The Quality Amendment to the Plastics Regulation

The so-called “Quality Amendment” (Regulation (EU) 2025/351) to the Plastics Regulation (EU) No. 10/2011, was published in the Official Journal of the European Union on February 24, 2025, and entered into force on March 16, 2025. This regulation introduces detailed rules regarding the regulation of plastic materials and articles (FCMs) intended for contact with food in the EU. 

As a preliminary point, we note that the Quality Amendment updates the definition of ‘additive’ [1] and introduces new definitions of ‘re-processing of plastic’ [2] and ‘UVCB substance’ [3]. 

I. High Degree of Purity Requirement

The Quality Amendment adds a new Article 3a to the Plastics Regulation which states that substances used in the manufacture of plastic FCMs shall be considered as having a high degree of purity when all of its constituents correspond to its identity, and it otherwise contain only minor amounts (not defined) of non-intentionally added substances (NIAS), that individually meet one of the following conditions:

(i) they comply with the applicable specifications or restrictions in the Plastic Regulation’s Union List, if any; 
(ii) they have been subject to a risk assessment in accordance with Article 19 of the Plastics Regulation and considered compliant; 
(iii) they have been subject to a toxicological assessment in accordance with the relevant guidance adopted by the European Food Safety Authority, which concludes that genotoxicity is ruled out, and that, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, it may be reasonably assumed that none of the substances will be present in the final plastic FCM at a level that could give rise to migration to food exceeding 0.05 mg/kg for each substance [4];  
(iv) they have not been subject to an assessment specified in points (ii) or (iii), but to a risk assessment which concludes, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, that it may be reasonably assumed that none will be present in the final plastic FCM at a level that could give rise to migration to food exceeding 0.00015 mg/kg.

II. Specific Requirements for Re-Processed Plastics

The Quality Amendment requires that re-processed plastics

• be a by-product for purposes of the Waste Framework Directive 2008/98/EC
• be collected in accordance with new good manufacturing practice (GMP) requirements also introduced by the Quality Amendment (and incorporated in section C of the Annex to the GMP Regulation (EC) No. 2023/2006)
• originate from off-cuts and scraps from plastic FCMs meeting the compositional requirements of the Plastics Regulation (the plastic FCMs could be held together by adhesives and printed and coated)
  • if the aforementioned plastic FCMs contain an adhesive/coating/printing ink, they must not contain a layer that functions as a functional barrier. Further, all of the individual constituents must meet the compositional requirements of the Plastics Regulation OR have been risk assessed in accordance with internationally recognized principles of risk assessment
• not contain substances in an amount which could lead to the plastic FCMs in which the reprocessed plastics are used exceeding the migration limits in the Plastics Regulation or causing any other non-compliance of the plastic FCMs

III. Other Notable Provisions

There are many other significant amendments introduced by the Quality Amendment, the importance/relevance of which may depend on a business operator’s position in the supply chain and his particular business. These include: 

General Requirements on Substances which require substances (including those manufactured from waste) to be of a ‘high degree of purity’ and technical quality suitable for the intended or foreseeable use of FCMs and that the composition be known to the manufacturer of the substance. Specific additional requirements apply to UVCBs mainly to ensure that their identity corresponds to the substance identified in the Union List.

Additional labelling requirements include the requirement that the manufacturer/ operator placing a repeat-use final article on the EU market must provide users with:

• Appropriate instructions designed to slow down the deterioration of the article
• A description of observable changes of the article that may indicate a deterioration of the article or material
• A warning in case specific damages/foreseeable misuse would cause increased migration/cause the article to become otherwise unsuitable for contact with food

The regulation of surface biocides in plastic FCMs has been amended. Surface biocides are no longer required to be listed in the Plastics Regulation or in the Provisional List of Additives. In fact, the Quality Amendment deletes the Provisional List of Additives (mainly containing silver based compounds that could be used in plastic FCMs subject to Member State legislation as well as the Biocidal Products Regulation (EU) No. 528/2012 (BPR) if they were used as surface biocides).

Instead, substances with a biocidal function used in biocidal products that may be made available on the EU market in accordance with the BPR for product-type 4 (Food and Feed Area) for use that covers incorporation into plastic FCMs may be used as additives in the manufacture of plastic FCMs.  

Another new requirement affects multi-material/multi-layer materials. Namely, if the surface layer in contact with food is plastic (printed or coated), that layer must comply with the specific migration limits (SMLs) and overall migration limit (OML) in the Plastics Regulations. 

While prior to the Quality Amendment, it was mandatory to use the standard EU surface area to volume of food ratio of 6 dm² per kg of food for certain FCMs (such as containers and other articles containing or intended to contain less than 500 milliliters or grams), this has been adjusted to “equal or higher than 6 dm² per kg food” (the rationale being that 6 dm² per kg food may underestimate migration for certain types of packaging).

The Quality Amendment also sets forth additional information to be included in the EU food contact Declaration of Compliance (DoC) for plastic materials that are a batch of material intended for reprocessing and for plastic materials that have been produced with one or more substances on the Union List manufactured from waste. It also states that “adequate information” should be provided on the presence of NIAS if the NIAS are present in an amount that could cause non-compliance of a final material with Article 3 of the Framework Regulation (EC) No. 1935/2004. The Quality Amendment also sets more detailed requirements on supporting documentation.

IV. Transitional Provisions

The Quality Amendment specifies that plastic FCMs for which compliance with the Quality Amendment has not been established but that comply with the Plastics Regulation/other relevant EU legislation as it stood before March 16, 2025 and that were first placed on the EU market before September 16, 2026 may continue to be placed on the market until exhaustion of stocks. However, in the case of substances and intermediate materials for which compliance with the Quality Amendment has not been established, the declaration of compliance accompanying them must state that they do not comply with the Plastics Regulation (as amended by the Quality Amendment) if they are first placed on the EU market after December 16, 2025 and that they can only be used in the manufacture of plastic FCMs to be placed on the market before September 16, 2026.

[1] Additive “means a substance which is intentionally added to the plastic to achieve a physical or chemical effect during processing of the plastic or in the final material or article and it is intended to be present in the final material or article, including substances in a solid state the surface of which becomes bonded to the polymer that constitute the plastic.” (Art. 3(7) of the Plastics Regulation - our emphasis) 

[2] Reprocessing of plastic “means the remelting, mixing, reacting or otherwise processing of plastic materials that result as a by-product from an intermediate or final manufacturing operation in the manufacture of plastic materials and articles, alone or combined with material originating from other manufacturing operations, by applying, if necessary, transfer and operations to make the use of these by-products possible again.” (Art. 3(20) of the Plastics Regulation)

[3] UVCB substance means “a substance of unknown or variable composition, complex reaction products or a material of a biological or other natural origin” (Art. 3(21) of the Plastics Regulation)

[4] For the purposes of point (iii) relating to substances for which genotoxicity has been ruled out, the Quality Amendment adds that the individual assessment of genotoxicity may be substituted with a group assessment of genotoxicity, if the assessed substances are chemically related and belong to the same or similar functional groups that could give rise to toxicity, or if the substances are obtained as a mixture representative for migration into food and this mixture is assessed through appropriate methods.