
Background
The European standardization system consists of three European Standards Organizations (ESOs), CEN, CENELEC and ETSI and their national member standards bodies.
European standards developed are implemented identically by all member bodies, with conflicting standards withdrawn. Starting work on a European standard begins a period of standstill where national members cannot continue or start work on an identical subject.
In this way, the European system is one of a single standard for the whole of the internal market across Europe, comprising the 28 members of the European Union, the EFTA members of the European Economic Area and other full members of CEN and CENELEC. The single standard brings the benefits of clarity and certainty for industry and enables easier reference in legislation. From the perspective of the European Union, the pan-European consensus of all Member States’ standards bodies that is contained in European standards give them the legitimacy to be used for public policy purposes.
European standardization is an integral part of European Union single market and is viewed as a tool to increase the competitiveness of enterprises and to remove barriers to trade at the international level. The European standardization system is based on European law, Regulation 1025/2012. This includes the following “founding principles” that are recognized by the World Trade Organization: “coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency”.
Regulation 1025/2012 sets out the legal framework for the interaction between the European Union – mainly through the European Commission – and the European standardization system. This interaction comes mainly through the co-regulatory “New Approach” to technical harmonization. In addition to this, some standards are used to support European policies without a legal framework, such as in the ICT and accessibility areas.
European Standards Organizations
The European “New Approach” to technical harmonization
The European Union uses standards to support both its legislation and policies. The primary use of standards is as part of a co-regulatory model known since the 1980s as the “New Approach” to technical harmonization. This has been updated and refined in the “New Legislative Framework” from 2008. There are now about 25 different legislative acts that follow the New Approach principles, for products as diverse as toys, machinery, gas appliances, medical devices, personal protective equipment, pyrotechnics, electrical equipment and recreational craft. There is other European legislation, like the General Product Safety Directive, that follows a similar model to the New Approach.
In the New Approach, European harmonization is limited to the “essential requirements” that products must meet before they can have free circulation within the single market. European law contains these essential requirements. The European Commission requests the ESOs to develop and adopt European standards, referred to as “harmonized standards”, by issuing a standardization request (“mandate”). The ESOs choose whether or not to accept the mandate; if they accept, they develop the requested standard(s) following the normal procedure for European standards. The policies of the ESOs are to use International Standards wherever they exist and are suitable.
Once the harmonized standards are published, they are notified to the European Commission. If all procedures are considered to have been satisfied, the Commission publishes the references of the standard in the Official Journal of the European Union. The references of about 4 500 European standards are published in the Official Journal.
Once the references are published, products manufactured in accordance with the harmonized standard receive a presumption of conformity with the relevant essential requirements of the legislation. The presumption of conformity is the crucial element in this co-regulatory approach that links the public interest (i.e. protecting public health and safety, consumer and environmental protection) and the interest of private business.
Manufacturers are nevertheless free to choose any other technical solution that can demonstrate compliance with the essential requirements of the law, as long as they follow the appropriate conformity assessment model. Compliance with standards is therefore still voluntary, even though their use brings advantages in terms of simplicity and cost effectiveness.
EU Directives
EU DIRECTIVE | NEW APPROACH INDIRECT REFERENCE TO STANDARDS |
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Directive 2009/48/EC, Safety of Toys Note: This is an example of a European New Approach Directive that meets the requirements of the New Legislative Framework. There are more than 20 European legislative acts that follow the New Approach, and a number of others that use similar principles. These include machinery, low-voltage electrical equipment, electromagnetic compatibility, personal protective equipment, recreational craft, gas appliances, pyrotechnics and medical devices. All New Approach legislation is being updated to meet the requirements of the New Legislative Framework. The legislation also refers to the legislation on European standardization, Regulation 2015/2012, which sets procedures for the Commission to request harmonized standards from the European Standards Organizations and to decide on formal objections against standards. |
Article 13 of the Directive states that “Toys which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the [essential requirements of the Directive]”. Article 14.1 states that Member States of the European Union or the European Commission can raise a formal objection against the publication of the references of the standard if it does not entirely satisfy the essential safety requirements of the Directive. The standard is then considered by expert groups and the Commission’s committee on standards before a decision is made about whether the standard can continue to provide a presumption of conformity. |
Directive 2001/95/EC on general product safety |
This legislation applies when there is no other European or national legislation covering the safety of consumer products. It sets a general requirement that products must be safe. In a similar way to the New Approach Directives, a product is presumed to be safe when it conforms to voluntary national standards transposing European standards, the references of which are published by the Commission in the Official Journal of the European Communities. If a standard does not ensure compliance with the general safety requirement, the Commission must withdraw the published reference to the standard, in whole or in part. |
Some national examples from France
French Policy / Regulation | Reference to standard/s |
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Décret n°94-699 du 10 août 1994 fixant les exigences de sécurité relatives aux équipements d’aires collectives de jeux. (Note: Il s’agit d'un exemple de réglementation nationale de type “nouvelle approche”.) Decree No 94-699 of 10 August 1994 fixing the safety requirements relating to collective playgrounds equipment. (Note: This is an example of national regulation of the “new approach” type.) |
Art. 3 “Les équipements d’aires collectives de jeux doivent satisfaire aux exigences de sécurité définies en annexe au présent décret.” Art. 4 “Le respect des exigences de sécurité définies en annexe est attesté par la mention: “conforme aux exigences de sécurité”.” Art. 5 “Peuvent seuls comporter la mention: “conforme aux exigences de sécurité” les équipements d’aires collectives de jeux qui satisfont à l’une des deux obligations suivantes:
La liste des références des normes pouvant être utilisées en application de l’article 5-1 du décret n° 94-699 fait l’objet d’avis publiés régulièrement au Journal officiel de la République française (voir par exemple l’avis publié au JORF du 06 mars 2009). |
Décret n° 95-937 du 24 août 1995 relatif à la prévention des risques résultant de l’usage des bicyclettes. (Note: Il s’agit d’un exemple de réglementation nationale de type “nouvelle approche”.) Decree No 95-397 of 24 August 1995 relating to the prevention of risks resulting from the use of bicycles. (Note: This is an example of national regulation of the “new approach” type.) |
Art. 3 - Les bicyclettes doivent satisfaire aux exigences essentielles de sécurité figurant en annexe au présent décret…). Art. 4 - Le respect des exigences de sécurité est attesté par la mention “Conforme aux exigences de sécurité” (…). Art. 5 - La mention prévue à l’article [4] ne peut être utilisée que si la bicyclette satisfait à l’une des deux conditions suivantes:
La liste des références des normes pouvant être utilisées en application de l’article 5-1 du décret n° 95-937 fait l’objet d’avis publiés régulièrement au Journal officiel de la République française (voir par exemple l’avis publié au JORF du 31 mai 2014). |
Décret n° 2006-18 du 04 janvier 2006 relatif à la sécurité des barbecues utilisant des combustibles solides. (Note: Il s’agit d’un exemple de réglementation nationale de type “nouvelle approche”.) Decree No 2006-18 of 04 January 2006 relating to the safety of barbecues using solid fuels. (Note: This is an example of national regulation of the “new approach” type.) |
Article 3
Article 4 Sont réputés satisfaire aux dispositions de l’article 3 les produits qui sont:
La liste des références des normes pouvant être utilisées en application de l’article 3-1 du décret n° 2006-18 a fait l’objet de l’avis publié au JORF du 01 mars 2006. |
Arrêté du 01 août 2006 fixant les dispositions prises pour l’application des articles R. 111-19 à R. 111-19-3 et R. 111-19-6 du code de la construction et de l’habitation relatives à l’accessibilité aux personnes handicapées des établissements recevant du public et des installations ouvertes au public lors de leur construction ou de leur création. Order of 01 August 2006 laying down the provisions for the implementation of Articles R. 111-19 to R. 111-19-3 and R. 111-19-6 of the Code of construction and housing relating to the accessibility for people with disabilities in establishment open to the public and in installations open to the public during their construction or their creation. |
Art. 7.2 Ascenseurs: “(…) les ascenseurs doivent être conformes à la norme NF EN 81-70 relative à l’"accessibilité aux ascenseurs pour toutes les personnes y compris les personnes avec handicap", ou à tout système équivalent permettant de satisfaire à ces mêmes exigences.” |
Arrêté du 14 août 2012 relatif aux conditions de mesurage des niveaux d’empoussièrement, aux conditions de contrôle du respect de la valeur limite d’exposition professionnelle aux fibres d’amiante et aux conditions d’accréditation des organismes procédant à ces mesurages. Order of 14 August 2012 concerning the conditions for measuring dust levels, the conditions of control compliance with the limit value for occupational exposure to asbestos fibres and the conditions of accreditation of organisms making these measurements. |
Art. 3: “Pour la stratégie d’échantillonnage, la mise en œuvre de la méthode définie dans la norme NF EN ISO 16000-7 de septembre 2007 et son guide d’application GA X 46-033 relatifs à la stratégie d’échantillonnage pour la détermination des concentrations en fibres d’amiante en suspension dans l’air est réputée satisfaire à l’exigence réglementaire d’établissement d’une stratégie d’échantillonnage. Art. 4: “Pour les prélèvements, la mise en œuvre de la partie concernée de la norme AFNOR XP X 43-269 d’avril 2012 relative au “Prélèvement sur filtre à membrane pour la détermination de la concentration en nombre de fibres par les techniques de microscopie: MOCP, MEBA et META - Comptage par MOCP” est réputée satisfaire à l’exigence réglementaire de réalisation de prélèvements.” Art. 5: “L’analyse des prélèvements est réalisée en microscopie électronique à transmission analytique (META). |
National Examples Overview

Canada

China

Europe

Japan

South Africa
