Tag Archives: Safety standard

Transfer of cargo and passenger ships between registers within the EU

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Transfer of cargo and passenger ships between registers within the EU

Outline of the Community (European Union) legislation about Transfer of cargo and passenger ships between registers within the EU

Topics

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

Transport > Waterborne transport

Transfer of cargo and passenger ships between registers within the EU

Document or Iniciative

Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer of cargo and passenger ships between registers within the Community and repealing Council Regulation (EEC) No 613/91 [See amending act(s)].

Summary

The purpose of the regulation is to eliminate the technical barriers to the transfer of cargo and passenger ships flying the flag of a European Union (EU) country between the registers of EU countries while ensuring a high level of ship safety and environmental protection, in compliance with international conventions.

Scope

The regulation applies to passenger ships built on or after 1 July 1998 and cargo ships built on or after 25 May 1980 or ships that were built before those dates but have been certified as complying with the relevant European and the International Maritime Organization (IMO) regulations.

However, the regulation does not apply to:

  • ships delivered after completion of their construction that do not carry valid full-term certificates from the EU country of the losing register;
  • ships that have been refused access to EU countries’ ports in accordance with Directive 95/21/EC during the three years preceding application for registration following inspection in the port of a State signatory of the Paris Memorandum of Understanding of 1982 on Port State Control;
  • ships of war or troopships, or other ships owned or operated by an EU country and used only for government non-commercial purposes;
  • ships not propelled by mechanical means, wooden ships of primitive build, pleasure yachts not engaged in trade or fishing vessels;
  • cargo ships of less than 500 gross tonnage.

Transfer between registers

EU countries will not withhold from registration, for technical reasons arising from the conventions, a ship registered in another EU country which complies with the requirements and carries valid certificates and marine equipment in accordance with Council Directive 96/98/EC.

Upon receiving the request for transfer, the EU country of the losing register will provide the EU country of the receiving register with all relevant information on the ship, in particular on her condition and equipment. This information contains the history file of the vessel, a list of the improvements required by the losing register for registering the ship or renewing her certificates and a list of overdue surveys.

Before registering a ship, the EU country of the receiving register will subject the ship to an inspection to confirm that the actual condition of the ship and her equipment correspond to the certificates.

Certificates

Upon the transfer, the EU country of the receiving register, or the recognised organisation acting on its behalf, will issue certificates to the ship under the same conditions as those issued under the flag of the EU country of the losing register.

At the time of renewal, extension or revision of the certificates, the EU country of the receiving register, or the recognised organisation acting on its behalf, will not impose requirements other than those initially prescribed for the full-term certificates.

Refusal of transfer and interpretation

The EU country of the receiving register will immediately notify the Commission of any refusal to issue, or to authorise the issuing of, new certificates to a ship.

Where an EU country considers that a ship cannot be registered for reasons relating to serious danger to security, safety or to the environment, registration may be suspended.

Reporting

EU countries will submit to the Commission a succinct yearly report on the implementation of the regulation. By 20 May 2008 the Commission will submit a report to the European Parliament and the Council on the implementation of this regulation.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 789/2004

20.05.2004

–

OJ L 138, 30.04.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 219/2009

20.4.2009

–

OJ L 87 of 31.3.2009

Successive amendments and corrections to Regulation (EC) No 789/2004 have been incorporated into the basic text. This consolidated versionis for information only.

Maritime safety: marine equipment

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Maritime safety: marine equipment

Outline of the Community (European Union) legislation about Maritime safety: marine equipment

Topics

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Transport > Waterborne transport

Maritime safety: marine equipment

Document or Iniciative

Council Directive 96/98/EC of 20 December 1996 on marine equipment [See amending acts].

Summary

This Directive applies to equipment (Annex A) * for use:

  • on board a new European * ship, even if it was constructed outside of the EU;
  • on an existing European ship in order to replace equipment or to install additional equipment.

This Directive does not concern equipment placed on board a ship before its entry into force.

Conformity assessment

Member States appoint bodies responsible for assessing conformity of marine equipment (Annex B). This assessment aims at:

  • ensuring the quality of equipment before being placed on the market;
  • checking marine equipment when issuing or renewing the safety certificate.

Equipment conforming to European standards must bear a mark.

Where a vessel, which is to be transferred to the register of a Member State is not registered in the EU, that State carries out an inspection in order to establish the actual condition of the equipment and whether it complies with European standards.

Non-compliant equipment

If a piece of equipment may compromise the health and/or safety of the crew or passengers, or to damage the marine environment, the Member State responsible shall withdraw it from the market, prohibit or restrict its use.

Testing standards

Certain types of marine equipment require international testing standards to be adopted. In cases where international organisations do not adopt the standards within a reasonable timescale, the standards of European standardisation organisations may be applied.

Key terms
  • Marine equipment: any article which could be used on board a vessel, voluntarily or in accordance with international rules, and for which the administration of the flag State must give its authorisation. In particular, this relates to life saving, fire protection, navigation and radiocommunication equipment.
  • European vessel: any vessel for which safety certificates are issued by EU Member States or in their name.

References

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

Directive 96/98/EC

1.1.1999

30.6.1998

OJ L 46, 17.2.1997
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 98/85/EC

28.11.1998

30.4.1999

OJ L 315, 25.11.1998

Directive 2002/84/EC

29.11.2002

23.11.2003

OJ L 324, 29.11.2002

Directive 2008/67/EC

21.7.2008

21.7.2008

OJ L 171, 1.7.2008

Regulation (EC) 596/2009

7.8.2009

–

OJ L 188, 18.7.2009

Successive amendments and corrections to Directive 96/98/EC have been incorporated into the basic text. This consolidated versionis for information only.

Related Acts

Proposal for a directive of the European Parliament and of the Council on marine equipment and repealing Directive 96/98/EC [COM (2012) 772 final – Not published in the Official Journal].

General safety of motor vehicles

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General safety of motor vehicles

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

General safety of motor vehicles

2 emissions.

Document or Iniciative

Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (Text with EEA relevance).

Summary

This Regulation establishes requirements for the type-approval of:

  • the safety of motor vehicles and their trailers;
  • the energy efficiency of motor vehicles by introducing the mandatory installation of tyre pressure monitoring systems and gear shift indicators;
  • the safety and energy efficiency of tyres and their levels of noise emissions.

Types of vehicles concerned

This Regulation applies to:

  • motor vehicles used for the carriage of passengers having at least four wheels (category M);
  • motor vehicles intended for the transportation of goods having at least four wheels (category N);
  • trailers (category O).

Obligations of manufacturers

Manufacturers shall guarantee that new vehicles that are sold, registered or put into service within the European Union (EU) are type-approved in accordance with the provisions of this Regulation.

The Regulation aims at making several UNECE regulations obligatory. Type-approval in accordance with these UNECE regulations shall be considered as EC type-approval.

In order to improve road safety, all vehicles must be equipped with an electronic stability control system. Furthermore, vehicles in categories M2, M3, N2 and N3 must be equipped with an advanced emergency braking system and a lane departure warning system.

Tyres shall satisfy requirements relating to:

  • wet grip;
  • rolling resistance;
  • rolling noise.

In addition, vehicles in category M1 must be equipped with a tyre pressure monitoring system and gear shift indicators.

Obligations of the Member States

Member States shall not grant EC type-approval or national type-approval to vehicles which do not meet the requirements laid down in this Regulation.

Transitional provisions

This Regulation contributes to the simplification of legislation insofar as it repeals a considerable number of basic directives and their amending acts.

This Regulation repeals Directives 70/221/EEC, 70/222/EEC, 70/311/EEC, 70/387/EEC, 70/388/EEC, 71/320/EEC, 72/245/EEC, 74/60/EEC, 74/61/EEC, 74/297/EEC, 74/408/EEC, 74/483/EEC, 75/443/EEC, 76/114/EEC, 76/115/EEC, 76/756/EEC, 76/757/EEC, 76/758/EEC, 76/759/EEC, 76/760/EEC, 76/761/EEC, 76/762/EEC, 77/389/EEC, 77/538/EEC, 77/539/EEC, 77/540/EEC, 77/541/EEC, 77/649/EEC, 78/316/EEC, 78/317/EEC, 78/318/EEC, 78/549/EEC, 78/932/EEC, 89/297/EEC, 91/226/EEC, 92/21/EEC, 92/22/EEC, 92/24/EEC, 92/114/EEC, 94/20/EC, 95/28/EC, 96/27/EC, 96/79/EC, 97/27/EC, 98/91/EC, 2000/40/EC, 2001/56/EC, 2001/85/EC, and 2003/97/EC from 1 November 2014.

It repeals Directive 92/23/EC from 1 November 2017.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 661/2009

20.8.2009

–

OJ L 200 of 31.7.2009

Quality and safety standards for human blood and blood components

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Quality and safety standards for human blood and blood components

Outline of the Community (European Union) legislation about Quality and safety standards for human blood and blood components

Topics

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

Public health > Threats to health

Quality and safety standards for human blood and blood components

Document or Iniciative

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [See amending acts].

Summary

The purpose of this Directive is to set standards of quality and safety for blood * and blood components * throughout the blood transfusion chain. To this end, it applies to the collection and testing of human blood and blood components, irrespective of their final destination. It also applies to the processing, storage and distribution * of human blood and blood components intended for transfusion.

Obligations incumbent upon the authorities of the Member States

With regard to the licensing of blood establishments, Member States shall ensure that activities relating to the collection and testing of human blood and blood components are undertaken only by the blood establishments * which have been designated, authorised, accredited or licensed by the competent authority for that purpose.

All the information to be provided by blood establishments to the competent authority for the purposes of designation, authorisation, accreditation or licensing is specified in Annex I. This includes general information (identification of the blood establishment, qualifications and contact details of responsible persons, etc.) and a description of the quality system (quality manual, qualifications of personnel, hygiene provisions, details of procedures for assessment of donors, etc.).

The competent authority must organise inspections * and appropriate control measures in blood establishments at least once every two years. It must also organise appropriate measures in the event of any serious adverse event * or reaction or suspicion thereof.

Responsible person

Blood establishments must designate a person responsible for:

  • ensuring that every unit of blood or of blood components has been collected and tested and, when intended for transfusion, has been prepared, stored and distributed in compliance with the laws in force in the Member State;
  • communicating to the competent authority the information necessary for the designation, authorisation, accreditation or licensing procedure;
  • implementing the requirements relating to quality management in blood establishments (cf. below).

These various tasks may be delegated to other persons who possess the necessary qualifications and experience.

The Directive stipulates minimum conditions of qualification for the person responsible for the blood establishment (university-level qualification in the field of medical or biological sciences and at least two years’ post-graduate practical experience).

The personnel of the establishment must also possess the necessary qualifications and receive relevant and regular training.

Quality management

A quality system based on the principles of good practice must be introduced by each blood establishment and hospital blood banks *. The Commission is responsible for establishing the Community standards and specifications relating to this system.

With regard to documentation and record-keeping, the blood establishments must keep the following up to date:

  • documentation on operational procedures, guidelines, training and reference manuals, and reporting forms;
  • records of the information required in Annexes II (report concerning the preceding year’s activity) and IV (basic testing requirements for whole blood and plasma donations).

The competent authority must keep records of applications made by establishments for accreditation, provisions relating to existing establishments and notifications of any serious adverse reactions or events.

Haemovigilance *

The traceability of blood and blood components, from donor to recipient and vice versa, must be guaranteed. In order to ensure full traceability, blood establishments and hospital blood banks must implement a system permitting unmistakable identification of each single blood donation and each unit of blood and components thereof.

A system permitting an equivalent level of traceability must be operated with regard to blood and blood components imported from third countries.

Product labelling must match the requirements listed in Annex III.

Any serious adverse events must be notified to the competent authority. Blood establishments and hospital blood banks must have in place a procedure for the efficient withdrawal from distribution of blood or blood components associated with a serious adverse event.

Conditions relating to donations and donors in order to ensure the quality and safety of blood and blood components

Donors must be provided with certain information when giving blood. This includes information on the characteristics of blood and blood products, and an undertaking by the blood collection centre to contact the donor if the results of the tests reveal any form of pathology.

Certain information must be obtained from donors, for example their identification, their state of health and medical history, and a signature confirming that the donor has read and understood the information provided.

The donor is subject to an evaluation procedure and must satisfy the criteria concerning physical suitability, such as age, and donation criteria, such as the time interval between donations. Permanent deferral criteria are also drawn up in order to protect both the donor and the recipient (for example in case of diseases that could place either the donor or the recipient in danger).

An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components.

Measures must be taken to encourage voluntary and unpaid blood donations, with a view to ensuring that blood and blood components are as far as possible provided from such donations.

Each donation of blood or blood components must undergo certain tests (listed in Annex IV). The same applies to blood or blood components imported into the Community.

Data protection and confidentiality

All data, including genetic information, must be rendered anonymous so that the donor is no longer identifiable.

Community code relating to medicinal products for human use

This Directive amends the Community code relating to medicinal products for human use in order to ensure that the safety and quality standards are the same whatever the intended purpose of blood or blood components, including their use as raw materials in the production of medicinal products.

Background

The purpose of this Directive is to set standards of quality and safety for blood and blood components throughout the blood transfusion chain in the European Union (EU). It is a response not only to the need to protect public health but also to the need to ensure that the internal market functions properly by facilitating the movement of these products within the EU.

Key terms used in the act
  • Blood component: a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (centrifugation, filtration and freezing).
  • Hospital blood bank: a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities.
  • Distribution: the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.
  • Blood establishment: any structure or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion.
  • Haemovigilance: a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.
  • Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
  • Inspection: formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.
  • Blood product: any therapeutic product derived from human blood or plasma.
  • Blood: whole blood collected from a donor and processed either for transfusion or for further manufacturing.
  • Autologous transfusion: a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 2002/98/EC

8.2.2003

8.2.2005

OJ L 33 of 8.2.2003
Amending Act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 596/2009

7.8.2009

–

OJ L 188 of 18.7.2009

Related Acts

Implementing measures

Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic [Official Journal L 288 of 4.11.2009].
This implementing Directive, applicable until 30 June 2009, gave Member States the possibility to derogate exceptionally and conditionally from certain eligibility criteria for blood donors in order to guarantee blood supply in the case of an Influenza A(H1N1) pandemic, whilst ensuring the health of blood and blood component donors and recipients is protected.

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the specific technical requirements for a quality system for blood establishments.
Member States must ensure that the quality system in place in all blood establishments and hospital blood banks complies with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the technical requirements to ensure traceability of blood and blood components from the donor to the recipient, and the procedures.
Member States must ensure that the systems and procedures for traceability and notification of serious adverse reactions in place at national level and in all blood establishments and hospital blood banks comply with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components [Official Journal L 91 of 30.3.2004].
In application of Directive 2002/98/EC, this text provides more detailed information, criteria and requirements relating to donations and donors, storage, transport and distribution of blood and blood components and to the quality and safety of blood and blood components.

Implementation reports

Communication from the Commission of 19 January 2010 to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [COM(2010) 3 final – Not published in the Official Journal].

This Communication reports a satisfactory implementation of Directive 2002/98/EC. Member States have now successfully designated and set up their competent authorities, as well as inspection systems, control measures and haemovigilance systems.
However, Member States must pursue the finalisation of the accreditation/designation/authorisation/licensing process for all blood establishments.
The Commission encourages the good practice of collecting reports on blood establishments in the preceding year. These reports could be a valuable source of information for both regulators and citizens.

Report from the Commission of 19 June 2006 – First report on the application of the Blood Directive [COM(2006) 313 final – Not published in the Official Journal].
This report sets out the measures adopted by the Member States in application of the Blood Directive. It covers the 15 Member States which belonged to the EU on 31 December 2003.
The report points out that ten Member States adopted more stringent protective measures than those provided for in the Directive, particularly with regard to donor selection, biological control of donations and haemovigilance.
The document describes the application, at national level, of the Directive’s provisions relating to:

  • the obligations of the competent national authorities, in particular those relating to inspection and control;
  • blood establishments and the obligation to designate a responsible person with at least the minimum qualifications;
  • quality management in each blood establishment;
  • haemovigilance;
  • the quality and safety of blood and blood components;
  • data protection.

Report from the Commission of 17 May 2006 on the promotion by Member States of voluntary unpaid blood donations [COM(2006) 217 final – Not published in the Official Journal].
This report summarises the measures taken by Member States to encourage voluntary unpaid donations (allowances, possibility of time off work, information campaigns, awareness programmes, etc.).
It also presents the measures the Commission intends to take in order to promote self-sufficiency in human blood and human plasma in the European Community. Such measures include:

  • a Europe-wide study to identify best practices with a view to developing a methodology and basic set of principles for awareness campaigns;
  • continuation of the discussion on self-sufficiency in the Community with an examination of the question of the optimal use of blood.

 

Checks on the transport of dangerous goods by road

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Checks on the transport of dangerous goods by road

Outline of the Community (European Union) legislation about Checks on the transport of dangerous goods by road

Topics

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

Transport > Road transport

Checks on the transport of dangerous goods by road

Document or Iniciative

Council Directive 95/50/EC of 6 October 1995 on uniform procedures for checks on the transport of dangerous goods by road [See amending acts].

Summary

This directive applies to checks carried out by European Union (EU) countries on the transport of dangerous goods by road in vehicles travelling in their territory or entering it from a third country. It does not apply to the transport of dangerous goods under the responsibility of the armed forces.

These checks are carried out in the territory of an EU country, provided that they are not carried out as frontier checks at the internal frontiers of the EU, but as part of normal checks without discrimination.

These checks must cover at least the items included in the checklist in Annex I to the directive, be carried out at different places, at any time of the day, and cover a sufficiently extensive portion of the road network to make checkpoints difficult to avoid.

Consignments found to be in infringement may be immobilised, and obliged to be brought into conformity before continuing their journey, or be subject to other appropriate measures, depending on the circumstances or the requirements of safety including, where appropriate, refusal to allow such vehicles to enter the EU.

Checks may also be carried out at the premises of undertakings.

EU countries must work together to effectively implement this directive (report of the infringement to the country in which the carrier is registered, cooperation between EU countries to exchange information, etc.).

Each EU country must send the Commission a report for each calendar year on the application of the directive, including the particulars listed in the directive, such as the number of checks carried out, the number of vehicles checked by place of registration, and the number and type of infringements recorded.

Starting in 1999 and subsequently at least every three years, the Commission will send the European Parliament and the Council a report on the application of the directive by the EU countries.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 95/50/EC

17.10.1995

31.12.1996

OJ L 249 of 17.10.1995
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2001/26/EC

23.6.2001

23.12.2001

OJ L 168 of 23.6.2001
Directive 2004/112/EC

3.1.2005

14.12.2005

OJ L 367 of 14.12.2004
Directive 2008/54/EC

11.7.2008

–

OJ L 162 of 21.6.2008

Successive amendments and corrections to Directive 95/50/EC have been incorporated in the basic text. This consolidated versionis for reference purposes only.

Related Acts

Report from the Commission to the European Parliament and the Council of 7 July 2010 on the application by the member states of Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road [COM (2010) 364 – Not published in the Official Journal].
This report covers the period from 2006 to 2007. It concludes that all EU countries have carried out road checks in accordance with Directive 95/50/EC. The Commission found a significant improvement in the volume and quality of the data submitted. Within the checks reported, there continues to be a proportion of vehicles found to infringe the EU legislation. The number of checks in the EU has increased, reaching about 285 000 annual checks in 2007. The number of infringements per check appears to be stable with an infringement detected in approximately one out of eight checks. The fact that almost 10,000 vehicles were immobilised following their check due to a serious infringement demonstrates that practical enforcement of rules on the transport of dangerous goods at the roadside is useful and helps to improve safety.

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods [Official Journal L 260 of 30.9.2008].

Report from the Commission to the European Parliament and the Council of 13 December 2007 on the application by the Member States of Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road [COM (2007) 795 final – Not published in the Official Journal].

Report from the Commission to the European Parliament and the Council on the application by the member states of Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road [COM (2005) 430 – Not published in the Official Journal].

Commission Directive 2004/112/EC of 13 December 2004 adapting to technical progress Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road [Official Journal L 367 of 14.12.2004].

Report from the Commission to the European Parliament and the Council of 6 September 2000 on the application by the Member States of Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road [COM (2000) 517 final – Not published in the Official Journal].

Road safety: Policy orientations on road safety 2011-20

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Road safety: Policy orientations on road safety 2011-20

Outline of the Community (European Union) legislation about Road safety: Policy orientations on road safety 2011-20

Topics

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

Transport > Road transport

Road safety: Policy orientations on road safety 2011-20

rd road safety action programme, the Commission has published policy orientations on road safety to provide a general framework, under which concrete action can be taken at European, national, regional or local levels from 2011 until 2020.

Document or Iniciative

Commission Communication of 20 July 2010 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – “Towards a European road safety area: policy orientations on road safety 2011-2020” [COM(2010) 389 final – Not published in the Official Journal].

Summary

Although progress was made on road safety in the European Union (EU) during the 3rd European road safety action programme (2003-10), the Commission highlights that efforts to improve road safety need to be further strengthened. This 3rd road safety action programme (RSAP) included an ambitious target to halve the number of road deaths by 2010 as well as numerous proposals for concrete actions in vehicle safety, safety of infrastructure and users’ safety. Although the Commission accepts that the initial target was not likely to be met by the end of 2010, the RSAP has encouraged EU countries to be more proactive in improving road safety and has gone a long way to dramatically reduce the number of fatalities on EU roads.

The European road safety policy orientations 2011-20 aims to provide a general framework and challenging objectives to guide national and local strategies, in accordance with the principle of subsidiarity. Within the general framework, the Commission highlights the need to:

  • create a cooperation framework based on the exchange of best practices across the EU;
  • adopt a strategy for injuries and first aid to address the need to reduce the number of road injuries;
  • improve the safety of vulnerable road users.

Principles and target

The Commission sets out three main principles:

  • striving for the highest road safety standards throughout Europe – by encouraging EU citizens to take primary responsibility for their own safety and the safety of others on EU roads, and by focusing on improving the safety of more vulnerable road users;
  • an integrated approach to road safety – through cooperation with other EU policy areas, such as energy, environment, education, innovation and technology, and justice.
  • subsidiarity, proportionality and shared responsibility – through the concept of shared responsibility, commitment and concrete actions at all levels from EU countries and their authorities to regional and local bodies.

Following the RSAP 2003-10, the Commission proposes to maintain the target of halving the overall number of road deaths in the EU between 2010 and 2020. This ambitious target demonstrates the EU’s clear commitment towards road safety and having a common objective is intended to provide EU citizens with a more uniform level of road safety within the EU. The Commission encourages individual EU countries to contribute to the achievement of this common target through their own national road safety strategies.

During the public consultation for these policy orientations, which took place between July and December 2009, a target for reducing road traffic severe injuries was proposed. Once a common definition exists for ‘severe injuries’, the Commission will propose to add a common “injuries reduction target” to these European road safety policy orientations up to 2020.

Strategic objectives

The Commission has identified seven objectives, for which actions will be proposed at both EU and national level:

  • improve education and training of road users – the quality of the licensing and training system needs to be improved, with emphasis on young drivers. The Commission will work with EU countries to develop a common educational and training road safety strategy including pre-test learning, the driving licence test, and post-licence training;
  • increase enforcement of road rules – the Commission, the European Parliament and the Council will work together to establish a cross-border exchange of information in the area of road safety. The Commission will also work towards a common road safety enforcement strategy which will involve enforcement campaigns, national enforcement objectives, and vehicle technology to assist enforcement, including the possibility of speed limiters in light commercial vehicles and alcohol interlock devices;
  • safer road infrastructure – the Commission will ensure that European funds will only be granted to infrastructure that complies with the EU safety requirements. The Commission will also promote the application of the relevant principles of safe management to the secondary road network of EU countries, in particular through the exchange of best practices.
  • safer vehicles – as well as continue to encourage the progress of vehicle safety, the Commission will also evaluate and propose actions in the area of harmonisation and progressive strengthening of EU legislation on roadworthiness tests and on technical roadside inspections;
  • promote the use of modern technology to increase road safety – the Commission will continue to promote the use of Intelligent Transport Systems to improve road traffic safety. The effectiveness and speed of rescue will be enhanced by the adoption of the European emergency call service fitted to vehicles, ‘eCall’;
  • improve emergency and post-injuries services – the Commission will propose the establishment of a global strategy of action on road injuries and first aid. The Commission will in particular examine the means to improve the efficiency of first aid intervention and post-care handling in order to reduce the impact of road accidents.
  • protect vulnerable road users – the Commission will work to improve the safety of motorcyclists, addressing behaviour, as well as vehicle and infrastructure safety. It will also encourage the establishment of adequate infrastructures to increase the safety of cycling and other vulnerable road users.

Implementation of the European road safety policy orientations 2011-20

A framework for open cooperation between EU countries and the Commission will be established to facilitate the implementation of the EU road safety policy. Parallel to this, EU countries should also develop national road safety plans including specific national objectives which are individual to their particular situation.

The Commission will pursue the improvement of the existing tools for data collection and analysis, such as CARE, the EU database on road accidents established in accordance with Council Decision 93/704/EC, as well as the European Road Safety Observatory (ERSO), which makes publicly available through the Internet road safety data and knowledge at European level.

Provision of health and safety signs at work

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Provision of health and safety signs at work

Outline of the Community (European Union) legislation about Provision of health and safety signs at work

Topics

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

Employment and social policy > Health hygiene and safety at work

Provision of health and safety signs at work

Document or Iniciative

Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of health and/or safety signs at work (ninth individual Directive within the meaning of Directive 89/391/EEC) [Official Journal L 245 of 26.8.92].

Summary

Directive 92/58/EEC lays down minimum requirements concerning health and safety signs at work *. For example, they relate to: location and identification of containers and pipes, fire-fighting equipment, certain traffic routes, illuminated and acoustic signs, as well as the introduction of appropriate verbal communications * and hand signals *.

This Directive complements the Framework Directive 89/391/EEC on health and safety at work.

The Directive does not apply to signs for the placing on the market of dangerous substances and preparations, products and/or equipment, nor to signs used for regulating road, rail, inland waterway, and sea or air traffic.

Employers’ obligations

Employers must provide safety signs where hazards cannot be avoided or adequately reduced by preventive measures or procedures used in the organisation of work.

Wherever appropriate, signs used for road, rail, inland waterway, sea and air transport can be installed inside companies or undertakings.

Supplementary information

Member States may specify certain exemptions within certain precise limits.

Workers must be informed of the measures to be taken and must be given appropriate training (precise instructions).

Workers must be consulted and allowed to participate on the matters covered by the Directive.

Technical adaptations to the Annexes will be adopted by the Commission, assisted by a committee (Article 17 of Directive 89/391/EEC).

Member States are required to report to the Commission every five years on the practical implementation of the Directive. The Commission is required to report periodically to the European Parliament, the Council and the Economic and Social Committee on the implementation of the Directive.

Context

The Directive repeals Directive 77/576/EC on safety signs in the work place.

Key terms of the Act
  • Safety and health signs: information or instructions about safety and/or health at work by means of a signboard, a colour, an illuminated sign or acoustic or hand signal, or a verbal communication;
  • Verbal communication: a predetermined spoken message communicated by a human or artificial voice;
  • Hand signal: a movement or position of the arms or hands for guiding persons who are carrying out manoeuvres which constitute a hazard or danger.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 92/58/EEC

22.7.1992

24.6.1994

OJ L 245 of 26.8.1992
Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 2007/30/EC

28.6.2007

31.12.2012

OJ L 165 of 27.6.2007

Related Acts

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the practical implementation of Health and Safety at Work Directives 92/57/EEC (temporary and mobile sites) and 92/58/EEC (safety signs at work) [COM(2008) 698 final – Not published in the Official Journal].
The Commission presents a positive report on the implementation of Directive 92/58/EEC. In fact, the majority of the 15 European Union Member States have completed their legislation through the new rules and requirements provided for in this Directive.
Implementation of the Directive has enabled the national systems of workplace safety signs to be streamlined. However, the Commission states that workers are still badly informed about the rules on signs and the Commission encourages companies to strengthen their training activities.

Extractive industries by means of boreholes

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Extractive industries by means of boreholes

Outline of the Community (European Union) legislation about Extractive industries by means of boreholes

Topics

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

Employment and social policy > Health hygiene and safety at work

Extractive industries by means of boreholes

Document or Iniciative

Council Directive 92/91/EEC of 3 November 1992 concerning minimum requirements for improving the safety and health protection of workers in the extractive industries (boreholes) (11th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) [See amending acts].

Summary

This Directive lays down the minimum requirements for protecting the health and safety of workers in extractive industries by means of boreholes *.

General obligations of the employer:

In applying this Directive, employers are required to:

  • apply safety considerations to workplaces right from the design stage;
  • ensure that there is a supervisor in charge;
  • entrust work involving a special risk only to suitably qualified staff;
  • ensure that safety instructions are comprehensible to all the workers concerned;
  • provide first aid facilities and run safety exercises at regular intervals.

Before the commencement of work, the employer must satisfy himself that a document on safety and health is prepared and brought up to date (in accordance with Articles 6, 9 and 10 of Directive 89/391/EEC). This document must show, in particular, that the risks run by workers at the workplace have been determined and assessed, that appropriate measures have been taken and that the workplace is designed, operated and maintained in line with safety requirements.

Where workers from more than one firm are present at the same workplace, the employer responsible for the workplace must coordinate the health and safety measures applying to these workers and set them out in the document.

This coordination does not affect the liability of individual employers.

The employer must immediately report fatal and serious occupational accidents and dangerous occurrences.

In terms of protection against fire, explosions and health-endangering atmospheres, employers must take preventive measures appropriate to the nature of the operation in order to:

  • avoid, detect and combat the starting and spread of fires and explosions;
  • prevent the occurrence of explosive and/or health-endangering atmospheres.

Employers shall provide and maintain appropriate means of escape and rescue in order to ensure that workers have adequate opportunities for leaving the workplaces promptly and safely in the event of danger.

Employers shall take the requisite measures to provide the necessary warning and other communication systems to enable assistance, escape and rescue operations to be launched immediately if the need arises.

Furthermore, they must inform workers of all measures to be taken concerning safety and health at the workplace.

Every worker must receive or be subject to a health surveillance before they are assigned to duties related to the activities referred to in the Directive and at regular intervals thereafter.

Employers must ensure consultation and participation of workers on the matters covered by the Directive.

Lastly, workplaces used for exploration for and extraction of minerals by means of boreholes must satisfy the minimum health and safety requirements (listed in the Annex).

When workplaces undergo changes, extensions and/or conversions after the date on which this Directive is brought into effect, the employer shall take the measures necessary to ensure that they are in compliance with the minimum requirements laid down in the Annex.

Key terms of the Act
  • Extractive industries (boreholes): all industries engaged in prospecting and extraction activities and in the preparation of extracted materials for sale but not the processing of such extracted materials.

References

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

Directive 92/91/EEC

11.11.1992

3.11.1994

OJ L 348 of 28.11.1992
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 2007/30/EC

28.6.2007

31.12.2012

OJ L 165 of 27.6.2007

The successive amendments and corrections to Directive 92/91/EEC have been incorporated into the original text. This consolidated versionis for reference only.

Risk of explosive atmospheres

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Risk of explosive atmospheres

Outline of the Community (European Union) legislation about Risk of explosive atmospheres

Topics

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

Employment and social policy > Health hygiene and safety at work

Risk of explosive atmospheres

Document or Iniciative

Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Summary

An “explosive atmosphere” is a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.

The employer must take technical and/or organisational measures to prevent the formation of explosive atmospheres, prevent the ignition of explosive atmospheres, and reduce the effects of an explosion in such a way that workers are not at risk.

The employer must ensure that a health and safety protection document, describing explosion protection measures and satisfying the requirements of Directive 89/391/EEC, is prepared and kept up to date.

Workers and/or their representatives must be informed of all the measures to be taken for their safety and health at work.

The employer must take the necessary steps to ensure that workers potentially at risk from explosive atmospheres receive appropriate training.

Work equipment for use in places where explosive atmospheres may occur must comply with the minimum requirements laid down in the Annex to the Directive.

Where workplaces which contain places in which explosive atmospheres may occur are already in use before the entry into force of the proposed Directive, they must comply with its minimum requirements no later than three years after its entry into force.

After consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work, the Commission must draw up practical guidelines in a guide to good practice of a non-binding nature.

Member States must, on request, endeavour to make relevant information available to employers, with particular reference to the guide to good practice.

Member States must report to the Commission every five years on the practical implementation of the Directive, indicating the points of view of employers and workers. The Commission must inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work.

Annex I contains the classification of places where explosive atmospheres may occur. Annex II describes the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres and criteria for the selection of equipment and protective systems. Annex III presents the warning sign for places where explosive atmospheres may occur.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 1999/92/EC of 16 December 1999 from the European Parliament and the Council

–

–

OJ L 23 of 28.01.2000

Related Acts

Communication from the Commission regarding the non-mandatory guide to good practice in order to implement Directive 1999/92/EC on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres [COM(2003) 515]

The present guide is be used alongside Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres.

Electrical equipment designed for use within certain voltage limits

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Electrical equipment designed for use within certain voltage limits

Outline of the Community (European Union) legislation about Electrical equipment designed for use within certain voltage limits

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 > Construction

Electrical equipment designed for use within certain voltage limits

Document or Iniciative

Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version) (Text with EEA relevance).

Summary

This Directive aims at ensuring that electrical equipment may be placed on the market only if it does not, when installed and maintained, endanger the safety of persons, domestic animals or property, and at promoting the free movement of this equipment in the European Union.

Scope

This Directive applies to electrical equipment designed for use with a voltage rating of between 50 and 1000 Volts for alternating current and between 75 and 1500 Volts for direct current.

It does not apply to:

  • electrical equipment for use in an explosive atmosphere;
  • equipment for radiology and medical purposes;
  • electrical parts for goods and passenger lifts;
  • electricity meters;
  • plugs and socket outlets for domestic use;
  • electric fence controllers;
  • radio-electrical interference;
  • electrical equipment for use on ships, aircraft or railways;
  • electrical equipment intended for export to third countries.

Safety objectives

Electrical equipment may be placed on the market if it complies with the safety objectives laid down in Annex I to this Directive concerning:

  • general safety conditions applying to equipment;
  • hazards arising from electrical equipment;
  • hazards caused by external influences on electrical equipment.

The free movement of electrical equipment must not be hindered if it meets the safety objectives defined in the Directive. Manufacturers may choose how they comply with safety objectives.

Presumption of conformity

Electrical equipment which complies with the provisions of the harmonised standards should be subject to a presumption of conformity with the safety objectives established by this Directive and be able to move freely.

Standards shall be regarded as harmonised if they are drawn up by common agreement between the bodies notified by the Member States and published under national procedures. Their references shall be published in the Official Journal of the European Union.

If standards have not yet been harmonised, Member States should take measures to ensure that their competent administrative authorities regard electrical equipment as complying with the safety objectives of the Directive if the electrical equipment complies with the safety provisions of the International Commission on the Rules for the Approval of Electrical Equipment (CEEel) or of the International Electrotechnical Commission (IEC).

If harmonised standards or safety provisions do not yet exist, Member States shall take measures to ensure that their competent administrative authorities regard electrical equipment as complying with the safety objectives of the Directive if the electrical equipment is in accordance with the safety standards in force in the Member State of manufacture.

Placing on the market

Before placing electrical equipment on the market:

  • the manufacturer or his authorised representative established in the European Union must affix the “CE” marking to each product and draw up a written “EC” declaration of conformity;
  • the manufacturer must establish the technical documentation.

The “EC” declaration of conformity must contain:

  • the name and address of the manufacturer or his authorised representative established in the European Union;
  • a description of the electrical equipment;
  • a reference to the harmonised standards;
  • if required, references to the specifications with which conformity is declared;
  • identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorised representative established in the European Union;
  • the last two digits of the year in which the “CE” marking was affixed.

Safeguard

If, for safety reasons, a Member State prohibits the placing on the market of any electrical equipment or impedes its free movement, it shall inform the Commission and the other Member States concerned.

The Directive codifies and repeals Directive 73/23/EEC.

Reference

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2006/95/EC

16.1.2007

–

OJ L374 of 27.12.2006