MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES GTS-PM-KSA-CVG-0403 CVG0710 PERFUMES AND COSMETICS 0B COVER PAGE AND REVISION RECORD REVISION NO. DATE 13 21-Oct-2010 14 04-Nov-2010 15 19-Dec-2010 16 26-Jan-2011 17 20-Mar-2011 18 31-July-2011 19 16-June-2013 20 13-April-2015 DESCRIPTION OF CHANGE Inclusion of cosmetic products in vial form; Inclusion of vial requirements as per SFDA circular; Removal of products “external intimate hygiene”, Typo error corrected for toothpastes heavy metal limit Products Hair extensions, wigs, artificial hair and the like are not to be certified; Added note for marking requirements for Cosmetics in Ampoules and Vials to be in Arabic or Arabic and English language; ‘MoH’ reference replaced with ‘SFDA’ Release of New GS Standard 1943/2009, requirements remain same as SASO 1953/2005 only clause numbers are changed. Circular from the SFDA on mouth wash and related products used for rinsing, cleaning or sterilizing of mouth and teeth which contain alcohol shall not be certified Added test tables and requirements from GS 1942/2009, GS 2061/2010, GS 2063/2010 Added table for “SFDA Restriction on Ingredients”; Added note in Test Tables for Shaving Cream and Skin Cream; Test parameter added to Hair Oil Test table. The term “Product Conformity Programme” is replaced by “Conformity Assessment Programme”; Additional SFDA Restrictions on Cosmetic Ingredients under Section C Deleted point (5) from Section E Update of the main conformity standard (GSO 1043/2009) and revision of test tables; Addition of procedure for evaluating Test reports under Section F; Revamping of the AIR section to add Inspection check points for RLCs, COs and Inspectors. DOCUMENT AUTHORISATION REVISION No. 13 14 15 16 17 PREPARED BY: Anil Fernandes Anil Fernandes Anil Fernandes Anil Fernandes Anil Fernandes APPROVED BY: Percival D’Souza Percival D’Souza Percival D’Souza Percival D’Souza Percival D’Souza REVISION No. 18 19 20 21 22 PREPARED BY: Aurelie Bafoil Rajni Jathan Aurelie Bafoil Aurelie Bafoil APPROVED BY: Percival D’Souza Percival D’Souza Percival D’Souza COPY STATUS: CONTROLLED / UNCONTROLLED This document is a property of Intertek International Ltd. No corrections/amendments are to be made except by the person authorized. No part of this document can be reproduced in any form or circulated outside Intertek offices without the prior approval of the authorized person above. Important Note: This document is current if it is being read from the Virtual Library on the Intertek GTS Intranet. If it is being read as a hardcopy, then please ensure that the revision number matches the one which is shown on the same document in the Virtual Library. This will ensure that you are reading the latest version. Description of changes on the revised versions not listed above could be provided by PM upon request. MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS INTRODUCTION The purpose of this document is twofold: 1) To provide Manufacturers and Exporters with technical information on compliance requirements in support of Shipment certification, Registration and Licensing procedures. 2) To provide CAP approved laboratories with information on the performance of Pre-supply Testing INDEX SECTION DESCRIPTION PAGE NO. A Scope 2–3 B Applicable KSA CAP And Equivalent/International And Other Standards 3–4 C KSA CAP Registration Procedures And Essential Requirements 4–6 D KSA CAP Type Approval Licensing E Procedure And Test Parameters To Be Applied By The Testing Laboratory F Procedure For Evaluating Test Documents 12 Additional Inspection Requirements (AIR) 13 – 28 6 6 – 11 I. Perfumery Products Based On Ethanol 13 – 15 II. Cosmetic Products (for Personal and Professional Use) 16 – 19 III. Perfumes and Cosmetics that are packed in Aerosol Dispensers 20 – 21 IV. Testers & Free Samples 22 – 23 V. Essential Oils (Finished form-Packed in small bottles for personal use and Semi-finished Form - Packed in drums) 24 – 25 G Exhibit 1 – Explanatory Notes and Glossary of Terms Exhibit 2 – Cosmetics Notification Plan 26 – 27 28 GTS-PM-KSA-CVG-0403-20 Page 1 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS SECTION A: SCOPE This category applies to Perfumes and Cosmetics i.e. 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 with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition. *HS CODES RISK (HIGH/MEDIUM/LOW) 330499 High Risk 330491 High Risk Tinted bases (liquids, pastes, powders). 330499 High Risk Deodorants and anti-perspirants 330720 High Risk Face masks (normal cosmetic peel-off products) 330499 High Risk Toilet soaps, deodorant soaps, etc. 340111 High Risk Perfumes, toilet waters and eau de Cologne. 330300 High Risk Bath and shower preparations (salts, foams, oils, gels, etc.). 330730 High Risk Depilatories. 330790 High Risk Hair care products: - Hair tints and bleaches. - Products for waving, straightening and fixing. - Setting products. - Cleansing products (lotions, powders, shampoos) - Conditioning products (lotions, creams, oils). - Hairdressing products (lotions, lacquers, brilliantines) 330510 330520 330530 330590 High Risk Shaving products (creams, foams, lotions, etc.). 330710 High Risk 330499 High Risk 340119 High Risk Products intended for application to the lips. 330410 High Risk Products for care of the teeth and mouth other than those containing alcohol. 330610 330690 High Risk Products for nail care and make-up. 330499 High Risk Perfumed tissues 330790 High Risk PRODUCTS COVERED UNDER THIS CATEGORY Creams, emulsions, lotions, gels and oils for the skin (hand, face, feet, etc.). Make up powders, after-bath powders, hygienic powders, etc. Products for making up and removing make-up from the face and the eyes. Wet wipes for face/body cleansing purpose, including baby wipes PROCESSED/ NON-PROCESSED PRODUCTS Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products Processed Products GTS-PM-KSA-CVG-0403-20 Page 2 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS *HS CODES RISK (HIGH/MEDIUM/LOW) Henna products 330590 High Risk Products for external intimate hygiene 330790 High Risk Stretch mark removal creams 330499 High Risk Artificial Nails and adhesive for its use (artificial nails without glue fall under IV-08) 330499 High Risk PRODUCTS COVERED UNDER THIS CATEGORY PROCESSED/ NON-PROCESSED PRODUCTS Processed Products Processed Products Processed Products Processed Products *H.S. Codes indicated only for High Risk Products, if any. PRODUCTS EXCLUDED FROM THIS CATEGORY Air-fresheners for home/office use both aerosol and non-aerosol types (These are covered under category IV-12) Toilet deodorants/Deodorizers (These are covered under category IV-12) Incense products (These are covered under category IV-12) Products that possess a therapeutical effect and claim medical properties or contain pharmaceutical substances or claims such as performance enhancers, best pleasure…are not considered as a cosmetic. (These require prior permission from the Saudi Food and Drug Authority (SFDA) for the import of such products into KSA. If KSA Saudi Food and Drug Authority (SFDA) classifies in writing that these are cosmetics then we can proceed with the certification) Wipes for cleaning floor/kitchen/furniture/products at home (These are covered by Category IV-05) Face masks (chemical peel-off products) Hair extensions, wigs, artificial hair and the like are not to certified/registered as these are religiously sensitive items. Exporters are to be directed to KSA Ministry of Commerce & Industry (MoCI) to obtain permission prior to export (For more Information Refer CD574- Certification of hair extensions, wigs, artificial hair and the like) Hand Sanitizers with claims to kill germs/bacteria (These require prior permission from the Saudi Food and Drug Authority (SFDA) for the import of such products into KSA. If KSA Saudi Food and Drug Authority (SFDA) classifies in writing that these are cosmetics then we can proceed with the certification) Products containing alcohol used for rinsing, cleaning or sterilizing of the teeth and mouth such as mouth wash shall not be certified/imported into KSA Note: Cosmetics and perfumes packed in vials and ampoules are also covered under this category. SECTION B: SAUDI EQUIVALENT/OTHER APPLICABLE STANDARDS 2 1 SAUDI STANDARD SASO 585/2000 SASO 1849/1997 SASO 1228/1998 SASO 1229/1998 1 GSO STANDARD GSO 1046 GSO 1047 GSO 917 GSO 918 EQUIVALENT/ OTHER APPLICABLE STANDARD TITLE --- Regulations for Perfumery Products Based on Ethanol --- Perfumery Products Based on Ethanol - Methods of Test --- Metal Aerosol Dispensers --- Methods of Testing Metal Aerosol Dispensers GTS-PM-KSA-CVG-0403-20 Page 3 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS 2 1 SAUDI STANDARD SASO 591/2007 SASO 1964/2001 SASO 1965/2001 SASO 1953/2009 SASO 2185/2003 Version 2.1 (15.04.2014) --- 1 GSO STANDARD EQUIVALENT/ OTHER APPLICABLE STANDARD TITLE GSO 303 ISO 875 Essential Oils - Evaluation of Miscibility in Ethanol --- --- --- --- GSO 1943/2009 76/768/EEC 1223/2009/EC --- --- The cosmetic products (safety) regulations - Test Methods --- --- SFDA Guidance for Product Classification --- ISO 16408 Essential Oils - General Rules for Labelling and Marking of Containers Essential Oils - General Rules for Packaging, Conditioning and Storage Cosmetic products - The cosmetic products (safety) regulations Dentistry -- Oral hygiene products -- Oral rinses Note: 1. For the current versions of the standard refer to the SASO/GSO/ Website. Products should comply with current SASO/GSO standard whenever such standards are available. 2. If SASO/GSO is not available then compliance can be accepted to International/National/Manufacturer’s Standards, Example: ISO/EN/UL/BSI….. etc. 1. SECTION C: KSA CAP REGISTRATION PROCEDURES AND ESSENTIAL REQUIREMENTS The product to be registered shall be identified by its type designation. Products of the same electrical and/or mechanical construction, being equal in all safety related aspects, may be defined by one family type designation/model number. This designation must be identifiable on the product(s). Products should meet the Saudi Standards wherever such standard exists. In the absence of specific SASO standards compliance to relevant international, regional or national standard can be accepted provided the Saudi Essential Requirements as well as the mandatory marking requirements are satisfied. Standard references stated in the registration and substantiating test document must be clearly identified by issue number, year of publication and the like. Any test data provided to substantiate the registration must make clear reference to product identification model(s), the laboratory name and appropriate standard(s). Any test data to be evaluated for compliance shall be examined towards the applicable standard or standards, including the relevant Saudi Essential Requirements GTS-PM-KSA-CVG-0403-20 Page 4 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS ESSENTIAL REQUIREMENTS INSTRUCTION MANUAL The instruction manual / direction of use should be in Arabic language MARKING All marking requirements shall be as per applicable SASO standard. In the absence of specific SASO standard, the marking requirements as stated in the Saudi Marking Law shall apply. All Markings related to warnings and handling safety instruction shall be in Arabic or Arabic and English language. – Refer AIR Section. COUNTRY OF ORIGIN All appliances shall be marked with Country of Origin (MoCI Royal Decree No. M/5, CD-444) GENERIC REQUIREMENTS SPECIFIC REQUIREMENTS Cautionary and warnings marking, if applicable shall be marked at least in the Arabic language. Have no Medical claims found on the product, product package or product Instructions & information leaflet Product Products shall not be offensive to the Islamic religion. In particular they shall Marking contain no pork, pork fat or pork derivatives or pictures of pigs, pig shapes or crosses Any pictures that may be offensive to the Islamic religion are forbidden on products and packaging Products must comply with the safety regulations with regards to restricted substances, preservatives and UV filters under GSO 1943/2009 (SASO 1953/2009) for cosmetic products or SASO 585/2000 + GSO 1943/2009 (SASO 1953/2009) for Perfumery Products based on ethanol. Cosmetic products must not cause any damage to human health when they are applied under normal or reasonably conditions of use GSO 1943/2009 (SASO 1953) clause 4.2 Product composition shall be conform to Table 1 to 5 of GSO 1943/2009 (SASO 1953/2009) (prohibited substances, restricted substances, coloring agents, authorized preservatives, authorized UV filters) Products must also comply with additional SFDA restrictions on ingredients used in cosmetics as per “SFDA Classification Guidelines” Products shall be classified as cosmetics, as per SFDA classification rules (function, composition and claims). In case of doubts, an official classification should be requested. Products containing alcohol for rinsing, cleaning or sterilizing of the teeth and mouth such as mouth wash shall not be certified/imported into KSA (Saudi Food and Drug Authority - SFDA) The concentration of ethanol in Perfumery products should not exceed 90% of its Perfumery volume. (Perfumery products packed in Aerosols are exempted from this Products requirement). SASO 585 /2000 Clause 5.4 Aerosol shall not contain formaldehyde and chlorofluorocarbon propellants shall not be used. All such products shall be marked in Arabic or both Arabic and Aerosol English languages. (SASO 1326/1996 Clause 4 and 8 & SASO 1228/1998 clause 3.4.) Toothpaste shall not contain Diethylene Glycol (DEG) (Saudi Food and Drug Toothpaste Authority - SFDA Saudi Food and Drug Authority (SFDA)Cosmetic Circular requires all Cosmetic Products in Ampoules and Vials shall: - Comply with Saudi Standard for Cosmetics - Have no Medical claims found on the product, product package or product information leaflet For Cosmetics in Ampoules Additionally the following instructions shall be clearly marked on the Inner and Vials Packaging (On the Container) on the Outer Packaging (On the wrapper) in Arabic or Arabic and English language: - Cosmetic Product for external use - Take proper precautions when opening - Avoid contact with eyes GTS-PM-KSA-CVG-0403-20 Page 5 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS ESSENTIAL REQUIREMENTS The application of a protective cover on or inside the product to ensure that the cosmetic products are to be opened only by the consumer. This requirements is mandatory as of 14/10/2015 only for the following: - Liquid mouth care products (excluding the products that are in the form of Aerosols). - Outer reproductive system care products (excluding the products that are in the form of Aerosols). The application of the cover is optional for other cosmetics until further direction issued by SFDA for other products. The manufacturer is at liberty to choose the appropriate type of protective cover. SPECIFIC REQUIREMENTS (Contd.) Cosmetics Packaging Factory/Warehouse Licensing Requirements The local Warehouse/Factory should be licensed by SFDA starting from 1 February 2015 onwards. st The registration of the different cosmetic products through eCosma will commence on April 2015 and will be completed on December 2016. The below table provides the enforcement schedule of eCosma registration of the different cosmetic products. eCosma Requirements Category Enforcement Date Oral Hygiene Products Nail and Cuticle Products Hair and Scalp Products Skin Products (including perfumery products and other skin products) April 2015 June 2015 October 2015 January 2016 Note: The cosmetic notification plan issued by SFDA for eCosma along with the specific cosmetic products covered by the above categories can be found in Exhibit 1. For detailed information refer to KSA CAP-POP-002-Procedure for Cosmetics and Perfumery Additional Information Products. SECTION D: KSA CAP TYPE APPROVAL LICENSING 1. PRODUCT EVALUATION Products must be evaluated for full compliance with the applicable Saudi Standards listed in Section B, including the relevant Saudi Essential Requirements listed in Section C. If the national Saudi standard is outdated or deviates heavily from the international equivalents or there are no SASO standards then, the relevant international standard may be used in conjunction with the Saudi Essential Requirements listed in Section C. 2. FACTORY INSPECTION/AUDIT All manufacturing sites must be inspected to confirm the existence of an on-going quality and product control system satisfying KSA CAP requirements. 3. ANNUAL SURVEILLANCE Samples may be selected for minimum verification tests as a part of annual routine inspections. Periodic pre-supply inspection will be performed. GTS-PM-KSA-CVG-0403-20 Page 6 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS SECTION E: PRE-SUPPLY TESTS FOR CAP APPROVED LABORATORIES Upon receipt of samples for pre-supply testing, Laboratories are to proceed as follows: 1. Examine the products to be tested and identify the applicable standard or standards from Section B. 2. Consult the tables given below and select only the test tables relevant to the standards you have selected in (1) 3. Read and note the Saudi Essential Requirements given in Section C and incorporate these points in your testing procedures. 4. Perform only the tests identified in the relevant test tables. (Laboratories are not to test to the complete standard unless specifically advised to do so). Saudi Standard test methods have been referenced where they exist. ISO 16408 Remark: Dentistry -- Oral hygiene products -- Oral rinses NO. TEST REQUIREMENT STANDARD REF. REQUIREMENT LIMITS ISO 16408 1 pH value 2 Ethanol/Methanol content 3 Fluoride content 4 Microbiological test 5.1 To check the pH value as declared by the manufacturer --- SASO 585, 5.4 Shall be Absent SASO 585, 5.4 5.2 1500ppm --- GSO 1943/2009 Article: 4.3.10 Max. 1000 cfu/gm GSO 409/1994 or SASO 757/1994 Heavy metals (in ppm): Lead (Pb) Arsenic (As) 5 TEST METHOD STANDARD REF. GSO 1943/2009 Article: 4.3.1 (Table 1 positions 43, 68, 221, 289) Lead (Pb) < 10 ppm for ingested products / < 20 ppm for products applied dermally ICPMS according internal method ICPMO-010 or by ICPAES according internal method ICPMO-012 Arsenic (As) < 3 ppm Cadmium (Cd) < 3 ppm Mercury (Hg) Mercury (Hg) < 1 ppm Antimony (Sb) Antimony (Sb) < 1 ppm Note: Products containing alcohol for rinsing, cleaning or sterilizing of the teeth and mouth such as mouth wash shall not be certified/imported into KSA as per Saudi Food and Drug Authority (SFDA) Circular No. 3597 Dated 12/2/1432 (16 January 2011) Cadmium (Cd) GTS-PM-KSA-CVG-0403-20 Page 7 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS GSO 1943/2009 (SASO 1953) Remark: Cosmetic products NO. TEST REQUIREMENT STANDARD REF. Microbiological tests: Aerobic mesophilic bacteria Yeast & Mould 1 Notes: 12- 2 Microbiological test is not required for Perfumery Compounds Microbiological test is applicable if the percentage of alcohol is below 20% Lard or lard derivatives <100 CFU/g for bacteria <100CFU/g for yeast & mould, NF ISO 21149 NF ISO 16212 GSO 1943 (SASO 1953) 4.1 Shall be absent --- Lead (Pb) Arsenic (As) Cadmium (Cd) TEST METHOD STANDARD REF. GSO 1943/2009 Article: 4.3.10 Heavy metals (in ppm): 3 REQUIREMENT LIMITS GSO 1943/2009 Article: 4.3.1 (Table 1 positions 43, 68, 221, 289) Mercury (Hg) Antimony (Sb) Lead (Pb) < 10 ppm for ingested products / < 20 ppm for products applied dermally ICPMS according internal method ICPMO-010 or by ICPAES according internal method ICPMO-012 Arsenic (As) < 3 ppm Cadmium (Cd) < 3 ppm Mercury (Hg) < 1 ppm Antimony (Sb) < 1 ppm Additional requirements for Toothpaste --- Triclosan test SFDA Circular 7484/2011 (and SFDA Classification Guidelines) shall be absent -- Additional requirements for Shampoo / Shower Gel / Liquid Soap / Intimate Wash / Bath Foam / Facial Cleanser …Etc --- 1-4 Dioxan --- pH GSO 1943/2009 Article 4.3.1 (Table 1 - position 343) Value to be reported < 10 ppm Testing by GCMS according to internal method As per manufacturer’s specification --- Additional requirements for Shampoo products with Keratin, Hair Straightener, Brazilian blowout and like GSO 1943/2009 Testing by GCMS Article 4.3.1 (Table 1 according to internal 1-4 Dioxan < 10 ppm position 343) method GSO 1943/2009 --Formaldehyde Article: 4.3.1 (Table 1 Shall be absent --position 1128) Additional requirements for Cosmetic baby Products (Shampoos, Creams, Lotions…etc, except baby powder which covered By “Talcum Powder” Category GSO 1943/2009 Testing by GCMS --4.3.1 (No. 343,Table according to internal 1-4 Dioxan < 10 ppm 1) method --- GTS-PM-KSA-CVG-0403-20 Page 8 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS GSO 1943/2009 (SASO 1953) (Contd.) Remark: Cosmetic products NO. --- --- --- TEST REQUIREMENT STANDARD REF. REQUIREMENT LIMITS TEST METHOD STANDARD REF. GSO 1943/2009 Article: 4.3.1 (Table 1 position 1128) shall be absent --- 24 IFRA Allergens GSO 1943/2009 Article: 4.3.2 (Table 2 positions 67-92) The presence of the substance must be indicated in the list of ingredients when its concentration exceeds: - 0.001% in leave-on products - 0.01% in rinse-off products --- Phtalates GSO 1943/2009 Article 4.3.1 (Table 1 positions 675, 677, 678, 1151, 1152) shall be absent --- As per manufacturer’s specification --- Formaldehyde Additional requirements for Moisturizing Skin Cream (Containing Urea) --- pH Value to be repoted SFDA Classifcation Guidelines (2.2.2 < 10 % --position 2.C) Additional requirements for All types of Skin Cream not covered by other Categories (Skin Cream, Body Cream, Body Lotion, Body Milk…Etc) As per --pH Value to be reported manufacturer’s --specification The presence of the substance must be indicated in the list of ingredients when its GSO 1943/2009 concentration --24 IFRA Allergens Article: 4.3.2 (Table 2 --exceeds: positions 67-92) - 0.001% in leave-on products - 0.01% in rinse-off products --- Urea Additional requirements for Whitening Cream, Skin Cream, Skin Lightening Cream, Fairness Cream --- --- pH Value to be reported As per manufacturer’s specification --- Hydroquinone GSO 1943/2009 article 4.3.1 (Table 1 position 1339) and SFDA Classification Guidelines (2.2.2 position 1.B) Shall be absent --- GTS-PM-KSA-CVG-0403-20 Page 9 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS GSO 1943/2009 (SASO 1953) (Contd.) Remark: Cosmetic products NO. TEST REQUIREMENT STANDARD REF. REQUIREMENT LIMITS TEST METHOD STANDARD REF. Additional requirements for Deodorant (rolls, sticks, no sprays), this Category excludes Deodorant products based on Ethanol which are covered by Category “Perfumery Products” SFDA Circular 7484/2011 and SFDA --Triclosan test Classification shall be absent -Guidelines (2.2.2 position 1.C) Additional requirements for Mouth Wash --- pH --- Ethanol / Methanol Content ISO 16408 - Article 5.1 SFDA Circular 3597/2011 and SFDA Classification Guidelines (point 2.2.2) Allergens shall be absent --- Shall be absent --- Absence in products intended for less than 3 years 5% max in talcum powder 0,1% max in products for all hygiene 3% in other products (excluding bath products and hair waving products) 18% max in bath products 8% max in hair waving products --- Additional requirements for Talcum Powder --- Boric Acid GSO 1943/2009 Article 4.3.2 (Table 2 position 1A & 1B) Additional requirements for Chemical Depilatories based on Thioglycolic acid --- --- Thioglycolic Acid GSO 1943/2009 Article 4.3.2 (Table 2 position 2A) 5 % ready for use for Thioglycolic acid --- pH GSO 1943/2009 Article 4.3.2 (Table 2 position 2A) In ready for use products, pH value shall be from 7 to 12.7 --- Additional requirements for Hair Colouring (Hair Dye, Kit for Bleaching, Eyebrow/eyelash dyes, Developer, Henna…Etc --- pH --- Hydrogen peroxide --- P-Phenylenediamine Value to be reported GSO 1943/2009 Article 4.3.2 (Table 2 position 12) GSO 1943/2009 Article 4.3.2 (Table 2 position 8) As per manufacturer’s specification --- < 12% --- < 6% --- GTS-PM-KSA-CVG-0403-20 Page 10 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS GSO 1943/2009 (SASO 1953) (Contd.) Remark: Cosmetic products NO. TEST REQUIREMENT STANDARD REF. REQUIREMENT LIMITS TEST METHOD STANDARD REF. Note: there are 3 options on this scope, the option is to be determined by the laboratory upon receipt of samples * Option 1: coloring cream alone (microbiology, HM, PPD, pH) * Option 2: oxydizer alone (HM, hydrogen peroxide, pH) * Option 3: kits including coloring cream and oxydizer (PPD on cream; hydrogen peroxide on oxydizer) Additional requirements for Nail Polish --- Phthalates GSO 1943/2009 Article 4.3.1 (Table 1 positions 675, 677, 678, 1151, 1152) shall be absent --- GSO 1943/2009 Article 4.3.5 & 4.3.6 (Table 4) Bio Preservatives must fit with manufacturer's declaration + restrictions of GSO 1943/2009 (=76/768/EEC) --- Additional requirements for Organic Products (BIO) --- Bio Preservatives (Sorbic acid and its salts / Benzoic acid, its salts and esters / Benzylic acid / Dehydroacetic acid) Additional requirements for Perfumery Products based on Ethanol (Edt, Edc, Edp, Body Spray, Body Mist, Body Splash…Etc --- Flash Point --- 24 IFRA Allergens Value to be reported GSO 1943/2009 Article: 4.3.2 (Table 2 positions 67-92) Extremely flammable: Flash point < 23°C and initial boiling point ≤ 35°C Highly flammable: Flash point < 23°C and initial boiling point > 35°C Flammable: Flash point ≥ 23°C and ≤ 60°C The presence of the substance must be indicated in the list of ingredients when its concentration exceeds: - 0.001% in leave-on products - 0.01% in rinse-off products --- --- GTS-PM-KSA-CVG-0403-20 Page 11 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS SECTION F: PROCEDURE FOR EVALUATING THE LABORATORY CREDENTIALS COs/RLCs should proceed as follows for evaluating the Test Reports: S.NO CHECKPOINTS 1 Is the laboratory test report an authentic report? 2 Is the laboratory issuing the test report an ISO 17025 accredited lab (by an ILAC approved accreditation body) or previously approved by Intertek? 3 Is the laboratory test report less than 1 year old? YES/NO? Is the product type/name/model stated in the laboratory test report the same as the product which is under certification? Has the laboratory carried out the tests stated in the test table of 5 Section E? Has the laboratory reported the test results as acceptable/pass? Does the 6 Laboratory provide test results interpretations? If the answer to any one of the above checkpoints is “No” then the exporter/manufacturer should be advised to take corrective action and to resubmit the test reports. 4 GTS-PM-KSA-CVG-0403-20 Page 12 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS SECTION G: ADDITIONAL INSPECTION REQUIREMENTS (AIR) NOTE: This document shall be used separately by Country Offices for pre-supply inspection purposes. I. PERFUMERY PRODUCTS BASED ON ETHANOL Introduction: All cosmetics products for personal and professional use should comply with the same minimum requirements, which are listed below, however in addition to these requirements some products need to meet specific product standard requirements. The explanatory notes should be refereed whenever these are applicable. Cosmetic products, which claim medicinal properties are non-regulated and require prior permission from the Saudi Food and Drug Authority (SFDA) for the import of such products into KSA PHYSICAL REQUIREMENTS CHECK POINT STANDARD REFERENCE SASO 585, 8.1 GENERAL PHYSICAL REQUIREMENTS Category (A) and Category (B) products shall be packed in suitable containers of not more than 250ml in capacity (1/4 litre). note: Refer explanatory notes for classification the containers of Category (A) and Category (B) products shall be fitted with tight non-removable pumps that could spray the contents in the form of small droplets, or the packages be of the aerosol dispenser type FOR COMPLIES? FOR REGN. & LIC. EXPORT ANALYST × × FOR INSPECTORS Y N NA 9B SASO 585, 8.2 10B MARKING REQUIREMENTS ON THE INNER PACKAGING (CONTAINER): STANDARD REFERENCE SASO 585, 9.1.1 SASO 585, 9.1.2 SASO 585, 9.1.3 SASO 585, 9.1.6 SASO 585, 9.1.5 SASO 585, 9.1.4 SASO 585, 9.1.8 SASO 585, 9.1.7 GSO 1943 (SASO 1953) 6.26 CHECK POINT EXPORT ANALYST 16Bname & Type of the product In English or Arabic × 17Bname of the manufacturer and/or his registered trademark In English or Arabic Address of the manufacturer or name and address of the person responsible for marketing the product (Could be abbreviated if possible to identify the undertaking) In English or Arabic, if the product is sold without wrapper only × × Date of production or Batch number In English or Arabic × Net cont. in volume or mass (metric system.) unless below 5g or 5ml In English or Arabic × Country of origin In English or Arabic Concentration of alcohol In English or Arabic** × List of ingredients in descending order of mass (INCI or CTFA)* if the product is sold without wrapper only × Instructions for use and storage (if any) In Arabic* × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA GTS-PM-KSA-CVG-0403-20 Page 13 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS STANDARD REFERENCE GSO 1943 (SASO 1953) 6.26 SASO 585, 9.2 CHECK POINT GENERAL MARKING REQUIREMENTS Any warning requirements related to the product that is found necessary by the manufacturer In Arabic* Special warning “For external use only” for Cat A & B products in Arabic** if the product is sold without wrapper only FOR COMPLIES? FOR REGN. & LIC. EXPORT ANALYST × × FOR INSPECTORS Y N NA Description (Details given on the inspected product): * Where it is impracticable for reasons of size or shape, it shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. ** Label accepted on the cellophane MARKING REQUIREMENTS ON THE OUTER PACKAGING (WRAPPER): STANDARD REFERENCE SASO 585, 9.1.1 SASO 585, 9.1.2 SASO 585, 9.1.3 SASO 585,9.1.6 SASO 585,9.1.5 SASO 585,9.1.4 SASO 585,9.1.8 SASO 585,9.1.7 GSO 1943 (SASO 1953) 6.26 GSO 1943 (SASO 1953) 6.26 SASO 585, 9.2 CHECK POINT EXPORT ANALYST Name & Type of the product In English or Arabic × Name of the manufacturer and/or his registered trademark In English or Arabic Address of the manufacturer or name and address of the person responsible for marketing the product (Could be abbreviated if possible to identify the undertaking) In English or Arabic × × Date of production or Batch number In English or Arabic × Net cont. in volume or mass (metric system.) unless below 5g or 5ml In English or Arabic × Country of origin In English or Arabic Concentration of alcohol In English or Arabic** × List of ingredients in descending order of mass (INCI or CTFA)* × Instructions for use and storage (if any) In Arabic* × Any warning requirements related to the product that is found necessary by the manufacturer In Arabic* × × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA Special warning “for external use only” for Cat A & B products in Arabic** Description (Details given on the inspected product): GTS-PM-KSA-CVG-0403-20 Page 14 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS * Where it is impracticable for reasons of size or shape, it shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. ** Label accepted on the cellophane GTS-PM-KSA-CVG-0403-20 Page 15 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS II. COSMETIC PRODUCTS (FOR PERSONAL AND PROFESSIONAL USE): MARKING REQUIREMENTS ON THE INNER PACKAGING (ON THE CONTAINER): STANDARD REFERENCE GSO 1943 (SASO 1953) 6.1& 6.8 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.23 GSO 1943 (SASO 1953) 6.5 CHECK POINT EXPORT ANALYST 27Btype/function of the product in English or Arabic 28B Note: If product is sold without outer packaging (wrapper), then type/function of product shall be in Arabic language. × 29Bname of the product In English or Arabic × Name of the manufacturer and / or his registered trademark In English or Arabic × Address of the manufacturer or name and address of the person responsible for marketing the product GSO1943, 6.1 (1953) (Could be abbreviated if possible to identify the undertaking) In English or Arabic if the product is sold without wrapper only × Date of production or Batch number In English or Arabic × × Net content in volume or mass (metric system.) unless below 5g or 5ml In English or Arabic × Country of origin In English or Arabic List of ingredients in descending order of mass (INCI or CTFA)* if the product is sold without wrapper only × Instructions for use and storage (if any) * in Arabic × Special warning (as per table II, III, IV, V)* in Arabic × GENERAL MARKING REQUIREMENTS Best before date (for product with a shelf life less than 30 months) *** Or Period After Opening (PAO) (indication of the life of the product after it is opened) for product with a durability of more than 30 months In English or Arabic (If products are only marked with # Expiry date then these are to be accepted. See below for more info) FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA Description (Details given on the inspected product): + Period in months (example: 6M) GSO 1943 (SASO 1953) 6.24 GSO 1943 (SASO 1953) 6.25 GSO 1943 (SASO 1953) 6.17.6 GSO 1943/2009 (SASO 1953) 6.26 GSO 1943/2009 (SASO 1953) 6.2, 6.3, 6.4 GTS-PM-KSA-CVG-0403-20 Page 16 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS STANDARD REFERENCE CHECK POINT GENERAL MARKING REQUIREMENTS FOR REGN. & LIC. FOR EXPORT ANALYST COMPLIES? FOR INSPECTORS Y N NA Additional Marking Requirements For Cosmetics Packed In Ampoules And Vials SFDA Circular Ref: 21662 The following instructions shall be clearly marked in Arabic or Arabic & English language: - Cosmetic products for external use - Take proper precautions when opening - Avoid contact with eyes × Note: No Medical claims shall be found on the product , product package or the product information leaflet Additional Marking Requirements for Liquid mouth care and Outer reproductive system care products (Excluding the products that are in the form of Aerosols) SFDA Circular The application of a protective cover on or inside the product to Ref: 10526/A ensure that the cosmetic products are to be opened only by the consumer. The application of the cover is optional for other cosmetics until further direction issued by SFDA for other products. × The manufacturer is at liberty to choose the appropriate type of protective cover. (This requirements are mandatory as of 14/10/2015) * Where it is impracticable for reasons of size or shape, it shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. *** The date of minimum durability shall be indicated by the words ‘best used before the end” or “best before” followed by either: the date itself, or details of where it appears on the packaging. In case products have both PAO/Best before and Expiry date marking then products are to be accepted. In case products are marked with PAO/Best before date only then Intertek offices are to convey to the exporter that in order to avoid any potential issues at the KSA customs it is recommended that the exporters apply the expiry date marking as well. Products having only Expiry date marking with/without production date should be accepted after issuing a discrepancy report to the exporter specifying that the PAO/Best before marking is recommended. For certain products such as single use products, eye shadows… period after opening (PAO) is not required. See explanatory notes at the end of this document for more information MARKING REQUIREMENTS ON THE OUTER PACKAGING (ON THE WRAPPER): STANDARD REFERENCE GSO 1943 (SASO 1953) 6.1& 6.8 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.1 CHECK POINT EXPORT ANALYST 35Btype/function of the product** In Arabic × 36Bname of the product × 37Bname of the manufacturer and/or his registered trademark in English or Arabic × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA GTS-PM-KSA-CVG-0403-20 Page 17 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS STANDARD REFERENCE GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.23 GSO 1943 (SASO 1953) 6.5 GSO 1943 (SASO 1953) 6.5 (Contd.) GSO 1943 (SASO 1953) 6.24 GSO 1943 (SASO 1953) 6.25 GSO 1943 (SASO 1953) 6.17.6 GSO 1943 (SASO 1953) 6.26 GSO 1943 (SASO 1953) 6.26 GSO 1943 (SASO 1953) 6.2, 6.3, 6.4 CHECK POINT EXPORT ANALYST Address of the manufacturer or name and address of the person responsible for marketing the product (Could be abbreviated if possible to identify the undertaking) In English or Arabic × Date of production or Batch number In English or Arabic × Best before date (for product with a shelf life less than 30 months)*** Or Period After Opening (PAO) (indication of the life of the product after it is opened) for product with a durability of more than 30 months (If products are only marked with Expiry date then these are to # be accepted. See below for more info) × × Net content in volume or mass (metric system.) unless below 5g or 5ml In English or Arabic × Country of origin (585,9.1.4) In English or Arabic List of ingredients in descending order of mass (INCI or CTFA)* × Instructions for use and storage (if any) Arabic* × Any warning requirements related to the product that is found necessary by the manufacturer Arabic* × Special warning (as per table II, III, IV, V) Arabic* × × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA Description (Details given on the inspected product): + Period in months (example: 6M ) Additional Marking Requirements for Cosmetics packed in ampoules and vials SFDA Circular Ref: 21662 The following instructions shall be clearly marked in Arabic or Arabic & English language: - Cosmetic products for external use - Take proper precautions when opening - Avoid contact with eyes Note: No Medical claims shall be found on the product, product package or the product information leaflet GTS-PM-KSA-CVG-0403-20 Page 18 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS CHECK POINT F OR FOR GENERAL MARKING REQUIREMENTS FOR REGN. EXPORT INSPECTORS & LIC. ANALYST Additional Marking Requirements for Liquid mouth care and Outer reproductive system care products (Excluding the products that are in the form of Aerosols) SFDA Circular The application of a protective cover on or inside the product to Ref: 10526/A ensure that the cosmetic products are to be opened only by the consumer. STANDARD REFERENCE The application of the cover is optional for other cosmetics until further direction issued by SFDA for other products. The manufacturer is at liberty to choose the appropriate type of protective cover. × COMPLIES? Y N NA (This requirements are mandatory as of 14/10/2015) * Where it is impracticable for reasons of size or shape, it shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. ** Label accepted on the cellophane *** The date of minimum durability shall be indicated by the words ‘best used before the end” or “best before” followed by either: the date itself, or details of where it appears on the packaging. In case products have both PAO/Best before and Expiry date marking then products are to be accepted. In case products are marked with PAO/Best before date only then Intertek offices are to convey to the exporter that in order to avoid any potential issues at the KSA customs it is recommended that the exporters apply the expiry date marking as well. Products having only Expiry date marking with/without production date should be accepted after issuing a discrepancy report to the exporter specifying that the PAO/Best before marking is recommended. For certain products such as single use products, eye shadows… period after opening (PAO) is not required. See explanatory notes at the end of this document for more information GTS-PM-KSA-CVG-0403-20 Page 19 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS III. PERFUMES AND COSMETICS THAT ARE PACKED IN AEROSOL DISPENSERS: PHYSICAL REQUIREMENTS STANDARD REFERENCE SASO 1228, 5.1 SASO 1228, 5.3.3 SASO 1228, 5.4.3, 5.4.5 CHECK POINT GENERAL PHYSICAL REQUIREMENTS Aerosol dispensers shall comprise of the following parts: Can Valve assembly Protection means such as a cap to prevent accidental operation of the valve The aerosol-can shall be cylindrical, of uniform thickness, regular in shape about the central axis and externally clean. It shall be free from sharp edges, burrs or similar defects. Seams shall be continuous, regular and free from defects. The valve button of the aerosol dispenser shall indicate the direction of discharge of the contents. It shall be adequately protected to prevent unintentional opening during storage or transport. FOR COMPLIES? FOR REGN. & LIC. EXPORT ANALYST × × × FOR INSPECTORS Y N NA MARKING REQUIREMENTS STANDARD REFERENCE GSO 1943 (SASO 1953) 6.1& 6.8 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.1 GSO 1943 (SASO 1953) 6.23 GSO 1943 (SASO 1953) 6.24 GSO 1943 (SASO 1953) 6.25 GSO 1943 (SASO 1953) 6.17.6 CHECK POINT EXPORT ANALYST Type/function of the product** In English or Arabic × Name of the product In English or Arabic × Name of the manufacturer and/or his registered trademark In English or Arabic × Address of the manufacturer or name and address of the person responsible for marketing the product (Could be abbreviated if possible to identify the undertaking) In English or Arabic × Date of production or Batch number × Net cont. in volume or mass (metric system.) unless below 5g or 5ml In English × Country of origin (585,9.1.4) In English or Arabic List of ingredients in descending order of mass (INCI or CTFA)* × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA GTS-PM-KSA-CVG-0403-20 Page 20 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS STANDARD REFERENCE GSO 1943 (SASO 1953) 6.26 GSO 1943 (SASO 1953) 6.26 GSO 1943 (SASO 1953) 6.26 -- CHECK POINT EXPORT ANALYST Instructions for use and storage (if any) In Arabic* × Any warning requirements related to the product that is found necessary by the manufacturer In Arabic* × Special warning (as per table II, III, IV, V) GSO 1943 (SASO 1953) 6.2, 6.3, 6.4 In Arabic* × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA Aerosol Warnings In Arabic: Pressured Container Protect from Sunlight and do not expose to temperature exceeding 50 degrees Celsius Do not spray on a Naked flame or any incandescent Material Do not pierce or burn even after use × Keep out of the reach of children Alternative Sentences such as below can be accepted: Container under pressure Do not Expose to the Sun Heat above 50°C Flammable or the Symbol * Where it is impracticable for reasons of size or shape, it shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. ** Label accepted on the cellophane GTS-PM-KSA-CVG-0403-20 Page 21 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS IV. TESTERS & FREE SAMPLES Testers (Remains at the point of distribution. Product presented together with the sales product, not given to consumer): Testers shall generally be marked as the sales product and comply with the sanctioned standards. However, when the product is clearly marked as “tester” “for demonstration” or other definition showing that the product is not for distribution, the following reduced marks are acceptable (in English only): Make-up testers displayed on a stand, provided the stand is marked with the relevant information, could be marked with batch number only. MARKING REQUIREMENTS STANDARD REFERENCE CHECK POINT GENERAL MARKING REQUIREMENTS FOR REGN. & LIC. FOR EXPORT ANALYST COMPLIES? FOR INSPECTORS --- Word “Tester” or “For demonstration” or Equivalent × --- Manufacturer’s Name × --- Country of Origin --- Batch Number or Production Date × Y N NA Note: If the word “tester” or equivalent is not clearly marked the product shall be clearly marked as a sale product. Free samples: Distributed to the consumers. The product shall be clearly marked with the word ”Free sample” or equivalent. It shall generally be marked as the sales product and comply with the sanctioned standards. However, when it is impractical for reason of size the required information could appear in an enclosed leaflet, notice, tape or card and could be marked in English only. Furthermore the volume marking is required only if it exceeds 5ml/gr. Durability of the Product (PAO / Best before Date) is not required STANDARD REFERENCE CHECK POINT GENERAL MARKING REQUIREMENTS FOR REGN. & LIC. FOR EXPORT ANALYST COMPLIES? FOR INSPECTORS --- Word “Free Sample” or equivalent * × --- Type/function of the product * In English × --- Name of the product* In English × Name of the manufacturer and / or his registered trademark* In English Address of the manufacturer or name and address of the person responsible for marketing the product (Could be abbreviated if possible to identify the undertaking)* In English × × --- Date of production or Batch number × --- Net cont. in volume or mass* (metric system.) unless below 5g or 5ml × --- Country of origin* In English --- List of ingredients in descending order of mass* (INCI or CTFA) × ----- Y N NA GTS-PM-KSA-CVG-0403-20 Page 22 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS STANDARD REFERENCE CHECK POINT GENERAL MARKING REQUIREMENTS FOR REGN. & LIC. FOR EXPORT ANALYST COMPLIES? FOR INSPECTORS --- Instructions for use and storage* (if any) In English × --- Any warning requirements related to the product that is found necessary by the manufacturer* In English × --- Special warning* (as per table II, III, IV, V) (if any) In English × Y N NA * It shall appear in an enclosed leaflet or on a notice, tape or card, which is enclosed or attached to the cosmetic product. In such cases the symbol is recommended to be marked on the product or on the product’s packaging to indicate this. Note: Product clearly marked with the word “free sample” or equivalent does not need the PAO and does not need any Arabic Marking. If the word “free sample” or equivalent is not clearly marked the product shall be clearly marked as a sale product. GTS-PM-KSA-CVG-0403-20 Page 23 of 28 KINGDOM OF SAUDI ARABIA MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME COMPLIANCE VERIFICATION GUIDELINES ISSUED: 13-Apr-15 PERFUMES AND COSMETICS V. ESSENTIAL OILS (SEMI- FINISHED FORM): PHYSICAL REQUIREMENTS CHECK POINT STANDARD REFERENCE SASO 1965, 2.1 SASO 1965, 2.4 SASO 1964, 3 SASO 1964, 3 GENERAL PHYSICAL REQUIREMENTS Essential oils shall be packed in containers which, by their nature, do not cause alteration of the product and which protect it against any external attack. Generally, the container materials shall be inert towards the packed product so as to prevent any simultaneous damage of the product and of the material. Materials for containers intended for containing essential oils for perfumery and cosmetic use may be of glass, metal and alloys (stainless steel, aluminium and aluminium alloys, tin, copper, zinc or galvanized iron), polymers (plastics and varnishes) or ceramic on condition that they do not alter the composition of the essential oil or its organoleptic properties; appearance, colour, odour, etc. Labels shall be fixed by means of a process which renders their replacement impossible, as preventing their subsequent use for other purposes. Marking shall be affixed directly onto the container by a process which makes it durable& indelible. FOR COMPLIES? FOR REGN. & LIC. EXPORT ANALYST × × × × FOR INSPECTORS Y N NA MARKING REQUIREMENTS CHECK POINT STANDARD REFERENCE SASO 1964 SASO 1964, 5.1 SASO 1964, 5.2 SASO 1964, 5.4 SASO 1964, 5.5 SASO 1964, 5.6 SASO 1964, 5.7 SASO 1964, 5.8 SASO 1964, 5.9 EXPORT ANALYST Marking shall be in Arabic or English × The commercial name of the essential oil, botanical name of the plant & part of the plant from which it is obtained The name or tradename and the address of the manufacturer or distributor The percentage of the main constituent if the commercial value of the essential oil depends on it × × × Mass × The specific condition of preservation (such as storage temperature), whether the essential oil has been decanted and the instructions for use × The batch number or the manufacturing date × The country of origin The symbols and the indications of hazards relating to the substances and the indications of the particular risks (following the national or international regulations in force in the countries concerned) × GENERAL MARKING REQUIREMENTS FOR COMPLIES? FOR REGN. & LIC. FOR INSPECTORS Y N NA GTS-PM-KSA-CVG-0403-20 Page 24 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS STANDARD REFERENCE CHECK POINT GENERAL MARKING REQUIREMENTS FOR REGN. & LIC. FOR EXPORT ANALYST COMPLIES? FOR INSPECTORS Y N NA SASO 1964, Flashpoint for storage (if any) × 5.10 SASO 1964, The shelf-life date up until which the essential oil retains all its × 5.11.1 properties GSO 1943 (SASO 1953) List of ingredients in descending order of mass (INCI or CTFA) × 6.17.6 Note: Essential oil in finished form i.e. for direct sale to consumers are covered under GSO 1943 (SASO 1953) - (Section II of AIR, Cosmetic Products) GTS-PM-KSA-CVG-0403-20 Page 25 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS EXHIBIT 1 – EXPLANATORY NOTES List of cosmetic products which the function is clear, obvious for the consumer and then, which are exempted from the translation in Arabic language: We understand that this list is not definitive and new products could be completed it depending on novelties which are sold on the market. Make up foundation Powders: Eye shadow, Cheek Blusher, Loose Powder, Compact powder Mascara Eye Liner Lipstick, Lip gloss Pencils: Eye pencil, Lip pencil Nail Polish, Nail Care Period After Opening Additional information: This information is mandatory for product with a durability of more than 30 months. The period after opening is indicated by the open jar Symbol and expressed in months inside or alongside the Symbol + Period in months (example: 6M) The mention of the period after opening is not relevant when : There is no physical opening of the product as is the case for products presented in containers where there is no possibility of contact between the product in the container and the external environment. The product are designed to be used only once (single use product) There is no risk of harm to the consumer as there is no risk of deterioration that could lead to damage to human health. Below are some products, which are exempted of PAO: Products with a minimal life time of 30 months or less since they will already have a “best before” date. Single use products/Free samples Samples with a content allowing only one application Aerosol sprays (sealed pressurised containers) Alcoholic products with a % of alcohol more than 20% Anhydrous products (some categories of lipsticks, eye shadows, skincare oils.) Permanent hair colouring products Classification: Perfumery products based on ethanol are classified according to the essential oil as follows: Category A: Essential oil content is between 2-2.999% by volume; Category B: Essential oil content is between 3-7.999% by volume; Category C: Essential oil content is 8% or greater by volume. Ingredients: A list of ingredients in descending order of mass. Using the designator of international inventory for cosmetics products. That list shall be preceded by the word “Ingredients:” (optional). Moreover, if product is perfumed, it must be specified by perfume / aroma or parfum. GTS-PM-KSA-CVG-0403-20 Page 26 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS However, the following should not be regarded as ingredients: Impurities in the raw material Subsidiary technical materials used in the preparation but not present in the final product. Materials used in strictly necessary quantities as solvent or as carrier for perfume and aromatic composition Denaturation: All perfume category (A) and (B) shall contain one or more of the following denaturants or any equivalent material that would make the product very bitter and undrinkable and shall be internationally permissible. Bitrex with minimum concentration of 10 ppm of ethanol Diethyl phthalate with minimum concentration of 0.5% by volume of ethanol Quassin with minimum concentration 120 ppm of ethanol Sucrose octa-acetate with minimum concentration of 4000 ppm of ethanol Multi-product package: Each individual product within the package should comply with the relevant marking requirements. For products packed in a gift box, the box is to be considered as the outer packaging and all information required as per Saudi standards on the outer packaging shall be on the box. For products inside the gift box the individual inner packaging (container) markings as per Saudi standards will be applicable. Glossary of Terms: S.No. 98BPPPPProducts Definitions 1 Aerosol dispenser A non-refillable dispensing container, in which the product is kept under pressure by means of a propellant, and incorporating a valve for the discharge of the contents in small droplets. 2 CTFA Cosmetic, Toiletry and Fragrance Association 3 Denaturant A substance, which is completely miscible in Ethanol and renders Ethanol or any aqueous solution thereof unfit for human consumption. 4 EDC Eau de Cologne 5 EDT Eau de Toilette 6 Essential oil A blend of natural and/or synthetic material with a characteristic pleasant smell. 7 INCI International Nomenclature of Cosmetic Ingredients 8 Indelible That cannot be removed, washed away, or erased. 9 Legible Capable of being read or deciphered. 10 Perfumery Product based on Ethanol Solutions prepared by dissolving one or more essential oils in pure Ethanol. 11 Period After Opening Indication of the period of time after opening for which the product can be used without any harm to the consumer 12 SFDA Saudi Food and Drug Authority GTS-PM-KSA-CVG-0403-20 Page 27 of 28 MINISTRY OF COMMERCE AND INDUSTRY KINGDOM OF SAUDI ARABIA KINGDOM OF SAUDI ARABIA CONFORMITY ASSESSMENT PROGRAMME ISSUED: 13-Apr-15 COMPLIANCE VERIFICATION GUIDELINES PERFUMES AND COSMETICS EXHIBIT: COSMETICS NOTIFICATION PLAN GTS-PM-KSA-CVG-0403-20 Page 28 of 28