Implementation of Ukraine

1
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Official Controls
• Legislative Framework
• Hazard Classification

2
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Introduction
• Tony Wheale

3
SWAP-RURAL Project
Project objectives

• Assist Ukraine to achieve greater EU integration
  and harmonisation with closer compliance with WTO
  requirements.

Project Purpose

• Support the application of a Sector Wide Approach
  (SWAP) for agriculture and rural development
  within the context of WTO accession and the ENP
  Action Plan

4
Food Safety Component
Activities in the pilot regions - Seminars

• We are presenting a series of mass seminars in
  each of the pilot regions to which will be
  invited
• Representatives of the food industry
• Representatives of regional departments of
  veterinary services and laboratories
• Representatives of regional offices of the Agency
  for the identification and registration
• Representatives of regional departments of the
  Sanitary-Epidemiological Service
• We also plan to present more detailed and
  in-depth seminars on An introduction to the
  HACCP system and pre-requisites.

Slide 4
5
Food Safety Component
Activities in the pilot regions - HACCP

• We also work with enterprises in the pilot
  regions to help develop and implement HACCP,
  traceability and pre-requisite systems
• Each of the pilot regions is scheduled to select
  companies for implementation of the HACCP system
  and pre-requisites
• Preliminary assessment of each enterprise under
  agreed criteria
• Training of responsible personnel at enterprises
  on HACCP and pre-requisite systems
• Providing advice on implementation of these
  systems
• Assisting enterprises to prepare for EU approval
  inspections by inspectors of the EU Food and
  Veterinary Office (FVO)

Slide 5
6
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)
Thank you for your attention
7
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Legislative Framework
• Yana Dobidovska

Slide 7
8
EU Food Safety Legislation

• Framework that defines obligations for food and
  feed business operators
• Defines official controls to be carried out by EU
  Member States
• Requires EU Member States to have effective
  sanctions and penalties
• Enables free trade within the EU
• Non-EU countries must have similar systems to be
  able to trade with the EU

Slide 8
Slide 8
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EU Food Safety Legislation

• Compare with owning and driving a car
• Obligations on car driver pass driving test,
  good state of health, keep car in safe condition,
  drive responsibly
• Powers of police check speed, check condition
  of vehicle, stop a car on the road, examine
  documents
• Contravene the law administrative fine,
  criminal prosecution, confiscation of car

Slide 9
Slide 9
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EU Food Safety Legislation

• EU Regulations that define obligations for Food
  Feed Business Operators include
• Regulation 178/2002 (General Food Law)
• 852/2004 (General Food Hygiene Rules)
• 853/2004 (Additional Hygiene Rules for Food of
  Animal Origin)
• 1935/2004 (Food Contact Materials)
• 183/2005 (Feed Hygiene Rules)
• 2073/2005 (Microbiological Criteria).

Slide 10
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Example Regulation 178/2002

• Not to place unsafe food on the market
• Ensure the safety of the food and feed they
  produce
• Ensure traceability of all materials at least one
  step forward / one step back
• Withdraw unsafe food from the market
• Identify Critical Control Points (CCPs) and apply
  appropriate controls
• Cooperate with Competent Authorities

Slide 11
Slide 11
12
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)
Thank you for your attention
13
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Official Controls
• Tony Wheale

Slide 13
14
Regulation (EC) No. 882/2004

• Official Controls
• Checks carried out by competent authorities to
  monitor compliance by business operators with
  legislation.
• Checks include inspections, audits, monitoring,
  surveillance, sampling and analysis.
• The objective of the Regulation is to improve the
  consistency and effectiveness of controls and
  raise standards of food safety and consumer
  protection.

15
Regulation (EC) No. 882/2004

• Official Controls
• Must be carried out regularly.
• Must be risk-based
• Must be without prior notice
• Must cover all stages of the food chain from
  farm to fork
• Must cover food and animal feed produced within
  the country, imported into the country, and
  intended for export from the country.

16
Regulation (EC) No. 882/2004

• Planning of official controls take into
  account
• Risks associated with animals, animal feed, food,
  processes, materials, substances, activities or
  operations that may affect the safety of animal
  feed or food
• The business operators' past record of compliance
  with legislation and with animal health and
  animal welfare rules and
• Other information that might indicate
  non-compliance.

17
Regulation (EC) No. 882/2004

• Competent Authorities
• Each country has one central competent authority.
• The central competent authority is usually a
  ministry or an independent agency.
• For example
• Danish Veterinary and Food Administration
• Food Safety Authority of Ireland
• Food Standards Agency (UK)
• Countries may devolve authority, e.g. to Oblast
  or Rayon administrations, but these must be
  supervised by the central competent authority.

18
Regulation (EC) No. 854/2004

• Competent authorities must ensure
• The effectiveness of official controls
• Impartiality and accountability
• Provision of suitable laboratories
• Legal powers to enforce legislation
• Contingency planning
• Supervision of Oblast and Rayon administrations
• Monitoring, surveillance and audit
• Training of control officials.

19
Regulation (EC) No. 882/2004

• Sampling and analysis
• Procedures and methods must comply with
  internationally recognised rules
• If there are no international rules, then there
  must be national rules that are objective and
  based on scientific evidence
• Annual official monitoring and surveillance
  programs for planned and coordinated sampling.

20
Regulation (EC) No. 882/2004

• Official Laboratories
• Competent authorities designate official
  laboratories, which must be accredited in
  accordance with
• (a) EN ISO/IEC 17025 on "General requirements for
  the competence of testing and calibration
  laboratories"
• (b)EN 45002 on "General criteria for the
  assessment of testing laboratories"
• (c) EN 45003 on "Calibration and testing
  laboratory accreditation system-General
  requirements for operation and recognition.

21
Regulation (EC) No. 882/2004

• Controls on imports from third countries
• Veterinary checks on products of animal origin
  are unaffected by Regulation 882/2004
• Competent authorities carry out risk-based
  official controls on imports of animal feed and
  food of non-animal origin from third countries
• Ports, airports and land border crossings for
  entry of imports of products of animal origin
  must be specified
• An importer must give the competent authority
  advance notice of every consignment.

22
Regulation (EC) No. 882/2004

• Controls on imports from third countries
• Consignments that do not meet the rules may be
  returned to their country of origin
• The rules for allowing consignments to be
  returned to the country of origin must be set out
  in detail
• The costs of returning a consignment to another
  country are paid by the importer.

23
Regulation (EC) No. 882/2004

• Controls on imports from third countries
• Competent authorities and national customs
  services must co-operate closely.
• Customs services must not release food or animal
  feed unless they have the approval of the
  competent authority.

24
Regulation (EC) No. 882/2004

• EU official controls in third countries
• EU experts carry out official controls in third
  countries to verify equivalence of the third
  countrys legislation and official control
  systems with EU animal feed, food, and animal
  health legislation
• These official controls are carried out by
  experts from the EUs Food and Veterinary Office
  (FVO)
• Recent FVO visits to Ukraine have looked at the
  production of fishery products, residue control
  and monitoring, sunflower oil, milk and dairy
  products, poultry meat and red meat production,
  egg production, and Ukraines official control
  systems in these sectors.

25
Regulation (EC) No. 854/2004

• Official Controls
• Products of animal origin
• Regulation 854/2004 sets out specific rules for
  official controls on products of animal origin
  intended for human consumption.
• Official veterinarians must carry out audits and
  inspections of slaughterhouses, game handling
  establishments and meat cutting plants
• The central competent authority should decide who
  are the most appropriate staff to audit and
  inspect other types of establishment.

26
Regulation (EC) No. 854/2004

• Official Controls
• Products of animal origin
• Establishments in the EU and imports from third
  countries are subject to similar controls
• Competent authorities approve establishments that
  comply with EU legislation.
• Approved establishments are given a unique
  approval code
• Approval may be suspended or withdrawn if the
  competent authority identifies serious deficiency.

27
Regulation (EC) No. 854/2004

• Official Controls
• Products of animal origin
• Business operators must give competent
  authorities all the assistance they need to carry
  out official controls (e.g. access to premises,
  documents, records)
• Official controls include
• audits of good hygiene practice and HACCP
• specific controls that are relevant to the
  specific food industry sector (e.g. fresh meat,
  fishery products, milk and dairy products).

Slide 27
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Regulation (EC) No. 854/2004

• Official veterinarian
• Appointed and authorised by the competent
  authority
• Professionally qualified
• Has passed a special test
• Responsible for auditing and inspecting good
  hygiene practice (maintenance of plant structure
  and equipment, plant hygiene, staff hygiene,
  training, processing of animal by-products not
  intended for human consumption, etc.)
• Responsible for auditing the HACCP system in
  relation to compliance of products of animal
  origin with microbiological criteria, and absence
  of excessive quantities of prohibited substances,
  contaminants or chemical residues, etc.

Slide 28
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Regulation (EC) No. 854/2004

• Official veterinarians responsibilities
• Traceability records
• Ante-mortem inspections
• Animal welfare during transport and slaughter
• Post-mortem inspections
• Specified Risk Material (TSE controls)
• Other animal waste and by-products
• Laboratory testing (zoonoses, TSE, other
  diseases)
• Health and identification marks
• Official veterinarians may be assisted by
  veterinary auxilliaries.

Slide 29
30
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Responsibilities of FBOs, and
• Responsibilities of the State
• Yana Dobidovska

Slide 30
31
Conclusions
FBO and OFFICIAL CONTROL RESPONSIBILITY
Food of animal origin
All foodstuffs
Feed for animals
Regulation 2073/2005 Microbiological criteria for
foodstuffs
Obligations of food/feed business operators
Regulation x 853/2004
Regulation 183/2005
Regulation x 852/2004
Regulation 882/2004
Regulation x 854/2004
Official controls
General Food Law (Regulation 178/2002)
32
Responsibilities of FBO

• Reg 178/2002 Article 17
• Food and feed business operators at all stages
  of production, processing and distribution within
  the businesses under their control shall ensure
  that foods or feeds satisfy the requirements of
  food law which are relevant to their activities
  and shall verify that such requirements are met.

33
Responsibilities of FBO

• Reg 178/2002 Article 17
• If a food business operator considers or has
  reason to believe that a food which it has
  imported, produced, processed, manufactured or
  distributed is not in compliance with the food
  safety requirements, it shall immediately
  initiate procedures to withdraw the food in
  question from the market where the food has left
  the immediate control of that initial food
  business operator and inform the competent
  authorities thereof. Where the product may have
  reached the consumer, the operator shall
  effectively and accurately inform the consumers
  of the reason for its withdrawal, and if
  necessary, recall from consumers products already
  supplied to them when other measures are not
  sufficient to achieve a high level of health
  protection.

34
Responsibilities of FBO

• Reg 178/2002 Article 17
• 2. A food business operator responsible for
  retail or distribution activities which do not
  affect the packaging, labelling, safety or
  integrity of the food shall, within the limits of
  its respective activities, initiate procedures to
  withdraw from the market products not in
  compliance with the food-safety requirements and
  shall participate in contributing to the safety
  of the food by passing on relevant information
  necessary to trace a food, cooperating in the
  action taken by producers, processors,
  manufacturers and/or the competent authorities.

35
Responsibilities of FBO

• Reg 178/2002 Article 17
• 3. A food business operator shall immediately
  inform the competent authorities if it considers
  or has reason to believe that a food which it has
  placed on the market may be injurious to human
  health. Operators shall inform the competent
  authorities of the action taken to prevent risks
  to the final consumer and shall not prevent or
  discourage any person from cooperating, in
  accordance with national law and legal practice,
  with the competent authorities, where this may
  prevent, reduce or eliminate a risk arising from
  a food.
• 4. Food business operators shall collaborate with
  the competent authorities on action taken to
  avoid or reduce risks
• posed by a food which they supply or have
  supplied.

36
Responsibilities of States

• Articel 17 Responsibilities (2)
• Member States shall enforce food law, and monitor
  and verify that the relevant requirements of food
  law are fulfilled by food and feed business
  operators at all stages of production, processing
  and distribution.
• For that purpose, they shall maintain a system of
  official controls and other activities as
  appropriate to the circumstances, including
  public communication on food and feed safety and
  risk, food and feed safety surveillance and other
  monitoring activities covering all stages of
  production, processing and distribution.
• Member States shall also lay down the rules on
  measures and penalties applicable to
  infringements of food and feed law. The measures
  and penalties provided for shall be effective,
  proportionate and dissuasive.

37
COMPETENT AUTHORIT(Y)IES

• Reg. 852/2004
• competent authority means the central authority
  of a Member
• State competent to ensure compliance with the
  requirements of
• this Regulation or any other authority to which
  that central
• authority has delegated that competence it shall
  also include,
• where appropriate, the corresponding authority of
  a third country
• Reg. 882/2004
• competent authority means the central authority
  of a Member
• State competent for the organisation of official
  controls or any
• other authority to which that competence has been
  conferred it
• shall also include, where appropriate, the
  corresponding authority
• of a third country
• Reg. 854/2004
• competent authority means the central authority
  of a Member State competent to carry out
  veterinary checks or any authority to which it
  has delegated that competence

38
COMPETENT AUTHORITIES

• Designation of competent authorities and
  operational criteria (Art. 4)
• Member States shall designate the competent
  authorities responsible for the purposes and
  official controls set out in this Regulation.
• The competent authorities shall ensure
• - the effectiveness and appropriateness of
  official controls on live animals, feed and food
  at all stages of production, processing and
  distribution, and on the use of feed
• - that staff carrying out official controls are
  free from any conflict of interest

39
COMPETENT AUTHORITIES

• The competent authorities shall ensure
• - that they have, or have access to, an
  adequate laboratory capacity for testing and a
  sufficient number of suitably qualified and
  experienced staff so that official controls and
  control duties can be carried out efficiently and
  effectively
• - that they have appropriate and properly
  maintained facilities
• - and equipment to ensure that staff can
  perform official controls efficiently and
  effectively
• - that they have the legal powers to carry out
  official controls and to take the measures
  provided for in this Regulation
• - that they have contingency plans in place,
• - that the feed and food business operators
  are obliged to undergo any inspection carried out
  in accordance with this Regulation and to assist
  staff of the competent authority in the
  accomplishment of their tasks.

40
COMPETENT AUTHORITIES

• The competent authorities shall ensure
• - when, within a competent authority, more than
  one unit is competent to carry out official
  controls, efficient and effective coordination
  and cooperation shall be ensured between the
  different units.
• - Competent authorities shall carry out
  internal audits or may have external audits
  carried out,

41
COMPETENT AUTHORITIES

• Delegation of specific tasks related to official
  controls
• The competent authority may delegate specific
  tasks related to official controls to one or more
  control bodies in accordance with paragraphs 2 to
  4.
• Any Member State wishing to delegate a specific
  control task to a control body shall notify the
  Commission. This notification
• shall provide a detailed description of
• (a) the competent authority that would
  delegate the task
• (b) the task that it would delegate
• and
• (c) the control body to which it would
  delegate the task.

42
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Criteria of FBO evaluation. Experience of EU
  countries.
• Yuriy Ohlashennyy

Slide 42
43
Criteria of FBO evaluation

• Each country has own system of FBO evaluation,
  but these systems are based on risk assessment.
• The risk can be considered as
• - high
• - medium
• - low and/or very low
• Depending on adverse effect on human health

44
Criteria of FBO evaluation, example

• FBO structure and equipment
• Buildings and facilities for processing, storage
  and marketing of food products of animal origin
  must be constructed and comply with relevant EU
  regulations (852, 853).
• Evaluation of risk. Depends on the year of
  construction, premises and equipment condition,
  layout, routine maintenace of equipment and
  premises.

45
Criteria of FBO evaluation, example

• Capacity of the sites
• Each establishment is designed in a way that
  allows processing and production of a certain
  amount of raw materials and foods on the base of
  hours capacity, daily capacity or weekly
  capacity and also allows their efficient storage.
  In determining the frequency of verification
  inspectors should also take into account seasonal
  factors.
• Evaluation of risk. Higher capacity leads in the
  case of deviation to increase of quantity of
  dangerous products and risk growth.

46
Criteria of FBO evaluation, example

• Range of products
• Establishments that produce a range of products
  will have different documentation relevant to
  each product. As such they are complicated and
  will have additional challenges in terms of
  meeting the food safety requirements.
• Evaluation of risk. Wide range of products,
  various structure and different technology
  treatment cause higher risk.

47
Criteria of FBO evaluation, example

• Technology (type of products)
• Different food products of animal origin undergo
  a diverse range of technological processes, each
  of which is associated with differing hazards and
  risks..
• Evaluation of risk. Evaluation of the risk
  depends on the process technology criteria in
  terms of compliance with process parameters
  (time, temperature, pressure, etc.) in the
  product process documentation.

48
Criteria of FBO evaluation, example

• Origin and quality of raw materials
• The raw materials used by FBOs for processing,
  production, storage and marketing of food of
  animal origin are particularly important
  criterion for evaluation of the risk in the
  production and marketing of a certain product.
• Evaluation of risk. Improper supplier
  evaluation, use of raw material of inappropriate
  origin, etc., lead to risk increase.

49
Criteria of FBO evaluation, example

• Water supply
• The water used for processing, production,
  storage and marketing is a very important factor
  with regard to the safety of food products. Each
  food processing establishment is unique in terms
  of the water used for different production
  processes.
• Evaluation of risk. Depends on
• the type of used water sources (public or own
  water sours)
• the condition of plumbing
• the quantity of incorporated in the product
  water
• flow of the water in the enterprise
• differences in the composition of the water in
  the regions(e.g. in some regions the level
• of heavy metals, or salt or calcium etc. could
  be higher)
• control over implementation of monitoring
  programs for water safety in accordance of
  legislation

50
Criteria of FBO evaluation, example

• Systems of self-control In accordance with the
  European and national legislations the
  establishment for processing, production, storage
  and marketing of food of animal origin should
  have developed and implemented food control
  systems (good manufacturing practices and HACCP).
  Each company has individual characteristics that
  must be taken into consideration when the self
  control systems are assessed (scope and stage of
  application)
• Evaluaton of risk. Self-control system shall be
  developed, fully implemented, validated, based on
  relevant legislation and shall cover whole
  product range.

51
Criteria of FBO evaluation, example

• Training of the enterprises staff. It is
  essential to have professional, well qualified,
  trained and experience staff to ensure the safety
  of food of animal origin during processing,
  production, storage and marketing is. In the
  countrys manufacturing industry, FBOS have
  different levels of training and production
  experienced available staff.
• Evaluaton of risk. The available staff in the
  establishments shall posess necessary education,
  professional experience and competence in
  carrying out the manufacturing process as well as
  the implementation of the self-control systems.
  The company shall have a developed program and
  financial resources for further training and
  qualification of the personnel and system of it
  evaluation.

52
Criteria of FBO evaluation, example

• Laboratory monitoring. The analysis of samples
  taken from production process is an important
  tool for detecting the presence of hazards in
  food and the results can be applied in risk
  analysis. Samples for the control of production
  environment and equipment must be taken
  regularly.
• Evaluaton of risk. Internal monitoring program
  for sampling and laboratory testing shall be
  developed and implemented.
• Survey results shall show that processed,
  produced and stored food is safe.
• Appropriate corrective actions shall be
  implemented in the case of deviation.

53
Criteria of FBO evaluation, example

• Management of the site. Management of sites must
  include all aspects of food safety controls. The
  management commitment directly affects the
  overall organisation of the site production,
  safety food and contributes to consumer
  confidence in the safety of the product(s).
• Evaluaton of risk. The executive body shall
  realize its responsibility regarding the safety
  of the manufactured products. The instructions
  made by the official authorities shall be
  observed within the deadlines. Complaints shall
  be analyzed. Internal audits shall be performed.
  Procedures of crisis management and correction
  action shall be implemented.

54
Criteria of FBO evaluation, example

• Improvement. FBO-s of any establishment on the
  basis of found by CA Non compliances have to draw
  an Action plan with specific activities that must
  be taken as well to define the reasonable time
  for this activities and to prepare the
  establishment in accordance with the structural
  requirements. The plan must be approved by the
  CA.
• Evaluaton of risk. All of non-conformities found
  during CA audit shall be removed according
  approved Action plan within timeframe and their
  effectiveness shall be verified.

55
Criteria of FBO evaluation, example

• Signal system for rapid alert. The presence or
  absences of incoming or outgoing notifications
  about manufacturing unsafe product are recorded
  as criteria for evaluation of the risk of a
  particular product.
• Evaluaton of risk. Depends on notification during
  defined time period.

56
Criteria of FBO evaluation, example

• Location. The location of FBOS that are
  producing, storing or marketing food of animal
  origin cannot be considered isolated from the
  environmental conditions, which will directly
  affect the safety of their food product.
• Evaluaton of risk. Establishments for production,
  processing, storage and marketing of food shall
  be located outside of settlements, near holdings
  and/or storage for grain and feed, industries
  polluting the environment. Measures shall be
  implemented to avoid invasion of pests. Shall be
  solid fence, appropriate piper/ sewer system.

57
Risk assessment in Bulgaria
Criteria Classification of the risk Classification of the risk Classification of the risk Classification of the risk
Criteria High Medium Low Very low
?. Structure and equipment. H 10 M 7 L 5 VL 2
??. Site capacity (throughput). H 5 M 3 L 2 VL 1
???. Range of products. H 7 L 2
?V. Technology (type of product) H 9 M 6 L 3 VL 1
V. Origin and quality of raw materials. H 9 M 6 L 3 VL 1
V?. Water suppliers. H 7 M 5 L 3 VL1
V??. Self-control systems. H 10 M 7 L 5 VL 2
V???. Qualification of the personnel H- 7 M- 5 L- 3 VL- 1
??. Lab monitoring. H 10 M 7 L 5 VL 2
?. Managing the site. H 7 M 5 L 3 VL 1
??. Establishments in transition period H 7 M 5 L 3 VL 1
???. Reports from RASFF H 5 L 0
????. Location (site). H 4 M 3 L 2 VL 1
58
Risk assessment in Bulgaria
FREQUENCY OF CONTROL
Group I establishments at high risk a
collection of over 75 points supervision
minimum once a week Group II medium risk
establishments a collection of 58 to 74 points
time control minimum once at every 10 days Group
III establishments with low risk the sum of
points is between 27 to 57 time controls at
least once per month Group IV establishments
with very low risk the set of points is up to
26 time control minimum once on every 2
months. In cases when a company has a risk
assessment higher than that of the group for one
or more criteria I, VII, IX and X, it is
automatically placed into the group with a higher
risk of hazards.
59
Risk assessment in Portugal
Approval
60
Risk assessment in Portugal
61
Risk assessment in Portugal
62
Risk assessment in Portugal
63
Risk assessment in Portugal
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Risk assessment in Portugal
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Risk assessment in Portugal
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Risk assessment in Portugal
67
Risk assessment in Portugal
68
Risk assessment in England

• 1.The potential hazard
• Type of food and method of handling.
• 40 Manufacturers subject to approval under
  Regulation 853/2004 and manufacturers of other
  high-risk food (foods which support the growth of
  micro-organisms, and/or are intended for
  consumption without further treatment that could
  destroy pathogenic micro-organisms or their
  toxins)
•  30 Preparation, cooking or handling of open
  high-risk foods by caterers and retailers, except
  caterers that prepare less than 20 meals a day.
•  10 Handling of pre-packed high-risk foods
• Caterers who prepare high-risk foods but serve
  less than 20 meals a day
• Other wholesalers and distributors not included
  in the categories above
• Manufacture or packing of foods other than
  high-risk
• Establishments involved in the filleting, salting
  or cold smoking of fish for retail sale to final
  consumer. 
• 5 Retail handling of foods other than high-risk,
  such as fruit, vegetables, canned and other
  ambient shelf stable products.Any other
  businesses not included in the categories above.

69
Risk assessment in England
1.The potential hazard B. Method of processing.
An additional score should be included for
processes listed in the table below. If an
additional score under this section is
appropriate, it may only be allocated once, i.e.
the maximum score under this section is 20.  20
Thermal processing or aseptic packing of low-acid
foods Vacuum and sous-vide packing (except
raw/unprocessed meat and dried foods)Manufacture
of cook/chill food, i.e. cooked and prepared
meals or foodswhich may be eaten cold or after
reheating. (NB Catering premises should not be
included in this category unless they are engaged
in the specific operation referred to
commercially, as the preparation of cookchill
meals. The simple reheating of cook-chill meals
is excluded from the scope of this
paragraph)Small-scale production of cooked meat
products in food business establishments which
are not subject to approval under Regulation
853/2004 e.g. by certain retailers including
butchers.  0 Any other case not included above.
70
Risk assessment in England
1.The potential hazard C. Consumers at risk. The
number of consumers likely to be at risk if there
is a failure of food hygiene and safety
procedures.  15 Manufacturers of food which is
distributed nationally or internationally.  10
Businesses serving a substantial number of
customers, including a significant proportion
from outside the local area, e.g. superstore,
hypermarket, airport caterer, motorway service
area caterer Manufacturers not included in the
category above.  5 Businesses, most of whose
customers are likely to be living, staying or
working in the local area, e.g. high street or
corner shop, high street supermarket, or high
street restaurant.  0 Businesses supplying less
than 20 consumers each day.
71
Risk assessment in England
1.The potential hazard C. Consumers at risk.
PLUS An additional score of 22 should be
included for establishments such as hospitals,
nursing homes, day-care centres and child
nurseries, where production and/or service of
high-risk foods takes place, and where more than
20 persons in a vulnerable group are at risk. In
this context, vulnerable groups are those that
include people who are under 5 or over 65 years
of age, people who are sick, and people who are
immunocompromised. Score Guidance on the scoring
system  22 Production and/or service of high-risk
foods in premises where there are more than 20
people in a vulnerable group at risk  0 Any
other case not included above.
72
Risk assessment in England
2.Level of (current) compliance. The food hygiene
and safety procedures (including food handling
practices and procedures, and temperature
control), and the structure of the establishment
(including cleanliness, layout, condition of
structure, lighting, ventilation, facilities
etc.), should be assessed separately using the
scoring system below.   The score should reflect
compliance observed during the inspection
according to the guidance set out below.
Adherence to any relevant UK or EU Industry Guide
to Good Hygiene Practice should be considered
when assessing compliance.   Conformity with
relevant national guidelines or industry codes of
recommended practice will also be necessary to
score 0 or 5.
73
Risk assessment in England
2.Level of (current) compliance. 25 Almost total
non-compliance with statutory obligations.  20
General failure to satisfy statutory obligations
standards generally low.  15 Some major
non-compliance with statutory obligations more
effort required to prevent fall in
standards.   10 Some non-compliance with
statutory obligations and industry codes of
recommended practice. Standards are being
maintained or improved.  5 High standard of
compliance with statutory obligations, industry
codes of recommended practice, and minor
contraventions of food hygiene regulations. Some
minor non-compliance with statutory obligations
and industry codes of recommended practice.  0
High standard of compliance with statutory
obligations and industry codes of recommended
practice conforms to accepted good practices in
the trade.
74
Risk assessment in England
3. Confidence in management/control
procedures The actual performance of management
is scored in Part 2 on the basis of the results
achieved and observed. A management that achieves
good food hygiene performance, well understood by
the workforce, should have achieved a good
standard in Part 2, and consequently a low score
for that factor. Confidence in management is not
meant to reconsider this aspect. It is to elicit
a judgement on the likelihood of satisfactory
compliance being maintained in the
future. Factors that will influence the
inspector's judgement include the "track
record" of the company, its willingness to act on
previous advice and enforcement, and the
complaint history the attitude of the present
management towards hygiene and food safety and
hygiene and food safety technical knowledge
available to the company (internal or external),
including hazard analysis/HACCP and the control
of critical points satisfactory HACCP based
procedures.
75
Risk assessment in England
3. Confidence in management/control
procedures 30 Poor track record of compliance.
Little or no technical knowledge. Little or no
appreciation of hazards or quality control. No
food safety management procedures.  20 Varying
record of compliance. Poor appreciation of
hazards and control measures. No food safety
management system.  10 Satisfactory record of
compliance. Access to and use of technical advice
either in-house, from trade associations and/or
from Guides to Good Practice. Understanding of
significant hazards and control measures in
place. Making satisfactory progress towards a
documented food safety management
system/procedures commensurate with type of
business. 
76
Risk assessment in England
3. Confidence in management/control procedures 5
Reasonable record of compliance. Technical
advice available in-house or access to, and use
of, technical advice from trade associations
and/or from Guides to Good Practice. Have
satisfactory documented procedures. Able to
demonstrate effective control of hazards. Will
have satisfactory documented food safety
management system. Audit by Food Authority
confirms general compliance with procedures.  0
Good record of compliance. Access to technical
advice within organisation. Will have
satisfactory documented HACCP based food safety
management procedures, which may be subject to
external audit process. Audit by Food Authority
confirms compliance with documented procedures
with few/minor non-conformities not identified in
the system as critical control points.
77
Risk assessment in England
3. Confidence in management/control
procedures PLUS An additional score of 20 (in
addition to the score above) should be included
where there is a significant risk of food
being contaminated with Clostridium botulinum and
the micro-organism surviving any processing and
multiplying or of ready-to-eat food being or
becoming contaminated with micro-organisms or
their toxins that are pathogenic to humans, e.g.
E. coli O157 or other VTEC, Salmonella sp.
Bacillus cereus. In this context, significant
risk means the probability that an incident is
likely to occur.
78
Risk assessment in England
3. Confidence in management/control
procedures The following matters should be
considered when assessing this factor the
potential for contamination or cross-contamination
by the specified microorganisms the
likelihood of survival and growth of the
specified micro-organisms the existence of
procedures based on HACCP principles and
confidence in their implementation, including
documentation and records of monitoring of
controls the extent and relevance of training
undertaken by managers, supervisors and food
handlers and whether intervention by the Food
Authority is necessary to reduce the probability
of an incident occurring.
79
Risk assessment in England
3. Confidence in management/control
procedures The additional score must also be
consistent with the baseline assessment of
Confidence in Management/Control Systems. If
confidence in management is assessed as 0 or 5,
and there is also assessed to be a significant
risk of contamination of food with one of the
specified micro-organisms, then one of the
assessments cannot be correct, and each should be
reviewed. Establishments should not pose a
significant risk if there is high or moderate
Confidence in Management/Control Systems. 20
Significant risk of food being contaminated with
Cl. botulinum, and the organism surviving any
processing and multiplying or Significant risk
of ready-to-eat food being contaminated with
microorganisms or their toxins that are
pathogenic to humans.   0 Any other case not
included above.
80
Risk assessment in England
4. Food hygiene intervention frequencies Category
Score Minimum intervention frequency A 92 or
higher At least every six months B 72 to 91 At
least every 12 months C 42 to 71 At least every
18 months D 31 to 41 at least every 24 months E 0
to 30 A programme of alternative enforcement
strategies or interventions every three
years   Establishments rated as low-risk (30 or
less) need not be included in the planned
inspection programme, but must be subject to an
alternative enforcement strategy at least once in
every 3 years.
81
Implementation of Ukraines Commitments under WTO
and ENP Frameworks in the Rural Sector
(Sector-wide approach)

• Inspections and Audits. How to organize audits.
• Yuriy Ohlashennyy

Slide 81
82
TERMS / DEFINITIONS

1. Inspection what an inspector does.
2. Audit what an auditor does.
3. Inspection and audit what an EU food control
   official does.

83
TERMS / DEFINITIONS

• Inspection means the examination of any aspect
  of feed, food, animal health and animal welfare
  in order to verify that such aspect(s) comply
  with the legal requirements of feed and food law
  and animal health and animal welfare rules
• (Article 2 (7) Regulation (EC) No.882/2004)

84
TERMS/DEFINITIONS

• Audit - is a systematic and independent
  examination to determine whether activities and
  related results comply with planned arrangements
  and whether these arrangements are implemented
  effectively and are suitable to achieve
  objectives
• (Article 2 (6) Regulation (EC) No.882/2004)

85
Inspection versus audit

• INSPECTION
• Can take a shorter time
• Aims to check compliance with (a part of) the
  legislation
• Unannounced
• In case of complaints/ rapid alerts
• As a follow up of audits

• AUDIT
• Can take a long time
• Aims to find out if the companys system is
  effective
• Pre-arranged / announced in advance
• Helpful in HACCP
• Helpful in EU approvals
• Basis for future inspections

86
Inspection versus audit

• Inspection
• Inspection is what you see, observe and view in
  the situation.
• Audit
• Audit is the art of finding out what you do not
  see.

87
Audit

• A systematic and independent examination to
  determine whether
• - food safety program/activities and related
  results comply with planned documented procedures
• - these procedures are implemented effectively
  and are suitable to achieve the objectives

88
Purpose of the audit

• The objective of the official audit is
• to provide assurance that the food business
  operators (FBOs) activities and controls are
  operating effectively
• to make recommendations to the FBO where
  improvements to internal procedures and controls
  are appropriate
• to undertake appropriate risk-based enforcement
  action, where necessary.

89
Types of audits

• First-party audits performed by the employees
  of a food business who carry out internal
  auditing of the business
• - to assess whether it is meeting regulatory
  requirements and
• - to review its food safety program to ensure
  that it is adequate.
• The outcomes of the first party audits will not
  be recognised by the enforcement agency.

90
Types of audits

• Second-party audits - audits of food businesses
  on behalf of the clients/suppliers.
• Third-party audits are private or official
  control audits which are independent of the food
  business. They can be contracted by a food
  business to fulfill its legal requirements to
  have its food safety program audited.

91
General principles for auditing

• IMPARTIALITY
• In second or third party audits the objectivity
  of the auditor may be compromised if the auditor
  has
• provided a consultancy service to the business
  for food safety program development and/or
  implementation
• provided food safety training courses that
  include specific advice on addressing food safety
  issues in a particular food business
• any ownership of the food business,
• previously been or is currently employed by the
  food business.

92
General principles for auditing (2)

• INDEPENDENCE
• In second and third party audits the auditor
  shall be impartial and free from engagements and
  influences which could affect his objectivity,
  and in particular shall not be
• a) involved in the design, construction of the
  establishment or servicing or supply of the
  equipment within the scope of the audit
• b) involved in the design, construction,
  implementation of the system being audited
• c) an authorised representative of the
  manufacturer.

93
General principles for auditing (3)

• Examples where independence could be compromised
• i) the auditor having a financial interest in the
  company being audited (e.g. holding stock in the
  company)
• ii) the auditor being employed currently by the
  manufacturer producing foods
• iii) the auditor being a member of staff from a
  consultant having a commercial contract or
  equivalent interest with the manufacturer.

94
General principles for auditing (4)

• PROFICIENCY
• Auditor shall undertake only those services that
  he can expect to complete with professional
  competence. He shall continually strive to
  improve his proficiency and effectiveness and the
  quality of his work

95
General principles for auditing (5)

• MATERIAL FACTS AND DISCLOSURE
• Auditor shall reveal to the audit client all
  material facts known to him which if not revealed
  could either distort reports of operations
  audited or conceal unlawful practices.

96
General principles for auditing (6)

• DUE PROFESSIONAL CARE
• Auditor must use care, diligence, skill and the
  judgment expected of a prudent and competent
  auditor in similar circumstances.
• He must perform professional services to the
  best of his ability, with concern for the best
  interests of the audit client.

97
General principles for auditing (7)

• CONFIDENTIALITY
• Auditor must not use confidential information
  gained in the course of his work for personal
  gain or in any other way that would be contrary
  to the law or reflect adversely on the auditors
  or the organization he represents.

98
Definition

• Policy
• External Standards
• Internal Standards
• Legislation
• Contracts
• Client requirements etc.

Audit criteria procedures, methods,
requirements which are used as a standard, or
document or separate paragraph , which determine
process activity requirements.
99
Definition
Audit evidence protocols, proven facts or other
information which is significant for audit
criteria and allow to verify them.
Audit findings result of evaluation of
collected evidence according to audit criteria
Audit conclusion audit summary, issued by audit
group as a result of consideration of audit data
taking into account the target of audit.
100
Definition
Auditor a person, who has a competence to carry
out the audit ?????, ??? ??? ?????????????? ???
?????????? ??????. Group of auditors persons
who carry the audit with support (if necessary)
of technical expert. Technical expert a person,
who has advanced knowledge and skills audit
plan)
101
Audit procedures

• DOCUMENTATION REVIEW
• Before undertaking an on-site audit of a food
  business, a food safety auditor will need to
  review the food businesss documentation to
  ensure that the business has adequately
  documented a food safety program and that the
  program meets the requirements of the Food Law.

102
Audit procedures

• Planning the audit.
• Determining the scope and objectives of the audit
  
• The scope of the audit will depend on
• the type of audit, that is, initial or
  follow-up
• the size and complexity of the food business
• the nature of the business, for example,
  whether seasonal or all-year.

103
Audit procedures

• Planning the audit
• Determining audit duration
• The duration of an audit depends on, but not
  restricted to
• the scope of the audit to be undertaken
• the size of the food business
• the complexity of the food business
• the complexity of and the level of
  documentation included in the food safety program

104
Example IFS Standard audit duration

• The IFS specifies the minimum time required for
  an audit on the basis of the following features
• Minimum 1,5 days for a company characterised by
• lt100 personnel and
• lt 2products from the single product group and
• lt 10000m2 site area and
• lt2 production lines and
• plus 0,5 days for the preparation of the audit
  report.
• Additional time will be required in the following
  cases
• 0,5 days for every additional 100 personnel
  and/or
• 0,5 days for every additional 2 products of a
  single product group and/or
• 0,5 days for every additional 10000m2 of the site
  and/or
• 0,5 days for every additional 3 production lines

105
Audit procedures

• Planning the audit
• Determining audit duration (cont.)
• the degree of cooperation of the food business
  in providing information and promptly remedying
  deficiencies when reported
• the number and type of changes in the food
  business since the last audit and
• the number of non-conformances found during the
  audit

106
Audit procedures

• Planning the audit
• Announced and unannounced audits
• The majority of audits will be announced to the
  food business before the audit date.
• The unannounced audits are permitted if the
  auditor believes that it will achieve a more
  satisfactory outcome or a more accurate
  indication of the businesss operations.

107
TO BE AN AUDITOR. RIGHTS

• Access to all premises
• All production units / departments
• All offices in the company
• Social rooms
• Buffets (canteens)
• Storage facilities/storage areas
• etc.

108
RIGHTS

• Access to all documentation
• Registers/records related to HACCP
• Samples/ tests (microbiological, chemical etc.)
• Clients and suppliers
• Production results (what they are producing,
  production quantity etc.)
• Secret recipes
• Economical results
• Business agreements (quality, labeling....)

109
RIGHTS

• Sampling
• At the entrance (the incoming materials)
• According a plan/programme
• For verification or in case of doubts
• Right to communicate with and interrogate the
  employees and the management.
• Assess
• the production
• the registers / records
• Procedures
• Training (hygiene )
• The sampling methods etc.

110
RIGHTS

• Ask for corrections in
• Production process, Registers/ records
• Procedures, Training (ex.hygiene)
• Testing/ sampling methods, etc.
• Impose administrative fines
• Forbid the production in different sectors in the
  company
• Or
• Forbid the production in the whole company
• Or even
• Withdrawing the rights

111
IMAGINE.........

• How the management and the employees are feeling
  about your visit!!!!

112
OBLIGATIONS

• To be professional
• Straightforward and correct
• Be competent and well prepared
• Delicate and wise
• Confidential
• Show an understanding
• Be honest and objective
• Be kind
• Independent, Impartial
• Be positive (listen and show an interest)
• Base your judgments on facts.
• Your note/registration should be precise and
  based on objective evidence

113
Knowledge and skills
Cocerning product, technology, HACCP
Work experience
Education
Not less, than 1 year/ At least 3 audits as
junior auditor
At least secondary vocational
Auditor competence criteria
Audit training
Training course
Personal abilities
Competent maintenance
Permanent auditing activity
114
Be polite

• Introduce yourself and your team
• Shake hands / smile!!!!
• Give the floor to and listen to the introduction
  of the management
• Respect the will of the organization of making
  clarifications

115
Be punctual

• If you arrive at the company very late you will
  demonstrate a lack of interest and respect,
  negligence
• If you show yourself very early you risk to
  arrive at a hard moment for the company and to
  create the impression that by a purpose you want
  to catch the company in doing something wrong

116
Planning an audit and Preparation

• Step No1
• What is the type of the audit?
• Action plan
• Audit plan
• Applicable legal framework
• Report of the previous audit
• The companys permission
• Own-control programme (self -control)
• Specific activities (organic, labeling, veal
  etc.)
• Do I need a colleagues/experts?
• Do we need/ want preliminary contact to be done /
  information/ taking samples/records?

117
Step No2

• Get into connection with colleagues/experts
• Find out - are they the right persons?
• When they will be available?
• What are their needs/what they want to see
• Whom they want to interview?
• Which documentation they want to review
• Do they need a technical equipment for their work

118
Step No3

• Get into connection with the company.
• Be sure that you connected the right person (s)
  (taking the decisions!)
• Whom we want to meet with/ to interview
• The management (financial or other)
• The person responsible for the internal audits of
  the company or responsible for the self control
  system
• The chiefs of the shifts (responsible for the
  production)
• Trusted employees
• What we are expecting to see
• Production process (which one)
• Self control programs
• Registers/records/procedures
• Reports of internal audits
• Reports for non conformities

119
Step No3

• Time schedule
• The time period which you envisage for conducting
  the audit in each department of the company
• Expected time necessary to talk to /meet with
  each of the employees/management
• Organize the visit/ meeting
• In addition if necessary send a confirmation
  letter to the company.

120
Prepare your programme for the opening meeting

• Introduction
• Explain the term audit
• What is audit (relevance with legislation/
  self-control programme)
• Purpose (legislation, permit, pre-registration
  ....)
• Scope (which department /persons involved)
• Programme
• Results (conclusions, report, sanctions)

121
Take a decision about the scope and the type of
the audit

• What type of audit?
• Permission
• HACCP (hazard analyses, HACCP-plan, documentary,
  for validation, for verification)
• Production (flow diagram, CCP, procedures,
  registration, labeling, sampling, packaging)
• Of the hygiene (how, who, procedures, control,
  microbiological control)
• Pest control (how, who, procedures, control)
• Employees (internal rules, training,
  requirements for visitors, servicing staff)
• Labeling
• CCP
• GMP

122
Check-list

• Prepare a check-list Compulsory!!! and
  Strictly individual (for the plant)
• Write and summarize all your questions, use the
  legislation in force, the self-control programme
  of the company, manuals (handbooks), maybe even
  map of the company to put your notes in good
  order....
• Leave blank field for additional notes,
  additional questions, references to legislation,
  manuals, self-control (monitoring) etc.
• Write in what way you would like to get the
  information, through an interview or
  documentation, or Procedures
• Compare your results with those of the company

123
Check-list

• Make your notes carefully and detailed as much as
  possible
• Who is saying what
• Records for temperature control
• Control intervals
• Person which not introducing himself
• Avoid abbreviations, incoherent and chaotic
  questions etc.!

124
The legible notes ease the preparing of the
report

• Why?
• Helps to remember all your questions
• Helps you to lead and control the situation
• Helps you to get the information in good order
• Helps you to organize the schedule for making
  your notes
• Help to remember why you asked these questions
• Ex Legislation (directive, no., ), Manuals
  (name, page no.), Self- control programme (page
  ?), Procedures , Sampling, Labeling, Special
  agreements with clients, Special requirements
  from customers , Previous problems , Non
  conformities against your notes
• Helps to refresh your memories when writing your
  report

125
Final preparation for the audit

• Location of the company - Where?
• How you can reach to the company?
• How we get back?
• Do not forget your clothes, documentation,
  records, equipment, etc.
• Prepare the agenda for the closing meeting
• Express your gratitude to the participants
• Scope and findings of the auditor/ audit team
• Non-conformities found
• Your decision (SANCTIONS?) or when the decision
  it to be taken (very quickly )
• Delivering the report or informing when it is
  expected to be delivered (very quickly).

126
Conducting an audit- examples

• HACCP
• Hazard analyses
• HACCP-plan
• Documentation
• Training of the personnel
• Or
• Hazard analyses
• Flow diagram
• Diagram of the processes for each category of the
  products (if relevant)
• Type of the hazard (chemical, physical,
  biological)
• Or
• HACCP-plan
• Health risks
• CCP and Critical limits
• Monitoring in CCP and Corrective actions
• Documentat