Presentation on theme: "EU Hygiene Regulations"— Presentation transcript:
1 EU Hygiene Regulations Food & Drug AdministrationBangkok, Thailand3rd April 2007Dorothy Guina-Dornan
2 Overview New legislative framework Part II Regulation (EC) 852/2004: General Hygiene RulesRegulation (EC) 2073/2005: Microbiological criteriaRegulation (EC) 853/2004: Hygiene Rules – Animal originSupporting documentationKey elements for the Food & Drug Administration, Thailand
3 Animal Origin Non-animal Origin Hygiene Rules for Food of Animal Origin (853/2004)Hygiene of Foodstuffs (852/2004)Official Control on products of Animal Origin (854/2004)Official Control of Feed and Food (882/2004)Micro- criteria (2073/2005)178/2002 General Food LawOfficial Control of Feed and Food (882/2004)Hygiene of Foodstuffs (852/2004)Repealing Directive (2004/41/EEC)Animal Health and Welfare (2002/99)Transitional measures (2076/2005)Implementing measures (2074/2005)Non-animal Origin
4 Hygiene Rules for Food of Animal Origin (853/2004) Rules for all foodsRules for animal origin foodsRules for industryRules for official controlsHygiene of Foodstuffs (852/2004)Hygiene of FoodstuffsHygiene Rules for Food of Animal Origin (853/2004)Official Control of Feed and Food(882/2004)OCFF +Official Control on products of Animal Origin (854/2004)All underpinned by Regulation 178/2002H1 is supported by Reg. 2073/2004 on microbiological criteria
6 Regulation 852/2004: Hygiene of Foodstuffs All food safety practitioners will enforce the Regulation on the Hygiene of FoodstuffsApplies to all stages of food and feed chainFood business operators obligationsGuides to good hygiene practiceHACCP – all non primary producers, all principlesRegistration of all premises, approval of someMicrobiological criteria, fixing maximum levelsTemperature control requirementsImport control /2002Annexes with specific hygiene rules
7 Regulation 852/2004 Prerequisites: Articles 3 and 4 and Annex II HACCP: Article 5Registration: Article 6Guides to good hygiene practice: Article 7EU guidance on certain provisions of Regulation 852/2004EU guidance on Implementation procedures based on the HACCP principles
8 ScopeApplies to all stages of production, processing and distribution of food and to exports i.e. it must be a food business including primary productionApplies only to undertakings with a certain continuity of activities and a certain degree of organisationAll food safety practitioners will enforce the requirements of the Hygiene of Foodstuffs
9 Regulation 852/2004 Exemptions Occasional preparation of food i.e. where there is no “certain continuity of activities” or “certain degree of organisation” (Note: 178/2002 applies)Primary production for private domestic useDomestic preparation, handling or storage for private domestic useDirect supply, by the producer, of smallquantities of primary products tothe final consumer orto local retail establishments
10 Hygiene Requirements: Prerequisites Article 3: Food business operators’ obligationsFood business operators must ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation
11 Hygiene Requirements: Prerequisites Article 4: General and specific hygiene requirementsPrimary producers must comply with Annex I and specific requirements of Regulation 853/2004All other food business operators must comply with the general hygiene requirements laid down in Annex IIMicrobiological criteriaTargets set to achieve objectivesTemperature control requirementsMaintenance of the cold chainSampling and analysis
12 Regulation 852/2004 Annex II Chapter Title I General requirements for food premisesIISpecific requirements where foodstuffs are prepared, treated or processedIIIRequirements for movable or temporary premises, premises used primarily as a private dwelling-house but where foods are regularly prepared for placing on the marketIVTransportVEquipment requirementsVIFood wasteVIIWater supplyVIIIPersonal hygieneIXProvisions applicable to foodstuffsXProvisions applicable to the wrapping and packaging of foodXIHeat treatmentXIITraining
13 Small Businesses businesses with no CCPs Document retention by very smallbusinessesBased onHACCPprinciplesHACCPGuidesNature andextent
14 HACCP Requirement: Article 5 (1) ‘Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.’= shall have a system based on HACCP principles
15 7 HACCP Principles Simplified What in my food could harm my customers?Which steps are most important to ensure I prevent the harm?What are the key things to control in these important steps?How do I know they are controlled?What do I do if they are not in control?Will the plan prevent harm to my customers?How do I show an inspector that I am being proactive and how do I introduce new staff to the plan?Conduct Hazard AnalysisIdentify critical control pointsSet critical control limitsMonitor critical control pointsEstablish corrective actionsVerify the HACCP planDocument the HACCP plan
16 Additionally Article 5 (2) emphasises the need to review ‘When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.’
17 Exemption for primary producers: Article 5 (3) ‘Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.’= HACCP does not apply to primary producers and related activities listed in Annex I‘the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;(b) the transport of live animals, where this is necessary to achieve the objectives of this Regulation(c) in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.’
18 Evidence of compliance: Article 5 (4) Food business operators must:provide evidence of their compliance with paragraph 1 in the manner that the competent authority requires, allowing for the nature and size of the food business(b) ensure documents describing the procedures developed are up-to-date at all times;(c) retain any other documents and records for an appropriate period.
19 Arrangements for implementation of Article 5: Article 5 (5) ‘Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2).Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1.Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c).’Q. A separate Regulation on HACCP?A. Unlikely
22 The Scenarios/Options: Businesses where hazards are controlled by good hygiene practices (GHP)/prerequisite hygiene requirements (PRPs)‘Presumed’ to be the case due to the nature of the business orDemonstrated by the business’ own Hazard AnalysisBusinesses which following a sector specific guide to good practice which has already applied the principles of HACCPBusinesses which develop own HACCP system
23 Hazard AnalysisFormal hazard analysis not needed where it is obvious that GHP is sufficient to control hazardsSuch businesses should be advised to follow a guide to good practiceFor certain categories of businesses the hazard analysis may be done for them in generic HACCP guides, i.e. in businesses where:there is a lot of commonalitythe process is linearthe hazard prevalence is highE.g. pasteurisation of liquid food or freezing/quick freezing of food
24 Businesses where hazards are controlled by GHP (prerequisites) alone In particular in food businesses where there is no preparation, manufacturing or processing of foodSimple food preparation operations(such as the slicing of food, bar, small shop)Where necessary, it must be ensured that the necessary monitoring and verification (and possibly record keeping) are carried oute.g where the cold chain must be maintained.
25 Guides to good practice May help food businesses to control hazards and demonstrate complianceApplied by any food sector, where procedures that are well known are used such as:Restaurants, including food handling facilities on board means of transport such as vessels,Catering sectors dispatching prepared food from a central establishment,The bakery and confectionary sector,Retail shops, including butcher shops.
26 Guides to good practice It may suffice that the guides describe in a practical and simple way the methods to control hazardsCover all significant hazards in a business and define procedures to control these hazards and the corrective action to be taken.Highlight the possible hazards linked to certain food (e.g. possible presence of Salmonella in raw eggs ), andMethods to control food contamination (e.g. the purchase of raw eggs from a reliable source and time/temperature combinations for processing).
27 Critical Limits 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) existIn a guide to good practiceDo not need to be numerical e.g.boiling of liquid foodthe change of physical properties of food during processing (e.g. cooking)
28 Alternative Critical Limits Use of alternative critical limits to those in the approved national guides is permitted providing the business can demonstrate that the alternative approach ensures the same level of food safetyA business can demonstrate by:Obtaining critical limit from a reputable sourceConducting own experiments
29 Monitoring Monitoring may in many cases be a simple procedure, e.g. A regular visual verification of the temperature of cooling/freezing facilities using a thermometer (i.e. visual check of the gauge)A visual observation 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).
30 MonitoringCertain foods may sometimes be processed in a standard way using standard calibrated equipment, e.g. certain cooking operations, roasting chicken etc.In such cases the cooking temperature of the product need not be systematically measured as long as it is ensured thatthe equipment is functioning properly,the required time/temperature combination is respected andthe necessary controls for that purpose are carried out (and corrective action taken where necessary).In restaurants, food is prepared in accordance with well established culinary procedures. This implies that measurements (e.g. food temperature measurements) need not be carried out systematically as long as the established procedures are followed.
31 Flexibility in theapplication ofHACCP principles
32 Registration of a food business All food business operators must notify the competent authority of each establishment under its controlProvide the competent authority with up to date information including any significant change in activity and any closure of an existing establishment
33 Approval Provision set out in 852/2004 and 882/2004 A risk-based approval system may be introduced under national regulationsOn receipt of an application an on-site visit is requiredApproval is contingent on compliance with food lawConditional approvalsubject to infrastructure and equipment requirements being met2 x 3 monthsSuspension and revocation
34 Guides to Good Hygiene Practice Member States must encourage the development and use of guides to good hygiene practiceVoluntaryDeveloped and disseminated by the food business sectorsIn consultation with all stakeholdersHave regard to CodexMay be developed through national standards institutesMember States must assess the guides and notify the European Commission who will set up a register of guides
35 Essential considerations when developing a guide All stakeholders should be involvedConsensus achievedGuides should be practical and user friendlyAddress compliance with local food safety requirementsAccount should be taken of practical concerns of small businessAccount should be taken of local and cultural customs and practicesReview periodically, when new significant hazards emerge or changes in legislationPossibly 3rd party certification
36 Regulation 853/2004 Exemptions Composite products Food containing both products of plant origin and processed products of animal originRetailActivities involving direct sale or supply by producers of small quantities of food of animal origin to the final consumerWholesaleStorage and transport only, where temperature requirements in 853/20004 will applyLocal, restricted, marginalisedEU Guidance on the implementation of certain provisions of Regulation 853/2004
37 Hygiene of Foods of Animal Origin These are in addition to H1Specific rules for certain foods i.e. meat, meat products, fish and dairy productsDefines “unprocessed” and “processed” productsApproval of premises and approval number to ensure only approved premises are allowed to place product on the marketHealth and identification markingApproval number to follow product through food chainFood business operators obligationsTrade, import control
38 Hygiene of Foods of Animal Origin Annexes – definitions, requirements concerning several products of animal originSpecific rules – meat, poultry, farmed game, wild game, minced meat and meat preparations, MSM, meat products, live bivalve molluscs, fishery products, raw milk and dairy products, eggs and egg products, frogs legs and snails, rendered animal fats and greaves, treated stomachs, bladders and intestines and gelatine
39 Regulation 2073/2005 on Micro - criteria Regulation on microbiological criteria for foodstuffsFood business operators own checksOfficial controlMaximum limits for undesirable micro-organisms in foodstuffs after risk assessmentLays down micro-criteria referred to in Regulation 852/2004Linked to Regulation 178/2002Safety of foodstuffs is mainly ensured through good hygiene practice and HACCPMicro criteria may be used to validate control measures and verify the correct functioning of these procedures
40 Microbiological Criterion Defines the acceptability of a product, a batch of foodstuffs or a process based on:absence, presence or a number of microorganisms and/or quantity of their toxins/metabolites per unit of mass, volume, area or batch
41 Types of criteria Food safety criteria Defines the acceptability of product or a batch of foodstuffsApplicable to products placed on the marketUnsatisfactory results: product recall / withdrawalProcess hygiene criteriaIndicates the acceptable functioning of the production processApplicable to products at a specified stages during their production processUnsatisfactory results: Improvements in hygiene practices
42 Examples of Food Safety Criteria Food categoryMicro-organismRTE foodsListeria monocytogenesMinced meat & meat preparationsSalmonellaCheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisationCooked crustaceans and molluscan shellfishDried infant formula & dried dietary foods for special medical purposes intended for children below 6 monthsEnterobacter sakazakiiLive bivalve molluscs and live echinoderms, tunicates and gastropodsE. coliDorothy, these are just 6 examples of food safety criteria. There are 26 food safety criteria in total.
43 Process hygiene criteria Food categoryMicro-organismMeat & Meat productsACC, Enterobacteriaceae, Salmonella, E. coliMilk & Dairy productsEnterobacteriaceae, E. coli, coagulase positive staphylococciEgg productsEnterobacteriaceaeFishery productsE. coli, coagulase positive staphylococciVegetable, Fruits & associated productsE. coliDorothy,Please note that each food category is sub-divided further in the legislation. For e.g. meat and meat products are sub divided into* Carcasses (criteria established for ACC, Enterobacteriaceae, salmonella)* minced meat (criteria established for ACC & e. coli)* mechanically separated meat (criteria established for ACC & e. coli)* meat preparations (criteria established for e. coli)
44 In Regulation 2073/2005 microbiological criteria are specified for the following food categories: 1. Meat & meat products2. Milk & dairy products3. Fish & fishery products4. Egg products5. Vegetables, fruits & associated products6. Ready-To-Eat (RTE) Foods
45 Who must comply with the Regulation? Food Business Operators (FBOs):i.e. all FBOs involved in the:processingmanufacturinghandling anddistribution of food (this includes retailers and caterers)Legal basis: Regulation 852/2004 (H1)Competent Authorities:Must verify that FBOs are complying with the RegulationLegal basis: Regulation 882/2004
46 Testing against the criteria * Traditional Approach: End product testing* New Approach: Validation & verification ofHACCP based procedures* FBOs must ensure that: Process hygiene criteria &Food safety criteria are met
47 Action to be taken in case of Unsatisfactory Results Process hygiene criteriaImprovements in production hygieneReview of process controlImprovements in selection/origin of raw materialsUnsatisfactory results: Improvements in hygiene practicesunsatisfactoryFood safety criterionProduct or batch of foodstuff must be recalled or withdrawn from the market (Article 19 of 178/2002)Unsatisfactory results: product recall / withdrawal
48 Analysis of trendEnvironmental samplingShelf life studies
49 How can compliance be verified? Sampling & testingNOTE: Sampling & testing is only one means of verifying complianceMonitoring & surveillanceAudits & inspections
50 EU Guidance on … Sampling plan and frequency Transport of samples, storage and starting analysisRequirements for official laboratoriesMethods of analysisInterpretation of test resultsSamples for supplementary opinionEU Guidance Document on official controls under Regulation (EC) No 882/2004 concerning microbiological sampling and testing of foodstuffs