ANNEX II

Procedures based on the hazard analysis and critical control points (HACCP) principles and guidelines for their application

1. INTRODUCTION

HACCP-based procedures are mandatory for all food business operators except primary producers in accordance with Article 5 of Regulation (EC) No 852/2004. HACCP-based procedures represent a systematic approach to the identification, evaluation and control of food safety hazards e.g. biological, chemical (including allergens) and physical hazards.

HACCP-based procedures provide a tool for FBO

— to identify potential hazards,

— to identify where these hazards are reasonably likely to occur at each step

— to identify which of these reasonably likely to occur hazards are such that their prevention, elimination, or reduction to acceptable levels is essential to the production of safe food (significant hazards)

— to consider if additional control measures are needed, in particular OPRP or CCP, if some significant hazards are not controlled by the preventive measures.

This Annex II describes in a simple way recommendations how the HACCP-based procedures can be applied. It is in line with Chapter II of the Codex Alimentarius document CXC 1-1969 (1).

HACCP-based procedures are considered to be a useful tool for food business operators to identify and control hazards that may occur in food and during food processing in their own establishment. In view of the wide range of food businesses to which Regulation (EC) No 852/2004 is addressed, and in view of the great diversity of food commodities and manufacturing procedures that are applied to food, it is appropriate to issue general guidance on the development and implementation of HACCP based procedures.

2. GENERAL PRINCIPLES

Prior to application of the HACCP-based procedures to any business, the food business operator should have implemented GHP (See Annex I) and other relevant PRP (See Section 5 of the main document).

The HACCP-based procedures should be science/risk-based and systematic, identifying significant hazards at each step of the production chain, and measures for control of those hazards, to ensure the safety of food. HACCP-based procedures are tools to identify and assess hazards and establish control systems that focus on prevention, as opposed to older systems that relied mainly on end product testing. All HACCP-based procedures should be capable of accommodating changes, such as advances in equipment design, processing procedures or technological developments as they include a requirement to review the procedures to ensure that new hazards haven’t been introduced when such changes are made.

As well as enhancing food safety, implementation of the HACCP-based procedures can provide other significant benefits, e.g. for inspection/auditing by regulatory authorities and promote international trade by increasing confidence in food safety.

The implementation of HACCP-based procedures is based on the following seven principles, laid down in points (a) to (g) of Article 5(2) of Regulation (EC) No 852/2004:

(1) Point (a): identifying any hazards that must be prevented, eliminated or reduced to acceptable levels (hazard analysis) and identify control measures, see Section 5;

(2) Point (b): identifying the critical control points at the step or steps at which control is essential to prevent or eliminate all relevant hazards or to reduce them to acceptable levels, see Section 6;

(3) Point (c): establishing critical limits at critical control points (CCP), which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards, see Section 7;

(4) Point (d): establishing and implementing effective monitoring procedures at critical control points, see Section 8;

(5) Point (e): establishing corrective actions when monitoring indicates a deviation at a critical control point, see Section 9;

(6) Point (f): validating the HACCP plan and establishing procedures, which shall be carried out regularly, to verify that the measures outlined in principles 1 to 5 are working effectively, see Section 10;

(7) Point (g): establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in principles 1 to 6, see Section 11.

During the development and application HACCP-based procedures, laid down in a HACCP plan, the FBO should give consideration to the likely intended use of the product (e.g. cooked or not), categories of vulnerable consumers and epidemiological evidence related to food safety.

The intent of HACCP-based procedures is to focus on control at CCP. They should be applied to each specific operation/step separately. The application of the HACCP-based procedures should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying the HACCP-based procedures to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation.

3. FLEXIBILITY ON THE IMPLEMENTATION OF HACCP-BASED PROCEDURES

3.1. Legal requirements

Article 5 of Regulation (EC) No 852/2004 requires food business operators to put in place, implement and maintain a permanent procedure or procedures based on HACCP principles.

The concept allows HACCP principles to be implemented with the required flexibility.

In Regulation (EC) No 852/2004, key issues for flexibility are:

(a) Recital 15 of the same Regulation which states that: ‘The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing “critical limits” does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses.’

(b) The clear statement in Article 5(1) that the procedure must be based on the HACCP principles.

(c) The statement in Article 5(2)(g) that the need for establishing documentation and records must be commensurate to the nature and the size of the food business.

(d) Article 5(5) of the Regulation, which allows the adoption of arrangements to facilitate the implementation of the HACCP requirement by certain FBOs. These include the use of guides for the application of HACCP-based procedures.

The Article 5(2)(g) of the Regulation (EC) No 852/2004 identifies two main criteria that render a FBO eligible for flexibility as regards HACCP-based procedures: its nature and its size.

a) The nature is the basis for a risk-based approach and depends on the activity of the FBO, for example: — Ready- or non-ready-to-eat food — The length of the supply chain — Processing, wrapping, etc. or just storage of prepacked food — Hazard reducing/eliminating (e.g. pasteurisation) step at end or not — Food of animal origin (still far more associated with food-borne outbreaks than other foods) or not — Hazards associated with raw materials/ingredients — Temperature requirements at handling/storage or not — Intended use and target consumers specific issue The hazard analysis plays a crucial role in assessing the risk.

b) The size (Volume of production, throughput, etc…) is linked to proportionality for small business operators and is mainly reflected in a reduction of administrative burden (use of generic guides, extent of documentation, records, etc.).

Although both criteria for flexibility might be relevant for certain FBOs (e.g. retailer), these criteria should be considered separately.

3.2. Simplified HACCP-based procedures

The seven HACCP principles are a practical model for identifying and controlling significant hazards on a permanent basis. This implies that where that objective can be achieved by equivalent means that substitute in a simplified but effective way some of the seven principles, it must be considered that the obligation laid down in Article 5, paragraph 1 of Regulation (EC) No 852/2004 is fulfilled.

Recital 15 of Regulation (EC) No 852/2004 clearly recognises that CCP might not be identified in all cases. In such cases the application of procedures based on the HACCP principles is limited to the first principle i.e. a hazard analysis required to justify in a risk-based manner why no CCP needs to be considered and to demonstrate that GHP, possibly including GHP requiring greater attention, are sufficient to control the hazards.

When CCP are identified in small businesses, proportionality in administrative burden additionally justifies a simplified approach to comply with the other HACCP principles.

Hazards may be grouped for the implementation of HACCP-based procedures if they are controlled in a similar way. In addition, similar products can be grouped together if they are produced in the same way and share common hazards.

Whenever there are needs connected with export or specifications of customers, all FBOs are free to use and fully implement HACCP-based procedures and get a certification on them, even if they would be eligible for a more flexible approach as described in this document.

Examples of such simplified HACCP-based procedures for retail activities, based on two opinions of the European Food Safety Authority (2), can be found in Commission Notice on retail.

3.3. Generic guides to the implementation of HACCP-based procedures

Generic HACCP guides have been developed addressing all the HACCP principles to be complied with when significant hazards are identified.

The generic guides could suggest hazards and control measures common to certain food businesses and assist the FBO or the HACCP team through the process of producing food safety procedures or methods based on a generic hazard analysis, and appropriate record keeping.

Food business operators should be aware however that other hazards may be present, e.g. those linked to the layout of their establishment or to the process that is applied, and that such hazards cannot be predicted in a generic HACCP guide. When generic HACCP guides are used, the FBO should check to ensure that all the activities in the business are covered in the guide. If not, then the FBO should develop its own procedures based on the HACCP principles for the additional activities.

In those sectors where there is a lot of commonality between businesses or the manufacturing process is linear and short, and where the hazard prevalence is well known, generic HACCP guides may be appropriate, e.g.:

— For slaughterhouses, establishments handling fishery products, dairy establishments etc.;

— For businesses that apply standard food processing procedures such as the canning of food, the pasteurisation of liquid food, the freezing/quick-freezing of food etc.

The Commission Notice on retail provides generic guidance on the hazard analysis for certain retailers. The content of generic HACCP guides where flexibility can be considered should respect the recommendations in Section 4.4.

4. PRELIMINARY ACTIVITIES

The preliminary activities below are not explicitly laid down in EU legislation, nevertheless they are considered as essential when developing and implementing HACCP-based procedures. These preliminary activities traditionally consist of 5 steps and when combines with the 7 HACCP principles, result a 12-steps approach.

4.1. Assembly of a multidisciplinary HACCP team

This team, which involves all parts of the food business concerned with the product, should include the whole range of specific knowledge and expertise appropriate to the product under consideration, its production (manufacture, storage, and distribution), its consumption and the associated potential hazards and should also involve as much as possible the higher management levels. The team should get the full support of the management who should consider itself owner of the HACCP plan and the overall FSMS.

Where necessary, the team should be assisted by specialists who will help it to solve difficulties in the development and implementation of the HACCP-based procedures.

The team may include specialists and technicians:

— who understand the biological, chemical or physical hazards connected with a particular product group;

— who have responsibility for, or are closely involved with, the technical process of manufacturing the product under study;

— who have a working knowledge of the hygiene and operation of the process plant and equipment;

— any other person with specialist knowledge of. food microbiology, legislative requirements, machinery used for food manufacturing, its maintenance and cleaning.

One person may fulfill several or all of these roles, provided all relevant information is available to the team and is used to ensure that the system developed is reliable. Where expertise is not available in the establishment in specific areas, advice should be obtained from other sources (consultancy, guides of good hygiene practices, etc. not excluding other companies of the same group (at sectorial or association level) where expertise is available).

FLEXIBILITY EXAMPLE: In small businesses, HACCP/FSMS activities might be carried out by one person who is (temporarily or regularly) assisted by external expertise. Where external expertise is used, it is essential that there is sufficient ownership of the FSMS by the food business itself. FBOs using this route should make sure that they know how the system works and how it is being applied to their business, and that their staff is suitably trained to ensure effective implementation.

4.2. Description of the product(s) at the end of process (called hereafter ‘end product’)

A full description of the end product should be drawn up, including relevant safety information such as:

— Origin of ingredients/raw materials, which may help identify certain hazards;

— composition (e.g. raw materials, ingredients, additives, possible allergens etc.);

— structure and physico-chemical characteristics (e.g. solid, liquid, gel, emulsion, moisture content, pH, water activity, etc.);

— processing (e.g. heating, freezing, drying, salting, smoking, etc. and to what extent);

— packaging (e.g. hermetic, vacuum, modified atmosphere) and labelling;

— storage and distribution conditions, including transport and handling;

— required shelf life (e.g. ‘use by date’ or ‘best before date’);

— instructions for use;

— any microbiological or chemical criteria applicable.

FLEXIBILITY EXAMPLE: When there is no processing or other manufacturing (e.g. cutting, wrapping), the description of the product can be limited to information available on the label (prepacked food) or other information on the food extracted from reliable sources.

4.3. Identification of intended use

The HACCP team should also define the reasonably foreseeable use of the product by the customer and by the consumer target groups for which the product is intended. In specific cases, the suitability of the product for particular groups of consumers, such as institutional caterers, travelers, etc. and for vulnerable groups of the population may have to be considered.

4.4. Construction of a flow diagram (description of manufacturing process)

All steps involved in the process should be studied in sequence and presented in a detailed flow diagram.

All processes (from receiving the raw materials to placing the end product on the market) including delays during or between steps, should be mentioned together with sufficient technical data that is relevant for food safety, such as temperature and the duration of heat treatment.

Types of data may include but are not limited to:

— plan of working premises and ancillary premises;

— equipment layout and characteristics;

— sequence of all process steps (including the incorporation of raw materials, ingredients or additives and delays during or between steps) and the disposal of waste/by-products;

— technical parameters of operations (in particular time and temperature, including delays);

— flow of products (including potential cross-contamination);

— segregation of clean and dirty areas (or high/low risk areas).

The nature of the business will define the complexity of the required flow diagram, which might be very simple in certain businesses (See examples for different retailers in the Commission Notice on retail).

4.5. On-site confirmation of flow diagram

After the flow diagram has been drawn up, the HACCP team should confirm it on site during operating hours. Any observed deviation must result in an amendment of the original flow diagram to make it accurate.

5. HAZARD ANALYSIS (PRINCIPLE 1)

5.1. Identification of relevant hazards

A hazard is a biological, chemical (including allergens) or physical agent in food or feed with the potential to cause an adverse health effect (3). While allergens are considered a chemical hazard, some FBOs find it easier to treat allergens as a fourth hazard during hazard analysis (see worksheet in section 5.3).

All major potential biological, chemical or physical hazards that may be reasonably expected to occur in a product should be identified and listed. It may be useful to consult external source of information (e.g. the Rapid Alert System for Food and Feed).

The HACCP team should then identify where these potential hazards are reasonably likely to occur at each process step (including production, acquisition, storage, transport and handling of raw materials and ingredients and delays during manufacture).

The HACCP team should next evaluate the hazards to identify at which hazards are of such a nature that their prevention, elimination or reduction to acceptable levels is essential to the production of a safe food (end product).

In conducting the hazard analysis to determine whether there are significant hazards, wherever possible the following should be considered:

— hazards associated with producing or processing the type of food, including its ingredients and process steps (e.g. from surveys or sampling and testing of hazards in the food chain, from recalls, from information in the scientific literature or from epidemiological data);

— the likelihood of occurrence of hazards, taking into consideration prerequisite programmes, in the absence of additional control;

— the likelihood and severity of adverse health effects associated with the hazards in the food in the absence of control;

— identified acceptable levels of the hazards in the food e.g. based on regulation, intended use, and scientific information;

— the nature of the facility and the equipment used in making the food product;

— survival or multiplication of pathogenic microorganisms;

— production or persistence in foods of toxins (e.g. mycotoxins), chemicals (e.g. pesticides, drug residues, allergens) or physical agents (e.g. glass, metal);

— the nature of the product as an intermediate product which is further processed by another FBO

— the intended use and/or probability of product mishandling by potential consumers that could render the food unsafe; and,

— conditions leading to the above.

5.2. Control measures

The FBO should consider and describe what control measures, if any, can be applied for each hazard at each process step.

Control measures are those actions and activities that can be used to prevent hazards, eliminate or reduce them to acceptable levels. Many control measures to prevent hazards are part of GHP and are intended to avoid contamination from the production environment (e.g. personnel, pest, water, maintenance which are listed as examples in Annex I). Other control measures aiming at reduction or elimination of hazards are more specifically linked to a particular production process e.g. pasteurization, thorough fermentation or are intended to avoid multiplication of the hazard (e.g. chilling), and may result in the establishment of CCP or OPRP.

In some cases a control measure may require to monitor more than one parameter e.g. pasteurization controlled by time, temperature and flow rate of the fluid and more than one hazard may be controlled by one control measure e.g. pasteurization or controlled heat treatment may provide sufficient assurance of reduction of the level of several pathogenic micro-organisms such as Salmonella and Listeria monocytogenes.

Control measures must be validated.

Control measures should be supported by detailed procedures and specifications to ensure their effective implementation.

5.3. Hazard analysis worksheet

A way to document the hazards analysis is the use of a hazard analysis worksheet.

Step Identify potential hazards introduced, controlled or enhanced at this step B = biological C = chemical P = physical A = allergen (*1) Is this potential hazard reasonably likely to occur? Justify your decision for column 3 What measure(s) can be applied to prevent or eliminate the hazard or reduce it to an acceptable level? Yes No B C P A B C P A B C F A

Hazards can be grouped when they are derived from the same possible source and control measures are similar without the need for a comprehensive hazard analysis on each of the specific hazards. For example microbiological hazards can be grouped in vegetative (Salmonella, Campylobacter, VTEC, etc.) and spore forming (Clostridium, Bacillus) bacteria as origin and controls can be similar for each category.

Fully elaborated examples of hazard analyses for retailers, grouping biological, chemical and physical hazards, can be found in the Commission Notice on retail.

In small businesses it may suffice that the hazard analysis in the HACCP plan describes in a practical and simple way the methods to control hazards without necessarily entering into detail on the nature of the hazards. Such analysis should nevertheless cover all significant hazards in a business and should clearly define procedures to control these hazards and the corrective action to be taken in case of problems.

Specific HACCP guides can suggest the significant hazards linked to specific products and processes.

6. IDENTIFICATION OF CRITICAL CONTROL POINTS (CCP) (PRINCIPLE 2)

The identification of a CCP requires a logical approach. Such an approach can be facilitated by the use of a decision tree or other methods, according to the knowledge and experience of the HACCP team.

The identification of CCP has two consequences for the HACCP team which should then:

ensure that appropriate control measures are effectively designed and implemented. In particular, if a hazard has been identified as significant and no control measure exists at that step, or at any other step further on in the production process, then the product or process should be modified at that step or at an earlier or later stage, to include a control measure;

establish and implement principles 3 to 7 of the procedures based on the HACCP principles at each CCP.

CCP are intended to address only significant hazards in an establishment.

In addition, for each control measure, the systematic approach shall include an assessment of the feasibility of:

— establishing measurable/observable critical limits and/or measurable/observable action criteria;

— monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria;

— applying timely corrections in case of failure.

When carrying out the hazard analysis by a semi-quantitative risk evaluation such as in Appendix 2, CCP are implemented to control significant hazards identified by the hazard analysis. Other examples of tools are the decision trees shown in Appendices 4A and 4B. The tools in Appendices 2 and 4 can be used separately or in combination, using the risk evaluation for identifying the significant hazards and for initial screening of required control measures and the decision tree for further refining of the control measures. For a high level of risks, which are not controlled by GHP, either a CCP or an OPRP should be established. Ideal decision trees, applicable in all kind of situations/steps, do not exist. Therefore decision trees might be rather considered as tools for the understanding how to decide whether GHP are sufficient or OPRP or CCP should be considered, than representing the incontestable way to make such evaluation.

CCP or OPRP? Both CCP and OPRP represent a step at which a control measure applies in order to control a significant hazard. CCP are intended to control the highest risks, while OPRP can be used to control intermediate risks or for any significant hazard when — no critical limit can be set, example: absence of visual contamination, integrity of packaging,.. or — no real time detection of a deviation/non-compliance is possible, example: allergen cross-contamination. Principles applicable to CCP also apply to OPRP e.g. — action criteria must be established to contribute to the assurance that the acceptable level of the hazard is not exceeded; — need for monitoring, validation and verification — Documentation and record keeping. The guidance provided for in this Section, as well as in Sections 7 to 11 are therefore also relevant to OPRP.

A comparison of GHP, OPRP and CCP is provided in Appendix 5.

Each process step identified in the flow diagram (see Section 4.4 of this Annex) should be considered in sequence. At each step, the decision tree and/or risk evaluation should be applied to each significant hazard. Application should be flexible, considering the whole manufacturing process.

Training in the application of a method to identify CCP is recommended.

CCP and OPRP depend on the result of the hazard analysis in each establishment and need to be assessed on a case by case basis:

— if the control measure cannot be used at the process step, then this step should not be considered as a CCP/OPRP for the significant hazard.

— If the control measure can be used at the step being analysed, but can also be used later in the process, or there is another effective control measure for the hazard at a later step, the step being analysed should not be considered as a CCP/OPRP.

— Determine whether a control measure at a step is used in combination with a control measure at another step to control the same hazard; if so, both steps should be considered as CCP/OPRP.

FLEXIBILITY EXAMPLES:

In certain cases, due to the nature of the food business and the food that is handled by it, a (generic) hazard analysis may demonstrate that no significant hazard has been identified and therefore there is no need for CCP or OPRP. In this case all food hazards can be controlled by the implementation of the GHP only. It must however be stressed that flexibility on identifying a hazard as significant or not in the hazard analysis is not directly linked to the size of the establishment and is not appropriate always even when the business is small e.g.

— when there is a high likelihood of failure in the method of processing such as canning;

— food production for vulnerable groups of consumers;

— allergen controls in products declared to be allergen free.

For certain categories of food businesses with very identical, standardised and limited handling of the food (e.g. retail shops, see the Commission Notice providing guidance on food safety management systems for food retail activities, including food donations (OJ C 199, 12.6.2020, p. 1.)), it may be possible to pre-determine hazards that need to be controlled. Guidance on such hazards and on their control can be addressed in a generic HACCP guide or a generic hazard analysis only.

Frying or grilling in a restaurant to control the survival of pathogens might not be a CCP since the high temperature of the oil/fat is easily observable and leads systematically to the elimination of a possible significant hazard

7. CRITICAL LIMITS AT CCP (PRINCIPLE 3)

Each control measure associated with a critical control point should give rise to the specification of critical limits.

Critical limits correspond to the extreme values acceptable with regard to product safety. They separate acceptability from unacceptability. They are set for observable or measurable parameters which can demonstrate that the critical point is within critical limits. They should be based on substantiated evidence that the chosen values will result in the correct application of a control measure.

Examples of such parameters include temperature, time, pH, moisture content, amount of an additive or salt, sensory parameters such as visual appearance or texture, etc.

In some cases, to reduce the likelihood of exceeding a critical limit due to process variations, it may be necessary to specify more stringent levels (i.e. target levels) to assure that critical limits are not exceeded.

Critical limits should be validated and should have clear, specific values.

Critical limits may be derived from a variety of sources. When not taken from regulatory standards or from guides of good hygiene practices, the HACCP team should ascertain their validity relative to the control of identified hazards at CCP.

Critical limits at CCP can be established on the basis of:

— experience (best practice);

— international documentation for a number of operations, e.g. canning of food, pasteurisation of liquids etc. for which internationally accepted standards (Codex Alimentarius) exist; critical limits can also be established;

— advice on specific steps in guides to good practice;

— scientific publications;

— EU legislation, EFSA opinions.

The requirement to establish a critical limit at a CCP does not always imply that a numerical value must be fixed. This is in particular the case where monitoring procedures are based on visual observation e.g.

— The faecal contamination of carcases after dressing in a slaughterhouse;

— The boiling temperature of liquid food;

— The change of physical properties of food during processing (e.g. the thorough cooking of food).

FLEXIBILITY EXAMPLE

Critical limits must have a scientific basis, however, is some cases they can based on experience. For many food production and processing scenarios, there is extensive history that specific measures used to control food borne hazards are effective.

8. MONITORING PROCEDURES AT CCP (PRINCIPLE 4)

An essential part of HACCP-based procedures is a programme of observations or measurements performed at each CCP to ensure compliance with specified critical limits.

Observations or measurements must be able to detect deviation at CCP and provide information in time for corrective action to be taken such that unsafe food is not placed on the market.

Where possible, process adjustments should be made when monitoring results indicate a trend towards deviation at a CCP. The adjustments should be made before a deviation occurs (the critical limit is not met). Data derived from monitoring must be evaluated by a designated and experienced person with knowledge and authority to carry out corrective actions when indicated.

Observations or measurements can be made continuously or periodically. When observations or measurements are not continuous, it is necessary to establish a frequency of observations or measurements which detect deviations in time for corrective actions to be taken. Monitoring procedures for CCP should be capable of timely detection of a deviation from the critical limit to allow isolation of the affected products. The method and frequency of monitoring should take into account the nature of the deviation (e.g. a broken sieve, deviation from pasteurization conditions, or a gradual increase of temperature in cold storage). Where possible, monitoring of CCP should be continuous.

The HACCP plan should describe the methods, the frequency of observations or measurements and the recording procedure for monitoring at CCP:

— who is to perform monitoring and checking;

— when monitoring and checking is performed;

— how monitoring and checking is performed.

Records associated with monitoring CCP must be signed by the person(s) doing the monitoring and when records are verified by staff of the company responsible for reviewing.

FLEXIBILITY EXAMPLES:

Monitoring is not only achieved by measuring. Monitoring may in many cases be a simple procedure, e.g.

— a regular visual checks of the temperature of cooling/freezing/heating facilities;

— a visual observation (of a cut surface) to verify whether a food preparation submitted to a particular heat treatment has the correct physical properties reflecting the level of heat treatment (e.g. boiling or steaming hot all the way through).

Monitoring should be as frequent as necessary to ensure that critical limits are permanently met. It should confirm that the critical limit or target is not exceeded. The type of CCP determines the frequency of monitoring. A reduced frequency of monitoring can sometimes be considered after prolonged period of good results.

When the critical limit is exceeded, all the production since the last satisfactory monitoring must be checked for compliance.

Certain foods may sometimes be processed in a standard way using a standard calibrated equipment, e.g. certain cooking operations, roasting chicken etc. Such equipment ensures that the correct time/temperature combination is respected as a standard operation. The cooking temperature of the product then needs not to be systematically measured if it is ensured that the equipment is functioning properly, that the required time/temperature combination is respected and that the necessary controls for that purpose are carried out (and corrective action taken where necessary).

9. CORRECTIVE ACTIONS (PRINCIPLE 5)

For each CCP, corrective actions should be planned in advance by the HACCP team, so that they can be taken without hesitation when monitoring indicates a deviation from the critical limit.

Such corrective actions should include:

— identification of the person(s) responsible for the implementation of the corrective action;

— means and action required to correct the observed deviation in the process;

— action(s) to be taken with regard to products that have been manufactured during the deviation;

— written record of measures taken indicating all relevant information (for example: date, time, type of action, actor and subsequent verification check) ;

— consideration of (long term) actions to avoid repetition of the deviation.

Monitoring may indicate that preventive measures (GHP or their robustness) or the process and its CCP shall have to be reviewed if corrective actions for the same procedure have to be taken repeatedly.

Root cause analysis should be a generic corrective action as very often it is impossible to know the cause of the deviation in advance.

If the critical limit is exceeded, there is an analysis of the situation to identify the causes and implement the most appropriate corrective actions. However, in the case of a one-off incident, it may happen that the analysis of the situation does not allow the precise identification of the cause; generic corrective actions can then be implemented to cover several suspected causes. If the incident is repeated, then the information collected can be cross-referenced and this can help better understand the situation and identify the most likely cause.

10. VALIDATION AND VERIFICATION PROCEDURES (PRINCIPLE 6)

At the start of a new process or in case of a change to an existing process that is likely to affect food safety, the HACCP team should carry out validation activities, in particular gather evidence to confirm the capability of all elements of the HACCP plan, even if not explicitly mentioned in Article 5 of Regulation (EC) No 852/2004. Such evidence includes scientific publications, in-house testing (sampling and testing to see if biological and chemical hazards are under control), predictive microbiology, guidance developed by competent authorities, … demonstrating that the critical limits set, will result in the intended effect on the hazard (no growth, reduction, …).

Additional guidance and examples of validation activities are in CXG 69-2008.

Examples of changes that may require re-validation include:

change in raw material or in product, processing conditions (factory layout and environment, process equipment, cleaning and disinfection programme);

change in packaging, storage or distribution conditions;

change in consumer use;

receipt of any information on a new hazard associated with the product.

Where necessary, such a review must result in the amendment of the procedures laid down. The changes should be fully incorporated into the documentation and record-keeping system in order to ensure that accurate up-to-date information is available.

After the procedures based on the HACCP principles have been implemented, the HACCP team should establish verification procedures to confirm that the HACCP-based procedures are working correctly. Methods for verification may include:

— random sampling and analysis, reinforced analysis or tests at selected critical points: — intensified analysis of intermediate or end products e.g. on compliance with microbiological criteria (see Section 12); — process hygiene criteria for spoilage bacteria such as aerobic colony count; — Time/Temperature hazard reduction/elimination: follow up of relevant pathogens in heat-treated food products e.g. absence of Listeria monocytogenes, Salmonella etc.; — Damaged packages: testing for the most likely bacterial or chemical contamination a product might be exposed to if its package was damaged;

— surveys on actual condition (e.g. temperature) during storage, distribution and sale and on actual use of the product;

— internal audits of HACCP-based procedures and their records;

— inspection of operations (people compliance);

— confirmation that CCP monitoring is implemented and maintained by: — control of the procedures/instructions; — physical check on the process being monitored; — verifying the calibration of instruments used for monitoring; — verification of records (frequency, outcome of measuring results over period of time);

— review of deviations and product dispositions; corrective actions taken with regard to the product;

— check on the person monitoring processing, storage and/or transport activities.

The frequency of verification should be sufficient to confirm that HACCP-based procedures are working effectively. The frequency of verification shall depend on the characteristics of the business (output, number of employees, nature of the food handled), the monitoring frequency, the accuracies of the employees, the number of deviations detected over time and the hazards involved.

When the verification detects failures in the HACCP system, review of the system must be carried out

FLEXIBILITY EXAMPLE: The use of alternative analytical methods instead of the reference method and exemptions of the sampling frequencies are authorised in accordance with Regulation (EC) No 2073/2005 as regards possible microbiological criteria that are applied for verification purposes.

Verification should be carried out by someone other than the person who is responsible for performing the monitoring and corrective actions. Where certain verification activities cannot be performed in house, verification should be performed on behalf of the business by external experts or qualified third parties.

FLEXIBILITY EXAMPLE: Verification may in many cases be a simple procedure by which it is possible to check that monitoring like the one described in Section 8 is done in a proper way in order to achieve a required food safety level.

Simple verification procedures may include:

— physical audit or check on the monitoring;

— physical audit or check on the monitoring records including the checking of corrective actions whenever a non-compliance or exception reporting has been recorded;

— In very small FBOs where very few persons are involved in the implementation of the FSMS, owner/managers usually use visual inspection for ongoing confirmation that the system is running according to plan. Thus, documented verification may be perceived to be a pointless, double checking exercise. This is especially true for micro businesses where the owner is the self-employed manager.

— External assistance for simplified audits could be used.

Generic HACCP guides should include examples of necessary verification procedures, and when standard processes are concerned, there should be a validation of the considered control measures on the targeted hazards as well.

Validation, verification or monitoring? Example 1: milk pasteurization — VALIDATION: before production activities: Experimental proof that the process used will heat milk to 72 °C for 15 seconds and will destroy Coxiella burnetti. Calibrated probes, predictive microbiology and microbiological tests can be used. — MONITORING: during production activities: System (time – temperature – pressure – volume throughput) which will enable the companies to see that the critical limit (72 °C for 15s) is attained during process. — VERIFICATION: fixed frequency per year: Periodic microbiological tests on the end product, regular check of temperature of the pasteurizer with calibrated probes. Example 2: Fermentation of dry cured sausages — VALIDATION: pH, water activity, time/temperature combination, not allowing Listeria monocytogenes to grow by predictive modelling or by challenge testing; — MONITORING during fermentation: measurement of pH, weight loss, time period, temperature, humidity of fermentation chamber, L. monocytogenes sampling in fermentation environment; — VERIFICATION: L. monocytogenes sampling plan in the end product. See also CXG 69-2008

11. DOCUMENTATION AND RECORD KEEPING (PRINCIPLE 7)

Efficient and accurate record keeping is essential to the application of HACCP-based procedures. HACCP-based procedures should be documented in the HACCP-plan and continuously supplemented by records on findings. Documentation and record keeping should be appropriate to the nature and size of the operation and sufficient to assist the business to verify that the HACCP-based procedures are in place and being maintained. Expert developed HACCP guidance materials (e.g. sector-specific HACCP guides) may be utilized as part of the documentation, provided that those materials reflect the specific food operations of the business. Documents should be reviewed and signed and any deviation should be recorded and followed up by the person responsible for HACCP in the business.

Recommended documentation includes:

— GHP documentation, see Annex I, Section 6.

— Description of the preparatory stages (before 7 principles);

— Hazard analysis, including hazard identification;

— CCP (and OPRP) identification;

— Critical limit (action criteria) determination;

— Validation activities;

— Corrective actions anticipated;

— Description of planned monitoring and verification activities (what, who, when);

— Record forms;

— Modifications to the HACCP-based procedures;

— Supporting documents (generic guides, scientific evidence, etc.).

A systematic, integrated approach can be taken by using worksheets for the development of the HACCP plan as provided in the Annex to CXC 1-1969, Diagram 3. Starting from the flow diagram, at each step of processing the potential hazards are described, relevant control measures (GHP) listed, CCP identified (if appropriate based on the hazards analysis) along with their critical limits, monitoring procedures, corrective actions and available records.

The documentation should be kept permanently available in any format for the HACCP team and at the request of the competent authorities e.g. for auditing purposes.

Record examples are:

— Outcome of monitoring activities on control measures;

— Observed deviations and executed corrective actions;

— Outcome of verification activities.

Records should be kept for an appropriate period of time in any format. That period should be long enough to ensure information to be available in case of an alert that can be traced back to the food in question. For certain foods the date of consumption is certain. For instance, in food catering, consumption takes place shortly after the time of production. For food for which the date of consumption is uncertain, records should be kept for a reasonably short period after the expiry date of the food. Records are an important tool for the competent authorities to allow verification of the proper functioning of the food businesses’ FSMS and should therefore be kept long enough for the performance of official controls by competent authorities.

FLEXIBILITY EXAMPLES:

A simple system for documentation and record-keeping can be effective and easily communicated to employees. It may be integrated into existing operations and may use existing paperwork, such as delivery invoices and checklists to record, for example, product temperatures.

The examples referred to below must be seen in the light of Article 5, paragraph 2(g) of Regulation (EC) No 852/2004 where it is stated that under the HACCP-based procedures, documents and records must be commensurate to the nature and the size of the food business.

As a general rule, the need for HACCP-related record keeping should be well- balanced and can be limited to what is essential with regard to food safety. It is important to consider that recording is necessary but not the goal in itself.

Taking into account the above, the following general guidelines could be used:

— Where generic HACCP guides exist, documentation on hazard analysis, CCP determination, critical limit determination, possible modification of the FSMS and validation activities can be substituted for individual documentation on HACCP-based procedures. Such guides could also clearly indicate where there is a need for records and the period of time during which records must be kept.

— The records of non-compliance should include the corrective action that has been taken. The use of a diary or a checklist might be a suitable way of record keeping in such cases. FBOs can simply tick boxes to indicate how they act or provide more detailed information by writing in text boxes how they comply with a control point. Daily record-keeping is based on confirming opening and closing checks with a tick and a signature to confirm that safe methods have been followed. When a box ticking approach is used, only problems or changes to procedures are recorded in more detailed additional writing (i.e. exception reporting).

— (Generic) models regarding own-check documents should be provided by stakeholders' organisations or competent authorities. These should be easy to use, understandable and simple to implement.

— A x-weekly review of methods only requires completing a check list of activities and possible impact on safe methods.

12. THE ROLE OF MICROBIOLOGICAL CRITERIA, CHEMICAL LIMITS AND OTHER LEGAL LIMITS SET IN THE EU OR NATIONAL LAW

EU legislation provides for microbiological criteria (4), chemical limits (5) and other parameters such as temperature/time conditions. Such criteria, limits or conditions are often considered very important for the safety of the products and are therefore often associated with a CCP. For example, heat treatment of dairy products is intended to kill bacteria and freezing of fish essential for the control of parasites as laid down in Regulation (EC) No 853/2004. Microbiological criteria and chemical limits normally cannot be used as critical limits for a CCP because they don’t allow a real-time measurement. They are used as parameters for the validation of HACCP-based procedures and GHP, as well as for the verification of the correct functioning of these control measures. Process hygiene as well as food safety criteria, and environmental monitoring e.g. for Listeria monocytogenes, can be used. Further guidance on the use of microbiological criteria for verification purposes can be found in the WHO document ‘Statistical Aspects of Microbiological Criteria Related to Foods’ (6).

For a particular operation or type of food, the guides to good practice can also include these limits.

(1) http://www.codexalimentarius.org/standards/list-of standards/en/?provide=standards&orderField=fullReference&sort=asc&num1=CAC/RCP

(2) Hazard analysis approaches for certain small retail establishments in view of the application of their food safety management systems (EFSA Journal 2017;15(3):4697) and Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion (EFSA Journal 2018;16(11):5432)

(3) Article 3(14) of Regulation (EC) No 178/2002.

(*1) Allergens are chemical hazards, however it might be more practical to assess them separately for the purpose of the hazard analysis since control measures can be quite specific.

(4) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).

(5) Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364 20.12.2006, p. 5)

(6) https://www.who.int/foodsafety/publications/mra_24/en/