Food Labeling as a market access tool

Food labelling as
a market access
tool:
Methodology

Daniele Pisanello
-Food Lawyer-

Parma, 5 luglio 2012

www.lexalimentaria.eu
www.lexalimentraia.eu

Few words about the Speaker

Daniele Pisanello is a 10-year experienced food lawyer
Current position
• Founder and owner of LEX ALIMENTARIA STUDIO LEGALE
(www.lexalimentaria.eu, offices in Bologna and Lecce; desks in Istanbul,
Turkey, and Jakarta, Indonesia)
• Board Member at Food Ingredient and Health Research Institute
(FIHRI), a no profit US organization involved in food safety and risk
communication
• Author for ItaliaOggi and EU Food Law Weekly
• Lecturer at: University of Bari – Veterinary Faculty and School of Law
Our Legal Services:
• Marketing standards for foodstuffs
• Food regulatory compliance
• Labelling and consumer Protection
• Sanctions and Orders by Official Controls
• Contracts and Liabilities
• Administrative and Trade Law
2 Avv. Daniele Pisanello

1 Food Labelling Regulations: an international outlook

2 Major recent changes in FLRs

3 A compliance-oriented approach

4 Enforcing guidelines - Country reports


Food labelling: an introduction

Accordingly to Codex Alimentarius’ Standard “Labelling of Prepackaged Foods”
(CODEX STAN 1-1985)

“Label” means any tag, brand, mark, pictorial or other descriptive matter,
written, printed, stencilled, marked, embossed or impressed on, or attached
to, a container of food.

“Labelling” includes any written, printed or graphic matter that is present on
the label, accompanies the food, or is displayed near the food, including that
for the purpose of promoting its sale or disposal.


Food labelling regulation (FLR) is designed to protect the economic
expectations of both consumers and the food industry

Since compliance with food labelling requirements is necessary to market
the product, FLRs have a straight impact on international trade and they may
pose obstacles to international trade;

Within the World Trade Organization (WTO), traditional trade barriers such
as tariffs are steadily being reduced, while food safety standards, regulations
related to traceability, product certification, environmental standards and
other regulations are increasing in scope and significance as international
trade in food opens up.
International Rules on Trade in Foods
Some highlights on major changes in FLRs


International Rules on Trade in Foods

WTO Agreements affecting Trade in Commodities and Processed Foods

GATT (General Agreement on Tariffs and Trade)
Agreement on Agriculture
Agreement on Sanitary and Phytosanitary Measures
Agreement on Technical Barriers to Trade


The Agreement on Sanitary and Phytosanitary Measures

The two-fold objective of the SPS Agreement is:

To recognize the sovereign right of WTO Members to provide the level of
health protection they deem appropriate; and

To ensure that SPS measures do not represent unnecessary, arbitrary,
scientifically unjustifiable, or disguised restrictions on international trade.


The Agreement on Sanitary and Phytosanitary Measures (cont.)

The scope of application of the Agreement (Article 1.1):

It applies to all sanitary and phytosanitary measures which may, directly or
indirectly, affect international trade;

Such measures shall be developed and applied in accordance with the
provisions of this Agreement (if they are not, a complaint can be field through
the Dispute Settlement Mechanism under the WTO Framework).



To fall under SPS Agreement’s provisions, a measure must:

Have the subjective intent to protect human, animal or plant life or health;
Aim to protect against either food-borne risks or against pest or disease
related risks;
“Directly or indirectly affect international trade.”

A non-exhaustive list of SPS measures is provided in Annex A of the SPS Agreement:
Additives in food or drink;
Contaminants in food or drink;
Certification: food safety, animal or plant health;
Processing methods with implications for food safety;
Other sanitary requirements for imports;
Labeling requirements directly related to food safety and others.



Basic Rights and Obligations:

WTO Members have the right to adopt appropriate SPS measures that they
consider necessary to protect health, provided that they are consistent with
the provisions of the SPS Agreement.

Standard based on Science:

Although WTO Members do have a certain degree of flexibility with regard to
SPS measures, Article 2 of the SPS Agreement provides that measures not
based on scientific principles are not valid within the terms of the agreement.



The SPS Agreement recognises three international standard-setting bodies:

CODEX ALIMENTARIUS COMMISSION

INTERNATIONAL OFFICE OF THE EPIZOOTICS

SECRETARIAT OF THE INTERNATIONAL PLANT PROTECTION CONVENTION


Codex and Labelling Regulations

General Guidelines on Claims (CAC/GL 1-1979 , rev. 1991)
Guidelines on Nutrition Labelling (CAC/GL 2-1985 , rev. 2011)
Guidelines for the Production, Processing, Labelling and Marketing of Organically
Produced Foods (CAC/GL 32-1999, rev. 2010)
General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985 , rev.
2010)
General Standard for the Labelling of Food Additives when sold as such (CODEX STAN
107-1981, rev. 1981)
General Standard for the Labelling of and Claims for Prepackaged Foods for Special
Dietary Uses (CODEX STAN 146-1985, rev. 1985)
Standard for Labelling of and Claims for Foods for Special Medical Purposes (CODEX
STAN 180-1991, rev. 1991)


The WTO Agreement on Technical Barriers to Trade

The WTO Agreement on Technical Barriers to Trade

General Objective of the TBT Agreement

The right of WTO Members to adopt Technical
Recognizes Regulations, Standards and Conformity
Assessment Procedures

But, at the Ensures that such measures do not create
same time unnecessary obstacles to trade


What a TBT measure deal with?

TBT measures typically deal with:

Labeling of composition or quality of food, drink and drugs;
Quality requirements for fresh food;
Volume, shape and appearance of packaging;
Testing vehicles and accessories;
Regulations for ships and ship equipment;
Safety regulations for toys and others.


Objectives of TBT Agreement

The WTO Agreement on Technical Barriers to Trade (TBT) seeks to assure that:

mandatory product regulations,
voluntary product standards, and
conformity assessment procedures (procedures designed to test a product’s
conformity with mandatory regulations or voluntary standards)

do not become unnecessary obstacles to international trade and are not employed to
obstruct trade.


Technical Regulation

Technical Regulation:

“Document which lays down product characteristics or their related processes
and production methods, including the applicable administrative provisions,
with which compliance is mandatory.
It may also include or deal exclusively with terminology, symbols, packaging,
marking or labelling requirements as they apply to a product, process or
production method.”
• Examples of technical regulations:
a) A law stating that all product packaging must be recyclable
b) A law stating that only refrigerators that are one meter high can be
sold in State X
c) A regulation establishing compulsory particulars for food labelling


Standards and Conformity Assessment
Standard:

Document approved by a recognized body, that provides, for common and
repeated use, rules, guidelines or characteristics for products or related
processes and production methods, with which compliance is not mandatory.
It may also include or deal exclusively with terminology, symbols, packaging,
marking or labelling requirements as they apply to a product, process or
production method.
• Examples of Standards:
a) A guideline defining what products can display a “recyclable symbol” is
a standard (provided that products that do not bear the symbol may
still be sold).
b) A government guideline saying that all eggs weighing 62 grams or more
are entitled to be labelled “Grade A” is a standard (provided that eggs
weighing less may still be sold).

Conformity Assessment Procedure:
“Any procedure used, directly or indirectly, to determine that relevant
requirements in technical regulations or standards are fulfilled.”

Private standards

Private standards: role and differences in respects to mandatory
requirements:

Requirements of private standards are often stricter than the law (for example,
in terms of MRLs)
Compliance with private standards is not required by law but by private
contracts with, for example, retailers
Third country suppliers often think they are mandatory by law

Examples for widely accepted standards in the European market
British Retailer Consortium BRC, EUREPGAP


Private Standards and WTO law

The taking up of consumer concerns about animal welfare, environmental,
occupational health and safety and consumer safety aspects of foods, for
example, in private voluntary standards is a phenomenon that largely post-
dates the negotiation of the SPS and TBT Agreements.

The possible application of the SPS Agreement to the development of
private voluntary standards or conformity assessment against such
standards was never anticipated.

The TBT Agreement, on the other hand, deals not only with the
development and implementation (including “conformity
assessment”) of mandatory technical regulations by governments but
also, explicitly, with private activities to develop and adopt standards
and to conduct conformity assessment.


At the national level there is no apparent legal impediment to prevent buyers from
defining and applying specific technical requirements to the products that they
purchase; and in the case of food wholesalers and retailers there are many good
reasons why the application of such requirements is justified in order to manage
business risks
While private voluntary standards may in many instances provide a stimulus to
improved production practices and performance in exporting countries, and
potentially give a competitive advantage to complying producers, they may also act
as significant barriers to market access for some industries in some countries –
especially least developed countries. There may also be a proportionately greater
disadvantage to smaller-scale producers
These barriers to trade are associated with a number of factors including up-front
capital costs, initial and on-going costs of third-party certification, higher operating
costs for producers, and reduced profit margins.


Notwithstanding that the TBT Agreement specifically addresses private standard-
setting and conformity assessment activities, there remain difficulties in the path of
its effective application in this sphere.
Members are obliged to take such reasonable measures as may be available to
them to ensure compliance by non-governmental organisations with the
provisions of Article 2 of the Agreement, but there is again the issue of the
scope of “ reasonable measures”.
Many developing countries believe that eco-labelling requirements that relate
to matters other than attributes incorporated into products (e.g. pesticide
residues) are proscribed under WTO rules; other Members do not agree.
Lack of significant case law prevent the understanding of the applicability of
the TBT Agreement to voluntary standards that are not product-related.


2 Major recent changes in FLRs


Changing Patterns in the field of FLRs in a Year and half

Within 1/1/2011 to 1/06/2012 , 158 TBT measures have been notified as regards
processed foods
Czech Ukraine: 1
EC: 6 Republic: 1 South Korea: 6

Canada: 1 Japan: 3
Kuwait: 40 Chinese
US: 3 Tapei: 4

Mexico: 40 Indonesia: 4
Guatemala: 4
Kenya: 3

El Salvador: 7

Costa Rica: 3 Brasil: 1 UAE: 15
Bahrain: 29
Chile: 15 South Africa: 10 Qatar: 3
Oman: 7 Australia: 1
Paraguay: 2 Saudi Arabia: 1

Rapid Changes in FLRs around the world: issues from
the last 12 months
ISRAEL.: proposal KUWAIT: mandatory
CZECH REP.: additional requirements for new labelling standard specifies
for the labelling of milled cereal requirements for requirements for low
products, pasta, bakery products and honey starch macaroni for
confectionery products, and doughs special dietary uses
intended for the final consumer.

JAPAN: revisions to
the "Labelling
Standard for Liquors
Made from Organic
Agricultural Products
and Others"
COLOMBIA:
Technical
Regulation FOR
foods
containing CHINA: technical and
trans and/or labelling requirements
saturated fats" for distilled spirits and
their integrated alcoholic
CHILE: optimize beverages
the Nutritional SOUTH AFRICA: INDONESIA:
Labelling of Regulations relating to Guidelines for The
Food; the use of Sweeteners Inclusion of Nutrition
in Foodstuffs and Facts on Food Label
related matters 24 Avv. Daniele Pisanello

Different FLRs: the trans fatty acids case

Trans fatty acids are substances posing growing health concerns as they increase risk of
coronary heart disease.
Several countries and regions in North America, South America, and Asia have
established mandatory transfatty acid labelling as one of the nutrients in the
nutrition labelling regulations.
Some other National Authority addressed specific guidelines as regards daily
intake or national labelling scheme to be adopted on a voluntary basis (Japan)
Developing labelling systems of transfatty acids is a top priority in several countries.


Nutrition Declaration and trans fatty acids: strong
CANADA
As of December eterogenity SOUTH KOREA
2005, nutrition As of 2006, JAPAN
SWITZERLAND UE
labelling including nutrition labelling is Nutrition labelling is
As of April 2008, Up to 13 December
transfatty acids is mandatory. voluntary
transfatty acids in 2016 Nutrition
mandatory. As of December
oils and fats must labelling is not
mandatory 2007, transfatty
not exceed 2% of acid labelling is TAIWAN
oil or fat. mandatory. As of 2002,
nutrition labelling is
US mandatory.
As of 1994, nutrition As of
labelling is January2008,
mandatory. transfatty acid
As of January 2006, CUBA labelling is
trans fatty acid nutrition
mandatory.
labelling is labelling
mandatory. mandatory ISRAEL HONG KONG
Transfatty acid nutrition As of July 2010,
labelling is labelling nutrition labelling
PARAGUAY voluntary mandatory, including transfatty
As of August 2006, BRAZIL Transfatty acid acids is mandatory.
nutrition labelling As of 2001, labelling is
including transfatty nutrition voluntary MALAYSIA CHINA
acids is mandatory. labelling is
nutrition nutrition labelling
mandatory.
CHILE labelling mandatory, Transfatty
As of August
As of November 2006, mandatory, acid labelling is
2006,transfatty INDIA
nutrition labelling Transfatty acid mandatory on January
acid labelling nutrition
including transfatty labelling is 1, 2013
is mandatory. labelling
acids is mandatory voluntary
URUGUAY mandatory,
ARGENTINA AUSTRALIA NEW ZELAND
As of August 2006, Transfatty acid
As of August 2006, nutrition labelling nutrition labelling
nutrition labelling labelling is
nutrition labelling mandatory, Transfatty mandatory, Transfatty
including transfatty voluntary
including transfatty acids acid labelling is acid labelling is
acids is mandatory voluntary voluntary
is mandatory
Based upon Japanese Consumer Affairs Agency, Regulatory trends of Nutrition labelling and transfatty Avv. Daniele Pisanello
26
acid labelling October, 2010, up-to-dated by D.Pisanello

Trans Fatty Acids in European Countries

AUSTRIA (2009)
Regulation of the Federal
DENMARK (2002) Minister of Health on the trans
Order on the content of fatty acid content of foodstuffs
trans fatty acids in oils and (Trans Fatty Acids Regulation)
fats etc. (Bekendtgørelse
om indhold af The Regulation applies to fats
transfedtsyrer i olier og and oils as well as other
fedtstoffer m.v.) foodstuffs containing fats and
oils either as an ingredient or as
Order applies to oils and a consequence of their
fats, including emulsions production process. BUT it does
with fat as the continuous not apply to trans fatty acids
phase which, either alone which occur naturally in fats of
or as part of processed animal origin.
foodstuffs, are intended, or It is prohibited to produce or
are likely, to be consumed market foodstuffs with a trans
by humans. fatty acid content exceeding 2g
BUT it does not apply to per 100g of total fat content.
trans fatty acids which
occur naturally in fats of
animal origin.

It is prohibited to sell the
oils and fats to consumers
if they contain the trans
fatty acids higher than 1
gram per 100 grams of oil
or fat, cf. 27 Avv. Daniele Pisanello

3 A compliance-oriented approach


Compliance with Law is the result of a process
Consistency with Food Law requires a process to be designed, enforced and
implemented
• So long as we have to deal with a process, the binding requirements
addressed can be explained by a process flow chart

1. Defining the Targets

2. Cost-Benefit Assessment

3. Setting Guidelines

4. Actions and Monitoring


Defining the targets

Defining the framework (actors, requirements, trends …)

Policy makers Legal Framework

Customs and
Executive bodies
Official control on
Regulatory Authorities imports
Trade
Inspections Authorities

Certification issuing Bodies Public Affairs &
communication
Importers

Agents

Clients

Consumer

Embassy & Media


Defining Requirements

Defining critical points

Does the product comply with all
Safety requirements?

Does the product comply with
YES NO
Food Labelling requirements?

Actions in order
to reduce trade
Does the product comply with contract’s requirements? barriers risks

YES NO

Continual Improvement Quality management

Fair and less risky trading


Safety requirements: a not exhaustive list of

Safety Requirements
(not exhaustive lists of)

FOOD HYGIENE REQUIREMENTS

Product origins from approved Countries and Establishments

Hygiene Related Obligations GMP, HACCP, other safety procedures

FOOD SAFETY REQUIREMENTS

Maximum Residue Level for certain substances

Additives, flavours, enzymes

Materials and articles in contact with food

Permitted substances

Ad hoc authorization / approval

TRACEABILITY AND SAFETY MANAGEMENT

Traceability

Risk Management tools 32 Avv. Daniele Pisanello

Consumer’s protection related concerns: a not exhaustive list

Labelling
(labelling, presentation &
advertising)

MANDATORY LABELLING OF
PREPACKAGED FOODS
GENERAL

ADDITIONAL MANDATORY
LABELING REQUIREMENTS

OPTIONAL LABELLING

PRESENTATION OF
MANDATORY REQUIR.
PRODUCT LAW



Labelling The name of the food
advertising) List of ingredients

MANDATORY LABELLING OF Processing aids and
PREPACKAGED FOODS carry-over of food
additives
GENERAL

ADDITIONAL MANDATORY Net contents and
LABELING REQUIREMENTS drained weight

OPTIONAL LABELLING Name and address

PRESENTATION OF Country of origin
MANDATORY REQUIR.
Lot identification
Date marking and
PRODUCT LAW

storage instructions

Instructions for use
Nutrition Facts



Labelling
(labelling, presentation & Quantitative ingredients
declaration
advertising)
Irradiated foods
PREPACKAGED FOODS Warning on specific
aspect
GENERAL

LABELING REQUIREMENTS Allergen related warnings

OPTIONAL LABELLING Warning on the
presence/absence of
PRESENTATION OF some substances
MANDATORY REQUIR.
High in caffeine content

Declaration that it is completely free of
pork products or their derivatives
Pregnant women and other categories of
vulnerable consumers

Avv. Daniele Pisanello


Labelling
advertising)

PREPACKAGED FOODS
GENERAL

ADDITIONAL MANDATORY Nutrition Claims
Health Claims
OPTIONAL LABELLING
Organic Product
PRESENTATION OF
MANDATORY REQUIR. Other process-related
claims

Environmental related claim

Social responsibility



Labelling
advertising)

PREPACKAGED FOODS
GENERAL


OPTIONAL LABELLING Minimum fonts’ size

PRESENTATION OF Languages
MANDATORY REQUIR. Mislabelling

Displaying mandatory
requirements


Setting Guidelines

What is the appropriate procedure to manage the process ?

The FIVE LATIN Q rule: Usually, it is up to importers
to guarantee products’ legal
QUI consistency with Importing
WHO must guarantee the country’s laws. This
compliance with FLRs obligation may be transfered
to manufacture by contract
QUID
Compliance with WHAT (laws &
contracts)
Manufacture's obligation
QUOMODO must be defined as regards
How, by which means, advices, legal requirements the
resources product must be consistent
with. They may depends on
QUONIAM product’s end use, intended
Timing use and other elements
QUIA which should be drafted in
the Contract
Main goals to reach

Setting Guidelines


The FIVE LATIN Q rule: Compliance with applicable
requirements should be
QUI assessed: due to changes in
WHO must guarantee the FLRs and taking into
complaince with FLRs account several legal
QUID implications, a (well-done)
Compliance with WHAT (laws & legal advice is highly
contracts) recommended

QUOMODO
How, by which means, advices,
resources

QUONIAM
Timing

QUIA
Main goals to reach

Setting Guidelines


The FIVE LATIN Q rule:
Generally speaking, food
QUI imports must be consistent with
WHO must guarantee the applicable legal requirements at
complaince with FLRs the time of Custom clearance, but
this is not a uniform rule:
QUID China’s current regulation
Compliance with WHAT (laws & requires the imports to comply
contracts) with GB7718 – “2004 General
Rules of Prepackaged Food
QUOMODO Labeling”) and other more
How, by which means, advices, specific legal act at the time of
resources cargo’s arrival.
Japan: under Japanese Law,
QUONIAM Labeling is required at the
Timing point of sales from importer to
other businesses in the
QUIA domestic market.
Main goals to reach

4 Enforcing guidelines - Country reports


Enforcing Guidelines


China – defining the targets

On May 13 2011, China's Ministry of Health published on its web site National Food
Safety Standard on General Rules for the Labeling of Prepackaged Foods to be
adopted on April 20, 2012.
These Rules prescribe the basic requirements for the labeling of pre-packaged
foods.
They apply to the labeling of all pre-packaged foods
• directly or
• indirectly
offered to consumers.


China – defining the actors (public affairs)

The Competent Authority in the field of export control is the General Administration
of Quality Supervision, Inspection and Quarantine (AQSIQ)
AQSIQ is a ministerial-level department under the State Council of the People's
Republic of China that is in charge of national quality, metrology, entry-exit
commodity inspection, entry-exit health quarantine, entry-exit animal and plant
quarantine, import-export food safety and accreditation, standardization, as
well as administrative law enforcement.
AQSIQ directly administers provincial Entry-Exit Inspection and Quarantine
Bureaus and Bureaus of Quality and Technical Supervision.


CHINA – Basic requirements

Applicable requirements depends on direct or indirect destination to the consumer;
Where food is intended to final consumer, basic legal requirements are as
below:
• Label must be clear, prominent, indelible and readily legible by customers
in purchase.
• easily understood by the public, precise and supported by scientific
evidence. Any indications, which are superstitious, pornographic, debasing
other products, or unscientific, shall be prohibited.
• true and accurate, and shall not be described or presented in a manner
that is false, misleading or deceptive; or is likely to create an erroneous
impression by means of different word size or color contrast.
• It is prohibited to use words, pictorial or other devices which refer to or
are suggestive either directly or indirectly, of any other product with
which such food or its certain property might be confused.
• It is forbidden to declare or imply contents with effect of prevention and
curing of diseases, and non-health care


CHINA – Language and fonts requirements

Language requirements
Language: label must be in normal Chinese characters (except registered
trademark).
Languages of minority ethnic groups may also be used at the same time, but
the size of words shall not be larger than the corresponding Chinese
characters.
Foreign languages are also allowed in addition to Chinese characters provided
that they are not larger than the corresponding Chinese characters (except for
registered trademarks).

Fonts requirements
If surfaces area of a package (container) of prepackaged food is more than 35
cm2: the minimum size of the words, symbols and numerals in the mandatory
labeling information shall not be less than 1.8 mm in height
• Note: Reg. EU no 1169/2011 will requires1,2 mm;


CHINA: labelling particulars

Labeling of prepackaged food for direct delivery to consumers shall include
name of foods, *
list of ingredients,
net weight and configuration, *
name of the food,
address and contact information of manufacturers and/or distributors,
date of manufacture and date of minimum durability,
conditions for the storage, *
food production license number,
code of the product standard and
Nutrition declaration (as from January 2013)
other contents needed to be labeled.


The new mandatory nutrition declaration in China

The mandatory labelling contents are energy and core nutrients: protein, fat, carbohydrate and
Sodium
Nutrition information contains the name, content and NRV (%) of each nutritional component.
The presentation order of the names of nutritional components is shown below. When any one
of the nutritional components is lacking, the next one simply moves upwards.
Energy
Protein
Fat
• -- Saturated fat (fatty acid)
• -- Monounsaturated fat (fatty acid)
• -- Polyunsaturated fat (fatty acid)
• -- Trans fat (fatty acid)
Cholesterol
Carbohydrate
• -- Sugar (lactose a)
Dietary fibre (or monomer component b)
• -- Soluble dietary fibre
• -- Insoluble dietary fibre
Sodium

The name of the food

The name of the food must indicate the true nature of food and it must be borne in the
prominent place of the label
Where a name or several names have been established in respect of a certain food
under a national, trade, or local standard, one of these names or an equivalent
name shall be selected for use.
In the absence of any such name, either a common or usual name which is not
misleading or confusing to the consumer shall be used.
A coined, fanciful, transliterated, brand name, folk name or trade mark may be also
used provided it in the same display panel one of the trade names as ruled by Law
(previous points)
Particular in regard to the true nature, physical condition of the food, or method of
preparation of the food are mandatory, as necessary to avoid misleading or
confusing the consumer; for example
• dried,
• concentrated,
• reconstituted,
• smoked,
• fried,
• powdery,
• granular 49 Avv. Daniele Pisanello

List of ingredients

The list of ingredients must declare all ingredients in descending order of their
weights added in the process of manufacture or preparation of the food;
those ingredients constituting less than 2% of the food may not be listed in
descending order;
Ingredients other than additives must be named according to rules on “name
of foods”
• Special rules apply to listing of additives.
Compound ingredient: where an ingredient is itself the product of two or more
ingredients (except compound food additives), such a compound ingredient
may be declared, as such, in the list of ingredients, provided that it is
immediately accompanied by a list, in brackets, of its primary ingredients in
descending order of proportion.
• Where a compound ingredient (for which a name has been established in
a national, trade or provincial standard) constitutes less than 25% of the
food, its primary ingredients need not be declared.
The processing aids need not be indicated.


Food Additives

On May 13, 2011, the Ministry of Health of the People's Republic of China (MOH)
published a new food additive standard, entitled "Food Safety National Standards -
Standards for Use of Food Additives (GB 2760-2011)," which became effective on
June 20, 2011, and replaces GB 2760-2007 ("Hygienic Standards for Use of Food
Additives").
GB 2760-2011 provides for the use of
• food additives,
• processing aids,
• flavors, and
• gum bases
in foods which are categorized into 16 groups.
A significant change is that the new Standard details both the applicable
principles and requirements for the use of processing aids and flavors in food.
GB 2760-2011 has also removed those food additives and processing aids that
are either no longer in use, or have been deemed not "technically necessary"
(e.g., benzoyl peroxide, calcium peroxide, formaldehyde, etc.).


Scope of Use and Level of Use of Food Additives

The new GB 2760-2011 has incorporated expanded uses and use levels for certain
food additives.
For instance, changes to the scope of use and level of use have been added to
over 40 food additives listed at Table A.1.
• For example, food additive tea polyphenol (TP) now has additional 8 types
of food added to its scope of use, including Cooked Nuts and Seeds
(limited to fried nuts and seeds), Oil Fried Flour Product, and etc.
Moreover, the use requirements of certain food additives are also revised,
including changes in the maximum level of use and/or additional use
requirements.
• "sorbic acid, potassium sorbate" (maximum level increased in egg
products)
• "erythrosine, erythrosine aluminum lake“: new calculation reference,
stating that "calculation is to be based on the amount of erythosine"。
。


Labelling food additives

The names of food additives shall be declared in general names in accordance with GB 2760.
Two form to food additive declaration:
Declare the specific names of all food additives in descending order of proportion;
example:
• Ingredient: water, whole milk powder, pouring cream, vegetable oil, chocolate
(cocoa mass, sugar, cocoa fat, lecithin, PGPR, food flavor and lemon yellow),
glucose syrup, propylene glycol ester of fatty acid, carrageenan, guar gum, annatto,
malto dextrin and food aroma;
Declare the class names and international code of all food additives in descending order
of proportion; example
(cocoa mass, sugar, cocoa fat, emulsifier (322,476)，food flavor, colorant (102)),
，
glucose syrup, emulsifier (477), thickener (407,412), colorant (160b) malto dextrin
and food aroma.
Declare the class names and specific names of all food additives in descending order of
proportion
(cocoa mass, sugar, cocoa fat, emulsifier (ecithin, PGPR)，food flavor, colorant
，
(lemon yellow)), glucose syrup, emulsifier (propylene glycol ester of fatty acid),
thickener (407,412), colorant (carrageenan and guar gum), colorant(annatto), malto
dextrin and food aroma.

Quantitative labeling of the ingredients

Quantitative labeling of the ingredients
Where the labeling of a food places special emphasis on the presence of or
adding one or more valuable and/or characterizing ingredients or components,
the percentage of the emphasized ingredients added at the time of
manufacture or the content of the emphasized components shall be declared.
Where the labeling of a food places special emphasis on the low content of
one or more ingredients or components, the percentage of the emphasized
ingredient or component in the final product shall be declared.
A reference in the name of a food to a particular ingredient or component
shall not of itself constitute the placing of special emphasis.


Net Weight and Configuration

Net Weight and Configuration
The net weight declaration shall be expressed using net weight, numerals and
the official unit of measurement. (Refer to appendix C for declared form)
The minimum font size of net weight declaration are set by the following table


Japanese FLRs: an introduction

Recently some specific administrative functions have been transferred from Ministry of
Health, Labor and Welfare to the Consumer Affairs Agency.
In September 2009, the new Consumer Affairs Agency issued
the “Guidance for Food Labeling based on Ordinance for Enforcement of the
Food Sanitation Act” and
the paper “On Labeling of Milk and Milk Products based on Ministerial
Ordinance on Milk and Milk products Concerning Compositional Standards,
etc.” (“On New Labeling based on the Food Sanitation Act,” CAA Notification
Label No. 8, September 17, 2009).


Japanese FLR: basic requirements

Main legal requirements are address by the Food Sanitation Act and Ordinance for
Enforcement of the Food Sanitation Act (Labeling).
Specific requirements are provided for
• Milk and Milk Products
• mineral water,
• tinned foods,
• frozen foods,
• raw fish,
• irradiated foods,
• oysters,
• allergy-related products,
• GM foods, and
• Food for Specified Health Uses (FOSHU) / Food with Nutrient Function
Claims (FNFC)


Mandatory particulars for consumer direct selling of containers or packages of
processed foods other than those for institutional use:
(1) Name;
(2) Names of ingredients;
(3) Net contents;
(4) Best before;
(5) Storage instruction; and
(6) Name or trade name and address of manufacturer, etc.

It is to be noted that foods other than imports must bear the place of origins of
ingredients.
Imported foods must only indicated the country of origin on the labels

Those foods whose total surface of the container or package is no more than 30cm2
are exempted from the obligation to indicate: names of ingredients; best before or
use-by date; storage instructions, and place of origin of ingredient


Name of food

The name must be labeled with a generic name expressing the product content.
Some foods are regulated by regulatory acts


Listing ingredients

Names of ingredients (other than food additives) must be labeled with the most
generic names in the descending order by weight.

Compound ingredients: Labeling of ingredients made from no less than two
ingredients (hereafter must follow as provided below:
i) The name of the mentioned compound ingredient followed by its
component ingredients with the most generic names in parentheses in the
descending order by weight in the mentioned compound ingredient.
• Where the compound ingredient consists of no less than three ingredients,
the ingredients consisting less than 5% by the total weight of the
mentioned compound ingredient may be labeled as “others”.
ii) The names of ingredients of the mentioned compound ingredient may be
omitted, if the weight of the compound ingredient in the total ingredients of
the product is less than 5% or the names of ingredients are easily identified
from the name of the compound ingredient.

Specific provision for naming of some ingredients: see table


Warning on allergens

Accordingly to Japanese FLRs, criteria for the labeling of food or food additives made
from specified raw materials are as follows:
(1) Labeling of foods made from “specified raw materials”: seven kinds of
food/ingredients which have been designated to have links to food allergies in
reference to the incidence and the severity of allergic reactions caused
thereby:
• prawn, crab, wheat, buckwheat, eggs, milk, and peanuts;
A processed food containing any specified raw material shall carry a label
stating that it contains them.
• Foods, which contain additives derived from specified raw materials, shall
carry a label, indicating that they contain these additives and that these
additives are derived from specified raw materials.
(2) Labeling of foods made from materials similar to specified raw materials :
abalone, cuttlefish, salted salmon roe, oranges, kiwi fruit, beef, walnuts,
salmon, mackerel, soybeans, chicken, banana, pork, matsutake mushroom,
peaches, yams, apples and gelatin have also been found through experience
and scientific studies to contain allergic substances.
• It is recommended that processed foods, which contain these foods as raw
materials, should indicate on their label that such foods are contained
therein as raw materials as far as possible.

Nutrition labelling

Nutrition labelling is voluntary in Japan.
Only Special diet food and foods for infant and babies are required to declare
their nutrient components and weight;
Nutrition information shall be provided in accordance with Nutrition Labelling
Standards under the Health Promotion Act if
• nutrient declaration,
• nutrient content claim such as
a) “X free”,
b) “X% reduced,” and/or
c) nutrient function claim
is made on the label of foods offered for sale


Importing into the United States - A Guide for Commercial
Importers (U.S. Customs and Border Protection)


Import procedure to US: some food-related focus

Importing food to US requires the importers to contact Customs Border’s Protection
(CBP) and other agencies when questions arise about particular commodities.
For example, questions about products regulated by the Food and Drug
Administration should be forwarded to the nearest FDA district office; in other
instances Department of Agriculture may be involved.
Agricultural Commodities as Cheese, Milk, and Dairy Products.
• Cheese and cheese products are subject to requirements of the Food and
Drug Administration and the Department of Agriculture (USDA). Most
importations of cheese require an import license and are subject to quotas
administered by the Department of Agriculture, Foreign Agricultural
Service.
• The importation of milk and cream is subject to requirements of the Food,
Drug and Cosmetic Act and the Import Milk Act. These products may be
imported only by holders of permits from Food and Drug Administration,
Department of Health and Human Services and the Department of
Agriculture.



Fruits, Vegetables, and Nuts. Certain agricultural commodities, including Fresh
tomatoes, Oranges, Grapefruit, Irish potatoes, Cucumbers, Eggplants, Dry
onions, Avocados, Mangoes, Limes, Processed dates, Prunes, Walnuts and
filberts Raisins, Olives in tins, Green peppers, must meet United States import
requirements relating to grade, size, quality, and maturity
• These commodities are inspected; an inspection certificate must be issued
by USDA’s Food Safety and Inspection Service to indicate import
compliance.



Livestock and Animals.
• Inspection and quarantine requirements of the Animal and Plant Health
Inspection Service (APHIS) must be met for the importation of ruminants,
Swine, Horses, avian species, animal by-products (untanned hides, wool,
hair, bones, bone, meal, blood meal, animal casings, glands, organs,
extracts, or secretions of ruminants and swine (if animal by-products for
food, drugs, or cosmetics, they are also regulated by the Food and Drug
Administration), Animal germ-plasm, including embryos and semen; and
Hay and straw.
• A permit for importation must be obtained from APHIS before shipping
from the country of origin.
• In addition, a veterinary health certificate must accompany all animal
imports.



Importing food to US requires the importers to contact Customs Border’s Protection (CBP) and
other agencies when questions arise about particular commodities.
For example, questions about products regulated by the Food and Drug Administration should
be forwarded to the nearest FDA district office; in other instances Department of Agriculture
may be involved.
Meat, Poultry and Egg Products.
• Country of origin must be listed as authorized exporting country
• All commercial shipments of meat and meat food products (derived from cattle,
sheep, swine, goats, and horses) are subject to USDA regulations and must be
inspected by the Food Safety and Inspection Service (FSIS). Special procedures for
Meat products from other sources (including, but not limited to wild game).
• Inspection certificates from the country of origin must accompany all imported
meat, poultry, and egg products. These certificates must indicate the:
• Product name,
• Establishment number,
• Country of origin,
• Name and address of the manufacturer or distributor,
• Quantity and weight of contents,
• List of ingredients,
• Species of animals from which the product was derived,
• Identification marks.


Foods, Drugs, Cosmetics, And Medical Devices
• The importation into the United States of food, drugs, devices, and
cosmetics is governed by provisions of
a) The Public Health Security and Bio-Terrorism Preparedness and
Response Act of 2002, or BTA; and
b) the Federal Food, Drug, and Cosmetic Act;



• BTA applies to all food imported or offered for import into the US, both for human
and animal consumption, is subject to the requirements of this Act.
• The BTA’s key elements require that manufacturers and shippers register the
facilities from which they export food and food products to the U.S. with the
Food and Drug Administration.
• Manufacturers and shippers must also provide the FDA with prior notification
(PN) for any food shipment covered by BTA regulations. Failure to provide the
PN will result in refusal of the food importation, which could cause the
shipment to be:
• Held at the port of arrival,
• Moved to secured storage pending compliance with PN requirements,
• Exported, or
• Destroyed.



• As ruled by provisions of the Federal Food, Drug, and Cosmetic Act, it is
prohibited any importation of articles that are adulterated or misbranded
and products that are defective, unsafe, filthy, or produced under
unsanitary conditions.
• The term misbranded includes statements, designs, or pictures in
labeling that are false or misleading or that fail to provide the
information required in labeling.
• Imported products regulated by the FDA are subject to inspection at the
time of entry.
• Shipments inconsistent are subject to refusal; these shipments must be
brought into compliance, destroyed, or re-exported.


Thank you for your attention

www.lexalimentaria.eu

Sedi

Taviano (Lecce), via Principe Umberto 2, Bologna, via D’Azeglio 27
tel./fax: (+39) 0833 91 47 27 40123 Bologna (BO), Italy
cell.: (+39) 349 58 49 718 Tel.: +39 0516486188
email: info@lexalimentaria.eu email: info@lexalimentaria.eu


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