CliniExperts regulatory advisers help to evaluate all aspects from legal to regulatory compliances for Medical devices/IVD's to meet all the requirements in the form directives, regulations and standards stated by CDSCO.
Cosmetic products require label compliance to prevent further rejection or queries from the regulatory authorities. The label compliance is an approval given by the registered regulatory body CDSCO or the State Licensing Authority.
A detailed list of things should be assessed before submitting the product label for compliance. The label should include a list of 15+ parameters based on New Cosmetics Rule 2022. Few are listed below
The label should include manufacturer details, manufacturer license number, the product's manufacturing date, and the manufacturing batch number.
The expiry date of the product
Customer care number and details for contacting the organization
The label should include the ingredients added to the cosmetic product.
Registration certificate no. or Manufacturing license no. should be mentioned
The net content/net weight/net volume should be mentioned on the product's label.
Product compliance is necessary for every cosmetic product label to prevent any objection or rejection from the regulatory body. There should be no non-cosmetic claims on the label artwork. For this, the copy of the label, product formula, and a copy of the manufacturing license/GMP certificate should be shared.
Before applying for label compliance, ensure that the label follows the guidelines as per the labelling requirements mentioned in the New Cosmetic Rule 2020.
Details on the label such as manufacturer name, net weight of the product, and ingredients should be verified with the official documents of the product.
The regulatory body can give a significant rejection or an update of the label if the label on the product does not comply with the New Cosmetic Rule 2020.
Ensure the product label is as per the New Cosmetic Rule 2020 and does not include any misleading information, resulting in the rejection of your label.
Do not include any non-cosmetic claim on your label, resulting in the rejection of your product.
Rule 34 of the New Cosmetic Rule 2020 should be followed for Cosmetic Product Label Compliance.
A complete list of ingredients should be printed on the label. The ingredients with a concentration of more than one per cent should be mentioned in the descending order of weight or by volume based on the time of their addition to the final product. In addition, the word "INGREDIENTS" should be mentioned on the label.
No, it is not mandatory to mention these ingredients on the label.
The BIS for cosmetics are covered under the Ninth Schedule of the New Cosmetic Rules 2020.
The exported cosmetic product should follow the guidelines depending on the country of exports. However, the mandatory labelling conditions mentioned as per the rule 34 'Manner of Labelling' should be followed.
Yes. For hair colouring products containing dyes, colours and pigments must follow the rule 37 of New Cosmetic Rule, 2020.