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Development of
Technical regulations and Standards
Folke Hermansson Snickars
Associate consultant
Ambi Prospect AB, folke@...
Training on better
Gambian regulations and standards
Why
Increased health, safety and
sustainability
➢

➢

➢

➢

Better tr...
Expected result I
3

After the training you should be better equipped to
➢

Address relevant TBT issues falling in your co...
Expected result II
4

The relation between
Technical regulations and International standards
● International standards and...
Expected result III
5

After the present training you are also expected to
do homework on projects relevant to Gambia and
...
Who are we?
6

Instructor:
Folke Hermansson Snickars
➢

➢

➢

In this project working for the TBT Programme
Management Uni...
Which are your expectations?
7
Outline I
8

Technical regulations and Standards according to WTO
➢

Legal differences

➢

Differences in purpose, languag...
Outline II
9

International standards and Technical regulations
Exploration of International standards
Risk assessment (RA...
Outline III
10

Additional requirements in the TBT agreement on
preparation, adoption and application of Technical
regulat...
Technical regulations
11

Technical regulation is a term used in WTO and
EU for binding regulations issued by public
autho...
Standards
12

Standard is a term used in WTO and EU for nonbinding rules for interoperability of
complementary products an...
Legal differences between
Technical regulations and Standards
➢

➢

Compliance mandatory: Technical
regulations
Compliance...
Other differences between Technical
regulations and Standards
➢

Purposes

➢

Language

➢

Attestation

➢

Promoters

➢

A...
Other differences between Technical
regulations and Standards
➢

Purposes
➢

Technical regulations implementing national
p...
Other differences between Technical
regulations and Standards
➢

16

Language

Requirements

shall

Technical regulations,...
Attestation
17

➢

Testing and
calibration

➢

Inspection

➢

Certification
➢

➢

➢

Products
Mangement
systems
Personell
The ISO/UNIDO Conformity
Assessment toolbox
Prepared by the
ISO Committee on
Conformity
Assessment (ISO
CASCO)

18
Other differences between Technical
regulations and Standards
Promoters
➢

Technical regulations 
Governments
➢ Importers
...
Other differences between Technical
regulations and Standards
Anchoring and execution
➢

Technical regulations
Governments...
Good Regulatory Practice (GRP)
21
➢

identify the problem (including its nature and magnitude)

➢

consider all the option...
GRP according to WTO
22

From Devin McDaniels, WTO, June 2013
Good Regulatory Practice
23

➢

identify the problem (including its nature and magnitude)

➢

consider all the options to ...
Risk assessment (RA)
➢

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

➢

In what circumstances will t...
Good Regulatory Practice
25
➢

identify the problem (including its nature and magnitude)

➢

consider all the options to a...
RIA according to WTO
26

From Devin McDaniels, WTO, June 2013
Regulatory Impact Assessment (RIA)
27

➢

Define the problem

➢

Set objectives

➢

Assess all feasible options

➢

➢

Ana...
Principal elements to be included in a
Regulatory Objective
Scope statement
Product requirements
➢

specified in terms of ...
Code of Good Practice for the preparation,
adoption and application of standards
The TBT Agreement lays out in its Annex 3...
Examples on implementations of the
TBT Agreement
Technical Regulations-Recommendations
for their elaboration and enforceme...
National adoptions of
International standards

31
Governments use of International standards
in regulation of their national value chains

32
Exploration of International standards
33

Existing standards
➢

NSSN: A National Resource for Global Standards
➢
➢

➢

By...
Organisation of national
standardisation
Role I
➢

➢

➢

Monitoring and contributing to international and
regional develop...
Organisation of national
standardisation
Role II
➢

➢

➢

➢

➢

➢

Conducting appropriate training activities in
standardi...
Tools and services from ISO
36

My ISO Job
Joining in
Fast forward
Building trust
Standards work on
the Web
Developing tal...
Reference to Standards
in Technical regulations
Exclusive reference to standards
➢

Dated reference

➢

Undated reference
...
Reference to Standards
in Technical regulations

From ITC/PTB Guide 1(2009)

38
Adoption of International standards (IS) as
national standards (ISO/IEC Guide 21)
Why identical adoptions?
➢

➢

Deviation...
Adoption of International standards (IS) as
national standards (ISO/IEC Guide 21)
Further arguments
➢

➢

➢

All users pre...
ISO/IEC Guide 21:2005
41

Regional or national adoption of International
Standards and other International
Deliverables
➢
...
ISO/IEC Guide 21:2005
42

ISO/IEC Guide 21
provides methods for adoption of International Standards as
regional or nationa...
ISO/IEC Guide 21:2005
43

Degrees:

Identical

Modified

Not equivalent

Identifiers:

IDT

MOD

NEQ

Adoption:

Yes

Yes
...
Identical adoption
44

A national standard is considered identical to the adopted
publication when:
The national standard ...
Modified adoption
45

A national standard is considered to be a modified
adoption of a publication under the following
con...
Non-equivalent correspondence
46

A national standard is considered to be not equivalent to a
source International Standar...
Methods of adoption
47

Endorsement method
(via an endorsement notice+original IS)

Re-publication, which includes:
➢

Rep...
Choice of methods of adoption
48

No editorial changes or technical deviations
(“Identical”)
– Any, but reprint of the ful...
Numbering of adoptions I
49

Numbering of identical adoptions:
“When regional or national standards are identical to
Inter...
Numbering of adoptions II
50

Option 2: Dual numbering (sometimes called “two-line
dual numbering”):
XYZ 87878:1998
ISO 13...
Numbering of adoptions III
51

Numbering of modified adoptions and non-equivalent
standards
Modified adoptions only carry ...
Dating of standards
52

Option 1 National adoption date
➢

XYZ IEC 61642:1998 (published by IEC in1996)

Option 2 Internat...
Additional requirements on preparation, adoption
and application of Technical regulations
53
Acceptance of technical regul...
Prescriptive standards
54

Define the processes and procedures
required to achieve compliance
Focus on the means by which ...
Performance standards
55

Define the outcome rather than inputs or
means
More difficult to enforce, but provide both
flexi...
Participation in the preparation of
International standards
Full member
Correspondent member
Full voting rights in any
No ...
Project selection and preparation of
Action plan
Select an example of a technical regulation
(existing or planned) within ...
Development of individual Action Plans
58

Characteristics of a Good Action Plan - Practical and
realistic
➢

Activity and...
What will happen during the recess
period of 10 weeks?
A virtual “classroom” will be available for
those participants who ...
What will happen after the recess period
of 10 weeks?
60

The instructor will be back
➢

To listen to presentations of you...
Collecting of the trainees´
reactions to the training
Before you leave
➢

Fill in the questionnaire

➢

Leave it to the tr...
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Technical regulations and standards

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A presentation of the relations between Technical regulations and Standards in relation to the WTO agreement on Technical Barriers to Trad

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Technical regulations and standards

  1. 1. Development of Technical regulations and Standards Folke Hermansson Snickars Associate consultant Ambi Prospect AB, folke@ambiprospect.com March 2014
  2. 2. Training on better Gambian regulations and standards Why Increased health, safety and sustainability ➢ ➢ ➢ ➢ Better transparency Less trade barriers What Technical regulations and standards ➢ 2
  3. 3. Expected result I 3 After the training you should be better equipped to ➢ Address relevant TBT issues falling in your competence What does that mean? You should know about ➢ The difference between Technical regulations and Standards ➢ Different Good practices ➢ Risk assessment and Regulatory Impact Assessment
  4. 4. Expected result II 4 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
  5. 5. Expected result III 5 After the present training you are also expected to do homework on projects relevant to Gambia and selected by you to demonstrate how your new knowledge is understood and applied in real life. After 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.
  6. 6. Who are we? 6 Instructor: Folke 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
  7. 7. Which are your expectations? 7
  8. 8. Outline I 8 Technical regulations and Standards according to WTO ➢ Legal differences ➢ Differences in purpose, language, promoters, and anchoring Good 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 developing ➢ Technical regulations ➢ Standards
  9. 9. Outline II 9 International standards and Technical regulations Exploration of International standards Risk assessment (RA) and Regulatory impact assessment (RIA) Reference to Standards in Technical regulations Adoption of International standards as national standards (ISO/IEC Guide 21) Participation in the preparation by international standardizing bodies of International standards
  10. 10. Outline III 10 Additional requirements in the TBT agreement on preparation, adoption and application of Technical regulations ➢ 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 work ➢ Project selection and preparation of project plan ➢ Development of individual Action Plans Collecting of your reactions to the training
  11. 11. Technical regulations 11 Technical regulation is a term used in WTO and EU for binding regulations issued by public authorities concerning, for example, what characteristics goods are to have and how they are to be tested and labelled in order for them to be offered for sale and used.
  12. 12. Standards 12 Standard is a term used in WTO and EU for nonbinding rules for interoperability of complementary products and services, or to provide agreed test methods and requirements for health, safety, organisational and environmental performance.
  13. 13. Legal differences between Technical regulations and Standards ➢ ➢ Compliance mandatory: Technical regulations Compliance voluntary: Standards 2 13
  14. 14. Other differences between Technical regulations and Standards ➢ Purposes ➢ Language ➢ Attestation ➢ Promoters ➢ Anchoring 14
  15. 15. Other differences between Technical regulations and Standards ➢ Purposes ➢ 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) 15
  16. 16. Other differences between Technical regulations and Standards ➢ 16 Language Requirements shall Technical regulations, standards Recommendations should Guides, standards Permissions can Guides, standards Possibilities may Guides, standards
  17. 17. Attestation 17 ➢ Testing and calibration ➢ Inspection ➢ Certification ➢ ➢ ➢ Products Mangement systems Personell
  18. 18. The ISO/UNIDO Conformity Assessment toolbox Prepared by the ISO Committee on Conformity Assessment (ISO CASCO) 18
  19. 19. Other differences between Technical regulations and Standards Promoters ➢ Technical regulations  Governments ➢ Importers ➢ Foreign exporters Standards ➢ ➢ ➢ ➢ ➢ Buyers Sellers Producers 19
  20. 20. Other differences between Technical regulations and Standards Anchoring and execution ➢ Technical regulations Governments (Ministries and agencies) Standards ➢ ➢ ➢ Stakeholders (Standards organisations) 20
  21. 21. Good Regulatory Practice (GRP) 21 ➢ identify the problem (including its nature and magnitude) ➢ consider all the options to address the problem; ➢ ➢ if technical regulations are chosen as the preferred option, consider the effect on trade; consider adopting performance based regulations rather than prescriptive; ➢ consider consistency with international standards; ➢ consider compliance mechanisms; ➢ ➢ consider providing for the review and monitoring of the technical regulation; and ensure that adequate consultation takes place.
  22. 22. GRP according to WTO 22 From Devin McDaniels, WTO, June 2013
  23. 23. Good Regulatory Practice 23 ➢ identify the problem (including its nature and magnitude) ➢ consider all the options to address the problem; ➢ Carry out if technical regulations are chosen as the preferred option, consider the Risk Assessment effect on trade; ➢ consider adopting performance based regulations rather than prescriptive; ➢ consider consistency with international standards; ➢ consider compliance mechanisms; ➢ ➢ consider providing for the review and monitoring of the technical regulation; and ensure that adequate consultation takes place.
  24. 24. Risk assessment (RA) ➢ What is the magnitude of the risk and which are its consequences? ➢ In what circumstances will the risk arise? This includes considering the chain of events which will lead to the undesirable event, and the probability of each step in that chain occurring. ➢ How widespread is the risk (e.g. local, national or international)? ➢ Which groups or sectors of the economy are most at risk? 24
  25. 25. Good Regulatory Practice 25 ➢ identify the problem (including its nature and magnitude) ➢ consider all the options to address the problem; ➢ ➢ ➢ ➢ ➢ ➢ if technical regulations are chosen as the preferred option, consider the effect on trade; consider adopting performance based regulations rather than prescriptive; consider consistency with international standards; Carry out consider compliance mechanisms; Regulatory Impact Assessment consider providing for the review and monitoring of the technical RIA regulation; and ensure that adequate consultation takes place.
  26. 26. RIA according to WTO 26 From Devin McDaniels, WTO, June 2013
  27. 27. Regulatory Impact Assessment (RIA) 27 ➢ Define the problem ➢ Set objectives ➢ Assess all feasible options ➢ ➢ Analyse the impacts arising from these options, and Consult with stakeholders
  28. 28. Principal elements to be included in a Regulatory Objective Scope statement 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 clause Compliance 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 28
  29. 29. 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).
  30. 30. Examples on implementations of the TBT Agreement Technical Regulations-Recommendations for their elaboration and enforcement, ITC/PTB Guide 1(2009) Code of Good Standardisation Practise ISO/IEC Guide 59:1994 Guidelines for the preparation, adoption and review of technical regulations, APEC Information note on Good Regulatory Practice, APEC, 2000 30
  31. 31. National adoptions of International standards 31
  32. 32. Governments use of International standards in regulation of their national value chains 32
  33. 33. Exploration of International standards 33 Existing standards ➢ NSSN: A National Resource for Global Standards ➢ ➢ ➢ By title, abstract, keyword By document number Ongoing standardization projects ➢ www.iso.org ➢ www.iec.ch ➢ www.codexalimentarius.org
  34. 34. Organisation of national standardisation Role 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 34
  35. 35. Organisation of national standardisation Role 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 35
  36. 36. Tools and services from ISO 36 My ISO Job Joining in Fast forward Building trust Standards work on the Web Developing talent
  37. 37. Reference to Standards in Technical regulations Exclusive reference to standards ➢ Dated reference ➢ Undated reference ➢ Direct reference Indicative 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 37
  38. 38. Reference to Standards in Technical regulations From ITC/PTB Guide 1(2009) 38
  39. 39. Adoption of International standards (IS) as national standards (ISO/IEC Guide 21) Why identical adoptions? ➢ ➢ Deviations or redrafting from the source IS that appear insignificant in a regional or national standards, can lead to non-acceptability across the border in another country A published IS is a known-quantity, almost certainly already adopted widely, and almost certainly adopted in many areas, at both national and regional levels 39
  40. 40. Adoption of International standards (IS) as national standards (ISO/IEC Guide 21) Further 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) 40
  41. 41. ISO/IEC Guide 21:2005 41 Regional or national adoption of International Standards and other International Deliverables ➢ ➢ Part 1: Adoption of International Standards Part 2: Adoption of International Deliverables other than International Standards
  42. 42. ISO/IEC Guide 21:2005 42 ISO/IEC Guide 21 provides methods for adoption of International Standards as regional or national standards, defines a system for indicating the degree of correspondence between International Standards and regional or national standards so as to promote coherence in the way regional or national standards bodies adopt International Standards and indicate the degree of correspondence with International Standard and contributes thereby to achieving greater uniformity in the indication of both correspondence and deviations among standards of different countries will aid communication, avoid confusion and facilitate trade.
  43. 43. ISO/IEC Guide 21:2005 43 Degrees: Identical Modified Not equivalent Identifiers: IDT MOD NEQ Adoption: Yes Yes No
  44. 44. Identical adoption 44 A national standard is considered identical to the adopted publication when: The national standard is identical in technical content, structure and wording (or is an identical translation), or The national standard is identical in technical content and structure, but may contain certain minimal editorial changes defined in Guide 21 and The “vice versa principle” is fulfilled, i.e. if an International Standard is adopted identically, the two standards (the International and the adopting) can be substituted for each other. In other forms of adoptions, this principle is not fulfilled.
  45. 45. Modified adoption 45 A national standard is considered to be a modified adoption of a publication under the following conditions: Technical deviations have been introduced but in a manner that ensures that they are clearly identified and explained in the Foreword, Introduction or in an Annex The national standard continues to reflect the structure of the source International Standard Changes to the structure of the source are limited and made in such a way that an easy comparison of the content and structure of the two standards is possible
  46. 46. Non-equivalent correspondence 46 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.
  47. 47. Methods of adoption 47 Endorsement method (via an endorsement notice+original IS) Re-publication, which includes: ➢ Reprinting ➢ Translation (with or without reprint of the original) ➢ Redrafting (Note:no adoption)
  48. 48. Choice of methods of adoption 48 No editorial changes or technical deviations (“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 introduced – reprint method or – the translation method with the incorporation of deviations within the text or in an annex be used. The redrafting of standards is not recommended
  49. 49. Numbering of adoptions I 49 Numbering of identical adoptions: “When regional or national standards are identical to International Standards, this should be evident to the reader immediately and not only after examination of the content. ” Two numbering options ➢ Dual numbering ➢ Single numbering Option 1: Single numbering: XYZ IEC 61642:1998 (for an identical adoption of IEC 61642)  The acronym for the national standards is added in front of the original reference number of the International Standard Note: XYZ = Acronym for the standards of a national standards body
  50. 50. Numbering of adoptions II 50 Option 2: Dual numbering (sometimes called “two-line dual numbering”): XYZ 87878:1998 ISO 13616:1996 (for an identical adoption of ISO 13616) 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
  51. 51. Numbering of adoptions III 51 Numbering of modified adoptions and non-equivalent standards Modified adoptions only carry a national number and do not include the reference number of the adopted International Standard.
  52. 52. Dating of standards 52 Option 1 National adoption date ➢ XYZ IEC 61642:1998 (published by IEC in1996) Option 2 International adoption date ➢ XYZ IEC 61642:1996 (published by XYZ in 1998)
  53. 53. Additional requirements on preparation, adoption and application of Technical regulations 53 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)
  54. 54. Prescriptive standards 54 Define the processes and procedures required to achieve compliance Focus on the means by which the objective will be achieved Easier to enforce, but less flexibile and more likely to restrict competition and inhibit innovation Example for a fire door?
  55. 55. Performance standards 55 Define the outcome rather than inputs or means More difficult to enforce, but provide both flexibility and predictability of outcomes Flexibility in in compliance provides incentives for firms to minimize the cost of complying Example for the fire door?
  56. 56. Participation in the preparation of International standards Full member Correspondent member Full voting rights in any No voting rights technical & policy committee. 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 56
  57. 57. Project selection and preparation of Action plan Select an example of a technical regulation (existing or planned) within your area of interest Carry out a Risk Assessment and a Regulatory Impact Assessment Explore if any international standard exist or are under preparation Plan your work for the recess period Submit your Action plans to the Instructor 57
  58. 58. Development of individual Action Plans 58 Characteristics of a Good Action Plan - Practical and realistic ➢ Activity and output based ➢ Contributes to a longer term vision ➢ States who does what ➢ Unambiguous ➢ Takes account of resources available ➢ Clear timetable with dates and targets ➢ Agreed by the parties involved
  59. 59. What will happen during the recess period of 10 weeks? A virtual “classroom” will be available for those participants who have a Google Account (free of charge) The URL of the “classroom” is http://tbt-gambia.blogspot.com The instructor will be available in the “classroom” for questions and advice 59
  60. 60. What will happen after the recess period of 10 weeks? 60 The 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
  61. 61. Collecting of the trainees´ reactions to the training Before you leave ➢ Fill in the questionnaire ➢ Leave it to the training organizers 61

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