Regulatory by Design: A More Predictable Route to Market Readiness for Food Projects

Regulatory by Design:

A more predictable route to market readiness for food projects

Why Regulatory Affairs should begin well before label review

A product idea can be technologically convincing, work well sensorially and appear commercially attractive—yet still stall shortly before launch. Often, no single error is responsible. The problem is a sequence of decisions that were individually plausible but were not assessed as an interconnected system.

Only at final artwork, customer approval or immediately before production begins does it become apparent that category and positioning do not align, an ingredient is permitted only under narrower conditions, the intended claim is unsupported by a realistic intake, or supplier documentation is insufficient for sound approval. Changes at this stage are expensive. They rarely affect just one passage of text; more often they involve formulation, specification, testing, packaging and marketing already agreed.

‘Regulatory by Design’ is not used here as a legally defined standard. It describes a method of integrating regulatory requirements into product strategy, development and project management from the outset. The aim is not to eliminate all risk, but to answer decisive questions while a commercially sensible response is still possible.

Regulatory work starts before artwork

The common request to ‘just check the label’ at a project’s end reduces Regulatory Affairs to a final formal check. In reality, reliable labelling presupposes that the relevant product decisions have already been made and documented.

The EU Food Information to Consumers Regulation generally assigns responsibility for the presence and accuracy of food information to the food business operator under whose name or business name the product is marketed, or to the importer where that operator is not established in the Union. [1] A late artwork review cannot fulfil this responsibility if product category, formulation version, raw-material identity, allergens, the basis of nutrition values, manufacturing process, intake or target markets remain unresolved.

Food business operators also have a general duty to ensure and verify compliance with applicable requirements within the activities under their control. [2] Development projects must therefore establish more than who approves the label. They must identify who supplies and assesses each technical assumption, and who reviews it again when changes occur.

A responsibility and approval matrix covering brand owner, developer, manufacturer, raw-material supplier and retailer can structure these processes. It does not automatically alter their statutory responsibilities. This distinction is particularly important in private label: operational tasks can be allocated contractually, while food-law responsibility still follows the applicable provisions and the activities actually controlled.

Product category is a development decision

Product classification is not a formality to be completed after formulation. It affects which substances and forms may be used, which dosage is appropriate and permitted, which mandatory statements and warnings arise, how the product may be presented and which national procedures must be considered before market entry.

The distinction between conventional foods and food supplements illustrates this particularly clearly. The legal definition of food supplements refers, among other things, to supplementing the normal diet, concentrated nutrients or other substances with a nutritional or physiological effect, and dose form. Additional labelling duties follow, and Member States may provide for national notification procedures. [3]

A technically functional formulation is therefore not yet a marketable product concept. If category, intended purpose, dosage form and communication do not align, a late correction can change the entire positioning. A sound product brief must capture these points together with the target group, target countries, price positioning and intended benefit promise.

Claims help determine the formulation

Many development projects begin with a desired statement. This is commercially understandable, but regulatorily sound only if that statement is translated into specific conditions of use early on.

The Claims Regulation covers not only express wording, but also pictorial, graphic or symbolic representations suggesting particular characteristics. Nutrition claims are permitted only where provided for and where their conditions are met. Health claims additionally require authorisation and must comply with the specified conditions of use and accompanying information. [4]

For development, this entails a chain of interdependent decisions rather than a later wording check: which specific statement is intended? Under what conditions is it permitted? What concentration must the finished product achieve? What intake is realistic? What losses are expected during processing and storage? And what margin is needed to support the statement throughout the intended shelf life, rather than only when the formulation is calculated?

The Claims Regulation refers to the product ready for consumption and a quantity reasonably expected to be consumed. [4] The nutrition declaration must also rest on reliable average values; the Food Information to Consumers Regulation permits analysis and appropriate calculations based on actual or generally established data. [1] Raw-material variation, overages, process losses and stability are therefore part of formulation and specification work, rather than details for later labelling.

Innovative ingredients: status depends on the actual raw material

For plant extracts, microorganisms, algae, fermentation products or functional protein ingredients, a general supplier statement about European market status is often insufficient. Raw-material identity, starting material, plant part or strain, manufacturing process, intended food category, inclusion level and target group are decisive.

The Novel Food Regulation covers foods not consumed to a significant degree within the Union before 15 May 1997 which also fall within one of its statutory categories. The food business operator must assess whether the intended food falls within scope; if uncertain, it must consult the country where first marketing is intended. [5]

The Novel Food Status Catalogue is an important guide, but neither complete nor legally binding. [6] Its entries therefore do not replace assessment of the actual raw material and use. Documented use in food supplements before the cut-off date, for example, cannot automatically be extended to conventional foods.

An existing authorisation is also only the beginning of the use assessment. The relevant Union list entry may specify composition, food categories, maximum amounts, target groups, additional labelling and other conditions. [7] Authorisations based on protected scientific data may also benefit from time-limited applicant-specific protection. [5] ‘Authorised in the EU’ is therefore technically inadequate without checking the raw material, intended use and list entry together.

An integrated approval process

Regulatory by Design does not mean burdening every project with extra approval stages. It aims to prevent decisions being made in separate functions whose interactions become visible only late in the process.

A sequence of clear decision points has proved effective in practice. Product briefing and classification come first, followed by raw-material and supplier-document review and joint assessment of formulation, intake and claims. Manufacturing process, product specification, shelf life and analytical acceptance criteria then provide the technical basis for labelling and communication. Only when these elements are consistent can artwork and market documentation be approved on a sound basis.

Decisions must not simply be recorded as completed tasks. Their assumptions matter: which raw-material specification was assessed? What calculation supports the nutrition value? Which markets were included? Which claim wording was approved? Which process losses were considered? Only then can it later be determined whether a change triggers reassessment.

Manufacturing also entails food hygiene requirements. Activities after primary production generally require procedures based on HACCP principles to be established and maintained. [8] Here too, regulatory assessment must connect with product and process development: a hazard control point, stability criterion or analytical specification can determine legal and commercial marketability just as a labelling rule can.

Change management is part of continuing legal compliance

Products rarely remain unchanged after launch. Suppliers change, raw materials are replaced, nutrition values are updated, claims are adapted and packaging is revised. The decisive question is not whether a change initially looks small, but which approved assumptions it affects.

A raw-material change may alter ingredient order, QUID, allergen assessment, nutrition values and claims, while also affecting sensory properties, process parameters, shelf life, specification and costing. The Food Information to Consumers Regulation links several of these consequences directly to the finished product’s composition and presentation. [1] Changes must therefore not be approved solely from purchasing or production perspectives.

Effective change management requires clearly identified versions of formulation, specification, artwork and supporting evidence. Defined reassessment triggers are equally important: which changes need only a document update, which require regulatory reassessment, which need further analysis and which need renewed customer or market clearance? This approach makes Regulatory by Design a tool for the entire product lifecycle.

Private label: interfaces are the real risk

In private-label projects, formulation development, manufacturing, artwork, marketing and approval often sit with different companies. The greatest risk may therefore be an unclear interface rather than insufficient expertise. Each party can perform its own task correctly while relying on an assumption never assessed elsewhere.

The Food Information to Consumers Regulation requires B2B suppliers to provide sufficient information for the downstream food business operator to fulfil its obligations. [1] What is ‘sufficient’ depends on the product and supply relationship. A specification may appear formally complete while omitting decisive information on raw-material identity, analytical basis or technologically induced variation.

Robust project management therefore distinguishes three levels: statutory responsibility, contractually agreed tasks and operational approval authority. Confusing these creates duplicate reviews or, more seriously, unintended gaps.

Regulatory Affairs as part of product quality

Regulatory Affairs is neither a late-stage repair function nor an opponent of innovation. Properly integrated, it creates a decision framework: which product idea can actually be delivered in the intended market? Which statements are supported by the formulation and legal framework? What evidence is needed? And which alternative provides a more reliable route to the objective at reasonable cost?

A product fit for lawful marketing does not arise from a formally correct label alone. It results from consistent decisions spanning classification, raw-material selection, formulation and process through to claims, specification and approval. Regulatory by Design makes these dependencies visible early. It does not remove every risk, but improves decision quality—and thus the predictability of development and launch.

Food Essentials helps companies structure product development, Regulatory Affairs and market launch as an integrated process—for branded products, private label and revisions to existing ranges.

Sources

Legal position and sources checked on 4 August 2026.

1. VO (EU) 1169/2011, Art. 7–10, 14, 21, 22, 31 und 36
2. VO (EG) 178/2002, Art. 17
3. RL 2002/46/EG, Art. 2 und 6–10
4. VO (EG) 1924/2006, Art. 2, 3, 5, 8 und 10 sowie Anhang
5. VO (EU) 2015/2283, Art. 3, 4, 26 und 27
6. EU-Kommission: Novel Food Status Catalogue
7. DVO (EU) 2017/2470
8. VO (EG) 852/2004, Art. 5

Note: This article provides professional information and does not constitute legal advice. The specific product, target market and legislation in force at the time of the decision are decisive.