Exception of Cosmetics Under Cosmetic Rules 2020

The exception of cosmetics refers to the condition under which the cosmetics manufacturer can provide reliable safety and quality data for cosmetic products under the cosmetic rule, 2020. This exception applies to cosmetic products that don’t fall under the scope of regulatory requirements by the Central Drug Standard Control Organization, CDSCO. Ministry of Health and Family Welfare, India, acquainted with Cosmetic Rule 2020 by presenting the power it possesses under the provision of the Drug and Cosmetic Act,1940, to segregate defined rules for effective regulatory compliance.

What are Cosmetics?

Before discussing the exception of cosmetics in India, let’s learn what cosmetics are. According to CDSCO, Drug and Cosmetic Act, 1940, cosmetic products refer to any article intended to be applied, rubbed, sprayed, poured, or otherwise applicable to the human body for beautifying, cleaning, and purifying purposes.

List Of Exemption Of Cosmetics

If you are an importer, manufacturer, or distributor of cosmetics devices, then you must understand the exemption of cosmetics. Here, you will find various categories in which exceptions are made as per Cosmetic Rule 2020 given below:

Cosmetics Import for Personal Use

Cosmetic products imported for personal use don’t need to follow the highly regulated guidelines except for the cosmetic rule, 2020. The stringent regulatory requirements mandatory for cosmetic products imported into India for sale are not required to be fulfilled in the case of self-use. However, specific requirements related to quantity limits shall be maintained for these exceptional cosmetic products, ensuring no misuse occurs commercially.

Compliance with the Bureau of Indian Standards (BIS)

The manufacturer of cosmetics must adhere to the standards of the BIS. Schedule S lists the cosmetics that must be complied with as per the BIS specification for cosmetics. However, some of the traditional and handmade products may be exempted from these requirements if they fall under specific cultural or artisanal categories.

Special Medical Cosmetic Products

Medical cosmetic products used primarily for medical purposes fall under different regulatory standards than cosmetics regulation. It involves medicated shampoo for anti-dandruff purposes or skin products for acne prescribed by doctors or healthcare professionals. These exceptions of cosmetic products fall under the drug regulatory standard rather than cosmetics.

Bulk Cosmetic Products

Bulk cosmetic products that are used for manufacturing the cosmetic products till it’s final packaging instead of the direct sale in the market fall under the exception of cosmetics in cosmetic rule,2020

Cosmetics for Testing Purposes

Cosmetic products imported for testing and research don’t need to follow stringent regulatory requirements because these cosmetic products come under an exception of cosmetics rules, 2020.

Labelling and Packaging Regulations

All cosmetics must adhere to strict labelling and packaging regulations, including declarations of ingredients and usage instructions. However, exceptions may apply to products meant exclusively for export, where the labelling can conform to the importing country’s requirements instead of Indian standards.

Clinical Trials and New Cosmetic Ingredients

Certain low-risk cosmetics may be exempted from the need for clinical trials before being marketed. However, new cosmetic ingredients typically require safety assessments unless they fall under an exemption based on their history of safe use.

Example of Exception of Cosmetic products

Following are the examples of cosmetic products that fall under the exception of the cosmetics rule, 2020:

•  Medicated Shampoo
•  Cream for Acne
•  Medicated Lip Balm
• Homemade Soaps
• Bulk Lotion

Conclusion – Exception of Cosmetics Under Cosmetic Rules 2020

The exception of cosmetics as per cosmetic rule, 2020 in India helps to navigate the regulatory standard for cosmetics if not imported or distributed for sale in India. Consumer safety is always CDSCO’s priority. Therefore, even except cosmetic products, there are specific requirements related to the quantity limits of cosmetics to maintain the integrity of regulatory compliance.

Moreover, cosmetic products imported into India in bulk quantities can be repackaged with 100 percent efficiency for export outside India without a registration certificate. In this case, the importer shall provide the undertaking confirming that the cosmetic products are not commercially available for sale.

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