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Allergen declaration review

Every allergen traced through the recipe and checked against the rules of each market, including compound ingredients, carry over and precautionary wording.

What is an allergen declaration review?

An allergen declaration review checks how allergens are declared on a product, against the recipe it is made from and against the rules of every market it is sold in. It covers which allergens are regulated in each market, whether they are named in a form consumers recognise, whether the required emphasis is applied, and whether any precautionary statement has a risk assessment behind it. Undeclared allergens are a leading cause of label driven food recalls.

The review works from the recipe and never from the previous label. Most undeclared allergen incidents originate in a compound ingredient nobody broke down, or a recipe change that was authorised without anyone considering the label consequence. Checking a declaration against the declaration that preceded it repeats the error.

Summary

Every allergen traced through the recipe, checked against each market's regulated list, with naming, emphasis and precautionary wording corrected. Delivered remotely, in any language, quoted on scope.

Allergen review at a glance

Assessed against
Your recipe and each market's regulated list
Covers
Naming, emphasis, carry over, cross contact, advisory wording
Basis
The recipe, never the previous label
Scope
Per SKU, with range consistency checked
Delivery
Remote
Output
Findings and corrected declaration text
Coverage
Worldwide
Languages
Any language, including English, Spanish, French, German, Italian and Portuguese

What the review checks

Eight checks applied to every product in scope, in every market it is sold in.

CheckWhat it establishesWhere it goes wrong
Regulated list per marketWhich allergens have to be declared. Lists differ between markets in both the number of allergens and how each is defined.An allergen regulated in the destination market and absent from the declaration.
NamingAllergens named in a form a consumer recognises, with the source named where the rules require it.A technical ingredient name that conceals the allergen source.
EmphasisThe allergen distinguished from surrounding text within the ingredient list, in the manner the market requires.Emphasis applied to some allergens and not others, or applied inconsistently across a range.
Recipe reconciliationThe declaration checked against the actual recipe, including compound ingredients and processing aids.An allergen entering through a compound ingredient that was never broken down.
Carry over and processing aidsAllergenic substances entering through additives, carriers, enzymes and aids that still require declaration.A carrier or processing aid treated as exempt when it is not.
Cross contact assessmentWhether unintended presence is genuinely possible given your segregation, scheduling and cleaning validation.A may contain statement with no assessment behind it.
Precautionary wordingThe form of any advisory statement, and whether the market restricts how it may be used.Wording that implies more or less control than the assessment supports.
Consistency across the rangeWhether the same ingredient is declared the same way across every product and every pack format.One product declaring an allergen and a sister product with the same ingredient omitting it.

How undeclared allergens reach the market

These eight account for most undeclared allergen recalls. Every one of them is visible before the product ships.

What you receive

Supplied per product and per market, in a form your designer can implement without interpretation.

ElementWhat it covers
Per SKU assessmentEach product assessed individually, since ranges diverge more than they appear to.
Recipe reconciliationThe declaration checked against the recipe, including compound ingredients, carriers and processing aids.
Market by market viewWhich allergens require declaration in each market in scope, and where the current declaration falls short.
Naming and emphasis findingsEvery naming and emphasis failure identified, with corrected text supplied.
Cross contact positionWhether precautionary labelling is justified by your controls, or whether the risk should be controlled instead.
Precautionary wordingCompliant advisory wording where it is warranted, and a clear statement where it is not.
Range consistency checkDivergence across products and pack formats identified.
Corrected declarationReplacement declaration text ready for your designer, per SKU and per market.

Who an allergen declaration review is for

Food and beverage manufacturers, food supplement companies, importers and brand owners. It suits any business using compound ingredients, running shared lines, or selling the same product into markets with different regulated lists.

A recipe has changed and the declaration has not been reassessed.

You use compound ingredients and cannot confirm they are broken down.

You are entering a market with a different regulated allergen list.

May contain appears on pack with no risk assessment behind it.

A customer or retailer has queried your allergen declaration.

Sister products in a range declare the same ingredient differently.

A supplier has reformulated a material you use.

You handle allergens on shared lines and rely on changeover cleaning.

How the review is carried out

  • 1

    Recipe and label in

    You send full recipes with percentages, compound ingredient breakdowns, current declarations and the markets in scope.

  • 2

    Regulated list per market

    The allergens requiring declaration in each market are established, since lists and definitions differ.

  • 3

    Recipe reconciliation

    Every allergen is traced through the recipe, including carriers, additives, enzymes and processing aids.

  • 4

    Naming and emphasis

    Each allergen is checked for recognisable naming and for the emphasis the market requires.

  • 5

    Cross contact assessment

    Whether unintended presence is genuinely possible is assessed against your segregation, scheduling and cleaning validation.

  • 6

    Corrected declaration

    Replacement declaration text is supplied per SKU and per market, with advisory wording only where it is justified.

Not included

Allergen controls on site. Segregation, scheduling, changeover cleaning and validation are covered by an allergen management review, which examines the controls this declaration depends on.

Laboratory analysis. Where cleaning validation or allergen testing is needed, the review states what is required.

Where a finding indicates product already on the market carries an undeclared allergen, you are told immediately, because that is an incident and not a labelling correction.

What an allergen declaration review costs

Every review is quoted against its own scope. A single recipe in one market and a range of twenty across four markets are very different pieces of work. These factors set the price.

Number of SKUs

Target markets

Recipe complexity

What this service is assessed against

These are the primary sources this work is built on. Where a market you sell into has its own requirement, that takes precedence and we assess against it.

Regulation (EU) No 1169/2011 on food information to consumers
Mandatory particulars, allergen declaration, quantitative ingredient declaration, nutrition declaration and legibility. EUR-Lex
21 CFR Part 101, food labeling
United States labelling requirements including nutrition labeling and allergen declaration. eCFR
CXC 1-1969, General Principles of Food Hygiene
The international reference for prerequisite programmes and for the seven HACCP principles. Codex Alimentarius
BRCGS, IFS Food, FSSC 22000 and SQF published requirements
The clause your certification body audits against, which differs between schemes and between issues. BRCGS

Allergen labelling terms

Allergen declaration
The information on a label identifying regulated allergenic ingredients present in a food.
Emphasis
Distinguishing an allergen from surrounding text in the ingredient list, by typeface, style, colour or background.
Compound ingredient
An ingredient itself made from more than one ingredient, requiring breakdown so allergens are visible.
Carry over
An allergenic substance entering a food through an ingredient of an ingredient, including additives and carriers.
Processing aid
A substance used during processing that may leave residues, some of which still require declaration.
Cross contact
Unintended transfer of an allergen from one food to another during production, handling or storage.
Precautionary allergen labelling
An advisory statement covering possible unintended allergen presence, requiring a risk assessment behind it.
Reference dose
A quantity of allergen protein below which a reaction is unlikely in most allergic individuals, used in quantitative risk assessment.

Allergen labelling questions

Regulated allergens must appear within the ingredient list, named in a form the consumer recognises, and emphasised so they stand out from the surrounding text. Which allergens are regulated differs between markets in both number and definition, so a declaration that is complete in one country can be incomplete in another.

It depends on the market. Each jurisdiction maintains its own regulated list, and both the number of allergens and the way each is defined differ. Some markets regulate allergens that others do not. The review works from the list applying in each market you sell into.

Emphasis distinguishes the allergen from the rest of the ingredient list, typically through bold type, capitals, contrasting colour or a different background. The permitted methods differ by market. The most common failure is emphasis applied to some allergens and not others across a product range.

Yes, and this is where most undeclared allergen recalls originate. An ingredient made from other ingredients has to be broken down so any allergen inside it is visible. Declaring the compound ingredient by its own name alone hides what is in it.

Only where a risk assessment establishes that unintended allergen presence is genuinely possible despite your controls. Applying it as blanket insurance devalues the warning for the people who rely on it, offers no defence where the risk was controllable, and is now restricted in some markets.

Sometimes, and it depends on the substance and the market. Allergenic material can enter through additives, carriers, enzymes and processing aids, and exemptions are narrower than businesses usually assume. Each is assessed against the rules of the markets in scope.

That is a food safety incident and not a labelling correction. It normally requires immediate assessment, notification of the competent authority, and a withdrawal or recall depending on where the product has reached. Speed matters more than certainty at that point.

Cleaning can reduce allergen residue to a level below which a reaction is unlikely, and whether your procedure achieves that has to be validated. An unvalidated changeover cleaning procedure cannot support a claim that a product is free from an allergen handled on the same line.

A label compliance review covers every mandatory element on the label. This review examines the allergen declaration in far greater depth, including recipe reconciliation, carry over, cross contact and precautionary labelling. Businesses with allergen concerns specifically should take this one.

This review covers what is declared. Segregation, scheduling, changeover cleaning and validation are covered by an allergen management review, which examines the controls the declaration depends on. The two are frequently commissioned together.

Any number, and a range is normally cheaper per product than individual reviews because ingredient work overlaps. Reviewing a range together also surfaces inconsistency between sister products, which individual reviews miss.

A per SKU assessment, recipe reconciliation including compound ingredients and processing aids, a market by market view of what requires declaration, naming and emphasis findings with corrected text, a position on precautionary labelling, a range consistency check and replacement declaration text ready for your designer.

Who carries out this work

Confi Food assigns work by subject. HACCP, labelling, certification standards, regulatory compliance, supplier assurance and monitoring are separate disciplines, and each piece goes to someone who works in that area. Every deliverable is reviewed internally by a second specialist before it reaches you.

Our technical positions are built from primary sources, meaning the legislation, the competent authority, Codex Alimentarius, the certification scheme owner or the relevant standards body. We set out how that works in our technical review and editorial policy, and what happens at each stage of an engagement in how Confi Food works.

Related services

Request an allergen review

Send the recipes, the current declarations and the markets, and receive a written quote covering the scope, the deliverable and the price.