BAK cheat sheet
BAK · Keep the key ideas within reach.
Regulatory Framework and Legal Requirements
Official controls on food and feed are governed in the EU by Regulation (EC) No 178/2002 (general food law) and Regulation (EU) 2017/625 (official controls).
Regulation (EC) 178/2002 Article 14: food must not be placed on the market if it is unsafe; unsafe means injurious to health or unfit for human consumption.
Article 17 of 178/2002 allocates responsibility: food business operators ensure compliance; competent authorities verify and enforce.
Article 18 requires traceability at all stages: operators must identify supplier and immediate recipient ('one step back, one step forward').
Article 19: when an operator considers food unsafe it must withdraw it from the market, recall if it reached consumers, and notify the competent authority.
Precautionary principle (Article 7): provisional risk management measures may be adopted when a risk is identified but scientific evidence remains uncertain.
Rapid Alert System for Food and Feed (RASFF) is the EU network for exchanging notifications of serious direct or indirect risks to human health.
Primary production rules for food of animal origin appear in Regulation (EC) 852/2004 (general hygiene) and 853/2004 (specific hygiene).
A 'competent authority' is the central body of a Member State responsible for official controls; official veterinarians and official auxiliaries act on its behalf.
Food Safety and Hygiene
HACCP has seven principles: hazard analysis; determine CCPs; set critical limits; monitor; corrective actions; verification; documentation and records.
A critical control point (CCP) is a step where control is essential to prevent, eliminate, or reduce a significant hazard to an acceptable level.
A critical limit is a measurable value separating acceptability from unacceptability at a CCP (e.g. 72 °C core temperature, pH ≤ 4.6).
Microbiological criteria under Regulation (EC) 2073/2005 include Listeria monocytogenes: 100 cfu/g limit for ready-to-eat foods during shelf life.
Regulation (EC) 852/2004 requires food business operators to establish, implement, and maintain permanent procedures based on HACCP principles.
Cold chain: chilled foods generally held at ≤ 8 °C (or ≤ 5 °C for certain products); frozen foods at ≤ -18 °C.
Prerequisite programmes (PRPs) cover cleaning, pest control, personal hygiene, water quality, waste, and maintenance; they underpin HACCP.
Danger zone for bacterial growth is approximately 5 °C to 63 °C; rapid cooling through this range limits pathogen multiplication.
Animal Health and Welfare
Animal welfare during transport is governed in the EU by Council Regulation (EC) No 1/2005, covering journey times, space allowances, ventilation, and water/food.
Journey log requirements apply to domestic journeys exceeding 8 hours between Member States and to third-country journeys.
Livestock transport: animals must be fit for travel; unfit animals (e.g. severe injury, late pregnancy) are excluded from transport.
Animal by-products are classified into Categories 1, 2, and 3 under Regulation (EC) 1069/2009; Category 1 is highest risk.
Notifiable animal diseases (e.g. foot-and-mouth disease, classical swine fever, African swine fever) must be reported to the competent authority.
Identification of bovine animals uses ear tags plus a passport and a computerised national database under Regulation (EC) 1760/2000.
On-farm welfare inspection covers stocking density, lighting, enrichment, and access to water; welfare is assessed against species-specific requirements.
Biosecurity measures on holdings include controlled entry, disinfection points, and separation of incoming and outgoing animals.
Plant Health and Crop Protection
EU plant health regime under Regulation (EU) 2016/2031 covers protective measures against pests of plants and establishes the Union quarantine pest list.
A quarantine pest is a pest of potential economic importance to an area where it is absent or not widely distributed and is officially controlled.
Plant passports are required for movement of specified plants and plant products within the EU; they identify the operator and the regulated material.
Plant protection products are authorised under Regulation (EC) 1107/2009; approval of active substances precedes product authorisation.
Maximum residue levels (MRLs) for pesticides in food are set under Regulation (EC) 396/2005 and enforced by residue monitoring.
Sustainable use of pesticides (Directive 2009/128/EC) includes integrated pest management (IPM) and training/certification of operators.
Official plant health controls at import include documentary, identity, and physical checks on regulated commodities at border control posts.
Integrated pest management prioritises prevention, monitoring, and non-chemical methods before pesticide use.
Quality Management and Traceability
Traceability records must allow identification of the supplier and the immediate recipient of food, feed, and food-producing animals (Regulation 178/2002 Article 18).
Traceability is required 'at all stages of production, processing and distribution' but excludes internal movement within a single operator's premises.
A batch or lot is a defined quantity produced under essentially identical conditions; lot identification enables targeted recall.
ISO 22000 specifies requirements for a food safety management system combining HACCP with prerequisite programmes.
ISO 9001:2015 is built on risk-based thinking and the plan-do-check-act cycle; it does not prescribe product safety limits.
A quality management system includes document control, management review, internal audit, and corrective/preventive action records.
Retention periods for traceability records are set by sectoral rules or defined by the operator; records must be available to the competent authority on request.
A recall plan must define decision authority, communication channels, and verification that recalled product is accounted for.
Inspection, Auditing and Enforcement
Official controls under Regulation (EU) 2017/625 include documentary, identity, and physical checks, and may be unannounced.
Risk-based planning: control frequency and intensity are determined by identified risks, operator history, and reliability of own-check systems.
An audit differs from an inspection: an audit is a systematic, independent examination against criteria; an inspection is a direct check of conformity.
Enforcement actions escalate: advice, improvement notice, remedial action notice, suspension of approval, withdrawal of approval, and penalties.
Non-compliance with food law must be pursued by the competent authority through official measures that are effective, proportionate, and dissuasive.
Sampling for laboratory analysis follows defined procedures; the sample must be representative and chain of custody documented.
An official veterinarian in an approved establishment verifies compliance with hygiene and HACCP requirements and may suspend operations.
Audit findings are classified by severity (e.g. critical, major, minor) and require corrective action with defined timescales.