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Nemko's Compliance & Market Access Seminar 2018 Nemko’s compliance & market access seminar 2018 1 Technical Regulation in the Eurasian Economic Union and Belarus Konstantin Prokhorenko (International Certification) BELLIS Testing and Certification NEMKO, Oslo 11.06.2018 Contents ► EAEU Technical Regulation System overview ► New requirements in EAEU → New Technical Regulations (RoHS, Medical) ► Belarusian National Requirements (Resolution 849) → Energy Efficiency → Telecommunication equipment → High voltage cables ► Market surveillance ► Acceptance of EAEU Certificates by Russian Customs ► Criteria to Select the Strategic EAEU Certification Partner Contents EAEU overview Eurasian Economic Union from 01.01.2015 (former Custom Union 2010-2014) Unified Technical Regulation System: Technical Regulations (similar to EU Directives) 1 EAEU Certificate – access to 5 EAEU Member States The Member States of the Eurasian Economic Union are: Belarus EAEU Conformity Mark Kazakhstan Russia Armenia (since 2 January 2015) Kyrgyzstan (since 12 August 2015) Forms of Conformity Approval: CoC/DoC List of products subject to conformity approval EAEU TR 004/2011 Safety, TR 020/2011 EMC Products beyond LIST of products the List subject to conformity approval in the form of CERTIFICATION Declaration Procedure Declaration Procedure can be always replaced by Certification procedure Issuing a EAEU Declaration can only be done by a legal entity registered in a EAEU Member country (manufacturer's authorized company based on the contract with the manufacturer specifying rights to declare and relevant responsibility) Eurasian Economic Union Technical Regulations EAEU TR 004/2011 covers the low-voltage equipment with rated voltage from 50 up to 1000 V a.c. and from 75 up to 1500 V d.c. New List of standards of EAEU TR 004/2011 is mandatory from November 26, 2016. New List of standards includes the follow standards which are the most frequently used: → GOST IEC 60950-1-2014 (IEC 60950-1:2013); OFF All applicable → GOST IEC 60065-2013 (IEC 60065:2011); TRON Standards must be → STB IEC 60335-1-2013 (IEC 60335-1:2010); HOUS listed in EAC CoC/DoC! → GOST IEC 60335-1-2015 (IEC 60335-1:2013); HOUS → GOST IEC 62368-1-2014 (IEC 62368-1:2010) - Safety of IT & AV equipment. New List of standards also cover Photobiological Safety of Lamps and Lamps Systems according to IEC 62471, mandatory requirements in end-product standards will be introduced with adoption of the latest editions of IEC stds. Eurasian Economic Union Technical Regulations • Electromagnetic fields (EMF) requirements are included in the New List of standards and mandatory from November 26, 2016. → GOST IEC 62311-2013 (IEC 62311:2007); → GOST IEC 62479-2013 (IEC 62479:2010) – electrical and electronic equipment; → GOST IEC 62493-2014 (IEC 62493) – lighting equipment; → GOST EN 62233-2013 (EN 62233:2008) – household appliances. Standards IEC 62311 and IEC 62479 cover all electronic and electric equipment (which are subjected of EAEU TR 004/2011). IEC 62311 covers electronic and electric equipment (0 Hz to 300 GHz) for which no dedicated product or product family standard regarding human exposure to electromagnetic fields applies. IEC 62479 covers low-power electronic and electric equipment (10 MHz to 300 GHz). Equipment which does not contain radio transmitters is inherently compliant with the applicable EMF exposure levels. Therefore Declaration can be provided. For equipment which contains radio transmitters EMF test report should be provided. Test report or other document should contain name of applied method and 8 calculation. Contents Conformity approval in EAEU New Unified Requirements (ROHS, Medical) Development Perspectives for the Technical Regulation Systems. Energy Efficiency/Energy Labelling EAEU Technical Regulation on Energy Efficiency/Energy Labelling has not been developed Will take a few more years to develop. It’s implementation may be expected in around 4-5 years Development Perspectives for the Technical Regulation Systems. RoHS EAEU Technical Regulation on the Restriction of Use of Hazardous Substances in Electrotechnical, Radio and Electronic Products has been approved Conformity approval procedure – mandatory Declaration (could be replaced by certification procedure) ➢ This EAEU TR 037/2016 requirements are harmonized with EU Directive 2011/65/EU - RoHS Enforcement date of RoHS EAEU TR 037/2016 has been postponed from 01.03.2018 to 01.03.2020 Development Perspectives for the Technical Regulation Systems. Medical Equipment ➢ Test rules regarding to the biological effect of medical devices were adopted: Decision #38 dated 16 May 2016 of the Council of Eurasian Economic Commission ➢ Unified Rules for market access of medical products to the EAEU Member Countries have been developed: Decision #46 dated 12 February 2016 of the Council of Eurasian Economic Commission ➢ 01.01.2017 – Unified Rules were expected to come into force and can be used to enter the EAEU Market. Transitional period until 31.12.2021 (National systems currently valid can be used until this date to enter national markets) .➢ Leadtime for medical products registration procedure: 6 – 12 months (registration procedure performed by Authorized Bodies defined in each Member country of EAEU. In Belarus – Ministry of Health) ➢ Mandatory labeling for EAEU Market access Current status of EAEU Tech Regulation system 2010 – 2018 What is done: 1 Technical Regulations 2. EAEU Treaty Missing: 1. Unified Rules and Procedures. 2 Unified accreditation approaches. 3 Peer Assessments 4 Proficiency testing Program 5 …. *CONCLUSION: unified technical regulation system in EAEU has not been created *EAEU Member States start to enforce their national requirements/protective measures (e.g. Kirgizia…) Contents Belarus National Requirements What is next - Belarus response and decision: to develop National Technical Regulation System (with possible integration) - Energy Efficiency (EE) in Belarus – one example - EAEU unified EE requirements have not been developed by the responsible country (Russia) since 2011. Heavy pressure on Belarus and EU Delegation in Belarus - EAEU unified EE requirements are expected to be implemented in around 5 years Levels of Technical Development and Cooperation with International and European Organizations According to the Eurasian Economic Commission, CB Certificates/Reports may only be recognized by IECEE NCBs (= certification bodies accredited within the IECEE CB Scheme – BELLIS in Belarus, VNIIS in Russia) Number Number Country IEC CENELEC IECEE of issued CB of recognized CB Certificates Certificates 2010-2016 in 2014-2017 Belarus Full Affiliated MB, FSB, 381 4559 membership member NCB, CBTL, CTF Russia Full — MB, NCB, 146 494 membership CBTL (0 in 2017) (0 in 2017) Kazakhstan Associated — — — Suspended membership Armenia — — — — — Kyrgyzstan — — — — — IECEE CB Recognition … Belarusian National Differences. Resolution No. 849. Mandatory requirements for Energy Efficiency, Radio/Telecom and certain types of cables are introduced in Belarus in 2017. This is regulated by the Resolution of the Council of Ministers of Republic of Belarus No. 849 from 21 October 2016 (Amended by Resolution 77 dd. 27.01.2017 and 156 dated 26.02.2018) ( http://www.bellis.by/en/news). Starting from the dates indicated later with respect to Radio/Telecom and Energy Efficiency, EAC Conformity approval covering just applicable EAEU Technical Regulations (Safety and/or EMC) is not sufficient in order to supply/sell electric products to Belarus. Conformity approval (STB Certificate/Declaration) in accordance with Belarus Energy Efficiency/Telecom requirements which is issued by an Accredited Belarus Certification Body is mandatory. EAC CERTIFICATE BELARUSIAN Resolution No. 849. MARKET STB CERTIFICATE Contents Belarusian National Requirements Energy Efficiency Belarus National Differences. Energy Efficiency Mandatory implementation dates of Energy Efficiency/Energy Labelling 1st September, 2017: 3.7. External power sources 4. Single-speed asynchronous (induction) three-phase electric motors. 1st July, 2018: most product categories 1st January, 2019: TV sets/TV monitors, microwave ovens Belarusian National Differences. Energy Efficiency Belarusian National Differences. Energy Efficiency Belarusian National Differences. Energy Efficiency Sample of BELARUS EE Certificate (EE STB) for EPS Belarusian National Requirements. Energy Efficiency Infrastructure created in Belarus. BY requirements harmonized with EU. Revision of National Rules on EE in under development (authorization procedure of third-party test labs and manufacturer test labs is being considered). Third-party test reports are accepted for EE STB Certificates obtained before 01.09.2018 (transitional period). The mandatory procedure is Certification (except for Motors, which is a Declaration of Conformity). Manufacturer shall be the Applicant, no Local Rep is required. STB EE Certificates for all products can be issued already now without waiting the implementation dates. Surveillance procedure: 1 time every 18 months(CIG 023 FIR) Belarusian National Requirements. Energy Efficiency Applicant National Accredited Certification Body Factory Inspection Testing Factory Inspection by Accredited to Factory Inspection Accredited ISO/IEC 17025 by National Certification Body National Testing Laboratory Accredited within EAEU Unified Certification Body Certification Body Register Testing of Certification Bodies Laboratory Until 01.09.2018 Manufacturer’s Testing Laboratory (with documented evidence of Surveillance control by compliance with
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