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European internal market.

Module D: Regulation of the internal market.

Chapter 3: Mutual recognition and co-ordination of national regulatory systems – harmonisation.

Harmonization: history and types
Ideal types for the options for a common/single/internal market are: host state control, home state control (mutual recognition &rarr; deregulation? race to the bottom/top?), harmonization (reregulation). Other methods include open method of coordination (reflexive harmonization) and the Lamfalussy process.

Before 1985, harmonization was hard because the usual legal basis, namely the predecessor to Article 115 TFEU required unanimity; plus the Luxembourg compromise allowed block of vote for “vital national interest”. Case 120/78 Cassis de Dijon provided the key elements for mutual recognition (see Commission communication in response) and diminished the need for full harmonization. See sequel Case C-184/96 Commission v France (foie gras), counterexample Case 188/84 Commission v France (woodworking machines), Case C-384/93 Alpine Investments where home state control for export is allowed.

Optional harmonization involves only the obligation to permit goods complying with the directive to be freely imported and marketed: each Member State is then free to allow the sale of goods not meeting the standards laid down in the directive. This is the choice of the New Approach and the Global Approach. Minimum harmonization is also commonly used and may lead to reverse discrimination: Case C-11/92 Gallaher, Case C-1/96 Compassion in World Farming.

New Approach and Global Approach
The New Approach and the associated Global Approach were established by the following decisions and the Commission is assisted by the committee procedure (comitology, see Case 25/70 Köster):
 * Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (see Case C-613/14 James Elliott Construction v Irish Asphalt):
 * Legislative harmonisation is limited to essential requirements that products placed on the Union market must meet, if they are to benefit from free movement within the Union: Case 60/86 Commission v UK (dim-dip), Case C-376/98 Germany v Parliament and Council (tobacco advertising I).
 * The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonised standards (set by CEN, CENELEC, ETSI).
 * Application of harmonised or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements.
 * Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements.
 * Council Resolution of 21 December 1989 on a Global Approach to conformity assessment
 * A consistent approach is developed in Union legislation by devising modules for the various phases of conformity assessment procedures, and by laying down criteria for the use of those procedures, for the designation of bodies operating those procedures, and for the use of the CE marking.
 * The use of European standards relating to quality assurance (EN ISO 9000 series), and to the requirements to be fulfilled by conformity assessment bodies operating quality assurance (EN 45000 series) is generalised.
 * Setting up of accreditation systems and the use of inter-comparison techniques are promoted in Member States and at Union level.
 * Mutual recognition agreements concerning testing and certification in the non-regulatory sphere are promoted.
 * The differences in existing quality infrastructures (such as calibration and metrology systems, testing laboratories, certification and inspection bodies, and accreditation bodies) between Member States and between industrial sectors are minimised by programmes.
 * International trade between the Union and third countries is promoted by means of mutual recognition agreements, cooperation and technical assistance programmes.
 * Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives; now replaced by Regulation 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and Decision 768/2008 on a common framework for the marketing of products.
 * The modules for the various phases of conformity assessment procedures were: internal production control, EC-type examination, conformity to type, production quality assurance, product verification, unit verification, full quality assurance.

See Directive 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services.

Standard elements of New Approach directives
Example: Toy Safety Directive 2009/48.
 * 1) Scope
 * 2) Placing on the market and putting into service
 * 3) Essential requirements
 * 4) Free movement
 * 5) Presumption of conformity
 * 6) Safeguard clause
 * 7) Conformity assessment
 * 8) Notified bodies
 * 9) CE marking
 * 10) Co-ordination of implementation
 * 11) Transposition and transitional provisions