technical regulations and standards

Development of Technical regulations and Standards

Folke Hermansson SnickarsAssociate consultant

Ambi Prospect AB, [email protected]

March 2014

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Training on better Gambian regulations and standards

WhyWhy

➢Increased health, safety and sustainability➢Better transparency➢Less trade barriers

➢WhatWhat

➢Technical regulations and standards

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Expected result I

After the training you should be better equipped toAfter the training you should be better equipped to

➢ Address relevant TBT issues falling in your competenceAddress relevant TBT issues falling in your competence

What does that mean? What does that mean?

You should know about You should know about

➢ The difference between Technical regulations and Standards➢ Different Good practices➢ Risk assessment and Regulatory Impact Assessment

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Expected result II

The relation between ● Technical regulations and International standards● International standards and Gambian standards

➢ Where to find existing International standards and information about ongoing international or regional standardisation projects

➢ The concept Reference to standards➢ How to influence on the development of International

standards

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Expected result III

After the present training you are also expected to After the present training you are also expected to do homework on projects relevant to Gambia and do homework on projects relevant to Gambia and selected by you to demonstrate how your new selected by you to demonstrate how your new knowledge is understood and applied in real life.knowledge is understood and applied in real life.

After the training I will be availableAfter the training I will be available

➢ from home for questions and advice,➢ and will return in May to Banjul for listening to presentations of

your work and to give you my feedback.

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Who are we?

Instructor:Instructor:

Folke Hermansson SnickarsFolke Hermansson Snickars

➢ In this project working for the TBT Programme Management Unit in Brussels

➢ In other projects self-employed consultant in Ambi Prospect AB

➢ Foundation : 25 years in SIS-Swedish Standards Institute and ISO

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Which are your expectations?

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Technical Technical regulationsregulations and Standards according to WTO and Standards according to WTO

➢ Legal differences

➢ Differences in purpose, language, promoters, and anchoring

Good PracticesGood Practices

➢ Good Regulatory Practice (GRP)

➢ Code of Good Practice for the preparation, adoption and application of standards (Annex 3 to the TBT Agreement)

➢ Code of Good Standardisation Practise, ISO/IEC 59

Who is developingWho is developing

➢ Technical regulations

➢ Standards

Outline I8

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Outline II

International standards and Technical regulationsInternational standards and Technical regulations

Exploration of International standardsExploration of International standards

Risk assessment (RA) and Regulatory impact Risk assessment (RA) and Regulatory impact assessment (RIA)assessment (RIA)

Reference to Standards in Technical regulationsReference to Standards in Technical regulations

Adoption of International standards as national Adoption of International standards as national standards (ISO/IEC Guide 21)standards (ISO/IEC Guide 21)

Participation in the preparation by international Participation in the preparation by international standardizing bodies of International standardsstandardizing bodies of International standards

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Outline III

Additional requirements in the TBT agreement on Additional requirements in the TBT agreement on preparation, adoption and application of Technical preparation, adoption and application of Technical regulationsregulations

➢ Acceptance of technical regulations of other WTO Members (2.7)➢ Performance and Prescriptive requirements (2.8)➢ Technical regulations not based on international standards (2.9)

Project workProject work

➢ Project selection and preparation of project plan➢ Development of individual Action Plans

Collecting of your reactions to the trainingCollecting of your reactions to the training

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Technical regulations

Technical regulationTechnical regulation is a term used in WTO and is a term used in WTO and EU for EU for bindingbinding regulations issued by public regulations issued by public authorities concerning, for example, what authorities concerning, for example, what characteristics goods are to have and how they characteristics goods are to have and how they are to be tested and labelled in order for them to are to be tested and labelled in order for them to be offered for sale and used.be offered for sale and used.

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Standards

Standard Standard is a term used in WTO and EU for is a term used in WTO and EU for non-non-bindingbinding rules for interoperability of rules for interoperability of complementary products and services, or to complementary products and services, or to provide agreed test methods and requirements provide agreed test methods and requirements for health, safety, organisational and for health, safety, organisational and environmental performance.environmental performance.

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Legal differences between Technical regulations and Standards

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➢ Compliance mCompliance mandatoryandatory: Technical : Technical regulationsregulations

➢ Compliance vCompliance voluntaryoluntary: Standards: Standards

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Other differences between Technical regulations and Standards

➢ PurposesPurposes

➢ LanguageLanguage

➢ AttestationAttestation

➢ PromotersPromoters

➢ AnchoringAnchoring

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➢ PurposesPurposes

➢ Technical regulations implementing national policies and legal framework

➢ Based on risks➢ Standards based on stakeholder needs

➢ To improve quality and productivity (producers and consumers)

➢ To achieve compatibility (trade partners, buyers and sellers)

➢ To satisfy requirements in technical regulations (governments)

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➢ LanguageLanguage

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Requirements shall Technical regulations, standards

Recommendations should Guides, standards

Permissions can Guides, standards

Possibilities may Guides, standards

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Attestation

➢ Testing and Testing and calibrationcalibration

➢ Inspection Inspection

➢ CertificationCertification

➢ Products➢ Mangement

systems➢ Personell

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The ISO/UNIDO Conformity Assessment toolbox

Prepared by the Prepared by the ISO Committee on ISO Committee on Conformity Conformity Assessment (ISO Assessment (ISO CASCO) CASCO)

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PromotersPromoters

➢ Technical regulations ➢ Governments➢ Importers➢ Foreign exporters

➢ Standards➢ Buyers➢ Sellers➢ Producers

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Anchoring and execution

➢ Technical regulations➢ Governments (Ministries and agencies)

➢ Standards➢ Stakeholders (Standards organisations)

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Good Regulatory Practice (GRP)

➢ identify the identify the problemproblem (including its nature and magnitude) (including its nature and magnitude)

➢ consider all the consider all the optionsoptions to address the problem; to address the problem;

➢ if technical regulations are chosen as the preferred option, consider if technical regulations are chosen as the preferred option, consider the the effect on tradeeffect on trade; ;

➢ consider adopting consider adopting performanceperformance based regulations rather than based regulations rather than prescriptiveprescriptive; ;

➢ consider consider consistencyconsistency with international standards; with international standards;

➢ consider consider compliance mechanismscompliance mechanisms; ;

➢ consider providing for the consider providing for the review and monitoringreview and monitoring of the technical of the technical regulation; and regulation; and

➢ ensure that adequate ensure that adequate consultationconsultation takes place. takes place.

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GRP according to WTO

From Devin McDaniels, WTO, June 2013

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Good Regulatory Practice



➢ if technical regulations are chosen as the preferred option, consider the if technical regulations are chosen as the preferred option, consider the effect on tradeeffect on trade; ;






Carry out Risk Assessment

24Risk assessment (RA)

➢ What is the magnitude of the risk and which are its What is the magnitude of the risk and which are its consequences? consequences?

➢ In what circumstances will the risk arise? This includes In what circumstances will the risk arise? This includes considering the chain of events which will lead to the considering the chain of events which will lead to the undesirable event, and the probability of each step in undesirable event, and the probability of each step in that chain occurring. that chain occurring.

➢ How widespread is the risk (e.g. local, national or How widespread is the risk (e.g. local, national or international)? international)?

➢ Which groups or sectors of the economy are most at Which groups or sectors of the economy are most at risk? risk?

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Good Regulatory Practice



➢ if technical regulations are chosen as the preferred option, consider if technical regulations are chosen as the preferred option, consider the the effect on tradeeffect on trade; ;






Carry out Regulatory Impact Assessment

RIA

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RIA according to WTO

From Devin McDaniels, WTO, June 2013

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Regulatory Impact Assessment (RIA)

➢ Define the problemDefine the problem

➢ Set objectivesSet objectives

➢ Assess all feasible optionsAssess all feasible options

➢ Analyse the impacts arising from these Analyse the impacts arising from these options, andoptions, and

➢ Consult with stakeholdersConsult with stakeholders

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Principal elements to be included in a Regulatory Objective

Scope statement Scope statement

Product requirements Product requirements

➢ specified in terms of performance requirements rather than design or descriptive characteristics. Requirements should be limited to relevant aspects and be proportionate to the hazard inherent in a given product

Reference to standards clauseReference to standards clause

Compliance clause Compliance clause

Market surveillance and Protection clause Market surveillance and Protection clause

➢ From the UNECE International Model for Technical Harmonization based on Good Regulatory Practice for the preparation, adoption and application of Technical Regulations via the use of International standards

Code of Good Practice for the preparation, adoption and application of standards

The TBT Agreement lays out in its Annex 3 separate disciplines for “standardizing bodies” ➢ Non-discrimination in standard setting ➢ Avoid unnecessary barriers to trade➢ Use international standards and encourage participation

➢ Ensure transparency and allow consultation➢ Notify acceptance and compliance with, or any withdraw from the Code of Good Practice(Art. 4.2).

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Examples on implementations of the TBT Agreement

Technical Regulations-Recommendations Technical Regulations-Recommendations for their elaboration and enforcement, for their elaboration and enforcement, ITC/PTB Guide 1(2009)ITC/PTB Guide 1(2009)

Code of Good Standardisation Practise Code of Good Standardisation Practise ISO/IEC Guide 59:1994ISO/IEC Guide 59:1994

Guidelines for the preparation, adoption Guidelines for the preparation, adoption and review of technical regulations, APECand review of technical regulations, APEC

Information note on Good Regulatory Information note on Good Regulatory Practice, APEC, 2000 Practice, APEC, 2000

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National adoptions of International standards

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Governments use of International standards in regulation of their national value chains

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Exploration of International standards

Existing standardsExisting standards

➢ NSSN: A National Resource for Global Standards➢ By title, abstract, keyword➢ By document number

➢ Ongoing standardization projectsOngoing standardization projects

➢ www.iso.org➢ www.iec.ch➢ www.codexalimentarius.org

http://www.nssn.org/

http://www.iso.org/iso/home/standards_development/list_of_iso_technical_committees.htm

http://www.iec.ch/dyn/www/f?p=103:6:0#%23ref=menu

http://www.codexalimentarius.org/committees-and-task-forces/en/

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Organisation of national standardisation

Role IRole I

➢ Monitoring and contributing to international and regional developments in standardization on behalf of stakeholders

➢ Providing information on standards and related conformity assessment issues

➢ Raising awareness and promoting the importance of standards and quality infrastructure as tools to improve market access, to transfer technology and to encourage good business practices and sustainable development

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Organisation of national standardisation

Role IIRole II

➢ Conducting appropriate training activities in standardization for staff as well as for stakeholders

➢ Spearheading and coordinating the process of regional and international harmonization

➢ Representing national interests in regional and international standards environment

➢ Developing national standards where needed

➢ Assisting regulators in the development of technical regulations

➢ Complying with WTO requirements

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Tools and services from ISO

My ISO JobMy ISO Job

Joining inJoining in

Fast forwardFast forward

Building trustBuilding trust

Standards work on Standards work on the Webthe Web

Developing talentDeveloping talent

http://www.iso.org/iso/home/store/free_publications.htm#STANDARDS_DEVELOPMENT

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Reference to Standards in Technical regulations

Exclusive reference to standardsExclusive reference to standards

➢ Dated reference

➢ Undated reference

➢ Direct reference

Indicative reference to standardsIndicative reference to standards

➢ application of the standard is urgently recommended, but will always remain voluntary. The preferred type of demonstration of conformity with the regulation is by means of compliance with the requirements of the standard. However, other options are not excluded

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Reference to Standards in Technical regulations

From ITC/PTB Guide 1(2009)

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Adoption of International standards (IS) as national standards (ISO/IEC Guide 21)

Why identical adoptions?Why identical adoptions?

➢ Deviations or redrafting from the source IS that Deviations or redrafting from the source IS that appear insignificant in a regional or national appear insignificant in a regional or national standards, can lead to non-acceptability across standards, can lead to non-acceptability across the border in another countrythe border in another country

➢ A published IS is a known-quantity, almost A published IS is a known-quantity, almost certainly already adopted widely, and almost certainly already adopted widely, and almost certainly adopted in many areas, at both certainly adopted in many areas, at both national and regional levelsnational and regional levels

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Adoption of International standards (IS) as national standards (ISO/IEC Guide 21)

Further argumentsFurther arguments

➢ All users prefer to have something they already recognise and know (from content to ‘look-and-feel’).

➢ A lot of time and effort has already been devoted to developing an IS. It has been subject to (world) wide expert consultation. Why not take advantage of that?

➢ There are other ways to make use of texts without changing the original (e.g. implementation guidelines)

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ISO/IEC Guide 21:2005

Regional or national adoption of International Regional or national adoption of International Standards and other International Standards and other International DeliverablesDeliverables

➢ Part 1: Adoption of International StandardsPart 1: Adoption of International Standards➢ Part 2: Adoption of International Deliverables

other than International Standards

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ISO/IEC Guide 21ISO/IEC Guide 21

providesprovides methods for adoption of International Standards as methods for adoption of International Standards as regional or national standards, regional or national standards,

definesdefines a a system for indicating the degree of correspondence system for indicating the degree of correspondence between International Standards and regional or national between International Standards and regional or national standards standards so as to promote coherence in the way regional or so as to promote coherence in the way regional or national standards bodies adopt International Standards and national standards bodies adopt International Standards and indicate the degree of correspondence with International indicate the degree of correspondence with International StandardStandard

and and contributescontributes thereby to achieving greater thereby to achieving greater uuniformity in the niformity in the indication of both correspondence and deviations among indication of both correspondence and deviations among standards of different countriesstandards of different countries will aid communication, avoid will aid communication, avoid confusion and facilitate trade.confusion and facilitate trade.

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Degrees: Identical Modified Not equivalent

Identifiers: IDT MOD NEQ

Adoption: Yes Yes No

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Identical adoption

A national standard is considered identical to the adopted A national standard is considered identical to the adopted publication when:publication when:

The national standard is The national standard is identical in technical content, structure identical in technical content, structure and wording (or is an identical translation)and wording (or is an identical translation), or, or

The national standard is identical in technical content and The national standard is identical in technical content and structure, but may contain certain minimal structure, but may contain certain minimal editorial changes editorial changes defined in Guide 21defined in Guide 21

andand

The The “vice versa principle” is fulfilled“vice versa principle” is fulfilled, i.e. if an International , i.e. if an International Standard is adopted identically, the two standards (the Standard is adopted identically, the two standards (the International and the adopting) can be substituted for each International and the adopting) can be substituted for each other. In other forms of adoptions, this principle is not fulfilled.other. In other forms of adoptions, this principle is not fulfilled.

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Modified adoption

A national standard is considered to be a modified A national standard is considered to be a modified adoption of a publication under the following adoption of a publication under the following conditions:conditions:

Technical deviations have been introduced but in a Technical deviations have been introduced but in a manner that ensures that they are clearly identified and manner that ensures that they are clearly identified and explained explained in the Foreword, Introduction or in an Annexin the Foreword, Introduction or in an Annex

The national standardThe national standard continues to reflect the structure continues to reflect the structure of the source International Standardof the source International Standard

Changes to the structure of the source are limited and Changes to the structure of the source are limited and made in such a way that an made in such a way that an easy comparison easy comparison of the of the content and structure of the two standards is possiblecontent and structure of the two standards is possible

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Non-equivalent correspondence

A national standard is considered to be not equivalent to a source International Standard publication when:

The national standard is not equivalent to the International Standard in technical content; and structure and the changes have not been clearly identified.

This also can include the case where only a minority in number or significance of the international provisions remain in the national standard

This degree of correspondence does not constitute an adoption.

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Methods of adoption

Endorsement method Endorsement method

(via an endorsement notice+original IS)(via an endorsement notice+original IS)

Re-publication, which includes:Re-publication, which includes:

➢ Reprinting➢ Translation (with or without reprint of the original)➢ Redrafting (Note:no adoption)

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Choice of methods of adoption

No editorial changes or technical deviationsNo editorial changes or technical deviations (“Identical”)(“Identical”)

– Any, but reprint of the full text is the method recommended for those countries whose language is one of the official ISO/IEC languages

Editorial changes or technical deviations are Editorial changes or technical deviations are introducedintroduced

– reprint method or

– the translation method with the incorporation of deviations within the text or in an annex be used.

The The redraftingredrafting of standards is not recommended of standards is not recommended

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Numbering of adoptions I

Numbering of identical adoptionsNumbering of identical adoptions::

““When regional or national standards are When regional or national standards are identicalidentical to to International Standards, this should be evident to the reader International Standards, this should be evident to the reader immediately and not only after examination of the content.immediately and not only after examination of the content.” ”

Two numbering optionsTwo numbering options

➢ Dual numbering

➢ Single numbering

Option 1: Single numberingOption 1: Single numbering: XYZ IEC 61642:1998 (for an : XYZ IEC 61642:1998 (for an identical adoption of IEC 61642) identical adoption of IEC 61642) The acronym for the The acronym for the national standards is added in front of the original reference national standards is added in front of the original reference number of the International Standardnumber of the International Standard

Note: XYZ = Acronym for the standards of a national standards bodyNote: XYZ = Acronym for the standards of a national standards body

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Numbering of adoptions II

Option 2: Dual numbering (sometimes called “two-line Option 2: Dual numbering (sometimes called “two-line dual numbering”):dual numbering”):

XYZ 87878:1998XYZ 87878:1998ISO 13616:1996 ISO 13616:1996 (for an identical adoption of ISO 13616)(for an identical adoption of ISO 13616)

The number is composed of two individual numbers, i.e.The number is composed of two individual numbers, i.e.

➢ A leading national standards number ( XYZ = Acronym

for the standards of a national standards body), followed by

➢ the original number of the International Standard

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Numbering of adoptions III

Numbering of modified adoptions and non-equivalent Numbering of modified adoptions and non-equivalent standardsstandards

Modified Modified adoptionsadoptions onlyonly carry a national number and do not carry a national number and do not include the reference number of the adopted include the reference number of the adopted International Standard.International Standard.

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Dating of standards

Option 1 National adoption dateOption 1 National adoption date

➢ XYZ IEC 61642:1998 (published by IEC in1996)

Option 2 International adoption dateOption 2 International adoption date

➢ XYZ IEC 61642:1996 (published by XYZ in 1998)

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Additional requirements on preparation, adoption and application of Technical regulations

Acceptance of technical regulations of other WTO Members (2.7)

➢ Performance instead of Prescriptive requirements (2.8)

➢ Technical regulations not based on international standards (2.9)

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Prescriptive standards

Define the processes and procedures Define the processes and procedures required to achieve compliancerequired to achieve compliance

Focus on the Focus on the meansmeans by which the by which the objective will be achievedobjective will be achieved

Easier to enforce, but less flexibile and Easier to enforce, but less flexibile and more likely to restrict competition and more likely to restrict competition and inhibit innovationinhibit innovation

Example for a fire door?Example for a fire door?

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Performance standards

Define the Define the outcomeoutcome rather than inputs or rather than inputs or meansmeans

More difficult to enforce, but provide both More difficult to enforce, but provide both flexibility and predictability of outcomesflexibility and predictability of outcomes

Flexibility in in compliance provides Flexibility in in compliance provides incentives for firms to minimize the cost of incentives for firms to minimize the cost of complyingcomplying

Example for the fire door?Example for the fire door?

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Participation in the preparation of International standards

Full member Correspondent member

Full voting rights in any technical & policy committee.

No voting rights

Can use & distribute ISO standards

Can use ISO standards as a basis

Kept fully informed

P - or O - member in technical committees

O - member in technical committees

Can contribute

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Project selection and preparation of Action plan

Select an example of a technical regulation Select an example of a technical regulation (existing or planned) within your area of interest(existing or planned) within your area of interest

Carry out a Risk Assessment and a Regulatory Carry out a Risk Assessment and a Regulatory Impact AssessmentImpact Assessment

Explore if any international standard exist or Explore if any international standard exist or are under preparationare under preparation

Plan your work for the recess periodPlan your work for the recess period

Submit your Action plans to the InstructorSubmit your Action plans to the Instructor

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Development of individual Action Plans

Characteristics of a Good Action Plan - Practical and Characteristics of a Good Action Plan - Practical and realisticrealistic

➢ Activity and output basedActivity and output based

➢ Contributes to a longer term visionContributes to a longer term vision

➢ States who does whatStates who does what

➢ UnambiguousUnambiguous

➢ Takes account of resources availableTakes account of resources available

➢ Clear timetable with dates and targetsClear timetable with dates and targets

➢ Agreed by the parties involvedAgreed by the parties involved

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What will happen during the recess period of 10 weeks?

A virtual “classroom” will be available for A virtual “classroom” will be available for those participants who have a Google those participants who have a Google Account (free of charge)Account (free of charge)

The URL of the “classroom” isThe URL of the “classroom” is

http://tbt-gambia.blogspot.com http://tbt-gambia.blogspot.com

The instructor will be available in the The instructor will be available in the “classroom” for questions and advice“classroom” for questions and advice

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What will happen after the recess period of 10 weeks?

The instructor will be backThe instructor will be back

➢ To listen to presentations of your project work

➢ To give feedback

➢ To deliver a workshop on the WTO TBT agreement for Gambian stakeholders

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Collecting of the trainees´ reactions to the training

Before you leave Before you leave

➢ Fill in the questionnaire

➢ Leave it to the training organizers

technical regulations and standards

Documents

gambian standards

binding regulations

technical regulationsstandards

standards compliance

application of standards

better gambian regulations

expected result

present training