Short answer
Novel foods, genetically modified organisms and plants produced by new genomic techniques do not follow one authorisation route.
A novel food must be authorised by the Commission and entered on the Union list. The applicant supplies composition, production, use and safety evidence; the European Food Safety Authority (EFSA) assesses human-health risk when requested; and the Commission and Member States decide through an implementing act. A simplified notification route exists for traditional foods with demonstrated safe use in a third country.
Genetically modified food and feed require an EU authorisation under Regulation 1829/2003, normally combining EFSA's food, feed and environmental assessment with risk-management conditions, labelling, traceability and monitoring. Other deliberate releases and market placement of GMOs fall under Directive 2001/18.
Regulation 2026/1388 creates a two-category regime for certain genome-edited and cisgenic plants. It is in force, but its main authorisation provisions apply only from 17 July 2028. Until then, the existing GMO rules continue. From that date, category 1 plants will use a verification procedure and be treated largely like conventional plants; category 2 plants will remain subject to adapted GMO authorisation and risk assessment.
Scientific uncertainty does not dictate approval or prohibition. Authorities may request data, impose monitoring or adopt proportionate provisional measures.
Start by classifying the product and intended use
“Novel food”, “GMO” and “NGT plant” describe different legal questions.
A novel food is generally food not consumed to a significant degree in the EU before 15 May 1997 and falling within a listed category, including food from new sources or production processes. Novelty does not imply genetic modification or danger.
A GMO has genetic material altered in a way not occurring naturally by mating or recombination, subject to statutory exemptions. The route depends on contained use, experimental release, market placement or food and feed use.
An NGT plant under Regulation 2026/1388 is a plant obtained by specified targeted mutagenesis or cisgenesis without genetic material from non-crossable species. Animals, microorganisms and transgenic plants are outside that regime.
One product can engage several regimes. Food authorisation does not replace seed, plant-health, pesticide, labelling or environmental requirements.
Novel foods: Union-list authorisation
Regulation (EU) 2015/2283 prohibits marketing a novel food unless it is authorised and included on the Union list with its specifications, conditions of use and labelling.
Only novel foods “authorised and included in the Union list” may be placed on the EU market. —
An applicant files with the Commission. The dossier covers the food, production, composition, uses, labelling, analytical methods and safety evidence. The Commission may ask EFSA for an opinion.
EFSA examines comparative safety, health risk and nutritional disadvantage. It can request more information, pausing the assessment clock. The Commission then proposes an implementing act, considering EFSA's opinion, precaution and legitimate factors.
Authorisation requires three results: available evidence must not show a health safety risk; the intended use must not mislead; and a replacement food must not be nutritionally disadvantageous in normal use. The Union-list entry may restrict use, protect vulnerable groups, prescribe warnings or require post-market monitoring.
For a traditional food from a third country, documented safe use supports notification. A reasoned safety objection from a Member State or EFSA sends the applicant to the fuller route.
GMOs: risk assessment before EU consent
Directive 2001/18 requires a notification and environmental risk assessment before an experimental release. Placing a GMO on the market as or in a product requires the Part C procedure, including assessment, consent, labelling and monitoring. GM food and feed instead use Regulation (EC) 1829/2003, which incorporates the necessary environmental assessment.
GM food must not harm health or the environment, mislead consumers or be nutritionally disadvantageous. The applicant must demonstrate compliance.
EFSA evaluates food and, where relevant, environmental safety; national authorities contribute. Detection methods are validated. The Commission proposes the decision to the Member State committee and must explain any departure from EFSA. Authorisation is normally EU-wide for ten years and may contain use, monitoring and ecosystem conditions.
Member States must, “in accordance with the precautionary principle”, take appropriate measures to avoid adverse effects from deliberate release or market placement. —
Authorisation holders must report new safety information. A Member State may provisionally restrict an authorised GMO where new information gives detailed grounds for risk, subject to the EU safeguard procedure. Emergency food-law measures may also apply.
Member States may opt out of GMO cultivation under Directive 2015/412, but cannot generally block an authorised GM food merely because they oppose the technology. In joined cases C-364/24 and C-393/24, the Court upheld the transitional mechanism used to exclude MON 810 cultivation from parts of Member States' territory. A transitional exclusion accepted by the authorisation holder did not need one of the later Article 26b(3) grounds, and national law could impose proportionate penalties for violating it. Cultivation geography must therefore be checked separately from EU product authorisation.
New genomic techniques: a new law with a delayed main regime
In Confédération paysanne, C-528/16, the Court held that organisms produced by newer mutagenesis techniques were GMOs and that only techniques conventionally used in several applications with a long safety record fell within the directive's mutagenesis exemption.
New mutagenesis techniques without that conventional use and safety record “come within the scope of Directive 2001/18”. —
That remains important during transition. Regulation (EU) 2026/1388 entered into force on 16 July 2026, but Articles 1–28 and 32–38 generally apply from 17 July 2028. Only its preparatory intellectual-property guidance, code-of-conduct and patent expert-group provisions in Articles 29–31 apply from 16 July 2026. The substantive NGT pathways therefore are not yet available on the review date.
From 17 July 2028, the regulation will distinguish:
- Category 1 NGT plants, whose modifications satisfy Annex I's equivalence criteria and do not convey herbicide tolerance or production of a known insecticidal substance. A national authority or the Commission must verify and declare category 1 status before release or marketing. Once verified, most GMO legislation will not apply, although database, reproductive-material labelling and organic-production rules remain.
- Category 2 NGT plants, meaning all covered NGT plants outside category 1. They remain subject to GMO rules as adapted by Regulation 2026/1388, including consent or authorisation, labelling and traceability. Their evidence package and risk assessment can be adjusted case by case to the modification and risk hypothesis.
Category 2 assessment must cover hazard, exposure, risk characterisation, possible management and an overall conclusion. The applicant must describe relevant uncertainty and, where possible, quantify it. A simpler dossier is justified only by evidence about the plant, trait, prior experience, intended use and receiving environment—not merely by calling the technique precise.
How scientific uncertainty is handled
EU food and environmental law separates risk assessment from risk management. EFSA and competent scientific bodies identify hazards, exposure, uncertainty and evidence gaps. The Commission and Member States decide what level of protection, conditions or provisional action the law requires.
Article 7 of the General Food Law captures the precautionary rule:
Where harmful effects are possible but “scientific uncertainty persists”, necessary provisional risk-management measures may be adopted pending fuller information. —
The measure must be proportionate, no more trade-restrictive than necessary, and reviewed within a reasonable period according to the risk and information needed. Precaution is therefore not a permanent evidence-free veto.
In an authorisation file, uncertainty can lead to:
- a request for additional studies, data or validated detection methods;
- refusal where the applicant has not demonstrated the statutory safety standard;
- narrower uses, intake limits, warnings or vulnerable-group restrictions;
- environmental or consumption monitoring and reporting;
- time-limited emergency or safeguard measures based on new evidence; or
- later modification, suspension or revocation of an authorisation.
Risk managers may consider factors beyond the scientific opinion but must explain their basis. An EFSA opinion is neither political authorisation nor something to disregard without reasons.
A practical authorisation map
- Establish the organism, food, feed, seed and environmental-release classifications.
- Identify the date: the NGT substantive regime does not apply until 17 July 2028.
- Check novelty history before assuming a product needs novel-food authorisation.
- Define the exact intended uses, population, intake, cultivation and receiving environment.
- Describe uncertainty and data gaps rather than hiding them behind detection limits.
- Track EFSA questions, Member State comments and the committee procedure.
- Match specifications, labels, traceability and monitoring to the final authorisation.
- Report new safety information and reassess whether safeguard or emergency action is needed.
Conclusion
The EU authorises novel foods through a Union-list procedure and GM food, feed and environmental releases through GMO-specific assessment and consent. Both require evidence tied to the proposed use and allow conditions, monitoring and later intervention.
The new NGT Regulation changes the future classification of specified plants, but not yet the operative authorisation route: its two-category system starts on 17 July 2028. Scientific uncertainty is managed through further evidence, case-specific assessment, proportionate precaution and review—not by presuming that every new technique is safe or dangerous.
Sources
This article provides general legal information, not advice for a specific matter. Laws, facts and procedural deadlines may change the result. Follow the linked primary sources and obtain local advice before acting.