Frame work of food labeling legislation
Food labeling is defined in Food labeling Directive as 'any words, particulars. trade marks, brand
name, pictorial matter or symbol relating to foodstuff and placed on any packaging, document,
notice, label, ring or collar accompanying or referring to such foodstuff'.
Anything stated on a food label is a trade description and must be correct.
In practice most of serious labeling irregularities relate to misdescribed or adulterated food
stuffs.
Marketing environment - or 'not me first' syndrome
Food industry is competitive with low margins and the emergence of large multiple retailers has
also a dramatic impact.
As the quality is concerned, there are enormous pressure on manufacturers to produce and sell
their goods at the most competitive price.
Even when companies accept that there is some merit to the challenge to the label by an
enforcement authority, they are still reluctant to correct matters on the basis that their
competitors could be left in a more advantageous position.
In other words they would be more than happy to comply with the law as long as they did not
have to do it first.
The marketing environment and 'not me first' syndrome is therefore a major constraint to
resolving problems associated with incorrect product labeling.
Modern technology - 'if you can't beat them, join them'
Intense competition in market places additional pressures on food manufacturers to reduce their
unit costs.
Sometimes the use of modern technology can result in a change to the nature and characteristics
of the product.
Dehydrated rind - Absorbs 4 times its weight of water... to replace 5 lbs of meat add 1 lbs of
............ and 4 lbs of water.
Textured Soy Protein - ... has the appearance and mouth feel of meat, and can be used to extend
meat products by up to 25%.
Cheese substitute - 'As a complete or partial replacement for natural cheese for money saving
ways. Smooth texture and wholesome food value of natural food for up to 35% less cost'.
Ice cream mix - 'use less powder to make more ice cream'.
Unless careful consideration is given to corresponding changes to the label, to reflect the way in
which the product has been changed, their undeclared use can amount to product debasement or
adulteration.
There are many who would prefer to produce their products without using a particular ingredient
or process which is said to 'add value' to the product in question.
However, many companies have often adopted the technological innovation on the basis that 'if
you can't beat them, join them!'
There are also financial implications. One company was challenged for failing to declare the
presence of TSP in meat products. To replace the meat, cost over £1 million. The company took
commercial decision to continue using TSP and made an appropriate change to the label!
Ambiguous legislation - the name of the food
Good Food manufacturers, do not aim deliberately to disobey the law, are especially law abiding
when legislative requirements are clear, straightforward and unambiguous.
For example: the law requirement to detail the name and address on pre-packed product leaves
little or no room for misinterpretation. Result is 100% compliance.
To label food with "a name which indicates its true nature and which enables it to be
distinguished from products with which it could be confused".
This is seemingly straightforward requirement but, it is quite clear that one person's version of
name which indicate true nature, is another person's false trade description.
Conflicting interpretations between food manufacturers and enforcement authorities may be in
the following cases:
- undeclared added water in meat and fish.
- undeclared cheese substitutes in cheese products.
- undeclared fish mince in fish products
Health claims - substantiation
There are major constraints on enforcement authorities attempting to prove that a particular
claim is not substantiated (proved).
Reputable manufacturer would benefit from a more effective enforcement regime which
prevented unsubstantiated claims and therefore unfair competition.
--------------------------------------------------Labeling requirements in European Union
17-4-15
The organization of EU legislation
The collection of rules which make up EU's food labeling legislation can be organized as
follows.
a. the main food labeling Directive, 79/112/EEC, and its amendments and associated subsidiary
Directives (now consolidated into 2000/13/EC);
b. labeling rules in other horizontal food Directives or regulations, currently covering nutrition
labeling and novel foods;
c. labeling rules adopted as components of Common Agricultural Policy management regimes
for basic agricultural products. e.g. for eggs, apples, beef and wine, and certain processed foods.
d. miscellaneous rules which establish schemes for food producers and suppliers to register their
labels, so that they will be recognized throughout EU.
e. disciplines on national labeling rule-making so that they do not conflict with the overriding EU
principles of non-discrimination between Member States and fair trade.
The EU rules often do not fit easily with existing rules or with the key principles.
For example: to inform purchaser of the use of artificial sweeteners not only in ingredients list
but also in legal name of food. There is no safety reason for this, and no requirement to treat
other additives similarly.
Other example: a special declaration on label when packaging gases are used in containers.
The gases are used to extend the shelf life of products. There is no safety concern about the use
of gases and meaning of declaration for the vast number of purchaser is obscure.
EU legislation and Codex standards
With some exceptions EU food labeling rules does not differ markedly from the standards and
guidelines of Codex Alimentarius.
Codex has commanded the consensus of countries which have participated and negotiated in
regular meetings of Codex Committees.
However, there is further need to strengthen the international consensus.
The main requirements for pre-packed foods
It applies to all foodstuffs delivered to the consumer, whether at the retail stage or in catering
establishments.
It imposes two general rules: that labeling, presentation and advertising should not mislead the
purchaser, with some helpful elaboration on how that might occur;
nor should they carry any medicinal claim about a food stuff, i.e. a statement that has property of
preventing, treating or curing a human disease or a statement with any reference to such
properties.
The Directive lays down the following categories of information which must appear on labeling.
- The name of food.
- The list of ingredients.
- The quantitative declaration of ingredients.
- Net quantity.
- Minimum durability.
- Any special storage conditions or conditions of use.
- Name and address of manufacturer, packager or seller.
- Place of origin, if omission of such information would mislead.
- Any necessary instructions for use.
- Alcoholic strength by volume for beverages containing more than 1.2% by volume.
The name of food
If name of a food is laid down in EU legislation, it must be used.
Failing that, the name prescribed in Member State where the product is marketed must be
followed.
If there is none, the supplier must use either a customary name or a description of foodstuff
which is clear enough to convey the purchaser its true nature.
The legal name in the Member State where food is produced is given equal status to legal name
of that food in Member State where it is marketed.
Legal name cannot be the brand or fancy name or trade mark used on the label.
If food has been treated or physical condition has been changed, e.g. dried, concentrated or
frozen, this must be indicated in the legal name.
- The list of ingredients
Ingredients be listed in descending order of weight.
Ingredient is any substance which is used in the manufacture or preparation of food and is still
present in finished product. It includes additives but not those which are used as processing aids,
solvents or media for other additives or flavorings nor those which may be present in the final
product but serve no technological function in it.
- The quantitative declaration of ingredients
All ingredients which appear in legal name, or are usually associated with food, or which are
emphasized on label, or which are essential to characterize a food and to distinguish it from
products with which it might be confused, should be quantified.
Exemptions apply to foods already covered by quantitative information requirements in other EU
legislation and remove the obligation to quantify for ingredients used in small quantities for the
purpose of flavouring.
The quantity must be shown in percentage; it must relate to preparation of food, not finished
product.
- Net quantity
The rule on net quantity applies only to pre-packed foods and establishes the principle that net
quantity must be expressed in metric units of volume (for liquids) or mass (for other products),
unless EU or national provisions lay down that some other type of quantity is required.
Directives: 'nominal wt' or 'nominal vol' must be shown on package, that contents must on
average not be less than the nominal quantity and a small 'e' must be placed in same field of
view as a guarantee that information meets the requirements of directives.
For solid foodstuffs sold in liquid media the drained weight must also be show.
- Minimum durability: defined as the date until which foodstuff retains its specific properties
when properly stored.
It must be indicated by the use of words 'best before' and the date itself.
Foodstuffs which are microbiologically highly perishable must carry a 'use by' in place of 'best
before' indication.
- Amendments
The words 'packaged in a protective atmosphere' should appear on the labels of foodstuff whose
shelf life has been extended by means of packaging gases.
The mention of sweeteners both in the ingredients list and in the name of food.
Volatile ingredients must be indicated on the basis of their proportion by weight in the final
product, and concentrated or dehydrated ingredients may be indicated in their whole form if that
is how they are consumed.
Generally applicable food labeling requirements is very similar to General Standard on Labeling
of Pre-packed Food of Codex Alimentarius.
The most important difference is that Codex Standard does not include mandatory requirements
for quantitative declaration of ingredients.
Nevertheless, there is no reason why Codex should not adopt these requirements.
They confirm to the internationally accepted principles of informing the consumer about the
nature of food as purchased and enhancing equal conditions of competition between food
suppliers.
Quantitative declaration of ingredients is an important additional information to compare
competing products which may appear similar.
Nutritional labeling and claims
Nutrition labeling means any information on the label which refers to energy value of food or to
protein, carbohydrate, fat, fiber, sodium or to other minerals or vitamins.
Nutrition claim is defined as any representation and any advertising message which states,
suggests or implies that a food stuff has particular nutrition properties relating to energy value or
to its nutrients.
If information about mono-unsaturates, poly-unsaturates and/or cholesterol is given, then amount
of saturates must also be specified.
If a claim about trans-fatty acids is made, the quantity must be shown in the nutrition labeling
format used; if no claim is made, strictly speaking no information about trans-fatty acids can be
given.
Specific labeling requirements in food composition Directives
Nine food sectors are covered: cocoa and chocolate products, coffee extracts and chicory
extracts, certain preserved milks, fruit juices and similar products, honey, certain sugars, jam,
caseins and erucic acid.
Depending on the product, descriptions or types of information are made compulsory. For
example, some chocolate product labels must carry the total dry cocoa content; if coffee has been
decaffeinated that must be shown; preserved milk must show percentage of milk fat.
National rules on addition of vitamins to preserved milks and fruit juices are permitted.
Specific labeling requirements in CAP marketing regulations
CAP (Common Agricultural Policy) marketing regulations which contain labeling provisions of
direct interest to consumers deal with eggs, poultry, fruit and vegetables, olive oil, beef, milk and
milk products and spreadable fats; and also with wines and some spirit drinks (because of the use
of agricultural produce, namely grapes and cereals, in their production).
The preambles of the regulations generally state that the aims are to promote the stability of the
agricultural market, safeguard the interests of producers and help consumers identify and
distinguish foods which may be confused or foods which may differ in quality.
The regulations require that labels should indicate the quality class.
Poultry meat from countries outside the EU must show its origin.
Regulation defines milk and milk products (whey, cream, butter, butter milk, butter oil, cheese,
yoghurt, and some others), reserves the names and prohibits the application or use of related
terms, such as 'dairy' to other products.
Some of reserved names have traditionally been used for completely different foods. e.g. cream
of cracker, coconut milk, cream of tomato soup - exemptions for the use of reserved names.
Novel foods and genetically modified foods: labeling rules
The supplier of Novel foods are required to include additional information in addition to the
information required by existing EU labeling rules.
- the presence of genetically modified organism.
- the presence of material in a novel food which is not present in an existing equivalent food and
which gives rise to ethical concerns.
- the presence of material in a novel food which is not present in existing equivalent food which
may affect the health of certain sections of population.
- a characteristic or property of food, such as composition, nutritional value or effect or intended
use, which renders it no longer equivalent to an existing food.
---------------------------------------------Labeling requirements in United States
24-4-15
Introduction
The guiding principles of laws and implementing regulations for food labeling in US are fostered
by both economic and public health concerns.
These concerns include the need to provide adequate information to:
- assure informed choice by consumers,
- create an awareness of actions necessary to assure food safety and wholesomeness,
- to promote honesty and fair trade dealing in the market place.
There are eight major laws that provide the authority to regulating agencies to implement and
enforce food-labeling requirements in US.
Federal Food, Drug and Cosmetic Act is the main law governing food labeling in US because it
applies to all foods except meat from domesticated animals, poultry and poultry products derived
from domesticated birds and alcoholic beverages.
Food and Drug Administration (FDA) administers this act.
Legislation and rule-making
All three branches of US government (legislative, executive and judicial) have a role in
establishing food labeling requirement.
Congress passes law that establish general requirements and provide authority to regulating
agencies to implement and enforce specific labeling requirements.
Once the President (executive branch) signs legislation, it becomes an official statute and is
published in United States Code (USC).
All regulations promulgated by executive branch of government must go through a public rulemaking process.
This procedure is initiated by publishing a proposal in Federal Register (FR).
FR process allows all affected citizens and organizations to comment on the provisions of the
proposed regulation, and gives the agency a chance to respond.
The regulation has the force and effect of law, unless reinterpreted by the courts (the third part of
US legislature).
The FR provides in a preamble to a proposed regulation a discussion why a regulation is being
proposed and the science base for the requirement.
Preamble for a final regulation contains cost/benefit analysis, potential environmental impacts
and an analysis of paperwork required for the public as result of regulation.
The preambles provide the public with valuable information on the agency's intent and how it
will implement the regulation.
The role of US Federal Court in the rule-making process is to resolve disputes on
appropriateness of the regulation.
In order to challenge a regulation in court, the affected party must be able to prove actual harm
has occurred or likely will occur.
The Courts have the final say as to what a law means unless Congress disagrees with the Court's
interpretation and passes a new law. The regulation agencies must follow the decisions of Courts
and Congress.
Main enforcement agencies
In US, enforcement of food labeling laws and implementing regulations is a shared responsibility
among several federal and state agencies.
For the most part each federal agency has specific responsibilities assigned by law.
However, in some cases there are overlapping responsibilities. In case where overlapping occur,
federal agencies have established a Memorandum of Understanding which establishes a lead
agency for enforcement.
Regulations on product name
In US packaged foods must bear a statement of identity on the principal display panel (PDP) of
the label.
PDP is part of label that is most likely to be displayed to consumer; generally it is front of
package.
Name specified by federal law or regulation - in the absence, a designated mandatory name,
common or usual name - in the absence, an appropriately descriptive term or fanciful name
commonly used by public may be used.
Under several conditions include descriptive terms like with or without salt, whole or in pieces.
Special requirements in naming of a food apply when food is an imitation of another food, or
food contain one or more ingredients, the quality of which has an impact on value of food. If
food resembles and substitute for anther food and is considered to be nutritionally inferior to
rational food, the word 'imitation' must modify the name of food.
A food is nutritionally inferior if it contains a lower level of an essential nutrient that is present in
rational food in a measurable amount.
Exceptions are made for reduction of calorie or fat content and for nutrients selenium,
molybdenum, chromium and chloride.
Measurable amount is defined as 2% or more of daily intake values established for nutrition
labeling.
If value of product is dependent on the level of characterizing ingredient (s). Example:
percentage of peanuts (considered a lower price item) in mixed nuts must be indicated.
Ingredients
Ingredients of prepackaged foods sold in interstate commerce in US must be declared in
descending order by wt on either principal display panel or information panel of product label.
There are few exemptions to this requirement and they are for ingredients present only at very
low levels in food.
Incidental additives are exempt from ingredient declaration.
Incidental additives are present in foods in insignificant amounts and do not have any technical
or financial effect in food being labeled. These include:
- substances which have been added to an ingredient of food but have no function in final food.
- substances which have been added to a food during processing but then removed in some
manner before being packaged (processing aid).
- substances which are added to the food during processing, but are converted to constituents
normally found in food.
- substances added to a food for some technical or functional reason but which only constitute an
insignificant level in the product and serve no technical or functional effect after processing.
- substances migrating into foods from processing equipment or packaging.
All ingredients must be designated by a specific name and not a collective or generic name
except for labeling spices, flavoring and colorings.
Ingredients which are composed of 2 or more ingredients (compound ingredients), there is
special provisions for labeling.
If a food, except for butter, cheese and ice cream, contains artificial flavoring, artificial coloring
or chemical preservative, it must bear labeling stating that fact. It may be mentioned in
ingredients list, a separate statement is not required.
Responsible agent for product
Name and place of business of US manufacturer, packer or distributer.
'Distributed by' or 'manufactured for' must accompany the name and address of responsible
agent.
Address on all product labels designated for consumers must include street address, city, state
and US zip code.
Net content labeling
All prepackaged foods offered for sale in US must bear a statement of net quantity.
This statement should appear on PDP, if more than one PDP exist, the statement must appear on
both.
Weight, measure, numerical count or combination of numerical count and wt or measure......
Separate declaration of net quantity of contents in terms other than those provided are prohibited
on PDP. However, such declaration can appear elsewhere on package provided it is not
misleading.
Nutrition facts
The US laws and regulations intend that all food products for human consumption bear
information related to that food.
Nutrition labeling information is presented in amounts relative to a serving of food as defined by
regulation.
The term 'serving' or serving size' is defined as an amount of food that is customarily consumed
per eating occasion by persons four years of age and older and is expressed in a common
household measure that is appropriate for food.
The nutrient labeling information, both mandatory and voluntary, is required to be presented in
prescribed format.
Country of origin
English name of the country of origin.
The product was imported from...............and packed in US.
When imported product is co-mingled with one or more products from another country (s), then
label must indicate all countries of origin.
Nutrient content claims
US permits the use of nutrient content claim (s) on a food label provided such a claim is
permitted by an implementing regulation.
A nutrient content claim is defined as any direct or implied statement that characterizes the level
of a nutrient in a food.
Regulations on nutrient content claims do not apply to infant formulas and medical foods.
When a nutrient content claim is made, if food contains a nutrient at a level that may increase
risk of disease or health-related condition, food must bear a statement calling the consumer's
attention to the nutrient label and the amount of that nutrient.
FDA has determined that four nutrients: total fat, saturated fat, cholesterol and sodium fall into
the category of possibly increasing risk of disease and has set the levels (Table3.1).
Nutrient
Fat (g)
Saturated fat (g)
Cholesterol (mg)
Sodium (mg)
Individual food
13
4
60
480
Main dishes
19.5
6
90
720
Meals
26
8
120
960
Approved nutrient content claims fall into several categories.
Definitions have been established for claims using the adjectives 'free', 'low', and 'reduced' or
'less' for nutrient's calories, fat, saturated fat, cholesterol, sodium and sugars (except low sugar).
The use of descriptors 'light' or 'lite', 'reduced', 'added' (fortified or enriched) and 'more' and 'less'
when used in comparative nutrient content claims has also been defined.
'Lean' and 'extra lean' for meat with lower fat content.......
'High potency', 'high' (rich in or excellent source of), 'good source' (contains or provides); 'more',
'added'; 'extra' or 'plus', to describe vitamin and mineral content.
Health claims
US laws permit the use of health claims (risk reduction claims) on the label or in labeling of
foods.
A health claim is officially defined as a statement or any implication conveyed by references,
symbols or vignettes which characterizes the relationship of any component of food, including
vitamins, minerals, herbs or other similar nutritional substances.
All health claims must be authorized by FDA.
A health claim can be authorized by regulation as a result of finding by FDA that there is
significant scientific agreement that the claim is valid.
A health claim can also be authorized by statute based on an authoritative statement of certain
scientific entities.
No need of regulation authorization the claim under this procedure.
Food must contain the substance in the amount specified in authorization document.
In addition food must meet following conditions to be eligible for use of an authorized health
claim:
i. product can not contain amounts of four nutrients (fat, saturated fat, cholesterol and sodium)
greater than those shown in Table 1.
ii. the product must provide at least 10% of the Reference/Recommended Dietary Intake (RDI)
or Daily Reference Value (DRV) of protein, fiber, vitamin A, vitamin C, calcium or iron.
For health claim on the basis of authoritative statement, the manufacturer must notify FDA that it
intends to use the particular claim.
The wording of claim on the label is restricted to the wording in the submission to the FDA.
Twelve health claims authorized through authoritative statement/ notification procedure are
given in Table 3.2 (Health claim chart - authorized claims.
Details of regulations by competent authorities
There is uniformity in required labeling of foods regulated by both FDA and Food Safety and
Inspection Services (FSIS) who jointly regulate virtually all foods sold in US.
Although each agency requires cautionary statement on some foods, FSIS cautionary statement
concerning the potential presence of harmful bacteria required on all raw meats is a significant
exception.
Other warning and cautionary statements relate to the presence of additives, are required by both
FDA and FSIS regulated foods.
FSIS does not have regulations on health claims, it has allowed meat and poultry to bear such
claims consistent with FDA regulations.
FDA has published regulations which permit structure function claims for dietary supplement
products without FDA review and approval. When such claims are used there must be disclaimer
indicating that US government has not reviewed or approved the claims.
---------------------------------------------Ch 12. Special issues in food labeling (Food Labeling by J.R. Blanchfield):29-4-15
2 lec
-------------------------------------------------Ch 15. The role of traceability in food labeling: (Food Labeling by J.R. Blanchfield):
Lec 3
Lec 4 Ch 21. page 459. Food traceability: overview, systems, laws, standards, guidelines,
important considerations; Food traceability systems: scope, fundamentals; Food identification
and linkage: principles, rules, organizing the flows of materials and information; Recording and
storing information; Verifying the traceability system; Transmitting and disclosing information;
Introducing a food traceability system: stages, preparing the system, clarifying roles and
responsibilities, drafting a plan for implementation, cooperation and coordination among
operators;
----------------------------------------------Writing a traceability procedural manual, establishing a schedule for introduction of the system,
training of relevant personnel; Important considerations in the creation of the electronic
information systems and after its introduction; Methods for authentication and traceability.
Practicals
Traceability in different food products through modern analytical techniques: PCR, DNA methods,
Enzyme immunoassays