Tag Archives: Conformity

Technical implications of road safety

Outline of the Community (European Union) legislation about Technical implications of road safety

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Motor vehicles > Technical implications of road safety

Technical implications of road safety

The technical implications of road safety cover both vehicle and infrastructure safety. By 2020, the European Commission aims to halve the number of deaths on the roads (in relation to the 2010 figures) in the European Union (EU).
To achieve this objective, the Commission promotes the use of modern technologies to improve road safety. It defines a legislative framework which aims to make vehicles and road infrastructure safer. The protection of vulnerable passengers is also a policy priority.

GENERAL PROVISIONS

General safety of motor vehicles
Road safety: Road Safety Action Programme (2003-2010)
Road safety: cross-border application of the legislation
EC type-approval system for motor vehicles

SPECIFIC PROVISIONS

Restraint devices for passengers

Passenger restraint devices on two-wheel vehicles
Compulsory fitting of safety belts

Vehicle protection in the event of impact

Motor vehicles with trailers: front underrun protection devices (until 2014)
Motor vehicles with trailers: protection of occupants in the event of a frontal impact (until 2014)
Motor vehicles with trailers: behaviour of steering device under impact (until 2014)
Motor vehicles with trailers: lateral protection for goods vehicles (until 2014)

Reduction of blind spots

Rear-view mirrors and supplementary devices for indirect vision (until 2014)

Protection of vulnerable road users

Protection of pedestrians and vulnerable road users
Protection of pedestrians and other vulnerable road users
Vulnerable road users and frontal protection systems

Control devices

Speed limitation on-board devices of certain categories of motor vehicles (until 2014)
Maximum authorised settings for speed limitation devices in commercial vehicles
Driving time in the road transport sector

Intelligent automobile security systems

Le service eCall
(FR)
eCall: Time for deployment
eSafety: the use of information and communication technology (ICT) for road safety
In-vehicle emergency call system “eCall” (Second eSafety Communication)
i2010 Intelligent Car Initiative (third eSafety communication)

Pharmaceutical and cosmetic products

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Pharmaceutical and cosmetic products

Outline of the Community (European Union) legislation about Pharmaceutical and cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Pharmaceutical and cosmetic products

The European pharmaceutical industry has an important role to play in ensuring that the people of Europe enjoy a good standard of health. The European Union strives, therefore, to guarantee broad access to medicinal products, to provide the public with high quality information, and to ensure that the medicinal products manufactured are safe and effective. The single market for pharmaceutical products makes it possible to achieve these aims by increasing the competitiveness of the industry through promoting research and innovation for the benefit of the public.
The European cosmetic industry is an important employer. 150 000 people work in the industry itself, and the sale, distribution and transport of cosmetics indirectly creates a further 350 000 jobs. With a production value of more than €35 billion, this innovative industry is a world leader in the field. The European Union aims to ensure free movement of cosmetic products in the internal market and to guarantee that the products are safe.

Single Market and the pharmaceutical industry

A renewed vision for the pharmaceutical sector
Parallel imports of proprietary medicinal products
A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient
IMI Joint Undertaking

Common provisions for medicines for human and veterinary use

Authorisation and supervision of medicinal products – European Medicines Agency
Good laboratory practice: tests on chemical substances
Good laboratory practice: inspection and verification of laboratory studies on all chemicals
Colouring matters for medicinal products (recast)
Supplementary protection certificate for medicinal products
Protection of laboratory animals
European Pharmacopoeia

Medicinal products for human consumption

Community code relating to medicinal products for human use
Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Advanced therapy medicinal products
Medicinal products for paediatric use
Price of medicinal products for human use: pricing and health insurance
Good clinical practice
Orphan medicinal products
Pharmaceutical Committee

Medicinal products for veterinary use

Community code relating to veterinary medicinal products
Good manufacturing practice for veterinary medicinal products
Residues of veterinary medicinal products in foodstuffs of animal origin
Preparation and marketing of medicated foodstuffs for animals

Cosmetic products

Cosmetic products (from 2013)
Cosmetic products (until 2013)

Patents and invention protection

Community patent
Legal protection of biotechnological inventions
Patent law in the field of biotechnology and genetic engineering: implementation report (2002)
Agreement on intellectual property rights relating to trade and pharmaceutical patents

Multilateral trade

Essential medicines for developing countries (HIV/AIDS, tuberculosis and malaria)
Compulsory licensing system for the production and export of generic medicinal products to developing countries
Duty free treatment

Motor vehicles

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Motor vehicles

Outline of the Community (European Union) legislation about Motor vehicles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Motor vehicles

Motor vehicles

The car industry accounts for 3% of European GDP and 7% of employment in the manufacturing sector, and is emerging as a key sector in the European economy. The European car industry must be strong in its resolve to meet the challenges of preserving and improving the sector’s global competitiveness while achieving further progress in terms of safety and environmental performance and guaranteeing acceptable prices for consumers.

Technical harmonisation for motor vehicles
Technical implications of road safety
Interactions between the automobile industry and specific policies

Technical harmonisation for motor vehicles

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Technical harmonisation for motor vehicles

Outline of the Community (European Union) legislation about Technical harmonisation for motor vehicles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Motor vehicles > Technical harmonisation for motor vehicles

Technical harmonisation for motor vehicles

Technical harmonisation for motor vehicles, implemented at Community level pursuant to Article 114 of the Treaty on the Functioning of the European Union (TFEU), is based on the Community’s WVTA (whole vehicle type-approval) system.
Under this system, manufacturers can obtain certification for a vehicle type in one Member State if it meets the harmonised technical requirements and then market it EU-wide with no need for further tests.
Total technical harmonisation has already been achieved in different vehicle categories (passenger cars, motorcycles, agricultural and forestry tractors, utility vehicles, coaches, moped and motorcycle trailers) and will soon be extended to other vehicle categories (other types of tractors and trailers).
It is essential that European car manufacturers be ensured access to as large a market as possible. While the Community type-approval system allows manufacturers to benefit fully from the opportunities offered by the internal market, worldwide technical harmonisation in the context of the United Nations Economic Commission for Europe (UN/ECE) offers them a market which extends beyond European borders.

FRAMEWORK FOR THE TECHNICAL HARMONISATION OF MOTOR VEHICLES

A competitive automotive regulatory framework for the 21st Century
Global technical harmonisation of vehicles

TECHNICAL HARMONISATION IN THE INTERNAL MARKET

Motor Vehicles and Trailers

EC type-approval system for motor vehicles
General safety of motor vehicles
Emissions from heavy duty vehicles (Euro VI): certification rules
Windscreen defrosting and demisting systems for motor vehicles
Rear registration plates on motor vehicles
Motor vehicle towing devices
Windscreen wiper and washer systems of motor vehicles
Motor vehicle wheel guards
Manufacturer’s statutory plate and identification number for motor vehicles
Spray-suppression systems for motor vehicles
Installation of tyres
Tyre labelling
Engine power of motor vehicles and trailers (up until 2013)
Motor vehicles and their trailers: steering equipment (until 2014)
Braking devices of certain motor vehicles (until 2014)
Direction indicator lamps for motor vehicles with trailers (until 2014)
Parking lamps on motor vehicles (until 2014)
Front fog lamps on motor vehicles (until 2014)
Motor vehicles with trailers: rear fog lamps (until 2014)
Headlamps which function as main-beam and/or dipped-beam headlamps for motor vehicles (until 2014)
Motor vehicles with trailers: liquid fuel tanks and rear underrun protection devices
Motor vehicles with trailers: tyres (until 2017)
Technical standards: tyre pressure gauges for motor vehicles (until December 2015)
Motor vehicles with trailers: spray-suppression devices (until 2014)
Motor vehicles with trailers: heating systems for the passenger compartment (until 2014)
Motor vehicles with trailers: interior fittings (until 2014)
Motor vehicles with trailers: cabs of commercial vehicles (until 2014)
Motor vehicles with trailers: fire behaviour of the materials used in the internal fittings of buses and coaches (until 2014)
Motor vehicles with trailers: safety glass and glazing materials
Motor vehicles with trailers: mechanical coupling devices (until 2014)
Motor vehicles with trailers: masses and dimensions of cars (until 2014)
Road safety: dimensions and maximum weights authorised for both national and international journeys
The reusing, recycling and recovering of motor vehicles
Reduction of pollutant emissions from light vehicles
Emissions from diesel and gas engines (up until 2013)
Emissions from air conditioning systems in motor vehicles
Motor vehicles with trailers: permissible sound level

Two or three-wheeled motorised vehicles

Two or three-wheeled motor vehicles: EC type-approval system
Two or three-wheeled motor vehicles: components and characteristics
Two- or three-wheeled motor vehicles: maximum design speed
Lighting and light-signalling for two or three-wheel motor vehicles
Two- or three-wheeled motor vehicles: audible warning device
Controls, tell-tales and indicators for two or three-wheel motor vehicles
Rear registration plates of two or three-wheel motor vehicles
Two- or three-wheeled motor vehicles: braking devices
Two- or three-wheeled motor vehicles: maximum dimensions, masses and loads
Statutory markings for two- or three-wheel motor vehicles
Two- or three-wheeled motor vehicles: anti-theft devices
Stands for two-wheel vehicles

Agricultural and forestry tractors

Agricultural or forestry tractors: EC type-approval procedure
Parts and characteristics of wheeled agricultural or forestry tractors
Lighting and light-signalling on agricultural and forestry tractors and machines
Driver-perceived noise level of wheeled agricultural or forestry tractors
Roll-over protection structures of wheeled agricultural or forestry tractors
The coupling device and the reverse of wheeled agricultural or forestry tractors
Tractors and agricultural or forestry machinery: braking
Tractors and agricultural or forestry machinery: driver’s seat
Tractors and agricultural or forestry machinery: passenger seats
Tractors and agricultural or forestry machinery: front-mounted protection structures
Tractors and agricultural or forestry machinery: rear-mounted protective devices
Pollutant gases of wheeled agricultural or forestry tractors

Hydrogen-powered motor vehicles

Approval of hydrogen-powered motor vehicles

The mutual recognition principle in the single market

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The mutual recognition principle in the single market

Outline of the Community (European Union) legislation about The mutual recognition principle in the single market

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Internal market: general framework

The mutual recognition principle in the single market

Document or Iniciative

Communication from the Commission “Mutual recognition in the context of the follow-up of the action plan for the single market” [COM(1999) 299 final – Not published in the Official Journal].

Summary

At the invitation of the Internal Market Council of March 1998, the Commission has undertaken an analysis of the difficulties encountered in the application of mutual recognition.

IMPORTANCE OF MUTUAL RECOGNITION FOR THE SINGLE MARKET

The mutual recognition principle guarantees free movement of goods and services without the need to harmonise Member States’ national legislation. Goods which are lawfully produced in one Member State cannot be banned from sale on the territory of another Member State, even if they are produced to technical or quality specifications different from those applied to its own products. The only exception allowed – overriding general interest such as health, consumer or environment protection – is subject to strict conditions. The same principle applies to services.

In general, the rules of the Member State of origin prevail. This guarantees compliance with the principle of subsidiarity by avoiding the creation of detailed rules at EU level and by ensuring greater observance of local, regional and national traditions and makes it possible to maintain the diversity of products and services. It is thus a pragmatic and powerful tool for economic integration.

PROBLEMS WITH APPLICATION AND ANALYSIS OF THE CAUSES

Available information. One of the problems concerns availability of reliable information necessary for evaluation. Available figures do not allow a precise estimation of the economic impact of mutual recognition, but it is clear that the principle is a very important mechanism for a large number of industry and services sectors. The only figures available concern the number of complaints lodged with the Commission. The number of cases where producers have complied with countries’ requirements or withdrawn their products is unknown.

Obstacles. According to the results of surveys conducted in industry, there are still some obstacles at the level of technical standards and regulations. The service sector estimates that in general the obstacles to free movement of goods remained practically the same between 1996 and 1998. Other problematic issues have been identified:

on consumer protection grounds, controls that are not always necessary are imposed in the countries of destination;
in the internal administrative organisation, better management is hampered by administrative delays, costs of procedures and inability to deal with complex issues (for example innovative products and services);
a lack of mutual confidence in the acts of other Member States continues.

These problems have prompted some operators to adapt their products to local requirements or even, in extreme cases, to forgo marketing their products or services in another Member State.

Products. Most problems relate to guaranteed protection, since the country of destination is often convinced that its safety arrangements are the only good ones. The fields most affected are food, electrical engineering, vehicles, precious metals, construction and chemicals.

Services. The service sectors about which the Commission receives most complaints are as follows: business communications, construction, patent agents and security services. Available figures do not give an accurate picture of the situation because of the small number of complaints lodged with the Commission. In the regulated professions, difficulties in the implementation of the mutual recognition principle continue to affect individuals. In the field of financial services, the Commission finds evidence of inappropriate use of the notion of “general interest” and of consumer protection designed to inhibit the marketing of financial products. In the field of business communications, national differences, in particular in advertising, frustrate the creation of a genuine single market. Finally, as regards electronic commerce, legal barriers still restrict the opportunities in the single market.

PROPOSALS

Ensure credible monitoring. In order to assess progress, the Commission will prepare, every two years, evaluation reports, whose conclusions will be included in the single market scoreboard in order to make Member States more aware of the existing problems and to find solutions. The Commission undertakes to give greater attention to the compliance with obligations by the Member States, including the opening of infringement proceedings. Moreover, the possibilities offered by the notification procedure should be fully used to promote mutual recognition and prevent the emergence of new obstacles.

Actions targeted at citizens and economic operators. The Commission proposes two action plans, one for the Commission itself, the other for the Member States.

Action by the Commission. The Commission undertakes to facilitate dialogue between the citizens and companies. To improve information and economic analysis, the Commission proposes:

producing a Guide on application of the mutual recognition principle in the field of industrial products and a brochure explaining the implementation of Decision 3052/95 concerning the measures derogating from the principle of free movement of goods;
an economic analysis of the application of mutual recognition in various different sectors in order to obtain a better evaluation (economic benefits and costs of non-implementation);
an analysis of the national consumer protection rules for financial products.

The Commission proposes the following training measures:

organise sectoral roundtables of representatives of Member States’ competent authorities and professional organisations;
draw up specific projects at national level in order to disseminate information about the mutual recognition principle to the target public.

In order to make mechanisms for dealing with problems more effective, it is planned to:

use biennial reports to assess more accurately whether or not new harmonisation initiatives are needed;
draw up a model application form to be used between bodies responsible for application of mutual recognition and the European and national federations;
make it possible for economic operators to ask for reasons why an application has been rejected and improve the handling of complaints by the Commission, in particular in problem sectors;
extend the “package meetings” on goods between the Commission and Member States to the services sector and follow more systematically solutions proposed by Member States;
develop a Community network for handling complaints in the field of financial services;
take specific sectorial initiatives for better application of the principle in services, in particular in the sectors of air transport and telecommunications.

In order to take into account the international dimension of mutual recognition and to reduce, or even eliminate, barriers to trade, the Commission intends to conclude mutual recognition agreements under the General Agreement on Trade in Services (GATS) and in the area of trade in goods under the World Trade Organisation (WTO).

Action by Member States. As Member States are the main actors in the implementation of the mutual recognition principle, the Commission proposes that they give the following undertakings:

to apply the judgments of the Court of Justice on including mutual recognition clauses in national legislation;
to reply within a reasonable time to requests for the application of mutual recognition, except in particularly sensitive cases;
to strengthen cooperation between the national administrations of Member States with the new telematics contact network, meetings of heads of coordination centres, and more systematic use of contact points as well as greater involvement of national coordinators (particularly in the area of regulated professions);
to prepare regular reports on problems with application and potential solutions.

Background

In 1997, the Commission adopted the Single Market Action Plan, which set out in detail the priority measures to be taken to improve the functioning of the single market by 1 January 1999. These included the application of the principle of mutual recognition.
Two years later in 1999, the Commission published this Communication, which serves as a basis for the Council Resolution on mutual recognition (see “Related Acts”).

Related Acts

Council Resolution of 28 October 1999 on mutual recognition [Official Journal C 141 of 19.5.2000].
The Council stresses the importance of mutual recognition for the proper functioning of the single market. This requires a coherent combination of harmonised legislation, standardisation, instruments for conformity assessment and mutual recognition. The Council considers further efforts necessary in the area of products (in particular food, electrical engineering, construction and motor vehicles), services (in particular financial services) and professional qualifications (recognition of diplomas). It criticises unduly burdensome and complicated administrative procedures and the lack of information in the administrations of several Member States about legislation and verification procedures in other Member States.

The Council urges Member States to:

review and simplify relevant national legislation and application procedures, step up the effectiveness and speed of these procedures, and strengthen administrative cooperation;
make economic operators and the general public aware of their rights;
keep the Commission informed about the problems with application and ensure that obligations relating to exchange of information are honoured.

The Council calls on the Commission to:

gather all information about successes and shortcomings and their economic impacts and publish this in the single market scoreboard;
make the general public and economic operators aware of their rights via general information campaigns;
ensure that the policies in that domain are coordinated with other Community policies.

Economic operators and citizens are encouraged to inform the Member States and the Commission about all problems they have encountered.

Commission interpretative communication on facilitating the access of products to the markets of other Member States: the practical application of mutual recognition [C/2003/3944 – Official Journal C 265 of 4.11.2003].
This communication aims to clarify the “mutual recognition” principle and thus help businesses and national administrations make it work better. It is a practical guide which describes how this principle should work in practice and summarises the rights it gives to economic operators. The communication forms part of the internal market strategy 2003-06. It will be followed by wide consultation with Member States, industry and consumer organisations. Depending on the results of this consultation, the Commission could submit a proposal for legislation to reinforce the way mutual recognition is implemented.

EXTERNAL ASPECTS – AGREEMENTS WITH THIRD COUNTRIES

Council Resolution of 24 June 1999 on the management of agreements on mutual recognition [Official Journal C 190 of 7.7.1999].
The Council welcomes the conclusion of mutual recognition agreements between the European Community (EC) and Australia, Canada, New Zealand and the United States of America. These agreements aim to ensure effective market access across the whole territory of the parties to all products covered by the agreements. The Council calls on the Commission to:

prepare a proposal for guiding principles for the management of agreements on mutual recognition with third countries and draft a model agreement for future negotiations;
prepare a vade mecum explaining the agreements on mutual recognition and their application;
prepare regular reports on the application of existing agreements.

Interactions between the automobile industry and specific policies

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Interactions between the automobile industry and specific policies

Outline of the Community (European Union) legislation about Interactions between the automobile industry and specific policies

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Motor vehicles > Interactions between the automobile industry and specific policies

Interactions between the automobile industry and specific policies

A number of policy fields are closely linked to the car industry and affect activity within the sector. The aim of the European car industry to build safer and more environmentally-friendly vehicles clearly ties in with transport and environmental policy, and also actively stimulates research and development.

INTERACTION WITH TRANSPORT POLICY

Road transport operators: conditions for the pursuit of the occupation
Responding to the crisis in the European automotive industry
Road safety: Road Safety Action Programme (2003-2010)
Road safety: cross-border application of the legislation
Motor vehicles and trailers: vehicle registration documents
Motor vehicles with trailers: distinguishing sign of the Member State of registration
Motor vehicles and their trailers: roadworthiness testing of heavy goods vehicles
Road safety: Driving licences
Motor vehicles with trailers: roadworthiness test
Drinking and driving: Maximum authorised level of alcohol in the blood

INTERACTION WITH ENVIRONMENTAL POLICY

End-of-life vehicles

End-of-life vehicles
The reusing, recycling and recovering of motor vehicles

Fuels

EU strategy for biofuels
Quality of petrol and diesel fuels: sulphur and lead

Polluting emissions

Reduction of carbon dioxide emissions from light commercial vehicles
Reduction in CO? emissions of new passenger cars
Emissions from heavy duty vehicles (Euro VI): certification rules
“Green” vehicles: a European strategy
Clean and energy-efficient road transport vehicles
Reduction of pollutant emissions from light vehicles
Emissions from diesel and gas engines (up until 2013)
Pollutant gases of wheeled agricultural or forestry tractors
Emissions from air conditioning systems in motor vehicles
Non-road mobile machinery: gaseous pollutants
Information on the fuel consumption and CO2 emissions of new cars

Noise pollution

Motor vehicles with trailers: permissible sound level

INTERACTION WITH COMPETITION POLICY

Motor vehicle distribution and after-sales service

INTERACTION WITH RESEARCH AND INNOVATION POLICY

Satellite navigation: Galileo

INTERACTION WITH THE RULES OF THE INTERNAL MARKET

Free movement of goods

Procedures for the registration of motor vehicles originating in another Member State

Car insurance

Civil liability insurance for motor vehicles
Motor vehicle liability insurance: freedom to provide services

Intellectual property

Harmonisation of Member States’ legislation on designs

INTERACTION WITH TAXATION POLICY

Passenger car related taxes
Tax-free allowances: permanent or temporary importation of private motor vehicles
Taxation of heavy goods vehicles: Eurovignette Directive
Community framework for the taxation of energy products and electricity
Fiscal marking of gas oils and kerosene

INTERACTION WITH THE AREA OF JUSTICE, FREEDOM AND SECURITY

Combating cross-border vehicle crime

A new boost to trade in goods

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A new boost to trade in goods

Outline of the Community (European Union) legislation about A new boost to trade in goods

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Free movement of goods: general framework

A new boost to trade in goods

Document or Iniciative

Communication from the Commission of 14 February 2007, “The Internal Market for Goods: a cornerstone of Europe’s competitiveness” [COM(2007) 35 final – not published in the Official Journal].

Summary

Improving the internal market is an ongoing process that requires continuous updating, taking account of recent technological progress, the constantly changing global situation and the needs of consumers.

Following a recent consultation process, the Commission has noted satisfaction at the considerable progress that has been achieved, although there are two major problems:

some national technical rules still constitute important barriers to free trade within the EU, particularly in sectors that have not been harmonised;
several EU rules are inconsistent and a burden to trade.

Small and medium-sized enterprises are the most seriously affected by this problem and the additional tests and red tape it entails.

The Commission proposes four initiatives:

mutual recognition

A proposal for a regulation laying down procedures that the national authorities must follow in applying national technical rules to products lawfully marketed in another Member State. This proposal also envisages the establishment of national “product contact points” to provide information on the applicable technical rules.
This proposal for a regulation will place the emphasis on transparency and efficiency: transparency in the exchange of information between businesses and the national authorities and efficiency by abolishing controls and tests involving duplication of work;
accreditation and surveillance

A proposal for a regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products. This measure will step up market surveillance activities – to ensure that non-compliant products are quickly withdrawn from the market – and make it easier to assess the conformity of goods. In order to do this, the certifications issued by accredited laboratories and testing facilities will have to be accepted throughout the EU;
conformity

A proposal for a decision on a common framework for the marketing of products, aimed at streamlining the various product conformity assessment procedures;
registration of motor vehicles

An interpretative communication on procedures for the registration of motor vehicles originating in another Member State. This will serve as the basis for a citizen’s guide on the transfer of vehicles within the EU, an issue that currently creates numerous practical difficulties as a result of bureaucratic registration formalities.

Background

This Communication is part of the Commission’s review of the Single Market in the 21st Century, which is based on a public consultation procedure launched in April 2006. As part of this review, a comprehensive analysis will be carried out on the four freedoms making up the Single Market, with a final report setting out the initiatives that will supplement the measures described in this Communication.

Accreditation and market surveillance

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Accreditation and market surveillance

Outline of the Community (European Union) legislation about Accreditation and market surveillance

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Free movement of goods: general framework

Accreditation and market surveillance

Document or Iniciative

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance).

Summary

This Regulation envisages the laying down of clear rules on the organisation and operation of accreditation, in the Member States, of conformity assessment bodies performing assessment of any substance, preparation or other product, transformed or not, to be placed on the Community market.

It is important to guarantee a high level of market surveillance in order to satisfy the requirements of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, the environment and security.

These rules reinforce the existing system, without weakening existing instruments such as the General Product Safety Directive, which has on the whole been successful.

Accreditation

This Regulation provides a framework for European accreditation policy. For the first time it establishes a common legal basis for accreditation, therefore providing a comprehensive legal framework for regulating the organisation of accreditation within the European Economic Area (EEA) from 1 January 2010.

Whether voluntary or compulsory, accreditation is recognised as the last level of control of the suitability of conformity assessment services. Accreditation has no commercial purpose, since this would reduce its value and credibility.

Accreditation is characterised by the following:

there is only one accreditation body per Member State
there is no competition between accreditation bodies and conformity assessment bodies;
accreditation is carried out by a public authority;
accreditation bodies operate on a not-for-profit basis and comply with the principles of impartiality and objectivity.

The European cooperation for Accreditation (EA) shall be responsible for managing the peer assessment which monitors the responsibilities and functioning of the national accreditation bodies. Through this peer evaluation system, the EA contributes to the quality of the services provided by national accreditation bodies and therefore to the mutual acceptance of conformity certificates throughout the EU and the rest of the world.

Market surveillance

Member States guarantee effective surveillance of their market. They are required to organise and carry out close monitoring so that the products covered by Community harmonisation legislation meet the requirements for protection of public interests such as health or safety.

The competent market surveillance authorities in each Member State monitor products on the Community market. They are responsible for:

monitoring compliance with product safety requirements;
following up complaints or reports on product-related risks;
monitoring accidents and damage to health suspected to have been caused by these products;
verifying corrective action has been taken;
following up and updating scientific and technical knowledge concerning safety issues;
following up on the notification of dangerous products on RAPEX.

The Member States must cooperate with each other and ensure that information is exchanged between them and the Commission and the relevant Community agencies.

Market surveillance authorities must perform appropriate checks on the characteristics of products – through documentary, physical and laboratory checks – and may require economic operators to make available the necessary information and enter their premises to better perform, totally independently, their surveillance task.

If the authorities identify a product as presenting a risk, they shall alert users by taking the appropriate measures. If it presents a serious risk Member States ensure that:

the product details are changed on RAPEX;
the product is recalled or withdrawn;
the product is modified and the risk removed.

In cases of risk, Member States must inform the economic operator in question and the Commission of their decision without delay, stating precisely the reasons for this.

Where controls on products entering the Community market are concerned, the Member States provide their customs authorities with all the means necessary to ensure that the appropriate checks are carried out on the product’s safety before it is released for free circulation. In the event of serious danger, assumed or actual, or in the absence of the necessary accompanying documents, the customs authorities must suspend release for free circulation of the product in question.
The market surveillance authorities and the customs authorities cooperate to ensure effective control of product safety.

Certain activities planned for the application of this Regulation may be financed by the Union.

This Regulation repeals Regulation (EC) No 339/93 as of 1 January 2010.

Reference

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 765/2008	2.9.2008	–	OJ L 218 of 13.8.2008

Related Act

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (Text with EEA relevance) [OJ L 218 of 13.8.2008].

Construction

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Construction

Outline of the Community (European Union) legislation about Construction

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Construction

Construction

Construction is one of the most important productive sectors in the European Union and one of the main driving forces of economic development. This sector, which covers both buildings and civil engineering works (such as roads, bridges, railways, etc.), is at the top of the list of industrial sectors in terms of employment, creating jobs both directly and indirectly.
The European Union has embarked on the harmonisation of European standards concerning construction products, on the one hand, and placed the emphasis on the environmental aspects linked to the sector, on the other.

Construction products

Construction products

ENERGY EFFICIENCY

Energy performance of buildings

THE IMPACT OF CONSTRUCTION MACHINES

Noise emission by equipment used outdoors
Fire safety in existing hotels

BUILDING EQUIPMENT

Lifts
Hot-water boilers
Appliances burning gaseous fuels
Ecodesign requirements for fluorescent lamps, for high intensity discharge lamps, and for their ballasts
Electrical equipment designed for use within certain voltage limits

THE HEALTH AND SAFETY OF WORKERS

Protection of workers exposed to asbestos
Exposure to asbestos
Temporary and mobile work sites
Exposure to mechanical vibration
Exposure to noise
Exposure to electromagnetic fields
Exposure to artificial optical radiation

Chemical products

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Chemical products

Outline of the Community (European Union) legislation about Chemical products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Chemical products

The action undertaken by the European Community in the field of chemical products is part of an ongoing process launched a long time ago. The first Directive, which is concerned with the classification, packaging and labelling of dangerous substances, dates back to 1967. The REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) Regulation, adopted at the end of 2006, establishes an enhanced framework which aims to guarantee the free movement of chemical products and the protection of human health and the environment.

DANGEROUS SUBSTANCES AND PREPARATIONS

Regulatory framework for the management of chemicals (REACH), European Chemicals Agency
Classification, packaging and labeling of chemicals and their mixtures
Classification, packaging and labelling of dangerous substances
Classification, packaging and labelling of dangerous preparations
International trade in hazardous chemicals
The Rotterdam Convention on the international trade in hazardous chemicals
Detergents
Community strategy for endocrine disrupters
Community strategy concerning mercury
Export and storage of mercury

PESTICIDES

Biocides
Biocides (until 1 September 2013)
Towards a thematic strategy on the sustainable use of pesticides

FERTILISERS

Fertilisers

CONTROL OF THE RISKS

Major accidents involving dangerous substances
The fight against bioterrorism (communication)
Good laboratory practice: tests on chemical substances
Good laboratory practice: inspection and verification of laboratory studies on all chemicals
Exposure to chemical agents

MANAGEMENT OF POLLUTANTS AND WASTE

Geneva Convention on Long-Range Transboundary Air Pollution
Stockholm Convention on persistent organic pollutants (POPs)
Controlled management of hazardous waste (until the end of 2010)
Basel Convention
Community strategy for dioxins, furans and PCBs
Disposal of polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs)