Navigating the Intricate Landscape of EU Food-Contact Material Regulations

The European Union (EU) has established a comprehensive regulatory framework to ensure the safety and quality of food-contact materials (FCMs), with a particular focus on plastics. This article provides a detailed overview of the regulations governing the production, composition, and compliance requirements for plastic FCMs marketed within the EU.

Unlocking the Complexities of EU Food-Contact Material Regulations

General Requirements: Ensuring Safety and Quality

The EU's "Framework Regulation" (EC) No. 1935/2004 sets forth the overarching requirements for all FCMs, mandating that they do not transfer their constituents to food in quantities that could endanger human health, alter the composition of food, or deteriorate its organoleptic characteristics. Additionally, the regulation requires FCMs to be produced in accordance with current Good Manufacturing Practices (GMP), as further articulated in the GMP Regulation (EC) No. 2023/2006.

Plastics Regulation: Stricter Standards for Plastic FCMs

In contrast to the more general Framework and GMP Regulations, the Plastics Regulation (EU) No. 10/2011 establishes highly specific requirements for the manufacture of plastic materials and articles intended to contact food. This regulation mandates that only authorized substances included on the "Union List" or positive list can be intentionally used in the production of plastic FCMs. The types of substances that must be listed include monomers, additives (excluding colorants), polymer production aids, and macromolecules obtained from microbial fermentation.

Scope and Exceptions: Understanding the Regulation's Reach

The Plastics Regulation applies to a wide range of plastic materials and articles, including those consisting exclusively of plastics, plastic multi-layer materials, and plastic layers or coatings in multi-material multi-layer products. However, certain materials, such as colorants, solvents, and aids to polymerization, are not subject to the positive list requirements but must still comply with the general safety provisions of the Framework Regulation.

Demonstrating Compliance: Navigating Migration Limits and Documentation

Plastic materials and articles must comply with specific migration limits (SMLs) for individual substances or classes of substances identified on the Union List or associated annexes, as well as the overall migration limit. While no formal migration limits exist for substances not required to be listed, such as aids to polymerization and non-intentionally added substances (NIAS), all substances found to migrate from plastic FCMs must meet the general safety requirements of the Framework Regulation.To demonstrate compliance, plastic FCMs must be accompanied by a written declaration of compliance (DOC) at all marketing stages, except at the retail stage. The DOC must provide extensive information, including administrative details, a summary of the permitted use of the product, and details on certain substances present in the finished product that may be subject to restrictions or require further assessment.

Navigating the Regulatory Landscape: Complexity and Challenges

While the regulation of plastic FCMs has achieved greater harmonization at the EU level compared to other types of FCMs, the lack of complete harmonization, complex technical requirements for establishing compliance, and frequent amendments to the Plastics Regulation make regulatory assessments of food-contact plastics marketed in the EU a complex and challenging task. Specialized expertise and experience are essential to ensure compliance and successful market access for plastic FCMs in the EU.