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

01Overview and value chain

Markers: [EC: Regulation (EU) 2015/2283 on novel foods / retained UK regime | OECD: 1.4 Agricultural biotechnology | Regulator: EFSA (EU)]

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.

02US

The US route is the GRAS notification, formally voluntary but treated as the expected path, and the service providers here combine regulatory science with the product-development work that precedes it.

GRAS notification practice, FDA oversight direction, product development integration

• Intertek (GRAS and regulatory science): its regulatory commentary describes a US GRAS landscape in which growing FDA oversight and expectations are driving a more proactive, science-led approach; GRAS notification remains voluntary but is widely viewed as best practice for gaining FDA engagement and consumer confidence, with further FDA action anticipated.
• Eurofins (product development and innovation): its US-based Product Development and Innovation division runs end-to-end work for food, beverage, supplement and pet food products — ideation, formulation, commercialisation, scale-up, regulatory and compliance, packaging and stability testing — placing the regulatory step inside a wider development service.
• Screening before regulatory spend: in one documented engagement, a multinational consumer-goods company’s set of more than 100 plant-based protein candidates was narrowed to a high-potential shortlist using performance-based testing against functionality criteria, with a searchable database enabling faster and cheaper ingredient selection — the work that determines which ingredients are worth a dossier at all.

03CN

China operates its own pre-market route for new ingredients, administered centrally and tracked publicly, but the sourcing shows a regulatory pathway rather than a service industry built around it.

new food raw material approval, National Health Commission administration, published approval tallies

• The approval route: new food raw materials are approved through an administrative licensing process run by the National Health Commission, accessed through the government service portal’s licensing section, requiring submission materials and a safety assessment before an ingredient may be used.
• Published approval flow: Chinese food-industry information services compile and publish periodic reviews of new-food-raw-material applications and approvals — quarterly and half-yearly tallies covering the first quarter and first half of 2026 — so the throughput of the system is publicly visible rather than opaque.
• Service layer, stated honestly: no dedicated Chinese novel-food approval-as-a-service consultancy was independently confirmed in 2026 sourcing. What the sources establish is the existence and administration of the route, and industry-information providers tracking it; the advisory layer is therefore described qualitatively rather than tabled.

04EU

Europe and the UK are where this service is most developed, and the defining feature is divergence: the UK regime no longer follows the EU automatically, so one ingredient now needs two dossiers.

EFSA opinions, UK pre-market authorisation after Brexit, 1919-founded research institutions

• Intertek Assuris (EFSA dossier work): EFSA granted a positive safety opinion on beta-nicotinamide mononucleotide in May 2026 after Intertek assisted the manufacturer Effepharm in preparing and submitting the scientific dossier for the novel food evaluation — a dated, specific instance of the service producing its intended outcome.
• Pen & Tec, now trading as Argenta (EU and UK scope): a Barcelona-based regulatory consultancy with more than 25 years of experience in European and international food and feed regulation, covering additives, foods for particular nutritional uses, enzymes, flavourings, novel foods and nutrition and health claims. Its published guidance sets out that the UK, having left the EU, now runs its own pre-market authorisation across novel foods, feed additives, flavourings, food contact materials, food additives, food enzymes, GMOs as food or feed, irradiated food and smoke flavourings.
• Campden BRI and Leatherhead Food Research (membership research institutions): Campden BRI, founded in 1919 and headquartered at Chipping Campden in Gloucestershire with 200 to 300 employees, provides science, technology, regulatory support, testing, processing, safety, training and information services to over 2,400 member companies across 75 countries. Leatherhead Food Research, also founded in 1919 and now part of Sagentia Regulatory, employs about 50 staff near London at Epsom and serves roughly 1,000 member locations with end-to-end regulatory and scientific guidance across foods, beverages, alcoholic drinks, supplements and packaging.

05Leading companies and research institutes

06Tech stack and innovations

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.

07Value chains and production pipelines

Industrial pipeline of a novel food authorisation (Regulation (EU) 2015/2283, retained UK regime, US GRAS notification, NHC new-food-raw-material licensing)

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Classification &       │ ───> │ 2. Evidence Generation    │
│    Filing Strategy        │      │                           │
└───────────────────────────┘      └───────────────────────────┘
                                                  │
                                                  ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Submission &           │ <─── │ 3. Dossier Assembly       │
│    Clarifications         │      │                           │
└───────────────────────────┘      └───────────────────────────┘
               │
               ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Opinion /              │ ───> │ 6. Launch & Ongoing       │
│    Authorisation          │      │    Compliance             │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Classification and Filing Strategy

The ingredient is classified — novel food, additive, enzyme or flavouring — and the filing sequence chosen across the EU, UK, US, China and Singapore. Because the UK regime no longer tracks the EU automatically, this step decides whether the applicant runs one evidence programme feeding several dossiers or duplicates work later.

Stage 2: Evidence Generation

Toxicology, compositional characterisation, stability and intake estimation are produced. Where a candidate set is still open, performance-based screening narrows it first — over 100 plant-protein candidates reduced to a shortlist in one documented case — so that regulatory spend goes only to ingredients that survive functional testing.

Stage 3: Dossier Assembly

The evidence is organised into the receiving regulator’s expected structure, with manufacturing process, specification and proposed uses described to its format. This is the step that distinguishes regulatory science from testing: the same dataset must be re-presented per jurisdiction.

Stage 4: Submission and Clarifications

The dossier is filed and the applicant answers the regulator’s questions through the evaluation. Most timeline risk lives here, because a clarification round can add months and an inadequate original dataset cannot be repaired by argument.

Stage 5: Opinion or Authorisation

The regulator issues its safety opinion or licence — an EFSA positive opinion, a UK authorisation, an FDA no-questions letter following GRAS notification, or a National Health Commission approval of a new food raw material. China publishes periodic tallies of applications and approvals, so throughput there is publicly observable.

Stage 6: Launch and Ongoing Compliance

The ingredient enters the market under its approved specification and permitted uses, after which claims substantiation and compliance maintenance continue — which is why the providers are structured as membership advisory bodies serving thousands of member companies rather than as one-off project shops.