Sufyan Al-Irhayim, Ph.D. Director, Conformity Assessment, GSO 16 May, 2017 sufyan@gso.sa

1. Sufyan Al-Irhayim, Ph.D. Director, Conformity Assessment, GSO16 May, 2017 sufyan@gso.org.sa GSO and its Technical Regulations on the Restriction of the Use of Certain Hazardous Substances (RoHS)

2. Content

4. GSO is a not-for-profit organization that serves as an “Umbrella Organization” for the GCC Standards, Conformity Assessment and Metrology systems.

5. GSO Strategy Deployment • Aim at achieving free circulation of products through: • Removal of technical barriers to inter- and intra-GCC trade • deriving from national technical regulations (mandatory standards), testing, and certification procedures. • And consumers protection through: • Setting up the essential requirements to safety and security • and providing effective technical tools to translate them technically and to attest conformity to them.

6. Strategic Objectives • Meeting GCC economic development needs of the GCC Custom Union & Common Market • via a regional approach (conformity assessment, metrology and accreditation). • Capacity building. • Participation of all stakeholders. • Spreading “Standardization” awareness. • Building and implementation of sound standardization infrastructure & practices. • Positive participation in various international forums & activities (i.e. ISO’s TC…)

7. GSO Main Functions

8. GSO Achievements GSO in brief Building an integrated system compatible with international regulations and practices and with the WTO provisions Developing the GCC Regulatory System for Control of Products Set up joint technical committees to develop and harmonize Gulf standards and technical regulations The establishment of technical committees in the area of conformity assessment Establishing the Gulf Association for Metrology Establishing the GCCLAB Establishing the GSO Training Center Establishing the Gulf Accreditation Center (GAC)

9. Quality Infrastructure Elements GSO Quality Infrastructure System Enforcement: Market Surveillance – Information Exchange … Technical Regulations Standards Metrology Inspection Testing Certification Conformity Assessment Accreditation Policies / Institutions / Legal framework

10. GCC Technical Infrastructure Common Legal Frame Work GCCLAB Technical outcomes that society can trust, and make risk management and investment decisions on

11. Stakeholders involvement Stakeholders involvement in GSO activates

12. Standardization Activities in GCC

13. RCAS Study

14. GCC Conformity Assessment Scheme Regional Conformity Assessment Scheme (RCAS)

15. Institutions • Gulf Committee for Conformity Assessment • technical regulations development • General Committee for Standardization • responsible for standards development • Interface procedure • to ensure effective coordination leading to a gradual change frommandatory to voluntary standards

16. GCC Committee for Conformity Assessment GCCA

17. Legal Framework • Comprises legal instruments for: • Defective products liability, • General Requirement for Safety of products, and respective responsibilities of Economic Operators, • Respective roles of Government and others CABs • Market Monitoring procedures • Ongoing work is leading to a single law on : • "Safety of Manufactured Products"

18. Two parts of compliance monitoring system • PRE-MARKET ASSESSMENT • Products must fulfil essential requirements. • Responsibility of the manufacturer (or importer) • POST-MARKET CONTROL • Member States ensure that products in their markets are compliant • MSA conduct market surveillance

19. Approach to Conformity AssessmentRole of Manufacturer • Manufacturer (or authorised representative) is responsible for conformity, therefore: • He shall use defined CAPs, • Most CAPs need the intervention of third-party Conformity Assessment Bodies. • He is free to choose any suitable Notified Body, including those in the country of origin.

20. CAP - Role of Producers • To determineapplicable TRs and CAPs • To choose suitablenotified body (if applicable) • To conductapplicable CAP • To draw up the Technical File • To issue the GCCdeclaration of conformity • Affix the GCC conformity mark • Free putting and circulation of products within the single market

21. Technical Regulations • Horizontal TRs applicable to all types of products or risks: • General Safety of Products, • GCC Conformity Mark, • Notified Bodies • Other TRs applicable to specific types of products or risks: • Toys • Low Voltage Electric Products • Or TRs applicable to a specific product or risk: • Barley malt • Motor vehicles-Speed limiters: Technical requirements.

22. Technical Regulations Cosmetics Toys Safety Regulation (Guidance) Low Voltage Equipment Construction materials Machinery Gulf Conformity Mark 18 Technical Regulations by the end of 2020

23. Action plan for 2016-2020 Sectors of priority

24. GSO-TR onthe Restriction of the use of certain Hazardous Substances

25. Ongoing Work Working Group from specialists in Member States Electronic Forum for exchanging views First draft prepared by Public Authority of Industry of Kuwait Based on EU Directive on Restriction of the use of certain Hazardous Substances in Electrical and Electronic Equipment

26. Large household appliances. Small household appliances. IT and telecommunications equipment. Consumer equipment. Lighting equipment. Electrical and electronic tools. Toys, leisure and sports equipment. Medical devices. Monitoring and control instruments including industrial monitoring and control instruments. Automatic dispensers. Other Electrical and Electronic Equipment (EEE) not covered by any of the categories above. SCOPE

27. The Restriction of the use of certain Hazardous Substances • The scope doesn’t include: • Equipment for the protection of the security of Member States, including arms, munitions and war material intended for military purposes; • Equipment designed to be sent into space; • Equipment which is part of another equipment that does not fall within the scope of this Directive; • Large-scale stationary industrial tools; • Large-scale fixed installations; • Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;

28. The Restriction of the use of certain Hazardous Substances • The scope doesn’t include: • Non-road mobile machinery made available exclusively for professional use; • Active implantable medical devices; • Photovoltaic panels; • Equipment specifically designed for research and development.

29. Conformity Assessment Technical file, treaceability Manufacturer Manufacturing process monitoring Internal Production Control G marking – DoC - traceability

30. Market Monitoring • Member States to develop and monitor: • Complaints & accidents • Market surveillance • Risk assessment and information exchange • Data bases • Products, producers, importation operations…

31. The Restriction of the use of certain Hazardous Substances The draft will include the following: Maximum concentration tolerated for hazardous substances in EEE Obligations of Manufacturers Obligations of Authorized Representatives Obligations of Importers Obligations of Distributors

32. The Restriction of the use of certain Hazardous Substances Identification of economic operators Conformity Assessment Procedure Gulf Conformity Mark GSO declaration of conformity Presumption of conformity

33. The Restriction of the use of certain Hazardous Substances • Market surveillance and controls of EEE entering the GSO market Applications exempted from the restriction (For example): • Mercury in single capped (compact) fluorescent lamps not exceeding (per burner): For general lighting purposes < 30 W: 5 mg • Lead in glass of fluorescent tubes not exceeding 0,2 % by weight

34. The Restriction of the use of certain Hazardous Substances Applications exempted from the restriction specific to medical devices and monitoring and control instruments (For example): Lead, cadmium and mercury in detectors for ionising radiation Cadmium in X-ray measurement filters

35. Thank you WWW.GSO.ORG.SA @GSO_ORG_SA Dr. Sufyan Al Irhayim sufyan@gso.org.sa