Novel food approval-as-a-service (EU/UK/SG)

Novel food approval-as-a-service exists because a new ingredient cannot be sold until a regulator has agreed it is safe, and because that agreement must now be obtained separately in each market. The European route runs through an EFSA safety opinion; the United Kingdom, having left the EU, operates its own pre-market authorisation covering novel foods alongside food additives, food enzymes, flavourings, food contact materials, smoke flavourings, irradiated food and GMOs used as food or feed; the United States uses a GRAS notification that is formally voluntary but is treated as best practice for engaging the FDA; China runs a separate new-food-raw-material approval administered by the National Health Commission; and Singapore maintains its own submission route. The consultancies in this category sell the dossier — the assembled toxicology, compositional characterisation, intake estimate and manufacturing description that a regulator will accept — plus the strategy of which jurisdiction to file in first. A worked 2026 example shows the shape of the service: EFSA issued a positive safety opinion on beta-nicotinamide mononucleotide in May 2026 after a consultancy prepared and submitted the scientific dossier on behalf of the ingredient’s manufacturer. The providers are mostly long-established food research institutions, two of them founded in 1919, now operating as membership-based advisory bodies rather than as laboratories alone.

The key directions of novel food approval services are:

1. Novel Food Dossier Preparation: assembling and submitting the scientific dossier for a regulator’s safety evaluation — the core deliverable, demonstrated by an EFSA positive opinion on beta-nicotinamide mononucleotide issued in May 2026 following consultancy-prepared submission.
2. GRAS Notification (US route): the voluntary but widely expected US pathway, where growing FDA oversight is pushing manufacturers toward a proactive, science-led approach rather than self-affirmation without notification.
3. Safety and Performance Substantiation: the underlying testing and evidence generation — compositional analysis, stability, and performance-based screening of candidate ingredients — that has to exist before a dossier can be written.
4. Post-Brexit and Multi-Jurisdiction Filing: managing the divergence created when the UK regime stopped tracking the EU automatically, so that a single ingredient requires parallel EU, UK, US, China and Singapore strategies rather than one filing.

Sectoral value chain#

[Ingredient & Claim] ──> [Evidence Generation] ──> [Dossier Assembly] ──> [Regulator Submission]
                                                              │
                                                     (questions & clarifications)
                                                              │
                                                              ▼
[Market Launch] <─── [Authorisation / Opinion] <──────────────┘

Value chain levels#

Cross-cutting technologies of the sector:

• Regulatory Science Services: the discipline of translating laboratory evidence into the form a specific regulator accepts, which is what distinguishes a dossier consultancy from a testing laboratory.
• Membership-Based Advisory Models: long-established food research organisations serving large member bases — one with over 2,400 member companies across 75 countries, another with roughly 1,000 member locations — which spreads the cost of regulatory watch across an industry.
• Performance-Based Ingredient Screening: narrowing large candidate sets against functionality criteria before regulatory investment, so that only viable ingredients enter an expensive authorisation process.

There is no laboratory instrument at the centre of this category — the stack is evidentiary and procedural, and its components are the things a regulator will and will not accept.

1. Dossier Construction:
   • The deliverable is a scientific dossier containing compositional characterisation, toxicology, intake estimation, manufacturing description and proposed conditions of use, organised in the format the receiving regulator expects.
   • Its success condition is external and binary: the May 2026 EFSA positive opinion on beta-nicotinamide mononucleotide followed a consultancy-prepared and submitted dossier, which is what the service is ultimately measured on.
2. Jurisdictional Divergence Management:
   • The UK now operates pre-market authorisation independently across novel foods, feed additives, flavourings, food contact materials, food additives, food enzymes, GMOs as food or feed, irradiated food and smoke flavourings, so EU approval no longer carries the UK with it.
   • Adding the US GRAS notification, the Chinese new-food-raw-material licence and the Singapore route, a single ingredient can require four or five parallel evidence packages built from one underlying dataset.
3. GRAS Practice in a Tightening Environment:
   • GRAS notification is voluntary in form but is widely treated as best practice for FDA engagement and consumer confidence, and growing agency oversight is pushing manufacturers toward proactive, science-led substantiation rather than silent self-affirmation.
4. Evidence Generation and Pre-Regulatory Screening:
   • Testing, stability work and compositional analysis supply the underlying dataset, and integrated providers place this inside a development service running from ideation to commercialisation.
   • Performance-based screening reduces regulatory waste: narrowing more than 100 candidate plant proteins to a shortlist against functionality criteria means the expensive authorisation process is spent only on ingredients that can actually work in the product.