Transcript EUROPEAN FOOD LEGISLATION - The "TACIS" Project

EUROPEAN FOOD LEGISLATION
Neville Craddock
EuropAid Project
Astana
March - April 2006
Astana April 2006
EU Organic Foods
Regulation 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
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
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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
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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 >1.2% 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 Legislation
for Imported Products
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.cfm
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; Anticoccidials, 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
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
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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)
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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/resources/mrl_crop.pdf
http://europa.eu.int/comm/food/plant/protection/resources/mrl_pesticide.pdf
via
http://europa.eu.int/comm/food/plant/protection/pesticides/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
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Cereals Standards – Common Agricultural Policy
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Cereals – Deoxynivalenol (“DON”)
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Cereals - Zearalenone
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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 CRITERIA
Regulation 2073/2005
Quick 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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