pharmacists regulations cosmetics 5773-2013 29 pages in hebrew . new draft regulations announced by israels ministry of health called em pharmacists regulations cosmetics em. this draft regulation fully adopts the european model for marketing of cosmetics outlined in em regulation ec no. 1223 2009 of the european parliament and of the council of 30 november 2009 on cosmetic products em which according to professionals provides the best basis for controlling the marketing of cosmetics the lowering of trade barriers and safeguarding of consumers. the new regulations are significantly different from the way cosmetics had been controlled and supervised in israel in the past. it does away with the suppliers need to obtain a registration certificate and requires only a notification 10 days prior to marketing. according to this change the major responsibilities of the ministry of health will shift to formulation of the rules and regulations for cosmetic marketing in israel and determination of the bodies and mechanisms authorized to manufacture and market cosmetics. all these will be accompanied by a strict market surveillance system. these are the major requirements introduced in the regulations - no person shall import into israel a cosmetic unless the product has been granted a certificate of free sale by a recognized country. - in order to establish clear responsibilities each cosmetic product should be linked to a responsible person who will be the legal entity responsible for the product and for the regulatory procedures governing it regulation 5 - in order to ensure their safety cosmetic products placed on the market should be produced according to good manufacturing practice gmp and distributors shall ensure that storage and transport conditions do not jeopardize their compliance with the requirements set out in these regulations regulations 8 and 11 - requires a safety assessment from a suitable professional that will cover all safety aspects of the cosmetic product including its ingredients side effects and required warnings regulation 12 and annex 3 - for the purpose of effective market surveillance a product information file should be made readily accessible to the competent authority and should include information and data about the product its safety assessment manufacturing procedures tests claims against it if served and data on any animal testing performed regulation 13 - prior to placing the cosmetic product on the market the responsible person shall provide the ministry of health electronically the general information required for the basic control by the director general of the ministry of health or his representative regulation 14 establishment of a national cosmetics poison center which will hold full information about the cosmetic ingredients including dosages which may include confidential trade secrets that will be kept safe by the ministry of health. the information will be used only in case of an emergency for providing medical treatment to people affected by cosmetics regulation 26 .