Regulation (EC) No 852/2004 • Commission Notice 2022/C 355/01 • Regulation (EU) 2023/915
1. Regulatory Foundation
Article 5 of Regulation (EC) No 852/2004 requires identification of "any hazards that must be prevented, eliminated or reduced to acceptable levels"—chemical as surely as biological. The 2022 Commission Notice defines hazard to explicitly include chemical agents with potential to cause adverse health effects.
Chemical hazards fall into three categories:
- Naturally occurring: Mycotoxins produced by moulds on cereals, nuts, spices, and dried fruits. Maximum levels are established in Regulation (EU) 2023/915.
- Intentionally added: Additives and processing aids that become hazardous when used improperly or excessively. Operators retain responsibility for ensuring additives are used within permitted parameters.
- Unintentionally introduced: Cleaning and sanitising residues, lubricants, pest control substances, and migrants from packaging. These are controlled primarily through prerequisite programmes (PRPs).
1.1 PRPs vs CCPs
The 2022 Notice clarifies that not all significant hazards require a CCP. PRPs—fundamental measures applied across the food chain—often provide sufficient control for chemical hazards. The separation of cleaning chemicals from food is properly a PRP: it applies across all operations, is monitored through visual inspection, and does not lend itself to binary critical limits at a specific step. The legal obligation is to control the hazard, not to designate a CCP.
2. Hazard Analysis
The first HACCP principle requires structured hazard analysis considering each process step. For chemical hazards, analysis must consider:
- Raw materials: Mycotoxin contamination, heavy metals, pesticide residues, undeclared allergens
- Processing: Formation of acrylamide or other heat-generated contaminants
- Facility: Chemical migration from food contact materials
- Personnel: Allergen introduction through inadequate handwashing
2.1 Mycotoxins
For operators not manufacturing at primary production level, mycotoxin control operates through supplier assurance: procurement from approved suppliers, certificates of analysis for high-risk ingredients (nuts, dried fruit, spices, cereals), visual inspection upon receipt, and appropriate storage to prevent post-receipt mould growth.
2.2 Process Contaminants: Acrylamide
Commission Regulation (EU) 2017/2158 establishes benchmark levels and requires mitigation measures. For kitchen operations, control focuses on frying temperature management, scheduled oil changes, and cooking to golden yellow rather than dark brown.
2.3 Cleaning Chemical Residues
Annex II of 852/2004 requires separate storage from food handling areas and use according to manufacturer instructions. Control requires documented procedures specifying concentration, contact time, and rinsing; staff training; and visual verification before use.
2.4 Allergens
Regulation (EU) 2021/382 amended 852/2004 to introduce explicit allergen management requirements. Control requires identification of all allergens present, prevention of cross-contact, accurate consumer communication, and verification of supplier allergen information.
3. Critical Limits for Chemical Hazards
| Type of Limit | Example | Application |
|---|---|---|
| Regulatory maximum | Mycotoxin limits in 2023/915 | Verified through supplier assurance |
| Process parameter | Frying temperature ≤175°C | Acrylamide mitigation |
| Concentration specification | Cleaning chemical dilution ratio | PRP monitoring |
| Allergen threshold | Presence/absence | Ingredient specification and segregation |
3.1 Distinguishing Limits from Targets
A CCP requires a defined critical limit, monitoring against that limit, corrective actions on deviation, and verification. An OPRP requires a defined control measure, appropriate monitoring, corrective actions when control is lost, and verification of effectiveness. Both require documentation.
3.2 Regulatory Maximum Levels
Regulation (EU) 2023/915 establishes binding maximum levels for contaminants. For individual operators, compliance is achieved through procurement from reputable suppliers, traceability documentation, visual inspection, and appropriate storage. Direct analytical testing is rarely practicable; the control is supplier assurance.
4. Monitoring Procedures
4.1 Monitoring PRPs
Supplier assurance: Annual review of approved supplier list; verification of certificates of analysis per delivery.
Storage and segregation: Weekly visual inspection of chemical storage; verification that allergenic ingredients are stored to prevent cross-contact.
Cleaning effectiveness: Visual inspection before use; periodic verification of chemical concentrations; documented sign-off.
4.2 Monitoring CCPs
Monitoring must detect loss of control in time for corrective action. Examples include temperature monitoring of frying oil (acrylamide), metal detection, and pH monitoring for acidified products. Records must show actual values, not merely ticks.
4.3 Allergen Monitoring
Includes verification of ingredient labels against specifications, visual confirmation of segregation, confirmation of dedicated utensils for allergen-free preparation, and front-of-house verification of accessible allergen information.
5. Corrective Actions
The fifth HACCP principle requires corrective actions addressing both immediate product disposition and systemic cause.
| Deviation | Immediate Action | Preventive Action |
|---|---|---|
| Missing certificate of analysis | Quarantine ingredients | Review supplier status |
| Chemical stored in food area | Remove; inspect adjacent food | Retrain staff |
| Allergen cross-contact | Quarantine product | Review segregation procedures |
| Acrylamide benchmark exceeded | Adjust frying temperature | Review procedures; retrain |
| Undeclared allergen discovered | Remove item; update matrix | Review supplier declarations |
Corrective action records must document the deviation, date/time, product disposition, root cause investigation, preventive action, verification, and responsible person signature.
6. Verification
The sixth HACCP principle requires periodic evaluation distinct from ongoing monitoring.
Documentation review: Supplier certificates; monitoring records; corrective action records.
Physical verification: Chemical storage inspection; allergen segregation audit; cleaning chemical concentration checks.
Analytical verification: Periodic laboratory testing of high-risk ingredients; swab testing for allergen residues; equipment calibration.
Frequency guidance:
- Supplier documentation: per delivery (high-risk) or annually (status)
- Chemical storage: weekly visual
- Allergen controls: monthly walk-through
- Documentation completeness: quarterly
7. Documentation and Record-Keeping
The seventh HACCP principle requires records commensurate with business nature and size.
| Record Type | Retention |
|---|---|
| Hazard analysis | Until superseded |
| Supplier approval | Current + 12 months |
| Certificates of analysis | Supply duration + 12 months |
| Ingredient specifications | Until superseded |
| Cleaning records | 3 months minimum |
| Allergen matrix | Current; superseded 12 months |
| Monitoring records | 3–12 months |
| Corrective actions | 12 months minimum |
| Verification records | 12 months minimum |
Standards: Records completed contemporaneously; actual values shown; person identified; legible and protected; electronic acceptable with equivalent integrity.
7.1 Traceability
Article 18 of Regulation (EC) No 178/2002 requires traceability records identifying supplier, product nature and quantity, receipt date, and batch/lot identification.
8. Integration with SFBB
The FSA's SFBB framework incorporates chemical hazard controls within its core structure:
- Supplier and traceability: documented approval and records
- Cleaning: chemical usage, storage, rinsing verification
- Allergen management: identification, segregation, communication
For SFBB users, the existing framework accommodates chemical hazard controls without requiring a separate system.
8.1 Food Safety Culture
Regulation (EU) 2021/382 introduced explicit food safety culture requirements. For chemical hazards, this means staff awareness that cleaning chemicals are hazards, willingness to report improper storage, understanding that allergen control is a safety obligation, and management commitment to appropriate facilities.
9. Summary Compliance Checklist
| Requirement | Evidence |
|---|---|
| Hazard analysis includes chemical hazards | Documented analysis |
| Controls identified (PRPs, OPRPs, CCPs) | Control measure documentation |
| Supplier assurance procedures | Approved list; certificates of analysis |
| Chemicals stored separately | Designated area; visual evidence |
| Cleaning procedures documented | Schedules; training records |
| Allergen matrix maintained | Current; reviewed on ingredient change |
| Monitoring records | Actual observations recorded |
| Corrective actions documented | Deviation, disposition, prevention |
| Verification conducted | Internal audit records |
| Traceability records | Supplier records with batch/lot |
| Staff trained | Training records; allergen awareness |
This guide reflects the regulatory position as of April 2026. Maximum levels are established in Regulation (EU) 2023/915. Operators should verify specific requirements with their local authority environmental health department. Commission Notice 2022/C 355/01 provides authoritative guidance on HACCP implementation and flexibility provisions.