EU · Regulations (EC) 1935/2004, (EC) 2023/2006 and (EU) 10/2011
Food-contact materials: composition and migration
Identify the market and product category first. Each dossier separates legal duties, referenced standards, evidence and the comparison needed for an award.
Product Scope
Articles intended or reasonably expected to contact food or transfer constituents to food. The framework applies across material types; Regulation 10/2011 specifically concerns plastics and does not establish a single EU harmonised regime for all metals, paper, silicone or coatings.
Requirements
Articles must not transfer constituents at levels harmful to health or unacceptably alter food composition or sensory properties. For plastics, verify authorised composition, specific migration limits and applicable overall migration rules; the usual overall limit is 10 mg/dm², with the specified infant-food-contact exception expressed in mg/kg. Choose food simulants, time, temperature and repeated-use conditions from the intended use and Annex V.
Required Evidence
Provide composition and substance restrictions, full migration reports, test selection rationale, surface-to-volume assumptions, relevant declarations of compliance, supporting documentation and GMP traceability. Food-contact testing of a detachable liner does not automatically cover the assembled article, lid, seal and printing.
Comparison for the Awards
Lower migration can be compared only against an applicable limit using the same material, simulant and exposure conditions. A general food-safe claim or use of an authorised substance alone does not prove superiority. National measures must be resolved for non-harmonised materials.
Version & Transition
Check amendments including 2025/351 and their transitional provisions. Separately assess Regulation 2024/3190 on BPA and relevant bisphenols, including product-specific derogations and transition dates; it is not a uniform immediate ban on every food-contact article.
Official Sources
Applicability depends on the product classification, intended use, configuration and actual sales territory. Manufacturing, placing-on-the-market and testing dates, together with transition provisions, are checked as required by each applicable rule. The directory identifies sources; it does not replace assessment of the specific model. Standards are identified by reference, and their authoritative texts remain with the issuing bodies. Official source documents retain their original language.