1

Nemko’s compliance & market access seminar

2018

Technical Regulation in the Eurasian

Economic Union and BelarusKonstantin Prokhorenko (International Certification)

BELLIS Testing and Certification

NEMKO, Oslo 11.06.2018

► 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

Contents

Eurasian Economic Union from 01.01.2015

(former Custom Union 2010-2014)

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

Forms of Conformity Approval: CoC/DoC

List of products subject to conformity approval

EAEU TR 004/2011 Safety, TR 020/2011 EMC

LIST of productssubject to conformity approval in the form of CERTIFICATION

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)

Products beyond

the List

Declaration

Procedure

Declaration Procedure can be always

replaced by Certification procedure

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

→ GOST IEC 60065-2013 (IEC 60065:2011); TRON

→ STB IEC 60335-1-2013 (IEC 60335-1:2010); HOUS

→ 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.

All applicable

Standards must be

listed in EAC CoC/DoC!

8

• 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.

Eurasian Economic Union Technical Regulations

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

calculation.

Conformity approval in EAEU

New Unified Requirements

(ROHS, Medical)

Contents

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

➢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

Conformity approval procedure –

mandatory Declaration (could be

replaced by certification procedure)

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

.➢ 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)

➢ 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)

➢Mandatory labeling

for EAEU Market access

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…)

Current status of EAEU Tech Regulation

system

Belarus

National Requirements

Contents

- 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

What is next

Levels of Technical Development and

Cooperation with International and

European Organizations

Country IEC CENELEC IECEE

Number

of issued CB

Certificates

2010-2016

Number

of recognized CB

Certificates

in 2014-2017

Belarus Full

membership

Affiliated

member

MB, FSB,

NCB,

CBTL,

CTF

381 4559

Russia Full

membership

— MB, NCB,

CBTL

146

(0 in 2017)

494

(0 in 2017)

Kazakhstan Associated

membership

—Suspended

— —

Armenia — — — — —

Kyrgyzstan — — — — —

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)

…

IECEE CB Recognition

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.

Belarusian National Differences. Resolution No. 849.

BELARUSIAN

MARKET

EAC CERTIFICATE

STB CERTIFICATE

Resolution No. 849.

Belarusian National Requirements

Energy Efficiency

Contents

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 National

Accredited

Certification Body

Factory Inspection by

Accredited

Certification Body

within EAEU Unified

Register

of Certification Bodies

National

Certification Body

Testing

Laboratory

Accredited to

ISO/IEC 17025

Testing Laboratory

Until 01.09.2018

Manufacturer’s

Testing Laboratory

(with documented

evidence of

compliance with

technical

competence

according to

ISO/IEC 17025)

Surveillance control by

National Certification

Body (1 time every 18

months)

Market Surveillance

Belarusian National Requirements

Telecommunication equipment

Contents

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

01.02.2017/01.05.2017) : 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

STBTELECOM

EMC SAFETY

EACCU TR

004/2011

CU TR

020/2011

Issuing a National Declaration can only be done by a legal entity registered in Belarus

Declaration Procedure can be always replaced by Certification procedure

List of products subject to BELARUS Telecom certification/declaration procedure see

Annex to Resolution # 849, Section 10 (http://www.bellis.by/en/news)

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 1st February, 2017 for the following products:

10. Telecommunication devices:

10.1. 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

10.2. 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

10.3. 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

10.4. 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

10.5. Communications electronics:

10.5.1. Radio equipment for radio link communication

10.5.2. Fixed transmitters, rebroadcasting and digital TV transmitters

10.5.3. Base stations and mobile radiocommunication system transponders

10.6. Signal converters for data transfer via switched channels and unswitched signaling channels, including those incorporated in any other

equipment, modems, fax-modems

10.9. Telecommunication devices functioning as digital transport systems:

equipment for optical channels spectral multiplex;

transmission media converters

Belarusian National Requirements. Radio/Telecom

List of objects for mandatory Radio/Telecom conformity assurance in Belarus:

…………..continued (mandatory from 01.02.2017)

10.10. 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

10.11. 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

10.13. Subscription stations

10.16. Radio transmitters of all categories and purposes not elsewhere classified in sub-items 10.5, 10.12-

10.15 hereof

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 1st May, 2017 for the

following products:

10. Telecommunication devices:

10.7. 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

10.8. Document electric communication terminals, including those incorporated in any other

equipment, fax machines, fax boards

10.12. End-user terminals for mobile cell systems including radio modules incorporated in other

equipment

10.14. Radio equipment of DECT standard, including radio modules incorporated in other

devices

10.15. 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 http://www.bellis.by/en/news/1226-implementation-dates-of-belarus-energy-

efficiency-3.html 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.

Belarusian National Requirements. Telecommunication Equipment

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

Belarusian National Differences

High voltage cables

Contents

Safety requirements to Electric cables designed for more than 1000 V AC and 1500 V DC are mandatory in Belarus from February 1st 2017

• GOST 16442 (IEC 60502-1, IEC 60502-2)

• GOST 24334 (IEC 60502-1, IEC 60502-2)

• GOST 18410

Сables subject to BELARUS declaration procedure.

See Annex to Resolution # 849, Section 5 (http://www.bellis.by/en/news)

Declaration Procedure can be always replaced by Certification procedure

Issuing a National Declaration can only be done by a

legal entity registered in Belarus

Belarusian National Requirements.

High-voltage cables

Market Surveillance

Contents

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:- http://gosstandart.gov.by/the-register-of-documents-confirming-the-conformity-of-

products-to-requirements-of-technical-regulations-of-the-customs-union,-whose-action-is-terminated-in-the-territory-of-the-republic-of-belarus

- http://gosstandart.gov.by/registers-of-product-bans,-certificates-and-declarations

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.0001.11АЛ16; 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.0001.10АЯ46, 10 Certificates

cancelled (electrotechnical products and clothing)

• “Certifikatsia i ekspertiza" (Moscow), Certificate of Accreditation No.: РОСС

RU.0001.10АУ04, 9 Certificates cancelled (electrotechnical products and

furniture).

Market Surveillance

Violating Certification Bodies and “Local Representatives” connected with them

Networks of improper CBs/TLs identified in Russia

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?

Market Surveillance

Market Surveillance. Current Status

➢ 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.

Enforcement Measures

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.

Current status of EAEU Tech Regulation

system

EAEU Certificates acceptance at Russian

Customs

Contents

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. 28.04.2017 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. 28.04.2017 obliges Russian Customs to accept EAEU Certificates issued in Armenia, Belarus, Kazakhstan, Kirgizia in electronic declaring mode without requiring any additional documents.

Russian Customs issues

Situation at the Russian Customs

Declarant

Broker

Russian Customs

Rosaccreditation

Russian Customs issues

Situation at the Russian Customs Ed 2.0

New Initiative of Rosaccreditation and Federal Customs Service of Russia dated 29.12.2017 (“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?

Russian Customs issues

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 non-

compliance of products to the requirements of the Union Technical

Regulations.

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.

Local Representatives in EAEU Certificates

Criteria to Select the Strategic

EAEU Certification Partner

Contents

*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, 2016. Most CBs do not

indicate EMF as they are not accredited).

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 low-

quality 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.

Strategic Approach

• 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

Criteria to Select the Strategic

EAEU Certification Partner

Thank you for your attention!

Questions?

Will be happy to

answer via

bellis@bellis.by

BELLIS Testing and Certification,

Minsk, BELARUS

54

Nemko’s compliance & market access seminar

2018