This article was accepted into the corpus but its outbound wikilinks were never NER-processed — typical at the deepest BFS hop or when the run's entity cap was reached. No expansion funnel to show.
| Regulation (EC) No 1935/2004 | |
|---|---|
| Title | Regulation (EC) No 1935/2004 |
| Adopted | 2004 |
| Jurisdiction | European Union |
| Status | In force |
Regulation (EC) No 1935/2004 is a European Union legal instrument establishing general principles and requirements for materials and articles intended to come into contact with food. It sets out safety objectives, traceability obligations and specific measures for certain materials while providing a framework for later implementing acts and national enforcement. The instrument interacts with sectoral rules and international standards to protect consumer health and facilitate the internal market.
The Regulation was adopted by the European Parliament and the Council of the European Union in the early 2000s against a backdrop of food safety reforms prompted by crises and policy initiatives involving World Health Organization, Food and Agriculture Organization of the United Nations, and negotiations with World Trade Organization. It aligns with the precautionary approaches reflected in the Lisbon Treaty era and complements instruments such as the General Food Law Regulation and directives originating from the European Commission. National authorities including Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail and Bundesinstitut für Risikobewertung implement the Regulation alongside judicial oversight from the Court of Justice of the European Union.
The Regulation covers materials and articles intended to be in contact with food, including primary food contact and other forms related to European Food Safety Authority risk assessments. Definitions provided in the text reference concepts such as "materials", "articles", "food contact materials", and "migration", linking to procedural contexts used by European Chemicals Agency and testing approaches from institutions like International Organization for Standardization and European Committee for Standardization. Exclusions and interface rules relate to other EU acts such as regulations governing pesticide residues, veterinary medicinal products, and organic production. The scope also interacts with trade measures overseen by European Commission Directorate-General for Health and Food Safety.
The Regulation requires that food contact materials must be manufactured so that, under normal or foreseeable use, they do not transfer constituents to food in quantities that could endanger human health, change food composition unacceptably, or deteriorate organoleptic properties. These principles echo safety frameworks from European Food Safety Authority opinions and testing paradigms used by European Pharmacopoeia and Joint Research Centre. Obligations on good manufacturing practice are informed by guidance from European Committee for Standardization and enforcement principles applied by European Anti-Fraud Office in product surveillance contexts.
While the Regulation sets a general framework, specific measures have been adopted for categories such as plastics, ceramics, metals and alloys, rubber, paper and board, and silicone. Plastics are governed by the Commission Regulation (EU) No 10/2011 framework with lists of authorized substances handled through European Food Safety Authority risk evaluations and Scientific Committee on Food precedents. Ceramic articles relate to migration testing traditions linked to Council of Europe resolutions. Metals and alloys are managed by specific national and Union-level limits consistent with directives and standards from International Organization for Standardization technical committees.
The Regulation mandates traceability "one step forward, one step back", requiring economic operators—manufacturers, importers, distributors—to maintain documentation enabling rapid identification of sources and flows. Technical dossiers, declarations of compliance and labeling obligations support conformity assessment processes akin to systems used under REACH regulation and market surveillance coordinated by European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Documentation must support testing data used by laboratories accredited under schemes such as European co-operation for Accreditation.
Member States are responsible for enforcement through their national authorities and must ensure appropriate penalties for non-compliance. Coordination mechanisms include information exchange via Rapid Alert System for Food and Feed and legal recourse through national courts with reference to precedents from the Court of Justice of the European Union. Sanctions, product recalls and market withdrawals are applied in line with administrative practices of agencies such as Food Standards Agency and Agence fédérale pour la sécurité de la chaîne alimentaire.
The Regulation has shaped harmonization of food contact rules across the European Union and influenced international trade negotiations with partners such as United States, China, and Japan. It has been complemented and updated by implementing measures, notably regulations on plastics and amendments reflecting scientific advances from European Food Safety Authority and policy shifts under the European Green Deal and circular economy initiatives led by European Commission. Case law from the Court of Justice of the European Union and guidance from bodies like European Chemicals Agency continue to refine its interpretation and application.
Category:European Union food safety law