PACKING AND LABELING COMPLIANCE FOR COSMETICS PRODUCTS IN INDIA
The Packing and Labeling in the Indian Cosmetic Industry is governed by several Laws and rules. Though most of them have are overlapping in nature & compliance structures, but there are differences on select few issues. Manufacture & Sale including Import & Export of cosmetics with regards to its comparison / standards related to its Packing & Labeling is governed by “The Drugs & Cosmetics Act of 1940 & The Drug & Cosmetics rules 1945”, “The Legal Metrology Act 2009”, “ECO Labeling Standards by BIS”.
This chapter will give its readers a glimpse of the statutory framework related to Packing and labeling standards to be followed in India pertaining to the Cosmetics Industry.
Packing and Labeling Compliance
|CDSCO Guidelines on Packing & Labeling|
|The Legal Metrology Act 2009|
|ECO Labeling Norms under BIS|
The Packing and Labeling in the Indian Cosmetic Industry is governed by several Laws and rules. Though most of them have are overlapping in nature & compliance structures, but there are differences on select few compliance issues. Manufacture & sale including import & export of cosmetics with regards to its comparison / standards related to its Packing & Labeling is governed by “The Drugs & Cosmetics Act of 1940 & The Drug & Cosmetics rules 1945”, “The Legal Metrology Act 2009”, “ECO Labeling Standards by BIS”. The provisions of the Act & Rules relevant for cosmetics are as follows:
LABELLING, PACKING AND STANDARDS OF COSMETICS
A. The Drug & Cosmetics rules 1945
146. Prohibition of sale or distribution:- Subject to the other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labeled and packed in accordance with these rules.
147. Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part: – Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adapted to meet the specific requirements, if any, of the consignee:
Provided that where a cosmetic is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the licensing authority mentioned in rule 21.
148. Manner of labeling: – Subject to other provisions of the rules, a cosmetic shall carry
(1) On both the inner and outer labels:
(a) The name of the cosmetics,
(b) The name of the manufacture4r and complete address of the premises of the manufacturer where the cosmetic has been manufactured:
Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be along with pin code.
(c) Use before/Expiry Date (Month and Year).
(2) On the outer label:
A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, and weight for semi-solids, combined with numerical count if the content is sub-divided:
Provided that this statement need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams.
(3) On the Inner Label; where a hazard exists:
(a) An Adequate direction for sale use,
(b) Any warning, caution or special direction required to be observed by the consumer,
(c) A statement of the names and quantities of the ingredients that are hazardous or poisonous.
(4) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter B:
Providing that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi- solid state, and 25 milliliters or less if the cosmetic is in a liquid state:]
[Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label]
(5) Manufacturing licence number, the number being preceded by the letter M.
(6) Where a package of cosmetic has only one label such label shall contain all the information required to be shown on both the inner and the outer labels, under these rules.
(7) The list of ingredients, present in concentration of more than one per cent shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one per cent, in any order, and preceded by the word “INGREDIENTS” :
Provided that this statement need not appear for packs of less than 60 ml of liquids and 30 gm of solid and semi solids.
(8) Labeling requirements, if any, specified in the relevant Indian Standards laid down by the Bureau of Indian Standards for the cosmetics covered under Schedule “S”.
148 A. Prohibition against altering inscriptions on containers, labels or wrappers of cosmetic: – No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:
Provided that nothing in this rule shall apply to any alteration, inscription to mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority.
148 B. Prohibition against false or misleading claims: – No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.
149. Labeling of hair dyes containing dyes, Colours and Pigments: – Hair dyes containing Para-Phenylenediamine or other dyes, Colours and pigments] shall be labeled with the following legend in English and local languages and these shall appear on both the inner and the outer labels.
“Caution: – This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product shall not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness.”
Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:
“This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water of alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.”
149 A. Special provisions relating to toothpaste containing fluoride:
(i) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.
(ii) Date of expiry should be mentioned on tube and carton.
B. The Legal Metrology Act, 2009:-
Overview of the Legal Metrology Act, 2009
All Pre-packaged commodities imported into India shall confirm to the requirements of the Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011. Under the Legal Metrology (Packaged Commodities) Rules, 2011, the importer of pre-packaged commodity should be registered under Rule 27.
The Legal Metrology Act, 2009 (Act 1 of 2010) repeals and replaces the Standard of Weights and Measures Act, 1976 and the Standards of weights and Measures (Enforcement) Act, 1985. The central government has appointed the date 01.04.2011 from which the provisions of the Act will come into force.
However, a state can enforce the provisions of the Act and Rules made there under after framing its own Legal Metrology (Enforcement) Rules for the state and on notification of the date from which it will come into force.
Declaration on Pre-packaged Commodities
- Manufacturing, packing, selling or importing any pre-packaged commodity is prohibited unless it is in a standard quantity and carries all prescribed declarations.Section 18(1) Penal provision is Section 36(1)
- Any advertisement mentioning retail price of packaged commodity shall also contain the net quantity thereof Section 18(2)
- If the net quantity in a pre-packaged commodity is short or excess beyond the prescribed MPE, the offense will be punishable underSection 36(2)
Under the Legal Metrology (Packaged Commodities) Rules, 2011, the importer of pre-packaged commodity should be registered under Rule 27. The registration will be done by the Director or controller of Legal Metrology of the State and the registration Fees is Rs. 500. Wherever the requirements of labeling are given in FSSA (Food Safety & standards Act 2006) or CDSCO in respect of food items, the labeling requirements under FSSA shall prevail over labeling requirements of Legal Metrology.
Important sections of Legal Metrology Act 2009:-
Every unit of weight or measure shall be in accordance with the metric system based on the international system of units. The base unit of –
(i) Length shall be the Meter;
(ii) Mass shall be the Kilogram;
(iii) Time shall be the Second;
(iv) Electric current shall be the Ampere;
(v) Thermodynamic temperature shall be the Kelvin;
(vi) Luminous intensity shall be the Candela &
(vii) Amount of substance shall be the Mole.
C. BIS ECO Labeling Standards:
A scheme for labeling environment friendly products known as ECO Mark (optional) has been introduced at the instance of the Ministry of Environment and Forests (MEF), Government of India. The ECO Mark is being administered by the Bureau of Indian Standards Act, 1986 as per the Resolution No. 71 dated 21 February 1991 and No.768 dated 24 August 1992 published in the Gazette of the Government of India. For a product to be eligible for marking with ECO logo, it shall also carry the Standard Mark of BIS besides meeting additional environment friendly requirements. For this purpose, the Standard Mark of BIS would be a single mark being a combination of the BIS monogram and the ECO logo. Requirements for the ECO friendliness will be additional, manufacturing units will be free to opt for Standard Mark alone also.
For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2: 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.
ADDITIONAL REQUIREMENTS FOR ECO MARK (OPTIONAL)
Requirements for quality, safety and performance prescribed under
- All the ingredients that go into formulation of cosmetics shall comply with the provisions of IS 4707 (Part I) and IS 4707 (Part 2). The product shall also meet specific requirements as given in the standard.
- The product package shall display a list of key ingredients in descending order of quantity present.
- The product shall not be manufactured from any carcinogenic ingredients.
The manufacturer shall produce to BIS environmental consent clearance from the concerned State Pollution Control Board as per the provisions of the Water (Prevention and Control of Pollution) Cess Act 1977 and the Air (Prevention and Control Pollution) Act, 1981 along with the authorization, if required under the Environment (Protection) Act, 1986 and the Rules made there under, while applying for ECO Mark. Additionally, provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall also be complied with.
- Product shall be dermatologically safe when tested as per IS 4011.
- Heavy metals calculated as lead (Pb) and arsenic (as As2 O3) shall not exceed 20 and 2 ppm, respectively when tested by the respective method prescribed Indian Standards.
- For ECO Mark the product package shall be packed in such packages which shall be recyclable or biodegradable.
PACKING AND MARKING
The material shall be packed in suitable well – closed containers.
The containers shall be legibly marked with the following information:
- Name of the Material
- Manufacturer’s name and /or his recognized trade-mark, if any
- Net mass of the Material
- Month and year of Manufacturing/Packing
- Batch or Lot Number, in code or otherwise
- Expiry date or “Best use before….” (Month and Year to be declared by the Manufacturer)
NOTE — This requirement is exempted:
- In case of pack sizes of 10 gm or less.
- If the shelf life of the product is more than 24 months.
- List of key Ingredients
NOTE — This is exempted in case of pack sizes of 30 g or less.
- Any other information required by statutory authorities.
- The containers may also be marked with the Standard Mark:-
The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards.
If the product is covered under ECO Mark (optional), it shall be suitably marked with ECO Mark logo besides Standard Mark. The label may clearly specify that ECO Mark is applicable to the contents or the package or both, as case may be. If the product package is not separately covered under ECO Mark scheme, it shall be clearly mentioned on the product that ECO Mark label is applicable to contents only.
FOR FURTHER ASSISTANCE on COSMETICS IMPORT REGISTRATION PLEASE CONTACT–
M/s S.J. EXIM Services- Q-Freight Team
Contact Person: Ravi Shekhar Jha
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