UKCA Mark: Product Safety Guide for the GB Market
Nov 04, 2022
If your business manufactures or imports products that are sold on the GB Market (England, Wales and Scotland) and your products were required to have CE marking before Brexit, you will now need to pass a new conformity assessment and obtain a UKCA mark. Read along for more information, key dates, rules and requirements about the UKCA certification.
What is UKCA? (Key Dates Included)
UKCA stands for UK Conformity Assessed and it is a new product making that came into effect following the UK’s exit from the EU on 1 January 2021. It is only applicable to products sold in Great Britain (England, Wales and Scotland).
Key Dates
- 1 January 2021: From this date onwards the UKCA mark will be accepted for all relevant products sold in Great Britain (including most of the previously CE marked goods)
- 1 January 2022: From this date onwards all relevant products sold in Great Britain (except medical devices) must be UKCA marked to demonstrate that they conform to the relevant safety requirements applicable on the market
- 30 June 2023: End of extended courtesy period for medical devices. All medical devices used in Great Britain must be UKCA marked as well
When do you need the UKCA mark before 1 January 2022?
You must have your product UKCA marked before 1 January 2022 to sell it on the GB market if it requires a third-party conformity assessment and if the mandatory conformity assessment has been carried out by a UK conformity assessment body before 1 January 2021.
The UKCA mark will also have to be obtained before 1 January 2022 for products where the EU rules on CE marking that affect it have changed after the CE certification had been issued.
Failure to comply with the UK product supply legislation will result in the product being disallowed on the GB market and you may be sanctioned by the market surveillance authorities.
What products should be UKCA marked?
Most of the technical requirements that were in place for CE marked products before 1 January 2021 are still in place, so if your product was in the scope of the CE marking requirements, it most likely should be UKCA marked. These include but are not limited to:
- Toys
- Lifts
- Personal Protective Equipment (PPE)
- Outdoor equipment
- Machinery
- ATEX
- Electrical equipment (low-voltage only)
- Category I pressure equipment
- Radio Equipment
- Restriction of hazardous substances
- Electromagnetic compatibility
- Recreational Crafts
The new UKCA marking also applies to aerosol products which were previously marked with a ‘reverse epsilon’ logo.
Some products, including medical devices, civil explosives, construction products, tobacco, fertilisers and cosmetics, require a UKCA mark but are also subject to additional rules and regulations, so please make sure you are familiar with those before you proceed with any conformity assessment procedures.
UKCA rules don’t apply to non-harmonised goods (national rules apply here) or goods regulated under the old approach, such as medicines, road and aerospace vehicles, chemicals and more. You can check which rules apply to your products online but you should always seek advice from a legal expert or a trade body if you have any doubts or concerns about the applicable regulations.
Who is responsible for the UKCA certification?
Undertaking the UKCA certification process is the responsibility of the first person or company that places the product in question on the GB market. Usually, this is the manufacturer (or a legally authorised representative of the manufacturer) but if you import goods that have never been sold on the GB market before, you also have a responsibility to ensure that the UKCA marking is in place.
This is because it’s the importer’s legal duty to verify that all imported products have undergone the correct conformity assessment and that the relevant marking has been affixed to prove that.
Who can carry out the UKCA certification procedure?
The UKCA mark is placed during the final step of the conformity assessment process. This can only be done by the manufacturer or by their authorised representative.
Most products that require a UKCA mark can be self-certified and don’t require the involvement of a UK Approved Conformity Assessment Body. However, you can enlist a professional conformity assessor to help carry out the UKCA certification process for you if you wish to do so.
If you manufacture high-risk goods and or if your products fall under special legislation, UKCA self-certification may not be applicable to you. If that is the case, you will have to turn to an Approved Conformity Assessment Body to obtain the UKCA marking.
What is a UKCA conformity assessment?
All products sold on the GB market must comply with certain safety requirements. The most basic principles that have to be covered are that products should be designed to avoid risk and that for any risks that can’t be removed completely there are protective measures in place. Also, if even a minimal risk remains, the product users must be given a warning.
To ensure that all of these are in place, every product covered by the scope of the UKCA legislation must undergo a conformity assessment, before it is placed on the GB market. The same applies to machinery which requires UKCA marking and has not yet been put to use.
If you are the manufacturer, it is your or your representative’s responsibility to identify the relevant legislation that applies to your product and follow the conformity assessment procedure outlined in it. You will either need to do a self-assessment, an assessment by a third party with type-examination and/or full quality assurance.
The details of the procedure will depend on the nature of the product and the potential risks involved, as outlined by the relevant legislation. However, all conformity risk assessments must include evidence of the following actions:
- Identify and assess potential risks posed by the product at any stage of its life
- Assess whether the product design meets all relevant health and safety requirements
- Assess whether the construction of the product meets all relevant health and safety requirements
- Assess whether the relevant quality standards are met to ensure the product is “state of the art” (as defined by the industry best practices)
- Compile a Technical File containing all information about the product design, construction and testing. This must be retained for at least 10 years after the final product of the line has been manufactured
- Prepare a UKCA Declaration of Conformity and attach this to the Technical File
- Ensure that the product is accompanied by a User Manual in English
It’s important to keep in mind that a single product may be in the scope of more than one legislation. If that’s the case, the requirements of all relevant legislation must be met for the product to pass the conformity assessment procedure successfully and obtain the UKCA marking.
What are the rules for affixing the UKCA mark?
If your product has passed the conformity assessment successfully and once all the relevant documentation has been compiled in the Technical File (including a UKCA Declaration of Conformity), the UKCA mark can be attached to the product to finalise the assessment procedure.
For the marking to be correctly affixed, you need to follow all the following rules:
- You must use the official UKCA logo
- The UKCA mark must be at least 5mm tall (where possible)
- The proportions of the logo must not be distorted in any way
- The label must be clearly visible and fully legible
- The name and details of the manufacturer/importer should be position nearby
If you are the person affixing the UKCA mark, you carry a legal responsibility for the conformity of the product with the relevant UKCA regulations.
What is a Type-Examination Certificate?
When a UK Approved Conformity Assessment Body completes the assessment and rules that your product conforms with the relevant standards and regulations, they will issue a Type-Examination Certificate to declare their findings. This document must be kept in the Technical File of the product for 10 years, along with the Declaration of Conformity.
You will also have to have a re-assessment done in 5 years to renew the Type-Examination Certificate. You may need to do this sooner if there have been major changes to the product that can affect its health and safety compliance.
What should be included in the Technical File?
Every product placed on the GB market must be accompanied by a Technical File while it is still in use. The technical field includes reports, a declaration of conformity, risk assessments, drawings and many other supporting materials that prove it is safe to use.
This documentation can be requested by the relevant authorities at any time and you, as the manufacturer or importer, must be able to provide it on short notice to prove your regulatory compliance. You must keep the Technical File for a minimum of 10 years after the last of the products have been made.
The Technical File will differ based on the legislation followed during the conformity assessment but generally, it should also include information on:
- The design and construction of the product
- List of the relevant legislation and requirements
- The conformity assessment procedures undertaken
- Declaration of Conformity (copy)
- User Instructions in English (copy)
- Details of any tests, research and reports made
- Any quality assurances applied if the product design has been changed
It is important to approach the construction of the Technical File systematically and with extreme diligence to avoid missing essential compliance information. Failure to present a complete Technical File if requested by the authorities could result in legal repercussions.
What should be included in the Declaration of Conformity?
Usually, every product subject to UKCA marking must be accompanied by a single Declaration of Conformity which includes the following information:
- The contact details (name & address) of the manufacturer/their authorised representative
- Details of the safety legislation applicable to this product
- Information about any quality standards applied to the product (if applicable)
- Information about the third-part assessor (if applicable)
- Date & signature of the manufacturer or their representative
Other Declarations
Some products require additional declarations to support the Declaration of Conformity in order to be placed on the GB market. Those include:
Declaration of Performance: for products subject to Construction Products Regulations
Declaration of Incorporation: for partly completed machinery (PCMs) as per the Supply of Machinery (Safety) Regulations
You are obliged to comply with the market surveillance authorities and provide all relevant information and required UKCA declarations if requested to do so.
What Standards apply to the UKCA certification process?
Standards are defined as a “repeat way of doing things” (BSI) and they are designed to support the implementation of the relevant legislation. Even though you are not technically obliged to follow these standards, doing so gives you the right to ‘presumption of conformity’, or simply put – provides you with a justification for affixing the UKCA marking.
Standards can be national (e.g. BSI) or international (e.g. ISO), as well as industry-specific and even in-house standards applied within your organisation.
The use of these standards is voluntary but if the standards are mentioned explicitly by the relevant legislation, they gain legal weight and must be followed.
Also, if you choose to conform with certain standards and declare this in your Declaration of Conformity, your product becomes legally bound to be compliant with those standards.
How can Spiers help?
If you are responsible for getting a product UKCA certified for the GB market, Spiers Engineering Safety can help you by offering:
UKCA Certification Training Courses – teaching you all the essential knowledge about self-certifying for UKCA UKCA Software & Support Service – a service packages including access to the purpose-made RiskMach Certification Manager software, as well as unlimited expert support from the Spires team across all your conformity projects
Spiers Safety Engineering is owner of the UK trademark for “UKCA Software” for the RiskMach Certification Manager.
Get in touch with our team today to discuss how we can help you with all your conformity assessment procedures needed to obtain the UKCA marking for your products.
Related Articles