Colouring foods classification decides whether a fruit or vegetable preparation that adds colour to a recipe stays a food ingredient under Regulation (EC) No 1333/2008 or falls into the authorised additive framework, and the deciding criterion is whether the pigments were selectively extracted away from the nutritive and aromatic constituents of the source material.
Key takeaways
- Article 3(2)(a) of Regulation (EC) No 1333/2008 excludes dried and concentrated foods from the additive definition only when two conditions hold at the same time: the material is used for aromatic, sapid or nutritive properties, and the colouring effect is secondary.
- The Commission Guidance Notes set the enrichment factor threshold at six, calculated on a dry weight basis, and the JRC evaluation of that method applies it to primary extracts.
- Sublimation removes water without separating pigments from sugars, acids and fibre, so a whole fruit or vegetable freeze-dried powder carries the same pigment to solids ratio as the raw material it came from.
- FD and C Red No. 3 lost its US food authorisation on 15 January 2025, with a compliance deadline of 15 January 2027 for foods and dietary supplements.
- Record the process description, the dry matter and the pigment assay basis in the raw material specification, because the classification argument rests on all three.
Where Regulation (EC) No 1333/2008 draws the line
Article 3(2)(a) of Regulation (EC) No 1333/2008 defines a food additive as any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, added intentionally to food for a technological purpose. The same article carves out an exclusion for "foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect" (consolidated text of Regulation 1333/2008). Colouring foods classification for a fruit or vegetable preparation turns on that exclusion.
Read that exclusion as cumulative. Two conditions have to hold at the same time. The material has to carry aromatic, sapid or nutritive properties, and the colouring effect has to be secondary to them. Treating the two as alternatives is the single most common error in supplier questionnaires, and it produces a classification that collapses the first time an auditor asks for the reasoning.
Annex I to the same regulation describes colours as substances that add or restore colour in a food, covering natural constituents of foods and natural sources that are normally not consumed as foods as such. The Annex reaches preparations obtained from foods through physical or chemical extraction where the process results in a selective extraction of the pigments relative to the nutritive or aromatic constituents. Selectivity is the operative word. The consolidated version of the regulation currently in force carries the date 18 February 2026, so quote that date when you cite the article numbers in a specification.
Codex uses a shorter formulation. Guideline CAC/GL 36-1989, revision 2008, defines the functional class colour as a food additive which adds or restores colour in a food, and lists colour, decorative pigment and surface colourant as the associated technological purposes (FAO/WHO Codex Alimentarius). Buyers exporting to the Gulf work against national lists built on that Codex class structure, so keep the Codex wording in the export dossier alongside the EU citation.
The enrichment factor of six
The Joint Research Centre published a technical evaluation of the classification method in 2015. It states the principle in one line: once the pigments are selectively extracted relative to the nutritive or aromatic constituents, the extract is a colour. The measurable form of that principle is the enrichment factor, defined as the ratio of pigment content to nutritive or aromatic constituents in the colouring preparation, compared with the same ratio in the source material. The report refers to the threshold value for the enrichment factor, which is six, as laid down in the Commission Guidance Note, and it carries out the analysis on a dry weight basis using reference values compiled for the source crops (JRC evaluation of colouring foods classification).
Dry weight basis matters for anyone buying freeze-dried material. Sublimation removes water and leaves the remaining solids in place. Pigment, sugars, organic acids, fibre and minerals all stay in the same proportion to each other as they were in the fresh crop. Calculate the ratio on dry solids and a whole fruit or vegetable freeze-dried powder returns a figure close to the source material itself, far below the threshold of six. A pressed juice concentrate, a solvent extract or a resin-purified fraction behaves differently, because each of those processes moves pigment away from the other solids.
Two practical consequences follow. First, the classification argument for a freeze-dried powder rests on the absence of a separation step, so the process description carries more weight than any analytical certificate. Second, blending a freeze-dried powder with a purified pigment concentrate rebuilds the enrichment factor, and the blend has to be assessed on its own numbers.
Colouring foods classification inside the raw material specification
Write the classification into the specification. Email threads vanish at the first change of personnel, and three specification fields do the work.
Process description. Name every unit operation from harvest to packing: washing, cutting, freezing, sublimation drying, milling, sieving, packing. State in one sentence that no extraction, fractionation, membrane concentration or resin step was applied. Auditors read this field first.
Dry matter and water activity. Record the specified range for both. The dry weight basis of the ratio calculation depends on a stated dry matter figure, and a specification that leaves it blank cannot support the calculation it is meant to justify.
Pigment content and basis. State the pigment class, the analytical method and whether the result is reported on the material as supplied or on dry solids. Two laboratories reporting on different bases will produce results that look like a quality problem and are arithmetic.
Add the reference value used for the source crop and the resulting ratio. Keep that one page with the batch documentation for the retention period of the finished product, because a query about a 2026 delivery will arrive in 2028.
Declaring the ingredient once colour is part of the reason for use
Regulation (EU) No 1169/2011, consolidated version dated 1 April 2025, governs what appears on the pack. Article 18 requires ingredients to be designated by their specific name and listed in descending order of weight, under a heading including the word ingredients. A freeze-dried beetroot powder therefore appears under its own descriptive name. Colour category names carrying an E number belong to authorised additives.
Article 17 adds a condition that catches dried materials. Where the omission of a physical condition or specific treatment could mislead, the name has to carry that information, and powdered and freeze-dried are given as examples of such treatments. Check how your legal or customary name reads once the treatment is appended.
Annex VII Part A changes the arithmetic for reconstitution. Ingredients used in concentrated or dehydrated form and reconstituted during manufacture may be listed in the order of weight recorded before concentration or dehydration, provided the water used for reconstitution does not form part of the finished composition in a way that conflicts with that treatment. Decide early which route your recipe uses, because it moves the ingredient up or down the list and the two versions of the label will differ visibly.
The additive route imposes a separate set of obligations. Authorised colours sit in the Union list in Annex II to Regulation 1333/2008, with purity criteria in Regulation (EU) No 231/2012 and specific labelling information for certain colours in Annex V (European Commission, EU rules on food additives).
Pigment behaviour that decides the application
| Pigment class | Source crops in the freeze-dried range | pH behaviour | Thermal behaviour | Application note |
|---|---|---|---|---|
| Betalains | beetroot | Usable across the mildly acidic range typical of dairy bases | Oxidises and turns brown at high temperature | Suits chilled and frozen formats over baked ones |
| Anthocyanins | aronia, blackcurrant, blackberry, black carrot | Stable at low pH, shifts towards purple and loses stability as pH rises | Loses intensity with prolonged heating | Suits acidified beverages and fruit preparations |
| Carotenoids | carrot, pumpkin, sea buckthorn | Largely independent of pH | Subject to oxidative degradation | Protect with barrier packaging and controlled headspace |
Sources for the pH and thermal columns: FoodNavigator, 26 June 2026 and New Food Magazine.
Dosage economics sit alongside the chemistry. Reporting on reformulation projects puts the multiple at up to twenty times the synthetic dye cost once the higher inclusion rate is taken into account, with natural colourants quoted at 80 to 200 US dollars per kilogram against 15 to 30 for synthetics, in a global colourant market of roughly 3.5 billion US dollars in 2023 where natural sources already held 65 percent by value (New Food Magazine on the colour additives sector). Build the trial around the inclusion rate your target shade actually needs, measured on the finished matrix.
Beetroot as a worked example
Beetroot illustrates both sides of the line. Beetroot red carries the additive number E 162 when it is supplied as an authorised colour, and its specification requires not less than 0.4 percent red colour expressed as betanin. EFSA re-evaluated the additive in 2015, established no acceptable daily intake, and concluded that it raises no safety concern at the reported use levels, while noting that the specification would benefit from expressing betanin content on a dried solids basis (EFSA Journal 2015;13(12):4318).
A freeze-dried beetroot powder made from washed, sliced and sublimation-dried roots occupies the other side. It carries the earthy taste and the sugar and fibre content of the root along with the pigment, so the aromatic, sapid and nutritive limb of Article 3(2)(a) is satisfied by the material itself. Aronia and blackcurrant follow the same reasoning with anthocyanins and a pronounced acid profile. Document the reasoning per raw material, because the balance between colour and taste differs between a beetroot and an aronia at the same inclusion rate. Formulators working on freeze-dried ingredients for dairy, ice cream and dessert bases usually settle this question during the first bench trial.
United States deadlines that reach European order books
FD and C Red No. 3 lost its authorisation for use in food in the United States on 15 January 2025. The compliance deadline runs to 15 January 2027 for foods and dietary supplements and to 18 January 2028 for ingested drugs, and the FDA has asked manufacturers to complete reformulation ahead of the food deadline (FDA guidance on the Red No. 3 phase-out).
Replacement authorisations followed. On 9 May 2025 the FDA approved galdieria extract blue from the algae Galdieria sulphuraria, butterfly pea flower extract, and calcium phosphate, each with its own list of permitted food categories (FDA press announcement). On 5 February 2026 the agency set out an enforcement position on labelling: products containing no FD and C certified colours may carry claims such as no artificial colours, while colours derived from natural sources still require pre-approval through the color additive petition process (FDA letter to the food industry).
Demand pressure from those deadlines reaches European suppliers of pigment-bearing crops through the same harvests that serve EU manufacturers. Plan volume for red and purple raw materials against the 2026 and 2027 campaign figures, and confirm the harvest window for each crop before committing a launch date. Acidified formats absorb the anthocyanin crops most readily, so freeze-dried fruit for beverage and tea applications is where the first substitution trials tend to land.
Documents to collect before the first colour trial
Request six items and keep them together. The technical data sheet with granulation, dry matter and water activity ranges. The certificate of analysis for the specific lot, with microbiology and the pigment result on a stated basis. The process flow diagram covering every operation. The allergen and GMO statements. The certification scope for the producing site, in standard terms such as BRCGS or ISO 22000. The declaration of compliance for the packaging in contact with the powder.
Match the lot number on the certificate of analysis to the lot you actually ran, and retain a sample from that lot under the same storage conditions as the trial. Colour claims break down in exactly this gap, where a trial is run on one lot and the specification is written against another. Anyone comparing formats across categories can start from the wholesale range of freeze-dried fruit for manufacturers and narrow down by pigment class.
SALESWAVE supplies these documents per delivery once the scope has been agreed at the specification stage. We confirm certificates and lead times against a specific batch.
Frequently asked questions
No E number applies while the powder remains a whole fruit or vegetable material with the pigments still bound to the original solids. Ask the supplier for a written process description covering every unit operation from raw material to packing, and keep it with the specification. The moment a step separates pigment from the rest of the solids, the material enters the authorised additive framework and needs an entry in the Union list.
Present three documents together: the process flow for the raw material, the certificate of analysis for the delivered batch, and the calculation showing the pigment to solids ratio on a dry weight basis against the reference value for the source crop. Auditors read the process flow first, so make sure it names the drying method and states that no extraction or fractionation step took place.
Wording differs by market, so draft one version of the claim for each destination. In the US the FDA set out its enforcement position on such claims on 5 February 2026 for foods carrying no certified colours. In the EU the claim sits under the general fairness rules of Regulation (EU) No 1169/2011 and has to match the ingredient list on the same pack.
Bakery narrows the field, because dough temperatures degrade several pigment classes. Run a small oven trial with the actual time and temperature profile before you commit a specification, and measure colour on the finished crumb. Order the trial quantity against a specific lot number so the retained sample matches the batch you tested.
Milling changes particle size distribution and dispersion behaviour, and it leaves the pigment to solids ratio where it was. Classification stays with the food ingredient framework. Record the target fraction in the specification anyway, because finer fractions absorb moisture faster and change the dosing behaviour of a dry blend.