1. WHO, Almaty 2002Legislation of food additives and contaminants 1 Terezia Sinkova

2. WHO, Almaty 2002Legislation of food additives and contaminants 2 What comes into food? 1. Classical raw materials 2. Other raw materials and processing aids 3. Chemicals used at plant production 4. Materials used at animal production 5. Contaminants from environment 6. Contaminants produced by microorganisms in food 7. Contaminants from materials coming in contact with food 1. Food ingredients of plant and/or animal origin 2. Food additives 3. Residues of pesticides 4. Residues of veterinary drugs 5. Heavy metals, dioxins, residues from cleaning preparations... 6. Mycotoxins 7. PVC,...

3. WHO, Almaty 2002Legislation of food additives and contaminants 3 Any hazardous material should be considered in legislation and watched Food additives Residues of pesticides Residues of veterinary drugs Heavy metals, dioxins,... Mycotoxins,PVC,... Are added in food intentionally /can be watched at food production Contaminants /need to be watched and minimized at sources/

4. WHO, Almaty 2002Legislation of food additives and contaminants 4 What type of legislation is needed to assure food safety Food additives Residues of pesticides Residues of veterinary drugs Heavy metals, dioxins,... Mycotoxins,PVC,... Maximum limits/Good Manufacturing Practice Maximum limits/Good Agriculture Practice Maximum limits/Good Veterinary Practice Maximum limits /other regulations/

5. WHO, Almaty 2002Legislation of food additives and contaminants 5 International support to legislation of food additives and contaminants International Programme on Chemical Safety /IPCS/, established in 1980, is a joint venture of the United Nations Environment Programme /UNEP/, the International Labour Organisation /ILO/, and the World Health Organisation /WHO/. established in 1980, is a joint venture of the United Nations Environment Programme /UNEP/, the International Labour Organisation /ILO/, and the World Health Organisation /WHO/. Objective: To establish the scientific basis for assessung the risk to human health and the environment from exposure to chemicals, through international peer-review processes, as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strenthening national capacities for the sound management of chemicals.

6. WHO, Almaty 2002Legislation of food additives and contaminants 6 Scientific base for legislation of food additives and contaminants b JECFA – Joint FAO/WHO Expert Committee on Food Additives /+ food contaminants + residues of veterinary drugs/ /+ food contaminants + residues of veterinary drugs/ Technical Reports on evaluation of... /e.g. mycotoxins in food/ Technical Reports on evaluation of... /e.g. mycotoxins in food/ WHO monographies on toxicological evaluation of... /e.g. certain veterinary drug residues in food/ WHO monographies on toxicological evaluation of... /e.g. certain veterinary drug residues in food/ Specifications for identity and purity of certain food additives b JMPR – Joint FAO/WHO Meetings on Pesticide Residues Evaluations of pesticide residues in /e.g. 1999/ Evaluations of pesticide residues in /e.g. 1999/ b Joint FAO/WHO Expert Consultations Reports Reports

7. WHO, Almaty 2002Legislation of food additives and contaminants 7 Scientific base for safety of food additives Scientific laboratories from over the world FA production aspects, effects on animals JECFA - indenendent committee FAO/WHO Evaluation of results FA identity and purity NOEL /no observed effect level/ Safety factor 100, 200, or higher ADI /Acceptable Daily Intake/ for human ADI = Acceptable amount of the FA, which can be consumed every day for the whole life without any health effect = mg/kg b. w./day Codex Alimentarius FAO/WHO Respecting food variety and nutritional patterns Maximum limits of individual FAs in individual foods

8. WHO, Almaty 2002Legislation of food additives and contaminants 8 Codex Alimentarius General principles for the use of food additives Toxicological evaluation No hazard at the levels of use proposed Re-evaluation whenever necessary Conformation with approved specifications Use justified only for purposes which cannot be achieved by other means Maximum limits at the lowest level to achieve the desired effect /GMP/ ADI and probable FA daily intake from all sources

9. WHO, Almaty 2002Legislation of food additives and contaminants 9 Codex Alimentarius Class names and the international numbering system INS Examples: 102 - Tartrazine - colour 140 - Chlorophyll - colour 200 - Sorbic acid – Preservative 290 – Carbon dioxide – carbonating agent, packing gas 461 – Methyl cellulose – thickener, emulsifier, stabiliser 953 – Isomalt – sweetener, anticaking agent, bulking agent, glazing agent

10. WHO, Almaty 2002Legislation of food additives and contaminants 10 Codex Alimentarius General standard for food additives /GSFA/ b Preamble b Annex A b Annex B b Annex C List AList A List BList B b Table 1 b Table 2 b Table 3 Annex to Table 3 b Definitions b General principles for the use of FA b Carry-over of FA into foods b Food category system b Format of the standard b Review and revisions of the standard

11. WHO, Almaty 2002Legislation of food additives and contaminants 11 Codex Alimentarius General standard for food additives /GSFA/ b Preamble b Annex A b Annex B b Annex C List AList A List BList B b Table 1 b Table 2 b Table 3 Annex to Table 3 Guidelines fod development of maximum levels of use for FA with numerical ADI

12. WHO, Almaty 2002Legislation of food additives and contaminants 12 Codex Alimentarius General standard for food additives /GSFA/ b Preamble b Annex A b Annex B b Annex C List AList A List BList B b Table 1 b Table 2 b Table 3 Annex to Table 3 GSFA Food categorization System

13. WHO, Almaty 2002Legislation of food additives and contaminants 13 Food categorization system /a selection as an example/ 0.4 Fruits and vegetables 0.4.1 Fruits 0.4.1.1 Fresh fruit 0.4.1.1.2 Surface treated fruit... 0.4.2 Vegetables 0.4.2.1 Fresh vegetables 0.4.2.1.2 Surface-treated vegetables 0.4.2.1.3 Peeled or cut vegetables.... 04.2.2.1 Frozen vegetables 04.2.2.3 Vegetables in vinegar, oil, or brine 04.2.2.4 Canned or bottled /pasteurized/ vegetables

14. WHO, Almaty 2002Legislation of food additives and contaminants 14 Codex Alimentarius Food categorization system b Is a tool for application of FA. b Applies to all foodstuffs including those in which no additives are permitted. b Is a hierarchical system based on product descriptors of foodstuffs as marketed. b Takes into consideration the carry-over principle /i. e. the system does not need to mention compounds of foodstuffs/

15. WHO, Almaty 2002Legislation of food additives and contaminants 15 Codex Alimentarius General standard for food additives /GSFA/ b Preamble b Annex A b Annex B b Annex C List AList A List BList B b Table 1 b Table 2 b Table 3 Annex to Table 3 Cross-reference to Codex commodity standards and the GSFA Index of Food additives A – JECFA „approved“ FAs, with ADIs and INS numbers B – INS numbers for JECFA „approved“ FAs with ADIs

16. WHO, Almaty 2002Legislation of food additives and contaminants 16 Codex Alimentarius General standard for food additives b Table 1 b Table 2 b Table 3 Additives permitted for use under specified conditions in certain food categories or individual food items Example: Aspartame, INS 951 05.2 Sugar-based confectionery GMP 05.3 Chewing gum 5000 mg/kg 14.1.4 Water-based flavored drinks 1000 mg/kg 14.2.1 Beer and malt beverages GMP.....

17. WHO, Almaty 2002Legislation of food additives and contaminants 17 Codex Alimentarius General standard for food additives b Table 1 b Table 2 b Table 3 Food categories or individual food items in which food additives are permitted under specified conditions Example: 03.0 Edible ices 355 Adipates 2000 mg/kg 334 Tartrates 1000 mg/kg 338 Phosphates 1000 mg/kg.....

18. WHO, Almaty 2002Legislation of food additives and contaminants 18 Codex Alimentarius General standard for food additives b Table 1 b Table 2 b Table 3 Annex Annex to the table 3 to the table 3 b Additives permitted for use in food in general, unless otherwise specified, in accordance with GMP b Example: 260 Acetic acid 406 Agar 162 Beet red Food categories and individual food items excluded from the general conditions of table 3

19. WHO, Almaty 2002Legislation of food additives and contaminants 19 EU directives of food additives A whole range of general directives /to harmonize approach of individual member states/ and amendments to the following directives: 1. Sweeteners 94/35 – definitions, limits, monitoring of intake 95/31 – purity criteria 2. Colorants 94/36 – definitions, limits, monitoring of intake 95/45 – purity criteria

20. WHO, Almaty 2002Legislation of food additives and contaminants 20 EU directives of food additives 3. Other food additives 78/663 – purity criteria 81/712 – EC methods for purity verifying 89/107 – FA control and general criteria of assessment 95/2 - definitions, limits, monitoring of intake 96/77 – purity criteria

21. WHO, Almaty 2002Legislation of food additives and contaminants 21 Internal structure of EU Directives on application of FAs Application of colorants in food products 94/36/EC 94/36/EC ANNEXES: b List of permitted colours b List of foodstuffs in which the colours are not allowed b List of foodstufsf in which only selected colours can be added b List of colours which can be added only to selected foodstuffs b List of colours which can be used under GMP

22. WHO, Almaty 2002Legislation of food additives and contaminants 22 Codex legislation of contaminants Residues of pesticides Residues of veterinary drugs Heavy metals, dioxins,... Mycotoxins,others Levels of contaminants should be as low as possible meeting requirements of good practice in each stage of primary and food production.

23. WHO, Almaty 2002Legislation of food additives and contaminants 23 Scientific base for legislation of food contaminants b JECFA – Joint FAO/WHO Expert Committee on Food Additives /+ food contaminants + residues of veterinary drugs/ /+ food contaminants + residues of veterinary drugs/ Technical Reports on evaluation of... /e.g. mycotoxins in food/ Technical Reports on evaluation of... /e.g. mycotoxins in food/ WHO monographies on toxicological evaluation of... /e.g. certain veterinary drug residues in food/ WHO monographies on toxicological evaluation of... /e.g. certain veterinary drug residues in food/ b JMPR – Joint FAO/WHO Meetings on Pesticide Residues Evaluations of pesticide residues in /e.g. 1999/ Evaluations of pesticide residues in /e.g. 1999/ b Joint FAO/WHO Expert Consultations Reports Reports

24. WHO, Almaty 2002Legislation of food additives and contaminants 24 Codex Alimentarius Maximum residue limits for contaminants b Are evaluated continuously by the CC FAC and CC PR, re-evaluated and adjusted b Monitoring of contaminants in food chain is reviewed by GEMS/Food

25. WHO, Almaty 2002Legislation of food additives and contaminants 25 Codex Alimentarius General standard for contaminants and toxins in foods b Preamble b Annex 1 – Criteria for establishment of maximum levels in foods b Annex II – Procedure for risk management decisios b Annex III – Format of the standard b Annex IV – List of contaminants and toxins b Annex V – Food categorization system

26. WHO, Almaty 2002Legislation of food additives and contaminants 26 EU regulations on contaminants For specific contaminants are defined: - Limits of a contaminant in individual foods - Reference analytical method - Detection limit needed - Sampling method,...

27. WHO, Almaty 2002Legislation of food additives and contaminants 27 EC Regulation No. 466/2001 setting maximum levels for certain contaminants in foodstuffs 1. Nitrates 2. Mycotoxins 3. Heavy metals 4. 3-monochloropropane-1,2-diol /3-MCPD/

28. WHO, Almaty 2002Legislation of food additives and contaminants 28 Selected example from the EC Regulation No. 466/2001 3.1 Lead /Pb/ 3.1.1 Cow´s milk /raw milk, milk for the manufacture of milk-base products and heat-treated milk milk as defined by Directive 92/46/EEC/ Maximum level: 0,02 mg/kg Performance criteria for sampling: Commission directive 2001/22/EC Performance criteria for methods of analysis: Directive 2001/22/EC

29. WHO, Almaty 2002Legislation of food additives and contaminants 29 Slovak legislation of food additives and contaminants b Involved in a horizontal Food Codex chapter b Harmonization with the EU provisions achieved gradually

30. WHO, Almaty 2002Legislation of food additives and contaminants 30 Updating permitted lists and MRLs Procedures at national and international levels are similar. Decisions should take into account: Identification of contaminant and toxicological information Potential health problems Validated analytical data, sampling procedures Intake data /food consumption data for average, most exposed consumer groups, dietary intake/ Technological possibilities to manage the problem Fair trade considerations