Post-Brexit Product Compliance for CE-marked Products
With less than 30 days to go until the end of the Brexit transition period on 31 December 2020, there are growing concerns as to what the impact of leaving the EU will be on product labelling and compliance – particularly for CE-marked products. CE is the administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
The certification of new products will change dramatically post Brexit and with just over two weeks to go, many questions remain. In this article, Nicky Strong of law firm Womble Bond Dickinson, looks to address some of the key areas of concern.
What's in the EU Withdrawal Agreement?
The provisions under the EU Withdrawal Agreement agreed on 19 October 2019 mean that any products which have already been assessed by a notified body, CE marked and placed on the EU market prior to the end of the transition period on 31 December 2020 will not be affected and can continue to be marketed in both in the UK and the EU. There will be no requirement for these products to be reassessed or re-labelled in any way.
However, after the end of the transition period, the UK's notified bodies will lose their status in the EU and UK notified bodies will no longer be authorised to assess whether products conform to EU standards or determine that a product may be CE marked. Instead, UKCA (UK Conformity Assessed) will be the new UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) and covers most goods which previously required the CE marking.
The EU's current position
The EU's last position on this is, that if no trade deal is negotiated, UK notified bodies will lose their status immediately after the UK leaves the EU. At that point, certificates issued by UK bodies will no longer be valid, unless the product in question has already been placed on the market. In other words, any products not in the EU market by the exit date will need to be re-assessed by an EU-27 notified body and certified as compliant before they can be CE marked and placed on the market. Alternatively, the file and certificate can be transferred to an EU notified body so that fresh valid certificates can be issued and products re-marked with the new notified body's number. This is likely to cause delay and disruption for manufacturers in the UK.
In addition, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the EU. As a consequence, an economic operator established in the EU who, prior to the end of the transition period, was considered as an EU distributor of products received from the United Kingdom will become an importer for the purposes of the legislation as of the end of the transition period. This operator will have to comply with the more stringent obligations imposed on importers, including verification of product compliance and, where applicable, including their contact details on the product or product label.
Where EU legislation provides for a "responsible person" established in the EU to be appointed by the manufacturer and to whom specific tasks are designated to ensure continuing regulatory compliance and be the point of contact with regulatory authorities, then UK-based responsible individuals will similarly lose their status at the end of the transition period, regardless of when products were placed on the market. Therefore, manufacturers need to ensure that, as from the end of the transition period, their designated responsible persons are established in the EU.
The UK's current position
The latest guidance from the Department for Business, Energy and Industrial Strategy, states that while the UKCA mark will be the conformity assessment mark for Great Britain from 1 January 2021, goods already placed on the EU market can continue to be marketed in the UK post 31 December 2020. In addition, goods that meet EU requirements, have been self-certified or tested by an EU-27 recognised notified body and are CE-marked can also still be placed on the UK market until 31 December 2021.
The Government has reiterated that goods can be CE marked up to 31 December 2021 only if UK and EU essential requirements and technical standards for these products are the same, but has also stated that there are no plans to diverge from EU requirements or standards at this time. It also makes clear that the UKCA marking will not be recognised on the EU or Northern Ireland markets. Products currently requiring a CE marking for sale in the EU will continue to need a CE mark. Under the Northern Ireland Protocol, Northern Ireland will continue to align with all relevant EU rules relating to the placing on the market of manufactured goods. Products for the Northern Ireland market can use either the CE or the CE mark with the newly-introduced UKNI marking. For goods being marketed in Northern Ireland, where a UK Approved Body is used to carry out mandatory third-party conformity assessment, then a UKNI marking must be applied from 1 January 2021. This mark cannot be used on its own. It can only be used in conjunction with an EU mark, such as the CE mark. However, the combined CE and UKNI marking will not be recognised in the EU – the CE mark must be used on its own.
Where a product is covered by legislation which requires a UKCA mark, and requires mandatory conformity assessment by a third party (i.e. the product cannot be self-declared as in conformity), and that conformity assessment has been done by a UK conformity assessment body and the files have not been transferred to an EU Notified Body before 1 January 2021, then the UKCA mark must be used from 1 January 2021.
However, this does not apply to fully manufactured existing stock which is ready to be placed on the market before that date. In that case, the UKCA mark is not required even if certification was done by a UK body. These goods can continue to be placed on the Great Britain market until 31 December 2021.From 1 January 2022, the UKCA marking must be used.
Where mandatory third-party conformity assessment was required for CE marked goods, it will also be required for UKCA marked goods. This conformity assessment must be carried out by a UK-recognised approved body and the type of conformity assessment procedures will be the same that were required for the CE marking.Where self-declaration of conformity is permitted for CE marking this will continue to be the case for UKCA marking.
UK distributors should also check whether they will be deemed an importer post transition – i.e. are they the 1st entity to bring goods from outside the UK and place them on the market in Great Britain.If so, then from 1 January 2021, those goods will need to be labelled with their company's details.However, the government has confirmed that these details can be on the accompanying documentation rather than the label itself until 31 December 2022.
As importer, the company will also be responsible for ensuring the correct conformity assessment procedures have been carried out and that goods have the correct conformity marks (CE or UKCA), that the manufacturer has drawn up the correct technical documentation and complied with their labelling requirements, and that a copy of the declaration of conformity is kept for a period of 10 years.
The new certification system and product labelling is likely to be a source of concern for many businesses who will no doubt face delay, disruption and more uncertainty in the first few months after the end of transition period, an uncertainty that has been with us for four years and exacerbated in 2020 by the COVID-19 pandemic and the devastating social and economic impacts it has brought.
For more information on this, or if you need advice, please contact Nicky Strong at Womble Bond Dickinson ([email protected]).