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Within the European Union (EU), goods such as machinery, electrical and electronic equipment, gas appliances, construction products, hot water boilers, medical devices, personal protective equipment (PPE) and toys have to carry a CE marking as mandatory.
Product groups which do not carry CE marking include chemicals, pharmaceuticals, cosmetics and foodstuffs. These standards are uniform across all EU member states, which until 31 January 2020 included the United Kingdom.
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation, confirms a product’s compliance with relevant requirements, and allows the free movement of products within the European market. CE stands for Conformité Européene which is French for European Conformity.
CE marking does not mean that a product was made in the European Economic Area (EEA), but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
When the UK decided to leave the EU and triggered Brexit, the UK began to amend, repeal or replace all EU legislation and regulations. This is to be completed by 2023, and includes replacing the CE marking system.
What is UKCA marking?
UKCA stands for UK Conformity Assessment and proves compliance with UK legislation in the same way that CE marking does in the EU. Any product sold in the UK which formerly carried a CE mark will now carry a UKCA mark.
This guarantees to the consumer that all relevant health and safety regulations, environmental legislation and applicable standards for the product have been met by the manufacturer and that it is safe and legal to use. It covers much the same range of products that were previously marked with the CE mark, such as electrical items, radio equipment, PPE and toys, plus the new addition to the list of aerosol products.
Is the UKCA marking replacing the CE marking?
The UKCA mark is the replacement for CE marking in Great Britain, that is England, Scotland and Wales, but not in Northern Ireland. At present, Northern Ireland remains in the Single Market so the CE marking rules continue to apply there. The UKCA marking cannot be used for goods placed on the Northern Ireland market. The UKNI mark may be used alongside the CE mark to demonstrate conformity.
From 1 January 2021, the UKCA mark started to replace the CE mark for goods sold within Great Britain. CE marking will continue to be acceptable in Great Britain until the end of 2022, so that manufacturers have sufficient time to adapt to the new system. For most products the UKCA mark must be applied by 1 January 2023. For medical devices the requirement to apply the UKCA mark is not compulsory until 1 July 2023. It does not apply to existing stock, such as goods which were fully manufactured, CE marked and placed on the market before 1 January 2021.
All UKCA technical documentation must be carefully recorded and kept for at least 10 years after product launch, to be produced for inspection where necessary. Documents should show how the product is manufactured and demonstrate its conformity with the relevant legislation. A UK Declaration of Conformity will also need to be drawn up, which will largely be the same as the declaration previously required by the EU.
Products that meet these requirements can be marked with a UKCA logo to show their compliance, but no longer enjoy free movement across participating countries as the UKCA mark is not recognised by the EU27 member nations. Anyone wanting to sell a product into both the European Union (EU) and the United Kingdom, will require both UKCA and CE marking.
What are the UKCA marking requirements?
UKCA marking is required from 11pm on 31 December 2022 for products that currently need to be assessed for conformity by a notified body, or that can be self-declared. This follows the same procedure and applies to the same products as CE marking, but may well begin to diverge over time.
Products and elements that are covered by the legislation for UKCA marking include the following:
- Electromagnetic compatibility.
- Equipment for use outdoors.
- Gas appliances.
- Low voltage electrical equipment.
- Measuring instruments.
- Non-automatic weighing instruments.
- Personal protective equipment.
- Pressure equipment.
- Radio equipment.
- Recreational craft and personal watercraft.
- Restriction of hazardous substances.
- Simple pressure vessels.
- Toy safety.
For most products, the applicable regulations are specified in SI 2019:696, with relevant amendments. The steps you need to take to prepare for UKCA marking will depend on the current status of your business and your future market access requirements. Companies bringing goods into the UK from EU countries are typically classified as “importers”; previously they were known as “distributors”.
It is the importer’s responsibility to meet both the relevant regulations and place UKCA marking on the product. Therefore, importing an applicable product from Europe now requires a UK Approved Body. UKCA marking directives are almost completely aligned with CE marking directives.
If you want to sell a product into both the European Union and the United Kingdom, you will require both UKCA marking and CE marking. It is possible to achieve and place both marks on a single product. Products placed on the market in Northern Ireland must be CE marked, regardless of their origin.
Across the EU and UK, market surveillance bodies are in place to ensure product compliance. The directives which apply to the product will, in turn, determine which market surveillance body is responsible for your product. The way in which enforcement is managed will vary across Europe and the UK depending on how it is written into national law. If an enforcement body finds your product to be unsafe, you will usually be given a chance to rectify the problem. Failure to do so will oblige you to take your product off the market, and can also leave you liable for a fine or prosecution.
To implement the new UKCA marking regime, the UK Government has issued several Statutory Instruments to amend current legislation. The main regulations are The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which runs to 659 pages. These regulations amend most of the UK CE marking regulations for products placed on the UK market and stipulate that the UKCA mark replaces the CE mark.
Where a directive required CE marking and UK regulations were already detailed, the amendments are limited to:
- Replacing the CE mark with the UKCA mark.
- Limiting applicability to products for the UK market.
- Changing references to Notified Bodies to Approved Bodies.
- Changing language references to English.
The British Standards Institution (BSI) emphatically maintains its commitment to the European Standards (EN) and international standards systems, and harmonised standards remain best practice for both CE marking and UKCA marking. The UK regulations term them designated standards and the lists of harmonised and designated standards are largely the same. BSI is unlikely to withdraw EN standards but in time the UK designated list is likely to differ slightly as UK authorities such as the Health and Safety Executive (HSE) bring their influence to bear on standards which they do not like.
UKCA marking is the responsibility of the person/company who places the product on the GB market for the first time, or in some cases, for example machinery where it may not have been placed on the market, the person who puts it into service for the first time. This duty primarily rests with the manufacturer, aspects of which may be performed by the manufacturer’s authorised representative, although this must be agreed in writing between the parties.
But it can also apply to those who import and place products on the GB market for the first time, particularly where goods are not yet compliant, for example those without UKCA marking or CE marking, and those who rebrand products made by another to supply under their own brand name.
How to use the UKCA marking
By affixing UKCA marking you take on responsibility for the conformity of the product. UKCA marking is a visible sign that the product complies with all relevant product supply legislation, and its presence together with the Declaration of Conformity and/or Performance gives the product to which it is affixed a presumption of conformity with relevant product legislation.
However, the UKCA mark is not a quality mark, nor a guarantee that the product actually meets all of the requirements of relevant product law. UKCA marking, just like CE marking, is the final stage of the conformity assessment process as specified in the relevant legislation for the product.
Placing the UKCA mark on a product signifies that you accept and acknowledge full responsibility for its conformity with the relevant legislation’s requirements. The UKCA mark itself is not evidence of compliance, but your technical documentation/technical file is. A Declaration of Conformity is a legal claim that products comply with applicable directives and standards, though it is not evidence of compliance.
As well as the official Declaration, you must keep records of your product’s conformity with regulatory requirements. You or, if permitted in the relevant legislation, your authorised representative must provide this documentation and keep it accessible for up to 10 years after placing the product on the market. Market surveillance or enforcement authorities are empowered to request these records from you at any time, so that they can confirm that your products are in compliance.
The information you provide in these records will vary in accordance with the specific legislation for each product.
In general terms, records need to demonstrate:
- How the product was technically designed and manufactured.
- How the product proves its conformity with the relevant requirements.
- The manufacturer’s address and that of any storage facilities for the product.
This information should be collated as a technical file which you can supply to a market surveillance authority if requested.
What are the rules for using the UKCA image?
The Government has drawn up guidelines to tell you how the new UKCA mark should be designed and displayed.
If UKCA marking is required you must:
- Use the initials “UKCA” in the prescribed form, although you can vary the form of the mark, for example by using outline lettering rather than a solid fill, subject to the provisions of visibility, legibility, and proportion.
- The initials must be of a minimum size, that is at least 5mm tall, unless this is not possible for very small products.
- Maintain the proportions shown whatever the size of the UKCA marking.
- Attach the UKCA marking to the product visibly, legibly, and indelibly.
- Where possible position the UKCA marking next to the name of the manufacturer, importer etc.
- Only place the UKCA marking on a product when the legislation specifically requires you to do so.
- Ensure that no other marking or sign is placed on the product that might lead third parties to misconstrue the UKCA marking’s form or meaning.
- Ensure that no other markings are attached to the product which might affect the legibility, meaning or visibility of the UKCA mark.
If the appearance and workmanship of a product do not allow for the UKCA marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents or literature, such as manuals or technical files. Where you place the UKCA mark is usually governed by specific regulations applicable to each product. You may affix additional markings to a product, provided they fulfil the above requirements and perform a function that differs from the UKCA marking. The UKCA marking is mandatory for those products it applies to.
Only the manufacturer or an authorised representative of the manufacturer, if the relevant legislation permits, may place UKCA markings on a product.
The UKCA marking system is a revision of the system used when the UK was part of the EEA, and will now follow UK legislation rather than that issued by the EU. The products which require the conformity assessment are pretty much the same as before, with the inclusion of aerosol products which were previously separate.
Manufacturers will have the same responsibilities for assessing and declaring their products’ conformity, and consumers will be able to place the same confidence in the safety of manufactured goods as they did before. The main difference in the new legislation is that it doesn’t currently cover Northern Ireland, and there will be some cross-over between CE marking and UKCA marking until this Brexit issue is resolved.