560 JOURNAL OF COSMETIC SCIENCE mainly to cleaning them, perfuming them, changing their appearance and correcting body odors and protecting them or keeping them in good condition.” Any product that is placed in the EU market under this category must comply the requirements of the EU cosmetic regulations irrespective of its place of origin or manufacturing. PREMARKET REQUIREMENTS In India, before placing any locally manufactured cosmetic product in the market, it is mandatory for the manufacturer or responsible person to take preapproval from the State Licensing Authority (SLA). Manufacturers must prepare a dossier file of the product’s information that should contain all the related information such as composition, ingredients, safety data, expiry period, etc. and that must comply the regulations of Cosmetic Rules, 2020 and the Indian Standards as laid down by the BIS. All these details need to be submitted to the SLA along with application form, fees, and other supporting documents. Thereafter, the SLA issues a license for the manufacturing of that cosmetic product for sale or distribution in India. The license shall remain valid in perpetuity, subject to payment of license retention fees before completion of the period of 5 y from the date of issue, unless it is suspended or canceled by the SLA. However, in case of “new cosmetics,” the concept of which has been introduced recently in Cosmetic Rules, 2020, no license shall be granted to a manufacturer by the SLA until the manufacturer takes prior permission from the Central Licensing Authority i.e., the Drugs Controller General of India (9). In the EU, the cosmetics products notification portal (CPNP) is the online notification portal created for the enforcement of Regulation (CE) No. 1223/2009, which requires an online notification before placing a cosmetic product in the market. The online notification includes information on the name and category of the product the name and address of the responsible person including his contact details the country of origin in case of import the first country where the product will be placed on the market the presence of nanomaterials and CMR substances the cosmetic product’s formulation and a compliant label with a photo of the external packaging (if legible). The manufacturer (legal person: individual or company) or responsible person (in case of imported cosmetic product/s) must prepare a PIF. The PIF is a regulatory file that contains the product’s related information such as composition, safety, ingredients, good manufacturing practices (GMP), sampling and analysis, CMR (carcinogenic, mutagenic or toxic for reproduction) substances, nanomaterials, animal testing, and labeling and packaging, and must comply the requirements set by EU cosmetic regulations. Overall, the PIF is divided into two parts: Part A, which contains detailed information of the cosmetic product, and Part B, which is more important and includes the safety assessment information of the cosmetic product. After preparing the PIF, the responsible person shall notify the EU authority online through the CPNP. The product must comply with the Regulation EC No. 1223/2009 and must be safe to human health. Only one notification is required for a product to be marketed in 30 countries controlled by the EU. Any change in composition, unwanted effects after use, recall, etc. must be reported by the responsible person using the CPNP (10). After the notification, the product can be placed into the EU market. REQUIREMENTS FOR IMPORT OF COSMETIC PRODUCTS The licensing process is totally different in the case of imported cosmetic products in India. Unlike locally manufactured cosmetic products for which the SLA issues a license,

561 A COMPARATIVE EVALUATION OF COSMETIC LEGISLATIONS IN INDIA imported cosmetic products must first be registered with the Central Licensing Authority through SUGAM, an online portal, by the importer, original manufacturer, or authorized agent. Only then can the product be placed into the Indian market. After the registration, regulatory persons examine and verify the documents, and, if satisfied, grant an import registration certificate that remains valid in perpetuity, subject to payment of registration certificate retention fees as specified in the Third Schedule before completion of the period of 5 y from the date of its issue, unless suspended or canceled by the Licensing Authority. As per the Cosmetic Rules, 2020, any cosmetic product that is prohibited to be manufactured, sold, or distributed in India shall not be imported in the same or other name, with an exception for analytical purposes. Apart from that, no cosmetics shall be imported unless the “use before” or “use by” date shown on the label, wrapper, or container of the cosmetic is more than 6 mo. from the date of import. Additionally, after November 12, 2014, no cosmetic that has been tested on animals or contains hexachlorophene shall be imported into the country. In the EU, cosmetic products imported from developing countries may be placed in the market subjected to prior notification through the CPNP. First, the responsible person or the designated person gathers all the information about the product to be imported, such as composition, stability of raw material/ingredients, formula, challenges, manufacturing method, safety documents, and studies to determine whether the finished product complies with the requirements and standards set by EU regulation. The labeling and packaging of the product must also comply with the requirements and regulations of EC No. 1223/2009. After gathering all the information, the responsible person shall prepare a PIF that contains detailed information about the product and safety assessment data and has been examined by a certified toxicologist or pharmacist, and then shall notify the European authority through the CPNP. Overall, the importer or responsible person would be accountable for any query raised by the authorities or public after placing the product in the EU market. LABELING REQUIREMENTS In India, labeling and packaging requirements are given in Chapter VI of Cosmetic Rules, 2020. As per the rules, no person can sell or distribute cosmetic products that are not manufactured by a licensed manufacturer and do not comply the labeling or packaging requirements. Furthermore, the outer and inner label of the packaged product must carry the following information: 1. The name of the cosmetic product. 2. The name of the manufacturer and complete address of the manufacturing location. 3. Use before or date of expiry (month and year). 4. A distinctive batch number [not applicable if amount is ≤10 g (in case of solid or semi-solid product) and ≤25 ml (in case of liquid state), and for soaps] on inner or outer label. 5. Manufacturing license number (on inner or outer label). (In case of imported products, if such provision is not mandatory in the country of origin, such cosmetics may be allowed without mentioning the manufacturing license number, subject to fulfillment of other import regulations). 6. Net content of the product (on outer label). 7. In case of cosmetics, where a hazard exists, every inner label shall clearly indicate adequate directions for safe use any warning, caution or special direction required to