THE MINISTRY OF INDUSTRY AND TRADE -------- No.:04/2012/TT-BCT | SOCIALISTREPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------- Hanoi, February 13, 2012 |
CIRCULAR
REGULATIONS ON THE CLASSIFICATIONS AND LABELING OF CHEMICALS
Pursuant to the Government’s Decree No. 189/2007/ND-CP of December 27, 2007 on defining the functions, tasks, powers and organizational structure of the Ministry of Industry and Trade; the Government’s Decree No. 44/2011/ND-CP of June 14, 2011 on amending and supplementing the Article 3 of the Decree No. 189/2007/ND-CP;
Pursuant to the Law on chemicals, of November 21, 2007;
Pursuant to the Government’s Decree No. 89/2006/ND-CP of August 30, 2006, on the label of goods; the Circular No. 09/2007/TT-BKHCN, of April 6, 2007 of the Ministry of Science and Technology guiding the implementation of some articles of the Decree No. 89/2006/ND-CP;
The Minister of Industry and Trade stipulates the classification and labeling of Chemicals under the Globally Harmonized System as follows:
Chapter I
GENERAL REGULATION
Article 1.Scope of adjustment
1. This Circular guides the classification and labeling for the Chemicals that are produced, imported and circulated in Vietnam.
2. The following Chemicals shall not in scope of adjustment of this Circular:
a) The Chemicals are temporarily imported for re-exported or for participation in fairs and exhibitions and then re-exported; Chemicals transited and transshipped from border gate to border gate; the non-trade imported Chemicals; the Chemicals are in the process of research at facilities of research and manufacture; the Chemicals manufactured and imported to serve the security and national defense, response to natural disasters, urgent epidemic diseases or other special cases;
b) The Chemicals that are gifts or donations and baggage of people on entry;
c) The Chemicals belong to the management scope of theMinistry of Science and Technology, Ministry of Health, Ministry of Agriculture and Rural Development;
Article 2.Subjects of application
The Vietnamese and foreign organizations and individuals having activities of manufacture and franchised manufacture, processing, dividing and re-packaging (hereafter called the manufacture), trading, importing of the Chemicals in the territory of the Socialist Republic of Vietnam.
Article 3.Interpretation of terms
In this Circular, the terms below are construed as follows:
1.Globally Harmonized System of Classification and Labeling of Chemicals (hereafter called GHS in brief)means the system guiding classification and labeling of chemicals of the United Nations in the global.
2.Chemicalmeans an element, a compound, or a mixture that is exploited or created by humans from natural or artificial raw material in accordance with the regulation in the Clause 1, Article 4 of the Law on chemicals.
3.Substancemeans an element or a compound, including any impurities deriving from the course of processing, the additives necessary to preserve the stability of physical and chemical properties, excluding any solvents that may be separated without changing their characters in accordance with the regulation in the Clause 2, Article 4 of the Law on chemicals.
4.The mixturemeans a combination of two or more substances which do not react under normal conditions in accordance with provision in clause 3, article 3 of the Law on chemicals.
5. Hazardous chemicalmeans the ones prescribed in clause 4, article 4 of the Law on chemicals having one or several of the hazardous properties in accordance with the classification principles of classification of the GHS as follows:
a) Easy to explode;
b) Strongly oxidative;
c) Strongly corrosive;
d) Flammable;
dd) Acutely toxic;
e) Chronically toxic;
g) Causing irritation to human;
h) Causing cancer or posing threats of causing cancer;
i) Causing genetic mutation;
k) Reproductive toxic;
l) Bio accumulative;
m)Organically polluting and hard to decay;
n/ Environmentally toxic.
6.Chemical labelis the written, printed, drawn words, figures, images, signs that are sunk printed, embossed directly or stuck, pinned or attached firmly on the commcercial packagings in order to presenting of necessary and principal information of chemicals to help the users know and used as the base for functional agencies to carry out inspection, supervision and control.
7.Chemical labelingis the presentation of necessary and principal contents about chemicals on their label to help consumersidentify the goods and serve as the basis for purchasers to select, consume and use such goods; and for manufacturers, traders to advertise their goods andfor functional agencies to conduct inspection and supervision.
8.Original label of chemicalsis the initial label are printed or stuck, pinned, attached firmly on the commercial packagings of chemicals after finishing packing manipulation in production line.
9.Supplementarylabelis the one showing compulsory contents translated from the original label in foreign language into Vietnamese and additional compulsory contents in Vietnameseas required by law which do not yet appear on the original labelchemical.
10.The commercial packaging of chemicalis the packaging containing chemicals, circulated together with such chemicals and including two kinds:
a) Holding packaging is packaging in direct contact with and directly holding chemicals;
b) Exterior packaging is packaging used to cover one or several units of chemicals contained in holding packaging.
11.Name and address of organization or individual responsible for chemicalsare name and address of organization, individual manufacturing, importing, being entrusted to import chemicals.
12.Manufacture dateis the point of time by which the manufacture, processing, bottling, packing or other forms to complete the final finishing stage of the chemical batch.
13.Expiry date of the chemicalsis the point of time being defined for a chemical batch that after this time period this chemical is not permitted to be used.
14.Chemical circulationis activities of displaying, transporting and storing chemicals during the process of chemical sale and purchase, except for the cases prescribed in the Article 11 of this Circular.
Article 4.Responsibility for classification and labeling of chemicals
1. The organizations, individuals manufacturing and importing chemicals are liable to label them before putting them in use and circulation in the market, except for the cases prescribed in Article 11 of the draft of this Circular and are liable to classify the chemicals in accordance with the Chapter II of this Circular.
2. For chemicals imported into Vietnam with original labels are not in accordance with provisions of this Circular, importing organizations and individuals make supplementary labels before putting them into circulation together with their original labels. The content written on the supplementary labels must be in accordance with provisions of this Circular.
3. The organizations, individuals manufacturing and importing chemicals must comply with the provisions of the law on the intellectual property and be responsible before law for the intellectual property matter for the contents written on the chemical labels.
Chapter II
CHEMICAL CLASSIFICATION
Article 5.Classification of chemicals according to the material hazard
1. The material toxicity is classified by the group of chemicals and characteristics as follows:
a) Explosive;
b) Flammable gas;
c) Flammable aerosols category;
d) Oxidized gas;
dd) Compressed gas;
e) Flammable liquid;
g) Flammable solid;
h) Self-reactive compound;
i) Pyrophoric liquid;
k) Pyrophoric solid;
l) Self-heating solid;
m) Self-heating compound;
n) Compound which, in contact with water, emit flammable gas;
p) Oxidized liquid;
q) Oxidized solid;
r) Organic peroxide;
s) Metal corrosion.
2. The details and standards of classification of hazard are prescribed in the Annex 1 attached with this Circular.
Article 6.Classification of chemicals by the degree of hazard affecting human health and environment
1. Hazards affecting the human health
a) Acute toxicity;
b) Skin corrosion;
c) Eye damage;
d) The agents causing respiratory sensitization or skin sensitization;
dd) Capable of causing the germ cell mutation;
e)Carcinogenic
g) Reproductive toxicity.
2.Hazard affecting environment
a) Waterenvironment;
b) Affecting the ozone.
3. The details and standards of classification of hazard are prescribed in the Annex 2 attached with this Circular.
Chapter III
CHEMICAL LABELING
Article 7.Position of chemical labels
The position of chemical label is implemented by provision of clause 1, Article 6 of the Decree No.89/2006/ND-CP.The chemical label must be shown in the form of printing, sticking, pinning or attaching on the commercial packaging of chemical where the compulsory prescribed contents of labelcan be noticeable easily and fully.
Article 8.Size of chemical label
Organizations, individuals manufacturing and importing are liable to label chemical shall determine themselves the size of label and, however, must ensure recording fully compulsory contents in accordance with provision in the section 1, chapter III of this Circular, and compulsory contents are easily readable by naked eyes.
Article 9.Colors of letters, symbols and images on chemical label
1.Color of letters, figures, figures, images, signs and symbols written on chemical label must be clear. For the compulsory contents as prescribed, colors of letters and figures must contrast with the background color of label in accordance with the regulation in Article 8 of the Decree No.89/2006/ND-CP
2. In case not showing the contrary color of letters and figures then letters and figures must be sunk printed, embossed, casted clearly.
Article 10.Language displayed on chemical label
1.Thecompulsorycontentson the chemical label must be written in Vietnamese, except for the case prescribed in Clause 4 of this Article.
2. The chemicals that are manufactured and circulated domestically, besides implementation of the provision in Clause 1, this Article, contents on label can be written in another language at the same time. The content written in another language must be correspondent to those in Vietnamese. The size of letters written in another language must not be bigger than that of contents written in Vietnamese.
3. If chemicals imported into Vietnam but the original labels do not show or show not enough compulsory contents in Vietnamese, they shall be kept together with supplementary labels showing contents prescribed in Article 12 of this Circular in Vietnamese and their original label must be kept intact.
4. The following content can be presented in other languages of Latin original letters must be truthful, clear, precise, correctly reflect the right nature of chemicals:
a) The international common names or scientific names of ingredients, quantities ingredients of chemicals in case they cannot be translated into Vietnamese or their Vietnamese translation are meaningless;
b) Names and addresses of foreign businesses that manufacturing and franchising the manufacture of chemical.
Article 11.Cases not apply chemical labeling
1. The cases prescribed in clause 3, clause 4, Article 5 of the Decree No. 89/2006/ND-CP.
2. Chemicals imported in the course of transportation from the border gate to the storage of organizations, individuals manufacturing and importing chemicals then their labels must have at least: code of chemical identification; warning images, warning words, risk warnings.
3. Chemicals in the course of transportation from the manufacturing place to the place of storage and preservation, where belongs to the management right of the same organization and individual manufacturing chemicals.
4. Chemicals haven t been finished the packing manipulation in production line at manufacturing facilities yet.
Section 1. CONTENT OF CHEMICAL LABELING
Article 12.The compulsory contents must be shown on chemical labels
The compulsory contents must be shown on chemical labels are in accordance with provision in clause 48, Article 12 of the Decree No.89/2006/ND-CP and under regulations of GHS including:
1. Name of chemicals.
2. Code of chemical identification.
3. Warning images, warning words, risk warnings.
4. Measurement of prevention.
5. Quantitative.
6.Intergradient or quantities ingredient.
7. Manufacture date.
8. Expiry date (if any).
9. Information of the manufacturer, importer and distributor.
10. Origin of goods.
11. Instruction of use and preservation.
Article 13.Duty of supplementary labeling
The contents written onsupplementarylabels must not lead to misunderstanding about the content of original label prescribed in Article 12 of this Circular. In case of writing additional compulsory contents that the original labels do not have, organizations and individuals labeling must take responsibility before law for the accuracy and honesty of the additionally written content.
Article14.Other information shown on chemical label
Besides compulsory contents prescribed in Article 12 of this Circular, the organizations and individuals manufacturing, importing chemicals can write the other contents on the label additionally. These contents must guarantee honesty and accuracy and must not lead to misunderstanding about characteristics of chemicals and compulsory contents written on chemical label. The other content can be written in the materialsafety data sheetor in the sheet of use instruction.
Article 15.Case of labeling when transporting chemicals
1. In the circulation of chemicals, except for the cases prescribed in Article 11 of this Circular, then chemicals when being transported, must have label in accordance with provisions in Article 12 of this Circular and have warning images in transportation in accordance with regulation of the Annex 3 of this Circular.
2. The warning images in transporting chemicals must be shown on the holding packaging for chemicals without exterior packaging. The warning imagesin transporting chemicals must be placed on the exterior packaging for chemicals have both holding and exterior packaging.
Section 2. WAY OF CHEMICAL LABELING
Article 16.Way of writing compulsory contents on chemical label
- Name of chemical
Names of chemicals are registered by manufacturers under common called names, commercial names or other names that are written on chemical labels. For some substances that are considered as business secret of organizations and individuals manufacturing, importing and trading, are written on the chemical label their international common names.
Example of writing name of chemicals:
Name called by IUPAC: n-Butyl Acetate
Commercial name: Normal Butyl Acetate
Other name (not scientific name): NBAC
2.Code of chemical identification
a) The code of chemical identification must be used on chemical label and it must be suitable with the symbol used on the Material Safety Data Sheet, abbreviated as MSDS;
b) The label for a compound must show chemical identifications of compound. When risks contribute to the acute toxicity, skin corrosionor serious eye damage, mutation of germ cell, carcinogenic,reproductive toxicity,sensitive to respiration or skin shown on label then information for the mixture or alloy must show the chemical identification of all ingredients or alloy elements that can cause these risks on label. When necessary, the competent authorities can require putting on label all ingredients or alloy elements that contribute to risks of mixture or alloy.
3.Thewarning images, warning words, risk warnings
a) The organizations, individuals manufacturing and importing chemicals must have appropriate warning images, warning words and risk warnings in accordance with the classification prescribed in the Annex 1 and Annex 2 of this Circular;
b) Thewarning images are information for users to understand correctly without leading to misunderstanding about chemical label. The details of warning images are prescribed in the Annex 4 attached with this Circular.
Example 1 Thewarning image: the “Fire” image shown on holding packaging shall warn one of the following chemicals:
- Flammable substance;
- Self-reacting substance;
- Pyrophoric substance;
- Self-heating substance;
- Substance emitting flammable gas when react;
-Organic peroxide.
c) The warning words are used on label to indicate the relative danger degree of risk and to warn readers about potential risks. The warning words are displayed by the lower or upper case letters, bold letters with height of letters not less than 2mm. The warning words are used in GHS including: “danger” word is used for levels of more serious risks (for example in the main part of levels of risk 1 and 2); “warning” word is used for risks that are less dangerous)
c) The risk warning shows the level of risk, describes nature of risk of chemicals. The words for contents of risk warning are printed in lower or upper case letters with height of letters not less than2mm.
Example: The flammable gas is classified and its correspondent warning images, warning words and risk warnings are shown as follows:
| Level 1 | Level 2 |
Warning images | Flame | No warning images |
Warning words | Danger | Warning |
Risk warnings | Highly flammable gas | Flammable gas |
4. Measurement of prevention
The measurement of prevention is shown by information or concrete figures describing measurements and suggestions that must be carried out in order to reduce or prevent hazardous effects due to contacting dangerous chemicals, or reserving them in wrong way or transporting dangerous chemicals.
For example: way of writing measurement of prevention of the chemical HI-URETHAN LV17 is as follows:
Measurement of prevention:
- Refer to the special instruction before use.
- If swallowed: ask for medical assistance immediately.
- If inhaled: move victim to clean air area.
- If skin contacted: wash clearly with soap and water.
- If eyes contacted: immediately, wash continuously with water and ask for medical assistance.
5.Quantitative
a) Way of writing quantitative of chemical is shown in accordance with state of chemicals: chemicals in form of solid, gas shall be shown in accordance with net quantity; chemicals in form of mixture of solid and liquid shall be shown in accordance with net quantity of mixture and quantity of solid; chemicals are compressed gas shall be shown in accordance with net quantity of compressed gas and net quantity of pressure vessel or net quantity of compressed gas and total quantity of compressed gas and pressure vessel; chemicals in viscous or pasty form, shall be shown in accordance with net quantity or the actual volume; chemicals in pasty form in spray bottles, shall be shown in accordance with net quantity including pasty substance and substance producing spraying pressure; chemicals in liquid form, shall be shown in accordance with actual volume at 20oC; chemicals in liquid form in spraying bottles, shall be shown in accordance with actual volume at 20oC including both liquid and substance producing spraying pressure;
b) Way of writing measurement units
- Writing quantitative measurement units on chemical label with their full names or symbols of measurement units. For example: write as “ gram” or “ g”, write as “milliliter” or “ ml”;
- Name of units is written in lower case letters, not using upper case letters for the initial letter. For example: kilogram, gram, not Kilogram, Gram (except for temperature: Celsius,0C)
- The symbol of units is written by lower case and upright letters. For example: kg, g, l not Kg, G, L;
- There must be a space between measurement units and number. For example: 200 g, 300 ml, not 200 g, 300 ml;
- When showing quantity with calculation, the general unit for number must be written in parentheses or for each number separately. For example: (500 ± 5) g or 500 g ± 5 g, not 500 g ± 5 or 500 ± 5 g;
- Showing decimal point of quantity value must use comma (,), not dot. For example: 1,250 kg not 1.250 kg;
- For the quantity measurement units: kilogram (kg), gram (g), milligram (mg). Using g unit if less than 01 kg (For example: write 500 g not 0,5 kg); Using “mg” unit if less than 01 g (For example: write 500 mg not 0,5 g);
- For volume measurement units: liter (l), milliliter (ml). Using “ml” unit if less than one liter (For example: write 500 ml not 0,5 l)
6. Ingredient or quantitative ingredient
a) Writing chemical formula. For chemicals contained in pressure vessel, the loaded capacity must be written additionally.
For example: sulfuric acid; formula H2SO4; concentration: 99%
b) For the mixture, write ingredient or quantitative ingredient such as: solid form is quantity percentage of each solid substance; liquid form is quantity percentage of each liquid substance; gas form is quantity percentage of each gas substance; solid and liquid form is quantity percentage of each solid and liquid substance.
7. Manufacture date
Way of writing date, month and year for manufacture date is specified as follows:
a) Manufacture date, expiry date on label are fully written or abbreviated in uppercase letter as: NSX by the order of date, month, year of solar year. Each number showing date, month and year is written by two digits. It is permitted to write the number showing the year by four digits. Numbers showing date, month and year of a timeline must be written on same line. For example: Manufacture date is 02ndApril 2006 then there are some ways of writing on the label as follows:
- NSX: 020406; or
- NSX 02 04 06; or
- NSX: 02042006; or
- NSX: 02 04 2006; or
-NSX: 02/04/06.
b) In case the “NSX” cannot be written with numbers showing date, month and year, there must have an instruction on label. For example: at the bottom of the packaging, the time of manufacture and expiry date is written “020406” then on the label we must write as follow: Refer to NSX at the bottom of packaging;
c) In case writing the manufacture time “NSX” in foreign language on label then there must have an instruction on label. For example: On packaging, the manufacture date is written “MFG 020406” then on the label we must write like this: NSX, refer to “MFG” on packaging;
d) In case on label the manufacture date is written in foreign language then on the supplementary label, we must write: manufacture date or abbreviated in uppercase letter as NSX, refer to “Mfg Date” on packaging.
8. Expiry date
In case chemicals have the expiry date then way of writing the expiry date is in accordance with provision in Article 15 of the Decree No.89/2006/ND-CPand clause 5, section II of the Circular No.09/2007/TT-BKHCN of April 06, 2007 of the Ministry of Science and Technology guiding theimplementation of some articles of the Decree No. 89/2006/ND-CP.
9. Information of manufacturer, importer and distributor.
Writing name, address and telephone number of manufacturer, importer or distributor of chemicals on chemical label.
10. Origin of chemicals
a) Way of writing the origin of chemicals is prescribed as follows: to write “made in” or “origin from” along with name of the country or territory where manufacturing such chemicals;
b) For chemicals manufactured in Vietnam in order to circulate domestically, address of manufacture place of such chemicals has been written then it is not imperative to write its origin.
11. Instruction of use and preservation
Chemical label must be written the instruction of use and preservation so that users could identify as a basis for selection of storage and preservation and use of chemical safely.
Example of the instruction of usage and preservation of the substance HI-URETHAN LV17 is as follows:
- Avoiding dust/smoke/dew/steam/water dust inhaling. Avoiding eliminating into environment. Keeping away from heating source/fire ray/top flame. Not eating or drinking or smoking when using products. Washing hands after contacting substance. Connecting the container with land to avoid electrostatic. Only using with equipments not producing fire ray. Always capping container.
- Using appropriate ventilation system.
- Using labor safety equipment as required.
- Preserving at low temperature. Closing the cap immediately after use.
12. Way of writing other information
Theother information written on chemical label must guarantee honesty and accuracy and not lead to misunderstanding about characteristics of chemical and other content of label.
Example of writing other information as follows: refer to further information onMaterial Safety Data Sheet(MSDS) or in sheet of use instruction.
Article17.Way of writing supplementary label
1. The supplementary label must be attached on packaging of chemical and not conceal content of original label.
2. In case the supplementary label’s area is enough wide then the whole compulsory content having not shown or not fully shown as prescribed in Article 12 of this Circular.
3. In case the compulsory label has small area and then cannot be written fully the whole compulsory content then contents such as measurement of prevention; instruction of use and preservation are written in documents attached with chemical and on supplementary label must indicate the document having such contents.
Article18.Way of writing the warning images when transporting chemical
The warning images when transporting chemical are the minimum information for users to understand correctly and therefore does not cause misunderstanding about chemical label. The details of the warning images of chemical transportation are prescribed in the Annex 4 attached with this Circular. The warning images must be recognized clearly by naked eyes on the holding packaging or the exterior packaging (if any) at the position being easy for observation.
Example ofwarning images of chemical transportation:thewarning image No. 5 in the Annex 4 with figure of a flame on a black circle on the yellow background on the holding packaging with warning that chemical transported is oxidizing substance (the oxidizing liquid, gas, solid)
Chapter IV
IMPLEMENTATION PROVISION
Article 19.Responsibility
1.The Department of Chemical Products are liable to diffuse, monitor and instruct and supervise the implementation of this Circular.
2. The Departments of Industry and Trade of centrally-affiliated provinces and cities are liable to examine and inspect the implementation of this Circular within their respective localities.
3. The organizations, individuals manufacturing and importing chemicals must submit the Sheet of classification and Sheet of chemical labeling together with the relevant documents to the Department of Chemical Products 15 (fifteen) working days in advance, from the day when chemical is put into use and circulation in the market. If there is any information considered business secrets then the organizations and individuals must inform to the Department of Chemical Products before putting them into use and circulation in the market and must inform the other competent authorities publicly when required.
4. The domestic and foreign organizations, individuals having activities of chemical manufacture and import and organizations, individuals having the relevant activities are liable to execute the Decree No. 89/2006/ND-CP, Circular No. 09/2007/TT-BKHCN and provisions in this Circular.
Article 20.Roadmap for application of chemical classification and labeling
1. The manufactured and imported chemicals that are classified or labeled in order to put into use and circulation in the market before the effective day of this Circular are permitted for continued circulation.
2. For element:
a) From the effective day of this Circular, organizations and individuals manufacturing and importing chemicals carry out the review of contents concerning the classification and labeling of chemicals as prescribed in this Circular;
b) After 02 (two) years from the the effective day of this Circular, before putting chemicals into use and circulation in the market, organizations and individuals manufacturing and importing chemicals must finish their classification and labeling of chemicals as prescribed in this Circular.
3. For the mixture
a) From the effective day of this Circular, organizations and individuals manufacturing and importing chemicals carry out the review of contents concerning the classification and labeling of chemicals as prescribed in this Circular;
b) After 04 (four) years from the effective day of this Circular, before putting chemicals into use and circulation in the market, organizations and individuals manufacturing and importing chemicals must have responsibilities for classification and labeling of chemicals as prescribed in this Circular.
Article 21.Effect for execution
1. This Circular shall take effect for execution since March 30, 2012.
2. During the course of execution, if there is any problem arising, organizations and individuals should timely reflect to the Ministry of Industry and Trade for examination and settlement./.
| FOR THE MINISTER DEPUTY MINISTER
Nguyen Nam Hai |