FSSAI License for Oral Cosmetics

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The Food Safety and Standards Authority of India (FSSAI) plays a crucial role in ensuring the safety & quality of food products in India. However, its purview extends beyond just food to include other consumable products, such as oral cosmetics. This guide explores the FSSAI registration process for oral cosmetics, its significance, requirements, and more.

Introduction To FSSAI

The Food Safety and Standard Authority of India is an independent regulatory body governed by the Ministry of Health and Family Welfare under the Food Safety and Standard Act of 2006. FSSAI aim to promote the availability of cosmetic of safe food for the consumers. It ensures the food available for people is safe and effective for their well-being.

FSSAI is responsible for overseeing the safety of oral cosmetic products. Oral cosmetic defined as product used for cleaning & maintaining the hygiene of teeth and mouth, preventing any disease or cause. Oral cosmetics such as dental braces, toothpaste, and mouthwash play a crucial role in enhancing the beauty of teeth and are also essential to our daily hygiene.

What Are Oral Cosmetics?

Oral cosmetics are products designed to be used in and around the mouth. It is used to prevent the disease of teeth as well as for beautifying, cleaning, and enhancing the appearance of teeth. Oral cosmetics also ensure the mouth has a good odour. Sometimes oral cosmetic products are utilised for treating diseases such as gum disease. Following are the examples of oral cosmetic products:

Toothpaste
Mouthwashes
Dental braces
Gargles
Lip balms
Lipstick

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What is the Role of FSSAI In Regulating Oral Cosmetics?

FSSAI is the regulatory authority for maintaining the regulation of oral cosmetic products as per the rigorous safety standards. It ensure safety and quality of oral cosmetic products are available commercially. The presence of harmful substances in oral cosmetic products may lead to serious conditions such as allergic reactions.

So, to protect the unwanted harm to consumers, safety standards along with a stringent regulatory framework are necessary. FSSAI regulation helps to build confidence in the oral cosmetic products supply chain.

Why FSSAI Registration is Important for Oral Cosmetics?

As per the FSSAI we find that most of the oral cosmetics such as mouthwashes, toothpaste and other oral care products connects directly with the mucous membranes in the mounth. Therefore ensuring the quality & safety of these products is very necessary. So the FSSAI registration for oral cosmetics is important to:

Ensure that the product is safe for the consumption.

Enhance the consumer trust.

Complies with legal requirements

Facilitate product the access market nationally or internationally.

What Are the Major Responsibilities of FSSAI In Oral Cosmetics Regulations?

FSSAI has major responsibilities that helps to make the regulatory compliance more quick and seamless. For the registration of FSSAI oral cosmetics the FSSAI perform the following responsibilities: Setting Standard

FSSAI designs specific standards and regulatory guidelines for food products and oral cosmetic products. This is to ensure the products are safe and effective for public health after commercialization. It includes the standard related to the minimum permissible limit of colour, additive, and contaminated substance present in the finished product ensuring the product is safe and does not contain harmful substances beyond the standard limits.

Registration

FSSAI made it compulsory for entrepreneurs, businessmen, and manufacturers to obtain registration for manufacturing oral cosmetic products. It must be confirmed by the manufacturer that the product meets the required standards and that all the entities comply with the prescribed safety and quality standards.

Inspection and Audit

FSSAI conducts a regular audit of the manufacturing site to confirm that the product complies with regulatory standards. In case the product is found to be non-compliant with the regulatory standard, it may face serious enforcement action sometimes the product is recalled from the market.

Steps To Apply For FSSAI for Oral Cosmetics Registration

If you are willing to apply for the registration of FSSAI for oral cosmetics then you must understand the key steps. By the help of these steps you can simply understand the application criteria to obtain this license:

First you have to figure out the eligibility criteria to determine whether your product falls in the oral cosmetics as showed by FSSAI. Typically, these are products used for cleaning, beautifying, promoting attractiveness, or altering the appearance of the teeth and oral cavity.

Then you have to figure out the overall process of the application or you can consult with the experts to understand it. The process of the application involves steps:

Filing Application - The first steps is to fill the application form to the FSSAI department. The application must contain the information related to the product and intent to use.
Documentation - Here are the several documents that are required for the registration process.

➤ Photo ID proof and passport photographs of the applicant.
➤ Proof of address.
➤ List of products to be registered.
➤ Details of the manufacturing process and equipment.
➤ No Objection Certificate (NOC) from the local municipal authority.
➤ Water test report (if applicable).
➤ Import Export Code (for imported products).

Inspection: After submitting the application the FSSAI officials inspect the manufacturing premises. They will ensure the safety standards. The inspection process is the critical part of the registration process.
Grant Of Registration: If the inspector is satisfied with the application and the site then they will grant the registration certificate for oral cosmetics to regulate in market freely. The registration number must be displayed on the product packaging.

You must get to know about which license do you required as per your manufacturing or import of product:

Basic Registration: For small-scale businesses with an annual turnover of less than INR 12 lakhs.
State License: For medium-scale businesses with a turnover between INR 12 lakhs to 20 crores.

Central License: For large-scale businesses with a turnover exceeding INR 20 crores or those operating in multiple states.

FSSAI registration is valid for 1 to 5 years, after which it must be renewed. Businesses must ensure continuous compliance with FSSAI regulations, which include maintaining hygiene standards, regular product testing, and prompt reporting of any issues.

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How ELT Can Assist You with Regulatory Compliance of Oral Cosmetics as per FSSAI?

ELT corporate is a leading regulatory affairs consultant, we bring our expertise in FSSAI regulations with our team of professional regulatory affairs experts who stay proactive with updates and guidelines along with the current regulatory market trends which helps them ensure the oral cosmetic products must meet all the regulatory standard of FSSAI.