Overview of European Approach to Regulations and Standards    

 George T. Willingmyre, P.E.

December 2003

The European Approach to Regulations and Standards consists of several coordinated policies and decisions which work together to promote  industrial competitiveness, product innovation, and the free movement of goods across the EU, at the same time as protecting the health, safety and environmental  concerns of European citizens. The European Approach to Regulations and Standards lead directly to the statement in March, 1998 by  Ray Kammer, Director of NIST:         

Europe does have a strategy and it is running at full throttle. It is fair to say that European governments and industries believe that they can create a competitive advantage in world markets by strongly influencing the content of international standards. Today, while our economy hums along and U.S. industries continue to do well, this view may be quickly dismissed. That would be a terrible mistake 

The main elements of the  European approach are: 

The New Approach to Technical Harmonization and Standardization (to setting of Directives)  

The Global Approach (to conformity Assessment) 

Product Liability and The General Product Safety Directive (92/59/EC) 

The 98/34/EC “Information Procedure” Directive 

Strategy  for external trade in the fields of standards and conformity assessment 

 The New Approach to Technical Harmonization and Standardization  

The New Approach is a legislative technique that consists of defining mandatory essential product requirements to ensure a high level of public protection, while leaving the choice of technical solution up to interested and  knowledgeable parties. The  New Approach has proven to be a highly efficient technique for promoting industrial competitiveness, product innovation, and the free movement of goods across the EU. It is an early example of a "co-regulatory" approach that involves all stakeholders in the drive for better regulation. "New Approach" directives  cover more than 20 industrial sectors and thousands of industrial products, including building materials, toys, medical devices, gas fires, pleasure boats, machinery, and Information Technology and Telecommunications equipment.  

The 'New Approach' is a legislative technique used in the area of the free movement of goods since 1985. The innovative feature of the 'New Approach' is that it has the aim of developing flexible and technology-neutral legislation, by moving from the detailed product specific technical requirements more usually used in directives, to defining the essential requirements for types of products. This legislative approach has the advantage, because of its flexibility, of promoting innovation and, thus, competitiveness.  

The main elements of the New Approach are:  

the definition of mandatory essential requirements to ensure a high level of protection of the public interest at issue, such as health, safety, consumer protection or the protection of the environment;  

Essential health and safety requirements are at the heart of the New Approach Directives. They are mandatory, legally binding obligations, and they are enforced. The aim of most essential requirements is the elimination of risks of accident to the extent possible. All manufacturers, domestic or foreign, are obliged to meet all the essential requirements pertaining to their product. 

that manufacturers are free to choose any appropriate technical solution that meets the essential requirements. Products that comply with harmonized standards are presumed to meet the corresponding essential requirements;  

European Standards (ENs) that play a role in New Approach Directives are known as Harmonized Standards. Harmonized Standards are standards that support European legislation. They (1) have been mandated by the European Commission, (2) have been developed by the European Standards Bodies, (3) address essential requirements of New Approach Directives; and (4) notification of their development has been published in the Official Journal of the European Communities. The standards bodies which create standards on a Europe-wide level are : (1) The European Committee for Standardization (CEN) in Brussels, Belgium; (2) the European Committee for Electrotechnical Standardization (CENELEC) in Brussels, Belgium; and (3) The European Telecommunications Standards Institute (ETSI), in Sophia Antipolis, France.  

Presumption of conformity is a legal concept surrounding Harmonized Standards that denotes the relationship between the legislative and standardization processes. The European Commission (the lawmaking body) and the European Standards Bodies collaborate to produce Harmonized Standards. The contract (or mandate) stipulates that the standards body will produce a standard that will provide a technical solution, or a technical interpretation, of an essential health and safety requirement. When the standard is completed and the conditions of the Commission's mandate are met, the Commission publishes the notice of its completion in the Official Journal of the European Communities. Once the notice is published, the standard takes on the presumption of conformity mantle. A manufacturer, therefore, using a Harmonized Standard in the design and/or production of the product, is presumed to be in conformity with the essential requirements of the law.  

CEN and CENELEC's principal members are national standards ETSI's membership incorporates a wider range of interested parties These three are the only recognized bodies from which a European Standard (EN) can emanate.  

There are many  European Standards (ENs)  not mandated by the Commission. They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences.

the definition of appropriate conformity assessment procedures, taking into account, among other things, the type of risk related to the products concerned;  

(See Discussion of the “Global Approach below) 

the affixing of the CE marking, by which the manufacturer declares conformity with the requirements of the directives that apply to it; 

The CE mark, consists of the initials "CE," must be affixed to the product, to its data plate or, where this is not possible, to its packaging. Instructions for the graphic design are contained in Annexes to the Directives The CE marking must be affixed visibly, legibly, and indelibly.

Member States may not maintain or introduce new markings that will denote compliance with requirements of the New Approach Directives. The CE marking is the only marking which implies conformity of a product to New Approach Directives. A product may bear other markings provided they do not reduce the visibility or legibility or create confusion with respect to CE marking.  

the obligation on Member States to take all appropriate enforcement measures, including market surveillance, to ensure that non-conforming products are withdrawn from the market.  

The purpose of market surveillance is to ensure that the provisions of the directives are complied with throughout the European Union. Member State Authorities are responsible for the enforcement of the New Approach Directives. These public authorities can be the Department of Health, Department of Industry, Department of Labor, or other established inspection authorities of a Member State.  

Surveillance authorities monitor products placed on the market. They may visit commercial, industrial and storage premises; work places and other premises where products are put into service and used; organize random checks; take samples of products and subject them to examination and testing; and demand  necessary compliance and test information If a  product is found to be non-compliant, corrective action will depend on and be appropriate to the level of non-compliance. The surveillance authority will hold the person responsible for affixing the CE marking to a non-compliant product accountable. Others who are responsible for the non-compliance of the product will be held accountable as well. Penalties, which may include imprisonment, are determined by National law.   

The Global Approach to certification and testing 

The Council Resolution of 1989 on the Global Approach to certification and testing states the following guiding principles for Community policy on conformity assessment. 

The Global  Approach entailed refining conformity assessment in such a way as to allow the Community legislator to evaluate the consequences of the utilization of different conformity assessment mechanisms. The Global Approach introduced a modular approach, which subdivided conformity assessment into a number of operations (modules). These modules differ according to the stage of development of the product (for example design, prototype, full production), the type of assessment involved (for example documentary checks, type approval, quality assurance), and the person carrying out the assessment (the manufacturer or a third party). The Global Approach was completed by Council Decision90/683/EEC, which was replaced and brought up to date by Decision 93/465/EEC. These decisions lay down general guidelines and detailed procedures for conformity assessment that are to be used in New Approach directives. Conformity  assessment under the Global Approach  is based on: 

_ manufacturers’ internal design and production control activities;

_ third party type examination combined with manufacturers' internal production control activities;

_ third party type or design examination combined with third party approval of product or production quality assurance systems, or third party product verification (5);

_ third party unit verification of design and production; or

_ third party approval of full quality assurance systems.

Product Liability and The General Product Safety Directive (92/59/EC) 

New Approach Directives do not always provide guidance on how to implement, nor do they provide interpretations of the law. Legal critiques of design(s) are conducted in hindsight at trials, where the issue may be whether or not the manufacturer was negligent, and whether or not the designer produced a reasonably safe design. When these are the issues, a national European court will inquire as to how the manufacturer of the product applied (or didn't apply) good safety engineering practices. 

Some manufacturers will have judgments rendered against them for failing to exercise reasonable engineering practices. The legal obligation to use good engineering practices in safety matters is not embedded in directives, but exists independently of them. 

Any product manufactured or imported into the European Union which causes damage to individuals or property is covered by the Product Liability Directive (85/374/EEC). This directive provides the right of civil action for product liability to all citizens of the European Union.  The Product Liability Directive covers all moving parts, electricity, raw materials, and components for final products, and holds the manufacturer liable for all damages. If the manufacturer cannot be identified, each supplier of the product becomes liable. 

The General Product Safety Directive (92/59/EC) describes the obligations to a manufacturer when no other directive or regulation A manufacturer is expected to consider and deal with the risks involved in the intended use and foreseeable misuse of its products. The scope of this directive includes packaging and instructions.  

The Information Procedure 

National standards may still govern products regulated at Member State level. The harmonization of regulation is also an ongoing process, and some products that are unregulated at European level are still regulated by Member States.  

If products are unregulated at the European level, the European Court of Justice has decreed that Member States must recognize them in each other's territory (i.e., acceptance in one Member State means acceptance in all) unless there are proven health or safety restrictions. This acceptance principle is known as mutual recognition. To this date, however, products outside of the food sector have not enjoyed a liberal and free exchange under the mutual recognition principle. The 98/34/EC Directive (formerly 83/189/EEC) sets up a procedure which imposes an obligation upon the Member States to notify to the Commission and to each other all the draft technical regulations concerning products and Information Society Services before they are adopted in national law. Such procedure aims at providing transparency and control with regard to those regulations.  

Implementing policy for external trade in the fields of standards and conformity assessment 

The Internal market has developed largely from a trade facilitation mechanism into one that marries trade facilitation with a high level of protection of public interests, as defined in the EC Treaty.  Policy relating to conformity assessment and product certification in external trade aims to ensure adequate representation of EU interests in a number of wider cooperation activities towards trade facilitation and harmonization practices, and coherence with the policies applied within the EU internal market for goods. 

The activities through which these trade objectives have so far been pursued are:  

(a)  Reliance on the WTO, notably the Agreement on Technical Barriers to Trade;  

(b) Conclusion of bilateral (inter-governmental) agreements to reduce barriers and the cost of trade, which have so far consisted in the conclusion of Mutual Recognition Agreements  (MRAs) for conformity assessment, certificates and marking, which are intended to reduce the costs of testing and certification in other markets, notably those of major trading partners;  

(c) Technical assistance to ensure that other countries’ regulatory regimes are transparent and trade-friendly, and that an appropriate infrastructure in the areas of testing and certification is being put into place;  

(d) Regulatory co-operation, aiming at harmonizing regulations with trading partners, achieving a common understanding of "best regulatory practice" (BRP), and promoting recourse to it, including increased transparency in regulations and standards, international standardization, and the harmonization of regulations amongst trading partners.