New Approach
The New Approach is a regulatory technique for technical harmonisation whereby product legislation is restricted to the requirements necessary to protect the public goals of health and safety - serving the Commission's strategy to complete the internal market and implement the Lisbon objective of better regulation.
Innovative features of this legislative technique include the definition of mandatory essential requirements, the setting up of appropriate conformity assessment procedures and the introduction of CE marking. The New Approach has recently been revised and integrated into the New Legislative Framework.
The New Approach has been an important industrial policy instrument as it provides for the essential requirements to be combined with technical specifications agreed by stakeholders and experts in the field, usually harmonised European standards. Added to this, the New Approach mechanism includes a coherent and transparent conformity assessment policy. This provides for standardised conformity procedures and criteria for their application, as well as clear standardised conditions for third party intervention when the legislator so requires.
The New Approach was introduced mainly because the traditional method for harmonising product legislation often was too slow and unsuitable for several product sectors. It was difficult and time consuming to negotiate in the Council many pages of very detailed technical legislative texts. In worst cases, a few years after adoption, the legislation had to be updated and revised because the technology had advanced even further.
Thus, the introduction of the New Approach provided a great amount of flexibility in the legislative process by allowing the harmonisation of only the essential requirements. It also helped innovation by leaving the definition of technical requirements to the economic actors - making the process more rapid - and by reducing considerably the burden of control by public authorities prior to a product being placed on the market. Most of all, the New Approach was instrumental in contributing to the completion of the 1992 Single Market programme, because it led to unblocking the harmonisation negotiations for many sectors.
However, two decades of operation of the New Approach revealed a number of areas where there still was room for improvement. Although New Approach was popular and supported in many sectors, it did not always guarantee a sufficient, perceptible level of confidence in the market place, whether for products manufactured in the EU or imported from third countries. This led to unequal implementation in the Member States, unequal market surveillance interventions, and misuse of safeguard mechanisms. In certain sectors, the consumers or end users also lacked trust in the validity and added value of the CE marking on products. Thus economic operators sometimes felt that they could not benefit from a level playing field on the market while consumers did not always feel that they were effectively protected.
With the aim of increasing the effectiveness of the system, and to improve its transparency as well as its smoother functioning for the benefit of all involved (manufacturers, conformity assessment bodies, authorities and consumers and users), the New Approach was therefore subject to a revision which in 2008 led to the New Legislative Framework for the marketing of products. Through the adoption of the New Legislative Framework, some of the constitutive elements of the New Approach have been reinforced without putting into question the basic tenets of the New Approach, but making it more credible and hence possibly more attractive to sectoral legislators who still had doubts in its appropriateness to deal with their concerns.
Not only does the New Legislative Framework fill in the missing chapters (market surveillance and accreditation) of existing legislation, but it takes the pressure off the systematic insistence on the use of standards, which is very often the cause of apprehensions vis à vis the New Approach in certain sectors. The New Legislative Framework leaves open the choice between the use of detailed technical legislative specification and European standards, which is in most cases an issue independent from all the other elements in technical harmonisation legislation.
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