Trading goods regulated under the ‘New Approach’ if there’s no Brexit deal
How trading in harmonised goods regulated under the ‘New Approach’ would be affected if the UK leaves the EU with no deal.
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Details
If the UK leaves the EU without a deal on 29 March 2019, the requirements for placing certain products on the UK and EU markets, including the arrangements for conformity assessment, marking and labelling, will change.
This notice explains the future arrangements that will apply to the regulation of most goods covered by the EU’s New Approach, in a ‘no deal’ scenario. It includes those goods regulated under the ‘New Legislative Framework’ as well as machinery, and arrangements for conformity assessment.
This notice does not cover areas such as automotive, aerospace, chemicals, medicines, construction products or medical devices.
Actions for businesses and other stakeholders
Manufacturers placing products on the UK market on or after 29 March 2019 should note:
- Goods already on the UK market by 29 March 2019 can continue to circulate in the UK.
- Products that meet EU regulatory requirements can continue to be placed on the UK market without any need for reassessment or re-marking, including where any assessment required is carried out by an EU-recognised body (for a time-limited period).
- Products that meet UK regulatory requirements and bear a UK conformity marking can be placed on the UK market as long as any third-party assessment required has been carried out by a UK-recognised body.
- Products that have undergone the complete process of manufacturing and conformity assessment (i.e. which are ready for placing on the market) can still be placed on the UK market with a CE Marking after 29 March 2019.
- For product areas covered by this notice, UK-based notified bodies will become UK approved bodies after March 2019 and will be listed on a new UK database.
- Distributors who bring products in from the EU to the UK may now be classified as ‘importers’ bringing in products to the UK from a third country and will need to understand their additional legal responsibilities.
Manufacturers placing products on or after 29 March 2019 on the EU market should note:
- Products which were assessed by a UK-based notified body will need to be reassessed by an EU-recognised conformity assessment body before placing on the EU market.
- Alternatively, manufacturers can seek to arrange for their files to be transferred to an EU-recognised notified body pre-exit to allow for certificates of conformity issued by a UK-based notified body to continue to be valid.
- In either of the scenarios above, products where third-party assessment is required would need to be re-marked with the new notified body’s 4-digit number.
- Where manufacturers use the CE marking based on self-declaration this can still be used when exporting goods to the EU.
- Goods brought into the EU from the UK will be classified as third country goods, and when placed on the market by EU distributors that distributor will be considered an ‘importer’. Such goods may need to be labelled with the EU-based importer’s address.
Additional information
Information about goods not covered by this notice is also available:
- Automotive (Vehicle type approval)
- Aerospace (Aviation safety)
- Pharmaceutical products (Batch testing medicines, Medicines, Medical Devices and Clinical Trials, further guidance on the regulation of medicines, medical devices and clinical trials, Submitting regulatory information on medical products)
- Medical devices (Medicines, Medical Devices and Clinical Trials, Submitting regulatory information on medical products)
- Chemicals (Regulating chemicals, classifying, labelling and packaging chemicals)
- Goods subject to national regulations (Non-harmonised goods)