Special Brexit Bulletin, September 2020
The UK Government published new guidance on 1st September 2020. With the end of the transition period fast approaching and given the limited information available to us, we attempt to clarify and foresee the implications that this will have on manufacturers of equipment that currently requires the CE Mark. Manufacturers who export into the EU single market will be most affected by the changes, in particular those who require Notified Body approval for their equipment.
Application of Standards
Let us get the easy part out of the way at first. Back in 2018 the EU standards bodies CEN and CENELEC approved the UK’s continuing membership, therefore the standards that apply will remain the same, although they may diverge at some point in the future. ‘EU harmonised standards’ will become ‘UK designated standards’ but the technical content should not change; please note that some published standards have national deviations and this will continue. With the exception of some labelling the construction requirements for your equipment should remain unchanged. CEN and CENELEC are non-political organisations and the UK through BSI the National Standards Body will continue to participate in the Technical Committees in order to publish and revise standards.
It should be noted that compliance with harmonised standards is voluntary but they prove to be a valuable route for compliance with applicable regulations since this demonstrates state of the art compliance. UK and EU law that relates to products is written in general terms, however the standards that could be used to demonstrate presumption of conformity with applicable regulations go into detailed technical and documentation requirements.
Placing Equipment on the GB Market
If the equipment is covered by a CE Marking directive and you are offering it for sale in England, Scotland or Wales, the UKCA Mark will apply. There is time to adjust since the CE Mark will be accepted until the end of 2021 unless the equipment requires third party approval and the certification has not been transferred to an EU Notified Body; in this case the UKCA mark will apply immediately in 2021. Northern Ireland is a special case and is covered separately in this bulletin.
Since CE Marking Directives are at present implemented into UK law as secondary legislation in the form of regulations, e.g., the Machinery Directive 2006/42/EC is implemented in UK law as The Supply of Machinery (Safety) Regulations 2008, these regulations will broadly remain the same but the declaration of conformity should state the UK legislation and not the EU directives. Further information including a list of the UK regulations is available at www.gov.uk/guidance/using-the-ukca-mark-from-1-january-2021
Exporting into the European Economic Area or Customs Union
If you export equipment into the EU, Iceland, Liechtenstein, Norway or Turkey the CE requirements will apply as before but there must be someone in one of those countries who has to make the technical file available following an inspection request by an enforcement authority. An office or agent is the obvious choice; your importer or customer may retain the technical file, otherwise you will have to appoint an Authorised Representative. The declaration of conformity (or incorporation) will need to state the contact in the EEA or CU, entry of your equipment may be refused if this representation is missing from your declaration. Your technical file remains confidential as it may contain proprietary design information, we advise thorough vetting when appointing someone to hold the technical file for you in order to prevent your design from being copied.
If the equipment requires certification by a Notified Body (e.g. high risk machines specified in Annex IV of the Machinery Directive 2006/42/EC, medical devices and construction products) and it is currently certified by a UK Notified Body, the certification for the EEA will no longer be valid after the transition ends and certification by a Notified Body established in the EEA will be required. More information can be found at the following websites:
Unlike the present where goods are subject to free movement, it will be subject to inspection when crossing into the EEA or CU and the equipment is likely to undergo checks at the border to verify that it has the appropriate certification. It is worthwhile checking that your documentation is correct, for example if you are sending a machine to France and the instructions are only in English, entry may be refused; likewise we advise having the equipment manual verified by a person who is proficient in the language of the country where the equipment is going to.
These additional checks could incur time delays and you should consider this in your delivery schedule.
What About Mutual Recognition Agreements?
Mutual Recognition Agreements are ‘bilateral agreements’ as described on the website https://ec.europa.eu/growth/single-market/goods/international-aspects/mutual-recognition-agreements_en. A manufacturer may have their product tested by an accredited conformity assessment body from a country outside of the EEA such as Australia, Japan or the USA: this certification supports CE compliance. According to the website above, the UK does not have any mutual recognition agreements, hence if you need Notified Body approval and you must choose a company that is listed on the NANDO website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm.
What About Northern Ireland?
This is very much a political subject but we attempt to examine the situation impartially based on
the information that is available. The UK Government website below contains information about
goods moving in and out of Northern Ireland.
Sections 11.3 and 11.4 of the following publication suggest that the CE Mark will be valid in
Northern Ireland and this correlates with section C of the European Commission publication that is
immediately below it.
As free movement of goods between Northern Ireland and the Republic of Ireland will take place, Northern Ireland will effectively become part of the outer border of the Single Market, hence the EU are highly likely to require checks on equipment entering Northern Ireland from Great Britain and other ’third countries’ in order to protect the integrity of the single market. You may also need to appoint an authorised representative in accordance with the CE requirements.
Examples of Some Realistic Situations
Situation 1: Asian Company selling to EU and GB
A company in Japan has their range of manually-fed presses certified by a Dutch Notified Body and sell their products all over Europe, their only European office being based in Amsterdam. This company has until the end of 2021 to adapt. In the first instance, the manufacturer should check if their Notified Body has a branch or partner that can cover Great Britain. If not then they will need a UK (which really should be GB) Approved Body to certify the equipment or find a company that can cover both markets. They will need to appoint a GB based point of contact on the UK declaration of conformity.
Situation 2: Scottish Company Selling to EU
A manufacturer of a transmitter currently exports worldwide, all operations are controlled from their only office and they have their equipment certified by a UK Notified Body. Time is critical as from 2021 they will not be able to sell into the EU without implementing changes. Firstly, their Notified Body should be consulted to see if they have a partner or subsidiary who is an EN Notified Body. If not, they may have to move their certification to an EU Notified Body. They will also require someone in the EEA to make their technical file available, this contact needs to be stated on their EU Declaration of Conformity.
Situation 3: English Company Selling to Northern Ireland
A small company that manufactures transmission assemblies for agricultural vehicles has a large customer in Northern Ireland. Their product is classed as partly completed machinery and is accompanied by a declaration of incorporation. From 2021 they will require someone in the EEA to make their technical file available and this contact needs to be stated on their EU Declaration of Incorporation. Please be aware that the requirements for Northern Ireland may change.
Situation 4: Welsh Company Importing Equipment from EU
A construction vehicle manufacturer purchases a collision avoidance device from a company in Milan; this device has been certified by an Italian Notified Body. No changes need to be implemented before the end of 2021 but after that, the controller will need to be UKCA marked which may require approval from a UK Approved Body if the Italian Notified Body does not have a partner that can cover GB.
Situation 5: Moving Existing Equipment to EU After Transition
A car parts manufacturer in England had a robot cell built for them by a local company in 2015 and they want to relocate the cell to their sister plant in Spain. If the move is made before the end of 2020 then the receiving plant will need to do the Spanish equivalent of a PUWER audit. If the move is made at a later date, then the equipment is crossing the EU outer boundary and the CE compliance may have to be revisited. Checking with the manufacturer of the cell to see what documentation they have and who can hold the technical file is advisable, however, please be aware that the person who is receiving the equipment may default to the responsible person and could insist on a re-assessment.
Situation 6: Acquiring Used Equipment from the EU
An automated warehouse wants to move a rail guided storage and retrieval system from their sister site in Copenhagen to their warehouse in Scotland. If the move is made before the end of 2021 then the receiving site will need to do a PUWER audit. If the move is made at a later date, then the equipment is subject to UKCA marking unless domestic legislation changes in the meantime.
Situation 7: American Company Selling into Europe
A large American manufacturer of injection moulding machines has their European HQ in Cardiff and has their manually-fed models certified by a UK Notified Body. From next year they will need to move their certification to an EU Notified Body unless their existing Notified Body has a branch or partner that can cover the EU. For holding the technical file, the sensible option would be for one of their offices in the EEA to retain their documentation.
Will the Kitemark Make a Comeback?
This is a question we have been asked recently. The answer is that the Kitemark (a trademark belonging to BSI) has never gone away as its symbolisation is different to the CE and UKCA marks. Whilst the latter marks are mandatory to state compliance with regulations and can in many instances allow for self- certification, the Kitemark can only be applied after BSI has examined your product and quality system.