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New Rules on CE and UKCA Marking

When the Brexit: Transition Period ends on 31 December 2020, it presents multiple challenges for UK importers and exporters; not least of all, knowing what conformity assessment (product) mark to use for their goods?

What applies now, may not apply on 1 January 2021; however, the current CE mark will remain temporarily valid to allow businesses time to adjust to the new requirements. There are some exceptions though, which comprise medical devices and construction products (go to Gov.UK for more information). The CE marking will only be valid in Great Britain for areas where GB and EU rules remain the same.

Who is responsible?

Replacing the current CE mark will be a new mandatory UKCA product mark to indicate that it conforms to UK legislation. Manufacturers or their authorised representative will be responsible for including the UKCA mark on the product. Where a product is sold in the UK and in the EU, it will need to be dual marked.

What is a CE mark?

The Conformitè Europëenne (CE) mark is defined as the European Union’s (EU) mandatory conformity mark for regulating goods sold in the European Economic Area (EEA), which comprises 27 EU member states, plus Iceland, Liechtenstein and Norway. It also includes Switzerland, which is not an EU or EEA member, but is part of the single market.

What are the differences between UKCA and CE marking?

The UKCA mark will just apply in Great Britain (England, Scotland, and Wales) and only requires information to be in English. This simplifies some aspects, such as where the technical information must be kept, and which language applies.  Other differences relate to the separation of UK conformity assessment bodies from the EU Notified Body System.

What aspects are not changing?

The scope of products covered, technical requirements and conformity assessment procedures will essentially be like for like.  The principal differences will be administrative.

Will UKCA marking apply throughout the UK or just GB?

The UKCA mark will apply only in Great Britain. Unless otherwise stated, the current CE mark will continue in Northern Ireland, thus due to its open border with the Republic of Ireland, which remains in the EU single market. Therefore, products placed on the market throughout the UK will eventually need to be both UKCA and CE marked.  Businesses in Northern Ireland will be in the unique position of being able to ship products certified to EU (CE mark) or UK (UKCA mark) rules into Great Britain.

Will Northern Ireland have its own conformity assessment mark?

It is anticipated that there will be a new UK(NI) mark, which will be used when a UK Approved Body is involved in the conformity assessment process of CE marked goods for placing on the Northern Ireland market. More information regarding this will be available in due course on Gov.UK

Can CE and UKCA marks be used on one product?

If they they comply with the associated requirements, then yes. It is already commonplace to see multiple conformity marks on internationally sold products.

Will there be specific UK legislation regarding the new conformity assessment?

The UK government has issued several statutory instruments to amend current legislation. The main regulations are The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. These regulations amend most of the UK CE marking regulations for products placed on the UK market and stipulate the UKCA mark. Where a directive required CE marking and UK regulations were already detailed, the amendments are limited to:

  • replacing the CE mark with the UKCA mark
  • limiting applicability to products for the UK market
  • changing references to Notified Bodies to Approved Bodies
  • changing language references to English

Where an EU CE marking regulation is being amended rather than a directive, more substantial amendments have been necessary similar to the regulations that implement the directives.

Is there a list of recognised UK Approved Bodies?

UK-based accredited Notified Bodies (NB) will automatically become (UKAS) UK Approved Bodies, and Recognised Third-Party Organisations (RTPOs), User Inspectorates (UIs) and Technical Assessment Bodies (TABs) will become UK recognised RTPOs, UIs and TABs respectively.

The UK Government is in the throes of setting up a new UK database which will replace, for UKCA (UK conformity assessed) marking purposes, the EU’s NANDO (New Approach Notified and Designated Organisations) Information System. Here is a current list of notified UK bodies.

  • For guidance on placing manufactured goods on the market in Great Britain from 1 January 2021, click here.
  • For guidance on placing manufactured goods on the market in Northern Ireland to/from Great Britain from 1 January 2021, click here.
  • For guidance on placing manufactured goods on the market in Northern Ireland to/from Great Britain from 1 January 2021, click here.
  • For guidance on placing manufactured goods on the EU market from 1 January 2021, click here.

For goods regulation questions, you can email goodsregulation@beis.gov.uk

Are standards changing?

The British Standards Institution (BSI) maintains its commitment to the EN and international standards systems and ‘harmonised standards’ remain best practice for both CE and UKCA marking. The UK regulations term them ‘designated standards’ and to start with harmonised and designated standards lists will be the same. BSI is unlikely to withdraw EN standards; however, the designated list may change slightly over time with the input of the Health & Safety Executive (HSE).

What do the changes mean for Notified Body certificates?

UK Notified Body accreditations will be withdrawn, and their CE marking will no longer be valid for products placed on the EU market after 31 December 2020. Many UK Notified Bodies are consequently transferring certificates to EU-established Notified Bodies and this usually requires product markings and Declarations of Conformity to be changed.

UK bodies that were Notified Bodies immediately before 31 December 2020 will automatically become UK Approved Bodies, and their certificates will remain valid only for products placed on the market in the UK, and for products CE marked and placed on the EU market before that day.

What needs immediate action?

From 1 January 2021, importers of products marketed in the UK must be established in the UK. Their product labelling obligations can be met by information on documents accompanying the product for a period of 18 months.

Authorised Representatives already established in the EEA (European Economic Area) will continue to be recognised in the UK, but those established after 31 December 2020 must be in the UK.

EU-based organisations that bring in UK products for marketing in the EU will become an importer with increased responsibility for compliance. Currently, these entities are classed as distributors with responsibility for checking declarations, instructions, and markings. As importers, they must also check that products have an adequate technical file, which is a significant extra obligation, and indicate their name and address on the product.

Regulation (EU)2019/1020

Unrelated to the UK’s withdrawal from the EU, important changes to manufacturers’ obligations are being introduced in July 2021 by Regulation (EU)2019/1020, which is likely to impact UK and other non-EU based manufacturers wishing to sell into the EU single market.

This regulation has been introduced with the intention of better defending the EU single market against non-compliant products and avoiding gaps in the enforcement system, particular in view of the increasing number of products being offered for sale online to end users within the EU. It states that for manufacturers based outside the EU, the EU-based responsible economic operator must be one of the following:

  • an importer
  • an authorised representative appointed by the manufacturer
  • a fulfilment service provider who handles the product, if neither of the above exist

For more information on conformity assessment, please click here.