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

562 JOURNAL OF COSMETIC SCIENCE be observed by the consumer and a statement indicating the names and quantities of ingredients that are hazardous or poisonous. 8. Import registration certificate number on the label of unit pack (for imported products). Apart from that, there are some special labeling requirements for hair dyes containing dyes, colors, and pigments, and for toothpaste containing fluoride (not more than 1,000 ppm), which have been described in Chapter VI of Cosmetic Rules, 2020. In EU, the cosmetic products placed in the EU market must comply the labeling requirements mentioned in Chapter VI, Article 19 of EC No. 1223/2009 and should include the following information: 1. The name or registered name and the address of the responsible person. 2. Country of origin (in case of imported product). 3. Net content of product at the time of packaging (except in the case of packaging containing less than 5 g or 5 mL, free samples, and single-application packs). 4. Date of minimum durability (if durability is 30 mo.). If durability is 30 mo., then duration for which the product is safe to use after opening should be listed. 5. Batch number. 6. Particular precautions to be observed in use. 7. The function of the cosmetic product unless it is clear from its presentation. 8. A list of ingredients. In the EU, the language of the label is determined by the member state in which product is intended to be used or marketed. Any ingredient that is a nanomaterial must be mentioned on the label by indicating “nano” in bracket. PROHIBITED AND ALLOWED LIST OF INGREDIENTS In India, the BIS issued a draft “classification of cosmetic raw materials and adjuncts” to specify the requirements for ingredients used in the manufacturing of cosmetics. The BIS has issued a positive list of dyes, colors, and pigments that are allowed (GRAS: generally recognized as safe) for use in cosmetics (IS: 4707 Part I) a negative list of raw materials that shall not form part of the composition of cosmetic products (Annex A) and a list of substances that cosmetic products shall not contain except subject to restrictions and conditions laid down (Annex B) (IS: 4707 Part II). In addition to that, Annex C and D provide a list of preservatives and UV filters that cosmetic products and sunscreen products may contain, respectively. In the EU, the list of prohibited substances that may cause cancer, mutations, genetic mutations, birth defects, etc., and the substances that cosmetic products must not contain (subject to the restrictions) are mentioned in Annexure II and III of Regulation (EC) No. 1223/2009, respectively. Recently, these lists were amended and mentioned in Commission Regulation (EU) 2020/1683 of November 12, 2020. When compared with (EC) No. 1223/2009, 3 chemicals (1,2,4-Trihydroxybenzene, 4-Amino-3-hydroxytoluene, and 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid), when used as a substance in hair and eyelash dye products, were added to the list of prohibited substances as mentioned in revised Annexure II of (EU) 2020/1683. Similarly, six new chemicals that cosmetic products must not contain (except subject to the restrictions laid down) were added in Annexure III.