Allergen Control Program
Document Control
| Field |
Value |
| Document ID |
FS-ALC-001 |
| Version |
2.4 |
| Effective Date |
2026-02-01 |
| Owner |
Allergen Control Manager |
| Approver |
Food Safety Team Leader |
| Review Frequency |
Annual |
1. Allergen Policy Statement
Flax Seeds Co. is committed to producing safe food products and managing allergens with the highest diligence. We recognise that allergen cross-contact poses a significant food safety risk to consumers with food hypersensitivities and allergies.
1.1 Policy
- All raw materials, processing aids, and finished products shall be assessed for allergenic potential.
- Allergen risks shall be controlled at every stage: receiving, storage, production, packing, and dispatch.
- No intentional cross-contact is permitted. Unintentional cross-contact shall be reduced to the lowest reasonably achievable level (ALARA).
- All finished products shall carry accurate, legally compliant allergen labelling.
- This policy applies to all employees, contractors, visitors, and suppliers.
1.2 Regulatory Framework
- EU: Regulation (EU) No. 1169/2011 (FIC Regulation) — 14 regulated allergens.
- UK: Food Information Regulations 2014 (as amended).
- Codex Alimentarius: General Standard for the Labelling of Prepackaged Foods (CXS 1-1985).
- FSMA (US, where applicable): Food Allergy Safety, Treatment, Education, and Research (FASTER) Act 2021 (sesame added).
2. Allergen Risk Assessment Matrix
2.1 Allergens Assessed at Flax Seeds Co.
| # |
Allergen |
Present as Ingredient? |
Present in Facility? |
Cross-Contact Risk Level |
Control Measure |
| 1 |
Cereals containing gluten (wheat, rye, barley, oats, spelt, kamut) |
No — gluten-free policy on all flax lines |
Incoming raw materials only |
High (shared supplier chain) |
Supplier declarations, dedicated storage, ELISA testing |
| 2 |
Crustaceans |
No |
No |
Low |
Not handled |
| 3 |
Eggs |
No |
No |
Low |
Not handled |
| 4 |
Fish |
No |
No |
Low |
Not handled |
| 5 |
Peanuts |
No |
No |
Low |
Not handled |
| 6 |
Soybeans |
Yes (soy lecithin in oil processing aid) |
Yes |
High |
Dedicated line for soy-free products, ELISA validation |
| 7 |
Milk (including lactose) |
No |
No |
Medium (shared tanker risk for oil) |
Supplier declarations, tanker wash certificate |
| 8 |
Nuts (almonds, hazelnuts, walnuts, cashews, pecans, pistachios, Brazil nuts, macadamia) |
No |
No |
Low |
Not handled — supplier declaration on raw flax |
| 9 |
Celery |
Yes (celery seed oil — specialty order) |
Occasional |
High |
Batch segregation, dedicated cleaning protocol |
| 10 |
Mustard |
Yes (mustard seed oil — specialty order) |
Occasional |
High |
Batch segregation, dedicated cleaning protocol |
| 11 |
Sesame seeds |
Yes (on same milling line — different SKU) |
Yes |
Critical |
Scheduling: flax and sesame NEVER on same day unless full deep clean |
| 12 |
Sulphur dioxide / sulphites (> 10 mg/kg) |
No |
No |
Low |
Not used |
| 13 |
Lupin |
No |
No |
Low |
Not handled |
| 14 |
Molluscs |
No |
No |
Low |
Not handled |
| 15 |
Sesame (already #11) |
— |
— |
— |
— |
| 16 |
Flaxseed |
Yes (primary ingredient) |
Yes (pervasive) |
Critical allergen for some consumers |
See Section 3 |
| 17 |
Sesame (see #11 above) |
Refer #11 |
Refer #11 |
Critical |
Refer #11 |
| 18 |
Mustard (see #10 above) |
Refer #10 |
Refer #10 |
High |
Refer #10 |
2.2 Risk Level Definitions
| Level |
Definition |
Required Controls |
| Critical |
Allergen is present in facility and may cross-contact with non-allergen products; severe health risk |
Full segregation, dedicated line/zone, validated cleaning, ELISA on every changeover |
| High |
Allergen is used in facility; cross-contact possible |
Scheduling control, validated cleaning, supplier declarations, label review |
| Medium |
Allergen not used but may enter via raw material contamination (unlikely) |
Supplier declarations, risk-based testing |
| Low |
Allergen not handled, not expected |
No additional controls beyond good hygiene |
3. Flaxseed as an Allergen
3.1 Status & Scientific Context
- Flaxseed (Linum usitatissimum) is recognised as an emerging allergen.
- Clinical evidence: documented IgE-mediated reactions including anaphylaxis in susceptible individuals (Fremont et al., 2010; Alonso et al., 1996).
- Major allergens identified: Lin u 1 (profilin), Lin u 2 (vicilin-like protein).
- Prevalence: rare but potentially severe. Increasing with flaxseed consumption growth.
- Not yet a regulated labelling allergen in the EU (14 allergens), UK, US, or Codex, but proactively managed under our policy.
3.2 Flaxseed Labelling Requirement
- Flaxseed (including whole seed, milled/ground flax, flaxseed oil, flax protein powder) must be declared in the ingredient list.
- May-contain / advisory statement: "May contain traces of flaxseed" is prohibited on non-flax products unless validated by risk assessment.
- Any product that does NOT contain flaxseed but is produced in a facility that handles flaxseed must carry a precautionary allergen label: "Produced in a facility that processes flaxseed."
3.3 References
- Fremont, S. et al. (2010). Prospective study of sensitization and allergy to flaxseed in 1317 subjects. Allergy, 65(9), 1210–1213.
- Alonso, L. et al. (1996). Flaxseed as a new food allergen. Journal of Allergy and Clinical Immunology, 98(4), 840–841.
- EFSA Journal (2019). Flaxseed as a novel food allergen — scientific opinion.
4.1 Identified Pathways & Controls
| Pathway |
Description |
Risk |
Control(s) |
| Airborne |
Dust from milling flaxseed can settle on other products, equipment, or packaging |
Medium (ground flax is dusty) |
Dedicated milling room with negative pressure, HEPA filtration on HVAC, airlock entry |
| Shared Equipment |
Same mill, press, conveyor, or packaging line used for different allergen groups |
Critical |
Full validated wet clean between allergen groups; schedule from least to most allergenic |
| Rework |
Incorporation of rework from allergen-containing batches into non-allergen batches |
Critical |
Rework only allowed into same-brand same-allergen product (see Section 7) |
| Raw Material |
Supplier cross-contact in raw flaxseed (e.g., shared harvesting with sesame or mustard) |
Medium |
Supplier questionnaire, COA requesting absence of regulated allergens, risk-based incoming testing |
| Maintenance |
Tools, spare parts, maintenance personnel cross-contaminating lines between allergens |
Medium |
Colour-coded tool sets per allergen zone, tool sanitisation between zones, maintenance training |
| Spills / Splashes |
Liquid or dry spills during production, transfer, or cleaning operations |
High |
Spill management procedure (see SSOP Section 2.1), designated absorbent materials, zone containment |
| Personnel / PPE |
Gloves, aprons, shoes carrying allergen residue between zones |
Medium |
Colour-coded PPE per zone, mandatory hand/glove wash on zone entry/exit, boot wash stations |
| Storage / Warehousing |
Shared pallet space, overhead leaks, damaged packaging |
Medium |
Segregated storage by allergen group, pallet inspection, secondary containment |
| Waste / Returns |
Cross-contact during waste handling or return product processing |
Medium |
Dedicated waste stream, return product quarantine and assessment |
5. Allergen Cleaning Validation Protocol
5.1 Scope
This protocol applies every time production changes between products containing different allergen groups (including changeover from allergen → non-allergen).
5.2 Validation Steps
| Step |
Detail |
| 1. Pre-Clean Assessment |
Identify previous product's allergen(s). Identify target ELISA kit(s). Worst-case swab sites identified from validation history. |
| 2. Execute Wet Clean |
Follow Master Sanitation Schedule (MSS) for the specific line. Full disassembly of product contact parts. |
| 3. Visual Inspection |
All surfaces visually clean under ≥ 500 lux. Photograph key areas. |
| 4. ELISA Swabbing |
Swab minimum 10 sites per production line. Each site: 10 cm × 10 cm (100 cm²). Include: (a) most difficult to clean, (b) highest product contact area, © dead ends/flanges/gaskets. |
| 5. Analysis |
Process swabs per ELISA kit manufacturer instructions (incubation, wash, substrate, stop, read). |
| 6. Result Interpretation |
All sites must be negative (below kit LOD) for line release. |
| 7. Documentation |
Record on Allergen ELISA Log (FS-ALC-F02). |
5.3 Acceptance Limits
| Allergen |
ELISA Kit |
Limit of Detection (LOD) |
Acceptable Result |
| Gluten |
R-Biopharm Ridascreen® Gliadin |
5 ppm gliadin |
< 5 ppm |
| Soy |
Neogen® Veratox® Soy |
2.5 ppm |
< 2.5 ppm |
| Sesame |
R-Biopharm Ridascreen® Sesame |
1 ppm |
< 1 ppm |
| Mustard |
R-Biopharm Ridascreen® Mustard |
2 ppm |
< 2 ppm |
| Celery |
R-Biopharm Ridascreen® Celery |
1.5 ppm |
< 1.5 ppm |
| Flaxseed |
Lateral Flow Device (LFD) — Veratox® alternative |
Varies per kit |
Negative line / < LOD |
5.4 Validation Re-Qualification
- Full re-validation: Annually (or after major equipment change).
- Concurrent (on-line) verification: Every allergen changeover — minimum 2 ELISA swabs per line.
- After maintenance: If allergen-contact parts were replaced or serviced, re-validate before next production run.
6. Production Scheduling
6.1 Sequencing Rule
Production order shall follow a least-to-most allergenic sequence to minimise cross-contact potential.
6.2 Production Order (Default)
| Priority |
Product Group |
Allergen(s) Present |
Scheduled Day |
| 1 |
Non-allergen (plain flax) |
Flaxseed only |
Monday AM |
| 2 |
Specialty — Celery seed oil |
Flaxseed + Celery |
Monday PM |
| 3 |
Specialty — Mustard seed oil |
Flaxseed + Mustard |
Tuesday AM |
| 4 |
Sesame line |
Flaxseed + Sesame + Sesame seed |
Tuesday PM |
6.3 Scheduling Rules
- No sesame product shall be scheduled on a day preceding non-sesame product without a full deep clean and ELISA validation.
- No changeover from high-allergen → low-allergen without validated full wet clean.
- Buffer production (non-allergenic or lowest allergen) recommended as first run after any deep clean.
- Scheduling exceptions must be approved by QA Manager and documented.
7. Rework Control Policy
7.1 Principle
Rework (product returned to process from a previous production run) shall only be incorporated into a product of the same formulation and same allergen profile.
7.2 Rules
| Rework Type |
Allowed? |
Conditions |
| Same product, same batch |
Yes |
Direct re-feed within shift |
| Same product, different batch |
Yes |
Must be labelled with allergen, supplier lot, and production date |
| Different product, same allergen profile |
Yes (with QA approval) |
Risk assessment required; colour and allergen match |
| Different allergen profile |
NO |
Never permitted |
| Contains an allergen not in target product |
NO |
Never permitted |
| Rework from external source / returns |
By exception only |
Quarantine, assess for foreign material, allergen contamination, sensory |
7.3 Rework Labelling
Each rework container must be tagged with:
- Original product name
- Batch/lot number
- Production date
- Allergens present
- Quantity (kg)
- Rework approval QA signature
7.4 Maximum Rework Percentage
- Maximum 5% of total batch weight unless otherwise approved by R&D and QA.
- Rework must be homogeneous in composition.
8. Label Review Procedure
8.1 Scope
All labels, packaging films, cartons, leaflets, and digital product information for finished products.
8.2 Review Triggers
Labels are reviewed upon:
1. Any change to formulation, supplier, processing aid, or raw material source.
2. Regulatory change affecting allergen labelling requirements.
3. New artwork or packaging supplier.
4. Post-incident (e.g., recall or consumer complaint related to allergen labelling).
5. Annual rolling review of all active labels.
8.3 Review Checklist
| Check |
Detail |
| Ingredient declaration |
All ingredients (including processing aids that remain) listed in descending order by weight |
| Allergen declaration |
All 14 EU allergens + sesame, mustard, celery if present — bold type or otherwise emphasised |
| Precautionary / may-contain statement |
Verified by risk assessment; consistent with Codex and national guidance |
| Net quantity |
Match with physical pack |
| Supplier / origin |
Correct company name and address |
| Lot code / best-before |
Format per FS-TRC-F02 |
| Claims |
No false or misleading allergen-free claims (e.g., "gluten-free" requires ≤ 20 ppm testing) |
| Legal compliance |
EU FIC 1169/2011, UK FIC 2014, or applicable jurisdiction |
8.4 Approval Workflow
- Draft by Marketing / Artwork team.
- Technical review by QA and Regulatory Affairs (using checklist above).
- Legal review (if significant change).
- Sign-off by Food Safety Team Leader.
- Proof approval — hard copy signed.
- Implementation — new stock use-by date set.
- Archive — old label version retained for regulatory records (5+ years).
9. Supplier Declarations
9.1 Requirement
All raw material suppliers must provide a written Allergen Declaration or complete an Allergen Questionnaire as part of the supplier approval process (see FS-SUP-001).
- Full list of allergens present in the supplied material.
- Confirmation of allergen status of shared equipment / production lines.
- Cross-contact risk assessment summary.
- Cleaning validation data for shared lines (if applicable).
- Any changes to formulation or processing must be notified minimum 30 days in advance (change notification agreement).
9.3 Frequency
- Initial approval: Full allergen questionnaire.
- Annual: Updated declaration / confirmation of no change.
- Upon change: Immediate updated declaration.
9.4 Incoming Verification
Where risk level is Medium or above, incoming raw material may be tested for specific allergens using ELISA or lateral flow devices on a risk-based schedule.
10. Training & Records
10.1 Allergen Awareness Training
| Role |
Training Content |
Frequency |
| All employees |
Allergen awareness: what allergens are, why they matter, facility allergens, colour coding, spill procedure |
Induction + annual refresher |
| Production operators |
Allergen changeover cleaning, scheduling rules, PPE changeover, rework control |
Induction + annual + on each procedure change |
| QA / Food Safety Team |
ELISA swabbing protocol, allergen risk assessment methodology, label review, regulatory updates |
Initial + annual + regulatory update training |
| Sanitation team |
Allergen cleaning validation, ATP/ELISA protocols, chemical selection for allergen removal |
Induction + annual |
| R&D / NPD |
Allergen risk assessment for new ingredients, supplier declaration review, formulation review |
Induction + annual |
| Procurement / Supply Chain |
Supplier allergen questionnaire, change notification requirements |
Induction + annual |
| Contractors / Visitors |
Basic allergen awareness, facility allergen zones, PPE requirements, no food in production |
On-site orientation |
10.2 Training Records
- Training register with date, attendee name, role, topic, trainer.
- Competency assessment (written test or practical observation) score recorded.
- Retraining triggered by failure, procedural change, or audit finding.
- Records retained for duration of employment + 1 year.
10.3 Retained Records
| Record |
Retention |
Location |
| Allergen Risk Assessment |
Current + 3 years |
QA Office FS-ALC-F01 |
| Allergen ELISA Swab Log |
2 years |
QA Office FS-ALC-F02 |
| Allergen Incident Log |
5 years |
Food Safety Office FS-ALC-F03 |
| Supplier Allergen Declarations |
Current + 3 years |
Procurement / QA |
| Label Approval Records |
5 years + current |
QA / Regulatory |
| Rework Log |
2 years |
Production Office |
| Training Records |
Employment + 1 year |
HR |
Appendices
- Appendix A: Allergen Flow Diagram (material flow through facility with allergen points)
- Appendix B: Colour-Coding Chart for Allergen Zones (PPE, tools, containers)
- Appendix C: ELISA Kit Inventory (active kits, lot numbers, expiry dates)
- Appendix D: Allergen Changeover Checklist (step-by-step QA release form)
End of Document — FS-ALC-001