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Wednesday, 2 November 2016

Health ministry to amend Rule 135A &145D of D&C Rules relating to presence of mercury in cosmetics

The Union health ministry will soon amend the Rule 135A and Rule 145D of the Drugs and Cosmetics Rules, 1945 relating to presence of mercury compounds in cosmetics.

The Drugs Technical Advisory Board (DTAB) in its 71st meeting held in May this year had given its green signal to amend Rule 135A as "Prohibition of import of cosmetics containing mercury-- Cosmetics imported into the country shall not contained mercury more than- (i) in cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0.0065 percent) of mercury, calculated as the metal, as a preservative. (ii) in other finished cosmetic products unintentional mercury should not exceed 1 parts per million (ppm).

Accordingly, Rule 145D will be amended to read as “Prohibition of use of mercury compounds in cosmetics.- Cosmetic manufactured in the country shall not contained mercury more than- (iii) in cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0. 0065 per cent) of mercury, calculated as the metal, as a preservative. In other finished cosmetic products unintentional mercury should not exceed 1 parts per million (ppm).

Earlier, a proposal to amend the Drugs and Cosmetics Rules, 1945 to simplify the provisions relating to registration of cosmetics imported into the country and specifying limits of mercury were considered in the 70th meeting of DTAB on the basis of the report of the sub-committee. The proposal was considered in view of the difficulties expressed by certain importers in respect of compliance to the various provisions introduced under the Drugs and Cosmetics Rules, 1945 in respect of registration of cosmetics imported into the country.

The DTAB had agreed to the recommendations of the sub-committee for the amendment of the rules as: "Rule-129: Registration of cosmetic products imported into the country.- No cosmetic shall be imported into India unless the product is registered under the Rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22 or unless otherwise the products are complying with the standards specified in Drugs and Cosmetics Rules, 1945".

"Rule 129H: Labelling and Packing of Cosmetics:- No cosmetic shall be imported unless it is packed and labelled in conformity with the rules in Part XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India or in case the products are not registered, the importer shall give undertaking at the port entry that products are manufactured by the manufacturer stated on the label".

"Rule 135A: Import of cosmetics containing mercury compounds prohibited.-No cosmetic shall be imported which contains mercury compounds. Provided the presence of traces of unintentional mercury should not exceed 1 parts per million (ppm) in finished cosmetics. Provided further that for those cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0.0065 per cent) of mercury, calculated as the metal, as a preservative".

"Rule 145D: Prohibition of manufacture of cosmetics containing mercury compounds.-No cosmetic containing mercury compounds shall be manufactured. Provided the presence of traces of unintentional mercury should not exceed 1 parts per million (ppm) in finished cosmetics. Provided further that for those cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0.0065 per cent) of mercury, calculated as the metal, as a preservative".

The proposed amendments were processed and forwarded to the Legislative Department of Ministry of Law and Justice for their approval. However, the Law Ministry did not agree to the proposed amendments as these were contradictory in nature.

The DTAB in its 71st meeting deliberated on the issue and agreed to the amendment of rule 135A and 145D relating to presence of mercury compounds in cosmetics. In regard to the proposal of simplification of registration procedures it was recommended that the provisions for registration may be simplified making it easier for the importers to import cosmetics into the country without compromising the quality of the cosmetics imported into the country.
Source:Pharmabiz

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