who, almaty 2002legislation of food additives and contaminants 1 terezia sinkova

WHO, Almaty 2002 Legislation of food additives and contaminants

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Legislation of food additives and Legislation of food additives and contaminants contaminants

Terezia SinkovaTerezia Sinkova


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What comes into food?What comes into food?

1.1. Classical raw materials Classical raw materials

2.2. Other raw materials and Other raw materials and processing aids processing aids

3.3. Chemicals used at plant Chemicals used at plant productionproduction

4.4. Materials used at animal Materials used at animal productionproduction

5.5. Contaminants from Contaminants from environmentenvironment

6.6. Contaminants produced Contaminants produced by microorganisms in by microorganisms in foodfood

7.7. Contaminants from Contaminants from materials coming in materials coming in contact with foodcontact with food

1.1. Food ingredients of plant Food ingredients of plant and/or animal originand/or animal origin

2.2. Food additivesFood additives

3.3. Residues of pesticides Residues of pesticides

4.4. Residues of veterinary Residues of veterinary drugsdrugs

5.5. Heavy metals, dioxins, Heavy metals, dioxins, residues from cleaning residues from cleaning preparations...preparations...

6.6. MycotoxinsMycotoxins

7.7. PVC,...PVC,...


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Any hazardous material should be Any hazardous material should be considered in legislation and considered in legislation and watchedwatched

Food additivesFood additives

Residues of pesticides Residues of pesticides Residues of veterinary Residues of veterinary

drugsdrugsHeavy metals, dioxins,...Heavy metals, dioxins,...Mycotoxins,Mycotoxins,PVC,...PVC,...

Are added in food Are added in food intentionally /can be intentionally /can be watched at food watched at food productionproduction

ContaminantsContaminants /need to be watched /need to be watched and minimized at and minimized at sources/sources/


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What type of legislation is needed to assure food What type of legislation is needed to assure food

safetysafety

Food additivesFood additives

Residues of pesticides Residues of pesticides

Residues of Residues of veterinary drugsveterinary drugs

Heavy metals, Heavy metals, dioxins,...dioxins,...

Mycotoxins,Mycotoxins,

PVC,...PVC,...

Maximum limits/Good Maximum limits/Good Manufacturing PracticeManufacturing Practice

Maximum limits/Good Maximum limits/Good Agriculture PracticeAgriculture Practice

Maximum limits/Good Maximum limits/Good Veterinary PracticeVeterinary Practice

Maximum limits /other Maximum limits /other regulations/regulations/


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International support to International support to legislation of food additives legislation of food additives and contaminantsand contaminants

International Programme on Chemical Safety International Programme on Chemical Safety /IPCS/,/IPCS/,

established in 1980, is a joint venture of the United established in 1980, is a joint venture of the United Nations Environment Programme /UNEP/, the Nations Environment Programme /UNEP/, the International Labour Organisation /ILO/, and the World International Labour Organisation /ILO/, and the World Health Organisation /WHO/.Health Organisation /WHO/.

Objective: To establish the scientific basis for assessung Objective: To establish the scientific basis for assessung the risk to human health and the environment from the risk to human health and the environment from exposure to chemicals, through international peer-exposure to chemicals, through international peer-review processes, as a prerequisite for the promotion of review processes, as a prerequisite for the promotion of chemical safety, and to provide technical assistance in chemical safety, and to provide technical assistance in strenthening national capacities for the sound strenthening national capacities for the sound management of chemicals.management of chemicals.


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Scientific base for legislation Scientific base for legislation of food additives and of food additives and contaminantscontaminants

JECFA – Joint FAO/WHO Expert Committee on Food JECFA – Joint FAO/WHO Expert Committee on Food Additives Additives

/+ food contaminants + residues of veterinary drugs//+ food contaminants + residues of veterinary drugs/ Technical Reports on evaluation of ... /e.g. mycotoxins in Technical Reports on evaluation of ... /e.g. mycotoxins in

food/food/ WHO monographies on toxicological evaluation of... /e.g. WHO monographies on toxicological evaluation of... /e.g.

certain veterinary drug residues in food/certain veterinary drug residues in food/Specifications for identity and purity of certain food Specifications for identity and purity of certain food additives additives

JMPR – Joint FAO/WHO Meetings on Pesticide ResiduesJMPR – Joint FAO/WHO Meetings on Pesticide Residues Evaluations of pesticide residues in /e.g. 1999/Evaluations of pesticide residues in /e.g. 1999/

Joint FAO/WHO Expert ConsultationsJoint FAO/WHO Expert Consultations Reports Reports


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Scientific base for safety of Scientific base for safety of food additivesfood additives

Scientific laboratories from over the worldScientific laboratories from over the worldFA production aspects, effects on animalsFA production aspects, effects on animals

JECFA - indenendent committee FAO/WHOJECFA - indenendent committee FAO/WHOEvaluation of resultsEvaluation of resultsFA identity and purity FA identity and purity NOEL /no observed effect level/NOEL /no observed effect level/Safety factor 100, 200, or higherSafety factor 100, 200, or higherADI /Acceptable Daily Intake/ for humanADI /Acceptable Daily Intake/ for humanADI = Acceptable amount of the FA, which can be consumed ADI = Acceptable amount of the FA, which can be consumed every day for the whole life without any health effect = mg/kg every day for the whole life without any health effect = mg/kg b. w./dayb. w./day

Codex Alimentarius FAO/WHO Codex Alimentarius FAO/WHO Respecting food variety and nutritional patternsRespecting food variety and nutritional patternsMaximum limits of individual FAs in individual foodsMaximum limits of individual FAs in individual foods


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Codex Alimentarius Codex Alimentarius General principles for the use of food General principles for the use of food additivesadditives

Toxicological evaluationToxicological evaluationNo hazard at the levels of use proposedNo hazard at the levels of use proposedRe-evaluation whenever necessaryRe-evaluation whenever necessaryConformation with approved specificationsConformation with approved specificationsUse justified only for purposes which cannot Use justified only for purposes which cannot

be achieved by other meansbe achieved by other meansMaximum limits at the lowest level to achieve Maximum limits at the lowest level to achieve

the desired effect /GMP/the desired effect /GMP/ADI and probable FA daily intake from all ADI and probable FA daily intake from all

sources sources


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Codex Alimentarius Codex Alimentarius Class names and the international Class names and the international numbering system INSnumbering system INS

Examples:Examples:

102 - Tartrazine - colour102 - Tartrazine - colour140 - Chlorophyll - colour140 - Chlorophyll - colour200 - Sorbic acid – Preservative200 - Sorbic acid – Preservative290 – Carbon dioxide – carbonating agent, 290 – Carbon dioxide – carbonating agent,

packing gaspacking gas461 – Methyl cellulose – thickener, emulsifier, 461 – Methyl cellulose – thickener, emulsifier,

stabiliserstabiliser953 – Isomalt – sweetener, anticaking agent, 953 – Isomalt – sweetener, anticaking agent,

bulking agent, glazing agentbulking agent, glazing agent


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Codex Alimentarius Codex Alimentarius General standard for food additives General standard for food additives /GSFA//GSFA/

PreamblePreamble Annex AAnnex A Annex BAnnex B Annex CAnnex C

• List AList A• List BList B

Table 1Table 1 Table 2Table 2 Table 3Table 3

Annex to Table 3Annex to Table 3

DefinitionsDefinitions General principles for the use General principles for the use

of FAof FA Carry-over of FA into foodsCarry-over of FA into foods Food category systemFood category system Format of the standardFormat of the standard Review and revisions of the Review and revisions of the

standardstandard


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Guidelines fod Guidelines fod development of development of maximum levels of maximum levels of use for FA with use for FA with numerical ADInumerical ADI


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GSFA Food GSFA Food categorization categorization SystemSystem


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Food categorization system Food categorization system /a selection as an example//a selection as an example/

0.4 Fruits and vegetables0.4 Fruits and vegetables0.4.1 Fruits0.4.1 Fruits0.4.1.1 Fresh fruit0.4.1.1 Fresh fruit0.4.1.1.2 Surface treated fruit0.4.1.1.2 Surface treated fruit. . . . . . 0.4.2 Vegetables0.4.2 Vegetables0.4.2.1 Fresh vegetables0.4.2.1 Fresh vegetables0.4.2.1.2 Surface-treated vegetables0.4.2.1.2 Surface-treated vegetables0.4.2.1.3 Peeled or cut vegetables0.4.2.1.3 Peeled or cut vegetables. . . . . . . . 04.2.2.1 Frozen vegetables04.2.2.1 Frozen vegetables04.2.2.3 Vegetables in vinegar, oil, or brine04.2.2.3 Vegetables in vinegar, oil, or brine04.2.2.4 Canned or bottled /pasteurized/ vegetables04.2.2.4 Canned or bottled /pasteurized/ vegetables


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Codex Alimentarius Codex Alimentarius Food categorization systemFood categorization system

Is a tool for application of FA.Is a tool for application of FA. Applies to all foodstuffs including those Applies to all foodstuffs including those

in which no additives are permitted.in which no additives are permitted. Is a hierarchical system based on Is a hierarchical system based on

product descriptors of foodstuffs as product descriptors of foodstuffs as marketed.marketed.

Takes into consideration the carry-over Takes into consideration the carry-over principle /i. e. the system does not need principle /i. e. the system does not need to mention compounds of foodstuffs/to mention compounds of foodstuffs/


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Cross-reference to Codex Cross-reference to Codex commodity standards commodity standards and the GSFA Index of and the GSFA Index of Food additivesFood additives

A – JECFA „approved“ A – JECFA „approved“ FAs, with ADIs and INS FAs, with ADIs and INS numbersnumbers

B – INS numbers for B – INS numbers for JECFA „approved“ FAs JECFA „approved“ FAs with ADIswith ADIs


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Codex Alimentarius Codex Alimentarius General standard for food additivesGeneral standard for food additives


Additives permitted for use Additives permitted for use under specified conditions in under specified conditions in certain food categories or certain food categories or individual food itemsindividual food items

Example:Example:Aspartame, INS 951Aspartame, INS 951

05.2 Sugar-based confectionery GMP05.2 Sugar-based confectionery GMP

05.3 Chewing gum 5000 mg/kg05.3 Chewing gum 5000 mg/kg

14.1.4 Water-based flavored drinks 14.1.4 Water-based flavored drinks 1000 mg/kg1000 mg/kg

14.2.1 Beer and malt beverages GMP14.2.1 Beer and malt beverages GMP

..........


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Codex Alimentarius Codex Alimentarius General standard for food additives General standard for food additives

Table 1Table 1

Table 2Table 2 Table 3Table 3

Food categories or Food categories or individual food items in individual food items in which food additives are which food additives are permitted under specified permitted under specified conditionsconditions

Example: 03.0 Edible ices Example: 03.0 Edible ices 355 Adipates 2000 mg/kg355 Adipates 2000 mg/kg334 Tartrates 1000 mg/kg334 Tartrates 1000 mg/kg338 Phosphates 1000 mg/kg338 Phosphates 1000 mg/kg..........


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Codex Alimentarius Codex Alimentarius General standard for food additivesGeneral standard for food additives

Table 1Table 1 Table 2Table 2

Table 3Table 3

Annex Annex to the table 3to the table 3

Additives permitted for use in Additives permitted for use in food in general, unless food in general, unless otherwise specified, in otherwise specified, in accordance with GMPaccordance with GMP

Example:Example:260 Acetic acid260 Acetic acid406 Agar406 Agar162 Beet red162 Beet red

Food categories and Food categories and individual food items excluded individual food items excluded from the generalfrom the general conditions of conditions of table 3 table 3


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EU directives of food EU directives of food additivesadditives

A whole range of general directives /to A whole range of general directives /to harmonize approach of individual member harmonize approach of individual member states/ and amendments to the following states/ and amendments to the following directives:directives:

1. Sweeteners1. Sweeteners94/35 – definitions, limits, monitoring of intake94/35 – definitions, limits, monitoring of intake95/31 – purity criteria 95/31 – purity criteria

2. Colorants2. Colorants94/3694/36 – definitions, limits, monitoring of intake– definitions, limits, monitoring of intake95/45 – purity criteria95/45 – purity criteria


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EU directives of food EU directives of food additivesadditives

3. Other food additives3. Other food additives

78/663 – purity criteria 78/663 – purity criteria

81/712 – EC methods for purity verifying81/712 – EC methods for purity verifying

89/107 – FA control and general criteria of 89/107 – FA control and general criteria of assessmentassessment

95/2 - definitions, limits, monitoring of 95/2 - definitions, limits, monitoring of intakeintake

96/77 – purity criteria96/77 – purity criteria


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Internal structure of EU DirectivesInternal structure of EU Directiveson application of FAs on application of FAs

Application of Application of colorants in food colorants in food productsproducts

94/36/EC94/36/EC

ANNEXES:ANNEXES:

List of permitted coloursList of permitted colours List of foodstuffs in which the colours List of foodstuffs in which the colours

are not allowed are not allowed List of foodstufsf in which only selected List of foodstufsf in which only selected

colours can be added colours can be added List of colours which can be added only List of colours which can be added only

to selected foodstuffsto selected foodstuffs List of colours which can be used under List of colours which can be used under

GMPGMP


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Codex legislation of Codex legislation of contaminantscontaminants

Residues of pesticides Residues of pesticides

Residues of veterinary Residues of veterinary drugsdrugs

Heavy metals, dioxins,...Heavy metals, dioxins,...

Mycotoxins,Mycotoxins,

othersothers

Levels of Levels of contaminants contaminants should be should be as low as low as possibleas possible meeting meeting requirements of requirements of good practice in good practice in each stage of each stage of primary and food primary and food production.production.


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Scientific base for legislation Scientific base for legislation of food contaminantsof food contaminants

JECFA – Joint FAO/WHO Expert Committee on Food JECFA – Joint FAO/WHO Expert Committee on Food Additives Additives

/+ food contaminants + residues of veterinary drugs//+ food contaminants + residues of veterinary drugs/ Technical Reports on evaluation of ... /e.g. mycotoxins Technical Reports on evaluation of ... /e.g. mycotoxins

in food/in food/ WHO monographies on toxicological evaluation of... WHO monographies on toxicological evaluation of...

/e.g. certain veterinary drug residues in food//e.g. certain veterinary drug residues in food/

JMPR – Joint FAO/WHO Meetings on Pesticide ResiduesJMPR – Joint FAO/WHO Meetings on Pesticide Residues Evaluations of pesticide residues in /e.g. 1999/Evaluations of pesticide residues in /e.g. 1999/

Joint FAO/WHO Expert ConsultationsJoint FAO/WHO Expert Consultations Reports Reports


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Codex AlimentariusCodex AlimentariusMaximum residue limits for Maximum residue limits for

contaminantscontaminants

Are evaluated continuously by the Are evaluated continuously by the CC FAC and CC PR, re-evaluated CC FAC and CC PR, re-evaluated and adjustedand adjusted

Monitoring of contaminants in food Monitoring of contaminants in food chain is reviewed by GEMS/Foodchain is reviewed by GEMS/Food


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Codex Alimentarius Codex Alimentarius General standard for contaminants and General standard for contaminants and toxins in foodstoxins in foods

PreamblePreamble Annex 1 – Criteria for establishment of Annex 1 – Criteria for establishment of

maximum levels in foodsmaximum levels in foods Annex II – Procedure for risk Annex II – Procedure for risk

management decisiosmanagement decisios Annex III – Format of the standardAnnex III – Format of the standard Annex IV – List of contaminants and Annex IV – List of contaminants and

toxinstoxins Annex V – Food categorization systemAnnex V – Food categorization system


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EU regulations on EU regulations on contaminantscontaminants

For specific contaminants are defined:For specific contaminants are defined:- Limits of a contaminant in individual Limits of a contaminant in individual

foodsfoods- Reference analytical methodReference analytical method- Detection limit neededDetection limit needed- Sampling method, . . . Sampling method, . . .


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EC Regulation No. 466/2001EC Regulation No. 466/2001setting maximum levels for certain contaminants in setting maximum levels for certain contaminants in foodstuffsfoodstuffs

1.1. NitratesNitrates

2.2. MycotoxinsMycotoxins

3.3. Heavy metalsHeavy metals

4.4. 3-monochloropropane-1,2-diol /3-MCPD/3-monochloropropane-1,2-diol /3-MCPD/


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Selected example Selected example from the EC Regulation No. 466/2001from the EC Regulation No. 466/2001

3.1 Lead /Pb/3.1 Lead /Pb/

3.1.1 Cow´s milk /raw milk, milk for the manufacture of 3.1.1 Cow´s milk /raw milk, milk for the manufacture of milk-base products and heat-treated milk milk as defined milk-base products and heat-treated milk milk as defined by Directive 92/46/EEC/by Directive 92/46/EEC/

Maximum level: 0,02 mg/kg Maximum level: 0,02 mg/kg

Performance criteria for sampling: Commission directive Performance criteria for sampling: Commission directive 2001/22/EC2001/22/EC

Performance criteria for methods of analysis: Directive Performance criteria for methods of analysis: Directive 2001/22/EC2001/22/EC


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Slovak legislation of food Slovak legislation of food additives and contaminantsadditives and contaminants

Involved in a horizontal Food Involved in a horizontal Food Codex chapterCodex chapter

Harmonization with the EU Harmonization with the EU provisions achieved graduallyprovisions achieved gradually


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Updating permitted lists and Updating permitted lists and MRLsMRLs

Procedures at national and international levels are Procedures at national and international levels are similar.similar.

Decisions should take into account:Decisions should take into account:Identification of contaminant and toxicological Identification of contaminant and toxicological informationinformationPotential health problemsPotential health problemsValidated analytical data, sampling proceduresValidated analytical data, sampling proceduresIntake data /food consumption data for average, Intake data /food consumption data for average, most exposed consumer groups, dietary intake/most exposed consumer groups, dietary intake/Technological possibilities to manage the problemTechnological possibilities to manage the problemFair trade considerationsFair trade considerations

who, almaty 2002legislation of food additives and contaminants 1 terezia sinkova

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