Nemko s compliance & market access seminar 2018

Transcription

1 Nemko s compliance & market access seminar

2 Technical Regulation in the Eurasian Economic Union and Belarus Konstantin Prokhorenko (International Certification) BELLIS Testing and Certification NEMKO, Oslo

3 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

4 Contents EAEU overview

5 Eurasian Economic Union from (former Custom Union ) The Member States of the Eurasian Economic Union are: Belarus Kazakhstan Russia Armenia (since 2 January 2015) Kyrgyzstan (since 12 August 2015) Unified Technical Regulation System: Technical Regulations (similar to EU Directives) 1 EAEU Certificate access to 5 EAEU Member States EAEU Conformity Mark

6 Forms of Conformity Approval: CoC/DoC List of products subject to conformity approval EAEU TR 004/2011 Safety, TR 020/2011 EMC LIST of products subject to conformity approval in the form of CERTIFICATION Products beyond the List 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)

7 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, New List of standards includes the follow standards which are the most frequently used: All applicable Standards must be listed in EAC CoC/DoC! GOST IEC (IEC :2013); OFF GOST IEC (IEC 60065:2011); TRON STB IEC (IEC :2010); HOUS GOST IEC (IEC :2013); HOUS GOST IEC (IEC :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.

8 Eurasian Economic Union Technical Regulations Electromagnetic fields (EMF) requirements are included in the New List of standards and mandatory from November 26, GOST IEC (IEC 62311:2007); GOST IEC (IEC 62479:2010) electrical and electronic equipment; GOST IEC (IEC 62493) lighting equipment; GOST EN (EN 62233:2008) household appliances. Standards IEC and IEC cover all electronic and electric equipment (which are subjected of EAEU TR 004/2011). IEC 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 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 calculation. 8

9 Contents Conformity approval in EAEU New Unified Requirements (ROHS, Medical)

10 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

11 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 to

12 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 Unified Rules were expected to come into force and can be used to enter the EAEU Market. Transitional period until (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

13 Current status of EAEU Tech Regulation system 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 )

14 Contents Belarus National Requirements

15 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 Heavy pressure on Belarus and EU Delegation in Belarus - EAEU unified EE requirements are expected to be implemented in around 5 years

16 Levels of Technical Development and Cooperation with International and European Organizations Country IEC CENELEC IECEE Belarus Russia Full membership Full membership Affiliated member 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) MB, FSB, NCB, CBTL, CTF MB, NCB, CBTL Number of issued CB Certificates Number of recognized CB Certificates in (0 in 2017) 494 (0 in 2017) Kazakhstan Associated membership Suspended Armenia Kyrgyzstan

17 IECEE CB Recognition

18 Belarusian National Differences. Resolution No Mandatory requirements for Energy Efficiency, Radio/Telecom and certain types of cables are introduced in Belarus in 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 and 156 dated ) ( 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 Resolution No STB CERTIFICATE BELARUSIAN MARKET

19 Contents Belarusian National Requirements Energy Efficiency

20 Belarus National Differences. Energy Efficiency Mandatory implementation dates of Energy Efficiency/Energy Labelling 1 st September, 2017: 3.7. External power sources 4. Single-speed asynchronous (induction) three-phase electric motors. 1 st July, 2018: most product categories 1 st January, 2019: TV sets/tv monitors, microwave ovens

21 Belarusian National Differences. Energy Efficiency

22 Belarusian National Differences. Energy Efficiency

23 Belarusian National Differences. Energy Efficiency

24 Sample of BELARUS EE Certificate (EE STB) for EPS

25 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 (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)

26 Belarusian National Requirements. Energy Efficiency Applicant National Accredited Certification Body Factory Inspection Testing Factory Inspection by National Accredited Certification Body Market Surveillance Factory Inspection by Accredited Certification Body within EAEU Unified Register of Certification Bodies Surveillance control by National Certification Body (1 time every 18 months) National Certification Body Testing Laboratory Accredited to ISO/IEC Testing Laboratory Until Manufacturer s Testing Laboratory (with documented evidence of compliance with technical competence according to ISO/IEC 17025)

27 Contents Belarusian National Requirements Telecommunication equipment

28 Belarusian National Differences. Telecommunication Equipment Each EAEU Member state has its own national radio/telecom requirements. Unified requirements will not be developed soon. Subject to mandatory telecom requirements in Belarus (mandatory from / ) : radio/telecom apparatus including those being a part of other devices. (e.g.: notebook, tablet with built-in telecom modules) Mobile phones, broadband access modules (Wi-Fi, Bluetooth) will fall under Mandatory approval procedure List of products subject to BELARUS Telecom certification/declaration procedure see Annex to Resolution # 849, Section 10 ( Declaration Procedure can be always replaced by Certification procedure Issuing a National Declaration can only be done by a legal entity registered in Belarus TELECOM STB EMC SAFETY CU TR 004/2011 EAC CU TR 020/2011

29 Belarusian National Differences. Radio/Telecom List of objects for mandatory Radio/Telecom conformity assurance in Belarus: A.1. Radio/Telecom requirements are mandatory in Belarus from 1 st February, 2017 for the following products: 10. Telecommunication devices: Telecommunication devices functioning as data transmitting systems: packet switching and routing equipment; equipment for data-communication network security; equipment of network services; equipment for data network resources access aggregation and management; equipment for voice, video and multimedia information transmission via data communication network except for end-user equipment Telecommunication devices functioning as digital transport systems: equipment for digital transmission systems of plesiochronous digital hierarchy; equipment for digital transmission systems of synchronous digital hierarchy; multifunction channel forming equipment enabling flexible configuration; equipment for optical transport network Telecommunication devices functioning as switching and service management systems: private and production automatic branch exchange systems; softswitches (controlled); media gateways; signaling gateways; media gateway controllers; proxy servers, forwarders, registration servers Telecommunication devices functioning as digital TV-radio signals generator, encoder, decoder, multiplexer, converter, transmitter and receiver: encoders; decoders used at communication stations; head-end stations Communications electronics: Radio equipment for radio link communication Fixed transmitters, rebroadcasting and digital TV transmitters Base stations and mobile radiocommunication system transponders Signal converters for data transfer via switched channels and unswitched signaling channels, including those incorporated in any other equipment, modems, fax-modems Telecommunication devices functioning as digital transport systems: equipment for optical channels spectral multiplex; transmission media converters

30 Belarusian National Requirements. Radio/Telecom List of objects for mandatory Radio/Telecom conformity assurance in Belarus:..continued (mandatory from ) Telecommunication devices functioning as switching and service management systems; Subsystem core equipment for multimedia services based on Multimedia Subsystem (IMS); application servers; equipment for video- and audio conferences monitoring and control Telecommunication devices used for subscriber access networking: equipment for wire digital subscriber access; equipment for Ethernet networks access, including Ethernet media converters; passive optical network equipment Subscription stations Radio transmitters of all categories and purposes not elsewhere classified in sub-items 10.5, hereof

31 Belarusian National Requirements. Radio/Telecom List of objects for mandatory Radio/Telecom conformity assurance in Belarus: A.2. Radio/Telecom requirements are mandatory in Belarus from 1 st May, 2017 for the following products: 10. Telecommunication devices: Telephone receivers of all types, coin telephones and other appliances, which can be connected to subscriber loops, and functioning via dialing number and transmitting and receiving voice messages Document electric communication terminals, including those incorporated in any other equipment, fax machines, fax boards End-user terminals for mobile cell systems including radio modules incorporated in other equipment Radio equipment of DECT standard, including radio modules incorporated in other devices Broadband wireless access equipment, including radio modules incorporated in other equipment (such as Bluetooth, WiFi) Form of Approval Certification or Declaration depending on the product see the annexed List here The customer can choose to order Certification (preferred by most Belarus vendors) instead of Declaration. In case of Certification a foreign manufacturer can be the Applicant, no local/authorized representative needed. For Declaration a local Belarus authorized representative is a must.

32 Belarusian National Requirements. Telecommunication Equipment

33 Belarusian National Requirements. Radio/Telecom New Belarus Radio/Telecom Technical Regulation is being developed which will substitute the requirements in acc. with Resolution 849. It is expected that the new Telecom TR will be approved within a few months. This national mark shall be used when the Belarus Radio/Telecom TR will come into force

34 Contents Belarusian National Differences High voltage cables

35 Belarusian National Requirements. High-voltage cables Safety requirements to Electric cables designed for more than 1000 V AC and 1500 V DC are mandatory in Belarus from February 1 st 2017 GOST (IEC , IEC ) GOST (IEC , IEC ) GOST Сables subject to BELARUS declaration procedure. See Annex to Resolution # 849, Section 5 ( Declaration Procedure can be always replaced by Certification procedure Issuing a National Declaration can only be done by a legal entity registered in Belarus

36 Contents Market Surveillance

37 Market Surveillance Over 1000 electrotechnical products selected from the market and tested in Belarus in Jan-Dec 2017 Over 75% of non-complying products (over 95% of them certified by Russian Certification Bodies) Over 300 Russian Certificates have been cancelled in Belarus. (Gosstandart of Belarus has the right to cancel at its territory a Certificate from any EAEU country) Information officially published in Registers by Gosstandart:

38 Market Surveillance In course of analysis of the market surveillance activity results, a range of certification bodies accredited in the Russian Federation have been identified which issue CU EAC Conformity Approvals connected with facts of supplying dangerous products to the territory of Belarus. Belarus government informed Russian Government about the violators: GARANT PLUS Ltd. (Moscow), Accreditation Certificate No.: РОСС RU АЛ16; 36 Certificates and 2 Declarations cancelled (electrotechnical products) Sertifikatsiya productsii STANDART-TEST Ltd. (Moscow), Accreditation Certificate No.: RA.RU.11АВ24, 12 Certificates cancelled (electrotechnical products) "ROSTEST-Moscow" CJSC Regional Body for certification and testing (Moscow), Certificate of Accreditation No.: RU АЯ46, 10 Certificates cancelled (electrotechnical products and clothing) Certifikatsia i ekspertiza" (Moscow), Certificate of Accreditation No.: РОСС RU АУ04, 9 Certificates cancelled (electrotechnical products and furniture).

39 Networks of improper CBs/TLs identified in Russia Violating Certification Bodies and Local Representatives connected with them

40 Market Surveillance Catastrophic results revealed during market surveillance Consumer safety affected Billions of $ being taken out of country No chance for development of national industry due to unfair competition Belarus informed Russian Government about the results Measures are being defined on the highest governmental level. Measures will be severe. What is being done by Eurasian Economic Union Officials?

41 Market Surveillance. Current Status Enforcement Measures Issuing bans on import and/or circulation of dangerous products in Belarus; Forwarding copies of such bans to national-level authorities including customs authorities, to prevent imports and/or circulation of such products in Belarus; Cancelling of validity of conformity assessment documents in Belarus. If they are issued by other EAEU Member State, the cancellation decision is communicated to Gosstandart for informing the Eurasian Economic Commission and relevant authorities of the issuing EAEU Member State; Issuing orders to respective manufacturers (suppliers, vendors, importers) to withdraw dangerous products from the market/circulation; Imposing fines up to 200 % of the sold products' price or at least 200 basic units (2000$); if the price is unidentifiable from 200 (2000$) to 500 (5000$) basic units.

42 Current status of EAEU Tech Regulation system Absence of unified technical regulation system = basis for corruption. All levels affected/involved. Multibillion losses for the Member Countries Problems at the Russian Customs A key element in the corruption chain Local Representatives for EAEU certification. Acc. to EAEU Treaty/TRs a Local Representative can be only the company that puts products on the Market. Local representatives in the majority of EAEU Certificates do not put products on the market (e.g. R-Group) = violation of the EAEU Treaty/TRs = risk of certificate cancellation.

43 Contents EAEU Certificates acceptance at Russian Customs

44 Russian Customs issues Problems at Russian Customs in 2017 result of absence of EAEU Technical Regulation System March 2017 problem started. Officially the problem has been resolved with Decision 20 dd adopted by five First vice prime Ministers of 5 EAEU Member States at the platform of EAEC Council) Decision of EAEC Council No. 20 dd obliges Russian Customs to accept EAEU Certificates issued in Armenia, Belarus, Kazakhstan, Kirgizia in electronic declaring mode without requiring any additional documents.

45 Russian Customs issues Situation at the Russian Customs Declarant Broker Russian Customs Rosaccreditation

46 Russian Customs issues Situation at the Russian Customs Ed 2.0 New Initiative of Rosaccreditation and Federal Customs Service of Russia dated ( Recommendation letter on customs control after Russian Certificates more strict) Requesting additional documents to prove that a Russian Certificate was issued based on local tests in Russia (e.g. customs invoice confirming that the test sample was imported to Russia; docs confirming that the test sample was locally tested). Question: isn t it easier just to stop accrediting thousands of Certification Bodies and Test Laboratories that do not have any relevant experts/infrastructure/test equipment?

47 Local Representatives in EAEU Certificates Indicating in the EAEU Certificate of a manufacturer (including a foreign manufacturer) as an Applicant is correct. But also it is allowed ( may be ) for local authorized representative to be the Applicant for certification. However, if an authorized representative is used as an Applicant for certification, it s needed to ensure that a proper authorized representative is used, in particular it must be an importer and release products into circulation to the EAEU market (including performing customs clearance of products) see requirements set forth to authorized representative in the EAEU Treaty (cl. 2 of Annex IX Protocol on Technical Regulation in EAEU): representative authorized by manufacturer registered in accordance with the legislation of the Member State at its territory legal entity or physical person as an individual entrepreneur, which, based on the contract with the manufacturer, including the foreign manufacturer, ensure actions on his behalf during conformity assessment AND releasing products into circulation of the Union market, as well as bear responsibility for noncompliance of products to the requirements of the Union Technical Regulations.

48 Local Representatives in EAEU Certificates Accordingly certificates with improper local representative fall under the risk of non-acceptance not only in Russia but also other EAEU Member States. An example of such local representative is R-GROUP Ltd., a company with founding capital worth of 200$ which is currently a local representative of over 80 manufacturers. Having in the Certificates/Declarations as Applicant of R-GROUP Ltd and local representatives similar to them shall be additional grounding for performing in course of market surveillance of analysis of Certificates/Declarations with respect to complying with conformity approval procedures during their issue/registration.

49 Contents Criteria to Select the Strategic EAEU Certification Partner

50 Strategic Approach *Acceptance and reliability of Certificates on the market is important (situation at the customs it is just the first step). *IECEE Members (NCBs) are allowed to issue EAC Certificates based on IECEE Test Reports * Verification of the EAEU Partner and EAEU Certificates (e.g. standards must be listed in EAEU Certificates from Dec, Most CBs do not indicate EMF as they are not accredited).

51 Strategic Approach Manufacturers and Institutes that choose improper certification bodies/testing laboratories and so called local representatives connected with them as partners they supply them with financial resources which they use to destroy EAEU technical regulation system, create problems for foreign manufacturers and to create conditions for access on the market of lowquality products which displace proper diligent manufacturers from the market. In the end, manufacturers choosing simplified certification procedure in violating certification bodies with improper local representatives trying to herewith save insignificant sums of money receive multi-million losses.

52 Criteria to Select the Strategic EAEU Certification Partner Accreditation. Availability of a competent testing laboratory and required test equipment Strict observance of established procedures (national and EAEU) Partner status: National. Regional. International Integration in international structures including international accreditation International operation experience. According to the Eurasian Economic Commission, CB Certificates/Reports may only be recognized by IECEE NCBs (= certification bodies accredited within the IECEE CB Scheme) Awareness of the current EAEU situation and changes planned Participation in the development of EAEU technical regulation documents Reliability and reputation Review of issued certificates for their compliance with EAEU and national requirements

53 Thank you for your attention! Questions? Will be happy to answer via BELLIS Testing and Certification, Minsk, BELARUS

54 Nemko s compliance & market access seminar