This guidance relates to products distributed in Great Britain — covering England, Scotland and Wales. This guidance does not cover Northern Ireland (which will have its own set of new rules and where products will require the CE marking or UK(NI) marking). The separate guidance for placing goods on the Northern Ireland market can be viewed here.
In this alert, we summarise the new rules coming from the guidance and consider how a supply chain entity might prepare for the changes being introduced. Based on the multiple rules regarding the application of the guidance, it is advised that all supply chain entities consider what rules from this guidance (if any) will apply and when.
Summary of the guidance
The guidance specifically relates to placing goods on the market in Great Britain. It does not cover the following:
- goods placed on the EU market
- goods placed on the Northern Ireland market - either from Great Britain or the EU
- goods already placed on the market in Great Britain before 1 January 2021
- goods covered by national rules (non-harmonised)
- certain goods for which other specific rules apply - including medicines, chemicals, vehicles, aerospace, medical devices, construction products, rail interoperability and civil explosives
- The new UK marking
From 1 January 2021, the UKCA mark will be the applicable mark to accompany products being sold in Great Britain for which a CE mark is currently required, although in most cases a transitional period applies. Note the following:
- The UKCA is mandatory for in-scope goods from 1 January 2022 - providing a transition period of one year where the CE mark can continue to be used (further details on this below).
- The UK Government has identified a select group of products that must use the UKCA "immediately after 1 January 2021." This rule will apply to products meeting all three of the following criteria:
- the product is covered by legislation that requires the UKCA marking
- the product requires mandatory third-party conformity assessment
- the product conformity assessment has been carried out by a UK conformity assessment body and has not been transferred to an EU recognised body before 1 January 2021
The UKCA marking rules do not apply to "existing stock." This means that pre-existing stock fully manufactured before 31 December 2020 and already conformity marked can continue to use the CE Mark.
Further details issued by the UK Government on the use of the UKCA can be found here.
- Continued use of the CE mark until 31 December 2021
To allow businesses time to adjust, the CE marking can continue to be used in the Great Britain market until 1 January 2022 for most products. The list of in-scope products that can use CE markings throughout 2021 can be found here and includes, by way of example, toys, personal protective equipment, electrical equipment etc.
The criteria for the continued use of the CE mark until 31 December 2021 is as follows:
- You currently apply the CE marking to your goods on the basis of self-declaration
- EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement) carried out any mandatory third-party conformity assessment.
- The certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body.
In addition to the above, it is only possible to place the CE marked goods on products that meet EU requirements in Great Britain while the UK and EU requirements are the same. This will be the case on 1 January 2021 and there are no UK plans to diverge at this time.
That said, if the EU changes its product laws and the UK does not follow suit, it would no longer be possible to use the CE marking in the UK for the transition period.
- Conformity assessment and use of the CE and UKCA marking in tandem
Products can carry both the CE and UKCA markings so long as they are fully compliant with both UK and EU regulations.
Conformity assessment criteria for the UK will be the same as currently applicable in the EU. This means that if your goods currently meet the technical requirements for CE marking then they will also meet the technical requirements applicable in the UK from 1 January 2021. As noted above, however, UK and EU technical requirements may diverge over time.
With respect to products that must be conformity assessed by third-party conformity assessment bodies (rather than being self-assessed by the manufacturer), the following rules apply: see the UK Government's Guidance on Assessment Bodies here. In summary:
- UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market, unless the EU agrees to recognise their competence as part of a future EU/UK trade agreement.
- From 1 January 2021, the UK Government is putting in place a domestic legal framework that will allow UK conformity assessment bodies to continue operating for most products being placed on the Great Britain market.
- Appointment of the Responsible Person/Authorised Representative
Authorised Representatives (appointed by non-EU manufacturers) and Responsible Persons (for cosmetic products) based in the EU will no longer be recognised in Great Britain from 1 January 2021. There is no transition period for this rule.
These entities will need to be based in the UK for products being placed on the Great Britain market.
- Legal obligations for supply chain entities
The guidance confirms that the obligations of a manufacturer will remain largely unchanged from 1 January 2021.
There is a risk, however, that UK entities currently having "distributor" status (and related obligations) under product laws may have "importer" status (and corresponding obligation) after 1 January 2021. This change of status will happen where a UK distributor is currently buying products from an EU seller.
An importer is an entity that brings goods into the UK from outside of the UK and makes them available on the market in Great Britain for the first time. Importers have relatively onerous and clearly defined responsibilities under existing product safety regimes. Generally, before making a product available on the market, they must ensure that the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation, and that the product is correctly labelled and accompanied by any required instructions and safety information. Note that products must be labelled with the importer's name and address, but under transitional arrangements, until 31 December 2022, these details can be included on the accompanying documentation rather than on the product.
In light of the new guidance, supply chain entities should check to ensure their obligations are understood and carried out accordingly.
Issues that need attention
While the guidance provides welcome clarification, it also provides a somewhat complex matrix of rules. Understanding the application of the guidance and the old and new approach to product regulation in the UK is far from straightforward. This will require supply chain entities to devote some time to confirm how to approach safety assessment and product labels. The task is an ongoing one given that any divergence in UK and EU product regulation will require a modification in the approach during the transition period.
How can we help
At Baker McKenzie, we have a team of specialists ready to help you navigate the guidance and any other Brexit-related issues. To discuss Brexit and the implications for your company, please get in touch with your usual Baker McKenzie contact or, alternatively, a member of our team listed on this page.