Are you an importer, distributor, or manufacturer and need to know whether cosmetic registration for mouth freshener is necessary before market entry? In India, you should adhere to CDSCO standards for oral care items upon entering the competitive market. The Central Drugs Standard Control Organization is India’s regulatory organization that ensures cosmetics utilized in India are effective, of good quality, and safe. Oral dentifrices have been classified as cosmetics under the Drugs and Cosmetics Act, 1940.
Step by step CDSCO clearance process of mouth freshener is given below, i.e., documents, validity, & price.
Understanding The Classification Of Mouth Fresheners
It is important to classify the products before proceeding further with the Cosmetic registration for mouth freshener. Following the Central Drugs Standard Control Organization (CDSCO):
- If the mouth freshener is for oral cleansing & is used externally without being ingested, it falls under the category of cosmetics.
- If the item is poor (such as pan or mint), it comes under the Food Safety and Standards Authority of India (FSSAI).
What Is Cosmetic Registration For Mouth Freshener?
Registration of mouth freshener comes under the CDSCO, which is the regulating drug and cosmetic agency of India. The Drugs and Cosmetics Rules, 1945, clearly mention that all cosmeceutical products imported or made domestically are to be registered with the CDSCO before sale in India.
Step-by-Step Process for Cosmetic Registration For Mouth Fresheners
To export and market mouth fresheners that are cosmetics in India legally, you need to register them under the CDSCO through the Drugs and Cosmetics Act, 1940.
Step 1: Verify Product Classification
Ensure that the product is a cosmetic (for beautification or cleansing purpose without any medicinal claims). If the product contains some therapeutic properties, it can be under the drugs regulations.
Step 2: Appoint Authorized Agent (For Foreign Brands)
Overseas producers are required to nominate an Authorized Indian Agent (AIA) to apply and interact with CDSCO on their behalf.
Step 3: Prepare Documents
Gather Form 42, Power of Attorney, composition of the product, labels, manufacturing information, Free Sale Certificate (FSC), Certificate of Analysis (CoA), and other documents according to Schedule D(III).
Step 4: Apply via SUGAM Portal
Get registered on cdsco.gov.in, upload the documents, and remit the applicable fees—USD 250 per brand and USD 1,000 per variant.
Step 5: Respond to Queries
CDSCO reviews the application and may raise queries. Submit clarifications or updated documents as needed.
Step 6: Get Registration Certificate (Form 43)
Once approved, you’ll receive Form 43, valid for 5 years, which is mandatory for import and sale.
Step 7: Clear Customs and Meet BIS Standards
Use Form 43 for customs clearance. Ensure the product meets relevant BIS standards and passes quality checks if tested.
Step 8: Follow Labeling Regulations
Ensure labels comply with Indian standards: provide manufacturer/importer information, batch number, MFG/EXP date, usage guidelines, and warning notices.
Step 9: Keep Records & Renew in Due Time
Retain import and distribution records. Initiate renewal procedure at least 6 months before certificate expiration.
Who Needs Cosmetic Registration For Mouth Freshener?
Any importer or manufacturer who would like to sell or market mouth fresheners in India, which are also known as cosmetic products, must obtain cosmetic registration under the Central Drugs Standard Control Organization (CDSCO). Foreign and domestic companies must undergo this. Foreign businesses must have an Authorized Indian Agent (AIA) through whom they obtain their product registered. Sale, promotion, or importation of cosmetic mouth fresheners in India must be registered before the same to fall in line with the provisions of the Drugs and Cosmetics Act, 1940.
Documents Required for CDSCO Cosmetic Registration for Mouth Freshener
Here’s a checklist of essential documents for CDSCO cosmetic registration for mouth freshener:
| Document | Description |
|---|---|
| Form COS-1 / COS-2 | Application form for import/manufacture |
| Cover Letter | Brief about the applicant and the product |
| Ingredient List | Complete formulation with % concentration |
| Label Samples | Product packaging and label artwork |
| GMP Certificate | Good Manufacturing Practices compliance |
| Certificate of Free Sale | For imported products |
| COA | Certificate of Analysis for product quality |
| Power of Attorney | For foreign applicants |
Cosmetic Labeling Requirements For Mouth Fresheners
CDSCO mandates proper labeling on every cosmetic product. The label must include:
- Product name and category
- Manufacturer/importer details
- Batch number and manufacturing date
- Expiry date
- Net content
- Directions for use
- Ingredients list
- Warning, if applicable (e.g., “For external use only”)
Non-compliant labels can result in registration rejection or seizure of goods.
Time and Cost for Cosmetic Registration
Here is information related to the timeline and cost involved in the cosmetic registration for mouth freshener:
| Parameter | Details |
|---|---|
| 3 to 6 months (approx) | 3 to 6 months (approx.) |
| Validity of Certificate | 5 years |
| Government Fees | ₹50,000 per category/product (import) |
| Consultant Charges | May vary (₹25,000–₹1,00,000) |
Note: Registration cost may differ based on the number of variants, brand complexity, and documentation readiness.
Is Cosmetic Registration For Mouth Fresheners Mandatory?
Yes, cosmetic certification is required for a manufacturer, importer, distributor, or retailer of mouth freshener. Unless a valid registration certificate is produced, the product cannot legally be marketed or sold in India. Non-conformity can result in penalty, product seizure, or blacklisting.
Why Choose ELT for Cosmetic Registration?
ELT Corporate is a reputed regulatory consultancy firm with expertise in CDSCO cosmetic registration in India. With complete familiarity with the Drugs and Cosmetics Act, 1940, and practical experience with the SUGAM portal, ELT Corporate facilitates effortless and seamless registration. From dossier preparation and legal documents to CDSCO query handling and compliance audits, our professional team offers end-to-end assistance for domestic as well as international cosmetic brands. We also provide tailor-made solutions, quick turnaround, and one-to-one support, which makes ELT Corporate your trustworthy business partner for secure and effective market access.
Is Mouth Freshener Considered A Cosmetic?
If it is topically applied in the mouth (like sprays or gels) and not ingested, it is considered a cosmetic under the Drugs and Cosmetics Act.
Do Imported Mouth Fresheners Require CDSCO Approval?
Yes, imported cosmetic mouth fresheners require CDSCO cosmetic registration before they can be sold in India
Are Ayurvedic Or Herbal Mouth Sprays Possible To Register As A Cosmetic?
Yes, if they are to be used outside the body and to improve oral hygiene or mouth breath, they need to be registered under cosmetic regulations, even if they are herbal.
What If I Neglect Cosmetic Registration?
It is unlawful to sell products that are not registered and can carry penalties, confiscation, or criminal prosecution under law.
