UK Government publishes third batch of Technical Notes regarding ‘No Deal’ preparation

On Monday 24th September the UK Government published its third batch of technical notes for businesses and consumers with advice on what to expect should the UK leave the EU without a deal next year. Key areas addressed in this release include flights, food labelling and regulation of medicines & chemicals.

This batch of 24 paper brings the total number of technical notes now published to 77.

For those members in the life sciences sector, you may be interested to know that the UK government has begun consultations on how the Medicines and Healthcare products Regulatory Agency’s (MHRA) legislation and regulatory processes would have to be modified in the event of a no-deal scenario. This consultation covers no-deal proposals on medicines, clinical trials and medical devices. Further information on the consultation process can be found here.

The full list of papers can be accessed here. Links and brief summaries of what is contained in this latest release of papers is detailed below.

The British Irish Chamber recommends all members whose UK operations would be impacted by a “no deal” outcome to read papers relating to their sector in full. 

  • Commercial road haulage in the EU if there’s no Brexit deal
    • Paper outlines current permissions for UK hauliers operating across the EU and steps already taken by the UK Government in the ambition of ensuring continued transport connectivity for hauliers post-Brexit. This includes the introduction of the Haulage Permits and Registration Act this year and the ratification of the 1968 Vienna Road Traffic Convention.
    • In the event of no deal, UK hauliers could lose the right to access EU markets with their Community Licence alone and might also be excluded from cabotage.
    • If UK issued licences and authorisations are not recognised by EU countries, hauliers will need have a European Conference of Ministers of Transport (ECMT) permit to operate in these markets – these are limited in number and cannot be guaranteed.
    • The UK will seek to reinstate old bilateral agreements with specific EU states and will also seek out new bilateral agreements to provide haulage access.
    • UK drivers may need to obtain an International Driving Permit for driving in the EU.
    • Regardless of the outcome, UK trailers will need to be registered with the DVLA and display their own registration plate from March 2019 – this will not apply to trailers being used solely for domestic journeys or for journeys between the UK and Ireland will not be required to register.
    • UK will retain a Certificate of Professional Competence (CPC) scheme and EU issued CPC documentation will continue to be recognised in the UK in no deal scenario. However, EU countries may no longer recognise UK issued CPC’s and drivers working for EU operators who hold UK-issued CPC will also need to hold an EU-issued CPC.
    • Note includes details on how to apply for an ECMT Permit, trailer registration requirements and CPC certification.
    • Hauliers are also advised to put contingency plans in place in the event of delays at ports  and to make themselves aware of EU required checks at ports including those for agri-food goods. 
  • Operating bus or coach services abroad if there’s no Brexit deal
    • In the event of no deal, it will be up to EU countries to decide whether they will continue to recognise UK-issued Community Licences.
    • The UK will seek to participate in the Interbus Agreement as an independent member but this can not be guaranteed to be in place by March 2019.
    • Bus and Coach drivers with UK licences may need to have an International Driving Permit (further info here).
    • The UK will develop its own Certificate of Professional Competence (CPC) scheme and will continue to recognise EU-issued CPC documentation.
    • Once participation in the Interbus Agreement is secured UK-issued CPC documentation will be recognised in the EU and in the additional participant countries of this agreement. If there is a time-lag between Brexit and participation in this agreement, recognition of UK-issued CPC papers by EU members cannot be guaranteed. To drive for EU operators, UK certified drivers will need to apply for an EU-issued CPC.
    • The ability of UK operators to provide regular and special regular services to the EU is likely to stop in the event of no deal. Cabotage rights in the EU will also end.
    • The UK will allow EU operators to continue to bring passengers into and out of the UK.
  • Vehicle insurance if there’s no Brexit deal
    • If there is no deal, UK motorists will need to carry a “Green Card” as poof of insurance cover when driving in the EU, EEA, Andorra, Serbia and Switzerland.
    • UK insurance providers will still be required to provide insurance cover for driving in the EEA.
    • EEA motorists travelling to the UK will be required to have insurance coverage for driving in the UK and will need to carry a “Green Card” as proof of insurance.
  • Producing food products protected by a ‘geographical indication’ if there’s no Brexit deal
    • The UK will introduce an independent geographical indication (GI) scheme in the event of no-deal which will broadly mirror the EU system.
    • All 86 UK products with EU GI’s will be given UK GI status automatically.
    • EU GI’s may no longer be recognised in the UK and EU producers will be able to apply for UK GI status.
    • It is expected that UK GI’s will continue to be recognised by the EU but in the event that this is not the case, UK producers can apply for EU GI status using the current “third country” regime.
    • Irish Whiskey, Irish Cream and Irish Poteen will maintain full protection in both the UK and EU.
    • Irrespective of the outcome the UK will introduce a new logo for UK GI protected products.
  • Producing and labelling food if there’s no Brexit deal
    • Initially the UK will maintain current standards on food safety and labelling with EU-based provisions rolled over as part of the Withdrawal Act.
    • UK domestic rules not linked to EU membership will remain unchanged.
    • Terminology and information on food labelling will change to reflect that the UK is no longer in the EU. Addresses for a UK based food business operator or importer will need to be included on all labels. The same will apply for labels on products for the EU market which will need to include an EU address. The UK is considering a grace period of 6 months to allow products with an EU address to continue to circulate on UK market.
    • The UK will adopt the same rules relating to Natural Mineral Waters (NMW) as the EU and UK producers will not to renew their recognition for the internal market. UK producers may need to apply for recognition of their water separately through an EU state to market their product in the EU.
  • Buying and selling timber if there’s no Brexit deal
    • Applies to the buying and selling of timber or timber products as covered by the EU Timber Regulation (EUTR) and Forest Law Enforcement Governance and Trade (FLEGT) regulation.
    • The UK will introduce its own UK timber regulation and UK FLEGT regulation, which will have the same requirements as the EUTR and EU FLEGT regulations.
    • UK businesses importing timber from the EU will have to exercise due diligence that it is legally harvested timber in the same way as is required for timber imports from the rest of the world or when placing UK produced timber on the domestic market for the first time.
    • The UK will further introduce its on CITES (EU Convention on International Trade in Endangered Species of Wild Fauna and Flora) regulation and timber covered permit under CITES will not require due diligence by UK importers.
    • EU businesses importing timber from the UK will be required to carry out due diligence on these products. UK exporters will need to provide the relevant documentation to prove timber was legally harvested.
    • Traders will still need to keep a record of who they buy timber from or sell it to.
  • Manufacturing and marketing fertilisers if there’s no Brexit deal
    • The manufacturing and marketing of fertilisers in the UK is currently governed two frameworks – domestic and EU. The domestic framework will remain unchanged by Brexit.
    • For a period, the UK will continue to run both regimes in parallel to provide continuity.
    • “EC fertiliser” will continue to be able to be placed on the UK market as now, for a limited period (expected 2 years).
    • A “UK fertiliser” label will be created for the UK market – over time all fertilisers on the UK market will need to meet the requirements of this regime.
  • Importing and exporting plants if there’s no Brexit deal
    • In the event of no Brexit, the UK will lose access to the EU plant passport regime and will be treated as a third country for the import and export of plants, plant products and wood packaging material (WPM).
    • UK companies exporting to the EU will need to meet EU third country import requirements. This process will be the same as that is currently in place for exporting outside of the EU.
    • Imports from the EU will largely be treated as they are now with some exceptions detailed in the note.
    • The UK will introduce its own plant passport regime to for the movement of plants and plant products within the UK.
    • WPM moving between the UK and EU will need to be ISPM15 compliant (treated and marked) after Brexit.
  • Exporting animals and animal products if there’s no Brexit deal
    • If there is no deal, Export Health Certificates (EHC) will be required for the export of all animal products and live animals from the UK to the EU and all consignments will need to travel through Border Inspection Posts (BIP).
    • Requirements for trade outside of the EU should not change although documentation may need to be updated.
    • The UK will apply to the EU to be a listed third country although when this would come into force is uncertain.
    • UK transporters of live animals in the EU will need to have an EU based appointed representative to obtain the necessary approvals, certifications and journey logs for the transport of live animals in the EU. UK documentation would only be valid for domestic transport.
  • Importing animals and animal products if there’s no Brexit deal
    • The UK will lose access to the EU import notification system TRACES if there is no deal. The UK is developing a new import notification system for UK importers of live animals, animal products and high-risk food and feed. 
    • For a limited period EU issued ransporter Authorisations, Certificates of Competence, Vehicle Approval Certificates and Journey Logs will continue to be recognised in the UK.
    • There will be no immediate change to the current import controls or requirements for notifications of imports of live animals and animal products for imports direct from the EU – they will not need to be notified on the TRACES replacement system.
    • Importers of high-risk food and feed from the EU will need to pre-notify the Food Standards Agency (FSA). 
    • The requirements for imports from third countries will remain the same.
    • Importers will need to notify UK authorities of imports of third country animal products and high-risk food and feed which move through the EU before arrival and these will need to go through a BIP on entry to the UK.
  • Taking your pet abroad if there’s no Brexit deal
    • Applies to the cats, dogs and ferrets travelling with their owners between the UK and EU.
    • UK will leave the EU Pet Travel Scheme and new requirements for the travel of pets will depend on the status the UK gains from the EU as a third country under the scheme.
    • Should the UK be granted listed Part 1 or listed Part 2 there will be limited change to the requirements for the travel of pets to those that are currently in force.
    • If the UK becomes an unlisted third countries, significant requirement will come into force including at least four months’ notice on when the pet is due to travel. Further information on these requirements is contained in the note.
  • Regulation of veterinary medicines if there’s no Brexit deal
    • The UK will fall outside the EU regulatory framework for veterinary medicines and sharing of systems and exchange of regulatory data would end.
    • Marketing Authorisation Holders (MAH) will need to be based in the UK after Brexit. This will allow the UK to accept Qualified Person (QP) release and Qualified Person Responsible For Pharmacovigilance (QPPV) to be based elsewhere outside of the UK.
    • Pharmaceutical companies will need to ensure they have an established location within the UK.
    • New Generic Marketing Authorisations (MA) will be restricted to reference products based in the UK.  The Special Import Scheme will remain in place in the event a specific EU-authorised product is required.
    • Existing generic-based UK MAs, which cite an EU authorised reference product, would still remain authorised after the UK leaves the EU.
    • Marketing Authorisation for Parallel Import (MAPI) – the UK will continue to accept veterinary MAPI applications but applicants will be responsible for supplying the necessary parent product data.
    • The UK will adopt EU Maximum Residue Limits (MRLs) which will enable the continued trade of animal food products with the EU and third countries that recognise the EU process.
  • Accessing animal medicine IT systems if there’s no Brexit deal
    • Applies to those who need to submit regulatory and notification information under the Veterinary Medicines Directorate (VMD).
    • In the event of no-deal the UK will no longer be part of the EU veterinary medicine regulatory network and the sharing and recognition of data between the UK and EU will end.
    • Regulatory information and applications will need to be submitted to, and process by the UK and EU separately.
    • The VMD will put in place provisions for the submission and exchange of information relating to veterinary medicines and to facilitate the submission and sharing of pharmacovigilance reports and data.
  • Registration of veterinary medicines if there’s no Brexit deal
    • Mutual recognition of batch testing and Qualified Person (QP) certification between the UK and EU/EEA along with third countries that the EU has arrangements in place with will end if there is no deal.
    • The UK will unilaterally continue to recognise batch testing and QP certification from EU/EEA states and third countries subject to EU arrangements for a limited period.
    • Manufacturers of veterinary medicines for the EU market are advised to consult the EU Commissions guidelines on this subject to familiarise themselves with additional requirements they may have to meet.
  • Regulating Chemicals (REACH) if there’s no Brexit deal
    • In the event of a No-Deal scenario, the UK will establish a regulatory framework to replace the functions of the European Chemicals Agency (ECHA) in the UK. The Health and Safety Executive (HSE) would assume lead regulatory authority.
    • REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals); the main piece of EU legislation in this area, would be preserved as far as possible.
    • Existing standards for the protection of human health and the environment would also be maintained.
    • New chemicals would need to be registered in the UK via a UK IT system similar to the current EU system. Businesses will need to register with this system.
    • Companies registered with REACH will need to transfer registrations to EEA based organisations to access the EEA market.
    • UK downstream users of EEA chemical imports and authorisations will face new registration requirements and will not be able to rely on authorisation decisions from EEA countries. 
    • The UK intends to “grandfather” REACH registrations into the new UK regime and carry-over existing authorisations.
    • Data regarding chemicals would need to be provided to the new UK Regulatory authorities.
  • Flights to and from the UK if there’s no Brexit deal
    • If there is no deal, UK and EU licenced airlines will lose the automatic right to operate services between the UK and EU and will need to seek individual permissions to operate between these markets. EU licenced airlines will no longer be able to operate wholly inside the UK and vice versa for UK airlines in the EU.
    • It is not expected that flights between the UK and EU will be grounded as both sides have expressed a desire to have a basic agreement on air services in place should there be no deal. In this scenario, EU airlines will need a foreign carrier permit and a UK safety authorisation to operate in the UK. UK airlines will need similar permission from the EU although foreign carrier permits will be required from the various national authorities of Member States.
    • For flights between the UK and the rest of the world, non-EU operators’ eligibility will be determined by bilateral agreements in place between the UK and that country. Airlines from the 111 countries that the UK has an air service agreement (ASA) will be unaffected. The UK will also seek to replace the 17 EU ASA’s to which it is party with bilateral agreements ahead of exit.
    • The UK will not impose nationality restrictions on the conditions for an operating licence. EU licenced airlines should consider that after Brexit that ownership of their airline still meet EU rules.
    • The current system for allocation of slots in UK airports will remain in place.
    • There will be no disruption to air traffic management.
    • EU passenger rights will be adopted into UK legislation as part of the Withdrawal Act. The paper includes an advisory to passengers to check insurance and ticket terms regarding possible disruption to flights from Brexit. The UK government will not provide assistance in this situation.
  • Aviation safety if there’s no Brexit deal
    • The UK will retain EU aviation safety legislation in UK law through the Withdrawal Act.
    • The UK Civil Aviation Authority (CAA) will take on the functions performed by the European Aviation Safety Authority (EASA) with regards to approvals for UK designed aeronautical products and approvals for third country organisations.
    • Mutual recognition of safety certificates issued by the EU and UK will end.
    • With regards to UK-registered aircraft activities, all certificates issued by the CAA that are valid on the day of exit will continue to be recognised in the UK. Documents and certificates issued by EASA or the competent authority of an EASA state will be recognised in the UK for a period of up to 2 years of until date of expiry depending on which is soonest. After this period, CAA issued certificates will be required.
    • The EU has stated that CAA issued certificates will no longer be recognised in the EASA system from date of exit. Those exercising the privileges of UK-issued certificates for aircraft registered in the EU have been advised to consult the European Commissions note on this issue.
    • Details on the impacts and requirements for pilots, engineers, cabin crew, air traffic controllers and those covered by training approval are covered in the note and those within these areas should consult the note in full to be aware of the implications. In most circumstance the UK will continue to recognise EU-issued approvals for up to 2 years although additional requirements will be put in place for the UK authorised/certified professionals looking to be recognised in the EU.
    • Aircrafts, parts and appliances certified as safe by the CAA or EASA competent authority will continue to be valid for use in the UK after exit (EASA certs for a period of 2 years). The EU has said it will not automatically accept CAA-certified aircrafts, parts and appliances for use in EU-registered aircraft and would need to be approved as third country production organisations. A similar approach is being taken by both parties towards maintenance and airworthiness certification.
    • Third country operators with a safety authorisation from EASA in advance of Brexit will continue to have their certificates recognised by the CAA for a period of 2 years after 29 March 2019. EU airlines will need to apply for approval from the CAA while UK airlines will need to apply for approval from the EASA to be able to deliver commercial services in each other’s markets.
    • Wet-leasing procedures will remain the same for UK airlines as those wishing to wet lease from outside the EU. EU airlines will have to satisfy their own national requirements to wet-lease aircraft from the UK.
    • Airport licencing will be unaffected by Brexit.
  • Aviation security if there’s no Brexit deal
    • The UK will retain its current standards and regulations with regards to aviation security. If the EU deems these to be equivalent to EU standards no changes will take place.
    • If the UK does not receive equivalence recognition from the EU, some changes may occur.
    • For passengers departing from and transferring through UK airports there will be no change to how this process operates. Passengers (and their luggage) departing from the UK transferring through EU airports may have to be rescreened when changing flights in EU hub airports.
    • For cargo, the UK will continue to recognise EU cargo security and designations given by EU airports. UK cargo security may not continue to be recognised by the EU and carriers bringing cargo from the UK to the EU may need to apply for an ACC3 designation from an EU Member State.
    • For international Cargo, the UK will grant UK-ACC3 designations to all holders of EU ACC3 designations to allow third countries to continue to fly cargo into the UK. Operators transporting cargo into the EU under UK-issued EU ACC3 designations may need to have these designations re-issued from an EU member state.
  • Generating low-carbon electricity if there’s no Brexit deal
    • Guarantees of Origin issued in the EU and NI will continue to be recognised in the UK. Guarantees of Origin issued in the UK and NI will no longer be recognised in the EU which may impact on requirements in contracts with EU electricity suppliers and traders.
    • Electricity suppliers do not need to take any specific actions although generators wishing to sell to EU suppliers may need to consider how they market their exports.
    • This same guidance also applies to Renewable Energy Guarantees of Origin.
    • The UK will continue to recognise EU certification (covered by Annex 4 of the Renewable Energy Directive 2009/28/EC) of installers of microgeneration technologies such as small scale biomass boilers, biomass stoves, solar photovoltaic systems, solar thermal systems, shallow geothermal systems and heat pumps. However, UK installers may need to apply for EEA certification to continue to be recognised in this area.
    • The UK will continue to apply all requirements of the Feed-in Tariffs Scheme and Contracts for Difference schemes and the Renewables Obligation meaning no action will need to be taken by businesses and other stakeholders
  • Trade marks and designs if there’s no Brexit deal
    • On exit, the UK will bring into force its own system to protect trade marks and registered Community designs.
    • UK registration will be required to protect existing EU registered trade marks and Community designs. Those already in the process of applying for an EU trade mark or Community design at the time of Brexit will have 9 months to apply in the UK for the same protections.
    • The UK will also seek to provide protection to trade marks and designs filed through the Madrid and Hague international systems.
    • Existing EU trade marks and designs will continue to be valid in the EU.
    • Unregistered Community Designs covered by EU regulations will continue to be protected in the UK for the duration of the protection of the right. The UK will also introduce a domestic unregistered design right law.
  • Exhaustion of intellectual property rights if there’s no Brexit deal
    • The UK will continue to recognise the EEA regional exhaustion regime after Brexit covering IP rights for right holders.
    • IP protected goods placed on the EEA market after Brexit with the consent of the right holder will continue to be considered exhausted in the UK, although goods placed on the UK market will not be considered exhausted in the EEA.
    • Businesses wishing to export  intellectual property-protected goods that have been legitimately put on the market in the UK to the EEA may need to seek the right holder’s consent.
    • It is advised for those businesses that may be affected to seek legal advice on this issue.
  • Patents if there’s no Brexit deal
    • The current systems governing UK patent law will remain in place and operate independently of the EU regime. Supplementary protection provided for under EU law will be kept in UK law.
    • All exiting rights and licences will remain in force in the UK after Brexit and the application process for patents and supplementary protection in the UK will remain the same.
    • There might be implications for businesses depending on whether the Unified Patent Court and Unitary Patent come into force before 29 March 2019 and also the UK’s position within these systems.
    • If they come into force before Brexit and the UK has to then withdraw from these systems, businesses will not be able to use them to protect their inventions in the UK but can avail of them to protect their inventions in the contracting EU countries. Likewise EU businesses will not be able to use these systems to protect their inventions in the UK.
    • There will be no immediate changes to the UK address for service rules. Privilege for patent attorneys will remain unaffected as this is not determined by reference to EU membership.
  • Copyright if there’s no Brexit deal
    • The UK will remain party to the main international treaties on copyright and related rights.
    • The UK will no longer be party to EU cross-border copyright mechanisms that cover a number of rights detailed in the technical note and will lose reciprocal recognition of these rights. The level of cover granted by these mechanisms will be retained domestically though in UK law.
    • Businesses affected by these changes are advised to seek legal advice.
  • European Territorial Cooperation funding if there’s no Brexit deal
    • Concerns European Territorial Cooperation (ETC) programmes funded by the EU.
    • Access to ETC funding will cease on exit if there is ‘no deal’.
    • The UK funding guarantee will cover projects granted funding before exit day. Funding is also guaranteed for programmes that would have secured funding under the current ETC period guaranteeing funding for projects after Brexit until the current programme closes in 2020.
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