The end of the Implementation Period for the EU-UK withdrawal agreement is fast approaching, and a ‘no-deal’ Brexit is becoming more likely. Therefore, on the 1st January 2021 there will be significant changes in product compliance and import regulations between the UK and EU and between Great Britain and Northern Ireland.
A transitional phase running for a year until 1st January 2022 will soften the impact of these changes as certain products will be able to continue using the CE mark in the UK, but at that date CE Markings will be invalid in the UK.
As of the 1st January 2021, the EU will no longer recognise CE marks based on conformity assessment carried out by UK notified bodies.
You will need to use the new UKCA or UKNI marking immediately after 1 January 2021 if ALL of the following apply. Your product:
- is covered by legislation which requires the UKCA marking
- requires mandatory third-party conformity assessment*
- conformity assessment has been carried out by a UK conformity assessment body and you haven’t transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021
*Products can be searched by relevant testing houses here.
There will also be a shift in who is seen as the ‘importer’ for regulatory and enforcement purposes: where goods are manufactured in the UK to be sold in the EU or vice versa; organisations will have to be aware of which role they currently occupy and what part they will play after the 1st January 2021.
The Department for BEIS has published 3 guidance documents in recent weeks covering 3 different situations:
- Placing manufactured goods on the market in Great Britain after 1st January 2021
- Placing manufactured goods on the market in the EU after 1st January 2021
- Placing manufactured goods on the market in NI from Great Britain after 1st January 2021
Different arrangements will be in place for other products: medicines/medical devices; vehicles; chemicals; aerospace; constructions products and products requiring energy labelling.
Current and Historic arrangements for Product safety and standards
Currently, any goods covered by the CE marking legislation need a CE mark before being offered for sale in the EEA. The mark itself indicates the goods have been declared as meeting EU standards for health, safety and environmental protection.
To be able to use a CE marking, a manufacturer must carry out a conformity assessment, set up a technical file, and sign a Declaration as required by the relevant legislation. For some products, such as toys, pyrotechnics or lifts, the CE marking may have to also be confirmed by an authorized third party (a Notified Body).
It’s a criminal offence to either not include the mark where required, or include it on a product that is non-compliant.
The new mark
From the 1st January 2021, the UKCA mark will be introduced as a replacement for the CE mark in Great Britain (i.e. not Northern Ireland – see below). It will operate in substantially the same manner, with much of the relevant EU legislation being carried across to or remaining in force for UK law.
The CE mark will generally remain acceptable in the UK until 1st January 2022, so long as EU and UK requirements mirror each other. While it seems unlikely that the UK will move to update standards in the transitional phase, a divergence could in theory occur where EU standards are updated. It is hard to see the UK declining imports of EU products produced to new standards between 2021 and 2022 as a matter of policy. However, businesses will have to keep a close eye on changes in product safety law if they wish to carry on relying on the CE mark until 2022.
If you have obtained a certificate of conformity from a UK Notified Body and plan to continue using the CE mark, before the 21st January 2021 you must: a) self-certify the goods if possible; b) arrange for an EU Notified Body to issue a certificate of conformity; or c) get the certificate of conformity previously held by the UK Notified Body transferred to an EU Notified Body. Any certificate issued by a UK Notified Body will cease to be valid for CE purposes. In practice, many UK Notified Bodies have been making arrangements or partnerships with EU Notified bodies in order that certificates can remain valid and minimal disruption is caused but it is important to check with your Notified Body.
Any existing stock produced and placed on the UK market prior to the 21st of January date can continue to be sold. A good is ‘placed on the market’ when a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.
Both CE and UKCA marks can be applied to the same product if the individual steps for each mark have been correctly completed.
A specific protocol will apply to product standards in The Northern from 1 January 2021. For as long as it is in force, Northern Ireland will align with relevant EU rules relating to the placing on the market of manufactured goods.
A separate mark for Northern Ireland will be introduced – the UKNI. In theory, either the CE or UKNI mark will be able to be applied to goods introduced to the Northern Ireland market, depending on whether an EU or UK Notified Body has provided a certificate of conformity for the goods (where needed); the manufacturer can then apply CE or CE UKNI as relevant.
Goods with either mark will currently be able to be sold throughout the UK; only goods with the CE mark will be able to be sold throughout the EU as well.
You do not need to make any changes if both of the following apply:
- you are a manufacturer based in Northern Ireland (or are the manufacturer’s authorised representative)
- you currently mark your goods on the basis of a supplier’s declaration of conformity, sometimes known as ‘self-certifying’
The UKCA marking cannot be used for goods placed on the Northern Ireland market.
UK Manufacturers and Producers
Currently, where goods are produced in the EU, the manufacturer is responsible for ensuring the goods comply with product compliance regulations. Where goods are produced outside of the EU, the company bringing them into the EU is often responsible for ensuring the manufacturer has complied with the relevant regulations. It is easy to foresee problems in practice here and importers/exporters should examine their contracts and the locations of their establishments to ensure they are clear taking appropriate responsibility and communicating with EU importers.
After the IP date, a similar system will apply to bringing goods into the UK. Goods manufactured in the EU and destined for the UK will have the UK-based importer responsible for ensuring manufacturing compliance – this is likely to impact who is ultimately responsible for mark application and compliance. Supply contracts will need to be reviewed to ensure any shift in liability is adequately captured.
Above all else, we note that the product standards requirements may change between now and the 21st January 2021, but knowing what changes may need to be done will leave organisations in a strong position going forwards. BEIS has strongly recommended to businesses that they begin to get to grips with the UKCA marking requirements as soon as possible, rather than rely on transitional arrangements.