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

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Weights and Measures

0022 From the earliest days of human communities

bartering or trading food, there has been a require-

ment for a mutually acceptable system of weights and

measures.

0023 The oldest weights identified by archeologists are

believed to be between 9000 and 10 000 years old.

There is also evidence that trade in weighed products

was used by the Indus civilization and in Sameria

about 5000 years ago. A little later, weighed trade

was adopted by the Babylonians and then by the

Egyptians about 4500 years ago.

0024 There are also references in the Bible (Old Testa-

ment) to the importance of weights and measures in a

structured society. They appear where Moses is told

the laws for the Israelites in Leviticus: ‘Ye shall do no

unrighteousness in judgment, in metyard, in weight

or in measure. Just balances, just weights, a just

ephah and a just hin, shall ye have’ (ephah and hin

were measuring equipment of that time). Also the

Book of Proverbs states: ‘A just weight and balance

are the Lord’s; all the weights of the bag are his work.’

0025 The Romans introduced an organized system of

weights and measures into all the countries which

became part of the Roman Empire. The Roman

libra was almost the same weight as a standard meas-

ure used by the Egyptians and another used by the

Babylonians. For a number of centuries after the col-

lapse of the Roman Empire, practically every country

in Europe had a weight with its name derived from

either the word libra or pondus, the latter being the

origin of the word pound. The pound was the princi-

pal unit of measure in UK law until it began to be

phased out in the mid-1980s in favor of metrication

and as part of the UK harmonization with the rest of

the European Community. It was finally abolished as

a measure of food in 2000. The pound is still retained

in the USA.

0026 In the Dark Ages that followed the collapse of the

Roman Empire, the system of weights and measures

deteriorated and in northern Europe there was a

gradual return to the primitive ways of measuring,

for example, with the human body. The situation

developed where almost every main town had its

own standards which could differ from those of its

neighbors. This resulted in considerable confusion in

trade.

0027 In England, the earliest law to introduce and en-

force consistent standards of weights and measures

was introduced during the reign of King Edgar (ad

959–975). To quote from a translation: ‘And let one

money pass through the King’s Dominions and that

let no man refuse; and let one measure and one weight

pass, such as is observed at London and Winchester.’

0028A major change in the weighing and measuring of

food began in France during the Napoleonic period,

with the introduction of the metric system. The prin-

cipal unit of weight became the gram, and that for

volume became the milliliter.

0029The metric system originated in 1791 when a com-

mittee of the French Academy made a report to the

National Assembly on proposals for a new scientific-

ally based method of measurement. These proposals

were subsequently adopted in France. The report

defined the standard of length as the meter (metre),

which was one ten-millionth of the earth’s meridian

quadrant at sea level.

0030The unit of weight, the gram (g), became a second-

ary standard based on the centimeter (one-hundredth

of a meter), and the density of water at a given tem-

perature. Minor inaccuracies were encountered in the

measurement of length and in 1875 the International

Bureau of Weights and Measures was established

at Se

vres in France. The meter was redefined as

1 650 763.73 wavelengths of the orange-red light

emitted when a gas consisting of pure krypton-86 is

excited in an electrical discharge. A standard kilo-

gram (1000 g) was produced from a platinum-iridium

alloy and is carefully preserved at Se

vres.

0031Through the twentieth century, the metric system

was adopted by more and more countries and has

now become the main system of measurement for

science and also for trade. One of the main areas

still retaining the imperial measurements of pounds,

ounces, and gallons is the USA.

Early Development of Food Law

in the USA

0032During the late nineteenth and early twentieth

centuries, the development of food legislation in the

USA was complex. Congress did not have consti-

tutional authority over the regulation of manufactur-

ing processes or the provision of pure and safe food.

The federal laws were primarily concerned with

interstate and international trade. Early federal food

legislation was mainly concerned with the export

and import of meats such as a law in 1890 requiring

the inspection of salted pork and bacon. This was

introduced to facilitate exports as a number of Euro-

pean countries were concerned about contamination

with trichinae.

0033Towards the end of the nineteenth century, there

was an intermingling of state and federal laws.

Among laws passed by individual states was the Cali-

fornia pure food and drug law of 1850; the Massa-

chusetts law prohibiting milk adulteration in 1856;

the New York food and drug law in 1881; and the

District of Columbia food and drug law of 1891.

LEGISLATION/History 3493

0034 Chiefly as a result of a campaign by Dr Harvey W

Wiley, chemist for the US Department of Agriculture,

against adulterated and misbranded foods, President

Theodore Roosevelt signed the Food and Drug Act in

1906. This was after 12 similar bills had failed over

the previous 20 years.

0035 In 1927 a separate enforcement agency covering

food was constituted as the Food, Drug and Insecti-

cide Administration. This became the Food and Drug

Administration in 1931.

0036 In 1939 the Federal Food, Drug and Cosmetic

Act was passed which, whilst retaining most of the

provisions of the 1906 Act, added new provisions

such as the definition of food, food standards of

identity, and making truthful labeling mandatory.

0037 The Hale Amendment in 1954 allowed for a more

simplified method of promulgating food standards,

and the Food Additive Amendment of 1958 required

that any substance added to food must be proved to

be safe by the manufacturer before being offered for

sale. It also permitted the use of food chemicals for

technological purposes where they were safe at the

intended level of use. The Delaney proviso prohibited

the approval of any food additive shown to induce

cancer in humans.

0038 Following the enactment of the Food Additives

Amendment, the Food and Drug Administration pub-

lished the first list of substances generally recognized

as safe (GRAS) in the Federal Register. This list con-

tained nearly 200 substances.

0039 In 1960 the Color Additive Amendment was

enacted requiring manufacturers to establish the

safety of all color additives intended for use in

foods, drugs, and cosmetics. This was also subject to

the Delaney proviso prohibiting the approval of any

color additive shown to induce cancer in humans or

animals.

0040 With the establishment of the Environmental Pro-

tection Agency in 1970, the program for setting limits

and tolerances for pesticides was transferred from the

Food and Drug Administration to the new agency.

Food Law of the European Union

0041 The most ambitious and comprehensive program to

develop new food law was that undertaken in the

European Union in the second half of the twentieth

century.

0042 From the signing of the Treaty of Rome, which

brought the European Economic Community into

existence in March 1957, it was realized that in order

to insure freedom of trade in foodstuffs it was essen-

tial to establish common rules on the presentation,

control, and in some cases the composition of the

foods.

0043Of particular concern in the first years of the Com-

munity were the diverse national laws regarding the

use of additives in foods and the first directive in the

food sector was that on food colors which was

adopted in 1962. During the early 1960s, work was

in progress on directives to control other groups of

food additives.

0044The first real step towards the harmonization of the

food legislation was a European Commission recom-

mendation published in 1965 which required prior

notification from the member states of any intended

new legislation or amendments to existing legislation

on foodstuffs.

0045Four years later, in 1969, the European Council

issued a resolution which included the drawing-up

of a program for the elimination of technical barriers

to trade in foodstuffs. The program that emerged as

a result of this resolution was ambitious as it was

divided into priority groups covering 70 subjects

with a time schedule built around five phases, with

completion in 1971, 2 years after the publication of

the program. As very little of the program had been

accomplished by the 1971 deadline, a new resolution

in 1973 revised the program and extended the dead-

line to 1978. Again, progress was slower than antici-

pated and a further revised program was adopted in

1977.

0046One of the main objectives of the harmonization

program during the 1970s was the development of

compositional or ‘recipe’ legislation, covering specific

groups of foodstuffs. This ‘vertical’ legislation, as it

came to be known, was considered essential for free

movement of foods and a large number of directives

were envisaged, each concerned with the composition

and control of a product category. By the mid-1970s,

over 30 categories of foodstuffs had been identified as

requiring recipe or vertical legislation.

0047The first of these directives was that on cocoa and

chocolate products, which was still in force in 2000,

having been amended 12 times. Although work com-

menced on over 25 vertical directives during the first

half of the 1970s, very little of this proposed legisla-

tion had been adopted by 1977. Most of the delays

were caused by lack of agreement between the

member states as to what was important for the con-

trol of the product category. One of the problems

associated with the vertical legislation was that, to a

considerable degree, it restricted product development

and the introduction of technological innovation.

0048A major turning point in the progress towards

harmonization and an important influence on the

revised programs for the 1980s was the European

Court of Justice judgment on the Cassis de Dijon

case. This concerned a German prohibition on the

import of the blackcurrant liqueur Cassis de Dijon

3494 LEGISLATION/History

from France as the alcohol content was lower than

that permitted by German law. The Court ruled that

the barrier created by the German regulation was

incompatible with the Treaty of Rome and that quan-

titative restrictions on imports should be prohibited.

This judgment provided a general principle for the

trade in foods between member states which was that,

provided a foodstuff complies with the regulations in

force in the member state in which it is manufactured,

it should be permitted on the market of any other

member state.

0049 The Cassis de Dijon judgment is now regarded as

being pivotal in the major change of approach by the

European Council and Commission to the harmon-

ization program. There was a shift of emphasis away

from the vertical directives and it was determined that

future Community legislation on foodstuffs should be

limited to provisions which are justified by the need

to protect public health, provide consumers with

necessary information about foods, provide for

necessary public controls, and insure fair trade.

0050 The new approach to harmonization was given an

additional impetus in mid-1985 with the publication

of a white paper from the Commission to the Council

entitled Completing the Internal Market. The white

paper addressed the fact that there has been a sig-

nificant imbalance between the ‘horizontal’ food

legislation (e.g., labeling and additives) where consid-

erable progress had been made and the ‘vertical’ le-

gislation covering composition in which there had

been relatively little progress.

0051 The white paper, and a Commission Communica-

tion which followed it, defined a new approach in

which the vertical system was to be replaced by a

horizontal one. The procedures were also simplified

to reduce the work involved and to speed up the

harmonization process.

0052 The new program was to be centered on five frame-

work directives that were considered crucial to the

single market in foodstuffs. These were:

0053 Additives

0054 Food labeling and presentation

0055 Materials and articles in contact with food

0056 Official control of foodstuffs

0057 Foods for particular nutritional uses

The framework directives were required to lay down

the general principles for control in the relevant areas

and specific technical directives were to be developed

as adjuncts to these framework directives.

0058 As some of the five key areas had already been

covered by earlier directives, priority was to be

given to revising them and bringing them into line

with the new requirements. However, even with the

more simplified and streamlined program, progress

was slow and much of the essential proposed legisla-

tion was not adopted by the introduction of the single

market in January 1993.

0059At the end of 1999, the European Commission

published a white paper on food safety which included

proposals to set up a centralized European Food

Authority and which also set timetables for the

completion of over 80 outstanding items of food

legislation.

0060In anticipation of their eventual incorporation into

the European Union, a number of states in the former

Soviet Union, particularly Hungary, Poland, and the

Czech Republic, have been revising their food laws in

line with those of the European Union.

Codex Alimentarius

0061Since the mid-1960s, the Codex Alimentarius Com-

mission has played an increasing role in shaping the

future of international food law.

0062Codex was instituted as a joint Food and Agricul-

ture Organization (FAO) and World Health Organ-

ization (WHO) initiative to develop internationally

accepted standards and codes of practice for food

commodities. All member nations and associate

members of the FAO and WHO can become members

of Codex. By 2000, the number of member countries

had reached 165, representing 97% of the world’s

population. Over the years a wide range of standards

covering a number of food categories have been

agreed, and in some countries these standards form

the basis for national laws.

0063The Codex Alimentarius has gained a greater sig-

nificance since the formation of the World Trade

Organization (WTO). The Agreement on the Tech-

nical Barriers to Trade (TBT) that was introduced

following the Tokyo Round on World Trade in 1979

had a substantial impact on the establishment of pol-

icies on food control. The TBT Agreement did not

specifically mention Codex but dealt with aspects of

food not directly related to safety, such as labeling,

quality, and packaging, and thus impinged on Codex.

The WTO, however, has recognized Codex as the

preferred international organization for the arbitra-

tion and settlement of disputes related to food trade.

See also: Adulteration of Foods: History and

Occurrence; Food Additives: Safety; Food Safety;

Legislation: Additives; Codex

Further Reading

Furia TE (ed.) (1972) Handbook of Food Additives. Boca

Raton, FL: CRS Press.

Marsh SB and Soulsby J (1982) Outlines of English Law,

3rd edn. London: McGraw-Hill.

LEGISLATION/History 3495

Rowell R (ed.) (1999) Butterworth’s Law on Food and

Drugs. London: Butterworths.

Smith G (1980) Something to Declare: 1000 Years of

Customs and Excise. London: Harrap.

Food and Agriculture Organization/World Health Organ-

ization (1999) Understanding the Codex Alimentarius.

Rome: FAO/WHO.

International Standards

J A Smith, Leatherhead Food Research Association,

Leatherhead, Surrey, UK

Standards

0001 The initial object of standardization was to provide

a means of communication between the supplier

and the user. Standards are, in principle, voluntary

instruments but, as legislation began to deal with

more complex technological developments, legisla-

tors referred to standards as a means of achieving

the desired objectives of legislation. Before the advent

of detailed food labeling, food standards provided the

only way to guarantee the consumer that the desired

quality in terms of product characteristics was main-

tained, and they thus became frequently referred to in

legislation or laid down under mandatory acts.

0002 Food standards generally lay down requirements

for the composition of a food in terms of percentage

and quality of ingredients and may include provisions

on food additives. They may also specify physical

properties, such as water content, particle size,

density, or processing methods.

0003 The Codex Alimentarius Standards of the Food

and Agriculture Organization/World Health Organ-

ization (FAO/WHO) are, in effect, model laws for use

in international trade; by granting full acceptance of a

Codex standard, a country or trading bloc engages to

accept conforming products on its market.

0004 Food standards have generally been established for

more basic food commodities, such as flour, bread,

and meat products, in order to insure minimum

standards are met, but have also been widely applied

to products such as soft drinks and chocolate, which

are consumed by a mass market. In insuring that

basic standards are met, food standards have partly

a social function in guaranteeing the quality of

basic necessities. Composite products, the appeal of

which depends on diversity, are rarely the subject

of standards. Standards are usually tied to a product

denomination or name and, since they reflect national

tradition and characteristics, there can be different

standards in different countries for the same product

descriptor.

0005Nowhere has this been more evident than in the

European Union (EU) with its variety of culinary

traditions. Examples include use of durum wheat

only in pasta in France and Italy, differences in com-

position of sausages in the UK and Germany, and the

use of vegetable fat in chocolate throughout the EU.

0006Attempts during the 1980s to harmonize compos-

itional food standards were unsuccessful due to the

unwillingness of the then European Community (EC)

member states to broaden the scope of their own

standards and come to a common level with others.

It is for this reason that the establishment of compos-

itional standards per se is no longer actively pursued

at EC level; the emphasis now is on public safety,

removal of barriers to trade, and prescribed food

labeling in order to allow the consumer to make an

informed choice.

0007This trend away from prescribed standards of com-

position has become international in recent years,

as such standards are seen as restrictive in terms of

product development and obstructive to trade. How-

ever, a large number of food standards are still in

force worldwide and are still a significant factor

when considering the scope of technical food

legislation.

0008In this article, to illustrate the role typically played

by food standards, the situation is described first

under EC law, in the UK as an EU member state,

and then in the USA, with is totally different system

of food legislation.

The EC

0009A number of food standards were set by so-called

vertical directives (i.e., directives applying to a spe-

cific product sector) in the 1970s and 1980s; products

such as jams, coffee and chicory extracts, fruit juices,

cocoa and chocolate products, honey, preserved milks,

sugars, caseins and caseinates were included. In order

to reach agreement on some of these, it was necessary

to allow certain national derogations or exemptions to

be maintained, the most famous being the use of

vegetable fat in chocolate (UK, Denmark, and Ireland

at the time allowed vegetable fat to be used up to 5%

of the total weight of the product in chocolate manu-

facture, whereas other member states were of the

opinion that the use of vegetable fat rendered the

product a ‘chocolate substitute’). Some issues were

left open to the member states to make a decision,

for example, the addition of vitamins for nutritional

purposes to fruit juices. These directives included

provisions on additives and labeling as well as min-

imum levels of required ingredients.

3496 LEGISLATION/International Standards

0010 Key to the change in emphasis in EC food law was

the ‘cassis de Dijon’ case, which was a case brought

under Article 30 of the EEC Treaty concerning the

composition of a blackcurrant liqueur. Under this

Article, no EC member state may refuse a product

legally made in another member state provided its

exclusion cannot be justified in terms of public health

or provision of information. In the absence of com-

positional standards at EC level for the majority of

foods manufactured the impact of this was highly

significant, as the concept of mutual recognition of

another EU member state’s products began to be

widely accepted. Certain of the member states began

writing mutual recognition clauses into any new

legislation on compositional standards to insure

they did not fall foul of EC law.

0011 Today EC directives on these foods are still in

existence, although work has been continuing for

some years to simplify them and bring them more

into line with trends in modern food legislation.

Examples of this are the removal of provisions on

additives (now covered by horizontal (i.e., applying

to all foods) additives directives) and the bringing of

labeling requirements into line with those required by

the general food-labeling directive, 2000/13/EEC. Re-

vised directives have been agreed on coffee and chic-

ory extracts and fruit juices and similar products;

after many years’ discussion, agreement has finally

been reached on a revised cocoa and chocolate prod-

ucts directive. The key issues of vegetable fat and the

naming of milk chocolate made with a lower percent-

age of cocoa solids have largely been resolved by

requiring more detailed labeling, as well as restricting

the types of vegetable fat that can be used.

0012 However, variations on compositional standards

are still being produced under EC law and are deemed

necessary in order to insure the market in key agricul-

tural sectors. Marketing standards have been pro-

duced for tuna, poultry, and a number of fruit and

vegetables. Of other EC regulations, the one which is

probably most familiar to many in the food industry

is that on spreadable fats. This standard details the

product descriptions that can be used for dairy,

animal, and mixed-fat spreadable fat products with

differing fat contents between 10 and 90%. Another

important regulation is that on drinking milk, which

lays down fat contents and descriptions for the dif-

ferent types of milk. As EC regulations, and not

directives, such legislation is binding on the individ-

ual member states.

0013 A new type of legislation has been introduced

during the 1990s. Although not generic standards in

the true sense, regulations on certificates of specific

character for agricultural products and foodstuffs

and on the protection of geographical indications and

designations of origin for agricultural products and

foodstuffs requires that names of the registered prod-

ucts may only be used when the product in question

complies with approved specifications. Only prod-

ucts that are traditional or are produced in a trad-

itional way will be able to be registered and protected

by their specific character; mozzarella cheese is thus

protected. PGIs/PDOs are intended to insure that a

product’s name is linked with its qualities and char-

acteristics that may be due to environmental factors.

Generic names (such as Cheddar cheese) may not be

registered; however, a range of meat products (includ-

ing Parma ham), olive oils, cheeses (including West

Country farmhouse Cheddar cheese and Parmesan

cheese) and other foods have been registered.

Following a European Court ruling in March 1999,

the name ‘feta’ has been deleted from the register,

but the name will remain protected at a national

level in the meantime.

The UK

0014Over the last 10 or so years, the number of food

standards still in force under UK law has been signifi-

cantly reduced. In some cases (for example, mayon-

naise and soft drinks) revocation has been total;

in other cases (for example, cheese, icecream) key

definitions have been included in revised regulations

on food labeling to insure that a minimum quality

of product is still maintained when a product descrip-

tor is used. To illustrate this, the minimum fat

content of icecream and milk fat content of dairy

icecream are still laid down, together with fat con-

tents for named cheeses. Standards still remaining

include those on bread and flour and meat and

spreadable fish products, as well as on basic foods

such as drinking milk, jams, honey, and other EC-

derived standards.

0015Typically, a standard includes a definition of terms

used in the regulations in order to aid interpretation;

any exemptions that may apply; minimum compos-

itional requirements for named foods; specific labeling

requirements that are relevant for named products;

penalties and enforcement, and any revocations of

existing standards. An explanatory note finishes the

text, summarizing the main points of the regulations.

The requirements detailed in regulations may be

backed up by codes of practice or guidelines, or by

decisions reached by case law, which can aid in the

interpretation of particular points contained within

the regulations, or by advice issued to enforcement

officers.

0016Are other EU member states similar to the UK?

Certain have undergone a similar extensive deregu-

lation exercise, most noticeably The Netherlands;

LEGISLATION/International Standards 3497

detailed guidelines are still used as indicators of con-

sumer expectation in Germany. Spain still has in

existence a large number of compositional standards

across a wide range of food products, which contrasts

with the Scandinavian countries, which tend to have

fewer standards. But throughout the EU the concept

of mutual recognition in terms of compositional

requirements insures that national standards of the

future can only be justified on the grounds of con-

sumer information or public health/safety needs.

The USA

Establishment of Food Standards

0017 Mandate for the production of standards for food

comes from the Federal Food, Drug and Cosmetic

Act (FFDCA), as amended. Section 401 of this Act,

concerning definitions and standards for food, states

that wherever, in the judgment of the Secretary of

Health and Human Services, such action will

promote honesty and fair dealing in the interests of

consumers, regulations shall be made fixing and es-

tablishing for any food, under its common or usual

name so far as practicable, a reasonable definition

and standard of identity, a reasonable standard

of quality, and/or reasonable standards of fill of a

container.

0018 Section 401 states that no definition and standard

of identity, and no standard of quality, may be estab-

lished for fresh or dried fruits, fresh or dried vege-

tables, or butter, with the exception that definitions

and standards of identity may be established for avo-

cados, cantaloupes, citrus fruits, and melons; how-

ever, these may relate only to maturity and the effects

of freezing.

0019 In prescribing any standard of fill of container, due

consideration must be given to the natural shrinkage

in storage and in transit of fresh natural food and the

need for necessary packing and protective material.

In the prescribing of any standard of quality for any

canned fruit or canned vegetable, consideration must

be given and due allowance made for the different

characteristics of the varieties of that fruit or vege-

table. When prescribing a definition and standard of

identity for any food or class of food in which op-

tional ingredients are permitted, the optional ingredi-

ents that must be named on the label will be

designated, for the purpose of promoting honesty

and fair dealing in the interests of consumers.

Agencies Responsible for Food Standards

0020 The major federal agencies responsible for food

standards in the USA include the Food and Drug

Administration (FDA), the US Department of

Agriculture (USDA) and the National Oceanic and

Atmospheric Administration (NOAA), which is

directed by the US Department of Commerce.

0021Food and Drug Administration The FDA, by dele-

gation from the Secretary of the Department of

Health and Human Services, regulates food other

than red meat, poultry, and eggs. These standards of

identity, established by the FDA for these products in

Title 21 of the Code of Federal Regulations (21CFR),

must be followed in every respect.

0022US Department of Agriculture The USDA is respon-

sible for the control of red meat, poultry, and eggs and

also for the quality assurance of other foods. Within

the USDA, specific responsibilities are delegated to

other agencies. Those involved in establishing stand-

ards for food include the following:

0023Food Safety and Inspection Service (FSIS)

0024Agricultural and Marketing Service (AMS)

0025Federal Grain Inspection Service (FGIS)

0026The AMS is primarily responsible for standardizing

the quality and grading of meat, poultry, dairy prod-

ucts, horticultural products, and certain other com-

modities. The grade standards established for these

commodities are published in 7CFR. The majority of

the functions of the AMS are voluntary, as are the

grade standards. Federal law does not require that a

food processor or distributor use the grade standards;

however, they are widely used in wholesale and retail

sale to enable the purchaser to select the required

grade or level of quality.

0027The Meat and Poultry Inspection regulations, es-

tablished by the FSIS and published in 9CFR, include

compositional standards and labeling requirements

for meat and poultry products. Definitions and stand-

ards of identity or composition established in 9CFR,

319 and 381 subpart P, for meat and poultry prod-

ucts, respectively, are mandatory and the producers

covered must meet the provisions laid down to be

legally manufactured and sold.

0028National Oceanic and Atmospheric Administra-

tion The National Marine Fisheries Service

(NMFS) is one of the major services administered

by the NOAA and is involved in the development of

specifications and standards for the quality, grade, and

identity for fishery products and the establishment of

grade standards for processed fishery products.

Procedure for Establishing Standards

0029The procedure for establishing a food standard, re-

ferred to in section 401 of the FFDCA, is governed by

the FDA in 21CFR. Any petition for a food standard

3498 LEGISLATION/International Standards

must show that the proposal, if adopted, would pro-

mote honesty and fair dealing in the interests of

consumers. A petition includes an application or

other document requesting the Commissioner of Food

and Drugs to establish, amend, or revoke a regulation

or order, or to take, or not, any other form of adminis-

trative action under the laws administered by the FDA.

0030 Review of Codex Standards All food standards

adopted by the Codex Alimentarius Commission are

reviewed by the FDA. These Codex standards will be

accepted without change, accepted with change, or

not accepted. This review is accomplished in one of

several ways, according to the procedures detailed

in 21CFR. The review is officially published in the

Federal Register for comments. After reviewing these

comments the FDA makes a decision on the standard.

A partial adoption of a standard makes it legally

enforceable in the USA.

0031 The FDA encourages all interested parties to confer

with different interest groups such as consumers,

industry, academia, and professional organizations

in formulating petitions or comments.

0032 Rule making Legal and scientific knowledge is used

by the FDA to formulate regulations on compos-

itional and processing requirements for food. There

is considerable interaction between the FDA and the

food industry during the establishment of regulations

and the FDA is often dependent on industry for ad-

equate scientific data on which to base regulatory

decisions. Petitions from industry may initiate regula-

tions. When federal agencies intend to issue a new

regulation, or amend an existing one, they publish a

notice of intent in the Federal Register; this stage is

often omitted by the FDA. This rule-making notice

gives the text of the proposed regulation, describes

the issues involved, and invites comment within a

specific period of time. If, after comments have been

received, the change is favorably viewed, a proposed

rule will be published, inviting comments, upon

which the final rule is judged. When the final rule is

published the background to the change and a sum-

mary of the comments is given.

Type and Scope of Standards

0033 The FDA issues three types of standards, as prescribed

by the FFDCA, namely standards of identity, quality,

and fill of container, for a number of food products.

0034 Standards of identity are the basic food standards

issued by the FDA and their purpose is to protect

consumers from being cheated by inferior products

or confused by misleading labels. These standards

establish or define the food product, e.g., by specific-

ally stating the ingredients that the food may contain.

They specify the correct name of the food and other

mandatory label information, including the type and

amount of certain vitamins that must be present in

foods labeled ‘enriched.’ Required amounts of certain

ingredients and maximum limits of others are speci-

fied. The standards are based on the assumption that

food represented as, or purported to be, a food for

which a standard of identity has been established

must comply with the specification of the standard

in every respect. However, temporary permits may be

issued for interstate shipment of experimental packs

of food varying from the requirements of definitions

and standards of identity.

0035Certain of the standards of identity are supple-

mented by standards of quality and fill of container.

Standards of quality establish specifications for qual-

ity requirements or factors for canned fruits and vege-

tables and are minimum standards. Standards of

quality must not be confused with standards for

grades that are published by the USDA for agricul-

tural products and by the NMFS for fishery products.

The standards for grades may classify the products

from average to excellent in quality.

0036Standards of fill of the container designate the

quantity in terms of solid or liquid components, or

both for products such as canned fruits and vege-

tables, and certain fish products. If a food for which

a standard of quality or fill has been established falls

below that standard, it must bear a label statement in

the prescribed size and style of type, stating that the

product is substandard.

0037Comparison of certain food standards Table 1 is

intended to illustrate some of the current differences

in composition between certain food products in

different countries. The product categories chosen

(icecream and chocolate products) have been selected

to show the contrast in these products. Similar

product designations are used, but the composition

is quite different. The tables include information

concerning the major mandatory compositional re-

quirements for the products covered; they are not

intended to cover complete compositional data for

these products.

The Future of Food Standards

The EC

0038New standards of composition in the traditional

format are no longer relevant in the legislative arena

of the twenty-first century. However, reference has

been made to EC marketing standards that have an

impact on all of the member states. The introduction

of legislation requiring the declaration of the quantity

LEGISLATION/International Standards 3499

of the characterizing ingredient(s) of foods (so-called

QUID legislation) has made compositional standards

irrelevant to a large degree; by requiring the content

of the key ingredient to be declared on a label there is

no need to set a minimum level as consumers can

make their own choice. The QUID labeling require-

ment will largely determine the future format of re-

vised legislation on meat products and spreadable fish

products in the UK. However, it is clear that the

revised EC standards on coffee, cocoa and chocolate,

preserved milks, and other named foods will be here

to stay for some time, particularly after the intensity

of debate in reaching agreement.

USA

0039In October 1995, the FDA published its policy on

the development and use of standards with res-

pect to international harmonization of regulatory

tbl0001 Table 1 Comparison of certain UK and USA standardized foods

UK USA

Icecream Minimum 5% fat, minimum 2.5% milk protein Minimum 1.6 lb total solids/gallon, weighs not less

than 4.5 lb to the gallon

Minimum 5% milk fat for ‘dairy icecream’ Minimum 10% milk fat (milk solids, not fat content,

may vary depending on the milk fat content)

Food Labelling Regulations 1996, as amended Title 21 CFR Part 135.110

Milk fat only in dairy icecream, other than that

present as a result of using egg, flavoring,

emulsifier, stabilizer, or vegetable fat in nondairy

icecream

Milk-derived fats only, except those natural

components of flavoring or incidental ingredients

Chocolate (EC)

Sweet chocolate (USA)

Minimum 35% total dry cocoa solids, including

minimum 14% dry nonfat cocoa solids and

minimum 18% cocoa butter

Minimum 15% chocolate liquor, less than 12% milk

solids

EC Directive 73/241/EEC, as amended Title 21 CFR Part 163

CFR, Code of Federal Regulations.

UN Headquarters

World Food Program

UN Development

Program

Autonomous

organizations

Convention

secretariat

Interagency

coordination

mechanisms

Programs

Funds

UN programs

UN system

Specialized

agencies

Codex Alimentarius

Commission

SPS Agreement

TBT Agreement

Offices

FAO

WHO

WTO

Reference

standards

fig0001 Figure 1 United Nations system of organizations. FAO, Food and Agriculture Organization; WHO, World Health Organization;

WTO, World Trade Organization; SPS, Sanitary and Phytosanitary Measures; TBT, Technical Barriers to Trade.

3500 LEGISLATION/International Standards

requirements and guidelines. The FDA established

that its main goals in standard-setting activities is to

preserve and to enhance its public health mission,

increase its efforts in harmonizing regulatory require-

ments with foreign governments, including setting

new standards that better serve public health, and

respond to laws and policies that encourage agencies

to use international standards that provide the desired

degree of protection.

0040 The FDA policy lays down the criteria it uses for

participating in standards development. For example,

the expected standard would be required to stress

product safety and effectiveness, thereby contributing

to safe, effective, and high-quality products.

Codex Standards

0041 In 1995, two agreements of the World Trade Organ-

ization gave a new significance to the work of the

Codex Alimentarius Commission (CAC). These were

the Agreement on the Application of the Sanitary and

Phytosanitary Measures (SPS) and the Agreement on

Technical Barriers to Trade (TBT). Both agreements

formally recognized that international standards,

guidelines, and recommendations, including the

Codex Alimentarius, are reference points that can be

used to facilitate international trade and resolve trade

disputes in international law. The SPS agreement goes

a step further and specifically identifies Codex texts

as scientifically recognized and as a means of harmon-

ization.

0042 The adoption of Codex texts as scientifically justi-

fied standards for the SPS and TBT agreements is of

immense significance (Figure 1). Codex texts are now

an integral part of the legal framework within which

international trade is being facilitated through har-

monization. They can be used as benchmarks in inter-

national trade disputes and to evaluate the relevance

of national measures. This formal recognition has

awakened considerable interest in CAC activities

and attendance at Codex meetings has increased

markedly in recent years.

0043 Until now, the individual commodity standards,

which dealt with the quality aspects of foodstuffs,

were the most important part of the Codex Commit-

tee’s work. However, interest in these recipe stand-

ards is shifting to a more horizontal approach. It

can already be seen that work from the so-called

horizontal committees, such as labeling and additives,

are attracting more interest and gaining in import-

ance and profile. Moreover, topical issues, such as

those concerning the use of biotechnology, are at-

tracting the interest of both consumer groups and

the food industry. The CAC is already examining

consumer protection against health hazards and

food safety in this key area. These provide an insight

into the direction that the CAC activities are likely to

take in the future.

0044Codex texts have formed the basis for food stand-

ards legislation in certain countries, for example the

Middle Eastern countries. They have often been used

as a guide in many other countries throughout the

world. This role is still significant and, in the light

of the SPS and TBT agreements, is likely to increase

further as Codex texts are used as reference in inter-

national trade disputes.

See also: European Union: European Food Law

Harmonization; Legislation: History; Additives;

Contaminants and Adulterants; Codex; World Health

Organization; World Trade Organization