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| Decision 768/2008/EC | |
|---|---|
| Title | Decision 768/2008/EC |
| Type | European Commission decision |
| Year | 2008 |
| Number | 768/2008/EC |
| Adopted | 9 July 2008 |
| Subject | Common framework for the marketing of products |
Decision 768/2008/EC
Decision 768/2008/EC introduced a common framework aimed at facilitating the marketing of products across the European Union by providing reference elements for conformity assessment, technical harmonisation, and traceability. It was adopted by the European Commission to support the implementation of sectoral directives and regulations while aligning national approaches in member states such as France, Germany, Italy, Spain, and Poland. The Decision interacted with institutions including the European Parliament, the Council of the European Union, the European Court of Justice, and standardisation bodies like CEN, CENELEC, and ETSI.
The Decision was developed in the wake of prior instruments such as the New Approach and the Global Approach to conformity assessment originating from the Single European Act and reinforced by directives like the CE marking regime and specific measures under the New Legislative Framework. It responded to jurisprudence from the European Court of Justice concerning free movement of goods and mutual recognition, and to policy debates in the European Council and among Commissioners such as Charlie McCreevy and Viviane Reding. The legal context also included interactions with international agreements administered by the World Trade Organization and standards produced by ISO and IEC.
The Decision set out reference elements for the marketing of products covered by sectoral Union harmonisation legislation, addressing objectives shared with the Treaty on the Functioning of the European Union and the Lisbon Treaty reforms. It aimed to support objectives of the Internal Market and the free movement principles upheld in cases like Cassis de Dijon, while assisting harmonised measures across member states including Sweden and Greece. The scope encompassed instruments such as technical regulations, conformity assessment procedures, and market surveillance arrangements coordinated with actors like European Chemicals Agency and European Medicines Agency where relevant.
Key provisions established common elements for conformity assessment modules, notified bodies, and marking procedures akin to provisions in the Machinery Directive, the Low Voltage Directive, and the EMC Directive. Requirements included use of harmonised standards produced by bodies like CEN and CENELEC, designation and notification of conformity assessment bodies under frameworks used by Notified Bodies, and documentation such as technical files traceable to manufacturers in Netherlands and importers in Belgium. The Decision promoted information exchange via mechanisms related to the NANDO database and alignment with procedures applied in sectors overseen by the European Aviation Safety Agency and the European Chemicals Agency.
The Decision reinforced harmonisation principles established by the New Approach and the New Legislative Framework, complementing mutual recognition doctrines developed through case law like Keck and Mithouard and Cassis de Dijon. It provided reference elements to reconcile national technical rules with harmonised Union legislation, facilitating interactions among market actors in Ireland, Portugal, Hungary, and candidate countries such as Turkey and Serbia engaged in approximation processes. Coordination with European Standardisation Organisations ensured technical coherence with international standards from ISO and IEC.
Member states implemented the Decision through administrative measures and by adapting national legislation in line with Union directives; ministries and agencies in Austria, Denmark, Finland, and Czech Republic adjusted procedures for conformity assessment and market surveillance. The impact included more consistent practices for notified bodies, clearer obligations for economic operators such as manufacturers and importers in Luxembourg and Malta, and improved cross-border trade in sectors represented by associations like BusinessEurope and UEAPME. National courts cited the Decision in administrative and judicial reviews alongside references to the European Commission's guidelines.
Enforcement relied on mechanisms including designation of notified bodies, market surveillance authorities, and administrative cooperation via networks like the Administrative Cooperation Group and the European Commission’s Expert Group structures. Compliance actions by authorities in Romania and Bulgaria employed procedures consistent with enforcement under the Product Liability Directive and customs checks coordinated with OLAF in cases of non-compliant goods. Dispute resolution invoked remedies available through the European Court of Justice and infringement procedures initiated by the European Commission against member states failing to fulfill obligations.
The Decision has been referenced in subsequent legislative developments, harmonisation efforts under the New Legislative Framework, and communications by Commissioners including Nicolas Schmit and Tibor Navracsics concerning market regulation. Reviews by the European Commission and inputs from standardisation bodies such as ETSI and international organisations like WTO influenced updates in sectoral law and guidance documents used by Notified Bodies and market surveillance authorities. Its elements continue to inform case law of the European Court of Justice and implementation practices in member states.
Category:European Union directives and decisions