Declaration of Conformity Requirements in the UK: A Complete Guide

Creating or obtaining a UK Declaration of Conformity is mandatory when selling most products which require UKCA marking. In this guide, we explain what UK manufacturers and importers must know about creating a DoC, and what the consequences are if you fail to do so.

This article also explains how a UK Declaration of Conformity differs from an EU Declaration of Conformity.

What is a UK Declaration of Conformity?

A UK Declaration of Conformity is a document issued by the manufacturer declaring which UK regulations and designated standards a certain product complies with. The Declaration of Conformity originates from EU regulations and directives that the United Kingdom adopted before Brexit.

Creating a Declaration of Conformity is generally mandatory for products which require UKCA marking.

Is the Declaration of Conformity mandatory in the UK?

Yes, issuing a Declaration of Conformity is mandatory for certain products sold in the United Kingdom. However, this is only a requirement if the product in question is subject to one or more UK regulations that require the creation of a Declaration of Conformity.

Which products require a Declaration of Conformity in the UK?

Here are some examples of products that require a Declaration of Conformity in the United Kingdom:

• Toys
• Electronics
• Machinery
• Sunglasses
• Protective gloves
• Helmets
• Other PPE
• Medical devices
• Gas appliances

Which UK regulations mandate a Declaration of Conformity?

Here is an overview of UK regulations mandating the creation of a Declaration of Conformity:

UK Regulation	Structure
The Toys (Safety) Regulations 2011	Schedule 3
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012	Schedule 1A
The Electromagnetic Compatibility Regulations 2016	Schedule 4
The Electrical Equipment (Safety) Regulations 2016	Schedule 8
The Radio Equipment Regulations 2017	Schedule 6
The Ecodesign for Energy-Related Products Regulations 2010	Schedule 1
The Supply of Machinery (Safety) Regulations 2008	Schedule 2, Part 2, Section A
Personal Protective Equipment Regulation (EU) 2016/425	Annex IX
The Medical Devices Regulations 2002	/
Gas Appliances Regulation (EU) 2016/426	Annex V
The Measuring Instruments Regulations 2016	Annex XIII to the Measuring Instruments Directive

Note that there are other UK regulations which mandate a Declaration of Conformity.

What information must be included in the UK Declaration of Conformity?

The exact information that must be provided depends on the specific UK regulation that applies. However, the following is information must often be included in a UK DoC:

• Product name and batch/serial number
• Manufacturer information
• Authorised representative information (if any)
• Product image
• List of UK regulations the product complies with
• List of designated standards
• Approved body information (if any)

Labels

The information in the Declaration of Conformity should also match the product and packaging labels. For example, the SKU, batch number, and manufacturer must match.

Test reports

Further, the DoC information must also match what is specified in the supporting test reports. In other words, any designated standard that you claim your product to comply with must also be specified in the test reports.

Example – Toy Safety Regulations 2011

Source: GOV.UK

What can happen if we don’t have a UK Declaration of Conformity?

Failing to provide a valid Declaration of Conformity upon request can result in fines or even a product recall.

Who is responsible for creating the UK Declaration of Conformity?

The manufacturer is responsible for creating the UK Declaration of Conformity. Note that the manufacturer is not necessarily the manufacturer.

Here is a definition from the Toys (Safety) Regulations 2011:

---

“manufacturer” means a person who—

(a) manufactures a toy or has a toy designed or manufactured; and

(b) markets that toy under that person’s name or trademark;

---

As such, a company designing toys and placing orders with contract manufacturers is likely deemed the manufacturer. For example, a UK company designing toys or applying their brand to toys manufactured in China likely assumes the responsibility of the manufacturer – which means that a DoC must be created by them.

Can UK importers issue a Declaration of Conformity?

No, importers are not meant to create the Declaration of Conformity. However, importers must obtain a UK Declaration of Conformity from the manufacturer.

That said, UK importers can be classified as manufacturers in many cases. If so, a company that is technically importing products into the United Kingdom would still be required to issue a Declaration of Conformity on the basis that they are the legal manufacturer.

How much does the Declaration of Conformity cost?

A Declaration of Conformity alone doesn’t cost more than the paper it’s printed on. That said, before you can create a Declaration of Conformity, you must ensure that your product complies with applicable designated standards.

Doing so requires lab testing, which results in costs ranging from a few hundred to thousands of pounds. The testing cost depends on the product and its complexity. As such, there is no uniform testing cost.

What are UK manufacturers or importers supposed to do with a Declaration of Conformity?

Here are some instances in which a UK importer or manufacturer may need to submit a Declaration of Conformity:

Approved Bodies

PPE, medical devices, and other products can only be sold after certification from a UK Approval Body. These entities need access to the product documentation, which includes the Declaration of Conformity.

With a Declaration of Conformity, you cannot obtain the necessary certification.

HMRC

His Majesty’s Revenue & Customs (HMRC) may also require compliance documentation when checking inbound shipments. If a Declaration of Conformity is required for your product, then it is likely that the HMRC will request it and its supporting documentation.

Government departments

UK government departments may conduct random checks or investigate products after receiving reports. Part of their initial assessment is often based on requesting the following:

• Declaration of Conformity
• Test reports
• Label photos

Failing to provide the required documentation can result in fines and a recall.

Amazon UK

Amazon UK may require a Declaration of Conformity in the following circumstances:

• When listing a new product in the UK for which a DoC is required
• Random product listing checks
• If they receive a product safety issue or an accident report

For how long should we keep a UK Declaration of Conformity?

Both UK manufacturers and importers must normally maintain a copy of the Declaration of Conformity for 10 years after the product was introduced on the UK market.

This doesn’t count from the initial date of introduction, but is pushed forward for each subsequent batch manufactured or imported into the United Kingdom.

The reason is likely that product safety issues can appear many years after a product is introduced. As such, UK government departments may need access to the Declaration of Conformity and other documentation long after production has ceased for a certain product model.

How does a UK DoC differ from an EU DoC?

A UK Declaration of Conformity is based on the requirements in one or more UK regulations. While these are based on EU directives and regulations, it is important to understand that the UK has its own versions that are no longer tied to their EU counterparts.

For example, the UK may amend their DoC requirements while the EU does not, or vice versa.

Furthermore, the EU has introduced new regulations which include Declaration of Conformity requirements. For example, the EU now requires that batteries come with a Declaration of Conformity.

Is a UK Declaration of Conformity accepted in the EU?

No. A UK Declaration of Conformity based on UK regulations and designated standards would not, by default, be accepted as a supporting document in the European Union.

Is an EU Declaration of Conformity accepted in the UK?

Yes, at least in some cases. The UK government made the decision to accept CE marking for certain products sold in the United Kingdom. Based on the current information, an EU Declaration of Conformity must be provided if the product is CE marked.

However, a UK Declaration of Conformity is required if the product is UKCA marked.

Is a UK or EU Declaration of Conformity required in Northern Ireland?

Northern Ireland generally aligns with EU regulations and directives. As such, an EU Declaration of Conformity is normally required when selling covered products in Northern Ireland.

Note: Contains public sector information licensed under the Open Government Licence v3.0.