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Pro/142/2005/Trade ©QSI 2005 Honey and the Requirements of Trade in Europe Quality Services International GmbH (Institute for Honey Analysis)

Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 Quality Services International GmbH (Institute for Honey Analysis)

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Page 1: Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 Quality Services International GmbH (Institute for Honey Analysis)

Pro/142/2005/Trade ©QSI 2005

Honey and the Requirements of Trade in Europe

Quality Services International GmbH(Institute for Honey Analysis)

Page 2: Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 Quality Services International GmbH (Institute for Honey Analysis)

Pro/142/2005/Trade ©QSI 2005 2

Honey and the Requirements of Trade in Europe

Honey and the Honey and the Requirements of Trade in Requirements of Trade in

EuropeEurope

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Pro/142/2005/Trade ©QSI 2005 3

Honey and the Requirements of Trade in Europe

Content

1. QSI profile

2. Background

3. European Requirements• Regulations on Honey

- Council Directive 2001/110/EC relating to honey - Council Directive 2004/432/EC

• Residues - Official Limits- EC-Regulation 2377/90

• Monitoring- Council Directive 96/23/EC - EC-Regulation 396/2005

• Food Safety- Decision 2002/657/EC- EC-Regulation 178/2002

• Rapid Alert System for Food and Feed (ASFF)

• Hygiene4. Comparison to Argentinean

Regulations5. Statistical Data relating European

Trade and Monitoring- Honey Import Data- Monitoring

6. Further Topics under Discussion- Antibiotics- Ultrafiltration- Adulteration

7. Examples of our Laboratory- Bee pharmaceuticals- Veterinary drugs - Antibiotics

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Pro/142/2005/Trade ©QSI 2005 4

Honey and the Requirements of Trade in Europe

QSI Profile

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Honey and the Requirements of Trade in Europe

.

Bremen

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Honey and the Requirements of Trade in Europe

Institute‘s History

1954 Dr. H. Duisberg becomes the head of the institute founded by the German Honey Association

the institute carried out basic research for quality control of honey e.g. HMF, enzymes as Invertase, Diastase.

1976 Dr. Belá Talpay becomes the new leader of the institutepublished the ‚Specification for Honey‘ which defined the

characteristicsfor the main unifloral honey types andbuilt the basis for the §4 of the German Honey Directive (still

effective)

1989 Dr. Cord Lüllman becomes the actual head of the instituteco-author of the book ‚Honey‘ (published 1992). The book gives a

survey of all actual aspects concerning honey production, packing, quality control and quality problems.Dr. C. Lüllmann is a member of the European Harmonisation Group and of the DIN committee for establishing official German methods for honey analyses

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Honey and the Requirements of Trade in Europe

Quality Management/Quality Control

Quality Management/Quality Control

DevelopmentDevelopment Education/Support

Education/Support

BeeproductsFlavour and PerfumesEssential OilsNatural extractsPharmaceuticaAnalysis of Residues in:-Food, -Food Products-Natural FoodMicrobiologySensoryCommodities

Formulation for:- Phytopharmaca- CosmeticsAnalytical Methods

Quality Management:- HACCP- ISO 9000-EN ISO/IEC 17025Organic production:- authorised inspection body- Organic EC 2092/91

QSIIndustrial Care

QSIIndustrial Care

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Honey and the Requirements of Trade in Europe

Institute ProfilePersonnel

Chemists, biologists, food chemists, pharmacists Biological/chemical technicians, assistant chemists Personal for sampling Edp-experts

Equipment (excerpt) Gas chromatographic systems (GC), GC-MS HPLC systems (high pressure liquid chromatography) LC-MS/MS system (Liquid chromatography mass spectrometry/mass

spectrometry) Equipment for: classical chemical analysis, microbiological analysis,

physical measurement Laboratory data system Literature service Conferences and seminars - Organisation

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Honey and the Requirements of Trade in Europe

Education/SupportSeminars, training sessions and workshops

Quality Management• HACCP (Hazard Analysis Critical Control Point)

• ISO 9000 ff

• Carry out the appropriate external audits

• Consulting of companies

• Licensed institute according to EN 17025

Organic Production (Natural Food / Natural Commodities)

for trading with products from organic production special care must be taken.

• Give assistance/support in fulfilling the legal regulations and duties

• Act as authorised private inspection body according to the regulation(EC) No 2092/91 and 1804/99.

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Honey and the Requirements of Trade in Europe

Background

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Honey and the Requirements of Trade in Europe

Quality Management / Quality Control of Bee Products

Means:

• analysing honey types from all over the world on origin and qualitymain subjects are: - control of residues (antivarroa chemicals, antibiotics, pesticides)- HMF, moisture, diastase, pollen, sugars, acid degree, prolin, pH-value- sensory (taste, odour, appearance)

• analysing bee products like royal jelly, pollen, propolis or beeswax • delivery of information and analysis of contents, adulteration and

residues• give consultancy for all honey importers and packers in Europe

concerning quality control of their products

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Honey and the Requirements of Trade in Europe

International Honey Standards

• Codex Alimentarius- valid for honey trade in the whole world

• European Honey Regulation- valid for Europe

 

Why do we need standards ?

• Honey is a natural product

• Honey is a pure product

• This unique quality of honey must be preserved

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Honey and the Requirements of Trade in Europe

Quality - Who is responsible ?

• The bee keepers have the key

• The honey traders

but

• The consumers are able to choose and there by have influence

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Honey and the Requirements of Trade in Europe

Influence on Monitoring Food Quality

International Recommendations e.g. Codex Alimentarius

European Community: EC-Regulations, EC Directives

National Law: German Food Regulation (LMBG) and related Directives e.g. German Honey Directive, Pesticide Directive

Specifications of the Importers

Specifications of the Packers

Trade specifications of Supermarkets

Consumer resp. Consumer journals

Associations e.g. German Beekeeping Association

Exporters resp. factories

Farmers

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Honey and the Requirements of Trade in Europe

What goes wrong ?

• Use of antibiotics– recently found in Indian and Chinese honeys e.g. from

Fluroquinolone group: Enro-, Cipro- and Norfloxacin

• Use of pesticides

• Transport

• Storage

• Overseas transport

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Honey and the Requirements of Trade in Europe

European Requirements

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Honey and the Requirements of Trade in Europe

Introduction

The European Commission is more and more focusing on the Quality Control of imported foodstuffs especially of animal origin.

Through this:

• The regulation concerning the quality control of honey have strongly increased

• The honey market is concerned by an increasing number of residue problems

• The honey trade is influenced by scandals caused by residues of not permitted substances in animal foode.g.in the case of Chloramphenicol (CAP) this has led to a complete ban of imports from China (2002-2004)

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Honey and the Requirements of Trade in Europe

European Community Legislation

• Council Regulations law in every member state

• EC Directives shall be adopted in member statesno legal force until promulgated by national

parliament

• Horizontal legislation refers to all food stuffs e.g. for contaminants, additives, labelling Regulation EEC 2377/90 (maximum residues limits for veterinary drugs )

Directive 96/23/EC (monitoring)

• Vertical legislation refers to specific products e.g. Honey Directive 2001/110/EC Directive 2002/337/EC (list of third countries allowed to import honey from)

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Honey and the Requirements of Trade in Europe

Problems

• Possibilitiesdifferent member states have different requirements

• WhyNational requirements but no measures of the Communitye.g. Pesticide Directive

• Example: EC Directive– National legislation is adopted at different times in every member state or with

different interpretations

– Mechanism of enforcement is different e.g. local government entities

– Different emphasis on individual parameters e.g. contaminants, adulteration(influenced by industries or consumers!!!)

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Honey and the Requirements of Trade in Europe

Directives and Regulations

In the following the most important directives and regulations on different topics of the European Community in force according to honey and by-products will be presented:

• Honey

• Residues

• Monitoring

• Food Safety

• Hygiene

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Honey and the Requirements of Trade in Europe

Regulations on Honey

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Honey and the Requirements of Trade in Europe

Change in Quality Parameters under Evaluatione.g for Honey

1980 1990 2005

Regulations in force:

Ger.Honey-Directive Ger. Honey-Directive 2001/110/EC Ger. Pesticide Directive 96/23/EC (Annex IV)

(EEC) No 2377/90 2002/337/EC 93/43/EC (EEC) No 396/2005 New Ger. Honey-Directive

Number of parameters (*) under Evaluation:

about 8 about 10 about 15

(*) Groups of e.g. Pesticides, Antibiotics, environmental contaminants etc are counted as one.

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Honey and the Requirements of Trade in Europe

Council Directive 2001/110/ECof 20. December 2001

relating to honeyArt.1 Where the Directive shall apply to (Annex I)

Which requirements the products shall meet (Annex II)

Art.5 Member States shall not adopt national provisions not provided for by this Directive

Art.9 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 August 2003.

The measures shall be applied so as to:

- authorise the marketing of the products defined in Annex I…..with the effect from 1 August 2003

- prohibit the marketing of products which fail to conform to this Directive, with effect from 1 August 2004

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Honey and the Requirements of Trade in Europe

Annex INames, Product Description and Definitions

1. Honey is the natural sweet substance produced by Apis mellifera bees from the nectar of plants or from secretions of living parts of plants or excretions of plant-sucking insects on the living parts of plants, which the bees collect, transform by combining with specific substances of their own, deposit, dehydrate, store and leave in honeycombs to ripen and mature.

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Honey and the Requirements of Trade in Europe

Annex I cont.

2. The main types of honey are as follows:

a) According to origini. Blossom honey or nectar honey

ii. Honeydew honey

b) According to mode of production and/or presentationi. Comb honey

ii. Chunk honey or cut com honey

iii. Drained honey

iv. Extracted honey

v. Pressed honey

vi. Filtered honey Honey obtained by removing foreign inorganic or organic matter in such a way as to result in the significant removal of pollen

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Honey and the Requirements of Trade in Europe

Annex I cont.

3. Baker‘s honey

Honey which isa) suitable for industrial uses or as an ingredient in other foodstuff

which are then processed and

b) may:

- Have a foreign taste or odour, or

- Have begun to ferment or have fermented, or

- Have been overheated

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Honey and the Requirements of Trade in Europe

Annex IIComposition Criteria of Honey

• Honey consists essentially of different sugars, predominantly fructose and glucose as well as other substances such as organic acids, enzymes and solid particles derived from honey collection

• The colour of hones varies from nearly colourless to dark brown.

• The consistency can be fluid, viscous or partly to entirely crystallised

• The flavour and aroma vary, but are derived from the plant origin.

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Honey and the Requirements of Trade in Europe

Annex II, cont.

• Honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey

• Honey must, as far as possible (except baker’s honey),

– be free from organic or inorganic matters foreign to its composition

– not have any foreign taste or odour

– not have begun to ferment

– not have an artificially changed acidity or

– not have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated

• No pollen or constituents particular to honey may be removed except where this is unavoidable in the removal of foreign inorganic or organic matter (except filtered honey)

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Honey and the Requirements of Trade in Europe

Annex II, cont.

Honey must meet the following composition criteria: 2001/110/EC German Honey VO

1. Sugar content1.1 Fructose and glucose content (sum)- blossom honey min 60% min 60 %- honeydew honey, blends of honeydew honey min 45% min 45%

with blossom honey1.2 Sucrose content- in general max 5% max 5 %- false acacia, alfalfa, menzies Banksia,

French honeysuckle, red gum, leatherwood, Citrus spp. max 10% max 10%- lavender, borage max 15% max 15%

2. Moisture content- in general max 20% max 20 %- heather and bakers‘a honey in general max 23% max 23%- baker‘s honey from heather max 25% max 25%

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Honey and the Requirements of Trade in Europe

Annex II, cont.

2001/110/EC German Honey VO

3. Water-insoluble content- in general max 0.1 % max 0.1%

- pressed honey max 0.5% max 0.5%

4. Electrical conductivity- honey not listed below, and blends of these honeys max 0.8 mS/cm

- Honeydew and chestnut honey and blends of these except with those listed below min 0.8 mS/cm

- Exceptions: strawberry tree, bell heather, eucalyptus, lime, ling heather, manuka or jelly bush, tea tree

5. Free Acidity- in general max 50 mequiv/kg max 50 mequiv/kg

- baker‘s honey max 80 mequiv/kg

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Honey and the Requirements of Trade in Europe

Annex II, cont. 2001/110/EC German Honey

VO

6. Diastase activity and hydroxymethylfurfural content (HMF) determined after processing and blending

a) Diastase activity (Schade scale)

- in general, except baker‘s honey min 8 min 8

- Honeys with low natural enzyme content (e.g.citrus honeys) and an HMF content of not more than 15 mg/kg min 3 min 3

b) HMF

- in general, except baker‘s honey max 40 mg/kg max 40mg/kg

- honeys of declared origin from regions with max 80 mg/kgtropical climate and blends of these honeys

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Honey and the Requirements of Trade in Europe

Council Directive 2004/432/ECof 27 September 2004

List of Third Countries from which the import of honey is allowed only :

Argentina Israel El Salvador Australia India ThailandBulgaria Jamaica TurkeyBrazil Kenya TaiwanBelize Moldavia Tanzania Canada Mexico UkraineSwitzerland Nicaragua USA Chile Norway Uruguay China New Zealand VietnamSerbia-Montenegro Paraguay South AfricaCuba Rumania ZambiaGuatemala Russia Croatia San Marino

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Honey and the Requirements of Trade in Europe

Residues - Official Limits

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Honey and the Requirements of Trade in Europe

Regulation (EEC) No 2377/90of 26 June 1990

on veterinary drug residues in foodstuff of animal origin

• The regulation binds the maximum residue limits (MRL) for veterinary medicinal products in foodstuffs of animal origins.

• Limits are established in accordance with the regulatory committee procedure following scientific evaluation by the Committee for Veterinary Medical Products (CVMP) of the European Medicines Evaluation Agency (EMEA)

• The pharmacologically active substances are classified in 4 Annexes to the Regulation.

Positive Lists!!

The lists will be continually updated.

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Honey and the Requirements of Trade in Europe

Residue Definition

Residues of veterinary medicinal products

Means all pharmacologically active substances – whether active principles, excipients or degradation products – and their metabolites, which remain in foodstuffs obtained from animals to which the veterinary medicinal product in question has been administered.

Maximum Residue Limit (MRL)

Means the maximum concentration of residue resulting from the use of a veterinary medicinal product which may be legally permitted or recognized as acceptable in or on a food

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Honey and the Requirements of Trade in Europe

Annexes to Regulation (EEC) No 2377/90

Annex I

List of pharmacologically active substances for which a MRL has been fixed:Pharm. active Animal/ MRLs Target tissuesubstance species

Sulfonamides (all) all kinds used for 0,1 mg/kg muscle, fatfood production

Tetracyclines all kinds used for 0,1 mg/kg musclefood production 0,2 mg/kg eggs

Streptomycines cattle, pig 0,5 mg/kg muscle, fat

Amitraz bees 0,2 mg/kg honey

0,01 mg/kg milk

Coumaphos bees 0,1 mg/kg honey

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Honey and the Requirements of Trade in Europe

Annexes to Regulation (EEC) No 2377/90

Annex II

List of substances for which there is no need to set a MRLe.g. Lactic acid Formic acid, Eucalyptus, Camphor Menthol Thymol Fluvalinate*)

Phenol

*) but: according to the German Pesticide Directive MRLs are given

0,05 mg/kg for tea

0,02 mg/kg for wheat and rye

0,01 mg/kg for all other species

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Honey and the Requirements of Trade in Europe

Annexes to Regulation (EEC) No 2377/90, cont.

Annex III

List of pharmaceutically active substances for which a MRL cannot be set definitively but which may be given a provisional MRL for a defined period

e.g. Cymiazol 1 mg/kg until 01.07.2001

Pharmaceutically active substances not listed in Annexes I, II or III are not allowed to be used in veterinary drugs, if the animal is used for food production (§ 14)

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Honey and the Requirements of Trade in Europe

Annexes to Regulation (EEC) No 2377/90, cont

Annex IV

List of Substances for which it appear no MRL can be set because they pose a risk to human health in whatever quantity

e.g. Aristolochia spp. and preparations thereof Chloramphenicol Chloroform Chlorpromazine Colchicines Dapson Dimetridazol Metronidazol Nitrofurane (including Furazolidone) Ronidazol

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Honey and the Requirements of Trade in Europe

EMEA

CVMP

Annex IDefinitive

MRL

Annex IIIMRL

Provisional

Annex IVForbidden Substances

Natural orSafe

Substances

Annex II - No MRL

SurePharmaceutical

Device/Formulation

Request of Additional

information

Regulation (EEC) No 2377/90

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Honey and the Requirements of Trade in Europe

Monitoring

(Official Control)

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Honey and the Requirements of Trade in Europe

Council Directive 96/23/ECof 29 April 1996

on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives

85/358/EEC and 86/496/EEC and Decisions 89/187/EEC and 91/664/EEC

The Directive lays down:

• Guidelines for the residue control in animals and in their products .

• Detailed procedures to set up a National monitoring plan

• Details on sampling procedures

• The set of substances and groups of residues that must be monitored (Annex I)

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Honey and the Requirements of Trade in Europe

Definitions

Unauthorized substances or products:

Shall mean substances or products the administering of which to animals is prohibited und Community legislation

Illegal treatment:

Shall mean the use of unauthorized substances or products or the use of substances or producers authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation or, where appropriate, in various national legislations

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Honey and the Requirements of Trade in Europe

Annex I to Directive 96/23/EC

Group A – Substances having anabolic effect and unauthorized substances

(1) Silbenes, Stilbene derivates, and their salts and esters

(2) Antithyroid agents

(3) Steroids

(4) Resorcylic acid lactones including Zeranol

(5) Beta-agonists

(6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990e.g. Chloramphenicol (CAP)

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Honey and the Requirements of Trade in Europe

Annex I, cont.GROUP B – Veterinary drugs (1) and contaminants (see also (EEC) No 2377/90)(1) Antibacterial substances, including sulphonamides, quinolones(2) Other veterinary drugs

a) Anthelminiticsb) Anticoccididials, including Nitroimidazolesc) Carbamates and Pyrethroidsd) Sedativese) Non-steroidal anti-inflammatory drugs (NSAIDs)f) Other pharmacologically actives substances

(3) Other substances and environmental contaminantsa) Organochlorine compounds including PCBsb) Organophosphorus compoundsc) Chemical elements, e.g. heavy metalsd) Mycotoxinse) Dyesf) Others

(4) Including unlicensed substances which could be used for veterinary purposes

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Honey and the Requirements of Trade in Europe

Bovine Porcine Ovine

Caprine Equine

Poultry Fish Milk Eggs Rabbit Honey

1 X X X X2 X X X3 X X X X4 X X X5 X X X6 X X X X X X

1 X X X X X X X

2 a X X X X X2 b X X X X2 c X X X X2 d X2 e X X X X2 f

3 a X X X X X X X3 b X X X3 c X X X X X X3 d X X X X3 e X

A

B

Substance categories

Veterinary drugs and contaminants are controlled in:

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Honey and the Requirements of Trade in Europe

Pesticide Residues

Recent situation

• Consumer in the EU are extremely sensitive to the issue of pesticides residues in food.

• Honey as regarded as natural and pure should be as free from residues as possible.

• Up to April 2005 each Member State applied its own maximum residue limits for pesticides. Previous European legislation set different limits for different kinds of products.

• In April 2005 a new regulation as set into force proposing harmonised maximum limits for all foodstuff

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Honey and the Requirements of Trade in Europe

Regulation (EC) No 396/2005of 23 February 2005

on maximum residue levels of pesticides in or on food of plant an animal origin and amending Council directive 91/414/EEC

• The regulation establishes the maximum quantities of pesticide residues permitted in products of animal or vegetable origin that are intended for human consumption, These maximum residue levels (MRLs) include, on the one hand, MRLs that are specific to particular foodstuffs that are intended for human consumption and, on the other hand, a general limit that applies where no specific MRLs has been set.

The maximum pesticide residue level in foodstuff “by default” is0,01 mg/kg

i.e. in all cases where no MRL has not been set.

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Honey and the Requirements of Trade in Europe

Regulation (EC) No 396/2005 cont.

• Annex IList of product groups including examples of products within the groups the regulation concerned.E.g. honey – jelly royal, pollen

• Annex IIList of Specific MRLslist should be drawn up until 6. April 2006

• Annex IIIList of provisional MRLs, in particular in the following cases:

– For honeys and herbal infusions– In exceptional circumstances where contamination by plant protection products has

taken place– For national MRLs which have not yet been harmonised– Where new products are listed in Annex I and a Member State request it, in order to

have enough time for a comprehensive scientific assessment and provided that no risk to the consumer has been detected.

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Regulation (EC) No 396/2005 cont.

• Annex IVList of active substances for which no MRL was considered necessaryto be drawn up until 6. April 2006

• Annex VDetection limit above 0,01 mg/kg

• Annex VIspecific factors concerning concentration and dilution of certain processed and/or composite products

• Annex VIIExceptionse.g. products not intend for immediate consumption

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Regulation (EC) No 396/2005 cont.

• Setting, amending and removing MRLsThe European Food Safety Authority (EFSA) will be responsible for the risk evaluation. It will make a decision on each intended new MRL, amendment of removal.

• Checking of MRLsMember States will carry out checks on pesticide residue to ensure compliance with the MRLs.The Member States will get the possibility to publish the names of companies that produce products which that exceed the MRLs set.

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Food Safety

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Are the limits fixed for authorised veterinary drugs enough to guarantee

Food Safety?

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If a control for a not authorised veterinary drug or forbidden substance is required, what limits are used for official or private

food control?

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‚Action Limit‘

Means:

• Safety for the consumer

• Reliability of analytical techniques used

• Knowledge of metabolism or distribution kinetics

e.g.: for the forbidden or not authorised substances a limit of action doesn't correspond in any case to authorise its use.

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‚General Limits‘

• In many countries a general safety limit exists when no limits are defined.

• This limit is generally 0,01 mg/kg (10 ppb), close to a generic instrumental detection limits

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Residue of Not Authorised Drugs (no toxic)

• Often these limits are specified in the National Residues Monitoring Plane.g. German Pesticide Directive

• There aren't uniform criteria for to define this type of residue in EC

Question:

10 ppb or the limit of detection of the analytical methods?

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Residue of Forbidden Drugs

• „0“- Tolerance – depends on the technique of detection (< 1ppb – 0.1 ppb)

• The ‚action limit‘ is generally fixed at 1 ppb

• Recently the EC requested a very low limit of detection (LoD) (LoD = 0.3 ppb for Chloramphenicol)

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Food Safety = Consumer Protection?

Annual consumption in Germany of meat, milk and honey compared to MRLs of antibiotics at the example of ‘Sulphonamides’

Food annual consumption 2004 intake of sulphonamides per head accepted acc. to MRL

Meat 63,3 kg 6,3 mg

Milk 89,4 kg 8,9 mg

Honey 1,5 kg 0,1 mg

Food Safety = Food is according to the actual regulations!

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Actual Situation

• The not well harmonised behaviour around EC Member States generates confusion

• For this reason a new Commission Decision was very recently set into force:

Commission Decision 2002/657/EClaying down rules for implementing Council Directive

96/23/EC

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Commission Decision 2002/657/ECof 12 August 2002

Implementing Council Directive 96/23/EC concerning the performance of analytical methods and interpretation of results

• It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control

• Require official control laboratories to be accredited according to ISO 17025 (1) from January 2002 onwards.

• It is necessary to determine common criteria for the interpretation of test results of official control laboratories in order to ensure a harmonised implementation of Directive 96/23/EC

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Commission Decision 2002/657/EC, cont.

• It is necessary to provide for the progressive establishment of minimum required performance limits (MRPL) of analytical methods for substances for which no permitted limit has been established and in particular for those substances whose use is not authorised, or is specifically prohibited in the Community, in order to ensure harmonised implementation of Directive 96/23/EC

• The result of an analysis shall be considered non-compliant if the decision limit of the confirmatory method for the analyte is exceeded.

• If no permitted limit has been established for a substance, the decision limit is the lowest concentration level at which a method can discriminate with a statistical certainty of 1- that the particular analyte is present.

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Regulation (EC) 178/2002of 28 January 2002

laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Main points are:

• The regulations provides the basis for the assurance of a high level of protection of human health and well-being of citizens, and to their social and economic interests.

• Considers necessary all aspects of the food production chain as a continuum from and including the production of animal feed in order to ensure safety of food.

• For ensuring continuous monitoring networking of laboratories of excellence, at regional and/or interregional level play an important role.

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Food Safety

Article 14 Food safety requirements

Food shall be deemed to be unsafe if it is considered to be:- unjurious to health- unfit for human consumption

In determining whether any food is unsafe, regard should be had:- the normal conditions of use- information provided to the consumer concerning the avoidance of specific adverse health effects

In determing whether any food is injurious to health, regard shall be had:- the probable effects of that food on the health of a person consuming- probable cumulative effects- particular health sensitivities of a specific category of consumers

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Traceability

Article 18 Traceability

It is necessary to ensure that a food or feed business including an importer can identify at least the business from which the food, feed, animal or substance that may be incorporated into a food or feed has been supplied, to ensure that on investigations, traceability can be assured at all stages

Proper information and labelling facilitates traceability!

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Risk management

• Risk evaluation• Option assessment• Option implementation• Monitoring and review

Risk Communication

Risk assessment

• Hazard identification• Hazard characterisation• Exposure assessment• Risk characterisation

Article 6 Risk Analysis

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Risk Communication

Article 19 Responsibility for food

If a food is considered as not to be in compliance with the food safety requirements the operator shall:

- initiate procedures to withdraw the food in question from the market where the food has left immediate control

- inform the competent authorities

- inform the consumers of the reasons for its withdrawal and if necessary recall products already supplied from the consumers

This article corresponds to §40a of the German Food Regulation (LMBG)

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EC Rapid Alert System

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Rapid Alert System for Food and Feed (RASFF)

§ 50 Rapid alert System (EC/178/2002)• The system allows for the rapid exchange of information at EU level,

on food products that present a serious and immediate risk to the consumer.

• The system is operated by the European Commission (DG SANCO) and primarily serves to protect consumers.

• Food alert are issued when a food product with immediate serious health consequences, or temporary adverse health implications, is on the market.

• The Rapid Alert System for Food informs the competent Authorities in the member States of the presence of a serious risk to the health of the consumer presented by a food product.

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Rapid Alert System for Food and Feed, cont.

Levels of Information

Three levels of information exist:

1. Alert Notificationfood still on the marketMore than one Member State is involvedimmediate action is required

2. Information Notificationaction not immediately requiredprovide useful information

3. NewsNeither Alert nor Information required

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Rapid Alert Syrem for Food and

Feed

FOODVERY URGENT _ TRES URGENT

ALERT NOTIFICATION: 2002/260

ORIGINAL NOTIFICATION

SUBJECT: CARBOFURAN AND CARBOSULFAN IN RED PEPPERS (VEGETABLES) FROM TURKEY

MARKET CONTROL. – ComplaintDistribution to AUSTRIADispatcher: KERVAN GIDA KOZMETIC HEDIYELIK ESYA LTED.STI

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Rapid Alert System for Food and Feed, cont.

Former information's given are:

• General Information: Country, Date

• Product e.g. fruiting vegetable, red peppers, trade name etc

• Origin e.g.name and address of the manufacturer, the dispatcher, country of origin, importer etc.

• Danger: e.g. excessive concentration of pesticide residues results of the tests: e.g. 0.36 mg/kg Carbofuran

• Methods of analysis

• Measures adopted: e.g. product rejected, Justification: LMBG, Order on maximum residue levels

• Other information: Ministry, person to contact

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NEWS

MEMBER STATE NOTIFICATION

RASFF ASSESSMENT

FEEDBACK FROM

MEMBER STATES

TRANSMISSION VIA

CIRCA/E-MAIL

ELABORATION OF THE

NOTIFICATION

INFORMATIONALERT

TRANSMISSION OF NOTIFICATIONS

TO THETHIRD COUNTRIES

CONCERNED

MEMBER STATES

COMMISSION SERVICES

E-MAILFAX

REPORTS/STATISTICS

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Rapid Alert System for Food and Feed, cont.

Any subject in food chain and food control has a different opinion in terms of limits and safety:

• Consumer food must be saferesidues must be absent

• Toxicologist safe for humansevaluation based on technical datalow honey consumption in the normal diet

• Analyst reliability of resultsbraid range of compounds covered in one analysisLoQ and LoD strongly depend on instruments and experience

• Industry safe für consumer• Beekeepers most important point of the chain

interested in product qualitybut...need disease control tools

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Hygiene

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Regulations on Hygiene

In 2004 new regulations were set into force:

• 852/2004 Food hygiene in general

• 853/2004 Specific requirements for food of animal originOpinion of the German Ministry: also honey is indicated as an animal productOpinion of business: operators specialised in the production and trade of hones are not required for approval according to the regulationstill in discussion

• 854/2004 New Requirements for veterinary official control for food of animal origin

All beforehand existing hygienic directives are not in force anymore!

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Regulations on Hygiene, cont.

The main points of these new Regulations are:

• Registration for all producers, processors, packers of animal food from 1. January 2006;

• Producers are only excluded in case of direct marketing, trade is excluded;

• Duty for quality control systems based on HACCP;

• Equivalency requirement for all imported food.

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Safe Food

Safe Food is the result of the combination of

• Keeping on relevant official regulations

• Performance of programs on food safety- to be done by the employers e.g. look for microbiological pollution

• Application of HACCP-systems in view of the CODEX guidelines