Regulatory compliance in Food product development

Compliance as a data problem

Manufacturers manage compliance across markets by holding one governed product record and deriving each market label from it. That means the recipe and supplier specification are stored once. The nutrition calculation shares that single source, while market variations are handled as controlled variants. Ingredient substitutions then flow through to every affected label instead of being caught by whoever remembers to check.

The scale of the problem is easy to underestimate. The European Court of Auditors put the audience at 450 million European consumers exposed to claims and scores in its 2024 report on food labelling, and every one of those claims traces back to a data point someone has to maintain.

Purpose of the regulation

The purpose of Regulation (EU) No 1169/2011 is to give consumers information they can compare, and to give manufacturers one harmonised rulebook instead of 27 national ones. It replaced the older labelling and nutrition directives with a single directly applicable text, which removed most of the room for member states to write their own mandatory particulars.

Two things follow from that. Consumers get a protected minimum covering the identity of the food and what's in it. They also learn what it will do to someone with an allergy. And manufacturers get a single legal basis for artwork that travels across borders, subject to language rules and a short list of national options.

The European Commission confirms the regulation entered into application on 13 December 2014, with the nutrition declaration obligation following on 13 December 2016. That two-year gap was deliberate, because reformulating a portfolio's nutrition data takes time.

The regulation has limits, and its own auditors say so. "Companies can be very creative in what they put on packaging, and EU rules have not caught up with a constantly evolving market," said Keit Pentus-Rosimannus, the member of the European Court of Auditors responsible for the 2024 food labelling audit.

Voluntary claims and front-of-pack scores sit largely outside the mandatory particulars. Environmental messages do too, and newer legislation has started to bite in this area.

When the regulations took force

These are the dates that decide what your product record has to hold, and when.

Obligations under Regulation (EU) 2025/40 continue to phase in after 2026, so treat the August date as the start of the work.

What must be on labels

Article 9 of Regulation (EU) No 1169/2011 lists the mandatory particulars for prepacked food. These start with the name of the food and the ingredient list. The label must emphasise allergens within that list and state the quantity of certain ingredients.

Further particulars cover net quantity and the date of minimum durability or use-by date. The label must also state storage or use conditions where needed and the name and address of the responsible food business operator. Country of origin where required and instructions for use where the food is hard to use without them must also appear. Finally, Article 9 requires actual alcoholic strength above 1.2% by volume and the nutrition declaration.

Content is half the obligation. Presentation is the other half. The European Commission states the mandatory particulars must be printed with an x-height of at least 1.2 mm, dropping to 0.9 mm where the largest surface of the pack is under 80 cm². Information must be easily visible and not obscured by artwork, which is why legibility questions belong in the specification and not in a late artwork review.

Allergens are the sharpest edge. Since 13 December 2014 each of the 14 allergenic ingredients has had to be emphasised inside the ingredient list itself through its typeface or style. This requirement rules out a separate allergen box in the EU, and background colour can also provide the emphasis. Get the recipe hierarchy wrong and the emphasis goes on the wrong word.

Nutrition figures must be expressed per 100 g or 100 ml so shoppers can compare packs of different sizes. Per-portion values are allowed as an addition.

5 data groups behind mandatory label information

Group the Article 9 particulars into five obligations and it becomes clearer which system owns which field.

Which food is exempt

Exemptions in Regulation (EU) No 1169/2011 are narrower.

Very small packs. Where the largest surface is less than 10 cm², the mandatory label information starts with the name of the food and net quantity. It also includes the durability date and allergens. The ingredient list has to be available by other means at the consumer's request.

Glass bottles intended for reuse keep a reduced set of particulars under Article 16 when they are indelibly marked and have no label or collar.

Foods exempt from the nutrition declaration under Annex V include unprocessed single-ingredient products and herbs and spices. Water is also exempt, as are coffee and tea. The same applies to packs whose largest surface is under 25 cm². Allergen rules still apply in full.

Non-prepacked food, where only allergen information is mandatory under EU law, and member states can require more.

Food prepacked at the consumer's request and food prepacked for direct sale, which the EU regulation treats differently from prepacked goods. The UK closed most of that gap in 2021.

Small quantities supplied directly by the manufacturer to the final consumer or to local retail outlets supplying that consumer, which sits in the same Annex V list.

Alcoholic drinks above 1.2% by volume were long exempt from the ingredient list and nutrition declaration. Wine and aromatised wine products lost that exemption under the 2021 reform of the Common Market Organisation rules.

Prepacked food

Prepacked food carries the full Article 9 set, because the consumer buys it without speaking to anyone who could answer a question. The regulation defines it as food enclosed in packaging before sale, where the food cannot be altered without opening or changing that packaging. If you wrap it in the factory, you label it in full.

That single definition drives most of the data burden in a manufacturing business. Every recipe version needs a matching declaration, and every pack format needs its own artwork with the right font size for its surface area. Each market also needs the particulars in a language the consumer understands. A 200 g pouch and a 30 g sachet of the same product require separate labelling cases.

Version control is where this goes wrong in practice. Artwork gets approved against a formulation that has since changed, or a supplier swaps an ingredient and the QUID percentage on pack no longer matches the recipe.

To fix this, link artwork to a released specification version and treat any formulation change as a trigger for label revalidation, which is the core of packaging and formula specification management done properly.

Non-prepacked food

For non-prepacked food, EU law requires allergen information and leaves the rest to member states. Article 44 of Regulation (EU) No 1169/2011 applies to food sold loose or packed at the consumer's request. It also covers food served by caterers and makes the 14 allergens mandatory, while national governments decide the format and whether anything else must be declared.

So the same tray of food can be governed differently in Germany and France, with Ireland applying another approach. For manufacturers supplying foodservice and bakery counters, that means the product record has to hold allergen data in a form the customer can reuse at the point of sale. The same requirement applies to meal solutions: customers need the data in their language and in a directly reusable form.

The United Kingdom went further. Food that is packed on the same premises from which it's sold is treated as prepacked for direct sale, and since 1 October 2021 it needs the name of the food plus a full ingredient list with the 14 allergens emphasised. The change followed the death of Natasha Ednan-Laperouse (known as Natasha's Law).

Precautionary labelling remains unharmonised, and the European Court of Auditors criticised the practice in its 2024 audit, finding that "may contain" statements are applied too liberally and are at times not based on risk assessments quantifying the presence of allergens. If you supply a customer who then relabels, expect to be asked to justify every precautionary statement you pass on.

EU regulation versus UK regulations

The UK and EU rulebooks started identical and have been drifting apart since 2021. Regulation (EU) No 1169/2011 was retained in UK law and is now assimilated law, with enforcement in England under the Food Information Regulations 2014, SI 2014/1855. Scotland, Wales and Northern Ireland have their own equivalent instruments, and breaching the English regulations is a strict liability offence.

An EU-facing label needs an operator established in the EU, and a Great Britain label needs a UK address. Prepacked for direct sale, where the UK requires a full ingredient list and the EU does not. Northern Ireland, which follows EU rules under the Windsor Framework, so "Not for EU" marking applies to goods moving into Northern Ireland while the UK government confirmed in 2024 it would not extend that marking to Great Britain on a mandatory basis.

Also, consider new legislation. Anything the EU adopts after Brexit applies to you as an exporter, not as a matter of domestic law. Regulation (EU) 2025/40 is the clearest example, because a UK manufacturer selling packaged goods into the EU needs a declaration of conformity for each packaging type from 12 August 2026, and the details of what that covers are set out in the EU packaging regulation.

What data compliance needs

Compliance data needs structure and ownership, backed by a version history. These are the elements to check before you blame the label.

• One governed product record. The formulation and specification reference the same released version. The nutrition calculation and label text do too. If artwork can be approved against an unreleased recipe, the control has already failed.
• Allergen and cross allergen data at ingredient level. Allergens are carried on the raw material record and inherited through the bill of materials. That's what lets you answer a "does this contain sesame" question across a portfolio in minutes.
• Market variants. One product, many market-specific attribute sets covering language, origin declarations and national options under Article 44.
• Traceable change control. Every change to mandatory label information is dated, attributed to the person responsible and linked to the corresponding artwork revision. This creates a clear audit trail, allowing reviewers to trace each label update back to the underlying data change.
• Sourcing and claiming evidence. Plot geolocation for commodities in scope of Regulation (EU) 2023/1115, packaging conformity documentation for Regulation (EU) 2025/40, and substantiation for any environmental claim before 27 September 2026.

Where compliance is decided

Mandatory particulars, exemptions, precautionary wording and the widening gap between EU and UK requirements all come back to the same question. For this version of this product, can you show where every printed value came from?

That is what we build. C+P Consulting helps food, beverage and ingredients manufacturers hold regulatory and labelling data in one governed record with market variants, from specification management through to data migration.

If your team is currently running two rulebooks off two spreadsheets, talk it through with us.

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