Caballero B. (ed.) Encyclopaedia of Food Science, Food Technology and Nutrition. Ten-Volume Set

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among experts qualified by scientific training and ex-

perience to evaluate its safety, as having been adequately

shown through scientific procedures (or, in the case of a

substance used in food prior to January 1, 1958, through

either scientific procedures or experience based on

common use in food) to be safe under the condition of

intended use; except that such a term does not include

0022 1. a pesticide chemical in or on a raw agricultural

commodity; or

0023 2. a pesticide chemical to the extent that it is intended

for use or is used in the production, storage, or

transportation of any raw agricultural commodity; or

0024 3. a color additive; or

0025 4. any substance used in accordance with a sanction or

approval granted prior to the enactment of this

paragraph pursuant to this act, the Poultry Products

Inspection Act (21 U.S.C. 451 and the following) or

the Meat Inspection Act of March 4, 1907 (34 Stat.

1260), as amended and extended (21 U.S.C. 71 and

the following).

This amendment categorized food chemicals as: (1)

those generally recognized as safe (GRAS); (2) those

with prior sanction; and (3) food additives. Pesticides

on raw agricultural products and food color additives

were excluded from the legal definition as they were

covered by other legislation.

Joint FAO/WHO Expert Committee on

Food Additives (JECFA)

0026 Since it was established in 1955 the Joint FAO/WHO

Expert Committee on Food Additives (JECFA) has

played an international role in providing a review

and opinion on food additives, particularly on safety

in use.

0027 JECFA was originally set up to consider the chem-

ical, toxicological, and other aspects of contaminants

and residues of veterinary drugs found in foods

intended for human consumption.

0028 The committee is composed of an international

group of independent scientists appointed in their

own right for their expertise in food additives, veter-

inary drug residues, and contaminants. The members

are not appointed as government representatives.

The committee is administered jointly by the FAO

and the WHO. JECFA provides scientific advice dir-

ectly to member countries of FAO and WHO and also

to two committees of Codex; the Codex Committee

on Food Additives and Contaminants (CCFAC) and

the Codex Committee on Residues of Veterinary

Drugs in Foods (CCVDF).

0029 In relation to Codex, the Codex committees iden-

tify the additives, contaminants, and residues that

should receive priority evaluation and refer them to

JECFA for assessment before considering them for

incorporation into Codex Standards.

0030The JECFA reports on their toxicological evalu-

ations are published so that the information becomes

widely available.

0031In its interaction with the Codex Committees,

JECFA is independent of Codex and is able to provide

impartial and independent advice without political

influence.

0032With the advent of the World Trade Organization

(WTO) in 1995, Codex has taken on a greater inter-

national significance as the WTO recognizes Codex

as the preferred international organization for the

arbitration and settlement of disputes related to

food trade.

0033As a consequence of the WTO and also the involve-

ment of Codex in setting international standards for

foods and commodities, Codex now has a major

influence on food additive legislation worldwide.

Approval of Additives

0034As part of the assessment of an additive, the JECFA

examines the available toxicological data and chem-

ical specifications of the additive and establishes an

acceptable daily intake (ADI). The ADI is the amount

that can be taken daily in a human diet for a lifetime

without risk. Unless stated to the contrary, ADIs are

expressed as mg kg

1

body weight, one of the excep-

tions being flour treatment agents that have been

given as parts per million.

0035The ADI is normally derived from the ‘no observed

adverse effect’ level (NOAEL) determined from long-

term animal (in vivo) studies. The ADI is calculated

by applying a safety or uncertainty factor, which is

commonly 100, to the NOAEL obtained from the

most sensitive test species. The 100-fold safety factor

is based on the need to take into account both the

differences in species and differences in toxicokinetics

and toxicodynamics. Although most commonly used,

the factor of 100 may be varied depending on

the nature of the toxic effect and the availability of

relevant toxicity data.

0036Approval for the use of an additive is given on the

understanding that the additive will be kept under

surveillance and reevaluated as necessary in light of

changing conditions of use or new scientific evidence.

The ADI value may be qualified in five different ways:

0037Not limited, which means that there is no explicit

indication of an upper limit: this is assigned to

substances of very low toxicity (this category has

now been superseded by ‘not specified’).

0038Not specified, which means that on the basis of

available data the total daily intake required to

LEGISLATION/Additives 3503

achieve the desired additive effect does not repre-

sent a hazard to health. For this reason the estab-

lishment of an ADI is not deemed necessary.

However, the usage of an additive in this category

must conform to good manufacturing practice

(GMP).

0039 Unconditional status is allocated to those sub-

stances for which the biological data include

favorable results from appropriate long- and

short-term toxicological studies and/or biochem-

ical and metabolic studies.

0040 Conditional is allocated when the committee has

considered that the quality of the available data is

inadequate for an unconditional ADI and further

work is required, or if there are other reasons such

as those arising from dietary requirements. The

reasons and the restrictions imposed on the use

of the substance are stated in the evaluation.

0041 Temporary acceptance means that there are insuf-

ficient data to establish whether or not the sub-

stance is toxic and further evidence must be

submitted within a stated period of time. Details

of the requirements are included in the evaluation.

After the JECFA has completed its assessment of an

additive and issued its opinion, Codex is responsible

for the formal approval or disapproval.

0042 When Codex gives approval for the inclusion of the

substance in the list of additives, in many cases the

approval is limited, as far as possible, to specific foods

for specific purposes at the lowest effective level of

use. Any judgments are determined on the basis of the

ADI of the additive and its probable intake from all

dietary sources.

Classification of Additives

0043 Food additives can perform a number of techno-

logical functions during food processing and storage

and in a few cases the same substance may have more

than one function.

0044 A comprehensive, but not exhaustive, list of addi-

tive functions is given in the Codex Standard on Food

Labeling (Table 1). This list illustrates the diversity of

functions covered by additives and in most countries

it forms the basis for the classification of approved

additives.

Legislative Controls on Additives

0045 Most countries, and particularly those which are

members of Codex, have introduced legislation for

the control of food additives. Whilst the details of the

legislation differ from country to country, the basic

requirements of only using approved additives tend to

be consistent. There is, however, no complete consist-

ency between the lists of different countries.

0046A significant group of countries now working to

one of the most complex laws on food additives are

those in the EU. A complete review and revision of the

European legislation on food additives took place

from the late 1980s to the mid-1990s.

0047Within the EU the framework legislation is found

in Directive 89/107/EEC which lists 24 categories of

food additives (Table 2). Whilst essentially similar,

the EU list differs in detail from that of Codex

(Table 1) in that the EU list includes sequestrants,

antifoaming agents and enzymes, whilst the Codex

list has color-retention agents that are not in the EU

list. These categories are further defined in the spe-

cific directives, such as those on colors, sweeteners,

and the directives on additives other than colors and

sweeteners (Directive 95/2/EC).

0048Also detailed in the legislation (Directive 95/2/EC,

Article 1,5) are substances or groups of substances

not considered to be food additives under European

food law (Table 2). This includes edible gelatin, case-

inates, inulin, and chewing gum bases. Since the

tbl0001Table 1 Codex Alimentarius additive classes for labeling.

Codex standard 1–1985 (revised 1–1991)

Acidity regulator Flavor enhancer

Acids Flour treatment agent

Anticaking agent Foaming agent

Antifoaming agent Gelling agent

Antioxidant Glazing agent

Bulking agent Humectant

Color Preservative

Color retention agent Propellant

Emulsifier Raising agent

Emulsifying salt Stabilizer

Firming agent Sweetener

Thickener

The following class titles may also be used for food additives

falling into the respective classes:

Flavor(s) and flavoring(s) Modified starch(es)

tbl0002Table 2 Categories of food additives in the European Union

(Directive 89/107/EEC)

Color Preservative

Antioxidant Emulsifier

Emulsifying salt Thickener

Gelling agent Stabilizer

Flavor enhancer Acid

Acidity regulator Anticaking agent

Modified starch Sweetener

Raising agent Antifoaming agent

Glazing agent Flour treatment agent

Firming agent Humectant

Sequestrant Enzyme

Bulking agent Propellant gas and packaging gas

3504 LEGISLATION/Additives

middle of the 1990s, the detailed European legislation

on food additives has centered on three directives:

0049 Directive 94/35/EC on sweeteners for use in foods

(as amended);

0050 Directive 94/36/EC on colors for use in foods (as

amended);

0051 Directive 95/2/EC on food additives other than

colors and sweeteners (as amended).

The interpretation of all three directives has become

complex, as in many cases the additives are not only

restricted to defined categories of foods, but can also

be subject to varying upper limits on their use depend-

ing upon the food category in which their use is

intended. Thus a color, sweetener, or technological

additive may appear in a list of permitted additives,

but its use may be severely restricted to a small

number of foods and its usage levels laid down as g

or mg of the additive per kg or liter of the product as

consumed. An example is given in Table 3. This table

clearly illustrates the way the controls are imposed.

The maximum levels of each additive are related to

both technological need and the degree of likely ex-

posure of the consumers to the additive in terms of the

relative proportions of the food consumed as part of a

diet. Thus, in case of propane-1,2 diol alginate, the

additive is restricted to 100 mg l

1

in beer, 300 mg l

1

in nonalcoholic flavored drinks, but allowed up to

10 g l

1

in an emulsified liqueur.

0052The introduction of these directives consolidated

and harmonized the legislation on food additives

across the EU and all food and drink products on

tbl0003 Table 3 Example of European Union food additive legislation showing food categories and maximum levels

EC no. Name Food Maximumlevel

E355 Adipic acid Fillings and toppings for fine bakery wares 2 g kg

1

E356 Sodium adipate Dry powdered dessert mixes 1 g kg

1

E357 Potassium adipate Gel-like desserts 6 g kg

1

Fruit-flavored desserts 1 g kg

1

Powders for home preparation of drinks 10 g l

1

Expressed as

adipic acid

E363 Succinic acid Desserts 6 g kg

1

Soups and broths 5 g kg

1

Powders for home preparation of drinks 3 g l

1

E385 Calcium disodium ethylene

diamine tetraacetate

(calcium disodium EDTA)

Emulsified sauces 75 mg kg

1

Canned and bottled pulses, legumes, mushrooms, and artichokes 250 mg kg

1

Canned and bottled crustaceans and molluscs 75 mg kg

1

Canned and bottled fish 75 mg kg

1

Minarine 100 mg kg

1

Frozen and deep-frozen crustaceans 75 mg kg

1

E405 Propane-1,2-diol alginate Fat emulsions 3 g kg

1

Fine bakery wares 2 g kg

1

Fillings, toppings, and coatings for fine bakery wares and desserts 5 g kg

1

Sugar confectionery 1.5 g kg

1

Water-based edible ices 3 g kg

1

Cereal- and potato-based snacks 3 g kg

1

Sauces 8 g kg

1

Beer 100 mg l

1

Chewing gum 5 g kg

1

Fruit and vegetable preparations 5 g kg

1

Nonalcoholic flavored drinks 300 mg l

1

Emulsified liqueur 10 g l

1

Dietetic foods intended for special medical purposes-dietetic formulae

for weight control intended to replace total daily food intake or an

individual meal

1.2 g kg

1

Dietary food supplements 1 g kg

1

E416 Karaya gum Cereal- and potato-based snacks 5 g kg

1

Nut coatings 10 g kg

1

Fillings, toppings, and coatings for fine bakery wares 5 g kg

1

Desserts 6 g kg

1

Emulsified sauces 10 g kg

1

Egg-based liqueurs 10 g l

1

Dietary food supplements quantum satis

Chewing gum 5 g kg

1

LEGISLATION/Additives 3505

sale in the EU must now comply with the requirements

of this legislation. The introduction of the new laws

between June 1996 and March 1997 resulted in a

number of products having to be reformulated as the

new requirements in some cases differed significantly

from the internal legislation of some of the member

states of the EU. In Germany, for example, the options

open to manufacturers for the selection and use of a

number of additives increased, whereas in the UK,

manufacturers were confronted with more restric-

tions, particularly in the use of colors and sweeteners.

0053 During the development of the directives on addi-

tives, there was considerable discussion about which

foods should be allowed to contain which additives.

The categories of foods and drinks were modified a

number of times during the debates, with the end

result that there was no pattern to the product cat-

egories finally agreed. Thus, in the section dealing

with food preservatives, there are general groupings

such as ‘nonalcoholic flavored drinks’ or ‘dried fruit,’

and very product-specific rules such as those for

gnocchi or polenta.

0054 All applications for the extension of the conditions

of use to allow other categories of foods to contain

additives, or applications for new additives, are re-

ferred by the European Commission to the Scientific

Committee on Food of the EU (SCF). The SCF has

published guidelines on the data required for applica-

tions for new additives and this was updated in July

2001. One of the conditions is that a new additive

must exhibit a technological function or a significant

advantage (i.e., considerably improved function or

organoleptic properties) over those already approved

for the technological purpose. Extensive toxicity

studies are required to establish the safety of the

additive. Since the EU directives on colors, sweeten-

ers, and miscellaneous technological additives were

adopted in the mid-1990s, there have been relatively

few additions to the lists.

Labeling of Food Additives

0055 The legal requirements for the labeling of food addi-

tives can vary from country to country.

0056 The Codex standard on the Labeling of Prepack-

aged Foods lays down guidelines for the labeling of

additives. These guidelines are closely followed in the

EU directive on Food Labeling (2000/13/EC). Codex

requires that for food additives falling into the re-

spective classes (Table 1), the class titles given in the

table should be used together with the specific or

recognized name or a recognized numerical identifi-

cation of the additive. The EU already has a recog-

nized numerical classification of food additives

commonly described as the ‘E number’ system. Thus,

in the EU sulfur dioxide can be labeled as either:

preservative: sulfur dioxide or preservative: E220.

0057Codex also requires that a food additive that is

carried over into a food in a significant quantity or

in an amount sufficient to perform a technological

function in a food as a result of the use of raw mater-

ials or ingredients containing the additive shall also be

included in the list of ingredients on the label. This

means, for example, that if a significant ingredient in a

food product contains an antioxidant or preservative,

which is in sufficient quantity in the final product to

continue to play its additive role, it must be added to

the ingredients list. Excluded from this requirement

are processing aids that do not have a technological

function in the final product.

0058In the USA there are a number of specific rules for

the labeling of additives. Substances that perform a

functional purpose (i.e., technological additives) may

be declared in the ingredients list using a collective or

generic term followed by the function in parentheses.

Alternatively, the function can be listed followed by

the substance(s) performing that function, e.g., soy

lecithin (emulsifier) or emulsifier (soy lecithin).

0059When a chemical preservative or antioxidant is

used, American law requires both the common or

usual name of the preservative and the function,

using terms such as ‘preservative,’‘to retard spoilage,’

or ‘to preserve (or retain) freshness.’

0060There is also a specific requirement in the USA for

the listing of colors. Food and Drug Administration

(FDA)-certified colors and their lakes must be listed

specifically by their complete or abbreviated name for

all food products except butter, cheese, and icecream.

0061Mixtures of colorings may be listed as ‘artificial

color’ followed by a sublisting of the certified colors

in parentheses, e.g., artificial color (FD and C yellow

FD and C red 40).

0062Other additives used for coloring (termed non-

certified), such as caramel, may be listed by their

specific, usual or common name, e.g., caramel

coloring or colored with caramel.

0063The differences in approach between the USA and

EU can lead to complications with transatlantic trade

in food products.

0064For countries other than the USA and those in the

EU, there are a number of instances where there are

requirements for the labeling of additives which

are specific to that country. For many countries, how-

ever, the general principles of the Codex standard on

labeling apply.

The Future

0065The complexities of international control on food addi-

tives together with the high costs of the toxicological

3506 LEGISLATION/Additives

studies have been instrumental in reducing the number

of food additives coming on to the market.

006 6 The rate of food additive developments appears to

have peaked in the mid-1970s and by the early 1980s

there were consumer reactions and food scares

related to additives, particularly intolerances to the

azo food colors, preservatives, and antioxidants.

006 7 Future developments will, in general, be focusing

on improvements to the efficiency or functionality of

additives and on reducing the overall intake of those

found to have relatively low ADIs.

006 8 It is likely to be some years before there is truly

international harmonization on the additives that are

permitted and their maximum levels of use in foods.

Seealso: Food Additives:Safety; Food and Agriculture

Organization of the United Nations; Food Safety;

Legislation:Codex

Further Reading

Codex Alimentarius Commission. Available at: http://

www.fao.org/es*/esn/codex.

Furia TE (ed.) Handbook of Food Additives. Florida: CRS

Press.

Joint FAO/WHO Expert Committee on Food Additives

(JECFA) (2001) Compendium of Food Additives Speci-

fications (FNP 52 plus addenda 1–7). Available at: http://

www.codexalimentarius.net/CONTACT/Htframe.htm.

Scientific Committee on Food of the European Commission

(2001) Guidance on Submissions for Food Additive

Evaluations. SCF/CS/ADD/GEN/26 Final of 12 July

2001. Brussels, Belgium: Scientific Committee on Food

of the European Commission.

Watson D (ed.) Food Chemical Safety, vol. 2 – Additives.

Cambridge: Woodhead Publishing.

Contaminants and Adulterants

C M Stansfield, Leatherhead Food International,

Leatherhead, Surrey, UK

Introduction

0001 Despite the fact that we now have a more tightly

controlled, and therefore safer, food supply than

ever before, there is a noticeable increase in consumer

awareness and interest in food quality and safety, and

one cannot exclude from this context adulterants,

contaminants, and residues. This article outlines the

way in which such areas of major public concern are

regulated and controlled, including pesticide and

heavy metal residues, microbiological contamination,

foreign substances, and others.

General Overview

0002In addition to specific legislative acts on food safety

issues, all modern food law embodies the fundamen-

tal concept that food should be of the nature, quality,

and substance demanded by the consumer. This im-

plies that, even where a country lacks specific legisla-

tion on a particular area, it is able to take action

against adulteration or contamination of food.

0003To achieve the objective of protecting the con-

sumer, each country has its own way of regulating

the occurrence of contaminants and adulterants in

foodstuffs. Some countries control food contamin-

ation at commodity level, i.e., levels for heavy metals

and microbiological criteria or other contaminants

are laid down in food standards of composition. In

contrast, other countries insure that food quality and

safety are achieved throughout the food process, as

opposed to being concerned with the examination

and control of the final product only.

0004In recent years, new technological developments,

consumer awareness, and demand for a healtheir diet

have resulted in an increase in the amount of new

legislation, either already in force or in circulation

as proposals, and much of this is related to food

safety. In addition to these factors, the increase in

new legislation in Europe is mainly a result of the

need to harmonize the area of food safety at Euro-

pean Union (EU) level.

Food Adulteration

0005In Europe, an adulterant is a substance added to food in

order to defraud the consumer, whereas in the USA,

food containing any substance that is not supposed to

be in the food is said to be adulterated. Deliberate

adulterants are frequently inferior, cheaper ingredients

that are used for economic advantage, e.g., water in

milk, and are not dangerous, but constitute fraud.

0006The addition of mineral oil to cooking oil in Spain in

1979 was a dangerous adulterant that caused injury to

some hundreds of people, and this incident incited the

EU to set up a rapid alert system between the control

authorities of member states. The task of such alert

systems is to insure that affected food is identified and

removed from the market and to return the trading

system to normal as soon as possible. Some countries

have powers to seize and destroy adulterated food but

others operate by warning the trade and the public.

Since lack of immediate action by the trade could not

only lay them open to prosecution but also lead them

to disrepute, it is extremely unusual for them not to

cooperate with the authorities.

0007The presence of foreign bodies such as stone, glass,

metal, rubber, wood, human hair, and parts of

LEGISLATION/Contaminants and Adulterants 3507

clothing usually arise from lack of care, and are dealt

with under general legal provisions on food. Unfortu-

nately, there have been cases of deliberate addition of

foreign bodies to food, usually by tampering with food

on display, with intent to inflict economic damage,

either for personal gain or as a threat against the manu-

facturer or trade, and such action is dealt with under

criminal law. Food alert systems have again proved

their worth in limiting risk and economic damage.

Contaminants

0008 Contaminants are defined by the World Health

Organization/Food and Agriculture Organization

(WHO/FAO) Codex Alimentarius as follows:

0009 ‘Contaminant’ means any substance not intentionally

added to food, which is present in such food as a result

of the production (including operations carried out in

crop husbandry, animal husbandry and veterinary medi-

cine), manufacture, processing, preparation, treatment,

packing, packaging, transport or holding of such food or

as a result of environmental contamination. The term

does not include insect fragments, rodent hairs and other

extraneous matter.

0010 It is interesting to note that the consumer would

certainly regard the first two exclusions as contamin-

ants. Legislation on contaminants has been developed

in response to specific concerns and is therefore

largely incoherent and in many cases outdated. Sub-

stances that accumulate in the environment, polluting

air, farmland, and sea, eventually become present in

foodstuffs. Specifying levels for the intake of environ-

mental contaminants in foods must create a balance

between encouraging the reduction of their presence

through good manufacturing practices and consider-

ation of conditions beyond the control of the produ-

cer that may determine the achievable level; for

example, aflatoxin levels in cereal-based foods reflect

climatic conditions during maturation and storage.

However, within the EU, harmonization of certain

areas is a continuing process. The Codex definition

of contaminant has been adopted by the EU in an

overriding framework regulation, Council Regula-

tion (EEC) no. 315/93, which lays down a general

prohibition on the marketing of foods containing

contaminants in unacceptable amounts. In this way,

levels are controlled through good manufacturing

practice; however, there is also provision for the

establishment of maximum tolerances, analytical

methods and detection limits and references to sam-

pling. There are separate committees that consider

industrial contaminants, such as heavy metals and

dioxins, and agricultural contaminants, such as

nitrates, mycotoxins, and inherent plant toxins. This

has resulted in the setting of maximum levels for

certain contaminants in foodstuffs. However, existing

limits on contaminants in each member state apply

where no level is laid down by the EU.

Heavy Metals

0011Heavy metals represent an important group of

inorganic contaminants that may be present in food

products as a result of (1) their natural occurrence in

food products in the raw materials used; (2) contam-

ination of raw materials; or (3) undesirable transfer

during the processes of manufacturing and pack-

aging. The heavy metals most commonly covered

by restrictive legislation are arsenic, copper, lead,

mercury, zinc, and tin.

0012Regulations on heavy metals are frequently

product-specific in nature, owing to susceptibility of

certain foodstuffs to contamination by particular

metals. For example, maximum levels for mercury

in fish and fish products are often laid down because

these products have been identified as principal

sources of this element in the human diet. Levels of

0.5 p.p.m., or 1 p.p.m., depending on fish species,

have been established by Codex Alimentarius and

the EU. Similarly, levels of tin are of primary concern

in canned foods, for obvious reasons. Tolerances for

tin in canned foods normally fall in the range of 100–

250 mg kg

1

(Table 1).

0013Most commonly, legislation on heavy metals is

covered by regulations specifying maximum toler-

ances for named metals in a range of foodstuffs

when the presence of a substance reaches a level

known to present significant risk; this is the case for

Canada, the UK, Australia, and South Africa. In some

cases, a general tolerance is also laid down for food-

stuffs not specifically listed, as in the UK, and Poland.

0014The limits for mercury in fish, and for lead and

cadmium in a range of food categories, are the only

heavy-metal limits set, at present, by the EU.

0015Some member states have approaches that differ

from the one outlined above. Certain countries, in-

cluding Spain, Austria, and Greece, lay down provi-

sions in individual standards of composition, as does

Israel.

0016Recommendations of the Codex Alimentarius

Commission are often considered in the formulation

of legislation on heavy metals but, as Table 2

tbl0001Table 1 Permitted levels of tin (p.p.m.) in canned solid foods

UK Finland Norway Hungary Canada Malaysia

200 150 250 200 250 250

Data from Legislation Unit (2000, updated March 2001) Contaminants in

Foodstuffs ^ An International Review of Maximum Limits Part 2. Leatherhead,

UK: Leatherhead Food RA.

3508 LEGISLATION/Contaminants and Adulterants

demonstrates for wine, there may still be variations in

levels set worldwide.

0017 The situation for lead in wine has been rectified

partly by action by the EU and the US Food and Drug

Administration (FDA), which have banned the use of

lead capsules on wine bottles, the major source of

lead in wine. Amongst efforts to reduce their presence

in other foods has been a prohibition on or general

phasing out of the use of lead solder in food cans.

0018 Heavy metals may also be indigenous in food, and

their presence in water can derive partly from the

rocks of the aquifer. In this case they are referred to

as undesirable substances and are regulated, in the

EU, the USA, and elsewhere, by legal provisions on

the quality of drinking water and bottled mineral

water, for which a Codex standard also exists.

Polychlorinated Biphenyls and Dioxin

0019 Various inert organic compounds with industrial

applications may pose a threat to food safety. Poly-

chlorinated biphenyls (PCBs) are examples of such

compounds; their presence is now widespread and

uncontrolled in the environment. These have a ten-

dency to accumulate in animal feeds, particularly

those of animal and marine origin, and are subse-

quently introduced into food.

0020 At EU level, there are no limits at present for PCBs

in foods and, in general, the regulations of most

countries do not make specific provisions for the

control of PCBs in foodstuffs. However, certain coun-

tries (e.g., Germany and the USA) have set maximum

tolerances for PCBs in a range of foodstuffs. In some

other countries, The Netherlands and France in-

cluded, maximum tolerances are laid down for fish

and fish products, which are particularly susceptible

to PCB contamination (Table 3). Concern over PCB

contamination led the UK and the USA to discontinue

their manufacture in 1977. In some countries, the use

of PCBs in industrial applications is restricted where

they may constitute a threat to food safety. For

example, in Denmark, the use of PCBs in heating

installations for foodstuffs is prohibited.

0021Dioxin, a contaminant from chemical manufac-

ture, has caused concern in recent years, as it can

accumulate in the fatty tissue of animals and humans.

In 1999 contamination from dioxin resulted in wide-

spread infection of poultry and eggs in various Euro-

pean countries. This was believed to have originated

from an oils- and fats-processing company in Bel-

gium, which supplied feed manufacturers. Protective

measures were established by the EU, and in the

longer term they are evaluating the risk of dioxins

and PCBs. ‘It has emerged that more than 90% of

human dioxin exposure derives from foodstuffs, with

a large portion of this derived from foodstuffs of

animal origin. Council Regulation (EC) No. 2375/

2001 lays down maximum limits for dioxins in prod-

ucts from meat, milk, fish and oils and fats. Levels for

the types of PCBs that exhibit toxicological properties

to dioxins have not been set due to limited data

available on their presence. The European Commis-

sion intends to review situation by the end of 2004.’

Nitrates

0022Concern over the harmful properties developed from

the reduction of nitrate to nitrite has led the EU to set

levels for nitrates in water, and for spinach and

lettuce, depending on the season in which they are

harvested. Currently, levels for fresh spinach range

from 2500 to 3000 mg kg

1

, for processed spinach

2000 mg kg

1

, and a range of 2500–4500 mg kg

1

set for lettuce. It has been estimated that, in many

European countries, vegetables contribute most of

the nitrate exposure, and some member states, such

tbl0002 Table 2 Permitted levels of lead (p.p.m.) in certain food commodities

Commodity Codex EU Sweden Canada Malaysia Japan Brazil

Wine 0.2 0.2 0.2 0.2 0.5 – 0.5

Soft drinks – – 0.05 0.2 0.2 Not detectable 0.2

Data from Legislation Unit (1999, updated) Contaminants in Foodstuffs ^ An International Review of Maximum Limits Part 1. Leatherhead, UK: Leatherhead

Food RA. Legislation Unit (2000, updated March 2001) Contaminants in Foodstuffs ^ An International Review of Maximum Limits Part 2. Leatherhead, UK:

Leatherhead Food RA.

tbl0003 Table 3 Maximum tolerances for polychlorinated biphenyls (PCBs) in fresh-water fish

France Germany Netherlands USA Japan

PCB content in fresh-water fish (mg kg

1

) 2.0 0.2 or 0.3

0.04–0.12

0.5–3.0

Levels set for individual PCBs.

Temporary tolerance.

Data from Legislation Unit (2000, updated March 2001) Contaminants in Foodstuffs ^ An International Review of Maximum Limits Part 2. Leatherhead, UK:

Leatherhead Food RA.

LEGISLATION/Contaminants and Adulterants 3509

as Austria and The Netherlands, have introduced

upper limits for other types of vegetables. In Austria,

guideline levels are laid down for a range of other

vegetables, including carrots, cabbage, and parsley.

Switzerland has levels for nitrates in cheese and infant

foods as well as vegetables. Outside Europe, Argen-

tina sets levels for nitrates in various milk products.

Radioactivity

0023 Natural radioactivity occurs in all foods, arising from

the radioactive isotopes carbon-14 and potassium-40.

The specific activity of carbon-14 is relatively low;

however, potassium-40 gives rise to specific activities

of 40–50 Bq kg

1

in cows’ milk, 400–500 Bq kg

1

milk powder, 600–800 Bq kg

1

in concentrated fruit

juice, and over 1000 Bq kg

1

in instant coffee. There

is no legislation governing this radioactivity since it

cannot be eliminated, and consumption of such foods

does not significantly alter the potassium content,

and hence the potassium radioactivity of the body.

0024 Human exposure to radiation is laid down in law

and national measures are usually based on recom-

mendations of the International Committee for

Radiological Protection (ICRP). Drinking water con-

tributes a very small radiation dose to total popula-

tion exposure and is largely due to naturally

occurring radionuclides in the uranium and thorium

decay series. WHO has established guideline levels

for radioactivity in drinking water, based on ICRP

recommendations and available data on risk expos-

ure. Some countries lay down limits for radionuclides

in bottled waters, for example in the USA, Sweden,

Israel, and Switzerland.

0025 Before the accident at Chernobyl nuclear power

station in 1986, very few countries had radioactivity

limits for food since the policy was, and still is, to

control emission and waste at source, with local inci-

dents being handled by monitoring of food and popu-

lation. Contamination of food on a continental scale

arising from Chernobyl required immediate action

and resulted in the EU setting limits for radioactive

contamination of imports from outside its member

states. Since then, contamination levels have de-

creased to a negligible risk of health, and later rules

exclude a number of products from the scope of the

original regulation. There is a maximum tolerance of

370 Bq kg

1

for combined cesium-134 and cesium-

137 in milk, milk products, and special infant foods,

and a single level of 600 Bq kg

1

for other food

products concerned. In 1999, the EU established pro-

cedures for carrying out checks on the radiocesium

content of such foods. A number of countries

followed the EU post-Chernobyl regulation. Infant

foods, milk, and milk products, and animal foods

are among the most widely regulated commodities

in this regard. The EU has also established a

regulation setting maximum permitted levels for

radioactive contamination of foodstuffs, which

could be applied in the event of a future nuclear

accident or other radiological emergency potentially

involving radionuclides other than cesium.

Mycotoxins

0026Theconcernoverthecarcinogenichazardofmyco-

toxins has also increased in recent years. Mycotoxin

contamination is most often related to the susceptibility

of certain crops, especially grains and nuts, during

storage, to the attack by toxin-producing fungi, in

particular Aspergillus flavus, which produces a group

of highly toxic metabolites called aflatoxins.

0027Specific mycotoxin legislation was developed in

several countries as a result of the discovery of afla-

toxin in the early 1960s; it was later extended to other

mycotoxins, including patulin, ergot, ochratoxin A,

and pomphsin. Currently, levels for some mycotoxins

are regulated at EU level, namely aflatoxins B

in nuts, dried fruit, cereal products, and spices

and a level of aflatoxin M

in milk, and limits

for ochratoxin A in cereals and vine fruit. Limits for

mycotoxins in infant foods and patulin in fruit juices

have been proposed, and further categories for ochra-

toxin A are under review at EU level. Certain coun-

tries may control the presence of aflatoxins in other

foods, as is the case in Germany, where limits are laid

down for enzyme preparations, dietetic foods for

babies and infants, milk, and other foodstuffs. Regu-

lations on aflatoxins in non-EU countries, where they

exist, usually determine levels for peanuts and peanut

products and milk, or lay down a general level for all

foodstuffs. Table 4 gives examples of maximum levels

of aflatoxins in foodstuffs, especially nuts and nut

products, in major countries worldwide.

Inherent Toxic Substances

0028If present in excessive amounts, certain inherent

toxins pose a threat to human health. Whilst such

toxins are not widely regulated, some countries have

laid down product-specific tolerances in certain

instances. For example, Finland has levels for

solanidine glycosides in potatoes and for indole in

crustaceans; however, in general, natural toxins can

be controlled through regulations that establish

species and strains that are for food use.

0029Levels for shellfish toxins have been established by

a number of countries, including Japan and the USA,

as well as in the EU. The adverse health implications

associated with erucic acid content in some rapeseed

3510 LEGISLATION/Contaminants and Adulterants

and mustard oils led the EU to set maximum levels

for erucic acid in oils and fats intended for human

consumption and for foodstuffs containing the same.

EU regulations on flavorings include a list of max-

imum limits for certain potentially toxic substances,

such as thujone and coumarin, which may be present

in a foodstuff as a result of the use of flavorings. 3-

monochloropropane-1, 2-diol is created during food

processing under certain conditions. At EU level max-

imum levels have been set for its presence in hydro-

lyzed vegetable protein and soy sauce.

Microbiological Contamination

0030 The contamination of foodstuffs by pathogenic and

spoilage microorganisms has always been one of the

major concerns of consumers and enforcement

authorities, owing to the great risk that this poses

to human health.

0031 Countries may differ in the way in which they

approach this problem; however, most governments

have the single philosophy of seeking to insure pro-

tection of public health. This is usually achieved by

provisions of food acts that exist in most countries

to insure food safety and quality by making it an

offence to sell food that is injurious to health and

does not conform with the quality demanded by the

purchaser. This means that in most countries it is an

offence to sell foodstuffs contaminated with patho-

genic organisms (Salmonella, Staphylococcus aureus,

sulfite- reducing Clostridium, Listeria monocyto-

genes, and others) or spoilage microflora. Through

the enforcement of food acts, powers may be given to

the relevant authorities to impose emergency control

measures in order to prevent the circulation and sale

of contaminated food at any time should they con-

sider that the public health is at risk. The UK Food

Safety Act 1990 illustrates this clearly in that powers

are given to ministers and other relevant authorities

to act immediately upon cases that endanger the

public health, e.g., to issue emergency orders, to

close down food premises, etc.

0032In addition, microbiological criteria may be set

which can be achieved throughout food processing

by means of the application of good manufactur-

ing practice. Microbiological criteria are generally

expressed as three main categories:

0033Microbiological standards: these are applicable to

the final product and have legal force; they are

mandatory.

0034Microbiological guidelines: these are guides

intended to help manufacturers to insure good

hygiene practice; although guidelines are optional,

it is strongly recommended that they are followed

in the absence of microbiological standards.

0035Microbiological end-product specifications: these

are generally contractual agreements between

manufacturers and purchasers to check that the

goods concerned are of the quality required.

tbl0004 Table 4 Examples of maximum levels of aflatoxins in nuts and nut products, in major countries

Country Food Aflatoxin Maximumlevel (mgkg

1

)

European Union

member states

Groundnuts, nuts, and dried fruit and

their processed products, intended for direct human

consumption or as an ingredient in foodstuffs

þ B

þ G

Groundnuts to be subjected to sorting, or other

physical treatment, before human consumption or

use as an ingredient in foodstuffs

þ B

þ G

Nuts and dried fruit to be subjected to sorting, or

other physical treatment, before human

consumption or use as an ingredient in foodstuffs

þ B

þ G

USA Peanut and peanut products, Brazil nuts and

pistachio nuts, other foodstuffs (except milk)

Aflatoxins 20

Australia Peanut and tree nuts and the nut

proportion of products containing nuts

Aflatoxins 15

Japan Peanut and peanut products, pistachio nut, almond,

Brazil nut, cashew nut, hazel nut, macedemia nut,

walnut, and giant corn

South Africa Grains, nuts, and their products and all other

foodstuffs

Aflatoxins 10 of which M

is maximum 5

Maximum limits apply to the edible part of groundnuts, nuts, and dried fruits. If nuts ‘in shell’ are analyzed, it is assumed when calculating the aflatoxin

content that all contamination is on the edible part.

Data from Legislation Unit (2000, updated March) Contaminants in Foodstuffs ^ An International Review of Maximum Limits Part 2. Leatherhead, UK:

Leatherhead Food RA.

LEGISLATION/Contaminants and Adulterants 3511

Where a microbiological standard exists, sampling

and analytical methods are required in order to

monitor, in qualitative and quantitative terms, the

criteria laid down.

Microbiological Criteria

0036 The development and application of microbiological

criteria for foods are carried out by international

bodies and national authorities, including the

WHO, the International Commission on Microbio-

logical Specifications for Foodstuffs (ICMSF – avol-

untary specific body, which provides basic information

on the microbiology of foods based on extensive

studies) and the EU.

0037 Certain countries place more emphasis on the

microbiological standard for the final product; in

other words, microbiological criteria are laid down

in food standards of composition. Examples include

Spain, The Netherlands, Australia, Sweden, and Ar-

gentina, amongst others. In contrast, other countries

follow a more systematic approach, where food

quality and safety are achieved by the identification

of hazard and assessment of risk throughout the

processing, from the raw material stage to the final

product. This is usually carried out by means of the

Hazard Analysis Critical Control Point (HACCP)

system or equivalent process, which is used in con-

junction with good manufacturing process. The UK is

an example of the latter trend, where there are very

few specific microbiological standards; instead, the

approach to food hygiene is that of prevention backed

up by codes of practice and microbiological guide-

lines. In the USA, HACCP is mandatory in meat

plants, seafood and juices used for beverages. Good

manufacturing process regulations are laid down for

foodstuffs in general, dietary supplements, low-acid

canned foods, and acidified foods, and there are

pathogen-reduction performance standards for Sal-

monella in slaughter plants and raw ground products.

0038 The EU general hygiene directive was established in

1993 with the aim of insuring confidence in the stand-

ard of safety of all foods in circulation, particularly in

respect of hygiene, through all stages from production

to sale to the final consumer. While this does not

establish criteria, the principles of HACCP are re-

quired and the directive makes provisions for future

criteria concerning microbiological criteria and

temperature control, requirements for food business

operators to insure appropriate training for food

handlers, and general hygiene requirements for prem-

ises. EU microbiological criteria are laid down for

mineral water, milk and milk products, mincemeat,

and meat preparations. The European Commission

is revising its food hygiene rules to streamline and

harmonize existing requirements. The new rules

would applyto all foodand all food operators through-

out the food chain, and requires HACCP systems to

be implemented by all food business operators.

Residues

0039Residues of pesticides and veterinary pharmaceuticals

in food are not legally regarded as contaminants but

are permitted to safe levels defined at the time that

each product is authorized.

Pesticides

0040The use of pesticides in agriculture has contributed to

the worldwide increase in food production. As well as

improving the efficiency or productivity of agricul-

tural practices, their use has also raised concern over

their side-effects on animal and human health.

0041In most countries the use of pesticides is strictly

controlled by regulatory bodies, whose responsibility

is to insure that their use is safe and that any residues

present in foodstuffs do not constitute any risk to

public health. The WHO/FAO Joint Meeting on

Pesticides Residues (JMPR) plays a major role at

international level in assessing the safety of pesticides

and by setting standards, and its recommendations

and rules are taken into account by most countries.

0042Legislation on pesticides at EU level is extensive

and the increasing tendency to use pesticides on cer-

tain crops, and the continuous formulation and com-

mercialization of new substances for pesticide use,

have resulted in a frequent revision of their safety

and a subsequent need to review the legal provisions.

Existing directives set mandatory maximum limits for

pesticide residues in and on fruits and vegetables,

cereals, and foods of animal origin, dried processed

and composite products, infant formulae, and baby

foods. Another directive prohibits the placing on the

market and use of plant protection products contain-

ing certain active substances, including ethylene

oxide. Methods of analysis for the detection and

monitoring of fixed maximum limits are required to

be established by these directives.

0043In comparison with the EU, non-EU countries may

have a similar approach to the way in which they

control residues of pesticides in foodstuffs, in that

their legislation is based on lists laying down max-

imum levels for certain pesticide residues in and on

specific food commodities. For example, in the USA,

tolerances are set for a wide range of foods, processed

foods, and animal feeds. Changes in the overall

framework of their regulation mean that all pesticide

tolerances must be reevaluated by 2007, establishing

safe tolerance levels for groups of pesticides with

similar mechanisms.

3512 LEGISLATION/Contaminants and Adulterants