Contaminant limits for freeze-dried ingredients derive from the maximum levels that Regulation (EU) 2023/915 sets for the fresh crop, adjusted by a concentration factor that the food business operator calculates and justifies under Article 3 of that regulation.
Key takeaways
- Annex I of Regulation (EU) 2023/915 carries no lead or cadmium category worded for dried vegetables or dried fruit, so the level applied to a freeze-dried batch derives from the fresh crop entry.
- Article 3(2) places the duty to provide and justify the concentration factor on the food business operator. Where the operator supplies none, the competent authority sets one with the objective of maximum protection of human health.
- Ochratoxin A in dried fruit and lead in dried spices sit in Annex I on the dried commodity itself, so applying a drying factor on top of those levels double counts.
- Codex CXS 193-1995 uses the same arithmetic, which keeps one calculation valid for EU, UK and GCC customers.
- A certificate of analysis serves the file only when it states the method, the limit of quantification and the basis on which the result is reported.
Contaminant limits for freeze-dried ingredients start with a level set on the fresh crop
Contaminant limits for freeze-dried ingredients begin in a table written for the harvested crop. Commission Regulation (EU) 2023/915 organises Annex I by food category and by contaminant, and Article 2 states that food listed in Annex I shall not be placed on the market and shall not be used as a raw material in food or as an ingredient in food where it contains a contaminant at a level which exceeds the maximum level set out in Annex I. The same article fixes the reference point for measurement: the maximum levels set out in Annex I, unless otherwise specified in that Annex, shall apply to food as placed on the market and to the edible part of the food concerned.
Read the vegetable entries and the gap appears immediately. Cadmium in root and tuber vegetables sits at 0,10 mg/kg under entry 3.2.2.1, with beetroots carved out at a lower value. Lead in root and tuber vegetables sits at 0,10 mg/kg under 3.1.2.1, with a separate entry for fresh ginger and fresh turmeric. Cadmium in bulb vegetables sits at 0,030 mg/kg. Lead in fruits sits at 0,10 mg/kg, and at 0,20 mg/kg for cranberries, currants, elderberries and strawberry tree fruits. Neither the lead section 3.1 nor the cadmium section 3.2 contains a category worded for dried vegetables or dried fruit, and the one dried plant category in the lead table covers spices, which is treated further down.
A quality department that compares a laboratory result for a freeze-dried powder against the fresh crop figure will reject conforming material. Sublimation removes water and leaves the mineral load in a smaller mass, so the analyte concentration in the dried batch rises by roughly the same ratio as the mass loss. The arithmetic is straightforward once the factor is documented. The documentation is the part that fails audits.
Article 3 hands the concentration factor to the food business operator
Article 3(1) of the regulation states that where no specific Union maximum levels are set out in Annex I for food which is dried, diluted, processed or compound food, four aspects shall be taken into account when applying the maximum levels: changes of the concentration of the contaminant caused by drying or dilution processes, changes of the concentration caused by processing, the relative proportions of the ingredients in the product, and the analytical limit of quantification.
Article 3(2) allocates the work. Where the competent authority carries out an official control, the food business operator shall provide and justify the specific concentration, dilution or processing factors for the drying, diluting or processing operations concerned. The paragraph continues with the consequence of silence: where the operator does not provide the necessary factor, or where the authority deems that factor inappropriate in view of the justification given, the authority defines the factor itself, based on available information and with the objective of maximum protection of human health. An authority working to that objective selects a conservative factor, which produces a tighter working limit than a factor built on the operator’s own yield records.
National law adds nothing to this for adult food categories. Regulation (EU) 2023/915 applies directly in every Member State and the Commission legislation page lists it alongside Council Regulation 315/93/EEC as the framework instrument, with no implementing act restating the levels. Article 3(3) opens the single national margin: where Annex I sets no specific level for food for infants and young children, Member States may provide for stricter maximum levels for such food. Check that margin whenever the finished product carries an infant or young child claim.
Build the working limit from documented mass yield
Calculate the factor from the batch, using the mass of fresh input against the mass of dried output for the same lot after trimming and peeling. Multiply the Annex I level for the fresh crop by that factor to obtain the working limit for the dried material. Record both weights, the trimming losses and the date, because Article 3(2) asks for a justification behind the number.
| Contaminant and Annex I entry | Level for the fresh crop | Documented mass yield factor | Working limit on the dried batch |
|---|---|---|---|
| Cadmium, entry 3.2.2.2 beetroots | 0,060 mg/kg | 8 | 0,48 mg/kg |
| Cadmium, entry 3.2.2.2 beetroots | 0,060 mg/kg | 10 | 0,60 mg/kg |
| Cadmium, entry 3.2.2.2 beetroots | 0,060 mg/kg | 12 | 0,72 mg/kg |
The factor values in the table illustrate the arithmetic. Substitute your own measured yield, one figure per raw material and per process route. Freeze-dried beetroot in dice and powder formats shows why one figure per crop falls short: the two formats come from the same input, and any additional milling or sieving step changes the mass balance again.
Classification decides which entry you start from, and ginger demonstrates the point. Entry 3.1.2.2 sets lead at 0,80 mg/kg for fresh ginger and fresh turmeric, inside the root and tuber vegetables group. Section 3.1.12 of the lead table carries the header "Dried spices" and sets 1,50 mg/kg for root and rhizome spices under entry 3.1.12.4, with parallel entries for seed spices at 0,90 mg/kg, fruit spices at 0,60 mg/kg and bark spices at 2,0 mg/kg. Material placed on the market as a dried spice therefore compares against 3.1.12.4 directly, since that entry already describes the dried form. Material placed on the market as a dried vegetable ingredient starts from 3.1.2.2 and takes the Article 3 route. Agree the classification with the customer before the first delivery of freeze-dried ginger and record the chosen entry number in the specification, because the two routes produce different acceptance limits from the same laboratory result.
Two adjustments deserve a line in the justification file. Washing and peeling remove part of the contaminant load along with the mass, so a factor derived from gross weights overstates the concentration effect for crops where the metal sits in the skin. The edible part rule in Article 2 already points at this, since the level applies to the edible part of the food concerned. Second, blend products need the ingredient proportions from Article 3(1)(c) applied after the drying factor, one calculation per component.
Ochratoxin A in dried fruit follows a separate rule
Check whether Annex I already names the dried form before reaching for a factor. For ochratoxin A the regulation sets 8,0 μg/kg for dried vine fruits, meaning currants, raisins and sultanas, together with dried figs, under entry 1.2.1.1, and 2,0 μg/kg for other dried fruits under entry 1.2.1.2. Those entries describe the dried commodity, so a laboratory result compares against them directly. Applying a drying factor on top produces a limit several times too permissive and will be treated as a control failure.
Several Annex I entries also carry the wording that the maximum level applies to the product as placed on the market, which overrides the general edible part rule for those categories. Build the check into the specification review: identify the entry number, confirm the physical state it describes, and only then decide whether Article 3 applies. Recording the entry number in the specification removes the ambiguity for every subsequent batch and for the auditor reading the file two years later.
Codex applies the same arithmetic outside the EU
Customers in the Gulf and in the United Kingdom frequently reference Codex in their own specifications. The General Standard for Contaminants and Toxins in Food and Feed, CXS 193-1995, states in its annex that when products are concentrated, dried or diluted, use of the concentration or dilution factor is generally appropriate in order to be able to obtain a primary judgement of the contaminant levels in these processed products. The same annex explains the drafting logic behind it, that maximum levels should preferably be set for primary agricultural products and may be applied to processed, derived and multi-ingredient food by using appropriate conversion factors.
Section 1.3.1 of the standard adds the principle that contaminant levels in food and feed shall be as low as reasonably achievable through best practice such as Good Agricultural Practice and Good Manufacturing Practice. One documented factor per raw material therefore serves the EU file, the Codex-referencing customer and the export documentation pack at the same time. Prepare it once, in a form that stays usable after translation, with the weights and dates attached.
Sampling, moisture basis and the limit of quantification
Sampling rules decide whether a result carries weight in an official control. For metals the Commission points to Regulation (EC) No 333/2007 for the control of levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs, a separate instrument from the sampling rules covering mycotoxins and plant toxins. Cite the sampling instrument in the raw material specification so that the supplier and the receiving plant draw increments the same way.
The analytical limit of quantification enters through Article 3(1)(d). At the levels involved for a fresh crop, a laboratory reporting a value at or near its own limit of quantification produces a figure that cannot support an acceptance decision. Ask for the limit of quantification in writing on every certificate of analysis, alongside the method reference and the measurement uncertainty. Ask separately for the basis on which the result is reported, since a value expressed on a dry matter basis and a value expressed as received differ by the residual moisture of the sample.
Write the acceptance rule to match. State the working limit for the dried material, the reporting basis it assumes, and the action when a result arrives on the other basis. Without that clause, two laboratories both working correctly produce figures that appear to contradict each other, and the dispute reaches the goods-in supervisor at the moment of unloading.
Set testing frequency by raw material group
Soil uptake drives most of the variation. "Bakery and Snacks" describes the mechanism plainly, that heavy metals are absorbed by plants through their roots, accumulating in edible parts and eventually entering food products, with acidic soils increasing metal bioavailability and contaminated irrigation water adding to the load. The same article recommends focusing testing on high-risk ingredients including root vegetables. Root and rhizome material, leafy material and berries therefore belong in separate frequency tiers.
Spices sit in their own tier for lead. "New Food Magazine" ranks spices among the five ingredient categories carrying the highest heavy metal risk, alongside chocolate, rice, fish-based ingredients and water, and cites a 2018 lead poisoning case in Michigan traced to curry powder. Ingredients dosed at low inclusion rates still carry their metal load into the finished product, so exclude nothing from the plan on the grounds of a small recipe percentage.
Lot-to-lot verification is justified where the contamination originates in the growing environment. In April 2026 "NutraIngredients" reported screening of 37 spirulina and greens products in which 18 of the 37 exceeded California Proposition 65 lead exposure limits, with follow-up testing across multiple production lots showing a consistent pattern that pointed upstream to cultivation conditions. A single conforming certificate describes one lot, which is the argument for a standing goods-in frequency on materials sourced from variable growing regions.
Set the tiers against health-based reference values so that the plan withstands challenge. EFSA established a tolerable weekly intake for cadmium of 2,5 micrograms per kilogram of body weight in March 2009 and identified cereals, vegetables, nuts, pulses, starchy roots, potatoes and meat products as the main dietary contributors. WHO states that there is no level of exposure to lead that is known to be without harmful effects and that lead is stored in the teeth and bones, where it accumulates over time. FDA applies interim reference levels of 2,2 micrograms per day for children and 8,8 micrograms per day for females of childbearing age and issued final guidance on action levels for lead in processed food intended for babies and young children in January 2025.
Write four contaminant clauses into the raw material specification
Four fields connect the regulation to the delivery note. Copy them into the template once and the calculation stops being rebuilt from memory at every audit.
| Specification field | What to enter | Why the auditor asks |
|---|---|---|
| Annex I entry and physical state | entry number, the exact category wording and whether it describes the fresh or the dried commodity | decides whether Article 3 applies at all |
| Concentration factor and its basis | the numeric factor, the mass balance it came from and the date of the records | Article 3(2) requires the operator to provide and justify the factor |
| Reporting basis and limit of quantification | as received or dry matter, plus the required limit of quantification and method reference | Article 3(1)(d) makes the limit of quantification part of the assessment |
| Sampling plan and frequency | the sampling instrument referenced and the goods-in tier for the raw material group | aligns supplier and receiving plant on the same increments |
Store the justification file with the supplier qualification records, since the official control question arrives through the quality system and reaches that file first. Documentation of supplier qualification and audit scope for ingredient deliveries sits in the same place, and an auditor tracing a single batch moves between the two in one session. Attach the calculation to the specification revision, so that a change of process route triggers a review of the factor.
Update the factor whenever the process changes and record the reason for the revision. A change of cut size, a change of blanching step or a change of peeling method moves the mass balance, and a factor carried over from an earlier route describes material that no longer arrives on the pallet.
We confirm the documentation scope, the analytical package and the lead time for a specific batch once the specification has been agreed.
Frequently asked questions
The level for the fresh crop in Annex I of Regulation (EU) 2023/915, adjusted by the concentration factor for the drying operation, once you have confirmed that Annex I holds no entry describing the dried form of that material. Article 3(1) lists four aspects to take into account: changes of concentration caused by drying or dilution, changes caused by processing, the relative proportions of the ingredients, and the analytical limit of quantification.
The food business operator. Article 3(2) requires the operator to provide and justify the specific concentration, dilution or processing factors during an official control. Where the operator provides none, or the competent authority judges the justification inadequate, the authority defines the factor itself based on available information and with the objective of maximum protection of human health.
No. Annex I sets 8,0 μg/kg for dried vine fruits and dried figs and 2,0 μg/kg for other dried fruits. Those entries already describe the dried commodity, so the result from the laboratory compares against them directly.
Commission Regulation (EC) No 333/2007 covers sampling and methods of analysis for the control of levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. Reference the sampling plan in the specification so that the supplier and the receiving plant sample on the same basis.
Regulation (EU) 2023/915 applies directly across the Union, so no national instrument restates these levels. Article 3(3) opens one margin: where Annex I sets no specific level for food for infants and young children, Member States may provide for stricter maximum levels for such food.
Treat it as one input. Testing across multiple production lots has exposed contamination patterns that single-lot documentation missed, which is why goods-in verification runs on a defined frequency alongside the supplier file.