The legal background of scientific authorisations comprises of some key pieces of primary and secondary legislation. On the 14th of December 2019, the previous scientific licensing (as it was known then) Directive 2008/61/EC was repealed, and a new scientific authorisation regime began. Since the end of the EU exit transition period, these are underpinned by various GB statutory instruments.
Primary legislation
The Plant Health Regulation
The Plant Health Regulation (PHR) is retained EU law (Regulation (EU) 2016/2031) and is the regulation which give us provision to issue authorisations for specific material to be imported for non-commercial work. Important articles include:
- Article 8
This provides the derogation for quarantine pests used for official testing, scientific or education purposes, trials, varietal selection or breeding to be imported into GB under a scientific authorisation and the conditions under which it can be imported, moved or kept.
- Article 48
This provides the derogation for plants, plant products and other objects used for official testing, scientific or education purposes, trials, varietal selection or breeding to be imported into GB under a scientific authorisation.
- Article 60-64
These provide the overarching rules behind scientific authorisations including the ability to designate quarantine stations/confinement facilities and their requirements, inspection of these facilities and release of material from scientific authorisations.
- Annex I, section III, subsection 1
This lays out the Provisional Quarantine Pest criteria, used to assess unlisted pests to determine whether they require an authorisation.
The Phytosanitary Conditions Regulation
The Phytosanitary Conditions Regulation is retained EU law (Regulation (EU) 2019/2072) that lists the quarantine pests, pest free area quarantine pests, provisional quarantine pests, regulated non-quarantine pests and other material of phytosanitary concern which may require an authorisation.
Secondary legislation
The authorisation regulation
The authorisation regulation is retained EU law (Regulation (EU) 2019/829). This is a delegated regulation (which can only supplement or amend non-essential elements of legislation) and can change with new information included in statutory instruments until they are consolidated. This provides more specific details on the scientific authorisation regime.
The release of plants regulation
The release of plants regulation is retained EU law (Regulation (EU) 2019/2148) and lays out the specific rules concerning the release of plants from quarantine stations/confinement facilities.
Statutory instruments
The Plant Health etc. (Fees) (England) Regulations 2018
The Plant Health (Miscellaneous Fees) (England) (Amendment) Regulations 2019 provides a legislative background for the fees involved in authorisations in England.
The Plant Health etc. (Fees) (Wales) Regulations 2019
The Plant Health etc. (Miscellaneous Fees) (Wales) (Amendment) Regulations 2019 provides a legislative background for the fees involved in authorisations in Wales.
The Official Controls (Plant Health and Genetically Modified Organisms) (England) Regulations 2019
The Official Controls (Plant Health and Genetically Modified Organisms) (England) Regulations 2019 implements the Plant Health Regulation in England. Amongst other powers, this confers the power on the competent authority to grant scientific authorisations (Regulation (21)).
The Official Controls (Plant Health and Genetically Modified Organisms) (Wales) Regulations 2020
The Official Controls (Plant Health and Genetically Modified Organisms) (Wales) Regulations 2020 implements the Plant Health Regulation in Wales. Amongst other powers, this confers the power on the competent authority to grant scientific authorisations (Regulation (21)).
Back to Additional guidance documents
Back to Scientific authorisations guidance for authorisation holders and applicants