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Marketing Consultancy Division (MCD)

Export Consultancy Unit (ECU)

______________________________________________________________

Export Study

Labelling, Marking & Packaging

Regulations

Part 2
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Labelling, Marking & Packaging Regulations (Part II)

TABLE OF CONTENTS

COUNTRY PAGE
 Introduction
 Argentina 1
 Australia 5
 Brazil 9
 Canada 13
 Chile 14
 China 17
 Colombia 23
 Japan 25
 Mexico 28
 Paraguay 33
 Poland 35
 Russia 38
 South Korea 44
 Uruguay 48
 USA 50
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Labelling, Marking & Packaging Regulations (Part II)
The importance of correct product labelling, marking and packing for exports cannot be
overstated. Exporters who do not meet the labelling, marking and packaging regulations of their
specific overseas markets could incur heavy penalties and loss of export business.
The regulations for product labelling, marking and packaging vary from country to country,
however, certain basic information is constant in all regulations. In essence, these regulations are
a policy instrument of governments which regulates the presentation of product-specific
information relating to particular consumer groups in their respective country. They are,
therefore, an import means of communicating product information between buyers and sellers and
serves four primary functions:-
 Provides basic product information on characteristics, such as the common name, list of
key ingredients, net quantity, durable life dates, grade/quality, country of origin and
name/address of responsible manufacturer, dealer or importer.
 Provides health/safety and nutrition information including instructions for safe
handling, nutritional profile or other specific information relevant to recommended
possible uses of the product.
 Provides information on ‘non-use’ characteristics, such as the environmental import or
moral/ethical elements surround the product’s manufacturing process – e.g. ‘halal foods’.
 Provides a vehicle for marketing, promotion and competition as it can advertise and
promote product sales and trade via their labels, promotional information and label
claims.
In this manner, product label information constitutes the primary means by which consumers can
differentiate between individual products and brands to make informed purchasing choices and
decisions.
In order to assist the KSA Producer/Exporter, the ECU has brought together some product
labelling, marking and packing requirements/regulations for various countries which are attached
as ‘Brief Notes’. The information is provided as an ‘early warning’ mechanism to assist local
producers to understand the relevant regulations and, where necessary, adjust their product
labelling, marking and packing specifications accordingly. Where possible additional information is
also provided on:- (a) specific laws and decrees relevant to the subject concerned, (b) import
regulations, (c) other formalities and documentary requirements, (d) quality standards, and (e)
other general information.
The information provided is on a general and cursory basis and should only be used as ‘direction
indicators’ by the Producer/Exporter. The ECU’s, therefore, stresses the need for the
Producer/Exporter to undertake their own market and legal investigation into the specific
regulations relating to their precise product ranges and to use the attached data as ‘basis-line’
information which can be used as a building block to put together their knowledgebase.
The attached reports will illustrate 15 different individual countries as identified in the table of
content and listed in alphabetic order.
The previous Export Study on the subject covered 28 other countries. The total number of
countries covered in both Studies is 43.
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Brief Notes on Labelling, Marking & Packaging Regulations

Country: Argentina

The Argentinean Law 22.802 of Lealtad Comercial establishes the basic minimal mandatory
requirements for any products imported into the Country, which are:-

 Name of the product.

 Quality.
 Country of origin.
 Net content.

In addition, some products must comply with regulations establishing specific requirements (see
www.mecon.gov.ar), mainly covering product sectors:-

 Foodstuffs.
 Textiles.
 Cosmetics.
 Toys.
 Electrical devices.

Labelling Requirements for Foodstuff

Food labelling is governed by various resolutions, of which the most important are:-

 National Resolucions 1399/92, and 1951/92.

 Resolucion 679/93 introducing MERCOSUR Resolucion GMC/Res/36/93 regulating the
labelling of packaging foodstuffs.
 Argentine Food Code, as amended by the Ministry of Health Resolution 686 of Sept. 2,
1998, concerning the ingredient list.
 Resolucion No. 34 of 10/01/96 of Ministry of Health on the packaged foodstuffs products
commercialised in MERCOSUR.
 Resolucion 572 of 2/9/98 and Resolucion 100 of 10/05/83 on fruits and canned products.
 Resolucion 494 of 6/11/2001 of SENASA on food products, prepared with different types
of minced meat (picado, molida o feteada) – specific label according to the cooking methods.

The mandatory data to be affixed to a single label are:-

 Name and address of the manufacturer.

 Name and address of the importer.
 RNPA and RNE registration numbers.
 Name of the product.
 Raw materials – in decreasing order by percentage or weight.
 Content (volume).
 Ingredient list.
 Date of production.
 Expiry date.
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 Storage conditions.
 Country of origin (compulsory for some products).

The importer must apply for an authorisation/registration number from RNPA (Registro Nacional
de Productos Alimenticios), providing the following information to INAL (National Institute for
Food):-

 Original label.
 Ingredients list.
 Short manufacturing method.
 Certificate of free sale in the country of origin.
 Nutritional information by canned unit.
 A draft of the label in Spanish.

The approval procedure lasts about four months, when INAL issues a certificate RNPA.

Labelling Requirements for Textiles & Apparel

The Argentinean authorities have enforced controls on textile labelling since a Resolution was
adopted at MERCOSUR Level and integrated in to the Argentinean Legal Order. Imports are now
governed by the requirements of MERCOSUR Resolucion No. 9 of Dec. 12, 2000 (que establece el
Reglamento tecnico de Mercosur de etiquetado de productos textiles), which was implemented in
June, 2001 (Resolucion 287/2000 de la Secretaria de Industria incorporando en el ordenamineto
juridico nacional la Resolucion Mercosur 9). This regulation establishes a model of label for the
MERCOSUR countries and lists the compulsory data to be affixed on the label, as per the
following:-

 Name, social reason and identification fiscal of the importer. This can be substituted by
the registered brand name.
 Country of origin.
 Name of the fibres, yarns and composition in percentage – detailed provisions on the
denomination of fibres.
 Cleaning instructions.
 Size.

The minimum size of the lettering is 2mm, and the label should be permanent.

Note that leather apparel products must comply with the requirements fixed by Resolucion MEOSP
558 of 1987.

Labelling Requirements for Footwear

Under Resolucion 850/96 MEOSP (labelling requirements for textiles and footwear), sports
footwear are subject to detailed labelling requirements. The tariff code most affected is the
Harmonised Code No. 640411 (footwear with textile uppers). The products in this sector must be
labelled with two labels/stickers, namely:-

 Cleaning instructions – must be written with symbols and written instructions.

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 Product composition and importer data – the second label must contains the following
information:-
o Upper composition with the percentage of the different components (e.g. 68% nylon,
32% polyester).
o Outsole composition (e.g. rubber).
o Lining composition (e.g. textile, 80% nylon, 20% spandex).
o Sock-liner composition (e.g. textile, EVA).
o Country of origin.
o Name of the brand.
o Importer code, importer CUIT.

The Argentinean authorities have issued a complex system of certification of labels previous to
the export of footwear to the Country. The system has been implemented by:-

 Resolucion 508/99 – establishing a mechanism of certification of truthfulness of the

information contained in the footwear labels.
 Disposition 921/99 – establishing a mechanism of certification through the testing of
samples. By origin, by manufacturer, composition of principal elements (upper, outsole,
lining), and functionality.
 Resolucion 977/99 (11.08.99) – establishing the certificate of importation for footwear
(non-automatic licence - LAPI). It is delivered in a maximum time duration of 30 days, and
has a validity of 30 days from the date of its delivery.

Under this system, importers require approval from the accredited certification authority on the
product composition and on the labels before importing the products. Following the procedure, the
importer puts together a detailed file for the concerned product and sends two samples of the
product to be imported to the certification institute (INTI). It is allowed to gather the products
with similar technical characteristics into a single product file. The aim of the test is to evaluate
the composition of the product and to assess if the product composition corresponds to the draft
label. Technical specifications are rather details. For example it is required to provide
information on the textile fibres. If the upper is in leather, the importer must indicate the type
of animal, and the type of finishing. Details on the function of the product are also required.

The time duration of the testing period in INTI is 30 working days. The approval of label
procedure costs US$25 plus an additional US$180.

When the INTI certificate is issued, the importer must provide the Ministry of Economy
(Secretaria de Economia – Lealtad Comercial) with various data in order to obtain the non-
automatic licence (LAPI):-

 Information regarding the constitutive materials.

 Weight and volume of each model.
 Number of INTI certification.
 Value of the product to be imported.
 Draft label.
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Labelling Requirements for Cosmetics

The basic resolutions covering cosmetic products are the following:-

 Resolucion of ANMAT 337 of 1992 – labelling of hygiene products.

 Disposition of ANMAT 110 of 15/3/99.

The mandatory requirements to be affixed to the label of the products are:-

 Name of the product.

 Importer name, registration No. of importer, address in Argentina.
 Country of origin.
 Reference of the ANMAT Resolution approving the product.
 A ‘caution’ warning if product is regarded as inflammatory.
 Storage conditions.

Some terms are prohibited, such as ’anti (e.g. anti-wrinkle), or ‘reduce’’ or ‘fight against'.

Before importation, the importer presents ANMAT all the required documents, including a copy of
the draft label and the certificate legalised by the Argentinean Consulate in the country of origin.
The Argentinean Consulate and the Chamber of Commerce legalise:-

 The certificate of free sale.

 The formula.
 The letter of proxy (letter of attorney) from the importer’s principal.

Labelling Requirements for Electrical Devices

The labelling requirements for these products are covered by Resolucion 92/98, which states that
the following information should be contained in the label:-

 Electrical voltage.
 Name of the manufacturer.
 Country of origin.
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Brief Notes on Labelling, Marking & Packaging Regulations

Country: Australia

At least two Australian Authorities control the compliance of imported products with labelling and
marking requirements and a third one in the retail phase, namely:-

 AQIS (Australian Quarantine Service) – active before the clearance process.

 Customs Authorities – active during the clearance process.
 ACCC Representatives (Authority monitoring the compliance with requirements of the
Trade Practice Act) – active after the clearance process, in the retail phase.

AQIS Controls

With respect to foodstuffs, AQIS controls the compliance of the products required to be
imported with the provisions of the Food Standard Code, which requires labels to identify:-

 The batch number.

 The country of manufacture.
 Best before date for products with a shelf life of less than two years.
 The ingredient list.

Australian Customs Controls

Under the Commerce (Import) Regulations 1940, implementing the Commerce (Trade Descriptions)
Act 1905 (see www.customs.gov.au), Customs Authorities control some mandatory data that shall
be affixed on the labels of the imported goods, namely:-

 Country of origin – (e.g. made in, plus name of the country). The ‘Made in GCC’ as country of
origin is not accepted.
 A fair description of the product.
 If necessary, the quantity (in volume or weight). If the weight is indicated, it is compulsory
to indicate whether it is a net or gross weight.

Customs Authorities recognise that the definition of the trade description is very broad, and is
sometimes difficult to enforce. There are mainly three aspects to be addressed on the label:-

 The requirements should be indicated on the label.

 The goods cannot carry a false trade description.
 The label should be permanent.

The Customs labelling requirements must be affixed on the goods before the goods are presented
for clearance. Some data can, however, be affixed after the clearance (e.g. import date). In the
majority of cases, the importer will be allowed to correct a wrong label, except if there is doubt
about ‘intentional wrong labelling’ (e.g. false country of origin). In this case, Customs can decide
either to destroy or sell the goods.
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ACCC Controls

ACCC is the Authority monitoring the compliance with the requirements of the Trade Practice Act
– from the prospective of the retail phase. The Acts cover two main areas:-

 The competition.
 The consumer protection (Part IV).

If a consumer makes a claim, the ACCC officials will verify if a given statement on a label is
correct or not. Section 52 deals with the prohibition against misleading deceptive conduct.
Section 53(a) and (b) deals with the country of origin mentioned. According to the criteria
followed by the ACCC, the product must be substantially transformed and, at least 50% of the
production costs must be spent in the country stated as origin country.

Labelling for Food

Imported foodstuff must meet Australian Standards of the Food Standard Code (FSC) and all
mandatory information must be present on the label. Food packaging legislation is administered
under the various State/Territory Trade Measurement Regulations or Weights & Measures Acts.
The Trade Measurement (pre-packed articles) Regulations primarily describe how the volume
statement, the name and the address of the packer must appear on the food packaging. The KSA
exporter should, therefore, check for text needs in terms of the various State/Territory
requirements – according to the State/Territory of final destination of the product.

Certain labelling requirements under the FSC are mandatory as they must appear on a label, and
must respect a specified format in terms of print size. The mandatory data to be affixed to
foodstuff products is as follows:-

 Name and address of the manufacturer – The label should contain the complete name and
business address, which must show the road/street number (if any), road/street, suburb,
town, state/territory (FSC part A1(2)).
 Name and address of the importer - The label should contain the complete name and
business address, which must show the road/street number (if any), road/street, suburb,
town, state/territory (FSC part A1(2)).
 Name of the product – there are no specific requirements.
 List of ingredients – under the FSC all ingredients should be listed in the label. Each
package must carry a nutritional information panel (FSC, 1.2.8). There are new provisions on
the presence of allergens. The imported food product has to be market with “allergen
labelling”. However, there are not formal requirements..
 Content (volume).
 Expiry date – The best before date is mandatory if the product has less than two years
shelf life. Format should be either ‘Best before dec 02’’ OR ‘Best before 12 02’’.
 Lot marking – this is required for the tracing back of the product for health or safety
reasons. The letter “L” followed by the year and date of packing must be indicated (FSC
Part A1(3)).
 Storage conditions – the label must include a statement on any specific storage conditions
required in order to ensure that the food will remain consumable during a specified period.
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 Country of origin – this is a compulsory requirement and it should be noted that ‘Made in
GCC’ is not accepted by the Australian Customs Authority but ‘Made in Saudi Arabia’ is
acceptable, as it is a country name.

The FSC has some standard labelling requirements (vol. 1, FSC Part A1) which require the
following:-

 A minimum print size for labels – the size depends on the product.
 All mandatory information must be shown in the English language.
 All mandatory information must be shown distinctly, legibly and must be indelible.
 All mandatory information must be conspicuously visible to a prospective purchaser.
 All mandatory information must be in standard type.
 All mandatory information must be in characters of uniform size, style and colour.
 All mandatory information must be in such colours as to afford a distinct contract to the
background.

The terminology used to describe the above in the regulations (vol. 2 1.2.9) is:-

‘Unless otherwise expressively permitted by this Code, each word, statement,

expression or design prescribed to be contained, written or set out in a label
must wherever occurring, be so contained, written or set out legibly and
prominently, such a to afford a distinct contrast to the background, and in the
English language. Any information in other languages must not negate or
contradict the information in English’.

With respect to the requirements of the States/Territories, ANZFA (Australian New Zealand
Food Authority ) states that the FSC is a national document and is automatically adopted in each
of the States/Territories. According to ANZFA, there are no or only a few different State
labelling requirements.

Labelling for Textiles & Apparel

All textile products imported into Australia must carry a label with the following mandatory data:-

 Country of origin – the product must be transformed significantly in the country indicated
‘made in’ and if 50% of the production costs have been spent in this country. To be market
‘product of’, if all raw materials are originating from the country indicated in the label.

Other Goods Subject to Mandatory Standards Under the Trade Practice (TP) Act

Under the Trade Practice Act, which is applicable to consumer products, there are some
mandatory labelling requirements for some consumer products, namely:-

 Bean bags (TP Regulations) – must carry a label warning of choking hazard of lightweight
beads and any openings must be child resistant.
 Care labelling - clothing and textile products (based on AS/NZS 1957:1998-gazette
15/7/98) – instructions for the correct care and maintenance of clothing, household
textiles, furnishings, upholstered furniture bedding, piece goods and yarns. Instructions
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must be accessible at the point of sale, in most cases permanently attached (there are some
exceptions).
 Children nightwear & limited daywear having reduced fire hazard (based on AS/NZS
1249:1999) – this mandatory safety stipulates two flammability labels.
 Cosmetics and toiletries (TP Regulation as amended) – unless covered by the Therapeutic
Goods Act, all cosmetics and toiletry products must be labelled with a full list of their
ingredients.
 Elastic luggage strap (TP Regulations notified in the Commonwealth of Australia Gazette
Dec. 1089 and Oct. 1999) – stretch tie-down straps and cords, including octopus straps
must carry a label warning of eye injury if overstretched.
 Paper patters for children’s night-clothes (Based on AS 1249, Gazettal of AS 1249-1990
occurred on 20/1/93, Gazettal of AS 1249:1999 occurred on 2/9/99) – must carry a label
advising of flammability of certain fabrics.
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Brief Notes on Labelling, Marking & Packaging Regulations

Country: Brazil

The general labelling requirements in Brazil are mainly established by the Law for the Protection
of the Consumer (Law 8.098 of Sept. 11, 1990). The Law does not enumerate specific requirements
for the product’s presentation or the labelling requirements. However, according to the Law, the
local producer or the importer is responsible both for the product and the information provided on
it. The seller is only responsible when the producer or the importer cannot be identified or while
the product is sold without producer or importer identification, or when the seller has not
provided the appropriate storage requirement for the product. This Law is supervised by a
Commission for the Protection of the Consumer, which acts mainly in response to consumer
complaints. The verifications on the implementation of this Law can only be undertaken once the
product is already in the Brazilian market. The authorities have the right to decide whether the
product contains a description sufficiently to properly inform the consumer of its contents and
application. The specific labelling requirements should be considered on a product by product
basis. The difficulty in the Brazilian system is that for some products, several different
regulations are applicable and the products need to comply with all the existing regulations.

Labelling Regulations for Foodstuffs

The main regulation applicable for foodstuffs is the Portaria 42 of Jan. 14, 1998 (labelling of pre-
packaged goods) from the Secretary for the Sanitary Vigilance of the Ministry of Health. This
legislation implements the MERCOSUR Resolutions on the labelling of food products (Resolucion
GMC No. 36/93, 06/94, and 21/94). The Portaria 42 is applicable to all foodstuffs and beverages.
According to the regulations, products intended to be sold to the final consumer in Brazil must be
labelled in the following manner:-

 Name/trade mark/description of the product.

 List of ingredients.
 Contents.
 Lot number.
 Country of origin.
 Product expiry date.
 Instructions for the use or the preparation of the foodstuffs (where necessary).

Portaria 42 provides additional details on the presentation of data on the labels. For example, the
ingredients should be listed in percentage terms and in decreasing order. The complete
denomination of all additives and the nature of aromas used should also be indicated. The Portaria
contains a list of the additives authorised. The content should be indicated in volume, mass or
units. The letter “L” should proceed the indication of the lot number.

In addition, the expiry date should be indicated with one of the following expressions -‘consumir
antes de …’, ‘valido ate …’, validade …’, Vence(em) …’, ‘vencimento …’, ‘venc …’, ‘consumir
preferencialmente antes de …’. The expiry date statement is not compulsory for some products,
such as fresh fruits and vegetables, bakery products and confectionaries, which due to their
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nature, should be consumed within 24 hours after the being shown/produced. Vinegar, sugar,
bonbons and caramels, chewing gums, and salt are subject to specific technical regulations. All
information should be presented in Portuguese, while the use of other languages is allowed, but
different languages should be clearly identifiable by the consumer. The Portaria forbids the
indication of false or misleading information on the product labels.

The Portaria contains quite exhaustive information on how the label should b prepared. The text is
available on the website of the National Agency for Sanitary Vigilance – www.anvisa.gov.br.

Nutritional Labelling for Foodstuffs

Nutritional labelling is compulsory in Brazil for all food products. According to the Portaria No. 94
of Nov 1, 2000, and Portaria 34 and 40 of March 22, 2001, all products sold in Brazil should bear a
nutritional label. According to the legal requirements, this label should be written in Portuguese
and affixed by the producer before the product is exported to Brazil. This label can be printed on
a sticky label or on the original label, however, according to the National Agency for Sanitary
Vigilance, the Portaria 42 forbids the use of stickers. According to the new legislation, the
nutritional labelling is not applicable to mineral waters and other bottle waters designed for human
consumption.

The nutritional labelling format is described as “any description whose purpose is to inform the
consumer about the nutritional property of the food” – Portario 40. The nutritional facts, which
should obligatory be mentioned on the label are as follows:-

 Calories.
 Carbohydrates.
 Protein.
 Total fat.
 Saturated fat.
 Dietary fibre.
 Calcium.
 Iron.
 Sodium.
 Other minerals and vitamins (if appropriate).

Regulations on nutritional labelling are essential to follow, given the fact that the label is strictly
regulated. The Brazilian Agency for Sanitary vigilance has take steps to facilitate the
implementation of the nutritional labelling in the sense that Resolucion 198 of Sept 11, 2001
(resolution on the implementation of Resolucion 39 and 40) deals with the obligation to affix the
nutritional label in the country of origin. Article 6 of the Resolucion 235 allows the importer to
affix the nutritional label after the clearance of the goods under its own responsibility.

When several products with different nutritional characteristics are packaged together, a
different nutritional label should be attached. According to the Brazilian legislation a unique label
should be used only if the difference in the nutritional characteristics of the products is between
5% and 10%. In this case, the average nutritional value should be used for the labelling.
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Labelling Regulations for Products of Animal Origin

Products of animal origin, which will be exported to Brazil, need prior approval from the
Department for Inspection of the Products of Animal Origin and the Department for Control of
the International Trade. This approval is normally made after an inspection is performed by
Brazilian veterinary inspectors in the country of origin, yet the Brazilian Authorities could
authorise other forms of approval. Labelling for these products must be approved by Brazilian
Authorities under the Circular No. 416/98/DCI/DIPOA. The producer must present the sample of
the label for approval within the special form identified in the Circular. The label should display
the following information in Portuguese:-

 The name and identification of the product.

 Ingredients – in decreasing order and eventually, the additives used.
 The name of the producer.
 Address of the production unit (e.g. city, country).
 The registration number of the producer with the Brazilian Authorities, the stamp of the
Brazilian Controlling Authority and its number needs to be put on the label.
 The lot number, in conformity with the Regulation No. 317/97 of the Ministry of
Agriculture.
 The expiry date, in conformity with the Regulation No. 371/97 of the Ministry of
Agriculture.
 The weight or net content.
 The following expression – “label approved by the Brazilian Ministry of Agriculture under
the No. ___”,
 The country of origin.
 The complementary instructions on the conservation and use of the product could be shown
on the label.

According to the Brazilian legislation, the labels of the products of animal origin must be affixed
in the country of origin of the products.

Labelling Requirements for Cosmetics

Cosmetics are also subject to very strict labelling requirements in Brazil. The new regulation on
cosmetic products is Regulacion 335/99. After 1999, cosmetics were divided into two groups:-

 Group 1 – included cosmetic products without special claims. Products in this Group need to
comply only with a notification to the Ministry of Health (Agency for Sanitary Vigilance).
 Group 2 – included the products with special claims (e.g. sun filter creams). Products in this
Group have to be submitted for registration.

Therefore, if an importer wants to import products from Group 1, only the Ministry of Health need
to be notified, and the a sample of the product label presented to them. One month after the
notification, the importer can import the product, without waiting for the approval of the Ministry
of Health.

The importation of products in Group 2 require submission for registration. The importer should
present a file to the Ministry of Health, including chemical formula of the product, the labels and
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packaging, the specification of the products, the mode of preparation, and the results of the
laboratory tests performed in the country of origin. The deadline for registration is three
months, however, in case of problems, the registration can take upto six months or one year. The
importer should wait for the publication of the registration number in the Official Journal. This
registration number must be on the label. The cost of registration is around Euro 2,500. The
registration is valid for five years and the cost for the renewal of the registration is around Euro
1,250. If minor changes are made in the product formula, a new application for registration should
be made.
The label for cosmetic products should contain the following information in Portuguese:-
 Name of the product.
 Trade mark.
 Lot number.
 Expiry date (e.g. month/year).
 Net content.
 Country of origin.
 Producer and importer.
 Direction for use (in needed).
 Warnings (in needed).
 Composition and ingredients.
 Fiscal number of the importer.
 Registration number of the product or if it is a group 1 product, the need to state that the
product is exempted from notification under Regulacion 335/99.
The Brazilian law of 1977 requires a principal and secondary packaging, however, the provision is
not applied and all the information could be attached on the principal packaging. If the product is
too small, the information could be displayed on the attached notice. It should be noted that
INMETRO (Brazilian National Standardisation Agency) requires that the minimum size of the
letters should not be less than 1mm (Decree 79.094).
Labelling Requirements for Textiles
Labelling requirements for textiles have been modified by the Resolucion 01/2001 of CONMETRO
of May 31, 2001. The Resolution implements into the Brazilian legislation the MERCOSUR
Resolution No. 9/2000 on textile labelling. According to the legislation, the textile labels should
bear the following information:-
 Name of the producer, exporter and importer (CUIT number of the importer).
 Country of origin (only the identification of regional blocks is not admitted, the country of
origin according to the rules of origin should be indicated).
 Fibre content (expressed in percentage, in decreasing order).
 Identification of size.
 Care instructions (e.g. washing, drying, ironing, etc.).
Some rules on the product’s packaging are also included. The country of origin and the composition
should be indicated on the packaging of the product if the packaging is non-transparent and does
not permit the consumer to identify all the information displayed on the product. Detailed
information on the new rules and the samples of label could be found on the website of the
Brazilian Textile Association on www.abravest.org.br.
 13
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Canada

The following are the basic labelling, marking and packing requirements, which are provided to give
a general idea of the Canadian regulations.

Labelling Requirements for Foodstuff

Under Canadian rules, the foodstuff products imported and commercialised in Canada must be
market with:-

 Specific bar code.

 Nutritional information.
 Warnings on the presence of allergens.
 Specific measuring (in ml, mg, bouchee, etc.)

In addition, it is also required to affix the inspection logo, the country of origin and the weight. It
must be stressed that the exporter/importer has access to a specific service of the Canadian
Food Inspection Agency (CFIA) in order to verify the compliance of the label of the product with
the Canadian requirements.

There are some additional requirements existing at provincial level (i.e. Quebec for fish products).
The importer/exporter must, therefore, contact CIFA local staff to become familiar with these
local requirements.

Labelling Requirements for Textiles

Under the Canadian Textiles Labelling Act, the product must only be marked with four types of
data:-

 CA number (registration number of the exporting company).

 Country of origin.
 Fibre content.
 Cleaning instructions.

It is required that the label contains the business name of the importer, manufacturer or
distributor, as well as the postal address OR the CA number, which can be requested from the
Industry Canada Administration.

Labelling Requirements for Electrical Equipment

Electrical equipment has specific labelling requirements for voltage, power and safety.
 14
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Chile

The general labelling requirements in Chile are established by Law No. 19.496 on the protection of
consumer rights. Article 32 of the Law states that the basic information on national and imported
products, such as their identification, the use instructions and guarantees should be in Spanish.
This information should be legible, conspicuous and in conformity with the regulations applicable in
the Country. Other languages are also permitted on the label. The information shown on the label
cannot be misleading for the customers. In addition to these general labelling requirements, Chile
has additional labelling requirements on foodstuffs, drugs and foodstuffs for medical use and
cosmetics.

Labelling Requirements for Foodstuffs

The labelling requirements for foodstuffs were established by the Decree (Docreto supreme) No.
977 of 13-05-1997. This Decree applies to all the foodstuffs designed for human consumption and
to additives. According to the Decree, the labelling of pre-packaged foodstuffs should contain the
following information:-

 Food name.
 Net content expressed in units of the decimal metric system.
 Name and legal address of the manufacturer, packer, distributor or importer of food
products, according to the situation.
 Country of origin (compulsory for the domestic and imported products).
 The number and the date of the resolution and the name of the Health Service that
authorises the establishment that elaborates or packs the product or allows the entry.
 The date of manufacture or date of packaging of the products, which should be indicated
on a visible place and in the following order:-
o The day, with two digits.
o The month, either with two digits or the first three letters of the month.
o The year, with two digits.
 The date of expiry, presented in the same way as the date of production.
 All ingredients and additives must appear on the label with the specific name in quantity or
percentage and in decreasing order.
 Additives indicated with their specific names.
 Storage instructions.
 Use instructions if needed.

It has to be underlined that for imported products, it is required to affix to the label the ‘day’ and
the ‘number’ of the ‘Resolution’ from the Health Service authorising the importation of the
products. This authorisation is given after inspection by the Health Authorities of the products
to be imported at the port of entry. However, the products which are frequently imported, the
Health Service could authorise the labelling in the country of origin. This authorisation should be
requested by the importer or his representative. A previous importation is then considered as a
reference. The Health Service’s ‘Resolution’ number is to be indicated on the labels in the country
 15
of origin. The products imported under this modality must have been stamped on the package with
its lot number.

All the information, specified in the Degree, which is not indicated on the original label or is not in
Spanish, or is not indicated in conformity with the provisions of the Decree, must be attached as
an additional label.

Nutritional labelling is only required for the products with nutritional claims. The nutritional
labelling contains the energetic value in Kcal, the quantity of proteins, carbohydrates and fat in
grams, the quality of any other nutrient, dietetic fibre or cholesterol.

It should also be noted that the importation of agricultural products from animal origin is
authorised only if the establishment of the producer is homologated by the Chilean Sanitary
Services (CSS). In order to be inspected by the CSS, the producer should already have been
homologated in the country of origin of the products. The CSS inspectors should be sent to the
exporting country in order to certify the establishment. The homologation is valid for a two year
period.

The importation of genetically modified food (GMO) is prohibited in Chile.

There are specific standards defining the essential characteristics of the products for milk and
milk products, ice-creams, fat and oils, meat products, fish, seafood, eggs, products with cereals,
sugars and honey, jams, canned products, pickles, dehydrated soups, spices, condiments and sauces,
mineral water, non-alcoholic drinks and food for special dietary uses.

Labelling of Food for Medical Use & Drugs

The labelling of food for medical purposes and drugs are regulated by the Supreme Decree No.
1876 of 1995. These products are subject to pre-marketing registration with the Institute of
Public Health (www.ispch.cl). The application for the registration must include inter-alia three
copies of the labels in Spanish, as well as copies of the packaging and information notice. The label
of the products must contain at least the following information:-

 The name of the product.

 The pharmaceutical form.
 The net quantity.
 The formula composition, and active ingredients.
 The name and address of the producing laboratory and the importer.
 The administration of the product.
 The use instruction and the precautions for use.
 If the product needs prescription or not.
 The expiry date.
 The number of the Institute for Public Health register followed by the lot identification of
the product.
 The storage conditions.
 Other information, which could be considered necessary by the Institute for Public Health
and which will be attached after the registration procedure.
 16
The labels should be attached on the external part of the packaging and should not be in contact
with the product.

Labelling Requirements for Cosmetics

Cosmetics should also be registered with the Institute of Public Health prior to importation
(Supreme Decree No. 1876). The importer applying for the registration should present two copies
of the label and the information notices. The labelling of cosmetic products should contain the
following information:-

 The name of the product.

 The cosmetic form.
 The net content according to the metric system.
 The complete formula including first the active ingredients. If it is not possible to list the
formula on the product, an additional information note should be attached to the product.
 The name and address of the manufacturer and the importer.
 The use instructions and precautions.
 The expiry date.
 The number of the Institute for Public Health register followed by the lot identification of
the product.
 Any other information, which could be considered necessary by the Institute for Public
Health and which will be attached after the end of the registration process.

Labelling Requirements for Textiles

Normal and care labelling is needed for the apparel and textile products, however, Western
labelling regulations are generally accepted.
 17
Brief Notes on Labelling, Marking & Packaging Regulations

Country: China

Since April 2001, Chinese Authorities have issued significant modifications to the labelling
requirements applied for imported products, which cover cosmetics, and foodstuffs. Additional
requirements exist for electronic appliances, textiles, and pharmaceuticals

Labelling Requirements for Foodstuff Products

From 1999 onwards, the Chinese Authorities have progressively modified the labelling
requirements for foodstuffs. In addition, they have issued a text called ‘Order 19’ which is
implemented since the end of 2002. This text has established the procedures for the approval of
labels before the importation process.

According to the Chinese food standard GB 7718-94 (part 4, mandatory labelling), the imported
food products shall carry the following data:-

 Name of the food (should indicate the true nature of the food).
 Name of the manufacturer, together with complete address, telephone and fax numbers.
 Name and address of the distributor.
 Brand name of the product.
 Standard certification number.
 Quality grades in accordance with the product standard or enterprise standard.
 Production date.
 Net content and drained weight.
 List of ingredients: ingredients in descending order of weight or volume at the time of the
manufacture of the food (as well as ingredients composing a compound ingredient which
represents above 25% of the food).
 Food additive names should be in line with Chinese standard GB 2760.
 Date of manufacture.
 Date of packaging.
 Expiry date or minimum durability date (year/month/date).
 Country of origin.
 Storage conditions.
 Special labelling when treated with ionising radiation.

The Label Approval Procedure – Order 19

These measures cover the examination and control of labels of pre-packed products for import or
export. CIQSA is the authority in charge of the monitoring, the examination of the labels and the
delivery of the certificate. Under Order 19, there are three steps in the procedure:-

 Preliminary examination of the labels and products to be imported.

 Control of labels.
 Delivery of the final certificate of approval.
 18
Order 19 replaces and removes the provisions of the rules on the management of labels for the
foodstuff products No 158-1994 and 112-94 (article 21).

For the first step (preliminary examination), the importer must present a request for approval of
the product labels to be imported to the State Bureau of Control & Quarantine (article 6 & 10).
CIQSA, the accredited authority, conducts the initial examination through one of its local offices
in China, who send the product to laboratories for a first set of chemical analysis. The request to
CIQSA must contain the following:-

 The official request for label approval – form to be filled in with three copies (see
www.ciq.gov.en).
 Submission of the description of the design of the label and the appropriate attestations.
 The description of the contents mentioned on the label.
 Six samples of the proposed labels or at least a picture of equivalent effect.
 Documents on the sanitary allegations and the verification methods.
 Attestations that the product has been legally manufactured and commercialised in the
country of origin.
 Any other appropriate documents.

The regulations regulating the labelling of imported products is issued by the State Bureau of
Technical Supervision as GB 7718-94 (general rules for the labelling of the foodstuffs products).
The following are the compulsory requirements of this regulation:-

 Name of the product.

 List of ingredients.
 Weight and net volume of the product.
 Name and address of the producer and retailer.
 Date of production.
 Instructions for the product conservation.
 Level of the quality of the product.
 Code of the norm of the product.
 Mention of any special treatments applied to the product – if applicable.

Regulation GB 7728-94 also contain voluntary standards which are non-compulsory.

If the labels are found in conformity with these rules, the State Office of Control and Quarantine
delivers a ‘certificate of examination of foodstuffs for import/export’. The products for which
such a certificate is delivered are listed in a document.

For the second step (control of labels), the importer must request tests on the imported products.
The certificate of examination has to be presented with a request for testing. The testing
authority will check the following:-

 If the label on the sample is the label already examined in the first phase.
 If the content description on the label corresponds to the content of the tested product.
 If the label examined can be used in the country of distribution.
 19
For the third step (final certificate of approval), the registration office for labelling will conduct
the final investigation and deliver the ‘certificate of examination of foodstuffs products for
import and export’, which is published and transmitted to the CIQSA.

Finally, attention should be drawn to the fact that there are also requirements on the ‘price labels’.
These labels must be approved by the Price bureau. Requirements are:-

 Brand name, as officially registered on the trade mark.

 Model.
 Size (e.g. medium).
 Place (province level).
 Sales price.
 Bar code.
 Approval of the (local price bureau (ex Beijing) (special logo-hologram).
 Quality level: quality number product.

Controls conducted on the price label are very strict.

Labelling Requirements for Cosmetic Products

In terms of classification of the cosmetic products, under Chinese standards, all cosmetics are
divided into two categories:-

 Cosmetics for ordinary use – refers to hair shampoo, hair conditioner, face wash, facial
mask, colour cosmetics, perfume, nail decoration products, etc.
 Cosmetics for special use – refers to sunscreen, hair grower, hair dyes, deodorant, sliming
products, freckle remover, breast beautifying, hair perm products, depilatory products.

Labelling Requirements for Imported Products

National Standards of China establish general labelling requirements for cosmetic products
(imported and domestic). These standards are contained in various texts. Most importantly is the
Standard GB 5296 3-1995 (General labelling of cosmetics), also relevant may be standards GB
7916-87 and GB 7916-199 of May 1999.
In addition, before April 2000, imported cosmetics needed to be pre-market and registered at the
Ministry of Health (MOH), while ordinary domestic products were only subject to notification
needed two months after the product’s launch in the market. In April 2000, the Chinese
Authorities issued new rules additional to those existing regarding the delivery of a certificate by
the MOH. These rules have implemented the requirement for the importer to obtain a certificate
of the label for the product to be imported. Therefore, all imported cosmetics are currently
subject to a double pre-market registration at the MOH and AQSIQ (Administration for Quality
Supervision & Inspection & Quarantine). The lead time for both registration is around 6-12
months.
General Labelling of Cosmetics

The Standards provide for the fundamental principles for general labelling of cosmetics, including
basic labelling requirements and contents labelling. Different forms of labelling are to be used,
according to the product features:-
 20

 Labelling directly printed or pasted on the product container.

 Labelling on the individual package.
 Descriptive materials enclosed in the individual package.

The content of labelling of cosmetics should be simple, clear and contain scientific and exact
information. The labelling of cosmetics should provide a practical introduction of the product,
without exaggeration and false advertisement content. All medical terms that may be easily
confused with pharmaceuticals should not be used. The regulations indicate the compulsory data
to be affixed on the labels, with their interpretation in Chinese:-

 Name of the product.

 Name and address of the manufacturer (including the packing firm and the sub-packing firm
of the product).
 For imported products – the name of the original production country or region, the name
and address of the manufacturer or the distributor importer or the legally registered
agent in China for the product.
 Net weight or net volume.
 Date of production (year, month, day) and quality assurance period (months or years) OR
batch number of production and expiry date (e.g. please use before … month/year).
 Production licence, hygiene licence, product standards numbers. For imported products –
the number of the approval document for the hygiene license.
 For special application cosmetics, the number of the approval document for the hygiene
license of these cosmetics.
 Safety precautions and indications (if necessary).
 Storage conditions to ensure quality assurance period and safety requirements (if
necessary).

Naked products with small volume and without any individual package (e.g. lipsticks, cosmetic pens,
etc.) on which the descriptive elements are difficult to be indicated, the name of the product and
the name of the manufacturer should be indicated only. For some special raw materials, contents
should be marked in accordance with the standard GB 7916.

The label should remain readable and should not fall during transportation. The wording should be
in Chinese characters. Chinese and foreign language may be used together. The measuring of the
content should be in the Chinese measuring unit system.

Registration Procedure by Ministry of Health (MOH)

This procedure applies to any imported product aimed to be marketed in China. These products
need prior approval by the MOH. The MOH issues a Hygiene Permit, whose registration number
should be affixed on all products sold in the market. The procedure includes two steps, namely (1)
testing, and (2) evaluation.

1 – Testing
Product composition testing is performed by designated laboratories according to Chinese
Standards. The tests aim, in particular, at finding out whether the product contains heavy metals,
the pH values forbidden and restricted substances. It is understood that 20 samples for product
 21
testing are required and that files have to be presented in 13 copies. Testing fees are according
to product category and can vary from US$600 to US$4,000. Lead-time taken is generally three
months for special use cosmetics and two months for ordinary cosmetics. For new companies, it is
estimated to take around four months. Products failing to pass any of the tests (chemical,
microbiological, safety) are rejected and there is no complaint procedure. If a product fails, the
tests are repeated (and fees charged) until passed or the composition of the product is changed.

2 – Evaluation
A file including a compulsory extensive listing of documents has to be prepared for the submission
to a panel of experts designated by the MOH. Such evaluation commissions meets four times a
year in Beijing only and can ask for any additional information they feel necessary. The panel of
experts examines the cases during two weeks and submits their reports to the MOH. For this
service, additional samples and fees are requested at US$240/product. Among the documents,
the importer has to provide proprietary information such as quantitative and qualitative formula
and the manufacturing process – these documents are provided in 13 copies/product. Since
information is often requested by the panel, the final decision is often delayed and rejections
cannot be challenged. Once the panel has finalised its decision, the results are submitted to the
MOH where two more months are necessary to get the final approval.

The Label Approval Procedure – Order 21

It should be noted that ‘Order 21’ is applicable to cosmetics and is the equivalent to ‘Order 19’ for
foodstuff, and the label approval procedure is basically the same.

Labelling Requirements for Pharmaceutical Products

Pharmaceutical products are subject to a registration procedure. State Drug Administration

issued a ‘Regulation for the Administration of Drug Packing, Labels & Insert Sheets (SDA Order
No. 23, which came into operation in mid 2002). The main provisions of this regulation are as
follows:-

 The regulations establishes general standards for packaging, labelling and insert sheets
(article 1). The standards are compulsory and all drug packaging, labels and insert sheets
should be printed according to these requirements. In order to be sold or used in China
they should be printed in the Chinese language as the main language and adopt the Chinese
simplified characters published by the State Working Committee of Language & Written
Characters. Additional text or graphics must be approved by the SDA (articles 2 & 3).
 The generic name of the product shall not be less than 50% of the size of the brand name.
Space shall be left between the generic name and the brand name, the two names shall not
be printed as on word (article 5). To be marked, the brand name shall previously be
approved by SDA (article 6).
 As for other products (article 7), the information should be presented in clear and readable
characters. No stickers are allowed.
 The regulation provides specific indications for inner and outside packaging (article 8), inner
packaging labels and outside packaging labels (article 9), and insert sheets (article 12). The
SDA approves the content of the insert sheet. The content of both inner and outside
 22
packaging of a drug shall not exceed the prescribed content of the insert sheet approved
by SDA.
 The regulations annexes formats for insert sheets. It includes requirements for packaging
and labelling of active ingredients. It require stability tests if the inner packaging is
changed.

Labelling Requirements for Electronic Appliances

Electronic devises are subject to certification requirements. They must also comply with specific
labelling requirements and should carry a specific sticker of CCIP (attesting of a former
commodity inspection carried out by CIQSA. The mark is the sign of a commodity certificate.
Production plants are visited by Chinese officials or private companies inspecting on behalf of
Chinese Authorities. The number of the manufacturer is printed on the label.

Labelling Requirements for Textiles & Clothing Products

There are specific labelling standards for textile products (GB 5296.4). This norm establishes the
basic principles, the content of labels and the rules applying to the labelling of textile and apparel
products sold in China. The labels should contain the following mandatory data:-

 Name and address of the manufacturer.

 Name of the product (in accordance with Chinese standards).
 Size (in accordance with Standard GB 1335).
 Product composition – name and composition of the various raw materials utilised.
 Cleaning instructions (compulsory use of symbols defined by GB 8685).
 Storage conditions and other recommendations – compulsory for delicate products.
 ‘Best before/ - only for products perishable. Date of manufacturing and expiry date (year,
month, day).
 No of standard.
 Quality classification (if required by a Chinese standard).

According to the product, labels can be attached in the following manner:-

 Printing or direct weaving into the fabric.

 Label sawed, or affixed or stitched to the product.
 Printing or pasted to the packaging.
 In the documents accompanying the product (point 6.1).

Some data must be affixed in a permanent label – model, type and specification of the product,
product composition and cleaning instructions (point 6.2). Some products, such as woollen socks,
can be exempted from permanent labels. These labels should be affixed in a visible place. For
clothing product, labels for model, style and specifications should be affixed in the middle of the
collar. Cleaning instructions and product composition should be affixed in specific places. Labels
for scarves, ties and house linen should be affixed at specific places (point 7.3). For fabrics, the
labels can be hanged, printed or woven (point 7.4.1). The content of the instructions must be clear
and precise and visible (point 8.1). The compulsory data should be written in Chinese characters.
These should not be smaller than the foreign language characters (Point 8.2). The label should
remain during the time of the product utilisation (point 8.3).
 23
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Colombia

Imports into Colombia must comply with the following labelling and marking requirements which are
covered by several regulations:-

Labelling Requirements for Food Products

Food products are subject to special labelling requirements aimed at protecting the consumers
health. These requirements apply to domestic and imported goods. All food products imported
into Colombia must be previously registered. The national Institute for Vigilance for
Pharmaceuticals and Foods (Instituto Nacionale de Vigilancia de Medicamentos y Alimentos –
INVIMA) is the relevant competent authority for the registration of the goods in the sanitary
register – exporting companies can find all the necessary information and the guide on product
registration and labelling at www.invima.gov.co). The registration is required in accordance to
Decree 3075 of 1997, which states that all food products introduced into Colombia should be
registered in the sanitary register. The registration is not required only for natural foods, such as
fruits and vegetables that have not undergone any transformation, frozen meat which has not
undergone any transformation and food imported for industrial use. The registration is valid for
10 years. In order to obtain the registration, the importer should submit the following documents
to INVIMA:-

 The application form with the name and address of the applicant, the name and the address
of the producer, the name and the mark of the product.
 The certificate for free sale from the country of origin.
 The payment of the registration tax.

The importer should also submit two copies of the label of the product to be imported. The
registration should be obtained before the entrance of the product. According to the law, the
products should be inspected during customs clearance in order to determine if all the labelling
requirements are correct and if the product is registered. The following information should be
indicated in Spanish on the label of the food products:-

 The name of the products.

 The ingredients of the product in order of pre-dominance.
 The name and the address of the importer and producer.
 The number of units.
 The instruction for storage and use (when required).
 The expiration date.
 The number of the registration in the Sanitary Register.

According to the law, the products must be labelled when the packages are being printed, but the
Authorities have tolerated stickers.

Labelling of Cosmetics & Drugs

Cosmetics are subject to specific labelling requirements. All cosmetics imported into Colombia
must be subject to registration in accordance with Decree 218 of 1998. The national authority
 24
responsible for this registration is INVIMA, as is the case with food products and beverages. The
importer must provide INVIMA with all the necessary technical information – see
www.invima.gov.co - and the copy of the label for the product which is to be sold in Columbia. The
label of cosmetic products must contain the following information:-

 The name and address of the importer.

 The name and address of the manufacturer.
 The country of origin.
 The content.
 The ingredients.
 The lot number.
 The instructions for use.
 The number of Sanitary Register.
 The country of shipment.
 The expiry date.

The labels should normally be attached in the country of origin, however, the Customs tolerate the
stickers being affixed during clearance.

The harmonisation of the labelling requirements for cosmetic products has been achieved by the
Andean Community through the implementation of Decision 516. This stipulates that the cosmetics
should be registered in the Sanitary Register of one of the Andean Community countries.

Drugs are subject to a similar registration procedure. In addition to the labelling requirements
needed for cosmetic products, the drug label must contain:-

 The generic and commercial name of the product.

 The net weight and volume.
 The weight or quantity of the active ingredients.
 The license number.
 The loc control number.

Labelling Requirements for Textile Products

Textile products are subject to specific labelling requirements under the Decree 087/93. The
following information is required, which is mandatory for textiles and apparel products:-

 The name of producer and importer.

 The country of origin.
 The textile care instructions.
 The percentages of fibre contents.
 25
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Japan

Food Labelling

In Japan, food labelling is governed by the JAS System, which is a mixed system of voluntary and
mandatory labelling and provisions of the Food Sanitation Law (Article 11). The mandatory data to
be affixed on a ‘single label’ are:-

 Name and address of the manufacturer – there are no specific formal requirements
regarding the name and address.
 Name and address of the importer - there are no specific formal requirements regarding the
name and address.
 Name of the product – there are no specific requirements. The name of the product should
NOT be translated into Japanese.
 Raw materials (in decreasing order by percentage of weight) – see relevant section below for
details.
 Content (volume).
 Expiry date – retail products should carry an expiry date which is above five days validity.
 Storage conditions – there is some flexibility for the producer to indicate the best storage
conditions recommended to the consumer Japanese rules propose a rough wording that can
be used as an example (it is not mandatory to stick to this specific wording). It must be
stated whether the product can (or cannot) be stored at the room temperature or needs to
be stored in a refrigerator. If should also be added (if necessary) whether the product
should be stored in a place where there is no direct sunlight.
 Country of origin (compulsory for some products) – under the JSA System, it is required
that some products should be labelled with the country of origin (e.g. mandatory for fresh
fruits and other perishable items). For perishable marine products, it is compulsory to
indicate the name of the water area, name of the port or prefecture in which the seafood
has been fished. For some processed foods, it is now also compulsory to indicate the place
where the raw material was produced (e.g. for pickled plum/scallion).

Ingredients/raw materials

Under Japanese rules, all ingredients should be listed in the labels. Under the Food Sanitation Law
(FSL), there are additional requirements on the ‘additives’. The KSA exporters should use as a basis
the ‘Positive List’ accepted ingredients. The ‘Positive List’ can be requested from the Standard
Division of the Ministry of Health. Under the same FSL, there are also additional requirements on
the presence of allergens for some products, including:-

 Eggs  ‘Soba’ – type of spaghetti

 Wheat  Peanuts
 Dairy milk products
 26
The presence of these products, as part of the raw materials in the processed foods, should be
indicated. For example, if a given product contains milk proteins, this should be indicated on the
label. There is a tolerance level (1dg to 9 dg) under which this stipulation is not compulsory. In
addition, there are 19 items that could cause less serious allergy reactions, in which Japanese
Authorities encourage the industry to indicate their presence in the fool processed products (this
is voluntary), which mainly include:-

 Salmon eggs  Crab  Peach

 Salmon  Chicken  Apple
 Shrimps  Walnuts  Gelatine
 Kiwi  Soya beans  Pan potato
 Beef  Mushrooms

Under the Sanitation Law there are additional labelling requirements for specific products, which
need to be checked.

Organic Food Labelling

Labelling of organic food is also an important issue as these requirements are in addition to the
existing JSA System - new rules have been issued for organic and biological products. Under the
new rules adopted by the Japanese Authorities, there is a compulsory certification procedure,
which has been implemented since 1/1/2002. It is now strictly forbidden to sell organic products
without the approval of the Japanese Authorities (JAS marking). The importation of an organic
product can either go:-

 Through certified importers OR

 Directly from the exporter to the customer, but it must be labelled with the eco-label
before shipment. The eco-label is given by a Japanese authorised organisation.

Genetically Modified Organisms (GMO)

Since April 1, 2001, Japan has enforced new rules for GMO labelling. Provisions cover about 30
products processed with corn, soya, potato, etc. The presence of a GMO product must be indicated
in the label. The Japanese Quarantine Authorities will take samples and proceed to testing at the
port of entry. In addition, sanitary control is conducted by local Municipal Officers in the retail
market.

Textile & Apparel Labelling

Cleaning instructions for textiles are to be affixed in a text in the Japanese language.

Other Product Labelling

Under the Quality Indication Law, applicable to consumer products, there are some mandatory
labelling requirements for some consumer products as per the following:-

 Textiles – some 35 product are concerned.

 Synthetic resin products – bathrooms, kitchen, plastic bags and polyester bags.
 27
 Electrical appliances – refrigerators, cooker, water boilers, washing machines, electric coffee
makers.
 Furniture – wood and non-wood products.
 Miscellaneous – various products.

It is not compulsory for the label to be affixed in the country of origin but can be affixed by the
importer before the product goes into the retail market. There are no compulsory requirements
concerning the size of the printed characters, however, the compulsory data to be affixed are:-

 Size or dimension of the item.

 Material (e.g. natural wood).
 Surface processing (if resin).
 Cushion material.
 Care instruction (e.g. not to be exposed to the sun). This is mandatory only for some
components (e.g. synthetic leather).

Control of Labels

Under the Consumer Quality Law, importers are responsible for the compliance of their products
with Japanese requirements.

The Japanese Trade Fair Commission control the labels under the Law for the prevention of illegal
prices and illegal labelling.

The Centre for the Food Quality Labelling and Consumer Service purchases goods and checks the
products distributed. It also conducts inspections in the plants. This Organisation was part of
MAFF (Ministry of Agriculture) but is now independent. Once a violation has been identified, MAFF
will ask the retailer to correct the product mislabelled. If the label is not adequately modified, an
order will be issued against the retailer. A maximum fine of Yen 500,000 can be imposed – local
governments can also issue similar instructions on behalf of MAFF.
 28
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Mexico

Mexican rules on labelling and marking are non-comprehensive and complex. The importer will have
to comply with general rules and, if the imported products are subject to specific requirements,
with these specific requirements. The basic, general requirements are set out in the following:-
 Federal Law on Measurement & Normalisation (‘Ley Federal Sobre Metrologia y
Normalizacion’) – these are the basic principles governing the compliance with the Compulsory
Mexican NOM’s (including on labelling), which cover:-
o The aim of the NOM’s (Norma Oficial Mexicana) are identified in Article 40.
o Compulsory compliance in Article 53.
o Accreditation of Verification Units in Article 68.
o Control of compliance in Article 89.
o Penalties in Articles 112 – 113.
 Regulation on the Federal Law of Measurement & Normalisation – implements the provisions
of the Law (obligation to comply with the NOM’s of commercial information, competencies of
the administration to issue interpretation criteria on the NOM’s, etc.
 Law on External Trade (‘Ley de Comercio Exterior’) – the Law establishes the NOM’s whose
compliance will be checked by the Customs Authorities at the point of entry, as per Article
26.
 Agreement Establishing the Verification Procedures for Imported Products Complying with
NOM’s 050 & 050 (‘Acuerdo por el que se Establecen los Procedimientos de Verificacion a que
se Sujetaran los Importadores de Mercancias que Opten por Cumplir con las normas Oficiales
Mexicanas’ NOM-050-SCFI-1994 y NOM-050-SCFI-1994 en el Territorio Nacional – Diario
Oficial de la Federacion [DOF] el Feb. 24, 1997) – the Agreement has set several voluntary
options for the compliance of the commercial information with the NOM’s.
 Agreement on the Tariff Items for which Compliance with NOM’s if Verified at the Border
(‘ACUERDO que Identifica las Fracciones Arancelarias de las Tarifas de la Ley del Impuesto
General de Importacion y de lay Lei del Impuesto General de Exportacion, en las Caules se
Clasifican las Mercancias Sujetas al Cumplimiento de las Normas Oficiales Mexicanas en el
Punto de su Entrada en el Pais, y en el de su Salida’ DOFI of June 2, 1997, y refermado el
Oct. 10, 1997, y el Dec 16, 1998) – this text lays down the voluntary options for compliance
with the requirements of Article 6 (e.g. it allows the importers, as an alternative to
compliance before importation, to comply with the labelling requirements in Mexico).
 Customs Law (‘Ley Aduanera’) – various provisions apply to compliance with labelling
requirements and their control by Customs Authorities (e.g. clearance process in Article 43,
sanctions for non-compliance with the NOM’s in Article 178, embargo definitive in Article
183).
In addition the following NOM’s, establish applicable requirements for imported goods into Mexico:-
 29
NOM’s TITLE PRODUCT COVERED
NOM-004-SCFI-1994 Eliquetado de prductos textiles, prendas de vestir y sus Textiles
accesorios
NOM-020-SCFI-1997 Informacion commercial: Etiquetado de cueros y pieles Leather finished products, raw hides &
curtidas, naturals y materials sinteticos o artificiales con skins, artificial/synthetic products
esa apariencia, calzado, marroquineria, asi como los
prodoctos eleborados con dishos materials
NOM-024-SCFI-1994 Informacion commercial para empaques, instructivos y Electronic/electrical products, household
garantias de los productos electronicos, electricos y appliances
electrodemesticos
NOM-051-SCFI-1994 Especificaciones generales de etiquetado para alimentos y Foodstuffs, and other pre-packed
bebidas no alcoholicas pre-envasados beverages
NOM-120-SCFI-1996 Etiquetado de productos de cuero Leather
NOM-050-SCFI-1994 Informacion commercial – disposiciones generales para General provisions for all the products
productos

General Labelling Requirements (NOM 050)

The basic text is the SECOFI NOM 050/94(‘Informacion commercial – disposiciones generales para
productos’ of 1996). It establishes the essential labelling requirements for all products. It has be
understood in relation with the provisions set forth by the Acuerdo of June 2, 1997 (‘Acuerdo que
identifica las fracciones arancelarias de las tarifas de la ley de Impuesto General de importacion y
de la Ley de impuesto General de exportacion, en las cuales se clasifican las mercancias sujetas al
cumplimiento de la norma oficiales mexicanas en el punto de su entrada de la mercancia en el paid,
conforme a lo dispuesto por el articulo 26 e la Ley de comercio exterior’ of June 2, 1997).
The NOM 050/94 applies both to domestic and to imported products. It establishes the set of
minimum compulsory commercial information required for products commercialised in the domestic
market. Under the NOM 050, the label of the imported products must contain:-
 The name and description of products.
 The quantity (in conformity with requirements NOM 030 SCFI).
 The name of the national producer (can be required).
 The country of origin.
 The risks announcements.
 The mention of the location of the ‘user guide’.
 Expiry date.
 Name, denomination or social trade mark of the importer and its fiscal registration number.
It also allows that ‘this information could be added to the product after the clearance process and
before the retailing of the product’. Under this provision, the producer is not required to affix this
information to the labels of the goods to be exported to Mexico.
Importers can use the services of the Verification Units (VU). These Units verify the conformity
of imported products to the NOM 050/94. The basic requirements for these verification
procedures are set by the Regulation of February, 1997 – ‘Acuerdo por el que se establecen los
procedimientos de verificacion a que se sujetaran los importadores de mercancia que opten por
complir con las normas oficiales mexicanas 0050 SFI 1994, y NOM 51 SCFI, 1994 en el territorio
nacional – DOF Feb. 24, 1994. Under the Acuerdo of 1997, the importer can choose amount four
different options in order to prove the compliance with the NOM 050:-
 Under the first option (Article 6, Sect. 1), the goods will be subject to the usual Customs
procedure. The Customs officials will perform a detailed check even if, according to the
regulations, the products are subject to a random controls - according to Mexican
 30
Authorities, there are only random controls. For infringement, the Customs Authorities
charge a penalty of 2% - 10% of the good’s value.
 Other options (Article 6, Sect. 2, 3, 4) imply the use of services of the Verification Units.
The activity of the Verification Units is authorised by the Government. Goods arrive in
Customs with a document already issued by the Verification Unit (‘constancia de
conformidao’), attesting the compliance with the NOM’s requirements.
 The third option provides the possibility to verify goods in Customs warehouse by the
Verification Units.
 The last option provides the importer, under certain conditions, with an opportunity to
accomplish the verification at its private warehouse, outside the Customs.
In all cases, if Customs Authority finds an infringement to NOM, when a Verification Unit did not
find any irregularity, no sanction is imposed on the importer, unless it is the importer’s fault.
Labelling Requirements for Foodstuffs
The basic labelling requirements are set out in NOM 051, in relation to packaged foodstuffs and
beverages. It applies to all imported and domestic products destined for the consumer in the
territory of Mexico (Point 1.1). The NOM is applied jointly with three other related NOM’s, which
define general and specific labelling requirements, and are:-
 The definition of ‘net content’ and verification methods – NOM 002-SCFI.
 The general system of measuring units – NOM 008-SCFI.
 The declaration of quantity in the label – NOM 030-SCFI.
The information contained in the label must be true and must not induce the consumer into making
an error.
The NOM 051 establishes a very detailed description of the compulsory labelling requirements and
cover the following:-
 Name and denomination of the product (4.2.1).
 The ingredients list (4.2.2) – it is compulsory for products containing more than one
ingredient. Among the different requirements, it is useful to note that the ingredients must
be presented in decreasing order, all ingredients of more than 25% of content must be
described regarding its constituent elements. Some products can be described with a
generic name.
 The net contents (4.2.3).
 The name or type of the company and the address for fiscal purposes (domicilio fiscal) of the
producer. This information must be delivered to the Ministry of Economy by the importer, if
required.
 Name, denomination or type of the company and address for fiscal purposes of the importer
(domicilio fiscal). This information can be affixed in Mexico after the end of the clearance
process but before the goods go to the retail market.
 Country of origin – unlike other NOM’s (0020 or 004), denominations other than ‘hecho en’
are acceptable, for instance ‘fabricado en’, ‘producto de’, etc.
 Lot identification.
 ‘Best before’ together with conservation warning.
 Nutritional information – it is optional, except for the declaration in quantity or quality of
any nutritional property. There are also some compulsory requirements (energy content,
 31
protein content, and soda content). The presentation of the nutritional information must
comply with specific rules regarding the energy content (Kcal/100g or by portion), the
protein content (/100g), vitamins and minerals (/100g or by portion or package). A table of
balanced recommendations ‘recomendaciones ponderadas’ must be used. The NOM also gives
an example of the presentation of the nutritional information.
 Declaration of nutritional properties (4.2.9) – the declaration of nutritional properties such
as ‘dietetic’, ‘rich in vitamins’ should comply with the domestic rules applicable for this kind
of products.
 Presentation of the compulsory requirements – a label must be affixed on every single unit,
multiple package or collective package. As far as a collective package is concerned, the best
before mention and the batch number must be affixed individually on every unit. The written
information must be visible and indelible. Among the various requirements, the mark and the
denomination of the product must appear in the product’s main surfaces (4.2.10). When
information is provided in a foreign language, it must also be written in Spanish, using the
same letter size, typographic proportions and must be obvious (4.2.11).
In addition, the NOM 051 also defines criteria for:-
 Optional labelling conditions – consumer date, additional nutritional information, but with
specific conditions, instruction for use and other (4.3).
 Calculations – nutritional, energy protein (5).
 Declarations prohibited on the label (6).
 Warnings (7).
The competent authorities and the authorised Verification Units control the compliance with these
requirements.
The NOM is to be understood with the provisions of the Measurement Law (DOF 1/07/92), the
Federal Law for the Consumer’s Protection (DOF 24/12/92), the CODEX Alimentarius and norms of
implementation, the Federal Health Law and the Regulations of the Federal Health Law.
Labelling Requirements for Textiles (NOM 004)
The basic regulation is the SECOFI NOM 004/94 (‘informacion commercial – etiquetado de
productos textiles, prendas de vestir y sus accesorios’ of 1996), which establishes the compulsory
requirements to be affixed on one or various labels, and covers apparel products and accessories:-
 Commercial brand name.
 Product composition (percentage in decreasing order).
 Size (for apparel products).
 Cleaning instructions (symbols are accepted).
 Country of origin.
 Name, denomination or social reason, and fiscal registration number of the importer.
The above data can be presented in any of the permanent or temporary labels as mentioned in Points
3.6.1 and 3.6.2 of the Regulations.
For other textile products, namely fabrics, the following should be shown on labels:-
 Product composition (percentage in decreasing order).
 Country of origin.
 Name, denomination or social reason, and fiscal registration number of the importer.
 32
Labelling Requirements for Leather & Footwear (NOM 020)
The basic regulation is the SECOFI NOM 020, which lays down the requirements to be affixed for
three different categories of products, as per:-
 Finished products.
 Hides & skins.
 Artificial materials or synthetic products.
These products must comply with different labelling/marking requirements (packaging, labelling of
the scroll, labelling of the product, etc.):-
Requirements Finished Product Hides & Skins Artificial Products
Name, denomination or complete or short Yes Yes Yes
social reason of the importer OR of its
branded trade mark
Country of origin Yes Yes Yes
Generic or specific description of Yes Yes Yes
materials and optionally the finishing (can
be placed on one separate label)
Labels in Spanish language Yes Yes Yes
It must be readable Yes Yes Yes
Permanent form Yes Can be marked in a Not available
readable place of
packaging, e.g. on an
adhesive label
Specific/additional information Footwear:- When there is a Not available
combination of minimum of
two materials, indicate which
of them predominates.
Apparel:- (jackets, pants,
skirts, handkerchiefs, travel
outlets, etc.) labels on
external or internal part.
Others:- Not available
 33
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Paraguay

Paraguay possesses a wide range of labelling requirements. The Country has adopted the majority
of the MERCOSUR labelling regulations on foodstuffs, cosmetics and pharmaceuticals. In addition,
Paraguayan Authorities implement some additional labelling requirements. In some cases the
imported products must be registered before importation with the Ministry of Health, according
to the Paraguayan Sanitary Code and the registration number must be shown on the product’s label.

Labelling Requirements for Foodstuff

The labelling requirements for foodstuffs are established by the Decree 8.734/95. This Decree
imports into the Paraguayan legislation all the MERCOSUR Resolutions and covers the technical
specifications of the goods. The resolutions related to labelling of the foodstuffs are the
following:-

 GMC/RES/41/92 – concerning the size of the labels of packaged products.

 GMC/RES/12/93 – concerning the labelling of packaged foodstuffs.
 GMC/RES/18/94 – concerning the nutritional labelling of packaged foodstuffs.
 GMC/RES/21/94 – concerning the declaration of ingredients of packaged foodstuff.

According to these regulations, the products must conform to the compulsory size of letters for
the indication of the net content of the product. The required size of letters depends on the size
of the package area available:-
Size of Principal Display Area – cm2 Minimum size of Letters - mm
 Less than 10 and more than 40 2.0
 Between 40 and 170 3.0
 Between 170 and 650 4.5
 Between 650 and 2,600 6.0
 Over 2,600 10.0

The compulsory information that must appear on the label is the following:-

 The list of ingredients – in decreasing order.

 The name and address of the producer and the importer as well as the registration number
of the importer.
 The net content.
 The country of origin.
 The lot number.
 The preparation and the use instructions (if required).

In addition to these labelling requirements, nutritional labelling is compulsory for all food products
with nutritional claims. For other products, the nutritional labelling is not compulsory. The
nutritional labelling must indicate the energy value, the proteins, fat, lipids, and alimentary fibres
with nutritional value.

Under Decree 1.635/99 (implementing article 175 of the Sanitary Code), the registration for all
food products, additives for human consumption and drinks is compulsory. Registration is
 34
conducted by the Ministry of Health (National Institute for Food Nutrition). Without
registration, the goods are not allowed for clearance. The products of animals and vegetable origin
are exempted from this registration. However, they must be registered with the Ministry of
Agriculture. The registration is valid for five years and should be renewed after this period. The
registration number must appear on the labels of food products, drugs and additives.

Labelling of Textiles & Footwear

Labelling of textiles and footwear was established by Decree 18.568/97. This Decree applies to
the products of Chapters 61, 62, 63 and 64. All these products must show the following
information on the label:-

 The country of origin.

 The name and address of the manufacturer.
 The name and fiscal number of the importer.
 The product composition
o For textiles – the fibre composition should be indicated with a special mentioned of
the recycled materials.
o For products of Chapter 64 (footwear) – the composition and materials of the upper
and inner parts and the soles must be indicated.
 The care labelling is compulsory for apparel products.

The products must be labelled in the country of origin and presented for Customs clearance with
labels complying with the Paraguayan requirements.

The Ministry of Industry & Commerce has issued Resolucion 4 of 1998, covering the labels for
apparel products, which must be sewn to the product. For footwear, the information should be
stamped or put on a sticky label and stuck on the product.

Other Labelling Requirements

Paraguay implements some other labelling and packaging requirements, covering the followings
sectors:-
 The list of permitted colourings.
 The list of ultra-violet filers permitted for use.
 The requirements for registration of pharmaceutical products.
 The registration of cosmetic products.
 The list of the ingredients used in products for personal hygiene, cosmetics and perfumes.
It is important to note that all products requiring registration, and the registration number should
be affixed on the label before importation. The importers must present a copy of the labels for
the registration procedure.
 35
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Poland

The establishment of a general list containing the Polish labelling requirements is difficult, given
the fact that the rules are not contained in general regulations but differ according to the
product. For products that have to meet mandatory standards, the labelling rules are provided in
the specific standard and the pictogram of the label. For other products, regulations by type of
product exist.

The most important Act is the Act on Polish Language of Oct. 7, 1999 (Dziennik Ustaw No. 90, item
999). According to Article 7, the use of the Polish language is necessary for “denoting goods and
services, offers, advertising, instructions, information on the property of goods and services,
guarantee conditions, invoices, bills and receipts”. The use of foreign language terms for common
or brand names is forbidden. Any foreign language rendering of goods and services as well as
foreign language offers and advertisement introduced to legal commerce, shall include a
concurrent Polish version. The performance of these obligations is monitored by the Trade
Inspectorate and the Office for Competition & Consumer Protection. These laws involve a
complete change in the trade practices of foreign companies on the Polish market. The difficulties
experienced by the foreign companies were mainly related to the translation of their goods, brand
names into Polish.

The main difficulty related to the current Polish legislation is the existence of numerous
mandatory standards containing labelling requirements. The majority of these standards were
developed during the communist period. The Ministers were entitled to declare the standards
mandatory for all products sold on the Polish market. These standards are currently often not in
conformity with the internationally accepted rules for labelling. Moreover, different organisations
(such as the Polish Centre for Testing & Certification or the Polish Sanitary Inspection), are in
charge of the certification activities and market surveillance. They have, in many cases, the
responsibility to check the correctness of product labelling.

Labelling Requirements for Foodstuffs

The Decree of the Ministry of Agriculture of July 15, 1994 (Dziennik Ustaw No. 86 – ‘Labelling of
food products, formulas and additives allowed and destined for trade’), establishes the labelling
requirements for foodstuff products. According to this Decree, the food products should be
labelled with the following information in the Polish language:-

 Name of the product.

 Thermal status (fresh, frozen or chilled).
 Name and address of the producer OR the exporter.
 Production date.
 Use by/best before date.
 Shelf life.
 List of ingredients.
 Product weight.
 36
According to the Act of Polish Language of 1999, not only the products which are intended for
consumer sale, but all products (even those for wholesale or for industrial purposes) should be
labelled in Polish.

Strict controls are performed by SANEPID (the local branch of the Polish Sanitary Inspection,
where a local branch exists in every Polish Region) on labels and the composition of the products.

The Polish Authorities conduct two kinds of inspections. The first is performed when the product
is introduced into Poland for the first time. It is intended to obtain an authorisation for sale on
the Polish market for the product. The importer should prepare the following documents:-

 The authorisation form from the sanitary authorities of the country of origin indicating
that the product is authorised for sale in the country of origin without sanitary
restrictions.
 An extract of the analysis of the product and its chemical composition, if not mentioned on
the label of the product.
 The name of the product, the Customs point of entry, the address of the importer’s bonded
warehouse, the labels and the packaging which will be used.

These documents should be submitted to a Polish representative of the company or to a physical

person, domiciled in Poland, who is authorised to request the clearance from SANEPID. In
addition, a sanitary inspection performed by SANEPID is required for every shipment of
foodstuff products sent to Poland. This inspection is done after Customs clearance. The product
cannot be presented for sale without the Sanitary Certificate. Importers should invite SANEPID
to come to its bonded warehouse and to select samples for analysis. The product is subjected to
different micro-biological and chemical analysis. The analysis remains valid for 6 months. If
during this period new shipments of the same products are received, the Sanitary Certificate is
issued without new analysis, except when the physical examination of goods reveals some
inconsistency. In some exceptional cases, the companies with a very good sanitary record, the
validity of the analysis can be extended to one year. Normally, the importer should submit three
samples for analysis. In addition, they should pay for the analysis performed as well as for the
issuance of the Certificate. The process can take up to one month, which could be too long for the
products with short shelf life. In case of refusal of the Sanitary Certificate by SANEPID, the
importer can appeal to the National Institute for Hygiene.

Labelling for Other Products

There are some other products that are subject to labelling and marking requirements in Poland,
which include:-

 Footwear –this is also subject to meeting compulsory standard in Poland which contains
labelling requirements. However, the application of this norm is less restrictive compared
to the apparel products, because the labels for footwear are not verified during Customs
clearance.
 Cosmetic products – could also experience problems with labelling requirements. The
cosmetic products are subject to inspections conducted by the National Institute for
Hygiene, which verifies the conformity of the labels with Polish requirements.
 37
 All products can be subject to the verification conducted by the Trade Inspection, once the
product is put on the market. The Trade Inspection is responsible for the protection of
the consumer from unfair trade practices and conducts inspections in the shops on a regular
basis.

Labelling Requirements for Apparel Products

Apparel products are the ones most affected by the labelling and marking requirements. The
Polish norm PN-90/P-84753 state the requirements which should be mentioned on the label of
apparel products, namely:-

 The name, address and trade mark of the producer.

 The denomination and the use of the article.
 The fibre composition (in percentage terms).
 The details of the finishing of the products.
 The size.
 The details of the quality of the product.

In addition to the normal paper labels of the products, some details should be sewn into the
products, namely:-

 A label containing the name and the trade mark of the producer should be sewn on all the
apparel products except for bed linen, table line, toilet linen and handkerchiefs.
 A label with the information on fibre composition and raw materials should be sewn on the
articles.
 The articles of wool and wool mixtures – with the mark WOOLMARK.
 The articles of cotton and cotton mixtures.

NOTE: A label with the instructions for washing, ironing and the use of the products (in Polish or
pictograms) should be sewn on all apparel products, except bed linen, table linen, toilet linen and
handkerchiefs.
 38
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Russia

Two types of labelling requirements are distinguished in Russia – the labelling requirements for
industrial products and those applied to foodstuffs.

General Labelling Requirements for Industrial Products

The Russian legislation implementing labelling rules officially aims at offering a high level of
consumer protection. The labelling requirements are set up in the Law for the Protection of the
Consumer and they are explained in the Regulation of the Gosstandard No. 51121-97.

The information must be provided as a ‘passport’ for the product, as either a ‘user notice’ or as a
label, and the information must be written in Russian. The translation of the information in other
languages is also permitted. However, at the importer’s request, the information may also be
translated in the other languages of the Russian Federation. The information must include the
following data:-

1. Name of the product.

2. Country of origin.
3. Name of the producer in Russian, the correct pronunciation of the name is an obligation (the
name of the company may be additionally written in Latin letters).
4. Essential or functional use of the product or its scope of application.
5. Rules and conditions for storing, transport, use, repairing and destruction of the product (if
necessary).
6. Essential consumer characteristics.
7. Information concerning mandatory certification.
8. Address of the producer and/or the seller.
9. Net weight, essential dimensions and quantity.
10. Composition.
11. Trade mark of the producer (if there is one).
12. Production date.
13. Expiration date.
14. GOST documents used during the production of the product (only for products produced in
Russia).
15. Information concerning voluntary certification (if there is one).
16. Information about the mark of conformity to the GOST standards (voluntary).
17. Bar code of the product (if there is one).
18. Specific information for the consumer (if necessary).

Points 1 to 8 are compulsory for the producer and/or the seller. According to the complexity of
the product, the producer or the seller can provide either the total or part of the information in
relation to Points 9 to 18, in order to provide the necessary information to the consumer.

The name of the product must be in conformity with the requirements of the Standards of the
Russian Federation. Products that are non-traditional for Russia and, therefore, imported, have to
 39
be named accordingly to the International and Regional Standards. The use of characteristics as
‘ecologically clean’, ‘without radioactive danger’, ‘produced without dangerous substances’ and
others that have advertising effect are allowed in certain conditions and after authorisation by
the competent body.

If the producer is not the exporter, then the name and address of the exporter must be added to
the label. All the rules and requirements covering the essential and functional use of the product
and its scope of application must be provided in conformity with the Regulations. In order to
inform the consumer or the authorities that the product has been subject to the mandatory
certification, the producer should mark the product with a specific sign, which is in conformity
with the GOST R 50460.

The quantity and the essential dimensions of the product must be provided according to the
international system. The composition of the product must be presented in a paragraph named
‘Composition’. The trade mark of the product must be put on the product or on the label. The
expiry date must be given using one of the following expressions:-

 ‘Best during’ (day, month, year).

 ‘Best before’ (day, month, year).
 ‘Use before’ (day, month, year).
 ‘Period of use’ (day, hour, cycle, and any others).

The information must be put on all products, on one or several places where it is easily readable.
The information has to always be at the same place on the product, package or the label. If the
product is too small, the information shall be presented on an information notice attached to the
product. The information concerning the storing, transport, utilisation and destruction of the
product must be indicated, but using different colours or letters. This information is to be
affixed on the label of the product. However, for imported products, it can be provided on
stickers, on the original label, or on the product package.

Given the complexity of some products, additional GOST Regulations may apply to those categories
of products (i.e. GOST R.MEK 335-1-94 for household appliances, GOST 700-80 for textile
materials, GOST 25779-90 for toys, COST 28389-89 for ceramics, etc.).

Certificate of Conformity

The compulsory certification, GOST-R, was introduced by the law ‘On the Certification of Goods &
Services’ of June 10,1993. The Resolution ‘On the Approval of the List of Goods & Services
Subject to Compulsory Certification’ identifies the products that are subject to mandatory
certification. Once the Government has determined the products requiring mandatory
certification, the Gosstandard (GOST Standards) establishes a mandatory product list that
require compulsory certification – on a tariff code basis, related to ‘Nomenclature’ coding (e.g. HS
codes), for ease of application by Customs Authorities.

On the basis of the ‘nomenclature, Customs Authorities establish a second list of products for
which a certificate of conformity is required for import. After the revision of the Customs Order
496 of May 12, 1999, the two lists must be identical. The compulsory certification is necessary
 40
for compliance with State Standards, Sanitary Regulations which relates to the safety of life and
health of the consumer.

Certification is compulsory for domestic and imported goods that are indicated in the mandatory
list. Certification normally has to be done before the goods are shipped to Russia. However, in
some cases, importers are authorised to request that on the arrival of the goods into Russia. The
Certificate should be issued by one of the Certification bodies accredited by Gosstandard. There
are 102 authorised organisations.

In practice, the Certification scheme can be divided into two groups, depending on the identity of
the applicant – the manufacturer or the importer:-

 The producer can either request a Production Certificate for his group products OR a
Shipment Certificate – a request for each shipment.
 The importer can request a Shipment Certificate for each shipment.

The applicant proposes the Scheme and the Certification body takes the definitive decision.
Additional information in relation to Certification is provided in the following:-

 Production Certificate – is considered by some companies as the easiest way for

Certification, in particular, when they have regular business with Russia. This Certification
requires that experts from the accredited Gosstandard Bodies evaluate ‘in-situ’ the
production system of the company. The evaluation must determine the capacity of the
company to maintain the quality of produced goods, its capacity to control its production
parameters, and to maintain the same quality if its suppliers change. This procedure is not
the same as the one followed to get the ISO 9001 certification, however, if the company
already has ISO Certification the GOST-R procedure may be simplified.
 Under Russian rules, the Certification Body issues one Certificate by ‘Homogeneous Group
of Products’ (Decision 1271/97, Article 2.7). The Production Certificate is normally issued
for three years if delivered by Russian accredited experts. It is important that the
importer submit samples to the Certification Institute in Russia every six months in order
to prove that the quality is maintained.
 Shipment Certificate – must indicate the quantity, the type and references of the product,
the number of the contract and of the invoice. The exporter or the importer should
request one Certificate by tariff code. This type of Certificate is the least expensive way
of Certification (in particular when a few different products are exported), although it is
only valid for one year. If after one year, there are any unsold stocks, new Certificates
have to be requested from the Certification Body. However, it is less convenient for
exporters maintaining regular business with Russia.

The Certification is based on a contract concluded between the Certification Body and the
applicant. The price for the certification services in Russia is determined by the Recommendation
of Gosstandard ‘Payment for Works of Certification of Goods & Services’ (Recommendation R50.3
001-96, amended Oct. 19, 1999). The products are tested according to Russian Standards
elaborated by Gosstandard. In case a Shipment Certificate is required, the producer or the
importer should normally request one Certificate by tariff code contained in the Gosstandard
 41
mandatory list. However, the Certification Body can authorise the applicant to perform
Certification by ‘group of homogenous products’.

While the Certificate of Conformity is issued, the product has to be marked with the GOST R
Certification logo on the package or on the label of the product. The marking requirements are as
follows:-

 The number of the Certification Body.

 The minimum size of the mark is 8mm.
 The label and size of the conformity logo should be verified, before commercialisation by
the Certification Body.

The importer or the exporter should also provide a translated version of the original label to the
Certification Body. The Certification Body must verify the identity of the product and the
information indicated on the label. Moreover, the applicant should also submit the label for the
Russian consumer. The Certification Institute should verify the conformity of the label with the
Russian requirements and the conformity of the certification logo. This Certification is
compulsory for the sale of imported products in Russia. An inspection body from Gosstandard
carries out the inspection of goods subject to mandatory certification. It verifies whether all the
products subject to certification are sold with a Conformity Certificate.

Certification of Hygiene

The Hygiene Certification is issued in accordance with the law ‘On Sanitary – Epidemiological Well-
being of the Population’. The certification is mandatory for some products (foodstuffs, products
having contact with the skin, cosmetics, etc.). It should be undertaken before GOST-R
Certification procedure is started. The list of products, requiring this certification is not clear, as
the nomenclature is not established on a tariff base but on a product group basis. The Hygiene
Certification is needed when a new product is sold in Russia for the first time. Hygiene
Certification are under the control of the Ministry of Health (DSESC) and this Certification is
different from the Certification of Conformity issued by Gosstandard. The aim of this
Certification is to prove that the product is in conformity with the Standards for security and
health established by the Russian Federation.

The Certificate is based on ‘type of product’ and has a one year validity period. The time limit for
delivery of the Certificate is four weeks from the moment, when all the documents and samples
have been presented to the competent body. The competent body is not always the Certification
Body but the majority of the Certification Bodies are also authorised to carry out tests for the
Hygiene Certification, or have contacts with accredited laboratories. The results of the tests are
transmitted to the DSESC, which issues a registration number based on the results of the tests
and this Certificate is necessary to obtain a GOST-R Certification. The companies should present
three samples of their products for Hygiene Certification – the same samples cannot be used for
the Conformity Certification. The tests conducted on the products are bacteriological,
physicochemical and toxicological.
 42
Labelling Requirements for Foodstuffs

Labelling requirements for foodstuffs are established by Decree No. 1575 and are detailed in the
Standard GOST 51074-97. They are all compulsory, while labelling requirements for industrial
products are not. The Standard GOST 51074-97 is divided into two sections. The first deals with
general requirements and the second provides additional requirements concerning some categories
of products. All foodstuff products must be labelled as follows:-

 Name of the product, it type (i.e. concentration, sterilised, etc.).

 Name and address of the producer, packaging company, exporter and importer of the
product, country and place of production.
 Trade mark of the producer (if there is one).
 Weight or volume of the product.
 Composition of the product (ingredients).
 Nutrition value (for all the products except coffee, tea and spices) – this should be
indicated in nutritional components for 100gr or 100ml, the energy value should be indicated
in Kcal for 100gr or 100ml.
 Conditions for storage.
 Expiry date or period of conservation.
 Information about the certification of the product.

Indications such as ‘ecologically clean’, ‘home-made’, ‘containing vitamins’ cannot be mentioned

without a reference to a published document and/or after receiving authorisation from the
competent authorities. The list of ingredients should be indicated for all products, except for
products consisting of a single component. If there is an addition of a bioactive component, a
warning about possible negative effect should be present on the label. The expiry date must be
provided using on of the following expressions:-

 Best before.
 Best during.
 Use before.
 Period of use.

If the product has a very short validity term, the hour, date and month should be indicated, as
per:-

 For products having a validity period which is less than three months, the day and the
month should be indicated.
 For other products, the day, month and year of the validity period must be present on the
label.

In order to inform the consumer about the certification, the mark of conformity should be
attached to the label.

The second part of the Standard GOST 51074-94, defines the relevant information concerning
the most important categories of foodstuffs. It contains general information and some additional
information according to the specification of each product group.
 43
Labelling Requirements for Textile Products

Textile products are subject to the general requirements applied to industrial products. As these
requirements are very complex and depend on the product, it is generally considered by the
importers and traders that textile products should be labelled in the following manner:-

 The name of the product (e.g. skirt, dress, etc.).

 The model of the product.
 Name and address of the producer or of the distributor.
 Country of origin.
 Composition (the ingredients are presented by order of importance and with the
percentages).
 The size according to the Russian size system.
 Indications for washing, ironing and the use of the product.
 Bar code.
 Mark of conformity (the logo of conformity, approved by the certification body with the
number of this certification body).
 Code recommended age (for children’s clothing).
 44
Brief Notes on Labelling, Marking & Packaging Regulations

Country: South Korea

Marking and labelling requirements affecting imported products into South Korea, are divided into
two categories:-
 Products subject to voluntary labelling requirements – most industrial imported products
are subject to voluntary requirements. The products will not be checked regarding their
labels during the clearance process. The importer could label the product in South Korea,
affixing a sticker after the clearance process. This label will, therefore, be the
translation of the original label. The importer can also comply with the voluntary
requirements. These voluntary requirements are issued by accredited Agencies of the
South Korean Government.
 Products subject to mandatory requirements – some industrial products (e.g. some
textile/furniture products, and some automobile/home interior devices) are subject to
mandatory requirements. In addition, other products are subject to specific mandatory
labelling requirements (e.g. foodstuffs, pharmaceuticals and cosmetics).
The basic requirements are set out in the following documentations:-
 Quality Management & Consumer Product Safety Act – this establishes basic principles
governing the compliance with the Korean Compulsory Norms (including on labelling).
 Specific Ministry Regulations – implements the provisions of the Law.
 Official notifications – various notifications establish the applicable requirements for
imported products.
General Labelling Requirements
The ‘Country of Origin labelling’ is required for all commercial shipments imported into South Korea.
The Korean Customs Service (KCS) publishes a list of the country of origin labelling requirement by
Harmonised (HS) Code number. Additional marking and labelling requirements exist for specific
products, which are covered by specific regulations issued by the South Korean Government
Agencies.
The country of origin labelling is controlled by Customs during Customs clearance. It is the only
labelling requirement controlled during the clearance process.
Labelling Requirements for Foodstuffs
Compulsory labelling requirements for products must comply with:-
 The Labelling Standards for Food, enacted in 1996 and revised in 2000 (KFDA Notice 2000).
 The Standards of Labelling for Foodstuffs of 2000 (KFDA).
The imported products sold in the South Korean market should carry a label in the Korean language
with the following data (article 4):-
 Country of origin.
 Name of the product – unique name representing the product (not applicable to equipment or
containers and packages).
 45
 Product type – (only to specified foods) if a product type is classified in the standards and
specifications for foods in accordance with the provision of the Food Sanitary Act, the
product should be indicated.
 Importer’s name and address.
 Manufacturing date – month and year applies only to specified foods. Manufacturing date is
understood when packing is completed (article 2).
 Best before – shelf life should be indicated on the label. Some products may be exempted
(e.g. sugar, ice cream, edible ice, chewing gum in small packages, etc.). Not applicable on
containers and packages.
 Content – weight, volume or number of pieces (if the number of pieces is shown, the weight
or volume must be indicated in parentheses).
 Ingredients or raw materials and the content of the ingredients (only when certain
ingredients are used for the product name or for the product name) - the name of at least
the top five ingredients or raw materials should be indicated.
 Nutritional information for special nutritional foods – health supplementary foods, products
wishing to carry nutritional labels and products wishing to carry a nutrients emphasis mark.
In addition, according to the Labelling Standards for Food, (a) caution, (b) standards for use, and
(c) preservation must also be indicated, where required (e.g. for products that must be kept at a
low temperature). There are also additional detailed requirements for specific products (e.g.
canned products).
Labelling information should be printed in ink. Sticker can be allowed subject to the characteristics
of the product packaging. Hence, imported food products can be labelled with stickers in the Koran
language, however, these shall be attached in a way that they cannot be removed and they shall not
cover the main labelling information (including nutritional information) stated on the original
container and package.
According to the KFDA (Korean Food & Drug Administration), the foodstuffs products must be
labelled with stickers during Customs clearance. KFDA controls the stickers during the clearance.
The stickers are affixed during the clearance process by the importer. The importer must submit
the product stickers to KFDA when applying for the import licence. During the clearance process,
KFDA will inspect randomly the products and may require samples to be tested and an example of
the label in Korean checked to ensure that the label corresponds to the product. If it does not,
then the KFDA is entitled to reject the product.
Labelling Requirements for Cosmetics
The labelling requirements for cosmetics are contained in various Government documents, in
particular the following:-
 Regulations on Imported Pharmaceuticals, in force since 2000.
 Regulation on Enforcement of Cosmetics Law – in force since 2000.
 Law of Economy a& Recycling of Resources.
The mandatory data to be affixed on the label of the imported product are:-
 Size of the product.
 Manufacturing date.
 Product name (e.g. makeup, etc.).
 Caution: how to use the product (e.g. not to put it in sunshine, or cold temperature, etc.).
 46
 Ingredients – list of most important ingredients.
 Manufacturers address and full address of the importer and telephone number.
 Lot number.
For very small items (e.g. pencils) there are only the following mandatory requirements – (a) name of
the product, (b) quality, and (c) name of the importer.
Prohibition of ‘third packing’ – under the Law of Economy & Recycling of Resources, only two
packaging surfaces are authorised in Korea for cosmetic products. Therefore, the cellophane paper,
is considered as a third packaging, is prohibited. Recently, operators have been subject to
increasing controls.
Labelling of Samples – Under regulation on Enforcement of Cosmetics Law – samples which are not
aimed to be sold in the retail (but distributed), must carry a label and comply with the labelling
requirements.
Labelling Requirements for Pharmaceuticals
All imported containers and packages must be marked in a conspicuous place with the following data
(South Korean: Trade Regulations & Standards):-
 Country of origin.
 Names and addresses of manufacturers and importers.
 Name of the product.
 Date of production and batch number.
 Names and weights of ingredients.
 Quality.
 Number of units.
 Storage method.
 Distribution validity date.
 Instructions for use.
 Import licence number.
 Effectiveness.
 Import price and suggested retail price.
Labelling Requirements for Textiles
According to Korean rules, the apparel products imported into Korea must carry a label on the
fabric, sewn to the product, with the following data:-
 Country of origin.
 Fabric composition, fibre content in percentage, in decreasing order (below 5% can be
classified as ‘other fibre’). The trade accepted descriptions (e.g. Lycra) is authorised.
 Name of the manufacturer.
 Name of the importer.
 Size.
 Cleaning instructions (international symbols).
The imported product must also carry a paper label with the price of the product (CIF) and the
estimated retail price. Sometimes labels in another language can be processed during clearance
with the importer affixing a Korean language label. At other times, the Korean importer sends the
exporter, the Korean language labels to be sewn into the product directly by the manufacturer.
 47
There are also labelling requirements for:- (a) outerwear, (b) middle wear, and (c) underwear. On
July 3, 2001, the Public Notice No. 2001-384 was implemented by the Agency for Technology &
Standards (MOCIE – www.ats.go.kr). The mandatory requirements under its Article 2 are:-
 Indication of name of fibre and composition.
 Size.
 When appropriate the appropriate fabric status – (e.g. ‘waterproof’, ‘water repellent’ or
‘fibreproof’).
 When appropriate for stuffed products – stuffing materials:-
o Name of textile fibre (in percentage for certain products).
o Garments, quilts and under quilts with down – indication of the nature of down cotton,
bird down, or others, with composition indication in percentage terms.
o Caution for use.
o Manufacturer’s name.
o Date of manufacturing (year and month).
o Importer’s name.
o Address or telephone number (inc. area code).
o Country of origin.
Under Article 4, the country of origin, the manufacturing date, the importer’s name, address and
telephone number (including area code) should be shown. Distributor’s name and address or
telephone can be additionally shown. The Notice establishes a labelling method. This method
foresees in practice the use of permanent labels. However, for certain products, stickers are still
allowed, as per the following quote:-
“Labels should be in distinct letters attached to a position easily recognisable by the
consumers – unless this is inconvenient or ugly – and in a manner that the label cannot
be detached or removed (no paper labels, tags or stickers). Yarns, fabrics, wadding,
foundations, undershirts, panties, socks, gloves, swimwear, gymnastic wear, scarves,
muffles, handkerchiefs can be labelled with paper labels, tags or stickers if labels are
not detached or removed until distributed to the end users. When products are sold
to the end users in packages containing 2 or more units (excluding pairs) of the same
product, labelling on the package is sufficient.”
 48
Brief Notes on Labelling, Marking & Packaging Regulations

Country: Uruguay

In relation to general labelling requirements, Uruguay has implemented some of the resolutions of
the Common Market Group of MERCOSUR. In addition, some specific Uruguayan legislation has
also been implemented. Products entering Uruguay must comply with the National legislation, as
well as with the MERCOSUR legislation adopted by Uruguay. It should be noted that some
municipalities are also entitled to establish labelling rules and inspections.
Labelling Requirements for Foodstuffs
Labelling requirements for foodstuffs were established by Decree 315/94 (Reglamento
Broamtologico National), Decree 41/92 and Decree 41/93. These Decrees implement the
MERCOSUR rules on labelling of food products in the Uruguayan legislation. According to the
legislation, the products must bear the following information on their labels:-
 Name of the product.
 Country of origin of the product.
 Name and address of the manufacturer and importer.
 Net content.
 Expiry date.
 List of ingredients.
 Lot identification.
 Use and preparation instructions (as necessary).
In addition in 1997, the Municipal Authority of Montevideo (IMM) passed a Reglamento
Bromatologico National (a municipal ordinance) confirming the requirements of the National
legislation and explaining how the different compulsory requirements must be shown on the label.
The IMM also established the Sanitary Registration for all food and drink products. Two samples
of the products must be supplied for registration. The food products should be registered with
the Customs and with the Municipality Bromatology Division of each Province where the products
are to be traded.
According to the Decree 338/92, all food and drink products specified in Resolution S/N of Dec.
30, 1998, should be submitted during the Customs clearance process to an inspection performed
by the Technical Laboratory of Uruguay (LATU). LATU will deliver a Commercialisation
Certificate for the sale in the Uruguayan market. This Certificate indicates that the imported
products comply with the Uruguayan Sanitary and Labelling Requirements. The Uruguayan
legislation also contains requirements on the additives and colours, which are admitted in products
commercialised in the Country.
Labelling Requirements for Textiles
The Decree 59/99 establishes the conditions for the labelling of textiles. The importers should
submit to the Section Consumer Protection of the General Directorate for Trade, an original and a
copy of a note which should include the following information:-
 The name of the importer.
 The importers fiscal registration number.
 49
 The 10 digit Customs code for the product.
 The volume imported.
 The country of origin.
 A sample of the label complying with the required labelling requirements. The label should
include the following information:-
o Country of origin.
o Name and address of the manufacturer.
o Name and fiscal number of the importer.
o Product composition.
o Care labelling.
If the products are not labelled before Customs clearance, the importer will have 60 days after
Customs clearance to label the goods. However, in order to obtain the Customs clearance, the
importer should present a copy of the note submitted to the General Directorate for Trade, duly
stamped by the latter.
Labelling Requirements for Footwear
The Decree 65/00 of Feb. 18, 2000 introduced labelling requirements for footwear. According to
this Decree, the footwear labels should contain the following information:-
 The country of origin.
 The name of the manufacturer or the importer and the fiscal number of the importer.
 The principal components of the product.
The label should be affixed in a visible place and should be permanently fixed.
The procedure for importation of footwear is similar to those applicable to textile products. The
importer should submit to the Section Consumer Protection of the General Directorate for Trade,
an original and a copy of the note which should include the following information:-
 Name of the importer
 His fiscal register number
 The 10 digit Customs code for the product.
 The volume imported.
 The country of origin.
 A sample of the label complying with the required labelling requirements.
The importer should have the stamp of the General Directorate for Trade in order to import its
products.
Other Labelling Requirements
Uruguay is implementing some other labelling requirements for cosmetic products,
pharmaceuticals, medical equipment and pesticides. Some of these products, such as cosmetics
and pharmaceuticals, require registration with the Ministry of Health. The labels are verified
during the registration procedure. The other products are subject to special Decrees which
define the specific data to be mentioned on the label.
 50
Brief Notes on Labelling, Marking & Packaging Regulations

Country: USA

The legal regime of product labelling in the USA is quite complex and it is necessary to distinguish
between different products, levels and objectives. There are also labelling requirements on a
Federal and State basis. Additionally, conformity is also required under the Fair Packaging &
Labelling Act and the labelling of energy efficient products.

The Food & Drug Administration (FDA) is the specific regulatory agency responsible for all foods
(except meat, poultry, frozen/dried eggs), cosmetics, drugs, biologics, medical devices, and
radiological products. The main responsibility of the FDA is to ensure that the consumer is
protected in the US. The laws that provide the regulatory authority are as follows:-

 The Pure Food & Drug Act, 1906.

 The Federal Food, Drug & Cosmetics Act, 1938, as amended.
 The Public Health Services Act, 1944.
 The Fair Packaging & Labelling Act, 1966.
 The Infant Formula Act, 1980, as amended.
 The Nutritional Labelling & Education Act, 1990.
 The Food Quality Protection Act, 1996.

Labelling Requirements under the Fair Packaging & Labelling Act

The Fair Packaging & Labelling Act (FPLA) was enacted in 1967 (16 CFR parts 500-503), and
directs the Federal Trade Commission (FTC) and the Food & Drug Administration (FDA) to issue
regulations requiring that all ‘Consumer Commodities’ be labelled to disclose net content, identity
of commodity, name and place of business of the product’s manufacturer, packer or distributor.
The Act authorises additional regulations, where necessary, to prevent consumer deception or to
facilitate value comparison. The Office of Weights & Measures of the National Institute of
Standards (US Department of Commerce) is authorised to promote uniformity of the Federal and
State regulations on the labelling of consumer commodities.

The term ‘Consumer Commodity’ means ‘any article, product, or commodity of any kind or class
which is customarily produced or distributed for sale through retail sales agencies or
instrumentalities for consumption by individuals, or use by individuals for purposes of personal care
or in the performance of services ordinarily rendered within the household, and which usually is
consumed or expended in the course of such consumption or use’. For the purpose of the
regulation, the following are not considered as consumer commodities – foods, drugs and cosmetics,
meat/poultry or meat/poultry products, beverage products, tobacco and pesticides, because they
are submitted to the requirements of other Federal Acts. The basic requirements of the FPLA
are as follows:-

 Statement identifying the commodity (e.g. detergent, sponges, etc.).

 The name and place of business of the manufacturer, packer or distributor.
 The net quantity of contents in terms of weight, measure or numerical count (measurement
must be in both metric and pound/inch units).
 51

The FPLA provide specific information on how the net content and measures should be expressed,
the permitted variations, the representation of servings, uses, applications and the multi-unit
packages. Some commercial practices are used to express the net quantity of specific products
(e.g. camera films, replacement bags for vacuum cleaners, paper table covers, bed sheets,
pillowcases, cellulose sponges, candles, and solder).

The FTC has the right of interpretation of the FPLA and could determine which commodities would
be considered as consumer commodities. According to the FTC, there are a large range of
commodities which are not considered to be consumer commodities under the meaning of the Act
(e.g. antifreeze, artificial flowers/parts, automotive accessories and chemical products, bicycle
tires and tubes, books, brushes, brooms, etc.). The list is quite extensive. However, it is
important to note that many products that are exempt from the FPLA, nevertheless fall within the
remit of the Weighs & Measures Laws of the individual States. The FPLA contains provisions on
the effect upon the State Laws, but they intend to supersede all the laws of the States or other
political subdivisions that provide for labelling of net quantity, which are less stringent or require
different information.

Labelling Requirements for Food Products

The US Code of Federal Regulations (Title 21) establishes the rules that govern the operation for
food safety. The main parts of Title 21 are as follows:-

 Parts 1 to 99 – general requirements for enforcement of Federal Food, Drugs & Cosmetics
Act, and the Fair Packaging & Labelling Act – Colour additives.
 Parts 100 to 169 – general regulations for labelling, food standards, current good
manufacturers practices for food, bottle water, low acid canned food, acidified food,
hazard analysis critical control points for seafood.
 Parts 170 to 199 – regulations for food additives.

According to the requirements of the Federal Food, Drugs & Cosmetics Act (FFDCA), a food label
must contain specified information clearly displayed and in terms that the ordinary consumer is
likely to read and understand under ordinary conditions of purchase and use. If the label of food
bears representations in a foreign language, the label must bear all of the required statement in
the foreign language, as well as in English. The Tariff Act of 1930 requires all imported articles to
be market with the English name of the country of origin. When the food is packaged, the
mandatory information should appear on the label in English, additionally, the 21 CFR details how
the labels should be drafted and where the information should be affixed on the product, as per
the following:-

 Name of food – the common or usual name of the food should appear on the principal display
panel, in bold type and in lines generally parallel to the case of the package as it is
displayed. The form of the product must also be included – sliced, a whole or chopped (or
other style, unless shown in the picture or the product is visible through the container).
The size must be proportional to the size of the food and should be one of the most
important features of the principal display panel. If there is a standard for this food, the
name as indicated in the standard should be shown on the package. A new food, which
resembles a traditional foods and is a substitute for it must be labelled as an imitation, if
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the new food contains less proteins or a less amount of any essential vitamin or mineral.
The size of the world ‘imitation’ should be the same as the size of the name of the product.
Beverages that purport to contain juice (fruit or vegetable) must declare the percentage of
juice. The percentage of juice must be put on the information panel near the top (the
information panel is the label immediately to the right of the principal display panel, as
displayed to the customer. If this panel is not usable due to the package design and
construction, then the information panel is the next panel immediately to the right). Only
the brand name, product name, logo or universal product could be place above it. The print
should be easily legible and contrast distinctly with the other printed or graphic material.
The type ‘% juice’ must be not less than the largest type on the information panel, except
that used for the brand name, logo, universal product code or the title phrase ‘Nutritional
Facts’. The principal display panel of the food is this portion of the package label, which is
most likely to be seen by the consumer at the time of purchase. Many containers are
designed with two or more different surfaces that are suitable for principal display panel.
 Net quantity and contents – an accurate statement of the net amount of food in the
package. The required units of measure are the pound (lbs) and the US gallon but metric
system measurement may also be used, in addition to required representation in English
units. The quantity of contents must appear on the principal display panel of the labels in
lines generally parallel to the base of the package when displayed for sale. If the area of
the principal display panel is larger than 5 sq. inches, the quantity must appear within the
30% of the label. The declaration must be in a type size based upon the area of the
principal display panel of the package (as listed in 21 CFR 101.105) and must be separated
from the other information.
 The name, street address, city, state and zip code of either manufacturer, packer or
distributor – this information must be placed on either the principal display panel or the
information panel. The street address may be omitted by a firm listed in a current city or
telephone directory. Imported products labels may omit zip code. However, if the food is
not manufactured by the company whose name appears on the label, the name must be
qualified : manufactured for, distributed for or a similar expression.
 Statement of the ingredients – the food’s ingredients must be listed by their common name
in order of their predominance by weight unless the food is prepared in conformity with
existing standards. In this case, the label must include only the ingredients, which the
standard make optional. However, in food standards most ingredients are optional and,
therefore, should be mentioned on the label. The word ‘ingredients’ do not refer to the
chemical composition but means the individual food components in mixed food. If a certain
ingredient is characterising another in a food (e.g. shrimp in shrimp cocktail), the percent of
this ingredient must be required as a part of the food’s name.
 Food additives and colours - Food additives and colours are required to be listed as
additives, but the law exempts butter, cheese, and ice-cream from the obligation to show
colours on the labels. Spices, flavours and colour may be listed as such, without naming the
specific materials, but any artificial colours or flavours must be identified as such, and
certain coal-tar colours must be named specifically. In order to avoid allergies, the
ingredient list should include, where appropriate:-
o FDA certified food additives, by name.
o Source of protein hydrolysates, which are used in many foods as flavours and flavour
enhancers.
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o Declaration of caseinate as a milk derivative in the ingredient list of food, which
claims to be non-dairy, such as coffee whiteners.
 Nutritional information – two aspects need to be identified:-
o Applicable foods – under US rules, the nutrition labelling is required for most foods.
In addition, voluntary labelling is available for many raw foods (the 20 most
frequently eaten raw fruits, vegetables and fish under the FDA’s voluntary point-of-
purchase nutrition information programme, and the 45 best-selling cuts of meat
under the USDA’s programme). Although voluntary, FDA’s programme for raw
produce and fish carries a strong incentive for retailers to participate. The
nutritional information is also required for some restaurant foods. FDA requires
nutrition information for foods about which health or nutrient-content claims are
made on restaurant menus, signs or placards.
o Exemptions – under NLEA, some foods are exempt from nutrition labelling. These
include:-
 Food served for immediate consumption.
 Read-to-eat food that is not for immediate consumption but is prepared
primarily on site.
 Food shipped in bulk, as long as it is not for sale in this form to consumers.
 Medical food, such as those used to address the nutritional needs of patients
with certain diseases.
 Plain coffee or tea, some spices, and other foods that contain no significant
amounts of any nutrients.
 Food produced by small business also may be exempt, under 1993 amendments
of NEA. Companies claiming this exemption must notify FDA that they meet
the criteria before they begin marketing their products.
The nutrition information panel must begin with the word nutrition facts and contains
information on some nutrients. The nutrients are either compulsory or voluntary, as
indicated:-
COMPULSORY VOLUNTARY
 Total calories  Sugars  Calories from saturated fat
 Calories from fat  Proteins  Polyunsaturated fat
 Total fat  Vitamin A  Monounsaturated fat
 Saturated fat  Vitamin C  Potassium
 Cholesterol  Calcium  Soluble fibre
 Sodium  Iron  Insoluble fibre
 Total carbohydrate  Other essential vitamins & minerals  Sugar alcohol
 Dietary fibre  Percent of vitamin A present as beta-corotene

If a claim is made about any optional component, or if a food is fortified and enriched with
any of them, nutritional information for those become mandatory. These mandatory and
voluntary components are the only one allowed on the nutritional fact panel. Other
information cannot appear on it.

Nutritional panel format – all nutrients must be declared as a percentage of Daily Values,
which are label reference values. This amount in grams or milligrams of macronutrients
(such as fat, cholesterol, sodium, and proteins) are still listed to the immediate right of
these nutrients. A column headed ‘% daily value’ appears on the far right side. Detailed
information on the nutrition label can be found on the FDA’s website: www.cfsan.fda.gov.
 54
Labelling Requirements for Meat Products

All food products containing more than 3% raw meat or 2% or more of cooked meats, come under
the responsibility of the USDA (US Department of Agriculture). The Food Safety & Inspection
Service (FSIS) will ensure that the imported products meet the US requirements. The
importation of meat, poultry and egg products are submitted to prior approval of labels to the
FSIS (to meet 9 CRF 317.3). The producer or importer should provide to the FSIS a sample of
the label (generally called a ‘sketch’) for approval (the address for the submission of the label is:-
USDA, Food Safety & Inspection Service, 300 12th Street, SW, Room 602 Annex, Washington DC
20250, Tel: +1-202-205-0279, Fax: +1-202-205-3625, email: FSIS.Labeling @usda.gov). A request
for approval should be submitted along with the sample of the label. If the label is approved, the
company would get an approval number, which should also be applied on the label. The ‘sample’
should contain all the required information, as per the following:-

 Product name – standardised name, common or usual name or descriptive name.

 Establishment name and the country of origin.
 Inspection legend – US inspected and passed by the Department of Agriculture.
 Name and address of the manufacturer and the distributor.
 Net quantity of content (pounds and ounces) or liquid measures.
 List of ingredients – required if the product is made from two or more ingredients, and they
should be listed in descending order or predominance.
 Nutrition factors – mandatory for most products other than the single ingredient items.
The requirements are the same as for food products under the supervision of the FDA.
 Handling statements – special statement required for perishable products such as those
kept in refrigerators or need to be kept frozen.
 Safe handling instructions – must be on any product, which is not ready to eat.

Some of the labelling requirements should be affixed on a predetermined place on a product and
have a specific size (9 SFR 317.2 and 381, subpart N). It should be noted that the expiry date is
not required by Federal Law nowadays, except for some infant formula and baby food. While
product dating is not required by Federal Law, dating of some foods is required in more than 20
States.

Labelling Requirements for Cosmetics

The US legislation is more prescriptive concerning the denomination of the products, the
ingredient list and the warning statement. The importers or the producers of cosmetics, which are
mislabelled or misbranded, could undergo criminal prosecution. The cosmetic marketed in the US,
whether locally manufactured or imported, must be in compliance with the provisions of the
Federal Food, Drug, and Cosmetic Act (FD&C), the Fair Packaging & Labelling Act (FP&L), and the
regulations published under the authority of these laws.

The main information, which should be included on the label of cosmetic products, on the principal
display panel per the following (the principal display panel is this portion of the package label,
which is most likely to be seen by the consumer at the time of purchase. Many containers are
designed with two or more different surfaces that are suitable for principal display panel.):-

 Name of the product.

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 Identity.
 Warning – cosmetics, which may be hazardous to consumers when misused must bear
appropriate label warnings and adequate directions for safe use. The statements must be
prominent and conspicuous. Some cosmetics must bear label warnings or cautions
prescribed by regulation (21 CFR 740). Cosmetics in self-pressurised containers (aerosol
products), feminine deodorant sprays, and children’s bubble bath products are examples of
products for which such statements are compulsory. Although the FD&C Act does not
require that cosmetic manufacturers or marketers test their products for safety, the FDA
strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are
appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is
not adequately substantiated, the product may be considered misbranded and may be
subject to regulatory action unless the label bears the following statement: ‘Warning – The
safety of this product has not been determined. Sec. 21 CFR 740.10’.
 Net quantity of contents – according to these requirements the net quantity should be in
the bottom area of the label, by using the US measures for quantity. In addition, the
metric units could be used, but it is not allowed to use only the metric system.

The following information must be shown on the information panel (the information panel is the
panel, which is on the right side of the principal display panel):-

 Directions for safe use.

 Additional warnings.
 Name and place of business – should be understood in the same way as for food products.
 Ingredient declaration – the US legislation is very strict regarding the ingredient
statement. The ingredients should be enumerated in specific order and the size of the
letters is strictly regulated. The ingredient declaration must be conspicuous so that it is
likely to be read at the time of purchase. It may appear on any information panel of the
package, i.e. the folding carton, box wrapping if the immediate container is so packaged, and
may also appear on a firmly affixed tag, tape or card. The letters must not be less than 1/16
of an inch in height (21 CFR 701.3(b)). If the total package surface available to bear
labelling is less that 12 sq. inches, the letters must not be less than 1/32 of an inch in height
(21 CFR 701.3(p)). Off-package ingredient labelling is permitted if the cosmetic is held in
tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package
surface area is less than 12 sq. inches (21 CFR 701.3(i)). The ingredients must be declared
in descending order of predominance. Colour additives and ingredients present at 1% or less
may be declared without regard for predominance. The ingredients must be identified by
the names established or adopted by regulation, those accepted by the FDA as exempt
from public disclosure, may be stated as ‘and other ingredients’ (21 CFR 701.3(a)).
Cosmetics, which are also drugs, must first identify the drug ingredient(s) as ‘active
ingredient(s)’ before listing the cosmetic ingredients. All label statements required by
regulation must be in the English language and must be placed on the label or labelling with
such prominence and conspicuousness that they are readily noticed and understood by
consumers under customary conditions of purchase. Attention: If the product is considered
as not clearly labelled for the consumer, the product could be declared as altered or
misbranded by the US authorities.
 Any other required information specific for some kind of cosmetic.
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The labelling requirements are codified at 21 CFR 701 and 740.

Labelling Requirements for Drugs

Drugs in the US must be labelled according to the Food, Drugs & Cosmetic Act. The main
information which should be present on the label is as follows:-

 Product name.
 Manufacturer and importer name and address.
 Active ingredients: therapeutic substances in medicine.
 Purpose: product category (e.g. antihistamine, antacid, or cough suppressant).
 Uses: systems or diseases the product will treat or prevent.
 Warning: when not to use the product, when to stop taking it, when to see a doctor, and
possible side effects.
 Directions: how much to take, how to take it, and how long to take it.
 Other information: such as storage information.
 Inactive ingredients.
 Quantity.

This information should be shown on the principal display panel. The USTR title 21/part 200-300
details general and specific labelling requirements for drug products. The labelling procedures
significantly differ for prescription drugs, and over-the-counter drugs, as per the following:-

 Prescription drugs – all the prescription drugs imported in the US should undergo through
the ‘New Drug Approval Process’. The approval process includes a verification of the
product labelling. For new products, the procedure lasts several years, because all the
laboratory tests must be performed. For generic drugs, an abbreviated new drugs approval
procedure is applied. The producer should strictly respect the US labelling requirements.
The information shown on the principal display panel should be in the following order:-

o Description.
o Clinical pharmacology.
o Instruction and usage.
o Contraindications.
o Warnings.
o Precautions.
o Adverse reactions.
o Drug abuse and dependence.
o Over dosage.
o Dosage and administration.
o How supplied.

Prescription drugs not authorised in the US cannot be imported in to the Country. If the
producer or the importer wants to change the label of authorised drugs, these changes
should be notified to the FDA.
 Over-the-counter (OTC) drugs – do not need preliminary approval by the FDA. They can be
imported into the US if they respect the US labelling requirements. In the US all the
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cosmetics containing claims are considered as drugs e.g. a cream containing UV protection is
considered as a drug in the US. Cosmetics with claims should follow the ‘over-the-counter’
drug legislation and not the cosmetics legislation. They should be registered before import.
The registration is not an approval but aims to constitute a list of all the drugs in the US.
The difference between drug and cosmetic is established according to the product claims,
the ingredients and the intended use of the product. The producer or the exporter must
register the cosmetic products before import if they feel the cosmetic might be
considered a drug by US authorities. Since May 6, 2002, the FDA has been implementing a
new form of labelling for the ‘over-the-counter’ drugs. The new labelling is introduced by an
amendment to the Food, Drug & Cosmetic Act of March 17, 1999. The new legislation
requires that the labelling is presented into a table similar to the nutritional labelling table
applicable to food products. The table for OTC drugs is named ‘Drug Facts’.

Labelling Requirements for Devices

FDA is also responsible for labelling ‘over-the-counter’ devices (e.g. contact lenses, devices for
medical tests, etc.). The US has particular legislation for labelling of these devices. The
importers of some of the prescription devices needs to be licensed before importing the products
to the US. The licence number should be indicated on the label. The OTC devices should bear the
information contained in 21 CFR Section 801, whose requirements are as follows:-

 Identity of the product.

 Name and place of business.
 Intended use.
 Adequate directions.
 Net quantity and contents.

Specific requirements exist for some devices, such as hearing aids, impact resistance lenses in
sun/eyeglasses, devices containing natural rubber, etc.

Labelling Requirements for Biologics

Labelling of biologics (blood products), therapeutics and vaccines also have to be submitted in
order to meet specific requirements. The majority of these products should have obtained a
licence before importation into the US. During the licensing process, the labels of the products
are verified, however, the verification of the label does not mean that the label is approved. The
FDA only states that the label corresponds to the current status of the product. In addition, for
blood products, the blood manufacturer/collector should be registered in a special register at FDA
(www.fda.gov/cber). The labelling requirements for biologics are very extensive and they are
related not only to the external labels of the goods but also to the information notice, which
describes the product, the tests performed and its efficiency.

Labelling Requirements for Textile Fibre Products

The labelling requirements for textiles in the US are quite complex. The labelling is verified by
the US Customs during the Customs clearance procedure. The Governmental body responsible for
the labelling of textile products is the Foreign Trace Commission (FTS) – www.ftc.gov. The FTC has
elaborated several sets of labelling rules for textile products, the main regulations, which relate
 58
to this sector are the Textile Fiber Products Identification Act, Wool Products Labelling Act and
Fur Products Labelling Act.

All textile fibre products imported into the US should be stamped, tagged, labelled, or otherwise
marked with the following information as required by the Textile Fiber Products Identification
Act, unless exempted from marking under Section 12 of the Act:-

 The generic names and percentages, by weight, of the constituent fibres present in the
textile fibre product. Exclusive of permissive ornamentation, in amounts of more than 5%,
in order of predominance by weight, with any percentage of fibre or fibres required to be
designated as ‘other fibre’ or ‘other fibres’ appearing last. Fibres present in amounts of 5%
or less must be designated as ‘other fibres’.
 The name of the manufacturer or the name or registered identification number issued by
the Federal Trade Commission (FTC) on one or more persons marketing or handling the
textile fibre product. A ‘word’ trademark, used as a house mark, registered in the US
Patent Office, may be on the labels in lieu of the name otherwise required, if the owner of
such trademark furnishes a copy of the registration to the Federal Trade Commission prior
to its use.
 The name of the country where processed or manufactured.

The Textile Product Labelling Act also indicates how the labelling should be displayed. The FTC
has also issued several guidelines for the industry explaining and ruling on what statements are
admissible on the labels.

Care Labelling Requirements for Apparel

Textile apparel should have care labelling. The care labelling rule was promulgated in December,
1971, and has been frequently modified (Care Labelling Act on FTC website: www.ftc.gov or in 16
CFR-Part 423). The rule makes it unfair or deceptive for the manufacturers and importers to sell
these items without attaching ‘care labels’ stating ‘what regular care is needed for the ordinary
use of the product’. The care instruction should be stated in appropriate terms or with any
appropriate symbols. The symbols, which should be used must be according to ASTM Standard
D5489-96c.

Labelling Requirements for Appliances

The FTC’s Appliance Labelling Rule (16 CFR, Part 305) is intended to help consumers in their
comparison of energy-efficient appliances, lighting, and plumbing products. The Rule requires
manufacturers of most major home appliances (e.g. refrigerators, freezers, dishwashers, clothes
washers, water heaters, furnaces, boilers, central air conditioners, room air conditions, heat
pumps, pool heaters) to attach labels that provide an estimate of the product’s energy consumption
or energy efficiency. These ‘Energy Guide’ labels must also show the highest and lowest energy
consumption or efficiency estimates of similar appliance models. The Rule also requires energy
disclosures for certain lighting products and water use labelling for certain plumbing products.
The Rule is very detailed and needs to be strictly followed by producers and importers. The FTC
could submit some products to testing by a designated laboratory at the manufacturer’s expense.
Detailed information on the Appliance Labelling Rule and examples for appliance ‘Energy Guide’ for
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all products could be obtained, by producers and importers, from the website of the FTC
(www.ftc.gov/bcp/conline/edcams/eande/index_applrule.html).

With respect to ‘home insulation material’, the Labelling & Advertising of Home Insulation Rule
adopted by the FTC (16 CFR, Part 460) needs to be applied. Known as the ‘R-value Rule’, it requires
labelling to include the type of insulation, the chart of the insulation factors, the R-value, which
represents the resistance to heat flows. The home insulation material is defined in the regulation
as any material which is mainly used to slow down heat flow. Additional information on the R-value
Labelling Rule can be found on the appropriate website of the FTC which is
(www.ftc.gov/bcp/conline/edcams/eande/index_applrule.html).

Other Labelling Requirements in the USA

Some other labelling requirements exist in the US and must be taken into account by producers
and importers. The FTC implements labelling requirements for fuels and automotive products. The
FTC is also in charge of implementing Guides for the use of recycling logos. Insecticides,
fungicides are under the jurisdiction of the Environmental Protection Agency. Some products that
could endanger consumer safety (e.g. toys, bicycles, etc.) are under the jurisdiction of the US
Consumer Safety Protection Commission.

Labelling Requirements by Individual States in the USA

Companies exporting to the US must not only conform to the Federal labelling requirements but
also the individual State legislation where their product will be available for sale. Large number of
States have additional requirements, however, they are mostly related to the ‘warning statement’
or ‘fiscal stamps’. It is, therefore, worthwhile for the producer and/or importer to ascertain the
specific labelling requirements and legislation references for those States where the product will
be put up for sales. The following are provided as examples of the requirements of some specific
States:-

 Louisiana – has State labelling requirements, particularly for food, drugs and cosmetic
products. Labelling requirements can be found in Section 40 of the Louisiana Revised
Statutes (www.legis.state.la.us). Some of these include RS 40-608 (misbranded food), RS
40-608-3 (organic food), RS 40-609 (fresh fruits & vegetables), RS 40-627 and RS 40-628
(bottled water), RS 40-621 (misbranded drugs), RS 40-617 (misbranded cosmetics), etc.
 Texas – has a Texas Food, Drug & Cosmetic Act, which is enforced by the State
Department of Health, the State Attorney General and the Consumer Protection Division.
The Act provides for specific labelling of food additives, drinking water and specific
requirements for misbranded food (Texas FDCA 431).
 Connecticut – several laws provide for labelling requirements including the Pure Food & Drug
Law, Sulfiting Agents Law, Apple Juice Law, Bottled Water Law, Non-alcoholic Beverages
Labelling Law, and Packaging of Consumer Commodities Law (www.cga.state.ct.us).