EUROPEAN FOOD LEGISLATION

1
EUROPEAN FOOD LEGISLATION

• Neville Craddock
• EuropAid Project
• Astana
• March - April 2006

2
EU Organic FoodsRegulation 2092/91

• Council Regulation No 2092/91
• on organic production of agricultural products
  and indications referring thereto on agricultural
  products and foodstuffs
• Official Journal L 198 of 22.07.1991

3
EU Organic Foods Regulation 1788/2001

• 3rd country imports must be produced, inspected
  and marketed under conditions equivalent to those
  applicable to EU products
• Imported products may only be marketed in the EU
  if
• an original certificate of inspection (15
  questions) is submitted to the importing Member
  State's authority
• consignment verified by the Member State
  authority
• endorsement of the certificate of inspection
• Further procedures specified when consignment
  split

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EU Organic Foods Regulation 2092/91

• Regulation is 89 detailed pages and applies to
• non-processed agricultural products (vegetable
  and animal)
• produced in accordance with specified rules 15
  pages
• processed foods which incorporate such products
• reference to organic production in labelling
  and advertising only if certain conditions
  specified in annexes are met
• plant protection products, detergents,
  fertilisers or soil conditioners, Annex II - 10
  pages
• inspection procedures Annex III - 8 pages

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EU Organic Foods Regulation 2092/91

• Annexes to the Regulation specify the following
• principles of organic production on farms
• products permitted for fertilisation, soil
  improvement or combating parasites and disease
• minimum inspection requirements and precautionary
  measures under the regular inspection scheme
• information to be notified to authorities
• authorised (non-organic) agricultural ingredients
• non-agricultural ingredients
• substances authorised for use during preparation
• GMOs and derived products are not permitted to be
  present

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EU Organic Foods Regulation 2092/91

• Operators who produce, prepare or import organic
  products must
• notify approved, specially-designated authorities
  who undertake regular inspections Annex III 8
  pages
• the minimum precautionary and inspection measures
  specified
• initial then at least annual (random and
  unannounced)
• fully documented
• include stock and financial records
• input purchases and output yields
• supplier and customer / exporter details
• packaging, storage and distribution strict
  rules
• complex procedures e.g. UK guidelines are 100
  pages

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Organic Trade Exports to USA

• Organic Foods Production Act 1990
• USDA National Organic Program (NOP)
• Effective from 21/10/2002
• ALL organic products sold in USA must be
  certified to NOP standards not identical to EU

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USA NOP Standards - Producers

• 3 years conversion (In EC, annual crops require 2
  years and perennials require 3 years)
• Organic Livestock must be fed 100 organic feed.
• Irradiation, and genetically modified organisms
  are not permitted. (Not permitted in EC either)
• Livestock must have been under organic management
  from the last third of gestation, except poultry
  which must be from day 2 of hatching. (EU
  Standards are species specific, in part they are
  tighter, in part less strict)
• There are some differences in permitted inputs

9
USA NOP Standards - Processors

• 100 Organic means 100 of ALL ingredients
  (except Water Salt) (In EC we express in
  terms of agricultural content only)
• To call a product ORGANIC it must have NOT LESS
  than 95 organic (same as for EC except that we
  base on agriculturals)
• With 70-95 Organic can say Made with Organic
  followed by up to three specific ingredients (In
  EC we have a prescribed special emphasis clause)
• With less than 70 organics (in US terms) only
  the listed organic ingredients can be mentioned.
  (In EC no reference to organic can be made)
• There are a few differences in the permitted
  non-organic inputs

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FOOD FORTIFICATION(Addition of Nutrients)

• Proposed EU legislation due to be finalised May
  2006

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EU FORTIFICATION current situation

• Addition of vitamins, minerals etc is not
  harmonised in EU and has led to numerous trade
  disputes (e.g. breakfast cereals, bread and
  flour)
• mandatory in some EU countries for some products,
  e.g.
• margarine, flour (to copy butter / replace lost
  nutrients)
• iodide in salt (to counter nutritional
  deficiency)
• voluntary in others
• banned in some
• e.g. UK requires mandatory fortification of bread
  and flour (but must accept these from other MS /
  EEA where production / sale of un-fortified
  products is legal due to Mutual Recognition
  Principle)

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Mutual Recognition Principle

• Member States can waive this principle only under
  very strict conditions
• If restrictions to free movement justified by
  grounds of public policy or security, protection
  of health and life of persons, animals, plants
  (art 30) and (more recently) environment
  protection
• overrides requirements of general public
  importance fair trade, consumer protection

14
EU FORTIFICATION PROPOSALS

• Growing market for wide range of
  voluntarily-fortified products
• many considered by consumers (and authorities) as
  misleading and unnecessary
• So EU is moving to restrict fortification by
  industry
• Vitamins and minerals will NOT be permitted to be
  added to
• unprocessed foods fruits, vegetables, meat,
  poultry and fish
• alcoholic drinks gt1.2 alcohol, except specific
  wine legislation
• additional categories of foods may be defined
  (nutrition profiles?)
• Any direct or indirect health and nutrition
  benefit claims will have to be formally-approved
  under separate (new) EU Regulation

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EU FORTIFICATION PROPOSALS

• Harmonisation internal market consumer
  protection
• Addition of vitamins, minerals and other
  substances
• Without prejudice to existing legislation that
  already specifies fortification
• Prescribes vitamins, minerals and their permitted
  chemical forms
• Addition will be permitted to take into account
• deficiency in population / groups (clinical
  evidence / low intakes)
• improvement to nutritional status / correction of
  dietary habit changes
• evolving scientific knowledge on role and effects
  on health

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EU FORTIFICATION PROPOSALS

• Conditions will be set
• must not exceed (not yet set) maximum levels,
  taking into account
• upper safe levels (risk assessment for different
  population groups)
• intakes from other sources
• reference intake levels and (if already close to
  Upper Safe Levels)
• contribution of individual products to diet
  (including sub-groups)
• nutrient profiles established for claims purposes
• must result in significant amount (Directive
  90/496)
• minimum amounts may be set for specific foods /
  categories of foods
• purity criteria must be met (but not yet defined)
• existing Community criteria
• generally-accepted international (or stricter MS
  national criteria)

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EU FORTIFICATION PROPOSALS

• Labelling, presentation and advertising claims
  will be restricted
• must not state / imply balanced and varied diet
  is inadequate
• must not mislead / deceive as to nutritional
  merit of fortified food
• must declare the Big 8 nutrition labelling
• must declare total amounts present of added
  vitamins and minerals
• may claim addition under conditions specified in
  Claims Regulation

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EU FORTIFICATION PROPOSALS

• Addition of Other Substances (e.g. plant
  extracts) will also be restricted
• if addition / use would result in consumption of
  amounts greatly exceeding those reasonably
  expected from normal consumption of balanced and
  varied diet and / or would otherwise represent
  potential risk
• Commission Decision (EFSA Assessment), substance
  may be
• prohibited
• conditionally permitted
• put under Community scrutiny 4 years for EFSA
  to evaluate
• Additional restrictions for specified foods may
  also apply

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EU Veterinary Legislationfor Imported Products
21
EU Food Legislation Structures

• General Food Law Regulation 178/2004 is framework
  for FOOD safety
• Depends on numerous secondary legislation for
  practical effect and to define parameters used to
  determine safety
• For animal-based products
• Animal Products Hygiene Regulation 853/2004
  (unprocessed products)
• Official Controls on Products of Animal Origin
  Regulation 854/2004
• General Food Hygiene Regulation 852/2004 (foods
  using POAO)
• Directives on Veterinary Drug Residues,
  Contaminants, Additives in products, Labelling,
  etc PLUS
• Numerous, specific ANIMAL HEALTH RULES have
  potential to override any FOOD Safety rules

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EU Veterinary Legislation - imports

• Specific ANIMAL HEALTH rules govern introduction
  from third countries of products of animal origin
  for human consumption (and for other uses under
  BSE legislation)
• to prevent introduction or spread of animal
  diseases that may present an animal health hazard
  for Community livestock.
• common EU provisions concerning in particular
• restrictions applicable to products coming from a
  holding or area infected by epizootic diseases
  and
• the obligation to subject products coming from
  restricted areas to treatment to destroy the
  disease agent

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EU Veterinary Legislation - imports

• Principal ANIMAL HEALTH Regulations and
  Directives (in all cases supplemented by specific
  and frequently changing Decisions)
• Directive 2004/68 bovine and other ungulate
  animal imports
• Directive 2002/29 specific rules for 3rd
  country imports
• Directive 1997/78 veterinary checks on 3rd
  country imports
• Directive 1992/65 animals not covered by
  Directive 1992/65
• Directive 1991/496 organisation of veterinary
  checks at import
• Directive 1990/426 horse (equidae) imports
• Regulation 999/2001 BSE (Mad cow disease)

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Animal product imports - general

• Administrative requirements in specific
  legislation Commission Decisions
• Prescribed format / wording for health
  certificates to guarantee EU import conditions
  are met
• must accompany all imports
• must be signed by an official veterinarian
• Products must be imported through a designated
  Border Inspection Post
• Products and certificates checked and verified by
  EU official veterinarians
• Further checks on products also possible at the
  final destination

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EU Veterinary Legislation Directive 1997/78

• Lays down principles governing organisation of
  veterinary checks on EU imports from 3rd
  countries
• all consignments subject to same scrutiny
• administrative, documentation and identity checks
• designated border inspection posts for imports
  to EU
• consignments which fail or by-pass veterinary
  checks will be seized and either destroyed or
  re-dispatched
• if doubts about validity of documents physical
  checks
• extends to PLANT products that may pose animal
  health risks
• Safeguard measures increased checks or
  outright ban

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EU Veterinary Legislation Directive 2002/99

• ANIMAL HEALTH rules governing the import from 3rd
  countries of products of animal origin and
  products obtained from them
• Products must be obtained from animals which
• are NOT from a holding or area subject to
  specified animal health restrictions
• were NOT slaughtered in an establishment in which
  animals infected (or suspected) with a specified
  disease, or carcasses or parts of such animals
  were present during slaughtering or production
  process
• (in the case of aquaculture animals and products)
  comply with Directive 91/67/EEC (notifiable fish
  diseases)

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EU Veterinary Legislation Directive 2002/99

• Imported products must meet specified EU
  procedures or offer equivalent animal health
  guarantees
• Must be on list of permitted 3rd countries
• FVO audit must have taken place
• must demonstrate that competent veterinary
  authority is able to deliver, in practice, the
  guarantees of compliance
• in practice, FVO will audit and assess the areas
  on the next slide
• EU may adopt Safeguard measures if outbreaks
  occur

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EU Veterinary Legislation Directive 2002/99

• Legislation of the 3rd country
• Organisation, powers, supervision, skills,
  independence and qualifications of the veterinary
  authority or other inspection services
• Animal health requirements applied to whole
  supply chain of animal products intended for EU
• Strength and validity of assurances of
  equivalence given
• EU past experiences with 3rd country
• Previous FVO inspections and/or audits, results
  and follow-up
• Health status of livestock, other domestic
  animals and wildlife
• Regularity, speed, accuracy of disease
  information (OIE rules)
• Rules on disease prevention and control,
  implementation, (including imports from
  neighbours and other countries)

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Requirements of Official Controls

• Competent Authorities must meet operational
  criteria that guarantee efficiency, effectiveness
  and impartiality
• Control staff
• adequate training to be able to perform duties
  competently
• free from conflicts of interest
• must respect professional confidences
• Specific tasks may be delegated to independent
  body, but only under strict conditions
• must be impartial have legal powers necessary to
  perform tasks
• systems to ensure co-ordination between relevant
  bodies

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Requirements of Official Controls

• access to adequate laboratory capacity
• appropriate, properly-maintained facilities and
  equipment
• sufficient, suitably qualified and experienced
  staff
• sampling and analysis methods
• validated - internationally-accepted protocols
  (e.g. CEN / ISO / IUPAC) including those based on
  performance criteria
• carried out by accredited laboratories
• if non-compliance appropriate measures to be
  taken measures and sanctions must be effective,
  dissuasive and proportionate
• contingency plans measures to be taken, reviewed
  as appropriate

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FVO - Typical Report Structures

• Refer to the two FVO Mission Reports available
  under references 1500/1998 and 1004/2000 by
  searching Kazakhstan on
• http//europa.eu.int/comm/food/fvo/ir_search_en.c
  fm
• Report on mission in field of animal and public
  health and fishery products (November December
  1998)
• Report on mission to assess compliance with
  Directive 91/493 on fishery products (April 2000)

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EU Veterinary Legislation Directive 2002/99

• Specified diseases (individual Directives apply)
• Classical swine fever (Directive 2001/89)
• African swine fever (Directive 2002/60)
• Foot-and-mouth disease (Directive 85/511)
• Avian influenza (Directive 92/40)
• Newcastle disease (Directive 92/66)
• Rinderpest (Directive 92/119)
• Sheep and goat plague (Directive 92/119)
• Swine vesicular disease (Directive 92/119)
• Aquaculture diseases
• Directive 91/67 (aquaculture animals and
  products)
• Directive 93/53 (certain fish diseases)
• Directive 95/70 (certain bivalve molluscs
  diseases)

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OIE Infectious Diseases

• Information on all up-to-date aspects of
  infectious animal diseases can be found on the
  OIE website
• http//www.oie.int/eng/maladies/en_classification.
  htm

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EU Veterinary Legislation - imports

• Principal PUBLIC HEALTH Regulations and
  Directives (in all cases supplemented by specific
  and frequently changing Decisions)
• Regulation 853/2004 - Animal Products Hygiene
  (unprocessed products)
• Regulation 854/2004 - Official Controls on
  Products of Animal Origin
• Regulation 852/2004 - General Food Hygiene (foods
  using POAO)
• Regulation 2160/2003 Salmonella and Zoonosis
  control
• Directive 1996/23 Monitoring of Residues of
  Banned Substances
• Regulation 2377/1990 Maximum Residue Levels
  (veterinary drugs)
• Directive 1986/363 - Maximum Residue Levels
  (pesticides)

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EU Animal Product Hygiene Regulation 853/2004

• Imported food must comply with Regulation
  178/2002 or equivalent
• Regulation 853/2004 defines PUBLIC HEALTH hygiene
  requirements for food of animal origin (replaces
  previous sector rules)
• manufacturers and competent authorities
  responsibilities
• establishment structural, operational and hygiene
  requirements
• procedures for the approval of establishments
• requirements for storage and transport
• health marks
• moves towards recognition / requirement for
  HACCP-based controls
• applies to small businesses with very limited
  derogations

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EU Animal Product Hygiene Regulation 853/2004

• Imported products may only come from
• 3rd countries on a permitted list
• establishments on a permitted list
• approved slaughterhouses and cutting plants
  (fresh meat etc)
• live bivalve molluscs, etc must come from listed
  production areas
• production facilities meeting requirements of
  Regulation 852/2004
• Detailed annexes set out specific requirements
  approx 50 pages
• special microbiological rules for Sweden and
  Finland

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EU Directive 1996/23 - Residue Monitoring

• 3rd country must have an agreed ACTIVE and
  EFFECTIVE residue monitoring plan which comprises
• legislation status (authorisation / prohibition)
  of list of defined substances
• the infrastructure (including type and size) of
  implementing departments
• list of approved laboratories, plus their testing
  capacity details
• national tolerances for authorized substances (if
  no EU MRLs)
• list of substances to be detected, methods of
  analysis, standards for interpretation of
  results, number of samples and justifications
• sample numbers and frequencies relative to
  animals slaughtered
• rules governing collection of official samples
  (random, unannounced)
• penalties and sanctions for contraventions

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EU Directive 1996/23 - Residue Monitoring

• List of substances and Schedule for monitoring by
  classification, animal type, feed, including
  water, and primary animal products
• Specified anabolic and unauthorized substances
• Stilbenes Anti-thyroid agents Steroids
  Zeranol Beta-agonists etc
• Veterinary drugs
• Lengthy list of classes and examples
• Anti-bacterials (sulphonamides, quinolones etc)
  Anthelmintics Anti-coccidials, including
  nitro-imidazoles Carbamates and pyrethroids
• Sedatives Non-steroidal anti-inflammatory drugs
• Other pharmacologically active substances
• Contaminants
• Environmental contaminants Organo-phosphorus and
  Organo-chlorines, including PCBs Mycotoxins
  Chemical elements Dyes etc

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Cereals Standards

• Safety Plant Health
• Safety Pesticides and Mycotoxins
• Quality CAP / Financial
• Commercial Aspects

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Directive 2000/29 Plant Health

• Protective measures against introduction into,
  and spread within the EU, of organisms harmful to
  plants / plant products (140 pages)
• The general principles are based upon provisions
  laid down in the International Plant Protection
  Convention FAO and the WTO Sanitary and
  Phytosanitary Measures
• The technical lists are detailed and complex and
  require specialist knowledge of plant diseases,
  insect pests etc

42
Directive 2000/29 Plant Health

• In general, listed plants, plant products and
  other objects (in Part B of Annex V) must be
  accompanied by a phytosanitary certificate,
  issued by the National Plant Protection
  Organisation of exporting country, (IPPC models),
  certifying that products
• have been subject to the appropriate inspections
  
• are considered to be free from quarantine harmful
  organisms, and practically free from other
  harmful organisms
• are considered to conform with phytosanitary
  regulations of EU
• Scope also includes associated soil and insect
  pests

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Directive 2000/29 Plant Health

• Specific reference to soil and growing medium,
  attached to or associated with plants,
  originating in
• Turkey
• Belarus, Georgia, Moldova, Russia, Ukraine
• non-European countries, other than Algeria,
  Egypt, Israel, Libya, Morocco, Tunisia
• (No reference to Kazakhstan)
• Special arrangements may be applied to cereals
  and their derivatives
• (but details are not apparent)

44
Pesticide MRLs Regulation 396/2005

• Sets the rules and procedures for fixing maximum
  residue levels of pesticides in or on food and
  feed
• applies to products to be used as fresh,
  processed and/or composite food or feed
• not apply to the products intended for
• the manufacture of products other than food or
  feed
• sowing or planting
• Crop and active chemicals combinations are
  defined in Directive 91/414 (currently undergoing
  total revision)
• 0ver 700 pages of tables!!

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Pesticide MRLs Regulation 396/2005

• Permits import tolerance MRLs to meet needs of
  international trade, where
• the use of the active substance on a given
  product is not authorised in EU for reasons other
  than public health or
• a different level is appropriate because the
  existing EU MRL can be shown to be inappropriate

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Pesticide MRLs Directive 1991/414

• Regulates the authorization, marketing, use and
  control of active substances and formulated plant
  protection products (195 pages)
• Active chemicals must be approved for specified
  classes of use
• Currently under total revision
• significant number will be deleted
• Maximum residue levels (MRLs) and residue
  definition
• Pre-harvest intervals for envisaged uses, or
  withholding periods or storage periods, in the
  case of post-harvest uses
• Labelling and marketing requirements for sales

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Maximum Residue Levels

• Consolidated tables for all active chemicals and
  the crops on which they can be used have been
  produced, by crop and by chemical, respectively
  and can be found on
• http//europa.eu.int/comm/food/plant/protection/re
  sources/mrl_crop.pdf
• http//europa.eu.int/comm/food/plant/protection/re
  sources/mrl_pesticide.pdf
• via
• http//europa.eu.int/comm/food/plant/protection/pe
  sticides/index_en.htm
• (Both these tables comprise over 750 pages and
  specific details can be provided by the project
  if requested)

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Maximum Residue Levels for Wheat
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Cereals Standards Common Agricultural Policy
50
Cereals Standards Common Agricultural Policy
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Cereals Deoxynivalenol (DON)
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Cereals - Zearalenone
53
Cereals Aflatoxins B and G
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CERTIFICATION PROCEDURE - Coceral

• COCERAL is the EU grain traders association and
  has its own commercial Code of Practice, Audit
  and Accreditation scheme
• Auditing and certification must be carried out by
  an independent institution, accredited in EU
  under EN 45012 or EN 45011.
• Audit Inspectors must have received relevant
  training, knowledge of relevant systems (Quality
  Management Systems, HACCP and organisational
  structures), sufficient knowledge in conducting
  similar inspections and proven experience in the
  food and feed sector.
• COCERAL has a country list of acceptable
  companies
• Auditing against a formal check list, which
  constitutes instructions on how to audit
  operators under the European GTP-code.

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EU MICROBIOLOGICAL CRITERIARegulation
2073/2005Quick Overview
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EU Microbiological Criteria

• Lays down the microbiological criteria to be
• met by food business operators, at all stages of
  chain, when implementing HACCP under Regulation
  852/2004
• food safety criteria applicable throughout
  product shelf-life to be met under foreseeable
  conditions of distribution, storage and use.
• used by competent authority to verify compliance
  in accordance with Regulation 882/2004
• Operators must test as appropriate, to validate
  HACCP and GHP
• Sets out product categories, sampling plans,
  methodology and interpretive guidelines

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EU Microbiological Criteria Annex I

• Food safety criteria
• Process hygiene criteria
• meat and meat products milk and dairy products
  egg products fishery products
• vegetables, fruits and their products
• Rules for sampling and preparation of test
  samples
• general rules for sampling and preparation
• bacteriological sampling in slaughterhouses and
  at premises producing minced meat and meat
  preparations
• may use alternative analytical methods
• if validated against Annex I or
• certified by 3rd party (EN/ISO 16140 or similar
  protocol)

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