Electrical Equipment Safety Regulations

Electrical Equipment Safety Regulations

Electrical Equipment (Safety) Regulations 2016

This Regulation shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, It applies to a wide range of electrical equipment for both consumer and professional usage, such as;

• household appliances
• cables
• power supply units
• laser equipment
• certain components, e.g. fuses.

For products with multiple voltage ratings, input or output, the products are considered within the scope of the Electrical Equipment (Safety) Regulations as soon as the highest of the ratings falls within the given voltage rating. Accordingly, electrical equipment exceeding 1000 V AC or 1500 V DC falls outside the scope of the Regulations, as such equipment is not designed for use within the voltage ratings.

Battery operated equipment outside the voltage rating is obviously outside the scope of the Regulations. Nevertheless, any accompanying battery-charger, as well as equipment with integrated power supply unit within the voltage ranges of the Regulations, are in the scope of the Electrical Equipment (Safety) Regulations. This applies also, in the case of battery-operated equipment with supply voltage rating below 50 V AC and 75 V DC, for their accompanying power supply unit (e.g. laptops).

In general, the scope of the Electrical Equipment (Safety) Regulations includes both electrical equipment intended for incorporation into other equipment and equipment intended to be used directly without being incorporated.

However, some types of electrical devices, designed and manufactured for being used as basic components to be incorporated into other electrical equipment, are such that their safety to a very large extent depends on how they are integrated into the final product and the overall characteristics of the final product. These basic components include electronic and certain other components.

Taking into account the objectives of the Electrical Equipment (Safety) Regulations, such basic components, the safety of which can only, to a very large extent, be assessed taking into account how they are incorporated and for which a risk assessment cannot be undertaken, then they are not covered as such by the Electrical Equipment (Safety) Regulations. In particular, they must not be UKCA marked unless covered by other regulations that requires UKCA marking.

However, other electrical components that are intended to be incorporated into other equipment and for which a risk assessment can be undertaken, such as transformers and electrical motors, are covered as such by the Electrical Equipment (Safety) Regulations and must be UKCA marked.

The General Product Safety Regulations 2005 UK Statutory Instrument 2005 No 1803 covers consumer goods with a voltage below 50 V for alternating current, or below 75 V for direct current. It aims to ensure that only safe consumer products are sold in the EU.

Equipment Outside 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.

Key Definitions

Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. From 1 January 2021, authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.

Declaration of conformity – A document prepared by the manufacturer which must detail the following: o The specific electrical equipment to which the declaration is referring o The name and address of the manufacturer and, where applicable, their authorised representative This must be kept by the manufacturer for a period of ten years from the date on which the electrical equipment was placed on the GB market. This declaration must be made available to the enforcing authority upon request.

Distributor – Any person in the GB supply chain, other than the manufacturer or the importer, who makes electrical equipment available on the GB market.

Enforcing Authority – In Great Britain, for equipment in the use in the workplace, this is the Health and Safety Executive. For products for consumer use this is local trading standards authorities. For nuclear sites in Great Britain, the Office for Nuclear Regulation is the enforcing authority.

Importer - A person established in the UK who places electrical equipment from a country outside of the UK on the GB market. This includes a person based in NI who has been supplied with the product from an EEA country, who would, under NI law, be a distributor. A person, who before 1 January 2021 (under EU Rules) distributed electrical equipment within the UK or the EU or from Switzerland, is now an importer if they are bringing such equipment into GB from another country (including EU Member States, the EEA or Switzerland).

Manufacturer – A person who manufactures electrical equipment, or has electrical equipment designed or manufactured, and markets that equipment under their name or trademark.

UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including electrical equipment) being placed on the GB market, in place of the CE marking which is the conformity marking used in Northern Ireland and the European Union.

UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.

Obligations of Manufacturer’s

A manufacturer is a person who manufactures electrical equipment, or has electrical equipment designed or manufactured, and markets that equipment under their name or trademark.

The obligations of manufacturers of electrical equipment include:

1. Before placing electrical equipment on the GB market, the manufacturer must ensure that the equipment has been designed and manufactured in accordance with the principal elements of the safety objectives. These are set out in Schedule 1 to the Regulations. Manufacturers must also have a relevant conformity assessment procedure carried out and technical documentation is drawn up.
2. Once this has been done, the manufacturer must draw up a declaration of conformity, and affix the UKCA marking visibly, legibly and indelibly to the equipment. Where this is not possible or warranted because of the nature of the equipment, the UKCA marking must be affixed on the packaging and accompanying documents. In any event, until 31 December 2022, the UKCA marking may be affixed to a label or a document accompanying the equipment.
3. Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings,
4. Manufacturers must store the technical documentation and the declaration of conformity for 10 years in the UK after the equipment has been placed on the GB market and make them available for inspection to the market surveillance authority.
5. Manufacturers must also label the equipment with their name, registered trade name or registered trademark and address; the type batch or serial number (or other identification); and ensure that it is accompanied by instructions which are clear, legible and in easily understandable English.
6. Manufacturers must ensure that procedures are in place for series production to remain in conformity with Part 2 of the 2016 Regulations. In doing so, they must take account of any changes in electrical equipment design or characteristics, and any change in a designated standard or in another technical specification by reference to which the UK Declaration of Conformity was drawn up.
7. Manufacturers must, when appropriate with regard to any risk posed to consumers, carry out sample testing of equipment they have placed on the GB market and must investigate any complaints that the electrical equipment is not in conformity with the legal requirements of the 2016 Regulations and keep records of these complaints.
8. Manufacturers must take action where they have reason to believe that the electrical equipment they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations; where the equipment presents a risk, the manufacturer must immediately inform the market surveillance authority.
9. Manufacturers must also cooperate with and provide information to enforcing authorities, such as local trading standards authorities, following any reasoned requests within 10 years of placing the equipment on the market.

Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals. However, they will also have to comply with the importer labelling duties (see obligations of importers).

Obligations of Authorised Representatives

Manufacturers are able by written mandate to appoint authorised representatives to perform certain tasks on their behalf.

Mandated authorised representatives for the GB market can be based in GB or Northern Ireland but after 1 January 2021 cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK under the Regulations as they apply in GB.

No GB-based authorised representatives are recognised under EU law to carry out tasks on the manufacturer’s behalf for equipment being placed on the EU market. This means that GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling equipment to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of that equipment, must appoint an authorised representative based in Northern Ireland or the EEA.

An authorised representative must comply with the duties imposed on the manufacturer, in particular, regulation 7 (retention of technical documentation) and regulation 13 (provision of information and cooperation), as well as perform other tasks which the mandate appoints them to perform.

The manufacturer remains responsible for the proper performance of any duties the authorised representative performs on their behalf.

Any references in the 2016 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties

Obligations of importers

An importer is a person or business based in the UK who places equipment on the GB market from a country outside the UK. This means that UK businesses which used to act as a ‘distributor’ before the end of the transition period legally become an ‘importer’ if they place products from an EEA country on the GB market.

This includes electrical equipment that is supplied to NI businesses from the EEA and then placed on the GB market. In this instance, the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market

Importers have additional legal obligations which go beyond those of distributors, such as checking that manufacturers have carried out the right conformity assessment procedures and including their (the importer’s) name, registered trade name or mark and a postal address on the equipment or, where this is not possible, on its packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2022 to allow UK distributors of goods from the EEA or Switzerland who become importers into the GB market to provide their details on the packaging or in accompanying documentation as an alternative to placing them on the equipment itself (even if it is otherwise possible to affix it to the electrical equipment itself). This applies to goods that are not qualifying Northern Ireland goods.

Can you be contacted easily if there is a problem?

A key principle underpinning product safety, for the benefit of consumers and regulators, is traceability of a product back to its source.

In recognition that under the new regulatory regime you may have the new status of an importer when placing goods from an EEA state on the GB market for the first time, you may provide your contact details by a document that accompanies the product. This will be allowed until 31 December 2022.

We understand that there may be a period of adjustment to the new arrangements for importer documentation for the GB market, and it may be difficult to provide your details on documentation accompanying each and every individual product.

You may therefore use an alternative method where, for example, your contact information is on a document accompanying a batch of products. This document would then follow each batch of products through the distribution chain. Your contact details must follow each product through the distribution chain, but not necessarily by one document per product. Ultimately, the end user, each distributor (and a regulator) must be able to access the information.

Methods which enable traceability of the product after the initial batch has been broken up could include:

• The importer address is present in shipping documents.
• The importer address is present on the invoice to the GB customer.
• The importer address is present on the label that is on the outer packaging (“shipper”) in which a number of finished goods are packed (normally customers will receive shippers unless the order is very small so that the shipper has to be opened and split).
• The importer address is included on the EU Declaration of Conformity and/or UK Declaration of Conformity (whichever is relevant for the product in question).

The EU does not have any such transitional provision. In the absence of this, equipment being sold from GB to NI or the EU must be labelled with the NI or EU-based importer’s address. For further detail about placing on the NI market please see:

https://www.gov.uk/guidance/product-safety-and-metrology-from-1-January-2021-northernireland

The obligations of importers in the UK include:

1. Before placing electrical equipment on the GB market, the importer must ensure that it is in conformity with the principal elements of the safety objectives and that the obligations in the 2016 Regulations have been met. If the electrical equipment presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

2. The importer must ensure that the relevant conformity assessment has been carried out by the manufacturer; the manufacturer has drawn up the technical documentation; the manufacturer has affixed the UKCA marking, to the equipment and has drawn up the declaration of conformity. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the equipment; this applies even where it would otherwise be possible to affix the UKCA marking to the equipment.

3. The importer must keep a copy of the declaration of conformity and technical documentation for a period of 10 years after the equipment has been placed on the GB market.

4. The importer must provide their name, registered trade name and a postal address at which they can be contacted on the electrical equipment or on its packaging or in an accompanying document.

5. The importer must ensure that equipment is accompanied by instructions which are in easily understandable English.

6. The importer must, when appropriate with regard to any risk posed to consumers, carry out sample testing of equipment they have placed on the GB market and investigate complaints about electrical equipment that is not in conformity with the legal requirements of the 2016 Regulations and keep a register of those complaints.

7. The importer must take action where they have reason to believe that the electrical equipment they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations.

8. The importer must ensure that while electrical equipment is under their responsibility, its storage and transport conditions do not jeopardise its conformity with the essential health and safety requirements.

9. The importer must also cooperate with and provide information to enforcing authorities following any requests.

Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may also be placed on the GB market.

Obligations of distributors

UK businesses that were distributors of electrical equipment within the EU single market should now consider whether they are importers from the EU single market and therefore what additional responsibilities they may have. The same applies to distributors of goods from the EEA and Switzerland. A distributor is any person, other than the manufacturer or importer, who makes electrical equipment available on the GB market.

The obligations of distributors include:

1. When making electrical equipment available on the GB market, the distributor must act with due care to ensure that it is in conformity with the principal elements of the safety objectives and that the obligations in the 2016 Regulations have been met.

2. Where a distributor considers that the equipment is not in conformity with the principal elements of the safety objectives, they must not make the equipment available on the GB market until it has been brought into conformity.

3. Before making equipment available on the GB market, the distributor must verify that the equipment bears the UKCA marking; is accompanied by the required instructions and safety information; and that the importer and manufacturer have complied with their obligations as to required labelling. The distributor must take action where they have reason to believe that the electrical equipment that they have made available on the GB market is not in conformity with the 2016 Regulations. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the equipment.

4. The distributor must also cooperate with and provide information to enforcing authorities following any requests.

Mandatory Safety Requirements

The Electrical Equipment (Safety) Regulations lays down the conditions to which electrical equipment should meet before being UKCA Marked and placed on the market;

All electrical equipment should be design and constructed taking into account good engineering practice in relation to safety matters. This means that the electrical equipment must be designed and manufactured according to the state of the art. (i.e. latest published standard)

Designed and constructed to conform with the principal elements of the safety objectives for electrical equipment designed for use within certain voltage limits which are shown at Schedule 1 to the Electrical Equipment (Safety) Regulations. These are the mandatory safety provisions, which electrical equipment must comply with in order to be allowed onto the GB market.

Electrical equipment must not pose a danger to health and safety of persons, domestic animals or damage to property when properly installed, maintained and used as intended by the manufacturer.

As the Electrical Equipment (Safety) Regulations places the responsibility to perform conformity assessment on the manufacturer: the manufacturer performs the conformity assessment and documents the assessment in his own right.

If you are a manufacturer, you have to follow these 7 steps to ensure compliance to the UKCA marking requirements:

1. Identify the applicable regulation(s) and designated standards
2. Verify product-specific requirements
3. Identify whether an independent conformity assessment (by a notified body) is necessary "There is no conformity assessment procedure in the Electrical Equipment (Safety) Regulations which requires the intervention of a notified body".
4. Test the product and check its conformity
5. Draw up and keep available the required technical documentation storing a copy in the UK if an importer
6. Affix the UKCA marking and draw up the UK Declaration of Conformity.
7. Ensure that procedures are in place for series production to remain in conformity with the applied regulation(s). "Changes in product design or characteristics and changes in the designated standards the international or national standards, or in other technical specifications by reference to which conformity of electrical equipment is declared shall be adequately taken into account".

Standard requirements

Standards have been defined as "an agreed, repeatable way of doing something". Normally they have published documents containing technical information to guide or define practice in a consistent way, and are used by designers and manufacturers of products to establish conformity.

Standards are valuable tools that can help your business to:

• ensure the quality and safety of products and/or services
• achieve compatibility between products and/or components
• access markets and sell to customers in other countries
• satisfy your customers’ expectations and requirements
• reduce costs, eliminate waste and improve efficiency
• comply with relevant legislation including other regulations identified
• gain knowledge about new technologies and innovations

Knowing which standards to use, and how to apply them in the correct way, is vital for the success of your business. It is also important to understand how standards contribute to the regulatory process.

Most Designated Standards require the manufacturer to conduct a level of testing to ensure the product meets the requirements of the standard and how to document this for the technical file

The extent of verification will be given in the dedicated product standard for a particular piece of electrical equipment. Where there is no dedicated product standard for the electrical equipment, the verification's shall always include the items a), b), c) and h) and may include one or more of the items d) to g):

a) verification that the electrical equipment complies with its technical documentation;
b) verification of continuity of the protective bonding circuit;
c) in case of fault protection by automatic disconnection of supply, conditions for protection
by automatic disconnection shall be verified;
d) insulation resistance test;
e) voltage test;
f) protection against residual voltage;
g) verification that the relevant requirements of the applied standard are met;
h) functional tests.

Identify the applicable Regulations and designated standards

When developing any product you first need to identify the mandatory regulations in the region you wish to place your product on the market, this can be achieved by reviewing the government websites, I know this is not easy and time-consuming, but this is where we can help. Note; If a regulation quotes a standard then that standard becomes mandatory too, but in the majority of cases standards are voluntary.

In the UK regulations state that a product is safe if it meets all essential safety requirements under UK law. If there are no regulations or designated standards, the product's compliance is determined according to other reference documents such as international standards, commission recommendations, codes of practice. This is most useful when supplying a new state of the art product on the market.

In accordance with Electrical Equipment (Safety) Regulations electrical equipment which is in conformity with designated standards or parts thereof, the references of which have been published in the Official Journal of the UK.GOV site, is to be presumed to be in conformity with the essential safety objectives.

Verify product-specific requirements

Unfortunately, there is only one way a manufacturer can hand on heart say that is product meets a particular standard(s) and that's to conduct or have conducted a clause by clause assessment against the applicable designated standards used to demonstrate compliance listed in the official journal, always remembering that additional regulations may need to be considered like EMC and RoHS. Note; if you use an international standard, an industrial standard which is not in the official journal you will be required to show how you have addressed the essential safety requirements in Schedule I of the regulations

Technical documentation

The manufacturer shall ensure compliance of the manufactured electrical equipment with the technical documentation, (think! Quality Plan)

The documentation shall make it possible to assess the electrical equipment’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, and operation of the electrical equipment.

The technical documentation shall, where applicable, contain at least the following elements:

• a design risk assessment to ISO 12100:2010 the risk assessment demonstrating the procedure followed, including:
• a list of the safety objectives which apply to the equipment,
• the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the electrical equipment,
• a general description of the electrical equipment,
• conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
• descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;
• an assessment of standards and other technical specifications applied, indicating the safety objectives covered by these standards if not using a designate standard, otherwise a clause by clause assessment of the designated standards use.
• any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
• a copy of the instructions for the electrical equipment,
• a copy of the EC declaration of conformity;
• for series manufacture, the internal measures that will be implemented to ensure that the electrical equipment remains in conformity with the provisions of the applied regulations.
• The original manufacturer’s instructions necessary for identification, transport, installation, use, maintenance, decommissioning and disposal of the electrical equipment shall be documented

Affix the UKCA Mark

In most cases, the manufacturer must apply the UKCA marking to the product itself or to the packaging. In some cases, it may be placed on the manuals or on other supporting literature.

The following general rules apply:

• UKCA markings must only be placed on a product by you as the manufacturer or your authorised representative (where allowed for in the relevant legislation)
• when attaching the UKCA marking, the manufacturer takes full responsibility for your product’s conformity with the requirements of the relevant legislation
• the manufacturer must only use the UKCA marking to show product conformity with the relevant UK legislation
• the manufacturer must not place any marking or sign that may misconstrue the meaning or form of the UKCA marking to third parties
• the manufacturer must not attach other markings on the product which affect the visibility, legibility or meaning of the UKCA marking
• the UKCA marking cannot be placed on products unless there is a specific requirement to do so in the legislation

UK Declaration of Conformity

The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should:
• declare that the product is in conformity with the relevant statutory requirements applicable to the specific product
• make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)

The UK Declaration of Conformity should be available to market surveillance authorities on request.

The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity.

This can vary depending on the applicable legislation but generally should include:

• your name and full business address or that of your authorised representative
• the product’s serial number, model or type identification
• a statement, stating you take full responsibility for the product’s compliance
• the details of the approved body which carried out the conformity assessment procedure (if applicable)
• the relevant legislation with which the product complies
• your name and signature
• the date the declaration was issued
• supplementary information (if applicable)

You will need to list:
• relevant UK legislation (rather than EU legislation)
• UK designated standards rather than standards cited in the Official Journal of the European Union

The UK standards are currently the same in substance and with the same reference as the standards used in the EU.

HOW WE CAN HELP:

Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.

The CE Marking Authority have a positive attitude and approach regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialise in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations

Our expert team is here to help you meet the UKCA and CE Marking the requirements

• Free initial consultation to assess your requirements and plan the UKCA marking of your product.
• Identify the statutory instruments, the essential safety requirements and designated standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the UK safety regulations.
• Provide a draft UK Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.

The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonisation of your systems