What Are UKCA Regulations and Directives?
The UKCA marking proves compliance with the legislation of Great Britain (England, Wales and Scotland). It covers most products which formerly required CE marking, with the addition of aerosols.
All the same technical documentation will need to be carefully recorded and kept to produce for inspection if necessary. A UK Declaration of Conformity will also need to be drawn up, essentially the same as the declaration previously required by the EU.
What is the UKCA Marking?
The UKCA marking (UK Conformity Assessment) is a mark that came into effect on 1 January 2021 to replace the CE mark on most products and machinery that will be sold in GB. It is similar to the CE mark and indicates that the product was designed and manufactured by essential health and safety requirements. It also demonstrates that the product complies with relevant sector-specific regulations, such as rail interoperability, construction and civil explosives.
The UKCA (UK Conformity Assessed) regulations and directives are standards and conformity assessment procedures that apply to particular products placed on the market in the United Kingdom. These regulations and directives are similar to the European Union’s CE (Conformité Européenne) marking system but are specific to the UK following its departure from the EU.
Only the manufacturer or an authorised representative can place the UKCA mark on a product. The mark must be visible, legible and indelible when affixed. Suppose a product’s appearance or artistry does not allow the UKCA marking to be positioned on the product. In that case, it can be placed on the product packaging or accompanying documents such as manuals.
- The lettering of the UKCA mark must be at least 5mm tall, but it can be more prominent as long as it remains visible, legible and keeps its proportions.
- The mark does not have to be a solid colour, although it cannot change to any colour not permitted in the UKCA guidelines.
- For most products lawfully bearing the UKCA mark, you must also draw a UK Declaration of Conformity document before placing it on the market. This document must include the manufacturer’s or authorised representative’s name and address and information about the product and its compliance testing.
- It should be collated as a technical file and made available to any market surveillance or enforcement authorities upon request.
|UKCA regulations and directives
|UKCA Mark: The UKCA mark is a new product marking used in the United Kingdom to indicate that a product meets specific safety, environmental, and technical requirements. It is used in place of the CE mark for products sold in Great Britain (England, Scotland, and Wales).
|UKCA Regulations and directives
|UKCA Regulations: UKCA regulations set out the requirements for specific product categories. These regulations define the essential safety and performance standards that products must meet before being placed on the UK market.
|While the term “directives” is more commonly associated with the European Union, in the UK, similar principles apply. UKCA directives guide how specific types of products should be assessed and tested to ensure compliance with the relevant regulations.
|Like the CE marking system, products subject to UKCA regulations must undergo a conformity assessment process. This process involves testing, documentation, and certification to demonstrate that the product complies with the applicable regulations and standards.
|To legally place products on the UK market, manufacturers, importers, or distributors must ensure that the products bear the UKCA mark and comply with the relevant regulations. This demonstrates that the product meets the necessary safety and quality standards.
|There has been a transition period for implementing the UKCA marking system. However, as of January 1, 2023, most products placed on the UK market must use the UKCA mark, although there are some exceptions and special rules for specific products.
How Do I Get My Product UKCA Marked?
If your products fall under UKCA regulations and directives, you must get them UKCA marked to continue trading in the GB market after 31 December 2022. The rules for getting UKCA marked are similar to those for CE marking. BSI is an Approved Body for the UKCA mark and can support you through conformity assessment procedures for a wide range of product areas.
As with the EU Declaration of Conformity, UKCA requires you to record a UKCA Certificate of Conformity with specific information about your product that is required by the regulations. This information must also be included in the accompanying document accompanying your product on the market.
Manufacturers are responsible for affixing the UKCA mark to their products and must do so in a visible, legible, and indelible manner per relevant regulations. Where possible, this mark must be situated on the product or its packaging or supporting documents, such as manuals.
UKCA marking is only valid for products placed on the GB market (England, Wales and Scotland). For your existing stock that was ready for the GB market before Brexit, you may need to undergo a new conformity assessment and obtain a UKCA mark if the EU rules on product supply that affect it have changed since your original CE certification.
Depending on the specific legislation, you must keep documentation demonstrating that your product complies with regulatory requirements. This can be a technical file or the UK Declaration of Conformity. Typically, enforcement authorities can request this information at any time.
When a toy is UKCA marked, the manufacturer or their authorised representative must create a UK Declaration of Conformity that declares that the product meets all statutory requirements. This must be kept in a technical file and made available if requested by an enforcement authority. The type of documentation required varies from sector to sector, but it is essential to consider how your product will move through the supply chain and what impact this might have on the documents you must maintain.
If your product is currently CE marked, and a UKCA mark is not yet necessary for your market, consider applying for the marking now to be prepared. This will enable you to start marketing your device in the UK and generating sales while waiting for the new EU medical devices and IVD regulations to come into force (and possibly be up-classed) after Brexit.
For most products, the UKCA marking can continue to be used on a label affixed to the product or accompanying documentation – rather than on the goods themselves – until 11 p.m. on 31 December 2027. The exception is for medical devices.
UKCA Certification Process
Like CE marking, UKCA certification requires a detailed technical file for most products to demonstrate compliance with relevant legislation. This will usually include a UK Declaration of Conformity. However, the specifics of this are mainly dependent on the regulations that apply to the product.
Where possible, the UKCA mark must be affixed directly to the product or placed on its packaging. It must also be visible and legible. Other markings that reduce its visibility, legibility or meaning must not be applied. This includes markings unrelated to the UKCA mark itself or any other marks or signs that may mislead third parties about the product’s quality or safety.
Manufacturers wishing to use the UKCA mark can do so either through self-declaration or the engagement of a UK Approved Conformity Assessment Body, depending on the legislation that applies to the product. This will be straightforward for most products and likely necessary for high-risk goods and those subject to special requirements. A UKCA conformity assessment will likely be necessary.
The UKCA scheme applies to 22 product groups previously using EU Directives for CE compliance. These include equipment, machinery, electrical and electronic devices, and automotive components. Generally, the UKCA rules are very similar to the EU ones. But there are some differences, and the UKCA regime will likely change over time as the country moves further away from the European Union.
Video About UKCA Regulations
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