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Here is a guide to various directives and safety statutes.
Machinery Directive (MD)
Low Voltage Directive (LVD)
Pressure Equipment Directive (PED)
ATEX-Guidelines (Third Edition)
REACH
RoHS and WEEE
EIGA
What products are to be CE-marked?
Go to this link (in Swedish) to find clear, comprehensive information about which products are to be CE-marked, and how to go about it. Here can be found, for example, information concerning legislation and accountable authorities, as well as information about forms.
Machinery Directive (MD)
Machinery Directive (98/37/EG) applies as of 1 January, 1995. Manufacturers planning to sell their products within the EES-area must meet the requirements of this machine directive. This also applies to those that merely manufacture or sell machines for their own use. A new, revised machine directive was published on 9 June, 2006. The new directive (2006/42/EEG) will come into force on 29 December, 2009. Until then, the present directive will apply. The EU Commission has a website that contains information concerning this subject. Links:
To the MD website of the EU-Commission.
To more information about the Machinery Directive (In Swedish).
Low Voltage Directive (LVD)
Directive 2006/95/EC* was issued on 19 February, 1973, and dealt with harmonizing member state legislation involving electrical equipment intended for use within specified voltage ranges. This was changed by directive 93/68/EEG. The LVD states that electrical material is to meet what is called “a good technical safety practice”. The directive was issued by the European Commission and is intended to provide uniform regulations for electrical safety within the EU/EES. These directives have been adopted into Swedish legislation through the electrical act, the electrical material ordinance and regulations of the Swedish National Electrical Safety Board.
The directive applies to all electrical equipment intended for use with rated voltages between 50 and 1,000 volts for alternating current, and between 75 and 1,500 volts for direct current. The rated voltage refers to both in and out flowing currents, not voltage that arises in the equipment. The term “electrical equipment” is not defined in the directive and is therefore to be defined in accordance with known international concepts. Electrical and electronic material is also normally covered by the electromagnetic compatibility regulations (see EMC-directive). The EU commission has a website for low-voltage equipment that offers a good deal of information regarding the subject. Links:
To the LVD website of the EU-Commission.
To the EMC website of the EU-Commission.
To the regulations of the Swedish National Electrical Safety Board (in Swedish).
*In 2006 directive 73/23/EEC has been the subject of a codification, requiring a new number. Readers should note that the text itself is identical, the changes from directive 93/68/EEG have been implemented.
Pressure Equipment Directive (PED)
As of 29 November, 1999, there is a common EU directive for pressure equipment. The EU directive (97/23/EG) specifies the basic health and safety requirements regarding the design, manufacture, and installation of pressure vessels, pipes, and other equipment having a positive and a negative pressure difference. These regulations governing the sale of products on markets within the EES area (EU countries plus Iceland, Liechtenstein, and Norway) also apply to sales limited solely to Sweden. Links:
To the PED website of the EU-Commission.
To more information about PED (in Swedish).
ATEX-Guidelines
(third edition, updated June 2009)
The ATEX-Guidelines (Third Edition, updated June 2009) have now been published. The ATEX-Guidelines are intended as a manual for those affected by directive 94/9/EG, the purpose being that all should apply the directive in the same way. A vital content of the guidelines are the interpretations by the committee. The committee also provides examples of how the directive is to be applied to equipment that is to be used as an interface in various types of potentially explosive environments. The original version in English (ATEX-Guidelines, Third Edition, updated June 2009) is available from the European Commission's website. Links:
To the ATEX website of the EU-commission.
Download:
ATEX-Guidelines (Third Edition, updated June 2009) (Pdf 1069kb).
REACH
As of 1 June, 2007, a new common chemical law is to apply throughout the EU: REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). It is believed that REACH will promote the safe handling of chemicals as well as focus on an advanced knowledge of the characteristics and effects of chemicals.
This legislation stipulates that all chemicals used in the EU are to be registered, evaluated and approved, which is to lead to their use becoming more limited. The responsibility of developing knowledge regarding the properties of chemicals rests on the industry. This information will then be disseminated in a joint EU-register.
This means that chemicals that are not registered in accordance with REACH may not be manufactured nor used within the EU.
• Pre-registration, step 1
All substances currently used within the EU should have been pre-registered by each manufacturer and importer between June 1, 2008, and December 1, 2008. A non-pre-registered substance may no longer be manufactured, imported nor supplied to the EU after December 1, 2008, without first having undergone a complete registration.
In some cases it may be possible to make a pre-registration instead of a complete registration if a substance, in quantities over one tonne a year, is manufactured or imported into the EU for the first time after December 1, 2008.
• Registration, step 2
All substances that are either manufactured within or imported into the EU in quantities of one tonne a year per manufacturer or importer must be registered. The registration of chemicals in the EU will be taking place gradually over a period of 11 years, whereby all chemical substances produced in large quantities (over 1,000 tonnes a year), i.e. substances suspected to be persistent and bio-accumulative, are to be registered first, that is to say, within 3.5 years.
More information about the directive is available here:
To the REACH website of the EU-commission.
To the Swedish Chemical Agency (KemI) (in Swedish).
RoHS (Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment) and WEEE (Waste Electrical and Electronic Equipment)
These directives apply to all of the EU, and their purpose is to eliminate environmentally hazardous materials from electrical and electronic waste.
In Sweden, it is the Swedish Chemical Agency (KemI) that addresses issues concerning RoHS (2002/95/EG), and the Swedish Environmental Protection Agency that deals with WEEE (2002/96/EG) issues.
• WEEE
On 13 August, 2005, the Producers' Ordinance governing responsibilities for packaging was augmented to include electrical and electronic products by SFS 2005:209 (Producers’ Ordinance governing electrical and electronic products). This ordinance was based on the WEEE directive (2002/96/EG) that all the member states are now implementing.
The purpose of the producers’ ordinance is that electrical and electronic products are to be designed and manufactured in such a manner that they ultimately create no waste. Producers, for example, are to CE-mark their products, ensure that a system for collecting electrical waste is operative, and also ensure that such waste is reused, recycled or taken care of in an environment-friendly manner.
All producers to which the producers’ responsibilities ordinance applies are, at various times, to:
• enter themselves into the EE-register (National Swedish Register, in Swedish),
• report how they plan to carry out collection as well as where others can find out how discarded products are to be taken care of,
• report quantities sold and quantities collected and processed, and report final disposition.
• RoHS
Directive 2002/95/EG (RoHS) bans the use of mercury, cadmium, lead, hexavalent chromium (Cr6+), and PBDE/PBB (Brominated Flame Retardants) in new electrical and electronic products released on the market as of 1 July, 2006. The directive has been adopted into Swedish legislation as ordinances.
The RoHS covers various product categories (the same product ranges as for WEEE) and additional categories are being studied. Furthermore, the directive has exempted some areas of use, and it also has a number of grey-zone areas. See the website of the Swedish Chemical Agency (KemI). There you will also find a FAQ-document for further guidance.
You are naturally welcome to contact Improvus for support in determining whether RoHS and WEEE apply to your products. Links:
To Directive 2002/95/EC (RoHS)
To Directive 2002/96/EC (WEEE)
To the website of the Swedish Chemical Agency (KemI).
EIGA, European Industrial Gases Association
Here, it is possible to find a number of informative pages on safety and environmental issues involving industrial gases.
Here is a guide to various directives and safety statutes.
Machinery Directive (MD)
Low Voltage Directive (LVD)
Pressure Equipment Directive (PED)
ATEX-Guidelines (Third Edition)
REACH
RoHS and WEEE
EIGA
What products are to be CE-marked?
Go to this link (in Swedish) to find clear, comprehensive information about which products are to be CE-marked, and how to go about it. Here can be found, for example, information concerning legislation and accountable authorities, as well as information about forms.
Machinery Directive (MD)
Machinery Directive (98/37/EG) applies as of 1 January, 1995. Manufacturers planning to sell their products within the EES-area must meet the requirements of this machine directive. This also applies to those that merely manufacture or sell machines for their own use. A new, revised machine directive was published on 9 June, 2006. The new directive (2006/42/EEG) will come into force on 29 December, 2009. Until then, the present directive will apply. The EU Commission has a website that contains information concerning this subject. Links:
To the MD website of the EU-Commission.
To more information about the Machinery Directive (In Swedish).
Low Voltage Directive (LVD)
Directive 2006/95/EC* was issued on 19 February, 1973, and dealt with harmonizing member state legislation involving electrical equipment intended for use within specified voltage ranges. This was changed by directive 93/68/EEG. The LVD states that electrical material is to meet what is called “a good technical safety practice”. The directive was issued by the European Commission and is intended to provide uniform regulations for electrical safety within the EU/EES. These directives have been adopted into Swedish legislation through the electrical act, the electrical material ordinance and regulations of the Swedish National Electrical Safety Board.
The directive applies to all electrical equipment intended for use with rated voltages between 50 and 1,000 volts for alternating current, and between 75 and 1,500 volts for direct current. The rated voltage refers to both in and out flowing currents, not voltage that arises in the equipment. The term “electrical equipment” is not defined in the directive and is therefore to be defined in accordance with known international concepts. Electrical and electronic material is also normally covered by the electromagnetic compatibility regulations (see EMC-directive). The EU commission has a website for low-voltage equipment that offers a good deal of information regarding the subject. Links:
To the LVD website of the EU-Commission.
To the EMC website of the EU-Commission.
To the regulations of the Swedish National Electrical Safety Board (in Swedish).
*In 2006 directive 73/23/EEC has been the subject of a codification, requiring a new number. Readers should note that the text itself is identical, the changes from directive 93/68/EEG have been implemented.
Pressure Equipment Directive (PED)
As of 29 November, 1999, there is a common EU directive for pressure equipment. The EU directive (97/23/EG) specifies the basic health and safety requirements regarding the design, manufacture, and installation of pressure vessels, pipes, and other equipment having a positive and a negative pressure difference. These regulations governing the sale of products on markets within the EES area (EU countries plus Iceland, Liechtenstein, and Norway) also apply to sales limited solely to Sweden. Links:
To the PED website of the EU-Commission.
To more information about PED (in Swedish).
ATEX-Guidelines
(third edition, updated June 2009)The ATEX-Guidelines (Third Edition, updated June 2009) have now been published. The ATEX-Guidelines are intended as a manual for those affected by directive 94/9/EG, the purpose being that all should apply the directive in the same way. A vital content of the guidelines are the interpretations by the committee. The committee also provides examples of how the directive is to be applied to equipment that is to be used as an interface in various types of potentially explosive environments. The original version in English (ATEX-Guidelines, Third Edition, updated June 2009) is available from the European Commission's website. Links:
To the ATEX website of the EU-commission.
Download:
ATEX-Guidelines (Third Edition, updated June 2009) (Pdf 1069kb).
REACH
As of 1 June, 2007, a new common chemical law is to apply throughout the EU: REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). It is believed that REACH will promote the safe handling of chemicals as well as focus on an advanced knowledge of the characteristics and effects of chemicals.
This legislation stipulates that all chemicals used in the EU are to be registered, evaluated and approved, which is to lead to their use becoming more limited. The responsibility of developing knowledge regarding the properties of chemicals rests on the industry. This information will then be disseminated in a joint EU-register.
This means that chemicals that are not registered in accordance with REACH may not be manufactured nor used within the EU.
• Pre-registration, step 1
All substances currently used within the EU should have been pre-registered by each manufacturer and importer between June 1, 2008, and December 1, 2008. A non-pre-registered substance may no longer be manufactured, imported nor supplied to the EU after December 1, 2008, without first having undergone a complete registration.
In some cases it may be possible to make a pre-registration instead of a complete registration if a substance, in quantities over one tonne a year, is manufactured or imported into the EU for the first time after December 1, 2008.
• Registration, step 2
All substances that are either manufactured within or imported into the EU in quantities of one tonne a year per manufacturer or importer must be registered. The registration of chemicals in the EU will be taking place gradually over a period of 11 years, whereby all chemical substances produced in large quantities (over 1,000 tonnes a year), i.e. substances suspected to be persistent and bio-accumulative, are to be registered first, that is to say, within 3.5 years.
More information about the directive is available here:
To the REACH website of the EU-commission.
To the Swedish Chemical Agency (KemI) (in Swedish).
RoHS (Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment) and WEEE (Waste Electrical and Electronic Equipment)
These directives apply to all of the EU, and their purpose is to eliminate environmentally hazardous materials from electrical and electronic waste.
In Sweden, it is the Swedish Chemical Agency (KemI) that addresses issues concerning RoHS (2002/95/EG), and the Swedish Environmental Protection Agency that deals with WEEE (2002/96/EG) issues.
• WEEE
On 13 August, 2005, the Producers' Ordinance governing responsibilities for packaging was augmented to include electrical and electronic products by SFS 2005:209 (Producers’ Ordinance governing electrical and electronic products). This ordinance was based on the WEEE directive (2002/96/EG) that all the member states are now implementing.
The purpose of the producers’ ordinance is that electrical and electronic products are to be designed and manufactured in such a manner that they ultimately create no waste. Producers, for example, are to CE-mark their products, ensure that a system for collecting electrical waste is operative, and also ensure that such waste is reused, recycled or taken care of in an environment-friendly manner.
All producers to which the producers’ responsibilities ordinance applies are, at various times, to:
• enter themselves into the EE-register (National Swedish Register, in Swedish),
• report how they plan to carry out collection as well as where others can find out how discarded products are to be taken care of,
• report quantities sold and quantities collected and processed, and report final disposition.
• RoHS
Directive 2002/95/EG (RoHS) bans the use of mercury, cadmium, lead, hexavalent chromium (Cr6+), and PBDE/PBB (Brominated Flame Retardants) in new electrical and electronic products released on the market as of 1 July, 2006. The directive has been adopted into Swedish legislation as ordinances.
The RoHS covers various product categories (the same product ranges as for WEEE) and additional categories are being studied. Furthermore, the directive has exempted some areas of use, and it also has a number of grey-zone areas. See the website of the Swedish Chemical Agency (KemI). There you will also find a FAQ-document for further guidance.
You are naturally welcome to contact Improvus for support in determining whether RoHS and WEEE apply to your products. Links:
To Directive 2002/95/EC (RoHS)
To Directive 2002/96/EC (WEEE)
To the website of the Swedish Chemical Agency (KemI).
EIGA, European Industrial Gases Association
Here, it is possible to find a number of informative pages on safety and environmental issues involving industrial gases.
Improvus
AB, Dalénum 11, SE-181 70 Lidingö, SWEDEN, Phone: +46 (0)
8 731 71 17
Improvus AB, Dalénum
31, SE-181 70 Lidingö, SWEDEN, Phone: +46 (0) 8 731 71 17
