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EUROPEAN FOOD LEGISLATION. Neville Craddock EuropAid Project Astana March - 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

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european food legislation
EUROPEAN FOOD LEGISLATION

Neville Craddock

EuropAid Project

Astana

March - April 2006

Astana April 2006

eu organic foods regulation 2092 91

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

eu organic foods regulation 1788 2001
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

Astana April 2006

eu organic foods regulation 2092 914
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]

Astana April 2006

eu organic foods regulation 2092 915
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

Astana April 2006

eu organic foods regulation 2092 916
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

Astana April 2006

organic trade exports to usa
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]

Astana April 2006

usa nop standards producers
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

Astana April 2006

usa nop standards processors
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

Astana April 2006

food fortification addition of nutrients
FOOD FORTIFICATION(“Addition of Nutrients”)

Proposed EU legislation due to be finalised May 2006

Astana April 2006

eu fortification current situation
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”)

Astana April 2006

mutual recognition principle
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

Astana April 2006

eu fortification proposals
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

Astana April 2006

eu fortification proposals15
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

Astana April 2006

eu fortification proposals16
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)

Astana April 2006

eu fortification proposals17
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

Astana April 2006

eu fortification proposals18
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

Astana April 2006

eu food legislation structures
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, etcPLUS

Numerous, specific ANIMAL HEALTH RULES have potential to override any FOOD Safety rules

Astana April 2006

eu veterinary legislation imports
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

Astana April 2006

eu veterinary legislation imports23
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”)

Astana April 2006

animal product imports general
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

Astana April 2006

eu veterinary legislation directive 1997 78
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

Astana April 2006

eu veterinary legislation directive 2002 99
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)

Astana April 2006

eu veterinary legislation directive 2002 9927
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

Astana April 2006

eu veterinary legislation directive 2002 9928
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)

Astana April 2006

requirements of official controls
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

Astana April 2006

requirements of official controls30
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

Astana April 2006

fvo typical report structures
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)

Astana April 2006

eu veterinary legislation directive 2002 9932
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)

Astana April 2006

oie infectious diseases
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

Astana April 2006

eu veterinary legislation imports34
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)

Astana April 2006

eu animal product hygiene regulation 853 2004
EU Animal Product Hygiene – Regulation 853/2004

Imported food must comply with Regulation 178/2002 or “equivalent”

  • Regulation 853/2004 defines PUBLICHEALTHhygiene 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

Astana April 2006

eu animal product hygiene regulation 853 200436
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]

Astana April 2006

eu directive 1996 23 residue monitoring
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

Astana April 2006

eu directive 1996 23 residue monitoring38
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

Astana April 2006

cereals standards

Cereals Standards

Safety – Plant Health

Safety – Pesticides and Mycotoxins

Quality – CAP / Financial

Commercial Aspects

directive 2000 29 plant health
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

Astana April 2006

directive 2000 29 plant health42
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

Astana April 2006

directive 2000 29 plant health43
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)

Astana April 2006

pesticide mrls regulation 396 2005
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!!]

Astana April 2006

pesticide mrls regulation 396 200545
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

Astana April 2006

pesticide mrls directive 1991 414
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

Astana April 2006

maximum residue levels
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)

Astana April 2006

cereals zearalenone
Cereals - Zearalenone

Astana April 2006

certification procedure coceral
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.

Astana April 2006

eu microbiological criteria
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

Astana April 2006

eu microbiological criteria annex i
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)

Astana April 2006