In 2016 several updated or recast EU Directives entered into force that impact many consumer and industrial market segments. These new Directives were a result of the New Legislative Framework to clarify responsibilities of both member states and responsible parties, as well as update the language in the Directives. Specifically the new directives set out to:
- Improve the market surveillance rules to better protect users from unsafe products
- Set clear and transparent rules for the accreditation of conformity assessment bodies
- Establish a common legal framework for industrial products
- Clarify the meaning of the CE marking and enhance credibility
The alignment package consisted of the following eight directives:
- Low Voltage Directive – 2014/35/EU;
- Electromagnetic Compatibility Directive: 2014/30/EU;
- ATEX Directive – 2014/34/EU;
- Lifts Directive – 2014/33/EU;
- Simple Pressure Vessels Directive – 2014/29/EU;
- Measuring Instruments Directive – 2014/32/EU;
- Non-automatic Weighing Instruments Directive – 2014/31/EU;
- Civil Explosives Directive – 2014/28/EU.
In addition to the eight directives, there was aligned legislation that impacted seven other directives which included Pyrotechnic Articles (Directive 2013/29/EU), Toy Safety (2009/48/EU), Restriction of Hazardous Substances in Electrical and Electronic Equipment (2011/65/EU), Recreational Craft (2013/53/EU), Radio Equipment (2014/53/EU), Pressure Equipment (2014/68/EU) and Marine Equipment (2014/90/EU).
In this article we are going to look at the impact of the Low Voltage Directive, EMC Directive, and ATEX Directive which went into force on April 20, 2016. We will also look at the Radio Equipment Directive which went into force on June 13, 2016. We selected to focus on these four directives in this article because of the broad reach of these requirements on many of our clients.
Low Voltage Directive
The Low Voltage Directive was repealed and replaced by the recast or new Low Voltage Directive. For those of you who track these by the Directive numbers, the old Low Voltage Directive 2006/95/EC was replaced by 2014/35/EU. The major changes in the recast Low Voltage Directive include:
- Change of scope to include the protection of people, domestic animals, and property (Article 1)
- Market surveillance procedures have been added (Article 19)
- Clarifying the responsibility of the manufacturer in preparing the documentation for CE Marking and the EU DoC (Article 6)
- Traceability via a type, batch, serial number, or other means of identifying the product (Article 6)
- Retention of documentation and DoC for 10 years after placing the product on the market (Article 6; Article 7; Article 8; Annex III, Module 2, 4.2 )
- Technical documentation must include an analysis of risk associated with the product (Annex III, Module A, 2)
When is it effective?
- The old Low Voltage Directive was repealed on April 20, 2016. (Article 27)
- The recast Low Voltage Directive went into force on April 20, 2016. (Article 28)
How do you know if you are subject to the Low Voltage Directive?
- If your product operates with an input voltage greater than 50 VAC and less than 1,000 VAC or 75 VDC and less than 1,500 VDC then your product is subject to the Low Voltage Directive.
- Products with an input voltage less than 50 VAC or 75 VDC are still subject to the General Product Safety Directive.
- Electrical equipment for use in an explosive atmosphere, radiological and medical purpose, lifts, electricity meters, plugs and socket outlets, electric fence controllers, Radio-electrical interference or special use equipment such as ships, aircraft, railways, or custom built for research and development facilities is excluded from the scope of the Low Voltage Directive, but likely covered under other specific Directives. (see Annex II)
- If your product is subject the Radio Equipment Directive (Previously the R&TTE Directive), then your product is subject to the Low Voltage Directive regardless of the operating voltage. (2014/53/EU, Article 3)
What should you do?
- Check the standards your product was tested to and make sure the testing is up to date with changes in the standards. If not, you will want to have testing conducted to ensure the product meets the latest adopted standard in the Official Journal. You can check the harmonized standards that are published in the Official Journal at the following URL: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/low-voltage_en and then select the Low Voltage Directive. The list of harmonized standards are not changing between the old and recast Directive.
- Update your DoC to reflect the Directives and standards the product complies with. Products being placed on the market in the EU on or after April 20, 2016 subject to the Low Voltage Directive should reference the recast Low Voltage Directive 2014/35/EU.
- Review your CE marking on your product and ensure it complies with the requirements.
- Make sure your retention policy for your technical construction file meets the 10 year requirement in the Low Voltage Directive from the time the product is placed on the EU market.
EMC Directive
The EMC Directive was repealed and replaced by the recast or new EMC Directive. For those of you who track these by the Directive numbers, the old EMC Directive 2004/108/EC was replaced by 2014/30/EU. The changes or enhancements in language in the recast EMC Directive include:
- Specifically requires the name and address of the manufacturer on the apparatus unless it is not possible, then on the packaging (Article 7)
- Retention of documentation and DoC for 10 years after placing the product on the market (Article 7)
- Traceability via a type, batch, serial number, or other means of identifying the product (Article 7)
- The DoC shall be translated into the language or languages required by the member state in which the apparatus is placed or made available on the market (Article 15)
- Market surveillance procedures have been added (Chapter 5)
When is it effective?
- The old EMC Directive was repealed on April 20, 2016. (Article 45)
- The recast EMC Directive went into force on April 20, 2016. (Article 46)
How do you know if you are subject to the EMC Directive?
- If your product is available on the market as a single function unit, intended for the end user, and liable to generate an electromagnetic disturbance or if the performance of the product is likely to be impacted by electromagnetic disturbances.
- The Directive provides for some exemptions in very special cases. (See Articles 2 & 3)
What should you do?
- Check the standards your product was tested to and make sure the testing is up to date with changes in the standards. If not, you will want to have testing conducted to ensure the product meets the latest adopted standard in the Official Journal. You can check the harmonized standards that are published in the Official Journal at the following URL: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/electromagnetic-compatibility_en and then select the EMC Directive. The list of harmonized standards are not changing between the old and recast Directive.
- Update your DoC to reflect the Directives and standards the product complies with. Products being placed on the market in the EU on or after April 20, 2016 subject to the EMC Directive should reference the recast EMC Directive 2014/30/EU.
- Review your CE marking on your product and ensure it complies with the requirements.
- Make sure your retention policy for your technical construction file meets the 10 year requirement in the EMC Directive from the time the product is placed on the EU market.
ATEX Directive
The ATEX Directive was repealed and replaced by the recast or new ATEX Directive. For those of you who track these by the Directive numbers, the old ATEX Directive 94/9/EC was replaced by 2014/34/EU. The changes or enhancements in language in the recast ATEX Directive include:
- Change in the content of the DoC to an EU DoC (Annex X)
- Updated terminology throughout the document
- Additional definitions of terms (Article 2)
- Scope has been clarified to include components intended to be incorporated into equipment and protective systems (Article 1)
- Clarifies obligations of manufacturers, authorized representatives, importers and distributors
When is it effective?
- The old ATEX Directive will be repealed on April 20, 2016. (Article 43)
- The recast ATEX Directive goes into force on April 20, 2016. (Article 44)
How do you know if you are subject to the ATEX Directive?
- Any product intended to be used in a potentially explosive atmosphere is likely subject to the ATEX Directive. This would include products or components used in for safety, controlling, or regulating devices also intended for use in potentially explosive atmospheres.
- This Directive does not apply to medical devices for use in a medical environment, equipment intended for use in domestic and non-commercial environments where explosive atmospheres do not normally exist, PPE, seagoing vessels and off shore units. (See Article 1 for more details)
What should you do?
- Check the standards your product was tested to and make sure the testing is up to date with changes in the standards. If not, you will want to have testing conducted to ensure the product meets the latest adopted standard in the Official Journal. You can check the harmonized standards that are published in the Official Journal at the following URL: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/equipment-explosive-atmosphere_en and then select the ATEX Directive. The list of harmonized standards is not changing between the old and recast Directive.
- Update your DoC to reflect the changes in Annex X of 2014/34/EU and standards the product complies with. Products being placed on the market in the EU on or after April 20, 2016 subject to the ATEX Directive should reference the recast ATEX Directive 2014/34/EU.
- Review your CE marking on your product and ensure it complies with the requirements.
- Make sure your retention policy for your technical construction file meets the 10 year requirement in the ATEX Directive from the time the product is placed on the EU market.
Radio Equipment Directive
The Radio and Telecommunications Terminal Equipment (R&TTE) Directive was repealed and replaced by the Radio Equipment Directive. For those of you who track these by the Directive numbers, the R&TTE Directive 1999/5/EC is being replaced by 2014/53/EU. The updated Radio and Telecommunications Terminal Equipment Directive is being referred to as the Radio Equipment Directive (RED). The changes or enhancements in language in the recast Radio Equipment Directive (RED) include:
- Name change is significant as Telecom Terminal Equipment is not included in this Directive
- Broadcast receivers are now included in the scope of the Radio Equipment Directive (Article 2)
- Updates the Directive in line with the new legislative framework as done in the other Directives.
- Provides a transition period between the old Directive and the new Directive (Article 48)
- Promotes use of a common charger for radio equipment (Article 3; Article 47)
- Updates responsibilities for manufacturers, importers, and market surveillance
When is it effective?
- The old Radio and Telecommunications Terminal Equipment Directive was repealed on June 13, 2016. (Article 50)
- The recast Radio Equipment Directive went into force June 13, 2016. (Article 49)
- There is a one year transition period until June 13, 2017 where product certified under the R & TTE could still be placed on the market (Article 48)
How do you know if you are subject to the Radio Equipment Directive?
- If your product is subject to the Radio Equipment Directive if it intentionally emits or receives radio waves for the purpose of radio communication, radio determination, or is an electrical or electronic product which when completed with an accessory such as an antenna will intentionally emit or receive radio waves for the purpose of radio communication or radio determination. (Article 1)
- Products that are used exclusively for public security, defense, state security, radio kits, and products under specific Directives or other regulations are excluded. (Article 1; Annex I)
What should you do?
- Check the standards your product was tested to and make sure the testing is up to date with changes in the standards. If not, you will want to have testing conducted to ensure the product meets the latest adopted standard in the Official Journal. You can check the harmonized standards that are published in the Official Journal at the following URL: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/red_en and then selecting the Radio and telecommunications Terminal Equipment Directive.
- Update your DoC to reflect the Directives and standards the product complies with. Existing products being placed on the market in the EU have a one year transition period. New products placed on the market after June 13, 2016 is subject to the Radio Equipment Directive 2014/53/EU.
- Review your CE marking on your product and ensure it complies with the requirements.
- Make sure your retention policy for your technical construction file meets the 10 year requirement in the Radio Equipment Directive from the time the product is placed on the EU market.