This article is written by Raslin Saluja, from KIIT School of Law, Bhubaneswar. This article enumerates the various provisions of the recent Cosmetic Rules, 2020 along with the Drugs & Cosmetics Act, 1940 with respect to consumer safety.
There is no doubt that the cosmetics market is on the rise at a rapid pace in India, especially in urban areas. There are many factors that contribute to this particular rise such as high-income groups with greater spending/purchasing power, increased influence and exposure to the cosmopolitan western culture, maintaining social lifestyle, personal desire to look a certain way, and the like. This sudden rise indeed attracts the need to be stringently regulated because of the sheer nature of the product and its use.
Definition of cosmetic
By virtue of the definition provided in the Drugs & Cosmetics Act, 1940, a ‘cosmetic’ means any article that can be applied to any part of the human body, intending to be rubbed, poured, sprinkled, and sprayed on. It could be introduced to/ or applied to any part of the human body to serve the purpose of cleaning, beautifying, promoting attractiveness, or altering the appearance.
Laws dealing with cosmetics
The industry had for long been regulated under the Drugs & Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, however back in December of 2020, the Ministry of Health and Family Welfare notified the new and updated the Cosmetic Rules, 2020. The new rules separately codify and update the rules pertaining to the matters of import, manufacture, labelling, sale, and distribution of cosmetics in India. Though, for convenience and smooth transition, the 2020 Rules allow the earlier granted licenses under the 1945 rules, to continue to remain valid until their expiry date or period of 18 months from the date of notification of Cosmetic Rules, 2020.
The aspect of consumer safety
The new Rules have introduced and made sure that microscopic licensing, inspection, and compliance requirements are adhered to. Huge transparency has been reflected in the disclosure and prohibitory provisions in terms of the quality and safety of ingredients used. Be it manufacturing, sales, and distribution or quality check of ingredients, licensing, inspection, or overall withdrawal of risky products from the market, these are all an extension to the attempts of maintaining consumer safety. The aspect of consumer safety has been proactively dealt with in every chapter under the Rules.
The Cosmetic Rules, 2020
According to the 2020 Rules, cosmetics are classified into 11 broad product categories under Seventh Schedule for the purpose of license permits to manufacture for sale:
- Skin Powder for infants;
- Creams, lotions, emulsions, pastes, cleansing milk, shampoos, pomade, brilliantine, shaving creams, hair oils, etc.;
- Nail Polishes and Nail Lacquers;
- Lipsticks & Lip Gloss etc;
- Preparations used for eyes like eyebrows, eyelashes, eyeliners, kajal, and surma;
- Alcoholic Fragrance Solutions (Cologne);
- Hair Dyes;
- Tooth Powders and Tooth Pastes etc;
- Toilet Soaps.
It further elaborates on the types of equipment to be used, the surface area for manufacture space, the customized specific requirements like usage of exhaust fans, mixers, storage tanks, etc along with the premise, storage and manufacture instructions that are to be complied with. The Eighth Schedule requires transparency to be maintained in terms of particulars that are to be compulsorily displayed in the manufacturing records namely:
- Serial number;
- Name of the product;
- Lot or Batch size;
- Lot or Batch number;
- Date of commencement of manufacture and date when manufacture was completed;
- Names of all ingredients, quantities required for the lot/batch size, quantities actually used;
- Control reference numbers in respect of raw materials used in the formulation
- Reference to analytical report numbers or unique code;
- Actual production and packing particulars indicating the size and quantity of finished packings;
- Date of release of finished packing for distribution or sale;
- Signature of the expert staff responsible for the manufacture.
The Ninth Schedule gives specifications in terms of the standard that is to be maintained for production in accordance with the Bureau of Indian Standards (BIS).
Under the Rules 2020, a new concept of a ‘New cosmetic’ has been introduced. It has been defined in Section 3(r) which reads as ‘ a cosmetic which contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any National or International literature.’ The Rules require the importers of new cosmetics to make an application to CLSA for their permit in the prescribed Form COS- 3 before registration of import of new cosmetics into India.
The application has to describe the method of test or analysis to be employed for evaluating the safety of new cosmetics as specified in the IS 4011: 2018 methods of test for safety evaluation of cosmetics, as updated and published by the BIS from time to time. If this requirement of the registration is not complied with by the manufacturer/importer, then after being given an opportunity to be heard, the CLSA can order their suspension or cancellation of registration for a certain period.
Import and registration of cosmetics
Most parts of this process remain largely unchanged from that of 1945 rules, however, under the new rules – significant changes like the introduction of new forms, reduction in the statutory fee have been brought forth.
The Rules also pave the way for importers by streamlining the application, making a single license application, and seeking a single registration certificate to import one or more cosmetics produced by the same manufacturer into a single production facility, which also involves multiple factories working jointly.
There is also prohibition imposed on the import of cosmetics, in the following cases:
- The manufacture, sale, or distribution of the cosmetic in question is prohibited in the country of origin;
- The ‘Use Before or Use by date is less than six months from the date of import;
- The cosmetic which contains ‘hexachlorophene’ (considered to have harmful effects on humans); and
- The cosmetic has been tested on animals after November 12, 2014.
Manufacture of cosmetics for sale or distribution
This as well remains the same as that of 1945 Rules with new forms and applications with a reduced fee. In addition, the Rules require the applicant to furnish a self-declaration confirming compliance with good manufacturing practices and another set of prescribed instructions. For instances where manufacturing is done at more than one premise, the Rules require obtaining separate licenses for each premise. Further, parallel to import registration certificate, license for manufacturing or loan must necessarily remain valid in perpetuity, subject to payment of retention fee before a time period of five years from the date of issuance of the license.
Quality and ingredients of cosmetics
The Rules have put forth stringent mandates in order to ensure safe practices and measures from the point of view of the consumer. The manufacturers have to declare all ingredients of their products, including those with a concentration of less than 1%, which would, in turn, help the consumers make a more informed choice. The Rules do not allow the import and/or manufacture of cosmetics that do not satisfy the requisite levels of the standard of safety and quality. Certain (specified) raw materials (as provided under Annex A of the Indian Standard IS 4707 Part 2) have also been prohibited from being added to the cosmetic product. Import of those cosmetics has also been prohibited which contain dyes, colors, and pigments other than those allowed by BIS.
Voluntary recall mechanism
The Rules also lay an additional obligation on the manufacturer or his approved agent concerned. If either of them have a reason to believe and are satisfied that such cosmetics which have been imported, manufactured, sold, or distributed are likely to affect the health of the consumer or have any negative impact and may therefore be unsafe, they can order and direct for withdrawal of such cosmetics from the market. Further, the concerned manufacturer or authorized agent must adhere to the prescribed procedure and inform the ‘State Licensing Authority or the CLSA, as the situation may be while withdrawing the products and stating the reasons to do so.
Types of cosmetic license in India
For initiating and setting up a cosmetic business in India, the licenses are classified into two types depending upon the nature of the cosmetic business.
wherein the Central Licensing Authority supervises the import of cosmetics along with coordination with State licensing authorities and the State Licensing Authorities are to supervise the manufacture, sale, stock, exhibit or offer for sale and distribution and granting of approval for carrying out various tests.
Requirements for getting a license of cosmetic business
For manufacturing, they are required to make an application to the state licensing authority through an online/offline portal in the prescribed form accompanied with fees and required documents as per the mentioned procedure under Section 23. Further, the manufacturer has to make sure that inspection is made by a competent and qualified technical staff to observe the process of production.
At least one staff member should be there, who must possess the required educational background. They should possess either of the following qualifications as required under Section 26 of the Rules:
- The staff should hold a Diploma in Pharmacy which must be approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
- The staff can be registered under the Pharmacy Act, 1948; or
- The staff should pass the intermediate examination with Chemistry as one of the subjects or any other examination as recognized by the Licensing Authority as equivalent to it.
- Or if the staff holds a bachelor’s degree in Cosmetic technology from a recognized university.
The manufacturer is also required to maintain documentary evidence of ownership or rental documents, the constitution of the firm, and maintain adequate staff at all times, and laboratory equipment.
Inspection before granting license
Before granting or refusing the license, it is the duty of the Licensing Authority to order for inspection of the whole process of the operations. Inspectors are appointed under Section 21 of the Act by the State Government. Then the inspectors are supposed to submit a detailed report about the operations to the Licensing Authority. After that, the Licensing Authority will decide whether to grant the license or not.
Even in general for already licensed manufacturers, the inspectors are under the duty to inspect not less than once in a span of three years, the premises of the site to his satisfaction, and send detailed reports to the controlling officer. They are empowered to institute prosecution upon breach and gather samples upon reason to believe for test and evaluation. They maintain a record and furnish such copies from time to time to CLSA and can make inquiries for any investigation of complaints.
Requirements for factory premises
The factory also has to maintain the provisions under the Seventh Schedule.
Location and surroundings
The area should have all the facilities for seating up a cosmetic manufacturing business. It should be ventilated and clean, with hygienic conditions, and must not be set up within or near any residential area.
Have to maintain the sanitary and hygienic conditions in the building, which should be free from rodents, insects, flies, etc. which can hamper the whole operation or product. There are several other conditions for the rooms and the area within the building. The height of the room should not be less than 6 feet from the floor with proper ventilation. Effective measures are to be taken to maintain hygiene and keep the rooms smooth, washable, well-lit, and adequately equipped.
There are other conditions as well for maintaining the water supply, disposing of the used water, sanitary requirements of staff, medical services, testing, and release of raw materials. The personnel and staff appointed for the manufacturing should be well capable of fulfilling the assigned task and be free from any communicable or infectious disease. They are also required to use the necessary tools such as hand gloves, masks, uniforms, etc.
Requirements pertaining to labelling of products
The labelling and packaging standards of cosmetics are dealt with under the Chapter VI of the Rules, 2020.
- No cosmetic product is allowed to be sold or distributed if it is not labelled and packaged in accordance with the provisions.
- Both the inner and the outer labels should contain the name of the product, manufacturer, and complete address of its manufacturing premise. In case, if the size of the container is too small, the name of the manufacturer along with the principal place of manufacturing and the pin code should compulsorily be given. It should also mention the expiry date within which the product is safe to use. Further, a distinctive batch number and a manufacturing license number should be mentioned.
- The outer label should contain and clearly mention the list of ingredients in terms of weight, fluid measure, and numerical count which are being used in the manufacturing of the product.
- To avoid any risk in case of the presence of any hazard, adequate directions for use, any warning or special instruction, and caution must be specified on the inner label. The manufacturer is also supposed to mention the names and quantities of ingredients that are of hazardous nature.
- In the case of only one label, it should include all the details that are supposed to be shown on inner and outer labels.
- For imported products, the import registration certificate number must be mentioned.
- No cosmetic must mislead or claim any false idea to its intended user.
- And some other requirements for products pertaining to import and export.
At all times, quality and safety standards in the case of the aforementioned categories of products must be in strict compliance with the Indian standards laid down and revised by the Bureau of Indian Standards (BIS) from time to time. Alongside this, it also has to adhere to the standards as prescribed and meet the requirements of the Ninth schedule.
Requirement for testing of cosmetic sample
Analysis and the quality check of the products by following the procedure of sample testing forms one of the significant features for assuring consumer safety. It has to meet all the criteria for imported cosmetic product registration and it should satisfy the manufacturer, buyer, and consumer. It is done by the inspector under the powers vested in him through Section 22 of the Act. The sample testing includes the following:
- Physical and chemical analysis of raw materials and active ingredients;
- Safety tests to assess the presence of heavy metals in cosmetics banned colours and chemicals;
- Microbiological quality check to ensure the absence of microbial counts and pathogens;
- Qualitative and quantitative estimation of active ingredients;
- Physical testing that includes parameters such as viscosity, spread-ability, scratch test, pay-off test, etc
- Estimation of sun protection factor;
- Skin irritation and sensitivity studies; and
- Stability testing, shelf-life determination, etc.
Fees of such tests and many others are provided under the Fifth Schedule. Certificates are issued by the Laboratory only after the report of the result of the test is supplied following full protocol under Section 51.
It should be remembered that each and every product that is manufactured or imported, should deal with the Cosmetics Rules, 2020 along with the Drugs and Cosmetics Act, 1940. The Drugs and Cosmetics Act, 1940 is a punitive Act, which outlines the offenses and their penalties upon contravention keeping in mind consumer safety.
Further with the 2020 Rules, the provisions have gotten more stringent and articulate in terms of safety measures that are to be complied with. For any cosmetic which is not in accordance with the Rules in terms of colours, labels, or imitation, they are covered under Section 9C as misbranded cosmetics and Section 9D as spurious cosmetics under the 1940 Act Section 10 enumerates the prohibition of certain cosmetics which are misbranded, or not of standard quality.
If any of the provisions or rules under the Act with respect to Cosmetics is/are not complied with for cases of import Section 13 lists down the penalties in terms of imprisonment and fine cap. Section 27A of the Act deals with penalties in cases of contravention to manufacture and sale provisions. It is as follows “Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale-
- Any cosmetic deemed to be spurious under Section. 17-C should be punishable with imprisonment for a term, which may extend to three years and with a fine;
- Any cosmetic other than a cosmetic referred to in Cl. (i) above in contravention of any provisions of this chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.
For subsequent contravention under Section. 27-A, the convict shall be punishable with imprisonment for a term which may extend to two years, or with a fine which may extend to two thousand rupees or with both.
Thus, we see at every step, the new Rules 2020 have ensured the goal of consumer safety. There are certain basic regulatory compliances that exist for the benefit of the users. For example, the rules demand very transparent packaging and labeling guidelines for ingredients. Mention any harmful substance if involved, or the composition of raw materials used and any undesirable effect that might occur – all of which transfers the responsibility on the user and their discretion if they want to use the product. Further proper license numbers, manufacturing batches, contact details of the company have been provided for the user’s convenience in case they want to reach out. Though there is always scope for improvement, the new Rules prove to be an efficient effort towards maintaining the control standards and safety information especially catering to consumers.
- The Drugs and Cosmetics Act, 1940 and The Drugs and Cosmetics Rules, 1945 available at: https://cdsco.gov.in/opencms/export/sites/CDSCOWEB/Pdfdocuments/actsrules/201 6DrugsandCosmeticsAct1940Rules1945.pdf
- Article on review of regulatory provisions regarding cosmetics in India, available at: https://www.pharmatutor.org/articles/review-regulatory-provisions-regarding-cosmetics-in-india
- Cosmetic Rules, 2020, pdf available at https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiIzM_1_bTwAhXczzgGHYcWCqsQFjADegQIAxAD&url=https%3A%2F%2Fthc.nic.in%2FCentral%2520Governmental%2520Rules%2Fe%2520Cosmetics%2520Rules%2C%25202020.pdf&usg=AOvVaw2lKLTuUS7FjA7LbhYaj_LM
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