, flattening the proposed goal of educating responsible plastic consumption. Such a choice, being in contrast with European Union law, led the Commission to initiate an infringement procedure against Italy. Once again, Italy opted for a partial adaptation of the regulation, sidestepping the core of the problem and diverging from France and Germany, which instead adoptedmore structured measures consistent with European objectives. France, with its “anti-wastelaw” (Loi n° 2020-105 du 10 février 2020relative à la lutte contre le gaspillage et à l'économie circulaire) and the consequent amendment of the EnvironmentalCode, aims to halve the consumption of single-use plastic bottles by 2030 (ArticleL 541-10-11 of the French Environmental Code) and hasimposed a ban on single-use tableware (ArticleL-541-15-10 of the French Environmental Code),extending producers' responsibility for waste disposal, thus encouraging less massive production. The German model promotes the ethic of reuse as a new standard and policies oriented towards the overall reduction of waste, as demonstrated by the Packaging Act, Gesetzüber das Inverkehrbringen, die Rücknahme und die hochwertige Verwertung von Verpackungen(Packaging Act - VerpackG), BGBl. I S. 2234.

The Regulation (EU)2025/351

Regulation(EU) 2025/351, effective from March 16, 2025, has introduced regulatory updates concerning plastic materials intended for food contact. The new regulatory framework modifies and integrates the previous regulations, including CommissionReg. (EU) No. 10/2011, CommissionReg. (EU) 2022/1616, and CommissionReg. (EC) No. 2023/2006. The aforementioned revision is part ofthe strategy aimed at promoting the use of eco-compatible materials,implementing food safety standards, and fostering the functioning of thecircular economy. Regulation (EU) 2025/351:

1. introduces new and stricter requirements on the purity of materials (Article 1,para. 3, which adds Article 3a to Regulation (EU) No. 10/2011);

2. It establishes thresholds for genotoxic and non-genotoxic substances, with particular attention to NIAS (non-intentionally added substances), which must be included in the product’s declaration of compliance, ensuring greaterattention to risk assessment and limiting harmful effects on human health (Article 1, par. 3 and Annex I to Regulation (EU) 2025/351, which respectivelyintroduce Article 3a and amend Annex IV to Regulation (EU) No. 10/2011).In particular, if a substance used in the manufacture of a material or object intended to come into contact with food products has a migration level in food products lower than 0.00015 mg of substance/kg of food (0.15 μg/kg), with the risk of genotoxicity assessed as unlikely, toxicity tests of the migrating substance will not be required. If the migration level is higher than 0.15μg/kg but lower than 0.05 mg/kg, only genotoxicity test data will be required (Recital No. 8 and Article 1, paragraph 3 introducing Article 3a in Regulation (EU) No. 10/2011).

3. Authorizes the use as additives in the manufacture of plastic materials and objects, of substances with biocidal function used in biocides, in accordance with Regulation (EU) No. 528/2012, for product-type 4, for use that covers incorporationinto plastic materials and objects that may enter into contact with food products (Article 1, para. 7, 4), which amends Article 6 of Regulation (EU) No.10/2011.

4. Introduces new provisions regarding information on food contact materials(MOCA), aimed at providing appropriate instructions to slow down the deterioration of the article; a description of observable changes in the object that may indicate the deterioration of the article or the material and awarning in case specific damage or foreseeable misuse causes an increase inmigration or makes the object otherwise unsuitable for further use in contactwith food products (Article 1, paragraph 14, which inserts Article 14ainto Regulation (EU) No. 10/2011).

5. To ensure high safety standards, it extends the migration limits to the plastic layers present in multi-material multilayer materials that must comply with the safety parameters set by Regulation (EU) No. 10/2011, provided that the side incontact with food is plastic (Recitals 14 and 15 of Regulation (EU) 2025/351and Article 1, paragraph 15, which amends Article 14 of Regulation (EU) No.10/2011).

6. Strengthens the collaboration between manufacturers and control authorities ,establishing that the former ensures the latter the possibility to take samples «during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used fortheir manufacture » (Article 1, para. 16 of Regulation (EU) 2025/351 which replaces Article 16 of Regulation (EU) No. 10/2011).

7. Distinguishes between reprocessing and recycling, imposing differentiated decontamination burdens in order to avoid accidental contamination incidents(Article 2 of Regulation (EU) 2025/351 amending Regulation (EU) 2022/1616).

8. Includes new specifications for compliance testing of migration from plastic materials and objects in contact with food products (Annex I, para. 3) that amend the Annexes of Regulation (EU) No. 10/2011.

9. For the purpose of promoting an efficient model of circular economy, it introduces new provisions on the reprocessing of plastic materials (Annex II,paragraph 3), which adds a section C to the annex of Regulation (EC) No.2023/2006.

10. Establishes an 18-month transition period, with the possibility of market retention for MOCA compliant with the previous regulations until September 16,2026, to allow the industry to adapt to the new European standards (Article 4of Regulation (EU) 2025/351

Concluding remarks

The European regulatory framework is evolving to reduce the environmental impact ofplastic and improve food safety. The implementation of the new standards could lead to an increase in costs for businesses, with likely repercussions on the final product price, a risk that society will have to accept to benefit from it in terms of food safety and environmental impact. The innovations introduced by the Regulation represent an advancement in the discipline of MOCA; however, the implementation and actual success will require a cohesive and synergistic approach of actions between the industrial sector, in terms of regulatory adjustment, cost balancing, and transition times. The institutions, which willneed to provide regulatory and financial support to facilitate its implementation, opening up to a concerted effort with other European entitiesand initiating a dialogue with the industrial sector; the community, which will have to strive to modify well-established logics, fostering a profound cultural change that supports the reduction of single-use items to enjoy the consequent environmental and health benefits. A challenging task, as the threeprotagonists carry interests that are not so aligned, but necessary.

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