Electromagnetic Compatibility Regulation
This Guide is for businesses placing electrical and electronic equipment on the market in Great Britain from 1 January 2021
The 2016 Regulations set out the requirements that must be met before products can be placed on the GB market. The purpose of the legislation is to ensure safe products are placed on the GB market by requiring manufacturers to show how their products meet the ‘essential requirements’.
Scope of Directive
The EMC Regulations sets out mandatory essential requirements that all equipment within its scope needs to comply with. These essential requirements don’t specify in detail the technical specifications but define the results that need to be attained. Moreover, they allow the product design of the electrical and electronic equipment to be adapted to technological progress. The essential requirements are legally-binding for all electrical and electronic equipment within the scope of the Directive and allow only compliant equipment to be placed on the UK market.
The essential requirements are split into two parts:
1. General requirements for all electrical and electronic equipment – All electrical equipment, when designed, manufactured, and placed on the UK market, must comply with the following criteria:
• The electromagnetic disturbance generated when specific equipment is utilised must not exceed the level allowing the normal functioning of radio or another type of equipment;
• The equipment has an adequate level of immunity to electromagnetic disturbance, and it can operate without unacceptable degradation of its intended use;
• The equipment shall be designed and manufactured with regards to the state of the art.
2. Specific requirements for fixed installations:
• Application of good engineering practice;
• All documents required in case of inspection should be kept safely by a responsible person;
• Respecting the information on the intended use of all of its components.
The EMC Regulations sets out obligations to manufacturers of electrical equipment (apparatus or fixed installations) in regards to the necessary conformity procedures for placing a product on the UK market. The EMC Regulations states expressly that it is no longer sufficient the electromagnetic compatibility of equipment to be verified only by test reports containing EMC test data or on the basis of expert analysis. Now, the electromagnetic compatibility of an apparatus or fixed installations has to be confirmed by appropriate risk analysis and assessment. Both, the adequate analysis and evaluation of the risk, shall be included in the technical documentation of the product.
Types of conformity assessment procedures
The EMC Regulations sets out the following conformity assessment procedures for apparatus and fixed installations:
A. Internal production control:
• Evaluation of the electromagnetic compatibility of the equipment on the basis of the relevant phenomena, with the aim of meeting the essential general requirements
• Creation of a technical file that shall contain the following information (see an example of a Technical file)
• The manufacturing of the product shall be in accordance with the product’s technical documentation and the essential requirements of the Regulations.
• Every individual product that complies with the EMC’s requirements must have affixed the UKCA mark to the electrical equipment.
• Creation of a UK Declaration of Conformity (see an example of a Declaration of Conformity).
B. An UK-type examination that is followed by Conformity to type based on internal production control.
a) UK-type examination refers to the assessment phase when an approval body needs to examine the technical design of equipment and verify and attest that the same meets the essential requirements of the EMC Regulations. Consequently, the approval body must issue a UK-type examination certificate to the manufacturer. A copy of the certificate, along with any annexes, additions, and the product’s technical documentation, shall be at the disposal of the national authorities for ten years after the product’s introduction to the market.
b) Compliance to type based on internal production control refers to the assessment phase where the manufacturer fulfils the following obligations:
• Manufacturing of the product according to the essential requirements of EMC Regulations and the product’s technical file
• Affixing the UKCA mark on every individual product that complies with the EMC’s essential requirements.
• Creation of a Declaration of Conformity for certifying the UKCA compliance of the equipment (see an example of a Declaration of Conformity).
Both procedures mentioned above are not mandatory in cases when the apparatus is intended for integration into a particular fixed installation and is otherwise not made available on the market
• Equipment covered by other specific instruments governing the conformity of the equipment with the essential requirements;
• Aeronautical apparatus, parts and appliances referred to in Regulation (EC) 216/2008; and
• Equipment which is incapable of generating electromagnetic interference that is harmful to radio and telecommunication equipment
For a full list of exceptions please refer to the 2016 Regulations. Nothing in the Regulations affects the application of legislation regulating the safety of the equipment.
Approved Body – A conformity assessment body which has been approved by the Secretary of State or was previously a UK ‘notified body’ before 1 January 2021.
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, among other things, the following:
o The specific 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 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 equipment available on the GB market.
Enforcing Authority – In Great Britain, for equipment intended for use in the workplace, this is the Health and Safety Executive. For products for consumer use, this is local trading standards authorities. For equipment intended for use on nuclear sites, it is the Office for Nuclear Regulation.
Importer – A person established in the UK who places pressure equipment from a country outside of the GB on the 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 pressure equipment within the UK or the EU or from Switzerland will now be an importer if they are bringing pressure equipment into the GB from another country (including EU Member States, the EEA or Switzerland).
Manufacturer – A person who manufactures pressure equipment, or has pressure equipment designed or manufactured, and either markets that equipment under their name or trademark or uses it for their own purposes.
UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including pressure equipment or assemblies) 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 manufacturers
A manufacturer is a person who manufactures apparatus, or has an apparatus designed or manufactured, and markets that apparatus under their name or trademark
The obligations of manufacturers of pressure equipment include:
1. Before placing apparatus on the GB market, the manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements as set out in Schedule 1 to the 2016 Regulations and that they have had have a relevant conformity assessment procedure carried out and technical documentation drawn up.
2. Once this has been done, the manufacturer must draw up a declaration of conformity, and affix the UKCA marking to the apparatus, except where it is not possible or warranted to affix the UKCA marking to the apparatus, in which case it must be affixed to the packaging and the accompanying documents. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the apparatus, even where it can otherwise be affixed to the apparatus.
3. Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings,
4. Manufacturers must keep the technical documentation and the declaration of conformity for 10 years after the apparatus has been placed on the GB market.
5. Manufacturers must also label apparatus with their name, registered trade name or registered trademark and address; the type batch or serial number (or other identification); and ensure that they are accompanied by relevant instructions in English.
6. Manufacturers must take action where they have reason to believe that the apparatus they have placed on the GB market is not in conformity with the 2016 Regulations.
7. Manufacturers must also cooperate with and provide information to enforcing authorities following any requests.
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.
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 2016 Regulations as they apply in GB.
No GB-based authorised representatives are recognised under EU law. 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 pressure equipment or assemblies to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of the product, must appoint an authorised representative based in Northern Ireland or the EEA.
An authorised representative must comply with all the duties imposed on the manufacturer under the 2016 Regulations that they are appointed by the manufacturer to perform. There are some duties that a manufacturer cannot mandate an authorised representative to perform (e.g. conformity assessment) and some that must form part of the authorised representative's mandate (e.g. retention of technical documentation).
A manufacturer remains responsible for the proper performance of any obligations 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 vessels 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 vessels that are 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 EEAsupplied 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 required 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 the accompanying documentation.
To assist with the transition, the UK is applying a transitional period ending on 31 December 2022 to allow UK suppliers of goods from the EEA or Switzerland (who from 1 January 2021 become importers into the GB market) to provide their details on the accompanying documentation as an alternative to placing them on the product 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 arrangements 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 in 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 is 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).
You should work with your distributors to ensure physical documentation does accompany batches of the product as far as possible, and in all cases that there are measures in place to ensure end-users are able to identify the UK importer.
Alongside that, but not as an alternative, you can use your company website to provide more information, access to product details and contact points for retailers, consumers and enforcement bodies.
These options are for a time-limited period only and may not be used after 31 December 2022. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address were required ahead of this date.
The EU does not have any such transitional provision. In the absence of this, pressure vessels and assemblies being sold from GB to NI or the EEA must be labelled with the NI or EU-based importer’s address.
The obligations of importers include:
1. Before placing apparatus on the GB market, an importer must ensure that it is in conformity with the essential requirements.
2. The importer must ensure that the relevant conformity assessment has been carried out by the manufacturer; the manufacturer has drawn up technical documentation; the apparatus is UKCA marked5 and is accompanied by the required documents and information regarding the manufacturer. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the apparatus. There is also a non-time-limited provision for the UKCA marking to be affixed on the packaging and accompanying documents where it is not possible or warranted on account of the nature of the apparatus to affix the UK marking on the apparatus or its data plate.
3. The importer must keep a copy of the declaration of conformity and technical documentation for a period of 10 years after the apparatus has been placed on the GB market.
4. The importer must provide their name trade, registered trade name and a postal address at which they can be contacted on the apparatus or in an accompanying document.
5. The importer must ensure that when placing apparatus on the GB market, it is accompanied by instructions which can be easily understood by the end-user in English in the circumstances that this is allowed (see above).
6. The importer must ensure that while apparatus is under their responsibility, their storage and transport conditions do not jeopardise their conformity with the legal requirements of the 2016 Regulations.
7. The importer must take action where they have reason to believe that the apparatus that they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations.
8. 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 which were distributors of simple pressure vessels within the EU single market should now consider whether they are importers from the EU single market and therefore what additional requirements they need to comply with. 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 a simple pressure vessel available on the GB market.
The obligations of distributors include:
1. When making apparatus available on the GB market, a distributor must act with due care to ensure that it is in conformity with Part 2 of the 2016 Regulations as amended, meaning that the apparatus is in conformity with the essential requirements and that each relevant economic operator has complied with their obligations established by Part 2 of the regulations.
2. Before placing the apparatus on the GB market, the distributor must verify that the apparatus bears the UKCA marking (or until 31 December 2021 the CE marking); is accompanied by the required documents as well as instructions and safety information; and that the importer and manufacturer have complied with their obligations as to required labelling. Until 31 December 2022, the UKCA marking may be affixed to a label or a document accompanying the apparatus.
3. The distributor must not make apparatus available on the GB market if they consider or have reason to believe it is not in conformity with the essential requirements. The distributor must take action where they have reason to believe that the apparatus that they have made available on the GB market is not in conformity with the legal requirements of the 2016 Regulations.
4. The distributor must ensure that while apparatus is under their responsibility, its storage and transport conditions do not jeopardise its conformity with the essential requirements.
5. The distributor must also cooperate with and provide information to enforcing authorities following any requests.
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