COSMETICS UPDATES NEWSLETTER

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1 COSMETICS UPDATES NEWSLETTER

2 TABLE OF CONTENTS ITEM DESCRIPTION PAGE 1 Introduction SFDA Circular - Factories and Warehouses of Cosmetics are Obliged to Obtain Licence from SFDA (in Arabic Language) SFDA Circular - Factories and Warehouses of Cosmetics are Obliged to Obtain Licence from SFDA (in Unofficial English Translation) SFDA Circular - Mandatory Inclusion Plan of Cosmetic Products (ecosma) (in Arabic Language) 5 5 SFDA Circular - Mandatory Inclusion Plan of Cosmetic Products (ecosma) (in Unofficial English Translation) 7 6 Cosmetic Products Notification System (ecosma) User Guide in Arabic and English Languages 9 7 SFDA Circular on Cosmetics Packaging (in Arabic Language) 60 8 SFDA Circular On Cosmetics Packaging (in Unofficial English Translation) 61 9 Exhibit I - Cosmetic Products that require Protective Casing SFDA Supplementary Circular on Cosmetics Packaging (in Arabic Language) SFDA Supplementary Circular on Cosmetics Packaging (in Unofficial English Translation) 65 Page 1 of 65

3 INTRODUCTION SFDA has introduced the regulations for Cosmetic products through distribution of several circulars. The major content of these circulars are: 1- From 1 st February 2015, If a cosmetic product / cosmetic material shipment, which does not have evidence of local warehouse / factory licence, arrives at the KSA ports and borders, then in such cases the KSA Authorities will suspend the shipment clearance and initiate regulatory proceedings against these unlicensed local factories and warehouses. For more information about licensing factories and warehouses of cosmetics, please visit SFDA website at: 2- Mandatory inclusion plan of cosmetic products (ecosma): ecosma notification process starts on 1 st April 2015, and will be gradually applied to all other Cosmetic products, initially for Oral Hygiene products, as per the Appendix of the circular. It is free of charge for 2015 but there will a fee to pay starting 2016 (we have no information about the costs that will be charged by SFDA). The first step of the process is the creation of account and request for licence (warehouse licence for importer/distributor, and manufacturing licence for manufacturer). Then, the notification process (product by product) can start. Website address is: (still not activated) The licence should be compulsory initiated by the local distributor (Saudi based company). It is recommended that the local company initiated at earliest so as to ensure that they will be able to issue the notification from April ecosma notification process is described in ecosma user guide document. 3- Cosmetic packaging: 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 th Oct 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. An information note should be added on the products packaging to inform the consumer of the existence of protective cover: the This information should not be marked on the protective cover to ensure that it is not removed or lost when the protective cover is removed by the consumer. 4- Note that ecosma registration doesn t replace the current requirements for certification of conformity for shipments to Saudi Arabia (Certification requirements (CoC) will exist along with ecosma notification process). For more information, please contact the Centre of Technical Expertise for Cosmetics (CTE-C) cte-c@intertek.com Page 2 of 65

4 SFDA CIRCULAR- FACTORIES AND WAREHOUSES OF COSMETICS ARE OBLIGED TO OBTAIN LICENSE FROM SFDA (IN ARABIC LANGUAGE) Page 3 of 65

5 SFDA CIRCULAR- FACTORIES AND WAREHOUSES OF COSMETICS ARE OBLIGED TO OBTAIN LICENSE FROM SFDA (IN UNOFFICIAL ENGLISH TRANSLATION) In the name of Allah, All-Merciful, Ever-Merciful Kingdom of Saudi Arabia Saudi Food & Drug Authority (255) Vice President of Drug Affairs "Circular" Subject: Factories and Warehouses of Cosmetics are Obliged to obtain License from Saudi Food and Drug Authority Circular no. : 6827/A, date: 26/2/1436 H Copy to His Excellency Secretary General of Council of Saudi Chambers of Commerce (May Allah grant him safety) Factories and importers of cosmetics Managers of drug and cosmetic warehouses May the peace and mercy of Allah be upon you, Based on the procedures of the Saudi Food and Drug Authority issued by the Royal Decree no. (M/6), dated 25/01/1428 H, and executive regulation thereof, regarding the Authority's powers to regulate cosmetics and their associated facilities, the Authority would like to inform you that local factories and warehouses for cosmetics are obliged to license their facilities. The Authority shall suspend clearance orders for cosmetic products and raw materials and take regulatory procedures against unlicensed local factories and warehouses for cosmetics as of 12 Rabie Thani 1436 H, corresponding to 1 February Accordingly, we hope that you will circulate this information to the concerned, in order to start licensing procedures for their facilities. For more information about licensing factories and warehouses of cosmetics, please visit the Authority's website at: Thanks to all for your cooperation, Vice President of Drug Affairs /signed/ Dr. Ibrahim bin Abd Al Rahman Al Jaffali 3292 Northern Ring Rd Al Nafal District Riyadh Kingdom of Saudi Arabia. Tel: Fax: Page 4 of 65

6 SFDA CIRCULAR- MANDATORY INCLUSION PLAN OF COSMETIC PRODUCTS (ECOSMA) (IN ARABIC LANGUAGE) Page 5 of 65

7 Page 6 of 65

8 SFDA CIRCULAR- MANDATORY INCLUSION PLAN OF COSMETIC PRODUCTS (ECOSMA) (IN UNOFFICIAL ENGLISH TRANSLATION) In the name of Allah, All-Merciful, Ever-Merciful Kingdom of Saudi Arabia Saudi Food & Drug Authority (255) Drug Sector "Circular" Subject: Mandatory Inclusion Plan of Cosmetic Products Circular no. : 6395/A, date: 24/2/1436 H Copy to His Excellency Secretary General of the Council of Saudi Chambers of Commerce (May Allah grant him safety) Factories and importers of cosmetics Managers of drug and cosmetics warehouses May the peace and mercy of Allah be upon you, The Authority is beginning to implement mandatory e-inclusion on locally manufactured and imported cosmetic products, based on the type of product, as of 12 Jumada Akhira 1436 H, corresponding to 1 April 2015, according to the schedule attached to this circular. This announcement comes in reference to the commencement of work with the electronic inclusion system for cosmetics products (ecosma), launched on 28 Dhul Hijja 1435H. It also takes into account the familiarization of new users with these systems together with the facilitation of the system s mandatory implementation. Noting that, all companies can apply for inclusion for their products from now, during the non-mandatory period. Factories and warehouses for local cosmetics products shall also be obliged to obtain license from the Authority for inclusion of their products. Accordingly, we hope that you circulate this to those concerned, so that they may schedule the start of their products inclusion, noting that the products included during 2015 shall be exempted from any product inclusion fees. Furthermore, we would like to inform you that the sector will organize workshops to introduce the system during the coming period. There will be an attached circular in this regard. For any inquiries about the inclusion of cosmetic products, please contact the management on the following switches: (5737, 5188, 5116) Thanks to all for your cooperation, Vice President of Drug Affairs /signed/ Dr/ Ibrahim bin Abd Al Rahman Al Jaffali 3292 Northern Ring Rd Al Nafal District Riyadh Kingdom of Saudi Arabia. Tel: Fax: Page 7 of 65

9 Page 8 of 65

10 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.1) Page 9 of 65

11 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.2) Page 10 of 65

12 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.3) Page 11 of 65

13 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.4) Page 12 of 65

14 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.5) Page 13 of 65

15 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.6) Page 14 of 65

16 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.7) Page 15 of 65

17 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.8) Page 16 of 65

18 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.9) Page 17 of 65

19 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.10) Page 18 of 65

20 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.11) Page 19 of 65

21 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.12) Page 20 of 65

22 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.13) Page 21 of 65

23 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.14) Page 22 of 65

24 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.15) Page 23 of 65

25 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.16) Page 24 of 65

26 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.17) Page 25 of 65

27 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.18) Page 26 of 65

28 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.19) Page 27 of 65

29 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.20) Page 28 of 65

30 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.21) Page 29 of 65

31 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.22) Page 30 of 65

32 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.23) Page 31 of 65

33 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.24) Page 32 of 65

34 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.25) Page 33 of 65

35 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.26) Page 34 of 65

36 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.27) Page 35 of 65

37 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.28) Page 36 of 65

38 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.29) Page 37 of 65

39 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.30) Page 38 of 65

40 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.31) Page 39 of 65

41 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.32) Page 40 of 65

42 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.33) Page 41 of 65

43 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.34) Page 42 of 65

44 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.35) Page 43 of 65

45 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.36) Page 44 of 65

46 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.37) Page 45 of 65

47 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.38) Page 46 of 65

48 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.39) Page 47 of 65

49 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.40) Page 48 of 65

50 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.41) Page 49 of 65

51 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.42) Page 50 of 65

52 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.43) Page 51 of 65

53 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.44) Page 52 of 65

54 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.45) Page 53 of 65

55 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.46) Page 54 of 65

56 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.47) Page 55 of 65

57 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.48) Page 56 of 65

58 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.49) Page 57 of 65

59 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.50) Page 58 of 65

60 COSMETIC PRODUCTS NOTIFICATION SYSTEM (ECOSMA) USER GUIDE IN ARABIC AND ENGLISH LANGUAGES (PG.51) Page 59 of 65

61 SFDA CIRCULAR ON COSMETICS PACKAGING (IN ARABIC LANGUAGE) Page 60 of 65

62 SFDA CIRCULAR ON COSMETICS PACKAGING (IN UNOFFICIAL ENGLISH TRANSLATION) Kingdom of Saudi Arabia Saudi Food & Drug Authority Circulated by fax Circular no / ع Dated: 28/7/1435 H 27/5/2014 G His Excellency President of the Council of Saudi Chambers of Commerce Copy with regards to His Excellency / Director General of Customs Managers of Cosmetic Factories and Warehouses Peace be upon you, In the course of the Saudi Food & Drug Authority efforts represented by the drug sector to ensure the safety of cosmetic products, and as illustrated by GSO 1943/2009 for safety requirements, in Article (5.1) cosmetic products should be reserved in a clean, proper, and well-sealed container, and Article (4.2) it should not cause any harm when used in normal circumstances. Due to some wrong practices observed in shopping places where they open the cosmetic products for trial by consumers and return to the shelf what can cause the possibility to be contaminated when used by another person. Hence, we request from cosmetic products manufacturers and importers to abide by the followings: Put plastic wrap or transparent on or inside the product to ensure that the cosmetic products are to be opened only by the consumer (Appendix 1 for clarification). So we hope that all companies and organizations trading with cosmetic products to comply with this recommendation when importing. A deadline of one year will be provided in order to implement it on all cosmetic products marketed in the Kingdom. Please accept my sincere greetings and appreciation Executive Vice President of the pharmaceutical sector A.D. Saleh Bin Abdul Bawazeer Exhibit (1) Table shows the cosmetic products that require protective casing to prevent using it by more than one person in accordance to GSO 1943 for the safety of cosmetic products. Page 61 of 65

63 EXHIBIT - COSMETIC PRODUCTS THAT REQUIRE PROTECTIVE CASING Page 62 of 65

64 SFDA SUPPLEMENTARY CIRCULAR ON COSMETICS PACKAGING (IN ARABIC LANGUAGE) Page 63 of 65

65 Page 64 of 65

66 SFDA SUPPLEMENTARY CIRCULAR ON COSMETICS PACKAGING (IN UNOFFICIAL ENGLISH TRANSLATION) Page 65 of 65

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