Statement of the ACNFP on Precision Bred Organisms - July 2023


Statement of the Advisory Committee on Novel Foods and Processes (ACNFP) on Precision Bred Organisms (PBOs) - Model options and data requirements for triage and Tier assignment of PBOs - July 2023

Last updated: 08 September 2023

Anticipated Effect – Any effect (desirable or non-desirable) on traits/phenotypes that can be predicted as potentially occurring as a consequence of the intended change. Anticipated effects from the initial submitted data will be considered by the safety assessment process being developed, whereas unanticipated effects (see below) cannot be risk assessed unless evidence emerges.

Cisgenesis – Transfer of genes (which may include their own regulatory elements) from a closely related and sexually compatible donor plant to the genome of a host plant; this could have occurred naturally.

De novo domestication – A recently developed strategy for crop breeding, where domestication-associated allelic variants are introduced into non-domesticated plants. It allows the domestication of elite wild plants while retaining the genetic diversity and associated elite traits and permits design of improved crops in one step where traditional breeding would have required multiple time-consuming crossings.

Donor organism – The source organism of a trait of interest to be transferred to a host organism’s DNA through genetic technology or traditional breeding; in the context of this document, the organism could be a plant or an animal.

Due diligence – Action taken by any actor in the production, processing and distribution of food and feed to ensure all precautions deemed reasonable were taken to avoid a bad outcome and prevent an offence from occurring; due diligence to ensure food safety is mandatory under General Food Law and is, under the Food Safety Act 1990, the best defence for a business to prevent legal repercussions if an incident takes place.

General Food Law (GFL) – The principal aim of retained EU law Regulation (EC) 178/2002, 'General Food Law' is to protect human health and consumer’s interest (Article 5) in relation to food. It applies to all stages of production, processing and distribution of food and feed. General Food law actions are science-based, using risk analysis (Article 6). When risk assessment is inconclusive, the precautionary principle is applied to protect from possible risks (Article 7). Food businesses must comply with food and feed safety law.

Host organism – The final recipient organism of a trait of interest transferred from a donor organism’s DNA through genetic technology or traditional breeding; in the context of this document, the organism could be a plant or an animal.

Novelty – In this context, novelty refers to foods or feeds with no significant prior history of safe consumption in the UK or EU (such foods would fall within novel food regulation (EU) 2015/2283 if they were not precision bred).

Progenitor – Organism from which a plant or an animal is descended or originates.

Traditionally Bred Organism (TBO) – Organism (plants -including algae- and animals) created by the application of genetic principles in agriculture and animal husbandry, carrying developed or improved desirable traits, obtained through a wide range of conservative tools or traditional processes as described in the Genetic Technology (Precision Breeding) Act 2023 (including sexual fertilisation, spontaneous mutation, in vitro fertilisation, polyploidy induction, embryo rescue (plants), grafting (plants), induced mutagenesis (plants), somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material (plants), artificial insemination (animals), embryo transfer (animals), recovery and transfer of primordial germ cells (animals)).

Traditionally bred counterpart – An organism where the same genetic change has been introduced using any conservative tool or traditional processes without the use of precision breeding technologies. This may be a theoretical/conceptual organism and may not be known to exist. The counterpart may be distantly related but will in all cases be sexually compatible.

Unintended effect – A change that was not the objective of the breeding and was not predicted to occur but has occurred and may have consequences for food safety in addition to the intended effect. Unintended effects are inevitable, and also occur in traditional breeding.