Guideline No: HS/001 Health Requirements for Cosmetic, Personal Care Products & Perfumes (Manufacturing/Warehouse) 1. Introduction: This guideline regarding cosmetics is intended to ensure better protection for consumers. Several steps are needed to be taken by the manufacturers, importers, suppliers, distributors, retailers, consumers and/or any concerned party for the safe manufacturing/distribution/sale of the products in the market. The cosmetics sold in Dubai markets must not affect customer s health when applied under normal or reasonably foreseeable conditions of use. All information related to its proper use should be provided especially on the product's presentation and its labelling which should include indication or contraindication information provided by the manufacturer. Purpose The foremost objective of this guideline is to assure public health & safety through implementing efficient regulatory control system To insure commitment to consumer safety of all establishments related to the use of cosmetic products in compliance with the public health requirements. To insure the implementation of unified health requirements of all above establishments in the area of Jurisdiction of Trakhees Ports, Customs & Free zone Corporation, Dubai. 2. Definition of Terms CPSS: Consumer Products Safety Section Establishment: Any building(s) or area(s), fixed or mobile, in which cosmetic, personal care & perfumery product is handled (Manufactured, displayed or stored). Importer/ Manufacturer: means any legal person or entity who/which manufactures a cosmetic product/s or has such a product designed, manufactured, and marketed under his name or company s trademark (including an association or partnership). This includes importers or retailers and manufactures who control the subject products. Revision 00 September 2014 Page 1 of 8
Distributor: means any legal person or entity in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available in the local market; Label: any tag, brand, mark, or other descriptive matter that are written or printed, stencilled, marked, embossed or pressed on, or attached to a container/packaging of cosmetic, personal care & perfumery products. Ingredient: An ingredient means any substance that is one of the components of a cosmetic that includes colouring agents, natural or synthetic ingredients, fragrance and flavours, that are added in the preparation of the cosmetic. This shall not include substances that are used in the actual preparation of the cosmetic but are not present in the final product as a result of the chemical process. Substance: A chemical element and its compounds in the natural state or obtained by any manufacturing process. This includes any additive necessary to preserve its stability and any impurity deriving from the process used. However, this should exclude any solvent which may be separated without affecting the stability of the substance or changing its composition. a. Definition of Cosmetic: A cosmetic product shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity mainly for purposes to clean, perfume, change appearance and/or correcting body odours and/or protecting the body part or keeping them in good condition. b. Functions for Cosmetics Products To clean To perfume To change the appearance To protect To keep in good condition To correct body odours c. The Field of Application of Cosmetics The epidermis The hair system The nails The lips The external genital organs The teeth Revision 00 September 2014 Page 2 of 8
The mucous membranes of the oral cavity Others d. List of Cosmetics The following list is not exhaustive but is provided by way of example: Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.) Face masks (with the exception of peeling products) Tinted bases (liquids, pastes, powders) Make-up powders, after-bath powders, hygienic powders, etc. Toilet soaps, deodorant soaps, etc. Perfumes, toilet waters and eau de Cologne Bath and shower preparations (salts, foams, oils, gels, etc.) Depilatories Deodorants and anti-perspirants Hair care products: Hair tints and bleaches Product for waving, straightening and fixing Setting products Cleansing products (lotions, powders, shampoos) Conditioning products (lotions, creams, oils) Hairdressing products (lotions, lacquers, brilliance enhancers ) Shaving products (creams, foams, lotions) Products for making up and removing make-up from the face and eyes Products intended for application to the lips Products for care of the teeth and mouth Products for nail care and make-up Products for external intimate hygiene Sunbathing products Products for tanning without sun Skin-whitening products Anti-wrinkle products. 3. Scope : The Health Requirement is applicable to allestablishments related to cosmetic products; operational in the Revision 00 September 2014 Page 3 of 8
area of Jurisdiction of Trakhees Ports, Customs & Free zone Corporation, Dubai. 4. Responsibility: Director of Environment, Health and Safety (EHS) Head of Environment& Public Health Safety Section Manager of Health and Public Safety Section Health and Public Safety Senior Officer Health and Public Safety Officer 5. Details of implementation 5-1. License 5-1.1. A valid trade license issued from Trakhees Commercial Licensing Division/JAFZA should be available for the approved activity and establishment should comply with the license activity. 5-2. Documents 5-2.1. EPHS file with required documents like Modification Compliance Certificate (MCC) and Operation Fitness Certificate (OFC). 5-2.2. Staff list with all related data of staff must be kept in the establishment including work permit. 5-2.3. Staff involved in the Production/ Manufacturing/storage must have Occupational Health Card (OHC) issued from Trakhees EPHSS including contracted housekeeping staff. 5-2.4. Cleaning & sanitizing schedule and procedures should be available. 5-2.5 Periodic water analysis report from an accredited laboratory for chemical and microbiological parameters of ingredient water. 5-2.6. Water tank cleaning contract from approved third party should be available. 5-2.7. Pest Contract with an approved pest control operator and service records should be available. 5-2.8 Periodic Chemical and Microbiological analysis reports of the product samples to assure the absence of contamination with filth, microorganisms or other extraneous substances, heavy metals etc. 5-2.9. Product Registration Certificate from CPSS according to the local Order 11 of 2003. 5-2.10 Label assessment report from suppliers/ label approval Documents reference to the product registration from CPSS. 4-2.11. Good Manufacturing Practices (GMP) GWP SOP s 5-2.12. Calibration records. 5-2.13. Training Records- Pink Code Accreditation Revision 00 September 2014 Page 4 of 8
5-3. Premises, Equipment. 5-3.1. Rooms and halls should be in a good condition as well as floors, walls, ceiling, windows, doors etc. 5-3.2. Good Ventilation and lighting should be provided. 5-3.3. Equipment and utensils used in processing, holding, transferring and filling are of appropriate design to prevent corrosion, build-up of material or adulteration with lubricants, dirt or sanitizing agent. 5-3.4. Utensils, transfer piping and cosmetic contact surfaces of equipment should be well maintained, clean and are sanitized at appropriate intervals. 5-4. Procedures & practices 5-4.1. Cleaned and sanitized portable equipment and utensils should be stored and located at an area that protect them from exposure to liquid, dust or other contamination 5-4.2. Raw materials and primary packaging materials are stored and handled separately to prevent mix up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture. 5-4.3. Manufacturing and control procedures should be established and written instruction (i.e. formulations, processing, transfer and filling)for process control methods etc. are being maintained. 5-4.4. Weighing and measuring of raw materials should be checked by a second person and containers used for holding the materials are properly identified. 5-4.5. Water used as a cosmetic ingredient is tested regularly for conformance with chemical analytical and microbiological specification 5-4.3. Good Warehousing and storage practices must be implemented through below written SOPs in raw material and finished goods. Receiving Storage Cleaning Temperature/humidity monitoring Damaged/expired products FEFO/stock rotation Traceability Calibration 5-4-4 Labelling Requirements The followings are the required components that must be declared in clear English or Arabic language: Revision 00 September 2014 Page 5 of 8
1. Brand name of the product 2. Product name (Product Identity) 3. Manufacturer s details 4. Country of origin 5. Ingredients 6. Size or Weight of the product 7. Production & Expiry dates or/ Period After Opening (PAO) 8. Storage conditions; unless it is clear from the product label or presentation/advertisement 9. Instructions of use; unless it is clear from the product label or presentation/advertisement 10. Health warning notes; unless it is clear from the product label or presentation/advertisement 11. Code Industrial number of product (Bar-Code) & Batch number 12. Medical claims not allowed 13. Pictures, illustration which are inconsistent with the prevailing social customs and values shall not be used. 5-5. Workers Revision 00 September 2014 Page 6 of 8
5-5.1. All staff should have valid Occupational Health Cards issued from Trakhees EHS Health Dept. 5-5.2. All Staff in the establishment should wear clean uniforms during working hours. 5-5.3. All Staff should maintain good personal hygiene. 5-5.3. Supervisor performing the manufacturing or control of cosmetics has the required education, training and experience to perform the assigned functions. 5-6 Water source & Drainage facility Establishments must be provided with water source & drainage facility. 5-7. The Establishment must be provided with First Aid kit must be available and should be replenished as and when required. Drinking water supply should be through approved supplier with valid food supplier vehicle pass. Foot operated waste bins must be provided in the factory and warehouse for general waste. No smoking sign should be affixed at prominent place inside the facility; No smoking Policy should be strictly enforced. Sufficient number of water closet (WC) should be provided & should be kept clean at all times Waste should be disposed properly. Proper fire extinguisher system approved by Civil defence. Hand wash basin should be available and provided with liquid hand soap and tissue. 5-8 Management responsibilities: Management must be aware of the health requirements implemented by Trakhees EHS- Public Health and Safety Department. Carry-out corrective and preventive actions to avoid and correct operational issues Monitoring health practices of employees and directing them to observe best practices continuously. Educating new employees about work procedures and best health practices before starting the job. Cooperating with Trakhees EHS- Public Health and Safety inspector during the inspection visit. Reviewing all points mentioned in the inspection report. Checking staff s occupational health cards and expiry dates. It is not allowed to allow new employees to start the job unless the card is obtained. It is important to provide (or participate in providing) healthy accommodation forthe staff to create healthy working environment and avoid, personal cooking or storing personal needs of staff in the work facility. First aid box with valid contents must be provided, and staff should be trained to deal with minor incidents. All establishment owners are responsible to follow the above instructions to prevent any Revision 00 September 2014 Page 7 of 8
violations related to wrong practices related to cosmetics manufacturing, storage and sale to protect public health &safety. 6. Co-packing Requirement: Approval from relevant authority (Dubai Municipality, Customs etc.)for each batch of operation Production and expiry dates of promo packed products should be displayed conspicuously Revision 00 September 2014 Page 8 of 8