The Packing and Labeling of Cosmetic products in the Indian Cosmetic Industry is governed by several Laws and rules. Although many of the laws and regulations are overlapping in nature & compliance structures, but there are certain differences in the Manufacture & Sale of the cosmetics including the Import & Export of cosmetics. In this blog, we shall discuss the packing and labeling compliance for cosmetics products in India.
The terms and conditions with regards to its comparison / standards related to its Packing and Labeling is governed by the following laws and regulations:
- CDSCO Guidelines on Packing and Labeling
- The Legal Metrology Act 2009
- ECO Labeling Norms under BIS
Packing and Labeling Standards of Cosmetics
Following are packing and labeling standards of Cosmetics in India:
A. The Drug & Cosmetics Rules, 1945
Prohibition of sale or distribution: – Under the section 146 of the aforesaid rules, no person is allowed to sell or distribute any cosmetic product unless the cosmetics (if belonging to Indian Origin) is manufactured by a licensed manufacturer and have been labeled and packed in harmony with the aforesaid rules
Under section 147 of said rules, the cosmetics which are not manufactured for consumption or sale in India have been exempted from the provisions of this Part: –
In such cases, the labels on packets or containers of cosmetics which are manufactured in India, but not for consumption or sale in India, shall be adapted to meet the requirements as specified by the consignee of such products.
In cases where a cosmetic product, as per the requirement of the consignee, is to be not labeled with the name & address of the manufacturer, then such labels of those cosmetic products shall contain a code number as approved by the licensing authority. The same has been mentioned in Rules 21 of the aforesaid rules.
Section 148 elaborates Manner of labeling of the Cosmetic Products: – As per the provision of the stated section of The Drugs and Cosmetics Rules, 1945[1], a cosmetic shall carry:
(1) On both the inner & outer labels of the cosmetics:
(a) The name of the cosmetics,
(b) The name of the manufacturer and complete address of the premises belonging to the manufacturer where the manufacturing of cosmetics took place.
In cases where the cosmetic is contained in a very small size container and it is not feasible to provide the address of the manufacturer, then the name and principal place of the manufacturer shall be given along with pin code.
(c) Use before/Expiry Date (Month and Year).
(2) On the outer label:
The net contents of the package shall be expressed in terms of weight for solids and semi-solids, fluid measure for liquids combined with numerical count if the contents of the packet is further sub-divided:
However, this shall not be applicable in case of a package of perfume, skin water or similar kinds, and whose net content does not exceed 60 ml and 30 grams in case of any package of solid or semi-solid cosmetics.
(3) In case a hazard exists, on the Inner Label;
(a) An Adequate direction for use after sale,
(b) Details of warning, caution or special use direction which need to be observed by the consumer,
(c) A declaration about the names and quantities of the ingredients that are hazardous or poisonous.
(4) A unique batch number, by whose reference the details of manufacture of the specific batch from which the substance in the container is taken are recorded & are available for inspection.
However, this clause is not applicable to any cosmetics packaging containing 10 grams or less if the it is in solid or semi- solid state, and 25 milliliters or less in case the cosmetic is in a liquid state:
[Provided further that in the case of packing and labelling of soaps, the month & year of manufacture of soap shall be mentioned on the label instead of the batch number.
(5) Mention of Manufacturing license number, the number starting with the letter M.
(6) In case of a cosmetic package having only one label, such label shall contain all the information which is required to be shown on both the inner and the outer labels.
(7) The detailed list of ingredients present in the concentration of more than one per cent shall be listed in the descending order of weight/volume since the time they are added.
For packs of less than 60 ml of liquids & 30 gm of solid and semi solids, the detailed list of the ingredients would not be required.
(8) Labeling requirements as specified by Indian Standards laid down by the Bureau of Indian Standards covered under schedule ‘s’ for cosmetics.
148 A. Prohibition against alteration of inscriptions on containers, labels or wrappers of cosmetics: – No alteration, obliteration or defacement of any inscription or mark should be made or recorded by the cosmetic manufacturer on the container, label or wrapper.
No alteration, inscription to mark shall be made on the container, label or wrapper of any cosmetics at the instance or direction of the licensing authority.
148 B. Prohibition against false or misleading claims: – No cosmetics products shall make any false or misleading claim which is against the benefit of the customers as well as society as whole.
149. Labeling requirements of hair dyes which contain dyes, Colors and Pigments: – Hair dyes generally contain chemical substances such Para-Phenylenediamine or other dyes, Colors and pigment. The same shall be labeled in English and local languages and these shall appear on both the inner and the outer labels of the package. The following line should be encrypted without fail:
“Caution: – This product comprises ingredients which may cause skin irritation in certain cases. Therefore, a preliminary test or a patch test according to the accompanying directions should first be made. The use of the product shall not be for dyeing the eyelashes or eyebrows; as it can cause blindness.”
149 A. Special provisions in relation to the toothpaste containing fluoride:
(i) The content of Fluoride in toothpaste shall not be more than 1000 ppm and the same shall be mentioned on the tube and carton of the toothpaste.
(ii) The tube and carton shall also contain the date of expiry.
B. The Legal Metrology Act, 2009:-
All Pre-packaged commodities which are imported into India shall qualify 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 shall acquire a registration under Rule 27.
The Legal Metrology Act, 2009 (Act 1 of 2010) is the replaced version of Standard of Weights and Measures Act, 1976 & the Standards of Weights and Measures (Enforcement) Act, 1985. The Act came into force on April 1, 2011.
However, the state governments can enforce their own provisions of the Act and Rules framing its own Legal Metrology (Enforcement) Rules and shall come into force from the date of notification.
Compulsory Declaration on Pre-packaged Commodities
- Manufacturing, packing, selling or importing of any pre-packaged commodity is restricted unless it is in a notified standard quantity and carries with themselves all prescribed declarations.
- Any advertisement which mentions the retail price of packaged commodity shall also contain the information about net quantity thereof.
- In case the net quantity of a pre-packaged commodity is short or excess beyond the prescribed MPE, it shall be considered a punishable offence under Section 36(2).
Under the Legal Metrology (Packaged Commodities) Rules, 2011, the importer of pre-packaged commodity shall seek registration under Rule 27. The registration shall be done by the Director or controller of Legal Metrology of the State. The registration Fees would be INR. 500. In the circumstances where the requirements of labeling are provided in FSSAI (Food Safety & standards Act 2006) or CDSCO regarding food items, the labeling requirements as mentioned under FSSAI shall supersede over labeling requirements of Legal Metrology Act.
Important sections in respect of Cosmetics packaging under the Legal Metrology Act, 2009:-
Every unit of weight or measure shall be in harmony with the metric system as defined under the International system of units. The base unit of –
- Length – Meter;
- Mass – Kilogram;
- Time – Second;
- Electric current – Ampere;
- Thermodynamic temperature – Kelvin;
- Luminous intensity – Candela &
- Amount of substance – Mole.
C. BIS ECO Labeling Standards
Environment friendly packaging is the need of the hour in order to curb the pollution levels and reverse the harmful impacts of environmental disasters. A scheme has been laid down for labeling environment friendly products known as ECO Mark (optional) by the Ministry of Environment & Forests (MEF), Government of India. The ECO Mark is being monitored and governed by the Bureau of Indian Standards Act, 1986.If a product requires eligibility for marking with ECO logo, it shall also carry the BIS Mark in addition of meeting additional environment friendly requirements. In such cases, the BIS Standard mark would be a single mark from the combination of the BIS monogram and the ECO logo. Requirements for the ECO friendliness mark will be additional, manufacturing units can opt only for Standard Mark alone also.
Additional Requirements for Eco Mark (Optional) – Packing and Labeling Compliance
Requirements for ECO Mark in order to assure for quality, safety and performance prescribed under:
- The ingredients going into the formulation of cosmetics shall fulfill the provisions of IS 4707 (Part I) and IS 4707 (Part 2). The specific requirements as given in the standard shall also be met by the product.
- A list of key ingredients shall be displayed on the product package in descending order of quantity present.
- The product shall not be prepared out of any carcinogenic ingredients.
The manufacturer shall apply for the BIS environmental consent clearance from the concerned State Pollution Control Board falling under the provisions of the Water (Prevention and Control of Pollution) Cess Act 1977 & the Air (Prevention and Control Pollution) Act, 1981 along with the authorization under the Environment (Protection) Act, 1986 & the Rules made there under, while registering themselves for ECO Mark. In addition to this, provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall also be complied with.
Additional Specific Requirements
- Product shall be safe to be used on skin, i.e. Dermatologically safe when being tested as per IS 4011.
- The constitution of heavy metals such as lead (Pb) and arsenic (as As2 O3) shall not exceed 20 and 2 ppm, respectively when being tested by the Indian Standards.
- In case of ECO Mark, the product package shall be packed in such packages which shall be recyclable or biodegradable.
Packing and Marking – Packing and Labeling Compliance
Following are some important points regarding packing and marking:
Packing
The material shall be packed in well – suited closed containers and packets.
Marking
The containers of the products shall be legibly marked with the following information:
- Name of the Material or Product
- Manufacturer Name and /or his recognized Trademark, if any
- Net quantity of the Material
- Month and year of Manufacturing/Packing
- Batch/Lot Number, in code or otherwise
- Date of Expiry or “Best use before….” (Month and Year of same to be declared by the Manufacturer)
NOTE — This requirement is exempted in the following cases:
- Where the pack sizes of is of 10 gm or less.
- Where the shelf life of the product is more than 24 months.
- List of key Ingredients
NOTE — The following is exempted in case of pack sizes of 30 g or less.
- Any other information required by regulatory authorities.
- The containers or packets shall also be marked with the BIS Mark:-
The use of the BIS Mark or commonly called as Standard Mark is governed under the provisions of the BIS or Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of provisions under which under the BIS Act may be granted to manufacturers or producers shall be obtained from the Bureau of Indian Standards.
If the product falls under the ECO Mark (optional), it shall be efficiently marked with ECO Mark logo along with the Standard Mark. The label shall clearly depict that ECO Mark is applicable to the contents or the package or both, as case may be. In case the product package does not separately falls under ECO Mark scheme, it shall be clearly mentioned on the product package that ECO Mark label is applicable to contents only.
Read our Article:Cosmetic Product Manufacturer License in India
