Horticultural IP specialist Darron Saltzman believes the EU’s NGT regulation can help to boost innovation in the breeding sector
On 16 July, 2026 the European Union Regulation (EU) 2026/1388 on New Genomic Techniques (NGTs) entered into force to exempt specific gene-edited plants from strict legacy GMO laws.
The EU NGT Regulation will apply as from 17 July 2028.
As previously reported, the EU NGT Regulation establishes a two-tier framework for the protection of NGT bred varieties.
NGT-1 plants - which will be treated effectively in the same way as conventionally bred plants - will cover those plants where the changes introduced by the NGT process(es) could have occurred either naturally or through conventional breeding.
Importantly, the EU NGT Regulation currently prohibits the use of NGT-1 plants in organic farming. The outcome of a pending review on this matter may or may not alter this.
All other NGT plants will fall in the NGT-2 category and will continue to be covered by the existing strict GMO rules which include risk assessment, authorisation, labelling, traceability, and member-state opt-outs for cultivation. Under the current Regulation production of organic NGT-2 plants is not permitted.
Potential applicants for PBR protection of NGT-1 plants will need to remember that as the EU NGT Regulation does not affect the (existing) availability of patent protection for a new variety, when applying for PBR protection they will need to identify – “to the best of their knowledge” – any relevant patents and published patent applications, which information will be recorded on a public database. The details of how this interface between NGT-1 plants and relevant patents and patent applications will work in practice are still to be finalised.
What next?
As the clock ticks towards 17 July 2028, breeders and potential applicants for protection of NGT bred varieties should be planning for the process of securing protection for their NGT bred varieties.
If appropriate and where possible, adjusting or honing the breeding process to increase the certainty of the new variety falling into the category of “NGT-1” would be strongly recommended. Also, prepare for NGT-1 verification by collating necessary information which the authorities will call for to support categorisation as “NGT-1”.
For NGT-2 plants, prospects of PBR protection will be stronger, with properly completed tailored risk assessments and maximum compliance with any prescribed measures for traceability, mandatory labelling and co-existence measures.
The EU NGT Regulation goes a long way to securing a level playing field between conventionally bred varieties and those varieties bred invoking more recent cutting-edge technologies. It also brings the EU closer to other jurisdictions – such as Australia – where all NGT bred varieties are already potentially eligible for PBR protection.
Most importantly, protecting NGT varieties in the EU will hopefully extend the incentive to innovate in the breeding sector on a more technologically neutral basis with a better overall and diverse impact.
Darron Saltzman is the founder of Hort-IP Law and has over 30 years’ experience as a lawyer and trademark attorney, specialising in the horticulture and agriculture industries. More information at www.hortip.com
