31st. DECEMBER, 2007 No. S 80 MEDICINES ORDER, 2007 .

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31st. DECEMBER, 2007No. S 80MEDICINES ORDER, 2007MEDICINES (COSMETIC PRODUCTS) REGULATIONS, 2007ARRANGEMENT OF REGULATIONSRegulationPART IPRELIMINARY1.Citation and commencement.2.Interpretation.3.Application.PART IIAPPOINTMENT OF AUTHORITY, ASSISTANTS ETC.4.Appointments.PART IIISUPPLY OF COSMETIC PRODUCTS5.Notification to Authority of supply of cosmetic products.PART IVSAFETY REQUIREMENTS6.Safety requirements.PARTVINGREDIENT LISTING7.Contents of cosmetic products.8.Labelling of cosmetic products.1937

BRUNEI DARUSSALAM GOVERNMENT GAZETTE9.Misleading labelling.10.Product information.PART VIADVERTISEMENT OF COSMETIC PRODUCTS11.Advertisement of cosmetic products.PART VIIADDITIONAL DUTIES AND OBLIGATIONS12. Reporting of defects and adverse events to the Authority.PART VIIIGENERAL13. Special cases.14. Offences by bodies corporate.15. Transitional.16.Penalty for offences not otherwise provided for.17. Amendment of Schedules.FIRST SCHEDULEregulation 7(1), (2), (3){a}, (4){a}, (S){a}SECOND SCHEDULEregulation 8(1)THIRD SCHEDULEregulation 10(1){c}1938

31st. DECEMBER, 2007MEDICINES ORDER, 2007MEDICINES (COSMETIC PRODUCTS) REGULATIONS, 2007In exercise of the power conferred by section 81 of the Medicines Order/2007 the Minister of Health, with the approval of His Majesty the Sultan andYang Di-Pertuanl hereby makes the following Regulations1PART IPRELIMINARYCitation and commencement.1. These Regulations may be cited as the Medicines (Cosmetic Products)Regulations, 2007 and shall commence on the 1st. January, 2008.Interpretation.2.In these Regulations, unless the context otherwise requires "Authority" means the Authority established under section 5 of theMedicines Order, 2007;"cosmetic producf' means any substance or preparation intended to beplaced in contact with the various external parts of the human body(epidermis, hair system, nails/ lips and external genital organs) or with theteeth and the mucous membranes of the oral cavity with a view exclusivelyor mainly to cleaning them, perfuming them, changing their appearance andcorrecting body odours, protecting them or keeping them in good conditionor all or any of those purposes;"importer", in relation to a cosmetic product, means any person who importsor who procures or arranges for the import of any cosmetic product intoBrunei Darussalam for supply in Brunei Darussalam;"manufacturer" means any person engaged in any process carried out in thecourse of making any cosmetic product in Brunei Darussalam for supply inBrunei Darussalam.Application.3.1939These Regulations shall not apply to a cosmetic product that is (a)imported into Brunei Darussalam solely for re-export; or(b)manufactured in Brunei Darussalam solely for export.

BRUNEI DARUSSALAM GOVERNMENT GAZETTEPART IIAPPOINTMENT OF AUTHORITY, ASSISTANTS ETC.Appointments.4. (1) The Authority may delegate to the Director of Pharmaceutical Servicesthe exercise of all or any of the powers and the performance of its duties underthese Regulations.(2) The Authority may authorise or appoint any person to assist in theexercise of its powers, duties and functions under these Regulations.(3) Any person delegated under sub-regulation (1) or authorised orappointed under sub-regulation (2) shall be deemed to be a public servant for thepurposes of the Penal Code (Chapter 22).PART IIISUPPLY OF COSMETIC PRODUCTSNotification to Authority of supply of cosmetic products.5.(1)The importer or manufacturer of a cosmetic product shall not{a) supply that cosmetic product in Brunei Darussalam unless he hasnotified the Authority of his intention to supply that cosmetic product inBrunei Darussalam; or{b) continue to supply that cosmetic product in Brunei Darussalamafter the expiry of one year from the most recent notification made in respectof that cosmetic product, unless he has submitted a further notification tothe Authority of his intention to continue supplying that cosmetic product inBrunei Darussalam.(2) The Authority has the right to suspend or cancel any notification for thepurposes of sub-regulation (1) if the product is suspected or found to causedamage to human health when applied under normal or reasonably foreseeableconditions of use.(3) A notification for the purposes of sub-regulation (1) shall be submittedto the Authority in such form and manner as the Authority may require and shallbe accompanied by {a) such particulars, information, documents and samples as theAuthority may require; and1940

31st. DECEMBER, 2007{b)if required by the Authority, a statutory declaration by theapplicant verifying any information contained in or related to thenotification.14) Any person who, in submitting a notification for the purposes ofsub-regulation (1)fa} makes any statement or furnishes any document which he knowsto be false or does not believe to be true; or{b) by the intentional suppression of any material fact, furnishesinformation which is misleading,shall be guilty of an offence and shall be liable on conviction to a fine notexceeding 5,000, imprisonment for a term not exceeding 2 years or both.PART IVSAFETY REQUIREMENTSSafety requirements.6. ll) The manufacturer, his authorised agent or any other person responsiblefor placing the product on the market shall not supply a cosmetic product thatcause damage to human health when applied under normal or reasonablyforeseeable conditions of use, taking account, in particular, of the product'spresentation, its labelling, instructions for its use and disposal, warningstatements as well as any other indication or information provided by themanufacturer or his authorised agent or by any other person responsible forplacing the product on the market.(2) The provision of such warnings in sub-regulation ll) shall not, in anyevent, exempt any person from compliance with the other requirements laiddown in these Regulations.PARTVINGREDIENT LISTINGContents of cosmetic products.7. (1) A person shall not supply a cosmetic product which contains anysubstance that is listed in Part I of the First Schedule to these Regulations unlessthe presence of such substance is fa}1941in trace amount; and

BRUNEI DARUSSALAM GOVERNMENT GAZETTE(b)technically unavoidable in good manufacturing practice.(2) A person shall not supply a cosmetic product which contains anysubstance that is listed in the second column of Part II of the First Schedule tothese Regulations unless(a) the cosmetic product is of a type listed in the third column of thatPart of that Schedule;(b) the substance as contained in the cosmetic product does not exceedthe appropriate limit as specified in the fourth column of that Part of thatSchedule; and(c) the cosmetic product complies with the other relevantrequirements as specified in the fifth column of that Part of that Schedule.(3) A person shall not supply a cosmetic product, other than a cosmeticproduct intended solely to colour hair, which contains any colouring agent unlessthat colouring agent (a)is listed in Part III of the First Schedule to these Regulations; and(b) is in accordance with the requirements as specified in that Part ofthat Schedule.(4} A person shall not supply a cosmetic product which contains anypreservative unless (a) that preservative is listed in the second column of Part IV of theFirst Schedule to these Regulations;(b) that preservative as contained in the cosmetic product does notexceed the appropriate limit as specified in the third column of that Part ofthat Schedule; and(c) the cosmetic product complies with the other relevantrequirements as specified in the fourth column of that Part of that Schedule.(5) A person shall not supply a cosmetic product which contains anyultraviolet (UV} filter unless(a) the ultraviolet (UV} filter is listed in the second column of Part V ofthe First Schedule to these Regulations;(b) the ultraviolet (UV) filter as contained in the cosmetic product doesnot exceed the appropriate limit as specified in the third column of that Partof that Schedule: and1942

31st. DECEMBER, 2007(c) the cosmetic product complies with the other relevantrequirements as specified in the fourth column of that Part of that Schedule.Labelling of cosmetic products.8. (1) No person shall supply any cosmetic product unless the cosmeticproduct has a label that sets out the information in the Second Schedule to theseRegulations and the information required thereunder, shall be in legible andvisible lettering.(2) All information on the label of a cosmetic product shall be provided inthe English language, the Malay language or both.(3) All numbers, letters and symbols used in providing the information onthe label of a cosmetic product shall be legible, permanent and prominent.(4) If a symbol or code (whether in the form of a colour or otherwise) isused in providing the information on the label of a cosmetic product, anexplanation of the symbol or colour shall be provided.Misleading labelling.9. No person shall supply any cosmetic product with a label which containsany statement, trademark, picture or other sign(a} to the effect, whether directly or indirectly, that the supply or useof the cosmetic product is being promoted or endorsed by the Authority; or(b) that is likely to create an erroneous impression regarding theformulation, composition, quality or safety of the cosmetic product.Product information.10. (1) The person responsible for placing the cosmetic product in the marketshall keep the following information or documents readily accessible to theAuthority(a} the qualitative and quantitative composition of the product; in caseof perfume compositions, the name and code number of the composition andthe identity of the supplier;(b)specifications of the raw materials and finished product;(c) the method of manufacture complying with the goodmanufacturing practice as laid down in the Third Schedule to theseRegulations;1943

BRUNEI DARUSSALAM GOVERNMENT GAZETTE{d) assessment of the safety for human health of the finished product,based on its ingredients, its chemical structure and its level of exposure;{e) existing data on undesirable effects on human health resulting fromthe use of the cosmetic product;(f) supporting data for claimed benefits of cosmetic products should bemade available to justify the nature of its effect;{g) the available methods used by the manufacturer to check theingredients of cosmetic products corresponding with the certificate ofanalysis; and{h) the criteria used for microbiological control of cosmetic productsand chemical purity of ingredients of cosmetic products, methods forchecking compliance with those criteria or both.(2) The information referred to in sub-regulation (1) shall be made in theEnglish language, the Malay language or both.(3) The Authority may, for purposes of prompt and appropriate medicaltreatment in the event of difficulties, require that appropriate and adequateinformation on substances used in cosmetic products be made available to theAuthority which shall ensure that this information is used only for the purposesof such treatment.PART VIADVERTISEMENT OF COSMETIC PRODUCTSAdvertisement of cosmetic products.11. No person shall advertise any cosmetic product or cause any cosmeticproduct to be advertised {a} with any claim, whether expressly or by implication, that thecosmetic product has a therapeutic benefit or can be used for a therapeuticpurpose; or{b) with any claim which is likely to create an erroneous impressionregarding the formulation, composition, quality or safety of the cosmeticproduct.1944

31st. DECEMBER, 2007PART VIIADDITIONAL DUTIES AND OBLIGATIONSReporting of defects and adverse events to the Authority.12.(1)The supplier of a cosmetic product -fa) upon becoming aware of any event or other occurrence thatconcerns any adverse effect arising from the use of the cosmetic product,shall(i)if the adverse effect has caused death or is life-threatening (A) inform the Authority of the event or occurrence no laterthan 7 days after the supplier becomes aware of the event oroccurrence; and(B) submit a detailed report to the Authority within 8 daysafter the initial report; or(iiJif the adverse effect has resulted in any person beinghospitalised or has caused any persistent or significantdisability or incapacity in any person, submit a detailed reporton the event or occurrence to the Authority no later than 15days after the supplier becomes aware of ihe event oroccurrence; andupon becoming aware of any event or other occurrence that revealsany defect in the cosmetic product, shall(b)(i)if the defect may cause death or may be life-threatening(A) inform the Authority of the event or occurrence no laterthan 7 days after the supplier becomes aware of the event oroccurrence; and(B) submit a detailed report to the Authority within 8 days ofthe initial report; or(ii)1945if the defect may result in any person being hospitalised ormay cause any persistent or significant disability or incapacityin any person, submit a detailed report of the event oroccurrence to the Authority no later than 15 days after thesupplier becomes aware of the event or occurrence.

BRUNEI DARUSSALAM GOVERNMENT GAZETTE(2) The reports referred to under sub-regulation (1) shall be in such formand manner, and shall contain such information in relation to the defect oradverse event, as the Authority may require.PART VIIIGENERALSpecial cases.13. The Authority may provisionally prohibit the marketing of a cosmeticproduct in Brunei Darussalam or subject it to special conditions if, on the basis ofa substantiated justification, the cosmetic product, although complying with therequirements of these Regulations, represents a hazard to health or for reasonsspecific to religious or cultural sensitivity.Offences by bodies corporate.14. Where an offence under these Regulations which has been committed by abody corporate is proved to have been committed with the consent andconnivance of, or to be attributable to any neglect on the part of, any director,manager, secretary