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Marketing Consultancy Division (MCD)

Export Consultancy Unit (ECU)

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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.

http://www.mecon.gov.ar

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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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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.

http://www.customs.gov.au

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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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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.

http://www.anvisa.gov.br

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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.


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.

http://www.abravest.org.br

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


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.


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.

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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

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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.

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The labels should be attached on the external part of the packaging and should not be in contact with the product.


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.


Normal and care labelling is needed for the apparel and textile products, however, Western labelling regulations are generally accepted.

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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.

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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.

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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:-

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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

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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

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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).

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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

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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.

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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

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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.

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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.

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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:-

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NOM�s TITLE PRODUCT COVERED NOM-004-SCFI-1994 Eliquetado de prductos textiles, prendas de vestir y sus

accesorios Textiles

NOM-020-SCFI-1997 Informacion commercial: Etiquetado de cueros y pieles curtidas, naturals y materials sinteticos o artificiales con esa apariencia, calzado, marroquineria, asi como los prodoctos eleborados con dishos materials

Leather finished products, raw hides & skins, artificial/synthetic products

NOM-024-SCFI-1994 Informacion commercial para empaques, instructivos y garantias de los productos electronicos, electricos y electrodemesticos

Electronic/electrical products, household appliances

NOM-051-SCFI-1994 Especificaciones generales de etiquetado para alimentos y bebidas no alcoholicas pre-envasados

Foodstuffs, and other pre-packed beverages

NOM-120-SCFI-1996 Etiquetado de productos de cuero Leather NOM-050-SCFI-1994 Informacion commercial � disposiciones generales para

productos General provisions for all the products

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

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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.


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,

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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.

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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 social reason of the importer OR of its branded trade mark

Yes Yes Yes

Country of origin Yes Yes Yes Generic or specific description of materials and optionally the finishing (can be placed on one separate label)

Yes Yes Yes

Labels in Spanish language Yes Yes Yes It must be readable Yes Yes Yes Permanent form Yes Can be marked in a

readable place of packaging, e.g. on an adhesive label

Not available

Specific/additional information Footwear:- When there is a 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

Not available

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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.


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

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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.

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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.


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.

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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.

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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.

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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

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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

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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

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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.

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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.

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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).

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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.


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).

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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.


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.).

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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.


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.

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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.�

http://www.ats.go.kr

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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 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.


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.

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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.

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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).

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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.

http://www.cfsan.fda.gov

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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.


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

http://www.fda.gov/cber

http://www.ftc.gov

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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

http://www.ftc.gov

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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).

http://www.ftc.gov/bcp/conline/edcams/eande/index_applrule.html

http://www.ftc.gov/bcp/conline/edcams/eande/index_applrule.html

http://www.legis.state.la.us

http://www.cga.state.ct.us

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