PRESENTATION ON THE SUPPLIER’S DECLARATION OF CONFORMITY (SDoC) IN THE EUROPEAN MARKET BY CHETAN BIJESURE DEPUTY DIRECTOR, FICCI 1
What is SDOC? What is SDOC? One of the Conformity Assessment One of the Conformity Assessment Procedures Procedures Definition of Conformity Assessment Definition of Conformity Assessment 2
Conformity Assessment Conformity Assessment Definition as per WTO TBT Agreement Definition as per WTO TBT Agreement “Any procedure used, directly and indirectly, to Any procedure used, directly and indirectly, to “ determine that relevant requirements in technical determine that relevant requirements in technical regulations or standards are fulfilled” ” regulations or standards are fulfilled Includes, inter inter alia alia : : Includes, Procedures for sampling, testing and inspection Procedures for sampling, testing and inspection Evaluation, verification and assurance of conformity Evaluation, verification and assurance of conformity Registration, accreditation and approval as well as their Registration, accreditation and approval as well as their combinations combinations 3
Types of Conformity Assessment Types of Conformity Assessment Three ways, broadly : Three ways, broadly : First Party Assessment – – by supplier by supplier First Party Assessment (SDOC) (SDOC) Second Party Assessment – – by by Second Party Assessment Customer or its appointee Customer or its appointee Third Party Assessment – – by by Third Party Assessment independent (like ISO) independent (like ISO) 4
Types of Conformity Assessment Types of Conformity Assessment Item First Party Assessment Second Party Third Party Assessment Assessment Confor- Supplier, Manufacturer Customer or Independent mity Appointee Testing Assess- Body/Regulatory ment Party Body Descrip- Manufacturer/Supplier Purchaser’s Assessment by an tion provides written own inspectors Independent assurance of the perform the Technically conformity of its product assessment of Competent Body to specified requirements supplier’s (not under the products and control of buyer or certify seller) Examples EC SDOC for Electrical Aircraft BIS / Spice Board / items manufacturers FDA etc. Motor Vehicles certifying their Certification in US suppliers of components 5
EC SDOC EC SDOC Definition as per submission (G/TBT/W/218) by EC Definition as per submission (G/TBT/W/218) by EC to WTO to WTO “The supplier himself declares conformity of his The supplier himself declares conformity of his “ product with the requirements of the applicable product with the requirements of the applicable legislation without any mandatory third party legislation without any mandatory third party intervention – – neither in design phase nor the neither in design phase nor the intervention production phase of the manufacturing process production phase of the manufacturing process – that would involve product tests according to the that would involve product tests according to the – relevant legislation. SDOC is based on an relevant legislation. SDOC is based on an assessment or test performed by the manufacturer assessment or test performed by the manufacturer himself or any other party” ” himself or any other party 6
EC SDOC EC SDOC EC Council Decision of 22 July EC Council Decision of 22 July 1993 1993 Modules for Conformity Modules for Conformity Assessment Procedures Assessment Procedures Module A (Basic Model) relates Module A (Basic Model) relates to SDOC to SDOC 7
EC SDOC EC SDOC Module A (SDOC) Internal Production Control Module A (SDOC) Internal Production Control Describes procedure whereby the manufacturer Describes procedure whereby the manufacturer or his authorised authorised representative within the representative within the or his community … ….. Declares that the products .. Declares that the products community concerned satisfy the requirements of the concerned satisfy the requirements of the directives that apply to them directives that apply to them Technical Documentation Technical Documentation To be kept for 10 years, at least To be kept for 10 years, at least Covers the design, manufacture and operation of Covers the design, manufacture and operation of the product the product 8
EC SDOC – – Product Coverage Product Coverage EC SDOC Mostly used for products and sectors Mostly used for products and sectors involving a low or medium risk to health, involving a low or medium risk to health, safety & environment safety & environment Not only guided by risk analysis approach but Not only guided by risk analysis approach but also depends on : also depends on : Regulatory and legal infrastructure existing in the Regulatory and legal infrastructure existing in the sector sector Level of commercial confidence Level of commercial confidence Higher risk products – – third third- -party intervention party intervention Higher risk products required through certification body required through certification body 9
EC SDOC – – Product Coverage Product Coverage EC SDOC Certain Categories of products in : Certain Categories of products in : Electrical Equipment Electrical Equipment Machinery Machinery Medical Devices Medical Devices Radio & Telecommunication equipments Radio & Telecommunication equipments Toys Toys Personal Protective Equipment Personal Protective Equipment Recreational crafts Recreational crafts Equipments for use in potentially explosive Equipments for use in potentially explosive atmospheres atmospheres 10
EC SDOC – – Scope Scope EC SDOC Mostly linked to application of Mostly linked to application of harmonised European European harmonised standards standards Deviation from Harmonised Harmonised Deviation from standards entails mandatory standards entails mandatory third- -party intervention party intervention third 11
SDOC – – Effectiveness Effectiveness SDOC In order to be effective In order to be effective Effective product liability laws Effective product liability laws Well developed market surveillance Well developed market surveillance Penalties for false declarations Penalties for false declarations Incentives to encourage suppliers’ ’ compliance compliance Incentives to encourage suppliers Customer redress system Customer redress system 12
Benefits of EC SDOC Benefits of EC SDOC OECD Study 2008 OECD Study 2008 Enabled trade among new countries with EU Enabled trade among new countries with EU (more so in the case of radio & (more so in the case of radio & telecommunication devices, medical devices) telecommunication devices, medical devices) Results are ambiguous in case of machinery Results are ambiguous in case of machinery Imports from non- -OECD countries OECD countries benefitted benefitted Imports from non most - - surprising ?? surprising ?? most Reduces complexity & cost - - ??? ??? Reduces complexity & cost Faster time to market & access to new Faster time to market & access to new products products 13
Concerns of Concerns of Indian Exporters with EU Indian Exporters with EU Lack of Harmonisation Harmonisation of Standards of Standards Lack of Stringent norms – – excessive MRL limits, excessive MRL limits, Stringent norms much beyond international standards much beyond international standards Private Standards (BRC, HACCP, Private Standards (BRC, HACCP, Kosher etc) Kosher etc) 14
EC SDOC – – EC SDOC Issues & Concerns for Indian Exporters Issues & Concerns for Indian Exporters Private Standards Private Standards Fundamental concern is rising private standards Fundamental concern is rising private standards in EU that are out of the scope of SDOC in EU that are out of the scope of SDOC OECD Study 2008 : “ “Abandonment by regulators Abandonment by regulators OECD Study 2008 : rd party of a mandatory requirement for 3 rd party of a mandatory requirement for 3 certification may simply be replaced by a certification may simply be replaced by a rd party certification demand by the market for 3 rd party certification” ” demand by the market for 3 Encourage private certification schemes (e.g. Encourage private certification schemes (e.g. German GS mark continues to be used for German GS mark continues to be used for electrical consumer products) electrical consumer products) 15
EC SDOC – – EC SDOC Issues & Concerns for Indian Exporters Issues & Concerns for Indian Exporters SMEs SMEs More administrative resources required to More administrative resources required to obtain information by exporter (especially obtain information by exporter (especially merchant exporter) merchant exporter) Internal technical expertise, facilities and Internal technical expertise, facilities and test required test required Non- -transparent regulations could further transparent regulations could further Non complicate process for SMEs SMEs complicate process for 16
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