Suchwerkzeug für das EU-Chemikalienrecht
Suchwerkzeug für das EU-Chemikalienrecht
EUCLEF vermittelt Ihnen einen Überblick über die Rechtsvorschriften der Europäischen Union im Bereich Chemikalien. Sie können nach Informationen über Ihre Stoffe suchen, geltende Gesetze finden und überprüfen, welche Verpflichtungen sich für Sie möglicherweise daraus ergeben.
Für jeden der nachstehend genannten Rechtsakte finden Sie eine Zusammenfassung aller einschlägigen Informationen, einschließlich Geltungsbereich, Verpflichtungen, Ausnahmeregelungen, Regulierungstätigkeiten und Listen von betroffenen Stoffen, zusammen mit Links zu den vollständigen Rechtstexten in allen EU-Amtssprachen.
EUCLEF wird aus dem EU-Programm für die Wettbewerbsfähigkeit von Unternehmen und für kleine und mittlere Unternehmen (COSME) finanziert.
The 5 pieces of legislation in ECHA’s remit (REACH, CLP, BPR, PIC and POPs) are automatically included in EUCLEF; details of the lists relating to these can be found on the Information on chemicals page.
The other pieces of legislation covered by EUCLEF are listed below, by category.
- Inland Transport of Dangerous Goods DirectiveDirective 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods
Directive 2008/68/EC establishes common rules for the safe and secure transport of dangerous goods within and between EU countries by road, rail or inland waterway. (It also covers aspects such as loading and unloading, the transfer to and from another mode of transport, as well as the stops in the course of the transport process.) It extends the application of international rules to national transport of dangerous goods. The international transport of dangerous goods is regulated by the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN) and the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID). The ADR, RID and ADN have drawn up a list of dangerous goods, indicating whether their transport is prohibited or not and defining the requirements for their transport if it is authorized.
- PPP - Plant Protection Products RegulationCommission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances
A plant protection product usually contains more than one component. The active component against pests/plant diseases is called ''active substance''. The Commission evaluates every active substance for safety before it reaches the market in a product. Substances must be proven safe for people's health, including their residues in food and effects on animal health and the environment.
- Pesticide Residues RegulationRegulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Regulation EC 396/2005 establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, in particular the need to ensure a high level of consumer protection and harmonised Community provisions relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin. This Regulation shall apply to products of plant and animal origin or parts thereof covered by Annex I to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present. This Regulation shall not apply to the products covered by Annex I where it may be established by appropriate evidence that they are intended for: (a) the manufacture of products other than food or feed; or (b) sowing or planting; or (c) activities authorised by national law for the testing of active substances.
- Statistics on Pesticides RegulationRegulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides
Regulation 1185/2009/EC concerning statistics on pesticides sets up rules and procedures for the collection and dissemination of statistics on the sale and use of pesticides. The statistics are used with other relevant data by the EU countries to draw up national action plans to reduce risks of pesticide use on human health and the environment, as well as EU policies on sustainable development and indicators of risks to health and the environment due to pesticide use. Data is collected every five years and must be presented in accordance with the classification in Annex III and the technical format established in Commission Implementing Regulation (EU) No 1264/2014. The Commission regularly adapts the list of active substances to be covered and their classification in categories of products and chemical classes, as set out on the Regulation's Annex III.
- Ambient Air Quality DirectiveDirective 2008/50/EC of the European Parliament and of the Counsel of 21 May 2008 on ambient air quality and cleaner air for Europe
The Directive establishes air quality objectives, including ambitious, cost-effective targets for improving human health and environmental quality up to 2020. It also specifies ways of assessing these and of taking any corrective action if the standards are not met. It provides for the public to be kept informed. This directive merges most of existing air quality legislation into a single directive.
- As, Cd, Hg, Ni, PAHs in Ambient Air DirectiveDirective 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air
The objective of this Directive is to establish a target value for the concentration of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air so as to avoid, prevent or reduce harmful effects of those heavy metals on human health and the environment as a whole. It determines common methods and criteria for the assessment of concentrations of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air. Where concentrations exceed certain assessment thresholds, monitoring of arsenic, cadmium, nickel and benzo(a)pyrene should be mandatory.
- Atmospheric Pollutants Emission Reductions DirectiveDirective (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC
The National Emission Ceilings Directive establishes emission reduction commitments for all EU member states as regards important air pollutants: nitrogen oxides (NOx), non-methane volatile organic compounds (NMVOCs), sulphur dioxide (SO2), ammonia (NH3) and fine particulate matter (PM2.5), as these pollutants are a major contributor to poor air quality and have significant negative impacts on the environment and human health. This legislation applies to member states, not individual firms; however, it indicates which pollutants are of particular concern to the European Union.
- Industrial Emissions DirectiveDirective 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control)
Directive 2010/75/EU is a recast of seven earlier pieces of legislation on industrial emissions; it lays down rules to prevent and control pollution into the air, water and land and to avoid generating waste from large industrial installations.
- VOC Emissions from Storage of Petrol and its Distribution DirectiveEuropean Parliament and Council Directive 94/63/EC of 20 December 1994 on the control of volatile organic compound (VOC) emissions resulting from the storage of petrol and its distribution from terminals to service stations
Directive 94/63/EC aims to reduce emissions from volatile organic compounds due to evaporation of petrol in the fuel storage and distribution chain.
- Batteries DirectiveDirective 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC
This legislation prohibits the placing on the market of most batteries and accumulators with a certain mercury or cadmium content and establishes rules for the collection, recycling, treatment and disposal of batteries and accumulators.
- End-of-Life Vehicles DirectiveDirective 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles
The end-of-life vehicles Directive sets out measures to prevent and limit waste from end-of-life vehicles and their components and ensures that where possible this is reused, recycled or recovered.
- Packaging and Packaging Waste DirectiveEuropean Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste
Directive 94/62/EC sets out the EU's rules on managing packaging and packaging waste. EU countries must take measures, such as national programmes, incentives through extended producer responsibility schemes and other economic instruments, to prevent the generation of packaging waste and to minimise the environmental impact of packaging.
- RoHS - Restriction of Hazardous Substances in Electrical & Electronic Equipment DirectiveDirective 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
Directive 2011/65/EU on the restriction on the use of certain hazardous substances in electrical and electronic equipment (EEE) is recast legislation that updates Directive 2002/95/EC.The recast strengthens existing rules on the use of hazardous substances, such as lead, mercury and cadmium, in EEE to protect human health and the environment, in particular by enabling environmentally sound recovery and waste treatment of EEE.
- Shipments of Waste RegulationRegulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste
The Regulation lays down rules for controlling waste shipments in order to improve environmental protection. It also incorporates the provisions of the Basel Convention and the revision of the OECD's 2001 decision on the control of transboundary movements of wastes destined for recovery operations (i.e. where a waste is processed to recover a usable product or converted into a fuel) in EU law.
- WEEE - Waste Electrical & Electronic Equipment DirectiveDirective 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE)
The Directive aims to protect the environment and human health by encouraging sustainable production and consumption. It does so by: (1) preventing the creation of waste electrical and electronic equipment (WEEE); (2) promoting reuse, recycling and other ways of recovering waste from electrical and electronic equipment (EEE); and supporting the efficient use of resources and recovery of valuable secondary raw materials.
- WFD - Waste Framework DirectiveDirective 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives
This Directive lays down measures to protect the environment and human health by preventing or reducing the adverse impacts of the generation and management of waste and by reducing overall impacts of resource use and improving the efficiency of such use.
- Marine Environmental Policy Framework DirectiveDirective 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive)
The Directive establishes a common approach and objectives for the prevention, protection and conservation of the marine environment against damaging human activities.
- Urban Waste Water Treatment DirectiveCouncil Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment
This Directive concerns the collection, treatment and discharge of urban waste water and the treatment and discharge of waste water from certain industrial sectors. The objective of the Directive is to protect the environment from the adverse effects of these waste water discharges.
- Water Environmental Quality Standards DirectiveDirective 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council
The directive sets environmental quality standards for priority substances and eight other pollutants, including the metals cadmium, lead, mercury and nickel, and their compounds; benzene; polyaromatic hydrocarbons (PAH); and several pesticides. Several of these priority substances are classed as hazardous. EU countries must ensure compliance with the EQSs. They must also take measures to ensure that the concentrations of substances that tend to accumulate in sediment and/or biota do not increase significantly.
- Water Framework DirectiveDirective 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
The purpose of this Directive is to establish a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater. It sets out rules to halt deterioration in the status of European Union (EU) water bodies and achieve 'good status' for Europe's rivers, lakes and groundwater.
- Water for Human Consumption DirectiveCouncil Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption
The Drinking Water Directive (Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption) concerns the quality of water intended for human consumption. Its objective is to protect human health from adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean.
- CMD - Carcinogens and Mutagens DirectiveDirective 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)
Directive 2004/37/EC sets out the minimum requirements for protecting workers against risks to their health and safety arising, or likely to arise, from exposure to carcinogens and mutagens at work. To reduce the risks associated with such exposure to workers' health and safety, it lays down preventive and protective measures, as well as exposure limits.
- Chemical, Physical and Biological Agents at Work DirectiveCommission Directive of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work
This Directive is based on Directive 80/1107/EEC,which was repealed and replaced by Directive 98/24/EC. It sets out limit values for certain substances in its Annex. The limit values for 17 of these substances were later on transferred to Directive 2006/15/EC. The current Directive establishes values for a reference period of eight hours for 6 substances.
- OELs - Occupational Exposure Limits - 1st listCommission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work
The list is based on Council Directive 98/24/EC. Member States shall establish national occupational exposure limit values for the chemical agents listed in the Annex, taking into account the Community values. The Directive establishes values for a reference period of eight-hours time weighted average and also for a short term period of 15 minutes for 61 chemical agents.
- OELs - Occupational Exposure Limits - 2nd listCommission Directive 2006/15/EC of 7 February 2006 establishing a second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC
The list is based on Council Directive 98/24/EC. Member States shall establish national occupational exposure limit values for the chemical agents listed in the Annex, taking into account the Community values but may determine its nature in accordance with national legislation and practice. The Directive establishes values for a reference period of eight-hours time weighted average and also for a short term period of 15 minutes for 33 chemical agents.
- OELs - Occupational Exposure Limits - 3rd listCommission Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Commission Directive 2000/39/EC
The Community indicative occupational exposure limit values are established as implementation of Council Directive 98/24/EC. In the Annex to Commission Directive 2000/39/EC, the reference to phenol is deleted and the new limit values are included in this Directive. The Directive establishes values for a reference period of eight-hours time weighted average and also for a short term period of 15 minutes for 18 chemical agents.
- OELs - Occupational Exposure Limits - 4th listCommission Directive (EU) 2017/164 of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU
The list is based on Council Directive 98/24/EC. Member States shall transpose this Directive by 21 August 2018 at the latest. Regarding the limit values introduced for nitrogen monoxide, nitrogen dioxide and carbon monoxide, Member States have until 21 August 2023 at the latest. The Directive adds limit values for 27 new chemical agents, and amends 6 existing ones established by earlier directives.
- Ceramic Articles DirectiveCouncil Directive of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs (84/500/EEC)
The Directive lays down maximum limits for the cadmium and lead transferred by ceramic objects to the foodstuffs with which they enter into contact. To be sold, these ceramics must be accompanied by a written declaration provided by the manufacturer or importer, guaranteeing that they do not exceed the maximum limits for lead and cadmium. The information required is described in Annex II (introduced by Directive 2005/31/EC).
- Food Contact Active and Intelligent Materials and Articles RegulationCommission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food
Regulation 450/2009/EC seeks to lay down specific rules for active and intelligent materials and articles, which supplement those set out in Regulation (EC) No 1935/2004, the general Regulation on materials and articles intended to come into contact with food. It also establishes specific requirements for the marketing of these materials and articles and sets out the procedure for their authorisation at EU level.
- Food Contact Materials (FCM) Framework RegulationRegulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
This Directive lays down common rules for packaging materials and articles such as bottles and containers, which come, or may come, into contact with food, either directly or indirectly. It seeks to protect human health and consumers' interests as well as ensure that the products used may be sold anywhere in the European Economic Area - the 27 EU countries, Iceland, Liechtenstein and Norway in which there is free movement of persons, goods, services and capital.
- Food Contact Recycled Plastic Materials and Articles RegulationCommission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006
This Regulation sets out specific measures for recycled plastic materials and articles, supplementing Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.
- Food Contact Regenerated Cellulose DirectiveCommission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs
The directive applies to regenerated cellulose film - either in the form of a finished product in itself or part of a finished product containing other materials - which is intended to come into contact or placed in contact with food.
- Plastic Materials and Articles RegulationCommission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food
The most comprehensive specific EU measure is Regulation (EU) No 10/2011 on plastic materials and articles. It sets out rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.
- CAD - Chemical Agents DirectiveCouncil Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
This directive lays down minimum requirements to protect workers from risks to their health and safety from the effects of chemicals they may encounter in the course of their job. It sets out exposure limit values and preventive measures.
- Protection of Pregnant and Breastfeeding Workers DirectiveCouncil Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
This Directive sets out the basic rights of all women before and after pregnancy in the European Union (EU). The Directive is one of several 'daughter directives' adopted under the Framework Directive 89/391/EEC on the safety and health of workers at work. Namely, it aims to protect the health and safety of women in the workplace when pregnant or after they have recently given birth, and women who are breastfeeding.
- Protection of Young People DirectiveCouncil Directive 94/33/EC of 22 June 1994 on the protection of young people at work
Directive 94/33/EC on the protection of young people at work sets minimum requirements in order to guarantee improvements in the health and safety of young workers.
- Safety and Health of Workers at Work DirectiveCouncil Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work
This Directive introduces measures to improve the health and safety of people at work. It sets out obligations for both employers and employees to reduce accidents and occupational disease in the workplace, including exposure to hazardous substances.
- Safety and/or Health Signs at Work DirectiveEU Directive 92/58/EEC on the minimum requirements for the provision of safety and/or health signs at work. OJ, L 245, p. 23, 26 August 1992, as amended through OJ, L 65, p. 1, 5 March 2014
Directive 92/58/EEC requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced. The annexes to this directive provide detailed information about the minimum requirements for all safety and health signs, and they have been adapted to reflect the requirements of subsequent related directives and technical progress in the field of health and safety signs at work.
- Active Implantable Medical Devices DirectiveCouncil Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
The aim of Directive 90/385/EEC is to ensure a high level of protection for human health and safety, smooth operation of the single market and to achieve the results for which the active implantable medical devices are intended. It does this by harmonising national legislation on active implantable medical devices. This ensures universally high safety standards for patients, giving the public confidence in the system. It enables the products to be used in any European Union (EU) country.
- Aerosol Dispensers DirectiveCouncil Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers
The Aerosol Dispensers Directive (ADD - Council Directive 75/324/EEC) has two objectives which are fulfilled by technical harmonisation at the European level: Guaranteeing those products within the scope of the Directive will be safe for consumers and other users in respect of hazards related to pressure and where appropriate, flammability and inhalation; and securing the free movement of aerosol dispensers throughout the EU. As such, Member States must allow the marketing on their territory of aerosol dispensers that comply with the Directive.
- Civil Explosives DirectiveDirective 2014/28/EU of the European Parliament and of the Counsel of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast)
Directive 2014/28/EU on making available on the market and supervision of explosives for civil uses sets out rules for the placing on the market and supervision of explosives for civil uses in the EU. The directive lays down manufacturers', importers' and distributors' responsibilities with respect to the trade in such commercial explosives.
- Construction Products RegulationRegulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC
This Regulation aims to make the single market work better and improve the free movement of construction products in the EU, by laying down uniform rules for the marketing of these products and by providing a common technical language to assess the performance of construction products. In this way the Regulation also enables EU countries to ensure the safety of construction works.
- Cosmetic Products RegulationRegulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
Regulation (EC) No 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality. The regulation replaces Directive 76/768/EC, which was adopted in 1976 and had been substantially revised on numerous occasions.
- Detergents RegulationRegulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
Regulation (EC) No 648/2004 on detergents ensures that only detergents with surfactants that are fully biodegradable may be placed on the market. In addition, detergent labels must contain ingredient and dosage information. This is to protect the health of consumers, especially against allergies, and to avoid the over-use of detergents.
- EU Ecolabel RegulationRegulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel
Established in 1992 and recognised across Europe and worldwide, the EU Ecolabel is a label of environmental excellence that is awarded to products and services meeting high environmental standards throughout their life-cycle: from raw material extraction, to production, distribution and disposal.
- Fertilisers RegulationRegulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers
Regulation 2003/2003/EC consolidates all the European Union rules that apply to fertilisers, and ensure that the technical requirements outlined in the regulation are implemented uniformly. The regulation only applies to mineral fertilisers consisting of one or more plant nutrients. Annex I lists fertilizer types according to their specific characteristics. Fertilisers that meet this type designation may be sold and used throughout the EU. For a new type designation to be listed in Annex I, the manufacturer must submit a request with a national competent authority, which is then forwarded to the European Commission, which consults the other EU countries and decides to accept or reject the application. Regulation 2003/2003/EC has been repealed with effect from 16 July 2022 by Regulation 2019/1009/EU.
- General Product Safety DirectiveDirective 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety
The Directive, also known as the General Product Safety Directive (GPSD), requires firms to ensure that items on sale are safe and to take corrective action when it is found not to be the case. It introduces an EU rapid alert system for dangerous non-food products. This enables national authorities to share information promptly on any measures taken to withdraw such products from sale.
- In Vitro Diagnostic Medical Devices DirectiveEU. Hazardous Substances for Purposes of Art. 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices
The Directive aims to guarantee the smooth operation of the single market by harmonising different national legislation on the reliability of in vitro diagnostic devices. It provides a high level of protection for the health and safety of patients, users and others and ensures the devices achieve the results for which they are intended.
- Medical Devices DirectiveCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices
The aim of Directive 93/42/EEC is to ensure a high level of protection for human health and safety, smooth operation of the single market and to achieve the results for which medical devices are intended. Specifically, it harmonises national legislation on medical devices. This ensures universally high safety standards for patients, giving the public confidence in the system. It enables the products to be used in any European Union country.
- Pressure Equipment DirectiveDirective 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast)
Directive 2014/68/EU lays down essential safety requirements for pressure equipment and assemblies (such as boilers, pressure cookers, fire extinguishers, heat exchangers and steam generators). All stationary pressure equipment must conform to strict specifications if it is to be sold in the EU.
- Toy Safety DirectiveDirective 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys
The Directive sets out the safety requirements that toys made available in the EU must meet. These requirements are designed to provide a high level of health and safety, to protect the public and the environment and to guarantee free movement of toys in the EU. It identifies the particular responsibilities of different operators in the supply chain from manufacturer to importer/retailer/distributor.