UK and EU EXIT – Preparing for a No Deal Exit
On 12th October the UK Government published a further collection of technical guidance notes giving advice to businesses and individuals about being prepared for a no deal when the UK leaves the EU on 29th March 2019. This note contains information for HTA members about some of the guidance relevant to members. The full guidance notes and other information can be accessed through the UK and EU section on www.gov.uk.
UK Government Approach:
The technical guidance stresses that the UK Government firmly believes that a deal will be reached with the EU prior to 29th March. However, it has published the guidance notes to allow people and businesses to start preparing should a deal not be agreed. The technical guidance also stresses the importance of the Northern Ireland border in the ongoing negotiations.
Plant Variety Rights and Marketing of Seeds and Plant Propagating Material:
Plant variety rights
If the UK leaves the EU in March 2019 without a deal, EU plant variety rights granted up to that point, including those held by UK businesses, would continue to be recognised in the remaining 27 EU countries. Those rights would also automatically be recognised and given protection under UK legislation, without rights holders needing to take any action.
Where EU rights have been applied for, but not granted before 29 March 2019, an application for rights in the UK would need to be made to APHA, following the normal process for UK plant variety rights, and using the same priority date and DUS test.
For new varieties, breeders would need to make two applications, where currently they make one, to achieve the same geographic coverage, as separate protection would be required in the UK and the EU. APHA is reviewing its processes to mitigate the resulting increased costs for plant breeding businesses, by increasing efficiency and where reasonable accepting DUS tests from the EU.
For protection in the UK, an application would need to be made to APHA, following the normal process and payment of fees for UK plant variety rights.
For protection in the EU, an application would need to be made to the Community Plant Variety Office, following the normal process and payment of fees.
Marketing seed and propagating material in the EU
Varieties registered solely via UK National Listing would no longer be listed on the EU Common Catalogue and would not be marketable in the EU. UK certified seed and propagating material and UK DUS testing of plant varieties would no longer be accepted in the EU. In order to market UK seed and propagating material in the EU, businesses would need to meet two requirements:
- The variety would need to be listed on the Common Catalogue - breeders would need to add them to the EU Common Catalogue through registration in an EU country.
- Seed would need to be certified, and the certification would have to be from the EU or from a third country recognised by the EU as equivalent for seed certification.
In the event of a no deal, the UK would apply to the EU to recognise its certification processes as equivalent, but Government cannot guarantee this recognition would be in place at the point the UK leaves the EU.
The UK has applied to join the international scheme for Forest Reproductive Material that will allow the UK to apply to the EU for recognition of its certification process and marketing of FRM in the EU.
Marketing seed and propagating material in the UK
Varieties that are already registered on the EU Common Catalogue, but not on the UK list, are currently being added to the UK National List, which would allow them to be marketed in the UK. Any business wanting to add varieties to the National List in this way should contact APHA. Email and phone numbers are on GOV.UK.
In a ‘no deal’ scenario, Defra intends to allow varieties on the EU Common Catalogue to be marketed in the UK for an interim period of two years after the UK leaves the EU, and to apply the same interim period to the marketing of EU certified seed and propagating material.
After this, businesses would need to comply with new UK arrangements. The main food and feed crop varieties marketed in the UK would need to be on the UK National List. The normal process and fees for National Listing would apply. Seed and propagating material from outside the UK would need to comply with normal international requirements. APHA is reviewing its processes to reduce costs and mitigate the impact.
For forest reproductive material (FRM), the intention would be to recognise EU standards as equivalent to UK standards and allow material to be marketed in the UK. Existing national schemes would continue to be used to register and certify material within the UK.
Defra plans to continue to accept EU DUS reports, providing they are of comparable quality to UK DUS reports. The exception will be agricultural species currently tested by the Agri-Food and Biosciences Institute (AFBI), NIAB and Science and Advice for Scottish Agriculture (SASA). For these species, only DUS reports from approved UK science organisations will be accepted.
Trading and Moving Endangered Species Protected by CITES:
If the UK leaves the EU without a deal, species that are currently freely moved and traded between the UK and the EU would require a CITES permit or import/export notification. This would mean movement of all species controlled under CITES between the UK and the EU would need to follow the same processes as those currently in place for movement between the UK and non-EU countries. HTA members involved with trading CITES protected species would need to contact the Animal and Plant Health Agency (APHA) to obtain the correct certification and/or notification.
Regulation and Control of Plant Protection Products (Pesticides), Biocidal Products, and Chemicals:
Plant Protection Products
In a no deal scenario, the UK would establish an independent standalone PPP regime, with all decision making repatriated from the EU to the UK. Government would ensure that a stable regulatory framework is put in place by retaining the two main directly applicable EU regulations in national law, through the provisions of the EU Withdrawal Act.
In the short-term, the UK regime will make changes from the EU regulatory framework only where they are required to operate in a UK-only context. All current active substance approvals, PPP authorisations, and MRLs in place on 29 March 2019 would remain valid in the UK after leaving, so businesses could continue to trade and products would continue to be available.
The Health and Safety Executive will continue to operate as the national regulator.
The UK would establish an independent standalone biocidal products regime. The UK would put in place a stable regulatory framework for biocidal products from the point of exit, by retaining the BPR and its subsidiary regulations in national law using the provisions of the EU Withdrawal Act. At the time of exit, the national regime would be essentially the same as the current EU framework.
The UK would ensure UK legislation replaces EU legislation via the EU Withdrawal Act, establish a UK regulatory framework and build domestic capacity to deliver the functions currently performed by ECHA. The legislation would preserve REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) as far as possible, while making technical changes that would need to be made because the UK has left the EU.
By doing this the UK would continue to be able to monitor and evaluate chemicals in the UK to reduce the risk posed to human health and the environment. It would also minimise disruption to the supply in chemicals. The Health and Safety Executive (HSE) would act as the lead UK regulatory authority.
Previous advice has been published on the HTA website, and can be accessed below:-
- Importing and Exporting Plants in a No-Deal Brexit
- 1st Notice: Preparing for a No Deal Brexit
- Is Your Business Brexit Ready?
For more information, please contact Sally Cullimore, HTA Policy Executive Tel 01235 776196. E-mail:- email@example.com