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On 21 February 2025, the EU Commission adopted Regulation (EU) 2025/351, the so-called 19th Amendment to the Plastics Regulation (Regulation (EU) No 10/2011), which introduces, inter alia, the notion of "high degree of purity" for substances used in plastic food contact materials and articles.
The 'high degree of purity' requirement is defined in the new Article 3.a and referred to in the revised Article 8.1 of the 19th Amendment. It regulates more explicitly the presence of non-intentionally added substances ("NIAS").
In essence, Article 8.1 requires that only substances with a high degree of purity, including substances produced from waste, are used in the manufacturing of plastic materials and articles, if they are expected to remain present in the final plastic material.
In addition, Article 3.a establishes criteria to determine when a substance used in the manufacturing of food contact plastics can be considered of a high degree of purity. It provides comprehensive requirements for the assessment the NIAS present in those substances. The 19th Amendment also incorporates new requirements to report information on NIAS in the Declaration of Compliance ("DoC").
The 19th Amendment entered into force on 16 March 2025, however, transitional measures have been set to allow business operators and supply chains adapt to the changes brought with this Amendment.
The 19th Amendment establishes two important transitional deadlines for business
By 16 December 2025, i.e., in less than one month, business operators placing on the market substances and intermediate products compliant with the Plastics Regulation – but not yet with the 19th Amendment based on the ongoing transitional provisions – will need to inform their customers that these substances and intermediate products cannot be used to manufacture plastic materials and articles intended to be placed on the market after 16 September 2026.
More specifically, the declaration of compliance ("DoC") for these products should state:
- that they do not comply with the 19th Amendment ; and
- that they may only be used in the manufacture of plastic materials and articles intended to be placed on the market before 16 September 2026.
Thereafter, from 16 September 2026, all food contact plastic materials and articles must comply with the new requirements brought by the 19th Amendment.
Plastic materials and articles which were first placed on the market before 16 September 2026, can continue to be placed on the market until exhaustion of stocks if they are compliant with the requirements of the Plastics Regulation before the 19th Amendment entered into force, and accompanied with the DoC – as specified above.
What does that mean for plastic food contact business operators?
Companies who can already show compliance with the new high degree of purity requirements may have a business advantage as compared to those who will have to declare in the DoC that their products may not be used to produce plastic materials and articles intended to be placed on the market after 16 September 2026.
Indeed, supply chains can consist of multiple intermediate producers and some of the late-stage intermediate producers may not be able to meet the final deadline if compliance is not confirmed early by their suppliers. This may influence their choice of product suppliers and therefore, business operators are encouraged to adapt swiftly to the new requirements of the 19th Amendment.
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