Enforcement of HACCP

A webinar presented by:

Dr Andy Bowles

Attendee Notes

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Enforcement of HACCP

Enforcement of HACCP

In this webinar I will discuss: Re-cap of webinars 1,2 & 3 Approach to enforcement Flexibility of HACCP Risk rating Formal enforcement options

HACCPRecap of webinars 1,2 & 3

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Pre-requisite programmes (PRPs)

Relationship between PRP and HACCP Source: Commission Notice (2016/C 278/01) on the implementation of food safety management systems covering

prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibilityof the implementation in certain food businesses

Preparing a HACCP – First Steps

Verify the Flow Diagram

Develop Flow Diagramof Process

Describe IntendedUse and Customers

Describe Food andDistribution

Assemble HACCP Team

Codex seven principles Conduct a Hazard Analysis Determine the Critical Control Points Establish Critical Limits Establish monitoring procedures Establish corrective actions Establish verification procedures Establish record keeping and documentation

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Legislative framework

Article 5 Regulation (EC) 852/2004

‘Food business operators shall put in place implementand maintain a permanent procedure or proceduresbased on the HACCP principles.’

HACCP PrinciplesArticle 5(2) 852/2004

(a) Identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) Identifying the critical control points at the step or steps at which control is essential toprevent or eliminate a hazard or to reduce it to acceptable levels;

(c) Establishing critical limits at critical control points which separate acceptability fromunacceptability for the prevention, elimination or reduction of identified hazards;

(d) Establishing and implementing effective monitoring procedures at critical control points;

(e) Establishing corrective actions when monitoring indicates that a critical control point is notunder control;

(f) Establishing procedures, which shall be carried out regularly, to verify that the measuresoutlined in subparagraphs (a) to (e) are working effectively; and

(g) Establishing documents and records commensurate with the nature and size of the foodbusiness to demonstrate the effective application of the measures outlined insubparagraphs (a) to (f).

Role of Local Authorities Officers should: Consider the nature of the business Identify the nature of the HACCP system required Verify the: Scope of the system; Training and awareness of staff Adequacy and validity of the system; Implementation of the system; Nature and adequacy of documentation.

Identify and take steps to rectify legal contraventions. Provide guidance and advice.

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Official control verification

Gap analysis Three key questions:

1. Is the HACCP plan correct? HACCP plan assessment

2. Is the plan fully implemented? Reality check

3. Is the business operating safely? Inspection

Official control verification

Three stage verification (“triangulation”)

Documentation Interview Observation

Evidence based decisions

Hierarchy of evidence: Verbal assurances Documentary evidence Observation by officers

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The role of documentation in HACCP

Enforcement of Article 5

Approach to enforcementFood Law Practice Guidance (England Nov 2017)

Food establishments that present significanthealth risk conditions or an imminent risk ofinjury to public health should be subject to formal enforcement action to

secure compliance and protect public health.

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Approach to enforcementFood Law Practice Guidance

Where food establishments do not presentsignificant risks to public health, the aim must be to help the business improve

standards of food safety and hygiene. In practice this means ensuring that significant

hazards are understood and controlled, and where understanding and control is lacking – provide advice and guidance so FBOs adopt good

practice to improve compliance with food law.

Approach to enforcementFood Law Practice Guidance

In following an educative approach,authorised officers should concentrate onsignificant hazards to public health, ensuringthat those responsible for food safetyunderstand these hazards and know how tocontrol and manage them.

Approach to enforcementFood Law Practice Guidance

A graduated approach should be based onthe expectation that businesses improve theirstandards over time, taking account of the understanding they gain

from the authorised officer and other sources. Where a business does not improve – given reasonable time, after being offered guidance, hygiene improvement notices and other formal

enforcement measures can be used.

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Flexibility of HACCP

Legislative framework

Article 5 Regulation (EC) 852/2004

‘Food business operators shall put in place implementand maintain a permanent procedure or proceduresbased on the HACCP principles.’

HACCP PrinciplesArticle 5(2) 852/2004

(a) Identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) Identifying the critical control points at the step or steps at which control is essential toprevent or eliminate a hazard or to reduce it to acceptable levels;

(c) Establishing critical limits at critical control points which separate acceptability fromunacceptability for the prevention, elimination or reduction of identified hazards;

(d) Establishing and implementing effective monitoring procedures at critical control points;

(e) Establishing corrective actions when monitoring indicates that a critical control point is notunder control;

(f) Establishing procedures, which shall be carried out regularly, to verify that the measuresoutlined in subparagraphs (a) to (e) are working effectively; and

(g) Establishing documents and records commensurate with the nature and size of the foodbusiness to demonstrate the effective application of the measures outlined insubparagraphs (a) to (f).

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Application of Article 5Recital 15 852/2004

“HACCP requirements should take account of the principlescontained 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, goodhygienic practices can replace the monitoring of critical control points.

Similarly, the requirement of establishing ‘critical limits’ does not imply that it isnecessary to fix a numerical limit in every case.

In addition, the requirement of retaining documents needs to be flexible inorder to avoid undue burdens for very small businesses.”

Flexibility

‘The seven HACCP principles are apractical model for identifying andcontrolling significant hazards on apermanent basis.

This implies that where that objectivecan be achieved by equivalent meansthat substitute in a simplified buteffective way the seven principles, itmust be considered that the obligationlaid down in Article 5, paragraph 1 ofRegulation (EC) No 852/2004 isfulfilled.’

Flexibility

‘In certain cases, in particular in food businesseswhere there is no preparation, manufacturing orprocessing of food, it may seem that all hazardscan be controlled through the implementation of theprerequisite requirements.

“In these cases it can be considered that the firststep of the HACCP procedure (hazard analysis) hasbeen performed and that there is no further need todevelop and implement the other HACCPprinciples.’

EU Commission Guidance

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Examples from the guidance mayinclude: Marquees, market stalls and mobile sales vehicles

Establishments mainly serving beverages (bars, coffeeshops, etc)

Small retail shops (such as grocery shops)

Transport and storage of pre-packed food or nonperishable food, where there is usually no preparation of food

Implementation of HACCP

June 2015

Some of the findings:

“In all Member States there is a reasonable level ofimplementation of HACCP-based procedures”

“Some of the core concepts are not always understood,particularly by small FBOs, and are not applied in aconsistent manner”

“Flexibility is the least understood HACCP concept andis inconsistently applied and evaluated”

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Prerequisites and HACCP

Widespread lack of understanding of the differencebetween prerequisites and HACCP i.e. HACCP implemented, without prerequisites being

in place then setting Critical Control Points (CCPs) for hazards which

should be controlled through prerequisites Concern re. incorrect use of CODEX decision tree =

prerequisite being categorised as CCP

Implementation of certain HACCPprinciples Concern in the implementation of HACCP principles

relating to “Hazard analysis”, setting and monitoring ofCCPs and “verification” resulting in HACCP plans not correctly addressing relevant hazards Too many CCPs and inappropriate Critical Limits Unnecessary multiplication of CCPs leading to reduced safety levels and extra burdens with no

extra benefits

Flexibility

Wide range of interpretation as to what constitutesflexibility

Uneven application in some Member States

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Official Controls

Generally risk-based systems of official assessment ofHACCP based procedures in place

Wide variation in the approach to controls frequency and content

Lack of clear national policies for flexible implementationand different approaches and interpretation resulting innot consistently applied

Administrative Burden

To reduce unnecessary admin burden,further clarity to FBOs on record keepingrequirements Consideration of prerequisites and flexible

implementation

Revised guidanceCommission Notice (2016/C 278/01)

Commission Notice (2016/C 278/01) on the implementation of food safety

management systems covering prerequisiteprograms (PRPs) and procedures based onthe HACCP principles, including thefacilitation/flexibility of the implementation incertain food businesses.

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Revised guidanceCommission Notice (2016/C 278/01)

See Annex 3 “Flexibility”

“Carrying out monitoring effectively is in generalmore important than recording it. Therefore,flexibility on the recording could be more easilyaccepted than flexibility concerning themonitoring itself (e.g. its frequency).”

“In particular for small businesses keeping theright temperature is far more important thanactually recording it.”

FlexibilityFood Law Practice Guidance (England Nov 2017)

Flexibility applies to all food businesses FBO should have the skills necessary to maintain a food

safety management system proportionate to their business, not simply be trained in HACCP principles. These skills can be

gained in many ways; formal training is not the only route. Staff in a business should have the skills needed to

undertake their duties and follow the food safetyprocedures in the business. Training for staff

should be proportionate and reflect the flexibility guidance. Formal training may not be necessary to achieve the objective of having

the required competencies. In practical terms, on the job training might be appropriate,

attendance at a formal training event is not necessary.

FlexibilityFood Law Practice Guidance (England Nov 2017)

Monitoring key activities in the business(critical control points) need not be numeric and can be based on

sensory observation, craft skills and supervision. Incident recording is an appropriate and

proportionate form of record keeping in manybusinesses

Corrective actions must supplement incidentrecording.

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Risk Rating

Part 3: Confidence inmanagement/controlprocedures

Food Law Code of Practice (England)

For small businesses which present onlybasic hygiene hazards, it may be sufficient that the business has in place

good hygiene practices and understands andapplies it i.e. meets the prerequisites.

The requirement for records needs to be balancedwith the nature and size of the business.

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Food Law Code of Practice (England)

Documentation and record keeping may not benecessary under the flexibility afforded by Article 5of Regulation (EC) 852/2004.

Officers should consider guidance in relation to theapplication of Article 5 in order to make a judgementon whether the business requires documented foodsafety management procedures, and if so on thelevel of documentation required.

The level of documentation will vary betweenbusinesses depending on the types and complexityof operations being undertaken and on the level ofcontrols being implemented.

Confidence in management/control procedures

Confidence in management/controlprocedures

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Confidence in management/controlprocedures

Confidence in management/controlprocedures

Enforcement Options

Hygiene Improvement Notice Hygiene Emergency Prohibition Remedial Action Notice Detention Notice Seizure Prosecution

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Questions?

Dr Andy Bowles FIFSTSpecialist food law solicitor

andy.bowles@abcfoodlaw.co.ukwww.abcfoodlaw.co.uk01603 274486

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Excerpt from Food Law Practice Guidance (England) November 2017

5.3.1 Approach to enforcement – requirement for food safetymanagement procedures based on HACCP principles

Article 5 of Regulation (EC) 852/2004 requires all food businesses (except primaryproducers) to develop food safety management procedures based on HACCPprinciples Recital 15 of the Regulation allows for a degree of flexibility in the applicationof these principles and implementation of such procedures, particularly in small,businesses where traditional HACCP might be difficult to apply.

5.3.1.1 Enforcement approach

Enforcement should be graduated and educative.

Regulation (EC) 852/2004

Regulation (EC) 852/2004 requires food businesses to put in place, implement andmaintain food safety management procedures based on HACCP principles. The FSAhas produced the Safer Food, Better Business package to help businesses complywith Regulation (EC) 852/2004, which is available through FSA’s web site athttps://www.food.gov.uk/business-industry/sfbb and there is EU guidance for bothcompetent authorities and food businesses athttp://trade.ec.europa.eu/doclib/docs/2013/june/tradoc_151371.pdf.

Food establishments that present significant health risk conditions or an imminent riskof injury to public health should be subject to formal enforcement action to securecompliance and protect public health.

Where food establishments do not present significant risks to public health, the aimmust be to help the business improve standards of food safety and hygiene. In practicethis means ensuring that significant hazards are understood and controlled, and whereunderstanding and control is lacking – provide advice and guidance so FBOs adoptgood practice to improve compliance with food law.

In following an educative approach, authorised officers should concentrate onsignificant hazards to public health, ensuring that those responsible for food safetyunderstand these hazards and know how to control and manage them.

A graduated approach should be based on the expectation that businesses improvetheir standards over time, taking account of the understanding they gain from theauthorised officer and other sources. Where a business does not improve – givenreasonable time, after being offered guidance, hygiene improvement notices and otherformal enforcement measures can be used.

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5.3.1.2 Flexibility and HACCP monitoring

Regulation (EC) 852/2004 is flexible, in that it requires food businesses to establishprocedures in the business that control food safety hazards, and integrate theseprocedures with documentation and record keeping appropriate to the size and natureof the business. Recital 15 of Regulation (EC) 852/2004 also recognises that:

“In particular, it is necessary to recognise that, in certain food businesses, it isnot possible to identify critical control points and that, in some cases, goodhygienic practices can replace the monitoring of critical control points”.

The European Commission has published a Commission Notice on HACCP andflexibility and which relates HACCP to Prerequisite programmes20. Commissionguidance on flexibility, in particular for traditional products / methods and other specificmanufacturing is available for FBOs21 and for competent authorities22.

Whilst larger, more complex businesses and businesses that have a high level ofunderstanding of food safety management may choose to demonstrate compliancewith the legislation by putting in place a ‘traditional’ HACCP system, others may do sowith simpler approaches that take account of the flexibility to put in place proceduresbased on the HACCP principles. This section describes this flexibility for smallbusinesses.

Whilst some businesses will wish to follow the traditional 7-principle HACCPframework this may not necessarily be implemented by others – particularly smallbusinesses. There is no requirement to use this 7-principle approach as long as thesame outcome is achieved – safe food being produced.

20http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0730(01)&from=EN

21https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety-hygiene-faq_all_business_en.pdf

22https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety-hygiene-faq_all_public_en.pdf

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For enforcement, in practice, compliance means:

• obtaining assurance that the person responsible for food safety understandssignificant hazards and has them under control e.g. by questioning;

• seeing that there are written procedures where necessary that demonstratehow the business controls these hazards at all times;

• seeing evidence that these procedures are followed, and that they are reviewedand kept up to date.

The key points are:

• Flexibility applies to all food businesses

• The FBO or manager of a business should have the skills necessary to maintaina food safety management system proportionate to their business, and notsimply be trained in HACCP principles. These skills can be gained in manyways; formal training is not the only route.

• Staff in a business should have the skills needed to undertake their duties andfollow the food safety procedures in the business. Training for staff should beproportionate and reflect the flexibility guidance. Formal training may not benecessary to achieve the objective of having the required competencies. Inpractical terms, on the job training might be appropriate, attendance at a formaltraining event is not necessary.

• Monitoring key activities in the business (critical control points) need not benumeric and can be based on sensory observation, craft skills and supervision.

• Incident recording is an appropriate and proportionate form of record keepingin many businesses

• Corrective actions must supplement incident recording.

In order to help businesses develop appropriate procedures and to adopt agraduated approach to its enforcement, it is important to understand how to judgeprogress. The table below describes the components of the legislation and how anauthorised officer might judge progress towards complying with it in smallbusinesses.

The table breaks down the components of the legislation into the standard 7principles of HACCP, with some of the flexibility in the legislation identified. Althoughguidance materials may use this 7-principle framework, it is not necessary for thisapproach to be used. Provided the same outcome is achieved, safe food beingproduced, this can be achieved by substituting, in a simplified but effective way,some or more of the seven principles. This is clarified in Annex II of the Commissionguidance on flexibility:

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf.

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Similarly, the terminology or ‘jargon’ of HACCP need not be used, and may beconfusing to some businesses

This breakdown is based on the FSA approach ‘Safer food better business’, butshould be useable to identify compliance in a business using other similarly flexibletools, or where the business has devised its own procedures.

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1. Identify any hazards that must be prevented eliminated or reduced;

Mapping Hazard Analysis with tools such as flow-charts might not besuitable for all businesses. It is sufficient that the business has thoughtabout its activities in a structured way. The effect of the analysis and theprocedures produced should be to ensure that safe food is alwaysproduced.

The traditional HACCP approach of controlling some hazards through pre-requisite programmes of Good Hygienic Practice and others through theHACCP system might not be appropriate, particularly in small businesseswhere it is not readily understood. Whatever the format of the guidance,the business must be managing all significant hazards including thosetraditionally controlled through Good Hygienic Practice.

For enforcement, in practice, this means:

• Being provided with sufficient evidence that the person responsible forfood safety has thought about their business and identified significanthazards and knows how to control them – for some businesses it maybe appropriate to follow standard advice from the FSA, industry guides,advice from trade bodies etc.

2.

3.

Identify the critical control points (CCPs) at the steps at which controlis essential;and Establish critical limits at CCPs;

Critical control points and their limits might not always be helpfulways of thinking about food safety for small businesses and they caninstead identify generic controls - like thorough cooking, togetherwith the ways of ensuring they know this has happened.

The legislation is flexible in stating the requirement that establishing acritical limit does not always imply that a numerical value must be fixed.This is in particular the case where monitoring procedures are based onvisual observation, for example a business might rely on sensoryinformation such as colour change, juices running clear, stews bubblingetc. Businesses must understand how these methods control hazards andbe sure they are effective. This validation can be done by the businessthemselves (on the basis of experience), or it might be appropriate to use

pre-validated procedures that follow established best practice, produced bythe FSA, trade bodies or others.

For enforcement, in practice, this means:

• Being provided with sufficient evidence that the business is followingprocedures that include steps where the significant hazards arecontrolled – for many businesses it may be appropriate to followstandard advice.

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4. Establish procedures to monitor the CCPs;

Management of food safety through the procedures detailed above willneed to be demonstrated. This can be shown in many ways. In some

larger businesses this may be achieved by monitoring protocols and recordkeeping. In other businesses – particularly where the person responsiblespends significant time in the food preparation areas, this can bedemonstrated by their ability to supervise their operation – that theirprocedures are being followed. It will be important to establish that if theprocedures are followed, safe food will result.

Monitoring might in many cases be a purely sensory exercise, for examplea regular visual verification of the temperature of cooked food by a colourchange.

For enforcement, in practice, this means:

• Being provided with sufficient evidence that the business is monitoringtheir procedures, either using physical checks such as notingtemperatures or via sensory checks such as noting that a stew or sauceis bubbling. The person responsible for food safety should be able toexplain the chosen method of monitoring.

5. Establish corrective actions to be taken if a CCP is not under control;

It is also important that the business knows what to do when things gowrong – the corrective action that needs to be taken.

For enforcement, in practice, this means:

• Verifying that the person responsible for food safety managementensures that there is adequate supervision of staff and equipment so asto assure that procedures are being followed and safe food produced,and also questioning staff working in the area where the CCP exists, toprovide assurance that HACCP based controls are understood,implemented and that when things go wrong appropriate action is

taken.

6. Establish procedures to verify whether the above procedures areworking effectively;

The business will need to demonstrate that its procedures are verified andreviewed and kept up to date, and that changes to menus, types of foodsand cooking methods, and new equipment are reflected. In largerbusinesses, verification may be achieved by third parties, but for smallerbusinesses it is sufficient that the business carries out periodic reviews ofits procedures and methods, and takes account of good practice and safemethods.

For enforcement, in practice, this means:73

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• Seeing sufficient evidence that the procedures in a business arereviewed to ensure they continue to be appropriate and reflect changesin the business.

7. Establish documents and records to demonstrate the effectiveapplication of the above measures;

Documentation and record keeping are particularly onerous for smallerbusinesses and the legislation is clear that this should be well balancedand limited to what is essential with regard to food safety.

For enforcement, in practice, this means:

• Seeing documentation that is up to date and describes the mainprocedures or methods used in the business to control the mostimportant hazards;

• Seeing periodic records that represent evidence that these procedureswere followed and that corrective action has been taken. This does nothave to record every monitoring and supervisory activity and in smallcaterers, exception reporting will be acceptable.

• However, for simple small businesses following good hygienic practice,guides, documentation and record keeping might not be necessary.

5.3.1.3 Role of Competent Authorities

Larger businesses and manufacturers may continue to develop and use traditionalHACCP systems. The approach developed by the FSA, Safer food, better business(SFBB) is one approach considered suitable for use by small caterers.

Small food manufacturers represent a specific banding of businesses falling betweenthose businesses where a SFBB type approach is suitable and larger manufacturingbusinesses with technical competence on the traditional 7- principle HACCPapproach.

To support small food manufacturing businesses, the FSA has developed

MyHACCP, (http://www.food.gov.uk/myhaccp) a free interactive web tool, that guidesfood businesses through the process of identifying food safety hazards and controlsand the production of a documented food safety management system based onHACCP principles.

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Guidance for authorised officers on MyHACCP can be accessed at:http://www.food.gov.uk/enforcement/enforcework/food-law/guidance-enforcement/myhaccp-guidance

Proper implementation of the appropriate support model constitutes compliancewith the HACCP requirements of Article 5 of Regulation (EC) 852/2004.Businesses should either have in place or be seen to be making progress towardshaving effective food safety management systems. For businesses that are not athreat to public health, it is expected that formal enforcement action should only betaken where the business has been:

• given reasonable opportunity to implement food safety management

• directed to appropriate training, if needed

• provided with appropriate guidance

The graduated approach should seek to educate businesses and improve theirstandards in realisable steps. Guidance material should be broken down in such away that the enforcer and business can agree that by their next visit, so muchprogress should have been made. The FSA’s advice, SFBB, is broken down into the

4Cs (cooking, cleaning, chilling and cross-contamination) and it may be appropriateto set a business one of these ‘Cs’ at a time. Other guidance material can also bedivided into ‘chunks’ like this. Where fundamental skills are missing, enforcersshould point businesses at sources of the competencies – guidance materials,books, courses etc.

A food safety management system should give assurance that the business knowshow to produce safe food, has procedures in place that assure this, repeatedly doesproduce safe food and is capable of taking appropriate corrective actions whenthings go wrong. Whether a business has an effective food safety managementsystem in place is a judgement for enforcement officers.

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