HACCP & Allergen Management Comprehensive Study Notes

HACCP Fundamentals

Meaning of HACCP
- Hazard Analysis and Critical Control Points
- Science-based, preventive system that identifies, evaluates and controls hazards significant to food safety at critical points in the supply chain
- Legal definition per Philippine Food Safety Act of 2013
Single-word associations raised in class: danger, control, safety, prevention, quality, system, education
Food Safety & Quality Pyramid (Figure 1)
- Base = Management Commitment + Prerequisite Programs (GMP, SSOP, GHP)
- Middle = Continuous Training / Education
- Apex = HACCP
- Continuous Quality Improvement overlays the entire pyramid
HACCP acronym dissected
- Hazard → danger to health
- Analysis → investigation of the hazard
- Critical → crucial for containment
- Control → handling of conditions
- Points → position in the process

Historical Milestones

$1959$ – NASA, US Army Labs & Pillsbury begin work on food safety for space missions ("zero defects")
$1964$ – Pillsbury formally adopts “CCP” system (5 principles)
$1971$ – 1st National Conference for Food Protection; CCP concept publicized
$1972$ – US FDA inspectors trained by Pillsbury (“Food Safety through HACCP”)
$1985$ – US National Academy of Sciences recommends HACCP for all regulators
$1992$ – NACMCF publishes revised HACCP guidance (7 principles)
$1993$ – Codex Alimentarius adopts first HACCP guidelines; EU makes HACCP legal (Directive 93/43/EEC); major Jack-in-the-Box E.coli outbreak & UK BSE crisis
$1996$ – USDA Pathogen Reduction/HACCP rule for meat & poultry
$2003$ – Codex HACCP revision: stresses PRP management & training
$2020$ – Codex “General Principles of Food Hygiene” Rev. 5: adds Food Safety Culture, updates terminology, decision tree, preliminary steps

Codex 2020 Key Changes

Introduction of food-safety culture
- Defined as “shared values, beliefs and norms affecting mind-set & behaviour toward food safety across and throughout an organisation”
- Elements: Management commitment; leadership; personnel awareness; open communication; adequate resources
10 new terms (acceptable level, allergen cross-contact, competent authority, food business operator, food hygiene system, GHPs, HACCP system, PRP, significant hazard, validation)
Expanded definitions (contaminant, control measure, CCP, critical limit, deviation, etc.)
Training & competence explicitly required; working instructions must support HACCP; retraining linked to corrective actions
Updated Codex Decision Tree: four-question flow to determine CCPs (Q1–Q4)

Legal & Regulatory Imperatives

RA 10611 (Food Safety Act) – Article IX §31(a): MSMEs must be trained in HACCP, GHP, technologies
Administrative Order 153 s-2004: cGMP mandatory prerequisite; revised guidelines for food manufacturing
Multiple importing countries require HACCP certification; EU & USDA rules cited

Cost–Benefit of HACCP vs Conventional QC

Conventional: inspect finished product → high rejection, shipment holds, late detection
HACCP: control during process → anticipates problems, flexible, efficient resource use, supports trade, eases inspection (WHO-ICD 1999)

Relationship Map

Prerequisite layer: GHP/GMP & SSOP
Assurance layer: HACCP Plan (food safety)
Quality layer: QACP / ISO 9000 (quality)
Cultural / managerial layer: TQM

Prerequisite Programs (PPs)

Must be fully implemented and verified before HACCP: GMP, SSOP, pest control, sanitation, calibration, traceability, recall, preventive maintenance, personnel hygiene, allergen management, etc.
Provide “basic environmental & operating conditions” (Codex 2020)

The 12 Codex Steps (5 Prelim + 7 Principles)

Assemble HACCP team & define scope
Describe product (composition, pH/aw, packaging, shelf life, distribution)
Identify intended use & consumers
Construct flow diagram
On-site confirmation of flow diagram
Principle 1 – Conduct hazard analysis & identify control measures
Principle 2 – Determine CCPs
Principle 3 – Establish validated critical limits
Principle 4 – Set up monitoring system
Principle 5 – Define corrective actions
Principle 6 – Validate & verify HACCP plan
Principle 7 – Establish documentation & record-keeping

Codex CCP Decision Tree (2022)

Q1 – Can hazard be controlled by PRPs (GHP)? → If Yes: not a CCP
Q2 – Do specific control measures exist at this step? → If No: not a CCP, evaluate next step
Q3 – Will a later step control hazard to acceptable level? → If Yes: that later step is CCP
Q4 – Can this step itself control hazard? → If Yes: CCP; if No: modify process

Example Application – Crispy Pilinut with Honey (JEP)

Team Composition

Internal Food Safety Auditor - Carlota R. Legaspi - Food Safety Consultant
НАССР Team Leader - Twinnee B. Pante - Technical Operations Manager
НАССР Team Members
- Maria Angelika P. Lomibao - Operations Manager
- Linard I. Carique - Production Supervisor
- Jesus Olin Jr. - Sales and Marketing Manager
- Imee Jane Navarro - HR Manager
- Ruel S. Banglo - FG & Warehouse Manager
- Mary Joy Robles - QA/QC Specialist
- Mecy Relleve - QA/QC Specialist
- Alyssa Ruiz - Raw Materials, Supply and Inventory Officer

Process Flow (simplified)

Raw nut receipt & inspection
Sorting
Deep-frying / Roasting / Dehydration (depending on SKU)
Cooling
Honey coating
Magnetizing
Filling & MAP packing
Boxing & palletizing
Storage & distribution

Identified CCPs & Critical Limits

CCP	Step	Hazard	Critical Limit
CCP-1B	Deep-frying	Pathogens (E.coli, Salmonella, coliforms, S. aureus)	Deep- frying time and temperature is achieved (100 °С minimum for 13-17 minutes)
CCP-1B	Roasting	Same pathogens	Roasting time and temperature is achieved (138 °C or 280°F minimum, for 5-10 minutes)
CCP-1B	Dehydration	Same pathogens	Dehydrating time and temperature is achieved (65°C minimum, for 20-22 hours)
CCP-2P	Magnetizing	Physical – metal fragments $0.3''–1.0''$	Presence and Absence of foreign materials with 0.3" (7 mm) to 1.0" (25 mm) in length

Monitoring (examples)

Deep-frying: cook records temp via calibrated probe each batch, logs time ≥ $13\,\text{min}$
Roasting: thermometer & oven gauge read after $4–8\,\text{min}$
Dehydration: thermometer & gauge read every $3–4\,\text{h}$
Magnetizing: visual check 5×/batch before filling

Corrective Actions (sample – Deep-frying)

If temp < $100\,^{\circ}!C$ : extend cooking; inspect fuel & burner; recalibrate/replace thermometer; retrain staff

Verification & Records

Weekly internal calibration; annual 3rd-party calibration
CCP monitoring forms, production log, lab test results, validation studies (per PNS/FDA 29:2010) retained

Allergen Management

Food Allergy Basics

IgE-mediated reaction; next exposure triggers histamine → symptoms; can progress to anaphylaxis (shock, airway constriction) needing epinephrine
Mild symptoms: hives, itching, GI upset, rhinitis
Severe symptoms: swelling of lips/throat, wheeze, BP drop, chest pain, loss of consciousness

Cross-Contact

Residual allergen unintentionally incorporated
- Raw material cross-contact – shared harvest/storage/packaging
- Processing – shared lines, equipment, tools, personnel

Major Allergens (global)

"Big 9" USA: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame
Additional common/regional: celery, mustard, lupin, molluscs, sulphites, buckwheat, latex, etc.
International regulatory chart (FARRP) maps country-specific mandatory declarations

Symptoms & Prevalence

$\approx6–8\%$ of children ≤4 y; $\approx4\%$ of adults
Onset: minutes → hours post-ingestion
Systems affected: skin, GI, respiratory, cardiovascular

Allergen Control Program (ACP)

Four “anatomical” pillars
1. Information & Mapping – identify allergenic ingredients, flow, CPPs
2. Procedures/Work Instructions – segregation, scheduling, cleaning
3. Management Commitment – policies, resources, leadership
4. Records – evidence of diligence (specs, training, cleaning, audits)

Key Risk-Management Areas

People

Mandatory training at induction + annual refresh; cover allergen recognition, handwashing, PPE, rework, cleaning, traffic flow
Dedicated workwear where high cross-contact risk; no personal food in processing zones
Visitors/contractors guided by host, comply with GMP

Suppliers & Raw Materials

Obtain full allergen status/specifications; review compound ingredients; demand notification of changes
Assess packaging materials (e.g., wheat-based release agents)
Emergency suppliers require testing & approval
Incoming inspection: intact containers, lot codes, supervised unloading; questionable loads rejected
Segregation: mark allergen pallets, bottom-rack storage, distinct lot tracking

Equipment & Plant Design

Shared equipment must be cleanable & validated; minimise dead spots
Allergen clean: remove dust bags, use low-air cleaning, validate swab/ELISA or ATP + specific protein kits; set acceptable residue limits (e.g., < $2.5\,\text{ppm}$ )

Manufacturing Controls

Internal labels for WIP & semis; checklist before using similar-looking packaging
Pre-start-up and changeover line clearance; automated label verification
Rework containing allergens: controlled, same allergen profile, documented

Documentation & Verification

Maintain risk assessments, validation reports, cleaning records, training logs, complaints analysis
Internal audits verify compliance; review whenever:
- New ingredients/processes
- Equipment/site change
- Regulatory updates
- Significant incidents

Communication to Consumers

Accurate label declaration of deliberate ingredients + precautionary ("may contain…") when scientifically justified
Point-of-sale, websites, spec sheets, customer orientation

Validation & Review

Clean-in-place/clean-out-of-place validation proves allergen removal to acceptable limit
Verification = routine monitoring (swabs, visual, protein tests)
Review frequency tied to change or at least annually

Summary Take-aways

HACCP = proactive, systematic, science-based food-safety management anchored on PRPs & backed by culture
12-step Codex methodology + updated decision tree guide practical implementation
Legal, economic & trade drivers make HACCP training/certification mandatory in many jurisdictions
Real-world Pilinut case illustrates development of product description, flow diagram, CCPs, limits, monitoring, corrective, verification & records
Allergen control integrates with HACCP through hazard analysis, PRPs, dedicated ACP, and clear communication to protect consumers & business