Allergen Control in a Multi-Product Export Facility: The Statement Buyers Should Ask For

Compliance snapshot

• The EU lists 14 allergens under Annex II of Regulation (EU) No 1169/2011. The US lists nine since sesame was added on 1 January 2023. Celery, mustard, lupin, molluscs and sulphites sit on the EU list only, and the EU’s “cereals containing gluten” is wider than the US “wheat”. One supplier answer rarely serves both markets.
• A usable allergen statement from a multi-product site has three parts: a site allergen list, a cross-contact risk assessment for the line your product runs on, and a written precautionary-labelling decision. “No allergens handled” is the wrong answer from almost any multi-category site.
• A “may contain” line does not replace control. The FDA says advisory statements cannot substitute for good manufacturing practice, and the UK Food Standards Agency (FSA) says they belong only where a risk assessment finds an unavoidable risk that cannot be controlled.
• Silk Foods Ceylon (SFC) runs its allergen programme under BRCGS and FSSC 22000 V6 at its Matale facility. Its product pages state that the site also handles tree nuts, sesame and mustard, so cross-contact is declared rather than assumed away.

On 1 January 2023, sesame became the ninth major food allergen in the United States under the FASTER Act. Overnight, every US-bound product made on a site that also handled sesame had a new line to answer for in its allergen file: sesame went from a voluntary disclosure to a regulated allergen subject to labelling, good manufacturing practice and preventive controls (US FDA, 2023). This piece sets out what a supplier allergen statement should contain, how it differs between the EU and US lists, and how Silk Route Ventures (SRV) answers it for the Silk Foods Ceylon (SFC) site in Matale.

What should an allergen statement from a multi-product site contain?

A buyer should receive three documents, not one sentence. A site allergen list names every allergen handled on the premises. A cross-contact risk assessment shows how each is kept apart on the line your product runs on. A labelling decision records whether a precautionary statement is used, and why. Together they let your regulatory team write the artwork without guessing.

Each part has a source in the standards a buyer already audits against. FSSC 22000 Version 6, in additional requirement 2.5.6, asks for a list of all allergens handled, documented validation of the controls and allergen training (Foundation FSSC, 2023). The FAO/WHO Codex Code of Practice on Food Allergen Management (CXC 80-2020) frames the same work as a risk assessment by the food business operator. In the EU, Commission Regulation (EU) 2021/382, in force from 24 March 2021, wrote allergen management and cross-contamination controls into the annexes of the food hygiene Regulation (EC) No 852/2004.

Element of the statement	What it should show	Document to request	Where the expectation comes from
Site allergen list	Every allergen handled on site, against the buyer’s market list	Allergen matrix by line and raw material	FSSC 22000 V6 requirement 2.5.6; Codex CXC 80-2020
Cross-contact assessment	How allergen-bearing and allergen-free runs are separated on the line your product uses	Line-level risk assessment, with the cleaning method named	Regulation (EU) 2021/382; 21 CFR 117.135 in the US
Rework control	Whether rework can carry an allergen into another product	Rework matrix	FSSC 22000 V6; Codex CXC 80-2020
Finished-product review	The allergen position of the specific SKU, checked before release	Finished-product allergen review	Buyer’s own label and artwork check
Labelling policy	Whether a “may contain” line is used, for which allergen, on what evidence	Written precautionary-labelling decision	FSA guidance; FDA position on advisory statements

Source: the standards and regulations named in each row, read 1 November 2026.

SFC’s written allergen management procedure carries this structure: an allergen matrix, a rework matrix, a finished-product allergen review and a label declaration decision tree, with a checklist and defined roles. Those are the records behind the statement, and the statement is available on request with the specification.

Why does one supplier answer not serve both the EU and the US?

Because the lists differ, and a site’s honest answer changes with the destination. The EU names 14 allergens. The US names nine. The overlap is large, but the five EU-only entries are exactly the ones that spice, seasoning and plant-based sites handle every day.

Allergen	EU (Regulation 1169/2011, Annex II)	US (FD&C Act, FASTER Act)
Cereals containing gluten	Listed (wheat, rye, barley, oats and others)	Wheat only
Crustaceans / crustacean shellfish	Listed	Listed
Eggs	Listed	Listed
Fish	Listed	Listed
Peanuts	Listed	Listed
Soybeans	Listed	Listed
Milk	Listed	Listed
Tree nuts / nuts	Listed, eight named nuts	Listed, species set by FDA guidance
Sesame	Listed	Listed since 1 January 2023
Celery	Listed	Not a major allergen
Mustard	Listed	Not a major allergen
Lupin	Listed	Not a major allergen
Molluscs	Listed	Not a major allergen
Sulphur dioxide and sulphites	Listed above 10 mg/kg	Not a major allergen; separate labelling rule at 10 ppm

Source: Regulation (EU) No 1169/2011, Annex II; US FDA FASTER Act page and allergen guidance, read 1 November 2026.

The practical consequence is that a spice exporter’s statement has to be written per market. The tree-nut question has its own wrinkle for coconut, which left the US tree-nut list in January 2025 and was never on the EU, UK or Australian lists; that is covered in the coconut allergen labelling post and is not restated here.

What does a multi-product site actually have to disclose?

Everything it handles, not only what is in your product. SFC’s catalogue spans spices, herbs, plant milks, capsules and plant-based foods. Its soya and oat plant milks and a cashew cheese are on the same site as spice and herb lines, and its mustard seed and powder are made there too. A “none handled” answer would be false, and a technical reviewer who knows the catalogue would read the whole questionnaire differently afterwards.

SFC’s product pages state the position plainly. Chia seeds and whole black pepper are “free from the 14 major EU allergens” and “packed in a facility that also handles tree nuts, sesame and mustard, cross-contact possible”. Ashwagandha and amla powders carry the same cross-contact note for tree nuts. That wording is the model for a buyer to ask for: the product’s own allergen status, then the site’s handling, in one statement, with the word “possible” kept where the risk is real.

Allergens in the product by design, such as soya in a soya milk powder, go in the ingredient list and the allergen statement. Allergens that could reach the product by cross-contact go through the risk assessment first, and into a precautionary line only if control cannot remove the risk.

Certification snapshot: Silk Foods Ceylon, Matale

• BRCGS and FSSC 22000 V6, so allergen management is an audited part of the certified system
• USDA Organic and EU Organic on selected SKUs, confirmed per SKU
• A COA on request, and an allergen declaration on request with the specification
• Lots traceable from raw material intake to shipment through batch coding

Does a “may contain” line replace allergen control?

No, and regulators in both main markets say so. The FDA’s position is that advisory statements such as “may contain [allergen]” cannot be used as a substitute for current good manufacturing practices intended to prevent allergen cross-contact (US FDA, allergen Q&A guidance).

The UK FSA’s technical guidance, updated in 2023, takes the same direction from the other side. A precautionary allergen label should only be applied when a risk assessment has found an unavoidable risk of cross-contact that cannot be sufficiently controlled, it should name the specific allergen among the 14 rather than a broad “nuts”, and it should not appear for an allergen the product claims to be free from (FSA, 2023). A “dairy free” product carrying “may contain milk” is the textbook failure.

For a buyer, that gives a clean test. Ask the supplier which precautionary lines it uses and for which products. A supplier that stamps the same advisory on every SKU has not assessed anything. A supplier that can show the assessment, line by line, and says “none” for one SKU and “possible tree nuts” for another is answering the question properly.

Changeover between allergen-bearing and allergen-free runs

Changeover is where the statement becomes a practice. The shared-line allergen and vegan question for plant-based work is in the five questions before you sign a plant-based co-manufacturing deal post, and the same separation logic for organic is in running a certified organic line beside conventional production. A site that runs mustard on one day and an allergen-free spice blend the next needs a defined clean between them, a way to verify the clean, and a rule for what happens to the first run of the new product. This is the part a technical reviewer probes hardest, because paper lists are easy and verified cleans are not.

Buyer’s checklist: the allergen statement to request from a supplier

1. A site allergen list, written against the allergen list of your destination market
2. The allergen matrix for the line your product runs on, and the allergens that share it
3. The cleaning method between allergen-bearing and allergen-free runs, and how it is verified
4. The rework rule: whether rework from one product can enter another
5. The finished-product allergen review for your SKU
6. The precautionary-labelling decision for your SKU, with the assessment behind it
7. Confirmation of which certificate scope covers the line, with the BRCGS and FSSC 22000 V6 documents

How the statement fits into supplier approval

The allergen section of a supplier approval questionnaire is site-specific. A BRCGS or FSSC 22000 V6 certificate shows that an allergen management system exists and is audited. It does not tell your regulatory team which allergens share your line. That detail comes from the statement above, and from the wider dossier described in the supplier approval questionnaire post. The FSSC 22000 V6 explainer and what BRCGS signals to a retail listing buyer cover what each scheme certifies.

Contract manufacturing buyers get the allergen position set during development: a product developed at SFC goes through the finished-product allergen review before release, within the 3 to 4 week maximum R&D window from signed brief to approved formulation. The guide to qualifying a coconut and plant-based contract manufacturer lists the questions to put to any co-manufacturer.

Where SRV’s offer doesn’t fit

Brands that want an allergen-free guarantee from a multi-product site. SFC handles tree nuts, sesame and mustard on site, and Silk Route Ventures will say so in the statement rather than write “none”. Brands that need a dedicated allergen-free facility for a clinical or infant-nutrition claim should specify that at the quote stage; a shared site with controlled changeover is a different product from a dedicated one.

Frequently asked questions

What allergens does a multi-product food site need to declare to an EU buyer?

All 14 listed in Annex II of Regulation (EU) No 1169/2011 that it handles, including celery, mustard, lupin, molluscs and sulphites, which the US major-allergen list omits. The exporter declares every allergen handled on site, then shows the cross-contact assessment for the line the buyer’s product runs on, as FSSC 22000 V6 requirement 2.5.6 expects.

Can a “may contain” statement replace allergen control?

No. The FDA says advisory statements cannot substitute for good manufacturing practice that prevents cross-contact. The UK FSA says a precautionary label belongs only where a risk assessment finds an unavoidable risk that cannot be controlled, and it should name the specific allergen. The label records residual risk. It does not manage it.

Does Silk Foods Ceylon handle allergens on the same site as spices?

Yes. SFC’s product pages state that the Matale facility also handles tree nuts, sesame and mustard, and the catalogue includes soya and oat plant milks and a cashew cheese. The site runs under BRCGS and FSSC 22000 V6, and an allergen declaration is available on request with the specification, so cross-contact is stated for each SKU.

Can Silk Route Ventures supply an allergen declaration for a private label order?

Yes. An allergen declaration is available on request with the specification, covering the product’s allergen status and the site’s handling. Private label and custom specifications run 4 to 6 weeks from PO to dispatch, standard SKUs 2 to 3 weeks, from 100 kg per SKU, with dried herbs from 25 kg and trial quantities from 10 kg.

How Silk Route Ventures can help

Silk Route Ventures (SRV) supplies Ceylon spices, herbs, plant milks and plant-based foods in bulk and under the buyer’s own label, made at the BRCGS and FSSC 22000 V6 certified Silk Foods Ceylon facility in Matale, with USDA Organic and EU Organic on selected SKUs, confirmed per SKU. For contract manufacturing and private label programmes, the trade desk sends the allergen declaration for the destination market with the specification, and a COA on request. Commercial orders start at 100 kg per SKU, dried herbs from 25 kg and trial quantities from 10 kg, with free samples for evaluation and the buyer covering the courier. Standard SKUs run 2 to 3 weeks from PO to dispatch, private label and custom specifications 4 to 6 weeks. Contact us to request a specification and an allergen declaration for your market.

Sources

1. Foundation FSSC, FSSC 22000 Scheme Version 6 (2023), additional requirement 2.5.6, allergen management. https://www.fssc.com/wp-content/uploads/2023/03/FSSC-22000-Scheme-Version-6-.pdf (retrieved 1 November 2026)
2. European Parliament and Council, Regulation (EU) No 1169/2011, Annex II, list of substances causing allergies or intolerances. https://eur-lex.europa.eu/eli/reg/2011/1169/oj (retrieved 1 November 2026)
3. European Commission, Regulation (EU) 2021/382 of 3 March 2021 amending the annexes to Regulation (EC) No 852/2004 on allergen management, food redistribution and food safety culture. https://eur-lex.europa.eu/eli/reg/2021/382/oj (retrieved 1 November 2026)
4. FAO/WHO Codex Alimentarius, Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020. https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ (retrieved 1 November 2026)
5. US FDA, FASTER Act: Sesame as the Ninth Major Food Allergen (2023). https://www.fda.gov/food/food-allergies/faster-act-sesame-ninth-major-food-allergen (retrieved 1 November 2026)
6. US FDA, Questions and Answers Regarding Food Allergens, advisory statements and cross-contact. https://fda.gov/media/80337/download (retrieved 1 November 2026)
7. UK Food Standards Agency, Food allergen labelling and information requirements technical guidance, precautionary allergen labelling (updated 2023). https://food.gov.uk/business-guidance/consultation-on-food-allergen-labelling-and-information-requirements-technical-guidance-summary-of-stakeholder-responses (retrieved 1 November 2026)