The UK Government has issued a series of guidance documents relating to placing manufactured goods on the market in Great Britain (England, Wales and Scotland), Northern Ireland, and in the EU after 1 January 2021, focusing on requirements relating to conformity marking requirements that are required in relation to certain goods such as toys, PPE, electrical equipment and machinery.
From 1 January 2021, the UK will introduce its own conformity mark – the UKCA mark – for goods sold in Great Britain (GB), which will apply for most goods that currently require a CE mark. The UKCA mark cannot be used alone for goods placed on the market in Northern Ireland; these will have their own regime and require the CE marking or UK(NI) marking.
Whilst the UK is introducing its own regime, in order to allow a period of adjustment for businesses, the Government has decided that (with some exceptions) relevant CE-marked goods can continue to be placed on the GB market until 1 January 2022 (i.e., without also having the UKCA mark), including where the goods have been assessed by an EU recognised notified body. However, this will only be the case for as long as the EU and UK requirements remain the same. The possibility of divergence seems unlikely in the short term (the Government has said there are 'no UK plans to diverge at this time'). Further, in some cases, it will be necessary to apply the UKCA mark to goods being sold in GB immediately from 1 January 2021.
As for placing goods on the EU market, the UKCA mark will not be recognised on the EU and Northern Ireland markets. Businesses that currently self-declare the conformity of their goods against the regulations (or voluntarily use a testing or notified body) can continue to use CE-marking for goods placed on the EU market from 1 January 2021 as now. However, where goods require mandatory third party conformity assessment, this must be conducted by an EU-recognised notified body. Accordingly, where a certificate of conformity has previously been held by a UK body, it must be transferred to an EU-recognised notified body.
Manufacturers and distributors should review the various guidance notes carefully and ensure they are in a position to comply from 1 January 2021 in relation to goods on the various markets (recognising it remains possible, of course, that a trade deal may be reached which impacts on these issues).
Placing goods on the GB market
Using the new UKCA marking
The new UKCA marking should be used immediately after 1 January 2021 where all of the following apply in relation to the product:
- It is for the GB market.
- It is covered by legislation requiring the UKCA marking (i.e., most goods currently subject to the CE marking; it will also apply to aerosol products).
- It requires mandatory third-party conformity assessment.
- The conformity assessment has been carried out by a UK conformity assessment body and the conformity assessment files have not been transferred to an EU recognised body before 1 January 2021.
Where required, authorised representatives and responsible persons based in the EU will no longer be recognised in Great Britain after 1 January 2021.
The Government guidance provides more details on the rules relating to the use of the UKCA mark, requirements in relation to record-keeping and for the UK Declaration of Conformity document. Transitional provisions provide that, until 1 January 2023, other than for certain goods subject to special rules, the UKCA mark can be affixed either to the label on a product or on an accompanying document.
Using CE marking
The CE marking can continue to be used on its own for goods on the GB market until 31 December 2021 where any of the following apply:
- CE marking is currently applied on the basis of self-declaration.
- Any mandatory third-party conformity assessment was carried out by an EU-recognised (including via mutual recognition agreements) notified body.
- The certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body.
However, this will only be the case for as long as the UK and EU requirements are the same. If the EU changes it rules such that they differ from UK requirements, the CE marking can no longer be used on its own, even in the period before 1 January 2022.
It will also be possible to sell goods in GB with a CE mark where those goods were 'existing stock' i.e., fully manufactured and ready to place on the market before 1 January 2021 (even where they are covered by a Certificate of Conformity issued by a UK body).
Placing goods on the EU market
The UKCA mark will not be recognised on the EU and Northern Ireland markets. Products that currently require a CE marking for sale in the EU will continue to need a CE mark. This will involve no change of approach where any of the following apply:
- Businesses currently self-declare the conformity of their goods against the regulations.
- They voluntarily use a testing or notified body to test against European or international standards.
- Any mandatory third party conformity assessment was carried out by an EU-recognised notified body.
- The certificate of conformity previously held by a UK body has been transferred to an EU-recognised notified body.
Where mandatory third party conformity assessment is required, this must be conducted by an EU-recognised body from 1 January 2021. Unless there is an agreement on this point in the negotiations, a UK conformity assessment body will not be able to carry out mandatory conformity assessment for products placed on the EU market.
The EU will also no longer recognise authorised representatives and responsible persons based in GB from 1 January 2021, and so one based in the EU, EEA or Northern Ireland will need to be appointed.
The Government advice on placing goods on the EU market is found here.
Other types of goods
The rules announced by the Government focus on what are known as 'new approach goods'. There are different rules for 'old approach goods' (which includes chemicals, medicines, vehicles and aerospace) and goods covered by national non-harmonised rules. Certain other goods, including in particular medical devices are covered by the UKCA marking scheme but have their own special rules.
Obligations on distributors and suppliers
Distributors and suppliers will become an importer into the UK or the EU (as appropriate) of relevant goods, and will need to take steps to ensure that obligations relating to labelling, conformity assessment procedures, technical documentation and record-keeping are complied with, including where appropriate by the manufacturer.