1. EU Hygiene Regulations
Food & Drug Administration
Bangkok, Thailand
3rd April 2007
Dorothy Guina-Dornan

2. Overview New legislative framework Part II
Regulation (EC) 852/2004: General Hygiene Rules
Regulation (EC) 2073/2005: Microbiological criteria
Regulation (EC) 853/2004: Hygiene Rules – Animal origin
Supporting documentation
Key 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 Law
Official 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 foods
Rules for animal origin foods
Rules for industry
Rules for official controls
Hygiene of Foodstuffs (852/2004)
Hygiene of Foodstuffs
Hygiene 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 178/2002
H1 is supported by Reg. 2073/2004 on microbiological criteria

5. Scope Definitions Hygiene Requirements Approval Guides to
HACCP
Scope
Registration
(notification)
Definitions
Regulation
852/2004
Hygiene Requirements
Approval
Guides to
Good Hygiene Practice
Adaptations &
Derogations
EU & FSAI Guidance

6. Regulation 852/2004: Hygiene of Foodstuffs
All food safety practitioners will enforce the Regulation on the Hygiene of Foodstuffs
Applies to all stages of food and feed chain
Food business operators obligations
Guides to good hygiene practice
HACCP – all non primary producers, all principles
Registration of all premises, approval of some
Microbiological criteria, fixing maximum levels
Temperature control requirements
Import control /2002
Annexes with specific hygiene rules

7. Regulation 852/2004 Prerequisites: Articles 3 and 4 and Annex II
HACCP: Article 5
Registration: Article 6
Guides to good hygiene practice: Article 7
EU guidance on certain provisions of Regulation 852/2004
EU guidance on Implementation procedures based on the HACCP principles

8. Scope
Applies to all stages of production, processing and distribution of food and to exports i.e. it must be a food business including primary production
Applies only to undertakings with a certain continuity of activities and a certain degree of organisation
All 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 use
Domestic preparation, handling or storage for private domestic use
Direct supply, by the producer, of small
quantities of primary products to
the final consumer or
to local retail establishments

10. Hygiene Requirements: Prerequisites
Article 3: Food business operators’ obligations
Food 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 requirements
Primary producers must comply with Annex I and specific requirements of Regulation 853/2004
All other food business operators must comply with the general hygiene requirements laid down in Annex II
Microbiological criteria
Targets set to achieve objectives
Temperature control requirements
Maintenance of the cold chain
Sampling and analysis

12. Regulation 852/2004 Annex II Chapter Title I
General requirements for food premises II
Specific requirements where foodstuffs are prepared, treated or processed
III
Requirements for movable or temporary premises, premises used primarily as a private dwelling-house but where foods are regularly prepared for placing on the market IV
Transport V
Equipment requirements VI
Food waste
VII
Water supply
VIII
Personal hygiene IX
Provisions applicable to foodstuffs X
Provisions applicable to the wrapping and packaging of food XI
Heat treatment
XII
Training

13. Small Businesses businesses with no CCPs Document retention by
very small
businesses
Based on
HACCP
principles
HACCP
Guides
Nature and
extent

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 Analysis
Identify critical control points
Set critical control limits
Monitor critical control points
Establish corrective actions
Verify the HACCP plan
Document 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

20. HACCP Flexibility

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 or
Demonstrated by the business’ own Hazard Analysis
Businesses which following a sector specific guide to good practice which has already applied the principles of HACCP
Businesses which develop own HACCP system

23. Hazard Analysis
Formal hazard analysis not needed where it is obvious that GHP is sufficient to control hazards
Such businesses should be advised to follow a guide to good practice
For 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 commonality
the process is linear
the hazard prevalence is high
E.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 food
Simple 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 out
e.g where the cold chain must be maintained.

25. Guides to good practice
May help food businesses to control hazards and demonstrate compliance
Applied 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 hazards
Cover 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 ), and
Methods 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) exist
In a guide to good practice
Do not need to be numerical e.g.
boiling of liquid food
the 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 safety
A business can demonstrate by:
Obtaining critical limit from a reputable source
Conducting 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. Monitoring
Certain 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 that
the equipment is functioning properly,
the required time/temperature combination is respected and
the 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 the
application of
HACCP principles

32. Registration of a food business
All food business operators must notify the competent authority of each establishment under its control
Provide 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 regulations
On receipt of an application an on-site visit is required
Approval is contingent on compliance with food law
Conditional approval
subject to infrastructure and equipment requirements being met
2 x 3 months
Suspension and revocation

34. Guides to Good Hygiene Practice
Member States must encourage the development and use of guides to good hygiene practice
Voluntary
Developed and disseminated by the food business sectors
In consultation with all stakeholders
Have regard to Codex
May be developed through national standards institutes
Member 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 involved
Consensus achieved
Guides should be practical and user friendly
Address compliance with local food safety requirements
Account should be taken of practical concerns of small business
Account should be taken of local and cultural customs and practices
Review periodically, when new significant hazards emerge or changes in legislation
Possibly 3rd party certification

36. Regulation 853/2004 Exemptions Composite products
Food containing both products of plant origin and processed products of animal origin
Retail
Activities involving direct sale or supply by producers of small quantities of food of animal origin to the final consumer
Wholesale
Storage and transport only, where temperature requirements in 853/20004 will apply
Local, restricted, marginalised
EU Guidance on the implementation of certain provisions of Regulation 853/2004

37. Hygiene of Foods of Animal Origin
These are in addition to H1
Specific rules for certain foods i.e. meat, meat products, fish and dairy products
Defines “unprocessed” and “processed” products
Approval of premises and approval number to ensure only approved premises are allowed to place product on the market
Health and identification marking
Approval number to follow product through food chain
Food business operators obligations
Trade, import control

38. Hygiene of Foods of Animal Origin
Annexes – definitions, requirements concerning several products of animal origin
Specific 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 foodstuffs
Food business operators own checks
Official control
Maximum limits for undesirable micro-organisms in foodstuffs after risk assessment
Lays down micro-criteria referred to in Regulation 852/2004
Linked to Regulation 178/2002
Safety of foodstuffs is mainly ensured through good hygiene practice and HACCP
Micro 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 foodstuffs
Applicable to products placed on the market
Unsatisfactory results: product recall / withdrawal
Process hygiene criteria
Indicates the acceptable functioning of the production process
Applicable to products at a specified stages during their production process
Unsatisfactory results: Improvements in hygiene practices

42. Examples of Food Safety Criteria
Food category
Micro-organism
RTE foods
Listeria monocytogenes
Minced meat & meat preparations
Salmonella
Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation
Cooked crustaceans and molluscan shellfish
Dried infant formula & dried dietary foods for special medical purposes intended for children below 6 months
Enterobacter sakazakii
Live bivalve molluscs and live echinoderms, tunicates and gastropods
E. coli
Dorothy, these are just 6 examples of food safety criteria. There are 26 food safety criteria in total.

43. Process hygiene criteria
Food category
Micro-organism
Meat & Meat products
ACC, Enterobacteriaceae, Salmonella, E. coli
Milk & Dairy products
Enterobacteriaceae, E. coli, coagulase positive staphylococci
Egg products
Enterobacteriaceae
Fishery products
E. coli, coagulase positive staphylococci
Vegetable, Fruits & associated products
E. coli
Dorothy,
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 products
2. Milk & dairy products
3. Fish & fishery products
4. Egg products
5. Vegetables, fruits & associated products
6. Ready-To-Eat (RTE) Foods

45. Who must comply with the Regulation?
Food Business Operators (FBOs):
i.e. all FBOs involved in the:
processing
manufacturing
handling and
distribution of food (this includes retailers and caterers)
Legal basis: Regulation 852/2004 (H1)
Competent Authorities:
Must verify that FBOs are complying with the Regulation
Legal basis: Regulation 882/2004

46. Testing against the criteria
* Traditional Approach: End product testing
* New Approach: Validation & verification of
HACCP 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 criteria
Improvements in production hygiene
Review of process control
Improvements in selection/origin of raw materials
Unsatisfactory results: Improvements in hygiene practices
unsatisfactory
Food safety criterion
Product 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 trend
Environmental sampling
Shelf life studies

49. How can compliance be verified?
Sampling & testing
NOTE: Sampling & testing is only one means of verifying compliance
Monitoring & surveillance
Audits & inspections

50. EU Guidance on … Sampling plan and frequency
Transport of samples, storage and starting analysis
Requirements for official laboratories
Methods of analysis
Interpretation of test results
Samples for supplementary opinion
EU Guidance Document on official controls under Regulation (EC) No 882/2004 concerning microbiological sampling and testing of foodstuffs