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

2. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 2 Honey and the Requirements of Trade in Europe

3. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 3 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) Hygiene 4.Comparison to Argentinean Regulations 5.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

4. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 4 QSI Profile

5. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 5. Bremen

6. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 6 Institute‘s History 1954Dr. 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. 1976Dr. Belá Talpay becomes the new leader of the institute published the ‚Specification for Honey‘ which defined the characteristics for the main unifloral honey types and built the basis for the §4 of the German Honey Directive (still effective) 1989 Dr. Cord Lüllman becomes the actual head of the institute co-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

7. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 7 Quality Management/ Quality Control Quality Management/ Quality Control Development Education/ Support Education/ Support Beeproducts Flavour and Perfumes Essential Oils Natural extracts Pharmaceutica Analysis of Residues in: -Food, -Food Products -Natural Food Microbiology Sensory Commodities Formulation for: - Phytopharmaca - Cosmetics Analytical Methods Quality Management: - HACCP - ISO 9000 -EN ISO/IEC 17025 Organic production: - authorised inspection body - Organic EC 2092/91 QSI Industrial Care QSI Industrial Care

8. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 8 Institute Profile Personnel  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

9. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 9 Education/Support Seminars, 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.

10. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 10 Background

11. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 11 Quality Management / Quality Control of Bee Products Means: analysing honey types from all over the world on origin and quality main 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

12. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 12 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

13. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 13 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

14. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 14 Influence on Monitoring Food Quality International Recommendationse.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

15. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 15 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

16. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 16 European Requirements

17. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 17 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 food e.g.in the case of Chloramphenicol (CAP) this has led to a complete ban of imports from China (2002-2004)

18. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 18 European Community Legislation Council Regulations law in every member state EC Directives shall be adopted in member states no 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)

19. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 19 Problems Possibilities different member states have different requirements Why National requirements but no measures of the Community e.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!!!)

20. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 20 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

21. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 21 Regulations on Honey

22. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 22 Change in Quality Parameters under Evaluation e.g for Honey 198019902005 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 8about 10about 15 (*) Groups of e.g. Pesticides, Antibiotics, environmental contaminants etc are counted as one.

23. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 23 Council Directive 2001/110/EC of 20. December 2001 relating to honey Art.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

24. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 24 Annex I Names, 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.

25. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 25 Annex I cont. 2.The main types of honey are as follows: a)According to origin i.Blossom honey or nectar honey ii.Honeydew honey b)According to mode of production and/or presentation i.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

26. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 26 Annex I cont. 3.Baker‘s honey Honey which is a)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

27. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 27 Annex II Composition 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.

28. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 28 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)

29. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 29 Annex II, cont. Honey must meet the following composition criteria : 2001/110/EC German Honey VO 1.Sugar content 1.1 Fructose and glucose content (sum) -blossom honeymin 60% min 60 % -honeydew honey, blends of honeydew honey min 45% min 45% with blossom honey 1.2 Sucrose content -in generalmax 5% max 5 % -false acacia, alfalfa, menzies Banksia, French honeysuckle, red gum, leatherwood, Citrus spp.max 10% max 10% -lavender, boragemax 15% max 15% 2.Moisture content -in generalmax 20% max 20 % -heather and bakers‘a honey in generalmax 23% max 23% -baker‘s honey from heathermax 25% max 25%

30. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 30 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

31. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 31 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 honeymin 8 min 8 -Honeys with low natural enzyme content (e.g.citrus honeys) and an HMF content of not more than 15 mg/kgmin 3min 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/kg tropical climate and blends of these honeys

32. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 32 Council Directive 2004/432/EC of 27 September 2004 List of Third Countries from which the import of honey is allowed only : ArgentinaIsrael El Salvador Australia India Thailand Bulgaria Jamaica Turkey BrazilKenya Taiwan Belize Moldavia Tanzania Canada Mexico Ukraine Switzerland Nicaragua USA Chile Norway Uruguay ChinaNew Zealand Vietnam Serbia-MontenegroParaguay South Africa Cuba RumaniaZambia Guatemala Russia CroatiaSan Marino

33. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 33 Residues - Official Limits

34. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 34 Regulation (EEC) No 2377/90 of 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.

35. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 35 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

36. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 36 Annexes to Regulation (EEC) No 2377/90 Annex I List of pharmacologically active substances for which a MRL has been fixed: Pharm. activeAnimal/ MRLs Target tissue substancespecies Sulfonamides (all)all kinds used for 0,1 mg/kgmuscle, fat food production Tetracyclinesall kinds used for 0,1 mg/kgmuscle food production 0,2 mg/kgeggs Streptomycinescattle, pig 0,5 mg/kgmuscle, fat Amitrazbees 0,2 mg/kg honey 0,01 mg/kgmilk Coumaphosbees 0,1 mg/kghoney

37. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 37 Annexes to Regulation (EEC) No 2377/90 Annex II List of substances for which there is no need to set a MRL e.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

38. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 38 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)

39. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 39 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

40. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 40 EMEA CVMP Annex I Definitive MRL Annex III MRL Provisional Annex IV Forbidden Substances Natural or Safe Substances Annex II - No MRL Sure Pharmaceutical Device/Formulation Request of Additional information Regulation (EEC) No 2377/90

41. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 41 Monitoring (Official Control)

42. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 42 Council Directive 96/23/EC of 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)

43. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 43 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

44. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 44 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 1990 e.g. Chloramphenicol (CAP)

45. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 45 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)Anthelminitics b)Anticoccididials, including Nitroimidazoles c)Carbamates and Pyrethroids d)Sedatives e)Non-steroidal anti-inflammatory drugs (NSAIDs) f)Other pharmacologically actives substances (3)Other substances and environmental contaminants a)Organochlorine compounds including PCBs b)Organophosphorus compounds c)Chemical elements, e.g. heavy metals d)Mycotoxins e)Dyes f)Others (1)Including unlicensed substances which could be used for veterinary purposes

46. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 46 Veterinary drugs and contaminants are controlled in:

47. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 47 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

48. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 48 Regulation (EC) No 396/2005 of 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” is 0,01 mg/kg i.e. in all cases where no MRL has not been set.

49. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 49 Regulation (EC) No 396/2005 cont. Annex I List of product groups including examples of products within the groups the regulation concerned. E.g. honey – jelly royal, pollen Annex II List of Specific MRLs list should be drawn up until 6. April 2006 Annex III List 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.

50. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 50 Regulation (EC) No 396/2005 cont. Annex IV List of active substances for which no MRL was considered necessary to be drawn up until 6. April 2006 Annex V Detection limit above 0,01 mg/kg Annex VI specific factors concerning concentration and dilution of certain processed and/or composite products Annex VII Exceptions e.g. products not intend for immediate consumption

51. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 51 Regulation (EC) No 396/2005 cont. Setting, amending and removing MRLs The 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 MRLs Member 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.

52. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 52 Food Safety

53. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 53 Are the limits fixed for authorised veterinary drugs enough to guarantee Food Safety?

54. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 54 If a control for a not authorised veterinary drug or forbidden substance is required, what limits are used for official or private food control?

55. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 55 ‚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.

56. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 56 ‚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

57. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 57 Residue of Not Authorised Drugs (no toxic) Often these limits are specified in the National Residues Monitoring Plan e.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?

58. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 58 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)

59. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 59 Food Safety = Consumer Protection? Annual consumption in Germany of meat, milk and honey compared to MRLs of antibiotics at the example of ‘Sulphonamides’ Foodannual consumption 2004intake of sulphonamides per headaccepted acc. to MRL Meat63,3 kg6,3 mg Milk89,4 kg8,9 mg Honey 1,5 kg0,1 mg Food Safety = Food is according to the actual regulations!

60. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 60 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/EC laying down rules for implementing Council Directive 96/23/EC

61. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 61 Commission Decision 2002/657/EC of 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

62. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 62 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.

63. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 63 Regulation (EC) 178/2002 of 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.

64. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 64 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

65. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 65 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!

66. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 66 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

67. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 67 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)

68. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 68 EC Rapid Alert System

69. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 69 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.

70. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 70 Rapid Alert System for Food and Feed, cont. Levels of Information Three levels of information exist: 1.Alert Notification food still on the market More than one Member State is involved immediate action is required 2.Information Notification action not immediately required provide useful information 3.News Neither Alert nor Information required

71. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 71 Rapid Alert Syrem for Food and Feed FOOD VERY URGENT _ TRES URGENT ALERT NOTIFICATION:2002/260 ORIGINAL NOTIFICATION SUBJECT: CARBOFURAN AND CARBOSULFAN IN RED PEPPERS (VEGETABLES) FROM TURKEY MARKET CONTROL. – Complaint Distribution to AUSTRIA Dispatcher: KERVAN GIDA KOZMETIC HEDIYELIK ESYA LTED.STI

72. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 72 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

73. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 73 NEWS MEMBER STATE NOTIFICATION RASFF ASSESSMENT FEEDBACK FROM MEMBER STATES TRANSMISSION VIA CIRCA/E-MAIL ELABORATION OF THE NOTIFICATION INFORMATION ALERT TRANSMISSION OF NOTIFICATIONS TO THE THIRD COUNTRIES CONCERNED MEMBER STATES COMMISSION SERVICES E-MAIL FAX REPORTS/ STATISTICS

74. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 74 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: Consumerfood must be safe residues must be absent Toxicologistsafe for humans evaluation based on technical data low honey consumption in the normal diet Analystreliability of results braid range of compounds covered in one analysis LoQ and LoD strongly depend on instruments and experience Industrysafe für consumer Beekeepersmost important point of the chain interested in product quality but...need disease control tools

75. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 75 Hygiene

76. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 76 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 origin Opinion of the German Ministry: also honey is indicated as an animal product Opinion of business: operators specialised in the production and trade of hones are not required for approval according to the regulation still 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!

77. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 77 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.

78. Honey and the Requirements of Trade in Europe Pro/142/2005/Trade ©QSI 2005 78 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