BUILDING CAPACITY OF SME’s ON EU
FOOD & PACKAGING STANDARDS
EU Legislation
Principles & Requirements of
Food Law
Thessaloniki 11.06.2012
EU
Institutions
EU Food Law
National
Legislation &
Standards
EU Institutions & policy
making
Κανονισμός 1169/2011
• Represents EU
interests as a
whole
• Commissioners
appointed by
M-S
• DG SANCO
• DG AGRI
Parliament
• Represents the
Governments
of M-S
• Presidency is
shared on a
rotating basis
• Minister of
Health
• Minister of
Agriculture
Commission
Council of the EU
Fundamental EU Institutions & Policy Making
• Represents EU
citizens
• Directly elected
by citizens
• ENVI
committee
The Ordinary Legislative Procedure
• 1992 – Maastricht Treaty : Co-decision procedure
• 2009 – Lisbon Treaty: renames “co-decision” as “The Ordinary Legislative
Procedure”
1.Right of initiative
Commission
2. Autonomous Promotion
of the community interest
THE EU
DECISION
MAKING
PROCESS
Council of the EU
Negotiations of national
interests
EU Parliament
Direct representation of EU
citizens
Ordinary Legislative
Procedure at a glance
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The Commission sends its proposal to
Parliament and the Council.
They consider it, and discuss it on two
successive occasions.
After two readings, if they cannot agree, the
proposal is brought before a Conciliation
Committee made up of an equal number of
representatives of the Council and Parliament.
Representatives of the Commission also attend
the meetings of the Conciliation Committee
and contribute to the discussions.
When the Committee has reached agreement,
the text agreed upon is sent to Parliament and
the Council for a third reading, so that they can
finally adopt it as a legislative text.
The final agreement of the two institutions is
essential if the text is to be adopted as a law.
Even if a joint text is agreed by the Conciliation
Committee, Parliament can still reject the
proposed law by a majority of the votes cast.
Proposal by Commission sent to
Parliament
Council
2 Readings for discussion & consideration
Agreement 
Conciliation
Committee
Approves a “joint” text
ENVI
Committee
Ministers
of Health
or
Agriculture
DG SANCO or DG
AGRI
EU Food Law & Decision Making
Legislative Acts
Opinion
EFSA
Council
Commission
Parliament
EU Food Law & Decision Making
Member State
Legislative Acts : EU vs National Acts
EU Legislation
• Regulation
• Directive
• Decision
National (Greek )
Legislation
• Law
• Presidential
Decree
• Joint Ministerial
Act
• Ministerial Act
Legislative Acts : EU vs National Acts
• Regulation
– Binding legislative act
– Mandatory in its entirety across the EU
• Directive
– sets out a goal that all EU countries must achieve
– M-S decide how
– Must be transposed to national legislation
• Decision
– Binding to whom it is addressed (e.g. a M-S or a
company)
EFET & EU Institutions
• EFSA’s National Focal Point
• Representation of Greece at
– EFSA Advisory Forum
– EFSA working group on communications
– Working groups and Standing Committees of DG SANCO & EU
Council
– Labelling
– Nutrition & Health claims
– Official Control, etc
• Coordination of national positions
• National Contact point for RASFF
• Member of BTFSF (Better Training For Safer Foods)
network
EU Food Law
An overview of basic requirements
Fundamentals of EU Food Law
The evolution of the current EU
Food Law framework
Timeline….
2000
The White Paper on
Food Safety
• Re-engineering of EU
Food Safety Bodies
1996-97
BSE Crisis – Mad cows
disease
• Integrated approach
on Food Safety
• From farm to fork
• From stable to table
2004
• Obligations of FBOs
• General principles of
Food Law
• Establishment of
EFSA
2002
Regulation 178/2002
The Hygiene Package
• General & specific
issues of food
hygiene
• The EU system for
official control
Timeline….
… this is not the end…
• Regulation 2073/2005 Microbiological criteria for food safety
& hygiene monitoring
• Regulation 2074/2005 Implementing measures for certain
products under the provisions of Reg 853/2004
• Regulation 931/2011 Traceability requirements
The EU Food Law at a glance
Specific rules (not safety issues
but standards)
General provisions
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Official controls
Hygiene
Microbiological criteria
Additives & Contaminants
Food Contact Materials
GMOs
Food Information to Consumer
PARNUTS
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Health & nutrition claims
Milk
Chocolate
Juices
Eggs
Honey
White Paper on Food Safety – Targets
High level of human health &
consumer
protection
and
maintenance of a strict food safety
standard
A food safety policy based on an
integrated & comprehensive approach
Coherent, dynamic legal framework
Broad body of legislation in primary
production and processed foods BUT
with NO COHERENCE – Need for
review
Fundamentals of EU Food Law
Regulation 178/2002
White Paper on Food Safety – The Strategy
• The 3 steps to reach the target
– Establishment of EFSA
– Integrated approach within the whole food chain
• From farm to fork
• From stable to table
– Setup of the following principles
• FBO has the main responsibility for food safety
• National Authorities must establish official control systems to inspect the ability of FB
concerning food safety
• EU must audit the competency of National Authorities
Regulation 178/2002
• The fundamental legal text on food safety
– establishes the common basis for food law in all
M-S
– provides the framework for the development of
EU food law which includes ‘the hygiene package’
Regulation 178/2002 – Outline
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Objective
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Basic principle
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to ensure a high level of protection for human health and consumers' interest in relation to food
the primary responsibility for ensuring compliance with food law, rests with the food business operator (FBO)
Key points
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Integrated approach for food safety
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Risk analysis procedure
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The precautionary principle
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Traceability systems
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Crisis management
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The need for transparency in decision making
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The establishment of EFSA
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Imports – exports equivalence
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The right of consumer for accurate information
Regulation 178/2002 – Key obligations of FBOs
Safety
FBOs shall not place on the market
unsafe food
Responsibility
FBOs are responsible for the safety
of the food which they
produce, transport, store or sell
Traceability
FBOs shall be able to rapidly
identify any supplier or owner
Transparency
Emergency
Prevention
FBOs shall immediately inform the
competent authorities if they have
a reason to believe that their food
is not safe
FBOs shall immediately withdraw
food from the market if they have
a reason to believe that it is not
safe
FBOs shall identify and regularly
review the critical points in their
processes and ensure that controls
are applied at these points
Traceability
• Means the ability to trace and follow a food, at all
stages of production
• Traceability facilitates the identity, history and source
of a product
– It does not make food safe, it is a management tool
– It enables the assurance of food safety and allows action to
be taken if food is found not to be safe, e.g. withdrawal or
recall
Traceability – The “one up”/”one down” concept
• Each stage in the food chain must
– Identify what is received (raw materials from the previous stage
in the chain)
– Identify where product is sent (to the next stage in the chain)
– Make information available on demand
• Each stage in the food chain is responsible for the
operations under their control
– No requirement for whole chain traceability
Traceability – The “one up”/”one down” concept
A stage in the food chain
Raw materials or
products from supplier
• One step down
Operation
Products to customer
• Storage
• Transport
• Manufacture
Make information available on demand
• One step up
Traceability – Industry
standards & practice
• One up/one down concept plus
link finished product to/from raw
materials
• Each food business operation
must be able to trace and follow
– All raw materials from source
– Through all stages of production
– To distribution of the finished
product
• Traceability is established from
raw material to finished product
and visa versa
• Identify what is
received from
where
Raw materials
Operation
• Identify what is
produced from
what, when,
how
• Identify where
product is sent
Products
Components of a traceability system
Organise & plan traceability
Implementation of
traceability
Verify that the system is
working
effectively
Establish documentation
and record keeping
Traceability – Regulation 931/2011
• From the 1st July 2012, the provisions set out in Regulation
931/2011 regarding the traceability requirements for unprocessed
or processed food of animal origin will be applicable.
– Sets the piece of information the FBO should provide to the
competent authority upon request
• an accurate description of the food
• the volume or quantity of the food
• the name and address of the food business operator from which the food has
been dispatched
• ……..
• a reference identifying the lot, batch or consignment, as appropriate
Reg 178/2002 - The precautionary principle
In specified circumstances where, following
an
assessment of available information, the possibility of
harmful effects on health is identified but scientific
uncertainty
persists,
provisional
risk
management
measures necessary to ensure the high level of health
protection may be adopted, pending further scientific
information for a more comprehensive risk assessment
Fundamentals of EU Food Law
The Hygiene Pack
Hygiene Pack
• It is the current regime of hygiene rules
• is often referred to as ‘The hygiene package’
• it aims to introduce consistency and clarity
throughout the food production chain from
'farm to fork'.
Hygiene Pack
The ‘hygiene package’ is comprised of rules on the following:
Regulation 852/2004
• Hygiene of foodstuffs
Regulation 853/2004
• Specific Hygiene Rules for Food of Animal Origin
Regulation 2073/2005
• Microbiological criteria for foodstuffs
Regulation 2074/2005
National rules
• Implementing measures
• For the implementation of regulations 852/2004,
853/2004 and for official control
Regulation 852/2004
• Basic obligation
– FBOs to ensure that all stages of production,
processing and distribution of food under their
control satisfy the relevant hygiene requirements
laid down in Regulation 852/2004
Regulation 852/2004 & HACCP requirements
• All FBOs (production, processing and distribution of food) must put
in place, implement and maintain a permanent procedure or
procedures based on the HACCP principles.
• Food business operators must:
– provide the competent authority with evidence of their compliance
with the requirement to have procedures based on the HACCP
principles taking account of the nature and size of the food business
– ensure that any documents describing the procedures developed in
accordance with this are up-to-date at all times
– retain any other documents and records for an appropriate period
Regulation 852/2004 & HACCP requirements
• For businesses undertaking low risk activities
the prerequisite hygiene requirements (App II
of Reg 852/2004) are sufficient
– No need for establishment of a HACCP-based
procedure (but it is desired)
– Guidance document for implementation of HACCP
Regulation 852/2004 and requirements
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Food Businesses must comply with the standards laid down in App II of Regulation 852/2004
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Chapter I: General requirements for food premises
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Chapter II: Specific requirements in rooms where foodstuffs are prepared, treated or processed
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Chapter III: Requirements for movable and/or temporary premises
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Chapter IV: Transport - Containers used for transporting foodstuffs
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Chapter V: Equipment with which food comes into contact
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Chapter VI: Food waste
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Chapter VII: Water supply
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Chapter VIII: Personal Hygiene
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Chapter IX: Provisions applicable to foodstuffs
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Chapter X: Provisions applicable to the wrapping and packaging of foodstuffs
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Chapter XI: Heat treatment
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Chapter XII: Staff Training
Regulation 853/2004
• Lays down more specific hygiene requirements for foods of
animal origin
• Other issues
– Registration or approval of establishments
– Health and identification marking
– Import of products of animal origin
Regulation 2073/2005 – Microbiological criteria
• Food business operators shall:
– Test against the values set for the criteria - take samples
– Conduct studies in order to investigate compliance with the criteria
throughout the shelf-life
– Implement corrective actions - HACCP plan, food law and/or the instructions
given by the competent authority
– Take measures to find the cause of an unsatisfactory result in order to
prevent the reoccurrence of unacceptable microbiological contamination
• Microbiological analysis is done for verification purposes , ie to
check that everything was done in such a way to obtain a safe
product
Regulation 2073/2005 – Microbiological criteria
• Food safety criterion
– a limit above which a foodstuff should be considered unacceptably
contaminated
– It applies to products placed on the market
– Salmonella, Listeria, etc
• Process hygiene criterion
– a limit indicating the acceptable functioning of a production process.
– Such a criterion is not applicable to products placed on the market.
– It sets an indicative contamination value above which corrective actions are
required
– E. coli, Coliforms, etc
National and other
International Standards
National Legislation
• Transpose EU Directives
• Set up of national implementing measures
• Specific national standards
– Food & Drink code
• Any new national legal act must be notified to
the EU institutions (TRIS System) before
adopted
Codex Alimentarius
• International body set up in 1961 as a
subsidiary body of FAO and the WHO
• Main scope
– to develop and adopt a series of food standards and
related texts that aim to protect the health of
consumers and ensure fair practices in the
international food trade.
• Not a legal requirement
– EU has sometimes stricter specifications