Tag Archives: Technical standards

Pharmaceutical and cosmetic products

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

Parking lamps on motor vehicles

Parking lamps on motor vehicles

Outline of the Community (European Union) legislation about Parking lamps on motor vehicles

Topics

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

Internal market > Motor vehicles > Technical harmonisation for motor vehicles

Parking lamps on motor vehicles (until 2014)

Document or Iniciative

Council Directive 77/540/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to parking lamps for motor vehicles [See amendingacts].

Summary

This Directive concerns any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, as well as its trailers.

Vehicles which run on rails, agricultural or forestry tractors and any mobile machinery.

Each Member State must grant component EC type-approval for any type of parking lamp which satisfies the construction and testing requirements laid down in the Annexes to the Directive, and issue an EC component type-approval mark for each type of parking lamp approved. The Member State which has granted EC component type-approval must take the measures required in order to verify that production models conform to the approved type.

According to the system of granting approval set out in the Directive, Member States may not:

  • prohibit the placing on the market of parking lamps on grounds relating to their construction or method of functioning if they bear the EC component type-approval mark.
  • refuse to grant EC type-approval or national type-approval of any vehicle on grounds relating to parking lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.
  • refuse or prohibit the sale, registration, entry into service or use of any vehicle on grounds relating to parking lamps if these bear the EEC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.

Nevertheless, a Member State may prohibit the placing on the market of parking lamps bearing the EC component type-approval mark that consistently fail to conform to the approved type.

This Directive is repealed by Regulation (EC) No 661/2009 from 1 November 2014.

References

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

Directive 77/540/EEC

29.6.1977

29.6.1978

OJ L 220 of 29.8.1977

Amending Act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 1999/16/EC

2.5.1999

1.10.1999

OJ L 97 of 12.4.1999

The successive amendments and corrections to Directive 77/540/EEC have been integrated into the original text. This consolidated version is for reference only.

Motor vehicles

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

Radio and telecommunications terminal equipment

Radio and telecommunications terminal equipment

Outline of the Community (European Union) legislation about Radio and telecommunications terminal equipment

Topics

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

Information society > Current general legal framework

Radio and telecommunications terminal equipment

Document or Iniciative

Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity [See amending acts].

Summary

This Directive is intended to encourage rapid dissemination of innovative technology and thus promote competition in the internal market for telecommunications.

Scope

The Directive applies to radio equipment * and telecommunications terminal equipment *. The Directive also applies where this equipment :

  • incorporates, as an integral part or as an accessory, a medical device within the meaning of Directive 93/42/EEC on medical devices;
  • incorporates, as an integral part or as an accessory, an active implantable medical device within the meaning of Directive 90/385/EEC on active implantable medical devices;
  • constitutes a component or a separate technical unit of a vehicle, within the meaning of Directive 72/245/EEC relating to radio interference caused by motor vehicles;
  • constitutes a component or a separate technical unit of a vehicle, within the meaning of Directive 2002/24/EC relating to the type-approval of two- or three-wheel motor vehicles.

The Directive does not apply to apparatus exclusively used for activities concerning public security, defence, State security and the activities of the State in the area of criminal law; nor does it apply to:

  • radio equipment used by radio amateurs, except when it is commercially available fully assembled;
  • equipment covered by Directive 96/98/EC relating to marine equipment;
  • wires and cables;
  • radio equipment intended to be used solely for the reception of sound and TV broadcasting services;
  • products, equipment or components within the meaning of Council Regulation (EEC) No 3922/91 relating to the field of civil aviation;

Essential requirements and harmonised European standards

Member States must ensure that apparatus complies with the essential requirements of the Directive where it is properly installed, maintained and used, which is a condition for its being placed on the market.

The following essential requirements are applicable to the apparatus:

  • protection of the health and safety of the user and any other person, including the security provisions laid down in Directive 2006/95/EC, relating to electrical equipment designed for use within certain voltage limits (but with no lower voltage limit);
  • electromagnetic compatibility as per Directive 2004/108/EC;
  • use of the spectrum allocated to terrestrial/space radiocommunication and to orbital resources, which make it possible to avoid harmful interference.

When an apparatus is in conformity with harmonised European standards, in accordance with the procedures established by Directive 98/34/EC, the Member States presume that the current Directive’s requirements have been met.

Information and notification

Member States shall ensure that the manufacturers or the persons responsible for placing the apparatus on the market provide information on its use in the documentation or packaging, together with the declaration of conformity with the essential requirements.

More specifically, for radio equipment, this information must be sufficient to identify on the packaging and in the instructions for use of the apparatus the Member States or the geographical area within a Member State where the equipment is intended to be used.

For telecommunications terminal equipment, such information must identify the interfaces of the public telecommunications networks to which the equipment is intended to be connected.

CE marking

Apparatus which complies with all the essential requirements bears the CE conformity marking. Manufacturers identify their apparatus by stating its type, batch and/or serial numbers and by the name of the manufacturer or of the person responsible for placing the apparatus on the market.

If a notified body has been consulted by the manufacturer regarding the equipment’s conformity with the Directive, its number accompanies the CE marking.

In its Decision 2000/299/EC of 6 April 2000, the Commission established a class of radio equipment and telecommunications terminal equipment that cannot be used everywhere in the EU (as in the case of non-harmonised national frequency plans). This type of equipment must bear a corresponding warning mark along side the CE marking.

Placing on the market and free movement

Member States must not prohibit, restrict or impede the placing on the market and putting into service on their territory of any apparatus if it complies with the essential requirements and other provisions of the Directive.

If a Member State decides that apparatus does not meet the requirements of this Directive, it may prohibit, interrupt or restrict the placing on the market and also the putting into service of that apparatus.

Putting into service and the safeguard clause

Member States may restrict the putting into service of radio equipment only for reasons relating to the efficient and appropriate use of the radio spectrum, the need to avoid harmful interference, or public health issues.

If a Member State decides that an apparatus does not satisfy the requirements of the safeguard clause, it may take measures to withdraw it from service, to prohibit its being in service or to restrict its free movement.

Conformity assessment and notified bodies

This Directive lays down the procedures from which the manufacturer may choose for assessing conformity with the essential requirements for different types of equipment. Member States notify the Commission of the bodies they have designated to carry out the conformity assessment procedures.

If the manufacturer so chooses, the procedures for assessing conformity with essential requirements in Directive 73/23/EEC and Directive 89/336/EEC may also be used for assessing conformity with the respective requirements of those directives.

Key terms used in the act
  • Radio equipment: a product, or component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication.
  • Telecommunications terminal equipment: a product, or a component of a product, which is intended to be connected directly or indirectly to interfaces of public telecommunications networks.
  • Apparatus: any radio equipment, telecommunications terminal equipment, or both.

References

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

Directive 1999/5/EC

7.4.1999

7.4.2000

OJ L 91 of 7.4.1999

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003.

20.11.2003

OJ L 284 of 31.10.2003

Regulation (EC) No 596/2009

18.6.2009

OJ L 188 of 18.7.2009

Successive amendments and corrections to Directive 2000/29/EEC have been incorporated into the basic text. This consolidated versionis for reference only.

Related Acts

Reports

Report from the Commission to the Council and the European Parliament of 9 February 2010 – second Progress Report on the operation of Directive 1999/5/EC, on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity [COM(2010) 43 final – Not published in the Official Journal].

This Report describes the operation of Directive 1999/5/EC with a view to its future revision.
The Report notes that the objectives of the Directive have been achieved in terms of:

  • protection of health for users;
  • the safety of users;
  • the electromagnetic compatibility of telecommunications terminals and radio equipment;
  • the avoidance of harmful interference.

However, the Report stresses that market entrance for innovative radio technologies and the traceability of the manufacturer or the person responsible for placing products on the market need to be improved.

Report from the Commission to the Council and the European Parliament of 22 April 2004 – First Progress Report Directive 1999/5/EC (the R&TTE Directive) [COM(2004) 288 final – Not published in the Official Journal].
This Report notes that the implementation of Directive 1999/5/EC has contributed towards the development of the internal market for radio and terminal equipment. However, the administrative provisions of the Directive are not sufficiently adhered to, which puts into question of the proportionality of these provisions and the effectiveness of communicating them to the sector.

Decisions

Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access to Cospas-Sarsat locator beacons to emergency services. [Official Journal L 225 of 31.08.2005].

Commission Decision 2005/53/EC of 25 January 2005, relating to the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) [Official Journal L 22 of 26.01.2005].

Commission Decision 2004/71/EC of 4 September 2003 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) [Official Journal L 16 of 23.01.2004].

Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons [Official Journal L 55 of 24.02.2001].

Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning the radiotelephone service on inland waterways [Official Journal L 269 of 21.10.2000].

Commission Decision 2000/373/EC of 26 May 2000 concerning the request by France to maintain pursuant to Article 18(3) of Directive 1999/5/EC of the European Parliament and of the Council (the Terminal Directive) a requirement for telecommunications terminal equipment intended for connection to the analogue public switched telephone network of France Telecom [Official Journal L 135 of 08.06.2000].

Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers [Official Journal L 97 of 06.04.2000].

Regulations

Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the interoperability Regulation) [Official Journal L 96 of 31.03.2004].

Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonization of technical requirements and administrative procedures in the field of civil aviation [Official Journal L 373 of 31.12.1991].

Recommendation

Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) [Official Journal L 199 of 30.07.1999].

Directive

Directive 98/10/EC of the European Parliament and of the Council of 26 February 1998 on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment [Official Journal L 101 of 01.04.1998].

Construction

Construction

Outline of the Community (European Union) legislation about Construction

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

Construction

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

Construction products

  • Construction products

ENERGY EFFICIENCY

  • Energy performance of buildings

THE IMPACT OF CONSTRUCTION MACHINES

  • Noise emission by equipment used outdoors
  • Fire safety in existing hotels

BUILDING EQUIPMENT

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

THE HEALTH AND SAFETY OF WORKERS

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

Chemical products

Chemical products

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

Topics

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

Internal market > Single Market for Goods > Chemical products

Chemical products

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

DANGEROUS SUBSTANCES AND PREPARATIONS

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

PESTICIDES

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

FERTILISERS

  • Fertilisers

CONTROL OF THE RISKS

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

MANAGEMENT OF POLLUTANTS AND WASTE

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