The British government announced the launch of a new conformity mark ukca (representing the British conformity assessment). When certain products such as automobiles, aerospace, pharmaceutical products, medical devices, chemicals, and articles subject to national regulations (uncoordinated articles) are sold in the UK market after brexit, EU specifications and compliance marks will not be allowed to continue to be used.
On September 1, 2020, the UK Department of Commerce, energy and industrial strategy issued guidelines on the use of ukca logo. From January 1, 2021, ukca logo will be used to launch products in Great Britain (GB), including England, Wales and Scotland, excluding Northern Ireland; However, in order to give the market more time to adapt to the new requirements, the CE mark on most products before January 1, 2022 can still be accepted.
I. relationship between ukca mark and CE mark
◆ ukca mark will take effect on January 1, 2021. However, in order to give enterprises time to adapt to the new requirements, the British market (Great Britain) will accept the CE mark of products before January 1, 2022. For products that have been fully manufactured and ready to be put on the market before January 1, 2021, these products can still be sold in the UK market (Great Britain) using the CE mark before January 1, 2022.
◆ the ukca logo shall be used from January 1, 2021 for the goods currently being sold to the UK market (Great Britain) and the new design products not yet launched.
◆ in order for the same new product to enter the EU market, it is also necessary to obtain CE mark. EU authorities will not accept the ukca logo. From January 1, 2022, the ukca mark will be a mandatory mark for entering the UK market (Great Britain) (there are exceptions for products with special transition deadlines).
◆ at present, products entering Northern Ireland will continue to use CE mark or UK (Ni) mark according to the agreement on special treatment. It is expected that Northern Ireland will make new adjustments after the referendum in 2024.
II. Relationship between British regulations and EU directives
| EU Directive | British regulations |
1 | Toy Safety-Directive 2009/48/EC | Toys（Safety）Regulations 2011 |
2 | Electromagnetic Compatibility-Directive 2014/30/EU | Electromagnetic Compatibility Regulations 2016 |
3 | Low Voltage Directive 2014/35 | Electrical Equipment（Safety）Regulations 2016 |
4 | Measuring Instruments- Directive 2014/35/EU | Measuring Instruments Regulations 2016 |
5 | Radio equipment- Directive 2014/53/EU | Radio Equipment Regulations 2017 |
6 | Personal protective equipment-Regulation（EU）2016/425 | Personal Protective Equipment Regulations(Regulation（EU）2016/425 as brought into UK law and amended) |
7 | Machinery Directive 2006/42/EC | Supply of Machinery（Safety）Regulations 2008 |
8 | Directive92/42/EEC hot-water boilers AND Ecodesign Directive 2009/125/EC | The Ecodesign for Energy-Related Products and Energy Information(Amendment)(EU Exit) Regulations 2019 |
9 | Restricyion of the Use of certain Hazardous Substances in Electrical and Electronic Equipment(RoHS)- Directive 2002/95/ec | The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 |
At this stage, the EU directives corresponding to British regulations are shown in the table. The requirements of British regulations on product scope, standards and conformity assessment procedures are basically consistent with EU directives. However, relevant UK regulations will be updated from time to time. For example, the 2019 regulation on ecological design and energy information of energy related products (Amendment) No. 8 has revised relevant terms and expressions, added provisions on the transition period from the EU, etc., so as to prepare for the use of ukca logo。
III. application scope of ukca mark
| Product range |
| Product range |
1 | Toy(safety) | 12 | Gas appliances |
2 | Recreational craft and personal watercraft | 13 | Machinery |
3 | Simple Pressure vessels | 14 | Outdoor noise |
4 | Electromagnetic compatibility | 15 | Ecodesign |
5 | Non-automatic weighing instruments | 16 | Aerosols |
6 | Measuring instruments | 17 | Low voltage electrical equipment |
7 | Lifts | 18 | Restriction of hazardous substances |
8 | ATEX | 19 | Medical devices |
9 | Radio equipment | 20 | rail interoperability |
10 | Pressure equipment | 21 | Construction products |
11 | Personal protective equipment | 22 | Civil explosives |
Ukca mark will cover most products currently controlled by CE mark and aerosol products.
IV. rules for use of ukca logo
1. Add ukca sign
Before January 1, 2023, for most products (except those subject to special rules), ukca logo can be attached to the label or attached documents of the product. From January 1, 2023, in most cases, the ukca logo must be attached directly to the product. Therefore, enterprises should begin to prepare for this.
The following are general rules:
◆ ukca logo can only be affixed on the product by the manufacturer or its authorized representative in the UK (where permitted by law)
◆ when the ukca mark is affixed, the manufacturer shall be fully responsible for whether the product meets the requirements of relevant laws and regulations
◆ only ukca mark can be used to prove that the product complies with relevant British laws
◆ do not provide any signs or marks that may misunderstand the meaning or form of ukca signs to third parties
◆ other signs that affect the visibility, legibility or meaning of ukca signs shall not be pasted on the products
◆ unless explicitly required by law, ukca logo shall not be affixed on the product
2. Rules for using ukca logo
The manufacturer must ensure that:
◆ if the size of the sign is reduced or expanded, the relevant proportion of ukca sign letters must be observed
◆ the height of ukca sign shall be at least 5mm, unless different minimum dimensions are specified in relevant regulations
◆ ukca signs must be clearly visible
V. requirements for technical documents
1. Record keeping
The manufacturer or its authorized representative (where permitted by law) must keep documents proving that the products meet regulatory requirements. The product must be kept for 10 years after it is put on the market.
The documents retained will depend on the specific regulations related to the product, but a general record of the following must be kept:
◆ how to design and manufacture products
◆ how to prove that the product meets relevant requirements
◆ address of the manufacturer and any storage facilities
UK market surveillance or law enforcement agencies may request this information at any time to check whether the product meets statutory requirements.
2. UK declaration of conformity (UK DOC)
UK doc is a document that must be drafted for most compliant products with ukca logo.
In the document, the manufacturer or his authorized representative in the UK (where permitted by law) shall:
◆ declare that the product complies with the relevant statutory requirements applicable to the specific product
◆ ensure that the name and address of the manufacturer (or UK authorized representative) and information about the product and Conformity Assessment Authority (if relevant) are on the document
The manufacturer must provide UK doc to the market surveillance authority upon request.
The information required for the declaration of conformity will be basically the same as that required for the current EU declaration of conformity, which may vary according to the applicable regulations, but should generally include:
◆ name and detailed business address of the manufacturer or its authorized representative
◆ product serial number, model or model identification
◆ statement (fully responsible for product compliance)
◆ details of authorities authorized to perform conformity assessment procedures (if applicable)
◆ the product complies with relevant laws and regulations
◆ name and signature of ukca doc signatory
◆ date of announcement
◆ supplementary information (if applicable)