Tag Archives: Technical regulations

Petrol vapour recovery during refuelling of vehicles

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Petrol vapour recovery during refuelling of vehicles

Outline of the Community (European Union) legislation about Petrol vapour recovery during refuelling of vehicles

Topics

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

Environment > Air pollution

Petrol vapour recovery during refuelling of vehicles

Document or Iniciative

Directive 2009/126/EC of the European Parliament and of the Council of 21 October 2009 on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations.

Summary

This Directive aims at ensuring that harmful petrol vapour displaced from the fuel tank of a motor vehicle during refuelling at a service station is recovered. The petrol pumps of many service stations in the European Union (EU) will have to be equipped to recover this vapour.

Service stations

This Directive applies to new service stations or those having undergone major refurbishment, of which the annual throughput must be in excess of 500 m3 of petrol. It imposes upon operators of these service stations an obligation to install a Stage II Petrol Vapour Recovery system or “Stage II PVR”. Furthermore, service stations with a throughput in excess of 100 m3 per year which are located under living accommodation must also install this equipment.

Larger existing service stations with a throughput in excess of 3 000 m3 per year must also apply Stage II PVR by 2018.

Stage II PVR equipment has already been installed in service stations in almost 50 % of the Member States. This Directive extends this practice to the whole European Union.

Minimum level of petrol vapour recovery

The Stage II PVR equipment installed on petrol pumps in service stations must capture 85 % of petrol vapour. The petrol vapour capture efficiency of such systems must be certified by the manufacturer in accordance with the relevant European technical standards or type approval procedures or, if there are no such standards or procedures, with any relevant national standard.

Stage II PVR equipment draws off petrol vapour. It is then transferred to a storage tank at the service station. The vapour/petrol ratio shall be equal to or greater than 0.95 but less than or equal to 1.05.

Periodic checks

The petrol vapour capture efficiency of Stage II petrol vapour recovery systems must be tested at least once a year. This test may be carried out either by checking the vapour/petrol ratio defined above under simulated petrol flow conditions, or by any other appropriate methodology.

If the service station has automatic monitoring equipment, capture efficiency shall be tested at least once every three years. If the tests detect anomalies, the service station operator must rectify the fault within seven days.

Consumer information

All service stations which have installed Stage II petrol vapour recovery systems must inform consumers thereof. In order to do this, the operator may place a sign, sticker or other notification on, or in the vicinity of, the petrol dispenser.

Context

This Directive comes under the Sixth Environment Action Programme adopted in July 2002 which established the need to reduce air pollution to levels which minimise harmful effects on human health and the environment.

This Directive supplements the technical specifications for the storage of petrol. These technical specifications are harmonised at European level by Directive 94/63/EC which forms Stage I of petrol vapour recovery.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2009/126/EC

31.10.2009

1.1.2012

OJ L 285 of 31.10.2009

Interoperability of the rail system within the EU

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Interoperability of the rail system within the EU

Outline of the Community (European Union) legislation about Interoperability of the rail system within the EU

Topics

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

Regional policy > Management of regional policy > Trans-european networks

Interoperability of the rail system within the EU

Document or Iniciative

Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (Text with EEA relevance).

Summary

This directive establishes the conditions to be fulfilled to achieve interoperability * within the EU rail system at the design, construction, placing into service, upgrading, renewal, operation and maintenance stages. Its provisions comply with Directive 2004/45/EC on railway safety and the health and safety of workers.

The gradual implementation of interoperability of the rail system is pursued through the harmonisation of technical standards. Thus this directive covers:

  • essential requirements with regard to safety, reliability, human health, environmental protection, technical compatibility and operation of the system (Annex III);
  • the technical specifications for interoperability (TSIs) adopted for each subsystem or part of subsystem pursuant to this directive;
  • the corresponding European specifications.

The railway network * is broken down into subsystems of a structural nature (energy, control-command and signalling, rolling stock) or functional (operation and traffic management, maintenance and telematics applications). European Union (EU) countries may request that the Commission grant derogations and the Commission may decide to exclude certain measures from the scope of the directive for specific cases and for a set period *.

TSI projects shall be prepared by the European railway agency which will examine the subsystems in consultation with associations and the social partners. Next, the projects shall be submitted to the European Commission which will modify and adopt them, having regard to the right of scrutiny of the Parliament.

Interoperability constituents
* shall be subject to European specifications (such as European standards). They shall be subject to the procedure for “EC” declaration of conformity or suitability for use.

Authorisations for placing in service of vehicles shall be granted by the national safety authorities responsible for each network.

Context

This Directive is a recast of Directive 2001/16/EC applicable to the conventional rail system and Directive 96/48/EC on the trans-European high-speed rail system.

The pursuit of technical harmonisation aims at developing transport services in the EU and with third countries. It facilitates the integration of the market in equipment and services for the construction, renewal and operation of the rail system.

Key terms used in the Act
  • Interoperability: the ability of a rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance for these lines. This ability depends on all the regulatory, technical and operational conditions which must be met in order to satisfy the essential requirements.
  • Network: the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the rail system.
  • Specific case: any part of the rail system which needs special provisions in the TSIs (temporary or definitive) because of geographical, topographical or urban environment constraints or those affecting compatibility with the existing system. This may include in particular railway lines and networks isolated from the rest of the Community, the loading gauge, the track gauge or space between the tracks and vehicles strictly intended for local, regional or historical use, as well as vehicles originating from or destined for third countries.
  • Interoperability constituents: any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem. The concept covers both tangible objects and intangible objects (such as software).

References

Act Entry into force Transposition in the Member States Official Journal
Directive 2008/57/EC

19.7.2008

19.7.2010

OJ L 191 of 18.7.2008

Subsequent amendments and corrections to Directive 2008/57/EC have been incorporated into the basic text. This consolidated version is for reference purposes only.

Related Acts

Commission Regulation (EU) No 201/2011 of 1 March 2011 on the model of declaration of conformity to an authorised type of railway vehicle [Official Journal L 57 of 2.3.2011].

Commission Decision 2009/107/EC of 23 January 2009 amending Decisions 2006/861/EC and 2006/920/EC concerning technical specifications of interoperability relating to subsystems of the trans-European conventional rail system [notified under number C(2009) 38] (Text with EEA relevance) [Official Journal L 45 of 14.2.2009].

Compulsory fitting of safety belts

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Compulsory fitting of safety belts

Outline of the Community (European Union) legislation about Compulsory fitting of safety belts

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 implications of road safety

Compulsory fitting of safety belts

Acts

Directive 2005/39/EC of the European Parliament and of the Council of 7 September 2005 amending Council Directive 74/408/EEC relating to motor vehicles with regard to the seats, their anchorages and head restraints.

Directive 2005/40/EC of the European Parliament and of the Council of 7 September 2005 amending Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles.

Directive 2005/41/EC of the European Parliament and of the Council of 7 September 2005 amending Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts.

Summary

The three Directives make it compulsory to fit safety belts in all vehicles, thereby improving their passive safety.

Fitting and use of safety belts

As many vehicles as possible must be fitted with safety belts in order to ensure the optimum effectiveness of the measures relating to the compulsory use of belts fitted in vehicles, an obligation imposed by Directive 91/671/EEC, as amended by Directive 2003/20/EC.

Failure to use the safety belt is the second-biggest cause of deaths, after non-observance of speed limits and before drunken driving. The obligations to fit and use safety belts will bring about a substantial improvement in road safety within the European Union and a reduction in the number of victims of road accidents.

Scope

The obligation to fit safety belts, initially relating to cars, is henceforth extended to all categories of vehicles and therefore to all commercial vehicles, particularly coaches and minibuses. The compulsory fitting of safety belts in coaches in particular is intended to prevent the risks of passengers being thrown out when coaches overturn after leaving the road, which is the most frequent accident for this type of vehicles.

Technical requirements

The three Directives establish a uniform legal framework for manufacturers by defining the technical requirements which motor vehicles must meet with regard to:

  • seats, seat anchorages and head restraints (Directive 2005/39/EC amending Directive 74/408/EEC);
  • safety belts and restraint systems (Directive 2005/40/EC amending Directive 77/541/EEC);
  • safety-belt anchorages (Directive 2005/41/EC amending Directive 76/115/EEC).

Timetable

The provisions of the three Directives apply, from 20 October 2006, to the new types of vehicles and will be extended, from 20 October 2007, to vehicles of the type already in production.

Safety belts for disabled persons

Technical standards relating to safety belts for disabled persons will be drawn up in the near future in order to ensure a level of safety equivalent to that laid down by the present Directives.

Context

The obligations relating to the fitting and use of safety belts help to achieve the objective, set by the European Commission in its European Action Programme for Road Safety of reducing the number of victims of road accidents by half by 2010.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 2005/39/EC 20.10.2005 20.04.2006 OJ L 255 of 30.09.2005
Directive 2005/40/EC 20.10.2005 20.04.2006 OJ L 255 of 30.09.2005
Directive 2005/41/EC 20.10.2005 20.04.2006 OJ L 255 of 30.09.2005

Related Acts

Council Directive 91/671/EEC of 16 December 1991 on the approximation of the laws of the Member States relating to compulsory use of safety belts in vehicles of less than 3.5 tonnes [OJ L 373 of 31.12.1991];

Directive 2003/20/EC of the European Parliament and of the Council of 8 April 2003 amending Directive 91/671/EEC [OJ L 115 of 09.05.2003].

The obligation to use the safety belt when the vehicle is in motion is extended to all categories of vehicles and to all seats fitted with one (Directive 2003/20/EC). It related initially only to vehicles of less than 3.5 tonnes fitted with restraint systems and, for certain vehicles (coaches, light goods vehicles), did not apply to the back seats (Directive 91/671/EEC).

The use of restraint systems specially adapted to the size and weight of children also becomes compulsory (Directive 2003/20/EC). Research has emphasised that the use of restraint systems for children can help to attenuate considerably the seriousness of injuries in the event of an accident. Children were initially authorised to travel without being restrained by an appropriate device if one was not available (Directive 91/671/EEC).

Certain exemptions may be granted, particularly in order to allow certain professional activities to be carried out efficiently, to ensure the proper functioning of activities relating to law-and-order, safety or emergency services, or to take account of the special conditions in certain types of transport.

These new provisions come into force in the Member States from 9 May 2006.

 

Motor vehicles and their trailers: roadworthiness test

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Motor vehicles and their trailers: roadworthiness test

Outline of the Community (European Union) legislation about Motor vehicles and their trailers: roadworthiness test

Topics

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

Transport > Road transport

Motor vehicles and their trailers: roadworthiness test

Document or Iniciative

Directive 2009/40/EC of the European Parliament and of the Council of 6 May 2009 on roadworthiness tests for motor vehicles and their trailers (Recast).

Summary

Motor vehicles registered in a European Union (EU) country and their trailers must undergo periodic roadworthiness tests. Annexes I and II to this directive detail the categories of vehicles to be tested, the frequency of the roadworthiness tests and the items which must be tested. The roadworthiness tests must be undertaken by the EU countries, or by a public body that has been entrusted with the task, or by bodies or establishments designated and directly supervised.

Annex I details the categories of motor vehicles that will be subject to roadworthiness tests and the required frequency of the tests for each category. The minimum testing frequency for the different categories of motor vehicles and their trailers is:

  • One year after the date on which the vehicle was first used, and thereafter annually for:
    • motor vehicles used for the carriage of passengers and with more than eight seats, excluding the driver’s seat;
    • motor vehicles used for the carriage of goods and having a maximum permissible mass exceeding 3 500 kg;
    • trailers and semi-trailers with a maximum permissible mass exceeding 3 500 kg;
    • taxis, ambulances;
  • Four years after the date on which the vehicle was first used, and thereafter every two years for:
    • motor vehicles having at least four wheels, normally used for the road carriage of goods and with a maximum permissible mass not exceeding 3 500 kg, excluding agricultural tractors and machinery;
    • motor vehicles having at least four wheels, used for the carriage of passengers and with not more than eight seats excluding the driver’s seat.

Annex II sets out which items must be compulsorily tested. The tests covered by Annex II should be undertaken using techniques and equipment available without the use of tools to disassemble or remove any part of the vehicle. Where the motor vehicle is found to be defective with regard to the test items below, the competent authority in the EU country concerned must set specific conditions under which the particular vehicle may be used before passing another roadworthiness test. The test must cover the items listed in the annex, provided that these are related to the equipment of the vehicle being tested in the EU country concerned. The compulsory test items include:

  • vehicle identification;
  • braking equipment;
  • steering;
  • visibility;
  • lighting equipment and parts of electric system;
  • axles, wheels, tyres and suspension;
  • chassis and chassis attachments;
  • other equipment – safety belts, fire extinguisher, locks and anti-theft device, warning triangle, first-aid kit, speedometer, etc;
  • nuisance – noise, exhaust emissions, etc;
  • supplementary tests for public transport vehicles – emergency exit(s), heating and ventilation systems, seat layout, interior lighting;

The vehicle operator or driver must be informed in writing of any defects, the result of the test and the legal consequences. EU countries will take the necessary measures to make it possible to prove that a vehicle has passed a roadworthiness test. Other EU countries and the Commission will be informed of these measures. All EU countries will mutually recognise the proof issued in another EU country showing that a vehicle registered in that other EU country, together with its trailer or semi-trailer, has passed a roadworthiness test in compliance with the provisions of this directive. EU countries will also implement all appropriate measures to establish that the brake performance of motor vehicles registered in their country complies with the requirements of this directive.

Exceptions

Notwithstanding the provisions of Annexes I and II, EU countries have the right to:

  • bring forward the date for the first compulsory roadworthiness test and, where appropriate, require the vehicle to be submitted for test prior to registration;
  • shorten the interval between two successive compulsory tests;
  • make the testing of optional equipment compulsory;
  • increase the number of items to be tested;
  • extend the periodic test requirement to other categories of vehicles;
  • prescribe special additional tests;
  • require vehicles registered on their territory to have higher minimum standards for braking efficiency than those specified in Annex II and include a test on vehicles with heavier loads, provided such requirements do not exceed those of the vehicle’s original type-approval.

EU countries also have the right to exclude vehicles belonging to the armed forces, the forces of law and order and the fire service from the scope of this directive. After consultation with the Commission, EU countries may exclude from the requirements of this directive certain motor vehicles operated or used in exceptional conditions, and motor vehicles which are never, or hardly ever, used on public highways. Following consultation with the Commission, EU countries also have the right to set their own testing standards for vehicles considered to be of historic interest.

The Commission will adopt all necessary directives to define the minimum standards and methods for testing the items listed in Annex II of this directive, as well as any amendments necessary to adapt to technical progress in these areas.

Within three years from the introduction of regular testing of speed limitation devices, the Commission will re-examine whether the tests laid down are sufficient to detect defective or manipulated speed limitation devices or whether the rules need to be modified.

This directive repeals Directive 96/96/EC.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/40/EC

26.6.2009

–

OJ L 141 of 6.6.2009

Successive amendments and corrections to Directive 2009/40/EC have been incorporated in the basic text. This consolidated versionis for reference purposes only.

Related Acts

Commission Recommendation 2010/378/EU of 5 July 2010 on the assessment of defects during roadworthiness testing in accordance with Directive 2009/40/EC of the European Parliament and of the Council on roadworthiness tests for motor vehicles and their trailers [Official Journal L 173 of 8.7.2010].

Railway safety

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Railway safety

Outline of the Community (European Union) legislation about Railway safety

Topics

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

Transport > Rail transport

Railway safety

Document or Iniciative

Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification [See amending act(s)].

Summary

The Directive applies to the railway system of the Member States and covers safety requirements for the system as a whole, including infrastructure and traffic management, and the interaction between railway undertakings and infrastructure managers.

In this connection, the Directive focuses on four major aspects:

  • the setting up, in each Member State, of an authority responsible for supervising safety;
  • the mutual recognition of safety certificates delivered in the Member States;
  • the establishment of common safety indicators (CSIs) in order to assess that the system complies with the common safety targets (CSTs) and facilitate the monitoring of railway safety performance;
  • the definition of common rules for safety investigations.

Development and management of safety

Safety rules and standards, such as operating rules, signalling rules, requirements on staff and technical requirements applicable to rolling stock have been devised mainly nationally.

These national safety rules, should gradually be replaced by rules based on common standards, established by technical specifications for interoperability (TSIs). The Commission has the power to suspend the implementation of a national safety rule for a maximum of six months.

In this connection, the Member States will ensure that:

  • railway safety is generally maintained and continuously improved, taking into consideration the development of European legislation;
  • safety rules are laid down, applied and enforced in an open and non-discriminatory manner;
  • responsibility for the safe operation of the railway system and the control of risks associated with it is borne by the infrastructure managers and railway undertakings;
  • information is collected on common safety indicators through annual reports in order to assess the achievement of the CSTs and monitor the general development of railway safety.

In order to coordinate the different rules, a distinction must be drawn between two sets of actors:

  • infrastructure managers, which are bodies or companies responsible, in particular for establishing, building and maintaining infrastructure or a part of it, and safety. In some Member States, however, safety may be delegated to railway undertakings.
  • Railway undertakings, which are public or private undertakings engaged in the supply of goods and/or passenger transport services by rail.

Safety certification

In order to be granted access to the railway infrastructure, a railway undertaking must hold a safety certificate. This safety certificate may cover the whole railway network of a Member State or only a defined part thereof.

For international transport services it should be enough to approve the safety management system in one Member State and give the approval European validity.

Adherence to national laws on the other hands should be subject to additional certification in each Member State.

The safety certificate must be renewed upon application by the railway undertaking at intervals not exceeding five years. It must be wholly or partly updated whenever the type or extent of the operation is substantially altered.

A railway undertaking applying for authorisation to place rolling stock in service in another Member State will submit a technical file concerning the rolling stock or type of rolling stock to the relevant safety authority, indicating its intended use on the network.

In addition to the safety requirements laid down in the certificate, licensed railway undertakings must comply with national requirements, compatible with European law and applied in a non-discriminatory manner, relating to health, safety and social conditions, including legal provisions relating to driving time, and the rights of workers and consumers.

An essential aspect of safety is the training and certification of staff, particularly of train drivers. The training covers operating rules, the signalling system, the knowledge of routes and emergency procedures.

Maintenance of vehicles

Before it is placed in service or used on the network, each vehicle is assigned a maintenance entity (which may be, in particular, a railway undertaking or an infrastructure manager). The entity ensures the working order of vehicles by introducing a system of maintenance in accordance with the vehicle’s maintenance book and the applicable safety requirements.

National safety authority

Each Member State must establish a safety authority which is independent from railway undertakings, infrastructure managers, applicants for certificates and procurement entities. It will respond promptly to requests and applications, communicate its requests for information without delay and adopt all its decisions within four months after all requested information has been provided.

The safety authority will carry out all inspections and investigations that are needed for the accomplishment of its tasks and be granted access to all relevant documents and to premises, installations and equipment of infrastructure managers and railway undertakings.

Accident and incident investigations

Serious train accidents, such as derailments and collisions with fatal consequences, occur rarely, but when they do they attract public interest and the interest of safety professionals all over Europe.

Criteria governing the independence of the investigating body are strictly defined so that this body has no link with the various actors of the sector. This body decides whether or not an investigation of such an accident or incident should be undertaken, and determines the extent of investigations and the procedure to be followed.

Each Member State must ensure that investigations of accidents and incidents are conducted by a permanent body, which comprises at least one investigator able to perform the function of investigator–in–charge in the event of an accident or incident.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2004/49/EC

30.4.2004

30.4.2006

OJ L 164 of 30.4.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2008/110/EC

24.12.2008

24.12.2010

OJ L 345 of 23.12.2008

The successive amendments and corrigenda to Directive 2004/49/CE been incorporated into the original text. This consolidated versionis of mere documentary value.

RELATED ACTS

Directive 2008/57/EC of 17 June 2008 of the European Parliament and of the Council on the interoperability of the rail system within the Community (Text with EEA relevance).
This Directive lays down the provisions relating to authorisations for placing in service of railway vehicles. This text recasts Directive 2001/16/EC on the interoperability of the trans-European conventional rail system and Directive 96/48/EC on the interoperability of the trans-European high speed rail system.
The procedures for authorisations for placing in service were previously regulated by Directive 96/48/EC (for the new or renewed parts of the rail system) and by Directive 2004/49/EC (concerning vehicles already in service).

Commission Regulation (EC) 653/2007 of 13 June 2007 on the use of a common European format for safety certificates and application documents in accordance with Article 10 of Directive 2004/49/EC of the European Parliament and of the Council and on the validity of safety certificates delivered under Directive 2001/14/EC (Text with EEA relevance).

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (Text with EEA relevance).

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

Non-road mobile machinery: gaseous pollutants

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Non-road mobile machinery: gaseous pollutants

Outline of the Community (European Union) legislation about Non-road mobile machinery: gaseous pollutants

Topics

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

Environment > Air pollution

Non-road mobile machinery: gaseous pollutants

Document or Iniciative

Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery [See amending act(s)].

Summary

The purpose of this Directive is to approximate the laws of the Member States with regard to:

  • emission standards;
  • type-approval procedures for engines intended to be fitted to non-road mobile machinery.

For the purposes of the Directive:

  • “non-road mobile machinery” means any mobile machine, transportable industrial equipment or vehicle with or without bodywork that is not intended to be used to carry goods or passengers on the road, in which an internal combustion engine as specified in Annex I, Section 1 is installed, for example excavators and other construction equipment. This definition to cover locomotives and inland waterway vessels has been extended by Directive 2004/26/EC (see below);
  • “type approval” means the procedure whereby a Member State certifies that an internal combustion engine type or engine family meets the relevant technical requirements of the Directive with regard to its level of emission of gaseous and particulate pollutants;
  • “engine type” means a category of engines which do not differ in such essential engine characteristics as specified in Annex II, Appendix 1);
  • “engine family” means a manufacturer’s range of engines which, as a result of their design, are expected to have similar exhaust-emission characteristics and which comply with the requirements of the Directive.

This Directive applies to compression ignition engines (diesel) and to positive-ignition engines (petrol) which are used in non-road mobile machinery, including locomotives and inland navigation vessels.

Type-approval procedure for engine types or families:

  • any application for type approval must be submitted by the manufacturer to the approval authority in a Member State. The application should be accompanied by a manufacturer’s information folder (cf. Annex II) [no application in respect of one engine type or engine family may be submitted to more than one Member State (Article 3)];
  • the Member State receiving the application must grant type approval to all engine types or engine families which conform to the particulars in the information folder and which meet the requirements of Directive 97/68/EC;
  • an approval certificate must be issued for each engine type or family that has been approved;
  • each month, the competent authorities in each Member State must send to their counterparts in the other Member States a list of the type approvals by type or family of engine which they have granted, refused or withdrawn during the month in question (Article 4);
  • any request for amendment or extension of a type approval is to be submitted exclusively to the Member State which carried out the original type approval (Article 5).

The manufacturer must affix the following marks to each unit manufactured:

  • the trade name or name of the engine’s manufacturer;
  • the engine type and family, together with an individual engine identification number;
  • the type approval number.

Member States may not refuse the registration or placing on the market of new engines which meet the requirements of the Directive (Article 8).

Since 30 June 1998 Member States may not refuse to type approve an engine type or family, and may not impose additional approval requirements relating to pollutant emissions if the engine in question meets the conditions laid down in the Directive (Article 9).

The provisions of Article 8 and 9 do not apply:

  • to engines used by the armed forces;
  • to engines taken from stocks of end-of-line engines or non-road mobile machinery covered by an exemption under Article 10(2).

Member States are required to provide the Commission with a list of the exemptions granted and the reasons given.

Member States must guarantee that conformity of production is checked effectively before type approval is granted (Article 11).

Engines not meeting the conditions set out in the approval certificate are considered not to conform to the type or family that has been approved. The Member State conducting type approval must take any action needed to ensure that engines in production conform.

The names and addresses of the type approval authorities and of the testing services responsible for matters arising from Directive 97/68/EC must be sent to the Commission and to the other Member States (Article 16).

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 97/68/EC

19.3.1998

30.6.1998

OJ L 59 of 27.2.1998
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 2001/63/EC

12.9.2001

30.6.2002

OJ L 227 of 23.8.2001

Directive 2002/88/EC

11.2.2003

11.8.2004

OJ L 35 of 11.2.2003

Directive 2004/26/EC

20.5.2004

30.4.2005

OJ L 146 of 30.4.2004

Directive 2006/105/EC

1.1.2007

1.1.2007

OJ L 363 of 20.12.2006

Regulation (EC) No 596/2009

7.8.2009

–

OJ L 188 of 18.7.2009

Directive 2010/26/EU

1.4.2010

31.3.2011

OJ L 86 of 1.4.2010

Directive 2010/88/EU

16.11.2012

24.11.2012

OJ L 305 of 23.11.2011

The successive amendments and corrections to Directive 97/68/EC have been incorporated in the original text. This consolidated versionis of documentary value only.

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

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

Outline of the Community (European Union) legislation about Procedures for the registration of motor vehicles originating in another Member State

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

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

Document or Iniciative

Communication from the Commission – Interpretative communication of 14 February 2007 on procedures for the registration of motor vehicles originating in another Member State [SEC(2007) 169 final – Official Journal C 68 of 24.3.2007]

Summary

Even though buying or transferring vehicles to another Member State has become increasingly simple, many citizens and enterprises still shy away from paperwork, extra costs and burdensome procedures. For all that, it has become easier to buy a vehicle in another Member State thanks to the introduction of the following:

  • EC type-approval system for whole vehicles;
  • regulation of distribution and after-sales service of vehicles;
  • harmonised registration certificate for vehicles.

This Communication is part of the new impetus for trade in goods in the European Union (EU). It lists the legislation on the registration of vehicles originating in another Member State and on transfer of registration between Member States. It also contains a commitment to draw up an explanatory guide and to assist the national authorities in optimum application of Community law.

REGISTERING A MOTOR VEHICLE IN THE MEMBER STATE OF RESIDENCE

Registration is the natural corollary of the exercise of the powers of taxation on vehicles. Private individuals must register their vehicles in the Member State of their normal residence, i.e. where the permanent centre of their interests is located.

  • Approval of the technical characteristics of the vehicle

Approval of the technical characteristics of the vehicle takes the form of either EC type-approval or national approval.

Valid in all Member States, EC type-approval is the procedure by which a Member State certifies that a type of vehicle complies with the European safety and environmental protection standards. Cars approved since 1996, motorcycles approved since May 2003 and tractors approved since 2005 are subject to this procedure.

Once in possession of EC approval, the manufacturer issues an EC certificate of conformity. This certificate shows that the vehicle has been manufactured in conformity with the approved vehicle type. It must accompany each new EC type-approved vehicle.

Vehicles that are not EC-approved may be subject to national approval in the receiving Member State before they can be registered. This national approval may be either individual (in particular for vehicles imported individually from third countries) or type (for a category of vehicle).

National type and individual approval procedures fall outside the scope of Community law. On the other hand, national approval procedures for motor vehicles which have already obtained a national approval in another Member State and for motor vehicles that were already registered in another Member State, must comply with the rules of the free movement of goods.

It is appropriate for the competent national authorities to:

  • take into account the tests and certificates issued by their counterparts and by the manufacturer;
  • refuse to approve a vehicle which poses a genuine risk to public health;
  • carry out tests if they enable further information to be obtained;
  • determine on which points the vehicle is not in conformity with the requirements;
  • apply proportionate national technical criteria.

The technical characteristics of a vehicle previously approved and registered in another Member State are assessed in the light of the technical rules in force in the receiving Member State, on the basis of the rules which were in force at the moment of approval in the Member State of origin.

  • Roadworthiness testing of used vehicles

The objective of roadworthiness testing is to verify that the vehicle is suitable for use on public roads. This type of testing may be carried out if it is based on objective, non-discriminatory criteria which are known in advance, if it does not duplicate controls which have already been carried out and if it is readily accessible and can be completed within a reasonable time.

  • Vehicle registration

By registering the motor vehicle, the Member State authorises its entry into service in road traffic, involving the identification of the motor vehicle and the issuing of a registration number.

On first registration, the receiving Member State may require data from the person concerned and the EC certificate of conformity of a new EC-approved vehicle if it originates from another Member State. On the other hand, for non-EC-approved vehicles, it may request presentation of the national type-approval or individual approval and proof of insurance cover. Member States are also entitled to check, at the moment of registration, whether VAT has been correctly paid.

For vehicles previously registered in another Member State, the receiving country may only request: the roadworthiness certificate, the EC or national certificate of conformity, the original or a copy of the non-harmonised registration certificate issued in another Member State, the harmonised registration certificate, the insurance certificate and proof of payment of the VAT.

TRANSFERRING A VEHICLE TO ANOTHER MEMBER STATE

As a general rule, a motor vehicle cannot be driven on public roads without displaying a registration number. In addition, civil liability must be covered by insurance and it is advisable for motorists to have the “green card” with them.

The vehicle licence plate is equivalent to an insurance certificate. This allows vehicles with a European licence plate to circulate freely in the EU without any checks of the compulsory motor liability insurance certificate at the borders.

To drive a motor vehicle lawfully to the Member State of destination, either the motor vehicle carries a professional registration plate or a temporary registration plate.

  • Driving the motor vehicle with professional number plates

Professional number plates allow retailers to drive vehicles temporarily without being obliged to formally register them. Member States usually provide a document establishing the link between the registration plates and their holder and/or require the holder to keep a logbook.

  • The motor vehicle carries a temporary registration plate

The system of temporary registration enables the motor vehicle to be driven for a short period before it obtains final registration. A Member State may impede its circulation for reasons relating to road safety, theft or invalidity of the certificate.

Insurance must be taken out in the Member State of destination.

SCOPE

This Communication applies to the first registration of vehicles, as well as the registration of vehicles previously registered in another Member State, regardless of whether they are new or used.

A vehicle is “previously registered in another Member State” when it has obtained the administrative authorisation for the entry into service in road traffic, involving its identification and the issuing of a registration number.

REMEDIES

Any decision taken by authorities refusing the type-approval or registration must be notified to the vehicle owner, informing him of the remedies available to him and of the time limits allowed.

Citizens and enterprises may also seek a solution for approval or registration problems through the SOLVIT network or by making a complaint to the Commission, which may then initiate infringement proceedings.

Related Acts

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

National technical regulations and free movement of goods

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National technical regulations and free movement of goods

Outline of the Community (European Union) legislation about National technical regulations and free movement of 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

National technical regulations and free movement of goods

Document or Iniciative

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.

Summary

The objective of this Regulation is to improve the free movement of goods in the Community. It establishes rules and procedures which should be followed by the authorities of Member States when they take or intend to take a decision which could hinder the free movement of a product lawfully marketed in another Member State and not covered by harmonised rules at Community level. It shall apply from 13 May 2009.

Scope

This Regulation shall apply to administrative decisions based on a technical rule which has the direct or indirect effect of:

  • the prohibition of the placing on the market of a product;
  • the modification or additional testing of that product before it can be placed on the
  • market;
  • the withdrawal of that product.

This Regulation does not apply to:

  • judicial decisions;
  • systems covered by Directives 96/48/EC and 2001/16/EC;
  • the procedure for authorisation of the placing in service of rolling stock provided for in Directive 2004/49/EC;
  • certain measures related to products posing a serious risk detailed in Directive 2001/95/EC;
  • certain measures related to food posing a risk taken under Regulations 178/2002 and 882/2004.

Procedures

This Regulation frames the assessment of product conformity with national technical rules. Competent authorities in the Member States must comply with the rules and procedures on:

  • gathering information on the product concerned;
  • the recognition of certificates or test reports issued by an accredited conformity-assessment body in accordance with Regulation No 765/2008: Member States cannot reject certificates or test reports on grounds related to the competency of that body;
  • an evaluation of the need to apply a technical rule: the decision should be based on technical or scientific elements proving the proportionality of the envisaged measure, should be notified to the enterprise concerned and can be legally challenged;
  • the temporary suspension of the marketing of a product: this is forbidden during the evaluation procedure, except in cases where the product poses a serious risk or is prohibited in a Member State on grounds of public morality or public security.

Product Contact Points

Each Member State shall designate one or more Product Contact Points in their territories and shall communicate their contact details to the Commission and to the other Member States. The task of the Product Contact Points is to provide information on the technical rules applicable in the territory in which they are established, on the contact details of the competent authorities and on the remedies available.

Reports

Each Member State shall send the Commission on a yearly basis a report on the application of this Regulation. The Commission shall review the application of this Regulation every five years and shall publish a list of products which are not subject to Community harmonisation legislation.

Context

This Regulation repeals and replaces Decision 3052/95/EC establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community, effective from 13 May 2009. This Act forms part of the strategy framework for a single market in the 21st century.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 764/2008 2.9.2008 – OJ L 218 of 13.8.2008