A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
The LVD 2014/35/EU (Low Voltage Directive) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits is entered into force on the 20th April 2016 replacing the previous Directive 2006/95/EC.
The Low Voltage Directive was one of the eight directives harmonised with NLF as a part of a so-called ’Alignment Package’.
EU Legislation on Low-Voltage Products
The Low Voltage Directive ensures that electrical equipment provides a high level of protection of health and safety of persons, and of domestic animals and property.
Therefore, the Low Voltage Directive lays down the essential requirements to protect against hazards that could arise from within the electrical equipment itself or from external influences.
- Chapter 1: General Provisions- Article 1-5
- Chapter 2: Obligation of economic operators- Article 6-11
- Chapter 3: Conformity of the electrical equipment – Article 12- 17
- Chapter 4: Union market surveillance and control of apparatus entering the Union market and Union safeguard procedure – Article 18-22
- Chapter 5: Committee, Transitional and final provisions – Article 23- 29
- Annex I: Principal elements of the safety objectives for electrical equipment designed for use within certain voltage limits
- Annex II: Equipment and phenomena outside the scope of this Directive
- Annex III: Module A – Internal production control
- Annex IV: EU Declaration of Conformity
- Annex V: Time-limits for transposition into national law and dates of application of the Directives set out in Part B of Annex V to Directive 2006/95/EC
- Annex VI: Correlation table
The term “electrical equipment” is not defined in the directive. It is to be interpreted according to the internationally recognized meaning of this term. The definition of electric equipment in the International Electro Technical Vocabulary of IEC (International Electro Technical Commission) is: “item used for such purposes as generation, conversion, transmission, distribution or utilization of electrical energy, such as machines, transformers, switchgear and control gear, measuring instruments, protective devices, wiring material, current-using equipment.”
The LVD Directive includes both electrical equipment and components designed for use with a voltage rating between 50 and 1000 V for alternating current (AC) or between 75 and 1500 V for direct current (DC). These voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.
Equipment listed in Annex II LVD 2014/35/EU are excluded from the scope of the Directive:
- Electrical equipment for use in an explosive atmosphere
- Electrical 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
- Specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.
- Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
In the main, these are items which are covered under other more specific directives or which are subject to international legislation outside of the jurisdiction of the EU.
Conformity assessment procedure (Annex III- Internal production control)
The manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the directive. It contains at least the elements set out in the Annex III.
The essential requirements
The essential requirements cover all risks arising from the use of electrical equipment, including not just electrical ones but also mechanical, chemical (such as, in particular, emission of aggressive substances), health aspects of noise and vibration, and ergonomic aspects which could cause hazard within the scope of the LVD Directive.
Evidently, non-compliant products enter the EU Market everyday – whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.
As there is no “approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
- Being publicly reported to the RAPEX
- Warehousing Fees
- Requested Withdrawal
- Mandated Withdrawal
- Product Recall (from end-users and/or the market)
- Complete ban on marketing of the product
- Destruction of the product
- Revocation of the CE Marking
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes,
- Continual updating of the technical file as modifications are made to the product,
- Reporting of any incidents related to the product use,
- Removal of non-compliant batches from EU economics operators and end-user,
- Keeping technical file available for 10 years after the last batch entered the EU market.
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.