As a consequence of the withdrawal of the United Kingdom from the European Union, all Union primary and secondary law will cease to apply to the UK from 12 April 2019, 00:00h (CET). The UK will then become a ‘third country’.
Economic operators should be aware of the consequent changes: EU rules in the field of non-food and non-agricultural products will no longer apply to the UK and to provide guidelines, the European Commission services published on 22 January 2018 a Notice to stakeholders. Additional Questions and Answers were published to address specific scenarios when it comes to industrial products – after the UK leaves the EU.
Unless a withdrawal agreement is ratified, the following rules and definitions will apply[1].
“PLACING ON THE MARKET”
The concept of placing on the market refers to each individual product, not to a type of products, whether it was manufactured as an individual unit or in series. It relates to the first making available on the Union (EU-27) market, i.e. the first supply of a good for distribution, consumption or use after the manufacturing stage. Placing on the market does not require physical delivery of the product but does require that the manufacturing stage has been completed.
- Criteria to establish whether a product was placed on the Union (EU-27) market before the withdrawal date.
Scenario 1 – Goods physically in the distribution chain or already in use in the EU-27 market on the withdrawal date (i.e. held in the EU-27 by a wholesaler or already supplied to hospitals).
These goods are considered as placed on the Union (EU-27) market before the withdrawal date and can therefore continue to be made available in the EU-27 market or remain in use with no need for re-certification, re-labelling or product modifications.
Scenario 2 – Goods manufactured either in the EU or in a third country, sold to an EU-27 customer before the withdrawal date after the manufacturing stage was completed but not yet physically delivered to the EU-27 customer on that date.
Same as Scenario 1. The date of placing on the Union (EU-27) market is the date of the transaction between the manufacturer and the EU-27 customer after the manufacturing stage was completed. Placing on the market does not require physical delivery of the product.
Scenario 3 – Goods imported into the UK from a third country or manufactured in the UK, subsequently sold to an EU-27 customer before the withdrawal date but physically delivered to the EU-27 customer as of that date.
Same as scenario 1 and 2. The date of placing on the Union (EU-27) market is the date of the transaction between the UK economic operator (manufacturer, importer or distributor) to the EU-27 customer.
Scenario 4 – Goods imported into the UK from a third country or manufactured in the UK before the withdrawal date, subsequently sold to an EU-27 customer as of the withdrawal date.
The goods are placed on the Union (EU-27) market after the withdrawal date as the date of their first making available to an EU-27 customer is on or after the withdrawal date. The goods are considered as imports from a third country and will have to fully comply with the provisions of Union law applicable at the time of their placing on the market. Goods will have to have been certified by an EU-27 Notified Body, if required. Where applicable, they will also have to indicate the details of the EU-27 importer and of an EU-27 ‘responsible person’.
RESPONSIBLE PERSONS
Responsible persons based in the UK will lose their status as from the withdrawal date. Therefore, manufacturers need to ensure that, as from the withdrawal date, their designated responsible persons are established in the EU-27.
Scenario 1. Goods placed on the Union (EU-27) market before the withdrawal date.
No need for relabelling with the contact details of the new EU-27 responsible persons but economic operators will need to inform the competent national authorities about the appointment of a new responsible person established in the EU-27.
Scenario 2. Goods placed on the EU-27 market as of the withdrawal date, whether coming from the UK or another third country.
These goods will have to fully comply with the provisions of Union law applicable at the time of their placing on the market. Therefore, labels shall indicate the details of a responsible person established in the EU-27.
IMPORTERS
The importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union.
Scenario 1. Products which were imported into the EU-28 via the UK and placed on the Union (EU-27) market before the withdrawal date.
These products will not need to be relabelled with the indication of the EU-27 importer. No change to the labels is required.
Scenario 2. Goods imported into the UK market before the withdrawal date and made available to the EU-27 market as of that date.
EU-27 economic operators which were previously mere distributors of those products will become importers when making those products available in the EU-27 market for the first time, with more stringent obligations as regards product compliance. These products will need to be relabelled with the indication of the EU-27 importer.
NOTIFIED BODIES
Notified Bodies must be established in a Member State and designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation. Products covered by a Certificate issued by a UK Notified Body will need to obtain another certificate from a EU-27 Notified Body in preparation for Brexit.
If a UK Notified Body Certificate is transferred to a EU-27 Notified Body, do the EU Declaration of Conformity and the actual Notified Body Certificate need to be updated to document this change?
Yes, these documents shall be updated.
Does the Notified Body number on the product itself need to be changed also for products already on the market or manufactured before the transfer of the certificates occurred?
In such cases there will be no need to change the Notified Body number on the products if:
- The abovementioned documentation has been updated;
- The products are already on the EU-27 market;
- The products have not been placed on the EU-27 market but were manufactured before the transfer of certificate has taken place.
Products manufactured after the transfer of certificate to a EU-27 Notified Body should instead mention the new NB number.
Manufacturers placing medical devices, IVDs, cosmetics and other products[1] on the EU market, having either a registered address in the UK or an Authorized Representative in the UK will need to take preventive actions in reference to these changes – such as designating a NEW Authorized Representative which has a registered address in the European Union. Contact us today to receive hands-on support on creating your BREXIT strategy.
Martina Quitadamo
April 15, 2019
[1] The text cited represents extracts from the European Commission Questions and Answers document.
[1] Annex to the Notice to Stakeholders presents an indicative list of all the affected EU product legislation.
