(At Step 5)
ANNEX IV - ANNOTATED LIST OF CONTAMINANTS AND TOXINS
INTRODUCTION
In this Annex an annotated list is presented of the contaminants and toxins that are or have been dealt with in the CCFAC. It does not only encompass the contaminants and toxins for which Codex standards exist or are being developed, but also those for which further information is sought or about which a Codex decision has been taken.
The annotated list has the purpose of providing an overview of the situation regarding Codex decisions about this subject and to give guidance about further actions required. Therefore also relevant information and references are added to the list. The information shall comprise at least the current situation regarding the criteria that are important for the decision procedure of the CCFAC.
It is thus an active list, which needs to be regularly updated. In order to provide a structure for it and to facilitate the filing and retrieval of data, a number is assigned to the contaminants and toxins in the list.
The situation regarding contaminants and toxins is very complex and many substances are or have been the subject of scientific research and discussion regarding their occurrence in foods and their significance for human and animal health. On a national level, there are many activities, sometimes implying legal measures which may affect international trade in foods and feeds. It is obviously important for the CCFAC to take note of the developments in this field and to consider the necessity of actions. In order to obtain an overview of the situation, the CCFAC shall develop and maintain a working document in which more comprehensive information regarding contaminants and toxins in foods is presented in summary form. The document shall consist of an annotated comprehensive list of contaminants and toxins (Annex IV-A), and a collection of summarized textual information to the substances on the list, with references (Annex IV-B). Annex IV-A shall be structured according to a substance categorization system, by which code numbers can be assigned to the substances on the list, to allow logical and easy filing and presentation of data. This more comprehensive list shall be the basis for the code numbers which are used in Annex IV.
ANNEX IV
ANNOTATED LIST OF CONTAMINANTS AND TOXINS, SITUATION REGARDING CODEX CRITERIA AND DECISIONS
| Contaminant | ||||
|---|---|---|---|---|
| Code No. | NAME | - Risk assessment status | + Risk management status | * Codex decisions (pending) |
| 1.3 | Arsenic | - PTWI mcg/kg BW (JECFA 19988) | +
Existing national MLs for inorganic arsenic + Existing Codex MLs not comprehensive + Potential trade problems | * Position paper will be elaborated by Denmark for discussion in the 1997 CCFAC |
| - Situation regarding organic arsenic in foods not clear | ||||
| - Potential health problems? | ||||
| 1.6. | Cadmium | - PTWI 7 mcg/kg BW (41st JECFA) | + Existing national MLs + No Codex MLs + Potential trade problems | * Position paper discussed in 1995 CCFAC |
| - Potential health problems | * New JECFA evaluation is awaited | |||
| - New JECFA evaluation requested | * Additional information on cadmium requested | |||
| 1.9. | Copper | - PMADI 500 mcg/kg BW (JECFA 1973, 1982) | + Existing national MLs + Existing Codex MLs (not comprehensive) + Potential trade problems | * Risk management aspect of MLs questioned |
| - Daily requirement 50 mcg/kg BW | * 26th CCFAC referred MLs in fats and oils to the CCFO | |||
| - Health problems by too much copper unlikely | * More general position report desirable | |||
| 1.10. | Iron | - PMTDI 800 mcg/kg BW (JECFA 19983) | + Existing national
MLs? + Existing Codex MLs (not comprehensive) + Potential trade problems? | * Risk management aspect of MLs questioned |
| - Daily requirement 10 – 20 mg (men/women) | * 26th CCFAC referred MLs in fats and oils to CCFO | |||
| - Health problems by too much iron in food unlikely | * CCFAC decision desirable about other MLs (More general position report desirable) | |||
| 1.11. | Lead | - PTWI 25 mcg/kg BW (JECFA 1993) | + Existing national MLs + Existing Codex MLs (not comprehensive) + Potential trade problems | * Proposed draft Standard with new Codex MLs (comprehensive) will be revised for 1997 CCFAC Further information required |
| - Potential health problems | ||||
| * Proposed draft Code of Practice on Source Directed Measures for lead to be further developed | ||||
| 1.13. | Mercury | - PTWI 5 mcg/kg BW (total Hg) | + Existing national MLs (not only for fish) + Existing Codex MLs for fish + Potential trade problems? | * Definition of Codex MLs to be reviewed |
| - Potential health problems | * CCFAC decision desirable about risk management justification of MLs in other products than fish. Position paper desirable. | |||
| 1.16. | Tin | - PTWI 14 mg/kg BW (inorganic Sn) | + Existing national MLs in canned products + Existing Codex MLs in canned products | * 1988 JECFA recommended efforts to keep levels of tin in canned foods as low as practicable (GMP). |
| - Potential health effects by high tin levels in canned products | ||||
| * CCFAC action desirable on GMP-levels in canned foods. Position paper will be developed for discussion in the 1997 CCFAC. | ||||
| 1.18. | Zinc | - PMTDI 1 mg/kg BW (JECFA 19973, 1982) | + Existing national MLs? + Existing Codex MLs in fruit juices and nectars + Potential trade problems? | * CCFAC decision desirable about risk management justification of MLs for Zn. Position paper desirable. |
| - Daily requirement ca 15–22 mg/person | ||||
| - Potential health problems by too much Zinc in foods unlikely | ||||
| 2.5.1. | Nitrate | - ADI of 5 mg/kg BW established for Sodium nitrate as food additive | + Existing national MLs + No Codex MLs + (Potential) trade problems + The 1995 JECFA stated that it is inappropriate to compare exposure to nitrate directly to the ADI and hence to derive limits from it | * Further toxicological guidance is awaited before Codex MLs can be developed |
| - Potential health problems due to ADI being exceeded? | ||||
| - Further studies are under way Nitrate remains on the JECFA priority list | ||||
| 3.4. | PCBs | - The JECFA did not establish an explicit toxicological recommendation on a safe intake level | + Existing national MLs + No Codex MLs + Potential trade Problems | * Revised discussion paper on dioxins and PCBs discussed by 1996 CCFAC |
| * Elaboration of Codex MLs awaits toxicological guidance | ||||
| - Potential health problems | ||||
| - TEFs to be established for dioxin-like PCBs | ||||
| 3.8. | Dioxins | - A 1992 WHO expert meeting established a TDI of 10 pg/kg BW for 2,3,7,8-TCDD | + Existing national MLs + No Codex MLs + Potential trade Problems | * Revised discussion paper on dioxins and PCBs discussed by 1996 CCFAC |
| - Further guidance is desirable on the use of TEFs to include other dioxins and PCBs. | * Elaboration of Codex MLs awaits further toxicological guidance | |||
| - Dioxins remain on priority list of JECFA | ||||
| - Potential health problems | ||||
| 4.3. | Polycyclic aromatic hydrocarbons (PAHs) | - PAHs are acknowledged carcinogens | + Existing national MLs + No Codex MLs + Potential trade Problems? | * No further CCFAC action required until new information comes available which shows need for a decision |
| - PAHs remain on the JECFA priority list | ||||
| - Potential health Problems? | ||||
| 4.7.1. | Phthalate esters | - No specific JECFA tox. recommendation | + National MLs? + Migration limits are established in relation to phthalate esters in food packaging materials + Potential trade problems? | * The 1995 CCFAC decided that at this stage no further action was needed. |
| - The 1995 CCFAC removed phthalates from the priority list of JECFA | ||||
| - Potential health Problems? | ||||
| 4.12.1 | Ethylcarbamate | - Ethylcarbamate is on the priority list of the JECFA; carcinogenicity studies that are under way are awaited. | + Existing national MLs + No Codex MLs + Potential trade problems | * The CCFAC awaits toxicological guidance |
| - Potential health problems? | ||||
| 5.1. | Aflatoxins | - Aflatoxins are carcinogenic (JECFA 1987) | + Existing national MLs + Codex MLs for peanuts and milk in procedure + Trade problems + Existing national MLs + Codex MLs for peanuts and milk in procedure | * Draft Code of Practice for reduction of aflatoxins in feedingstuffs for lactating animals to be revised (Canada) |
| - Risk assessment of aflatoxins is being reviewed by JECFA | * Position paper on alfatoxins to be revised for 1997 CCFAC (UK) | |||
| - (Potential) health problems | ||||
| * The CCFAC awaits the JECFA evaluation of the risk of aflatoxins | ||||
| 5.2. | Ochratoxins | - PTWI 0.1 mcg/kg BW (44th JECFA) | + Existing national MLs + Potential trade problems | * Revised position paper to be developed for 1997 CCFAC (Sweden) |
| - Potential health problems | ||||
| 5.3 | Trichothecenes | - No JECFA evaluation yet; trichothecenes are on JECFA priority list, but additional data are required | + Existing national
MLs? + No Codex MLs + Potential trade problems? | * Specific contributions desirable on toxicity and occurrence |
| - Potential health problems? | ||||
| 5.4. | Patulin | - PMTDI 0.4 mcg/kg BW (1995 JECFA lowered the previous PTWI of 7 mcg/kg BW) | + Existing national MLs in apple
products + No Codex MLs + Potential trade problems? | * CCFAC evaluation will be developed for the 1997 CCFAC |
| - Potential health problems? | ||||
| 7.3. | Cyanogenic glycosides (natural toxins) | - No safe intake level established by 1992 JECFA; 10 mg/kg level in food not associated with acute toxicity | + National
MLs? + Proposed draft Standards for Gari and edible cassava flour contain MLs for hydrogen cyanide. + Potential trade problems? | * The 1995 CCFAC requested clarification on the proposed ML for Gari (95-74) |
| * Development suggested of guidelines for the processing of beans (95-75) | ||||
| - (Potential) health problems | ||||
| * CCFAC awaits the outcome of the 1995 requests | ||||
| 8. | Radionuclides | - There is no safe threshold level for radionuclides; MLs are based on risk assessment calculations | + Existing national MLs + Existing Codex GLs + (Potential) trade problems | * The 1991 CCFAC identified the need to review the GLs regularly. Also, the application to minor dietary components seemed unnecessarily restrictive. No action has yet been taken on these issues. A CCFAC decision desirable. |
| - (Potential) health problems | ||||
ANNEX V
FOOD CATEGORIZATION SYSTEM TO BE USED IN THE GSC
INTRODUCTION
The food categorization system of the Codex General Standard for Contaminants and Toxins in Foods is constructed to perform the following functions:
It has a logical structure which enables a clear and systematic presentation of the (proposed) MLs. It contains (references to) product definitions and definitions of the part of the product which is analyzed and to which the ML refers. It contains codes for the food categories and the individual foods, so that data can be stored and retrieved in a convenient way.
To achieve as much harmonization as possible, an existing agreed categorization system is used.
The GSC uses the system which is developed in the framework of the CCPR as it is also suitable for contaminants. It is adopted for characterizing the various food and feed groups and the individual commodities. This system is especially elaborated regarding primary agricultural commodities, but needs further extension regarding processed products. Where necessary, new (sub)group codes or commodity codes are therefore introduced. These are described in Annex V-A. Annex V-A will also contain product descriptions as far as they are different from those contained in the existing system described by the CCPR.
Where appropriate and possible, the descriptive texts accompanying the food categories do or should also contain indications about the concentration or dilution factor in the processed commodities mentioned, in relation to the primary product(s) involved. In that way a first estimate can be made of the possible carry-over of contaminants from primary products to the various processed products. It has to be borne in mind however that the specific distribution of a contaminant in the primary product and the behaviour during processing is a complicating factor here. Further advice may be necessary in those cases. See also the general indications in Annex I and possible specific information mentioned in relation to the contaminant.
Description of the food categorization system of the GSC
The first part contains the categorization system as developed and maintained by the CCPR. It consists of 5 classes, covering primary food commodities of plant, resp. animal origin, primary feed commodities and processed commodities of plant, resp. animal origin. The classes are subdivided in 19 types and 93 groups, which are identified by code numbers and letters.
[Reference is made to Vol. 2 of the Codex Alimentarius, section 2 (1993), in which this system is described, and to CX/PR 92/6 (in which a different kind of group numbering was introduced)].
Annex V-A is the other part of the food categorization system for the GSC. It is developed and maintained by the CCFAC, and is complementary to the system described in the first part. It is mainly directed to processed, derived and multi-ingredient foods and encompasses all those types and groups and commodity descriptions that are necessary to assign food categorization codes to existing or planned Codex MLs for contaminants.
ANNEX V-A
COMPLEMENTARY FOOD CATEGORIZATION SYSTEM FOR ANNEX V-A THE GSC
INTRODUCTION
The following additions to the food categorization system described in Annex V-A will serve the need of assigning a food code number to commodities that are not covered by Annex V-A. The commodities involved are mainly processed, derived and multi-ingredient foods.
The system has been designed as a comprehensive list (on a general level), in order to be able to accommodate possible future needs.
In this phase no individual product definitions and codes are given. It seems sufficient to go no further than a type or group level in judging the acceptability of the system. The classification can be developed in further detail as the need arises.
The system used in the GSFA for food classification has been utilized as far as it is compatible with the existing Codex classification system described in Annex V-A.
See the annexed list of proposed new food categories. Some explanations are added, and also some existing related food categories, for a better insight in the proposed system.
Commodity descriptions can often be derived from existing Codex Standards.
Information regarding concentration and dilution factors, in relation to contaminant carry-over from primary products, will be added where appropriate and available.
Definitions for the part of the product that shall be analyzed and to which the ML of a contaminant will apply, that are different from existing definitions in Annex V-A, may also be mentioned in this Annex.
| Class | Type | Group | Letter Code | Product group description |
|---|---|---|---|---|
| D | PROCESSED FOODS OF PLANT ORIGIN | |||
| (existing) | ||||
| D | 01 | Secondary commodities of plant origin | ||
| (5 existing groups) | ||||
| D | 01 | 06 | TF | Treated fruit products (peeled, cut, frozen etc.) |
| (New proposed group; commodity codes can be derived from existing fruit codes) | ||||
| D | 01 | 07 | TV | Treated vegetable products (cleaned, cut, frozen etc.) |
| (New proposed group; commodity codes can be derived from existing vegetable codes) | ||||
| D | 02 | Derived products of plant origin | ||
| (7 existing groups) | ||||
| D | 02 | 08 | JV | Vegetable juices and purees |
| (New proposed group; commodity codes can be derived from the existing vegetable codes) | ||||
| D | 02 | 09 | SH | Sugars, syrups and honey |
| (New proposed group; commodity codes to be developed) | ||||
| D | 03 | Manufactured foods of plant origin (multi-ingredient) | ||
| (1 existing group) | ||||
| D | 03 | 01 | CP | Manufactured multi-ingredient cereal products (e.g. bread and other cooked cereal products) |
| (existing group) | ||||
| D | 03 | 02 | CB | Beverages derived from cereals (e.g. beer) |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| D | 03 | 03 | NF | Fruit nectars |
| (New proposed group; commodity codes can be derived from the existing fruit codes) | ||||
| D | 03 | 04 | FF | Fermented fruit beverages (wine, cider) |
| (New proposed group; commodity codes can be derived from the existing fruit concerned) | ||||
| D | 03 | 05 | DA | Distilled alcoholic beverages |
| (New proposed group; commodity codes to be developed when the need arises) | ||||
| D | 03 | 06 | FJ | Fruit jams, jellies, marmalades etc. |
| (New proposed group; commodity codes to be derived from the existing fruit codes) | ||||
| D | 03 | 07 | SF | Fruit chutneys and comparable preparations |
| (New proposed group; commodity codes to be derived from the existing fruit codes) | ||||
| D | 03 | 08 | SV | Vegetable chutneys and comparable preparations |
| (New proposed group; commodity codes to be derived from the existing vegetable codes) | ||||
| D | 03 | 09 | PS | Preparations from nuts, oil seeds and other seeds |
| (New proposed group; commodity codes to be derived from the existing product codes) | ||||
| D | 03 | 10 | PP | Other manufactured plant products |
| (New proposed group; commodity codes to be developed when the need arises) | ||||
| E | PROCESSED FOODS OF ANIMAL ORIGIN | |||
| (existing class) | ||||
| E | 01 | Secondary commodities of animal origin | ||
| (2 existing groups) | ||||
| E | 01 | 03 | MS | Secondary meat products (e.g. cooked meat) |
| (New proposed group; commodity codes to be derived from the existing meat codes) | ||||
| E | 01 | 04 | ES | Secondary egg products (e.g. egg powder) |
| (New proposed group; commodity codes to be derived from the existing egg codes) | ||||
| E | 02 | Derived animal products of animal origin | ||
| (4 existing groups) | ||||
| E | 02 | 05 | MC | Derived meet products (e.g. meet extract) |
| (New proposed group; commodity codes to be derived from existing meat codes) | ||||
| E | 02 | 06 | ED | Derived egg products (e.g. egg white, yolk) |
| (New proposed group; commodity codes to be derived from existing meat codes) | ||||
| E | 03 | Manufactured food (single ingredient), animal origin | ||
| (1 existing group) | ||||
| E | 03 | 01 | LI | Manufactured milk products (single ingredient) |
| (existing group) | ||||
| E | 03 | 02 | MT | Manufactured meat products (e.g. cured meat) |
| (New proposed group; commodity codes to be derived from existing meat codes) | ||||
| E | 03 | 03 | EM | Manufactured egg products (e.g. egg white powder) |
| (New proposed group; commodity codes to be derived from existing egg codes) | ||||
| E | 04 | Manufactured food (multi-ingredient) of animal origin | ||
| (1 existing group) | ||||
| E | 04 | 01 | LM | Manufactured milk products (multi-ingredient) |
| (existing group) | ||||
| E | 04 | 02 | MP | Manufactured meat products (multi-ingredient) (e.g. sausage) |
| (New proposed group; commodity codes to be developed in relation to commodity description) | ||||
| E | 04 | 03 | EP | Manufactured egg products (multi-ingredient) |
| (New proposed groups; commodity codes to be developed in relation to commodity description) | ||||
| F | MULTI-INGREDIENT MANUFACTURED FOODS | |||
| (New proposed class) | ||||
| F | 01 | Beverages (multi-ingredient) | ||
| (New proposed type) | ||||
| F | 01 | 01 | BS | Beverages (soft drinks and comparable preparations) |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 01 | 02 | BA | Alcoholic multi-ingredient beverages |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | Sauces, salad dressings, soups, bouillons etc. | ||
| (New proposed type) | ||||
| F | 02 | 01 | SP | Seasonings and condiments |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | 02 | PV | Vinegars (multi-ingredient) |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | 03 | PM | Mustards |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | 04 | BS | Soups and broths |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | 05 | ME | Sauces and comparable products |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 02 | 06 | BC | Salads and sandwich spreads |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 03 | Chocolate & other confectionery | ||
| (New proposed type) | ||||
| F | 03 | 01 | CC | Chocolate products |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 03 | 02 | CS | Sugar confectionery, including nut based and comparable multi-ingredient confectionery |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 03 | 03 | CG | Chewing gum |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 04 | Margarines & other multi-ingredient fatty foods | ||
| (New proposed type) | ||||
| F | 04 | 01 | FF | Margarines > 80 % fat |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 04 | 02 | LF | Margarines < 80 % fat |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 04 | 03 | OF | Other products based on fat emulsions |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 05 | Multi-ingredient bakery wares | ||
| (New proposed type) | ||||
| F | 05 | 01 | BF | Fine bakery wares |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 05 | 02 | BS | Savoury snacks (potato, cereal or starch base) |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 05 | 03 | NS | Savoury coated nuts, other nut snacks, nut mixtures |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | Multi-ingredient foods for special dietary uses | ||
| (New proposed type) | ||||
| F | 06 | 01 | ID | Infant and follow-on formulae |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | 02 | CD | Weaning foods |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | 03 | HD | Dietetic foods intended for special medical purposes |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | 04 | TD | Dietetic formulae for slimming purposes and weight reduction |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | 05 | SD | Supplementary foods for dietetic uses |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| F | 06 | 06 | AD | Food supplements |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| G | OTHER EDIBLE PRODUCTS | |||
| (New proposed class) | ||||
| G | 01 | Water, minerals and organic compounds | ||
| (New proposed type) | ||||
| G | 01 | 01 | DW | Drinking water, mineral water, table waters |
| (New proposed group; commodity codes to be developed when the necessity arises) | ||||
| G | 01 | 02 | SW | Salt, salt substitutes, mineral preparations |
| (New proposed group; commodity codes to be developed when the necessity arises) |
