???????: ???? ???????? ??????? ??????? ??????? Standardization, principles, scope, faces, objevtives and benefits

1
??????? ???? ???????? ??????? ???????
???????Standardization, principles, scope,
faces, objevtives and benefits

• Standardization or standardisation is the process
  of developing and agreeing upon technical
  standards.
• A standard is a document that establishes uniform
  engineering or technical specifications,
  criteria, methods, processes, or practices.
• Some standards are mandatory while others are
  voluntary.
• Voluntary standards are available if one chooses
  to use them.

2

• Some are de facto standards, meaning a norm or
  requirement which has an informal but dominant
  status.
• Some standards are de jure, meaning formal legal
  requirements.
• Formal standards organizations, such as the
  International Organization for Standardization
  (ISO) or the American National Standards
  Institute, are independent of the manufacturers
  of the goods for which they publish standards.
• The goals of standardization can be to help with
  independence of single suppliers
  (commoditization), compatibility,
  interoperability, safety, repeatability, or
  quality.

3
Usage

• Standardization is the process of establishing a
  technical standard, which could be a standard
  specification, standard test method, standard
  definition, standard procedure (or practice),
  etc.
• The existence of a published standard does not
  necessarily imply that it is useful or correct.

4

• Just because an item is stamped with a standard
  number does not, by itself, indicate that the
  item is fit for any particular use.
• The people who use the item or service
  (engineers, trade unions, etc) or specify it
  (building codes, government, industry, etc) have
  the responsibility to consider the available
  standards, specify the correct one, enforce
  compliance, and use the item correctly.
  Validation of suitability is necessary.

5

• In the context of social criticism and social
  sciences, standardization often means the process
  of establishing standards of various kinds and
  improving efficiency to handle people, their
  interactions, cases, and so forth.
• Examples include formalization of judicial
  procedure in court, and establishing uniform
  criteria for diagnosing mental disease.

6

• Standardization in this sense is often discussed
  along with such large-scale social changes as
  modernization, bureaucratization, homogenization,
  and centralization of society.
• In the context of business information exchanges,
  standardization refers to the process of
  developing data exchange standards for specific
  business processes using specific syntaxes.

7

• These standards are usually developed in
  voluntary consensus standards bodies such as
• the United Nations Center for Trade Facilitation
  and Electronic Business (UN/CEFACT),
• the World Wide Web Consortium W3C, and
• the Organization for the Advancement of
  Structured Information Standards (OASIS).

8

• In the context of customer service,
  standardization refers to the process of
  developing an international standard that enables
  organizations to focus their attention on
  delivering excellence in customer service, whilst
  at the same time providing recognition of success
  through a 3rd Party organization, such as British
  Standards Institution (BSI).

9

• The International Customer Service Standard
  (TICSS) has been developed by The International
  Customer Service Institute (TICSI) with the
  objective of making it the cornerstone global
  standard of customer service.
• This standard has the status of an independent
  standard, managed by The International Customer
  Service Institute.

10

• Standards can be
• de facto standards which means they are followed
  by informal convention or dominant usage.
• de jure standards which are part of legally
  binding contracts, laws or regulations.
• Voluntary standards which are published and
  available for people to consider for use
• In general, each country or economy has a single
  recognized National Standards Body (NSB).
• Examples include ABNT, ANSI, AENOR, BSI, DGN,
  DIN, IRAM, JISC, KATS, SABS, SAC, SCC, SIS, SNZ.
  An NSB is likely the sole member from that
  economy in ISO.

11

• NSBs may be either public or private sector
  organizations, or combinations of the two.
• For example, the three NSBs of Canada, Mexico and
  the United States are respectively the Standards
  Council of Canada (SCC), the General Bureau of
  Standards (Dirección General de Normas, DGN), and
  the American National Standards Institute (ANSI).
  
• SCC is a Canadian Crown Corporation, DGN is a
  governmental agency within the Mexican Ministry
  of Economy, and ANSI and AENOR are a non-profit
  organization with members from both the private
  and public sectors.

12

• The determinates of whether an NSB for a
  particular economy is a public or private sector
  body may include the historical and traditional
  roles that the private sector fills in public
  affairs in that economy or the development stage
  of that economy.
• Many specifications that govern the operation and
  interaction of devices and software on the
  Internet are in use.
• To preserve the word "standard" as the domain of
  relatively disinterested bodies such as ISO, the
  W3C, for example, publishes "Recommendations",
  and the IETF publishes "Requests for Comments"
  (RFCs).

13

• These publications are sometimes referred to as
  being standards. Drafts and working documents
  should not be considered as formal published
  standards.
• In a military context, standardization can be
  defined as The development and implementation of
  concepts, doctrines, procedures and designs to
  achieve and maintain the required levels of
  compatibility, interchangeability or commonality
  in the operational, procedural, material,
  technical and administrative fields to attain
  interoperability.

14

• There are at least four levels of
  standardization
• compatibility,
• interchangeability,
• commonality and
• reference.
• These standardization processes create
  compatibility, similarity, measurement and symbol
  standards.

15

• Techniques
• There are typically four different techniques for
  standardization
• Simplification or variety control
• Codification
• value engineering / value analysis
• Statistical process
• Other uses
• In statistics, standardization refers to
  conversion to standard scores.
• In test theory, standardization refers to
  measurements or assessments conducted under
  exact, specified, and repeatable conditions.

16

• In supply chain management, standardization
  refers to approaches for increasing commonality
  of either part, process, product or procurement.
• Such change will enable delayed making of
  manufacturing or procurement decisions, thus
  reducing variability found in having many
  non-standard components.
• From a New institutional economics point of view,
  standardization process starts with a social
  problem known as "coordination dilemma".
• Standards, as "voluntary norms", serve to
  facilitate the resolution of coordination
  dilemmas and realize mutual gains then standard
  refer also to a kind of social dilemma solution.

17

• Types
• Types of standardization process
• Emergence as de facto standard tradition, market
  domination, etc.
• Written by a Standards organization
• in a closed consensus process Restricted
  membership and often having formal procedures for
  due-process among voting members
• in a full consensus process usually open to all
  interested and qualified parties and with formal
  procedures for due-process considerations.
• Written by a government or regulatory body
• Written by a corporation, union, trade
  association, etc

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EUROPEAN FOOD STANDARDIZATION

• CEN, (Committee European de Normalisation) the
  European Committee for Standardization, draws up
  voluntary technical specifications to help
  achieve the the Single Market in Europe,
  promoting the welfare
• ELEMENTS FOR A CEN STRATEGY AND ACTION PLAN
• Agricultural and food standardization has become
  a reality at national and international level
  since a long time.

19
(No Transcript)
20

• European food standardization has also become a
  reality in this field since 1988 and may receive
  a new impetus under the pressure of safety
  necessities resulting from the establishment of
  the European Food Safety Authority and the new
  European regulation on food safety
• It is one priority of the CEN Business Plan. The
  outline and prospects of European Food
  standardization were reported to the CEN
  Administrative Board of 26-27th March 2001 (CEN
  CA N 1242-2001-03-16).
• A CEN Strategy and action plan is now proposed to
  the CEN Technical Board taking into account the
  experience of CEN and the new opportunities at
  European and international level.

21

• The document will present the following issues
• The ongoing work of CEN (existing European
  standards, actions undertaken, work programmes)
• The elements of a CEN Strategy at national,
  European and international level
• A proposal for an action plan for the short term
  concerning the CEN National Members, CMC, ISO and
  the Codex Alimentarius.

22
I - THE ONGOING WORK OF CEN

• Since 1988 CEN produced more than 266 European
  standards in the food sector developed by now 7
  Technical Committees and 2 sub-sectors, mainly
  for methods of sampling and analysis1. European
  standardization supports European legislation
  (e.g.
• ENs based on EC mandates for materials and
  articles in contact with food, for
• irradiated food) and contributes to the quality
  and the safety of food.

23

• CEN also develops European standards for
  specifications as shown by EN 131882000 for
  vinegar and EN 131892000 for acid acetic.
• A part of these standards are EN ISO
• standards under the Vienna Agreement (10 to
  100).
• European standards cover a big part of the food
  chain from the food producer to the food
  processor and address the consumer interests.

24

• On 10 October 2000 CEN organized a seminar on
  food safety and European standardization in order
  to identify the European food industry problems,
  needs for and use of voluntary tools.
• CEN can assist as a service provider to
  facilitate the European initiatives (e.g.
  analytical methods, or more).
• The industry and the food authorities have also
  to express their needs to CEN.

25

• The main outcomes of the seminar were the
  awareness of the outside world on the useful
  contribution of European standardization to food
  safety and therefore a better visibility of CEN.
• It was used as a basis for further discussions
  with the European Commission and European
  Parliament.
• CEN is now working on specific projects in the
  field of food standardization new
• technologies (GMOs2), rapid test methods at low
  cost (microbiology), animal feeding
• stuffs (new mandate from DG Sanco/Enterprise
  M/315 in co-operation with CEMA3),

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• cereals (new CEN Technical Committee 338
  established since October 2001)
• and traceability of fish (development of a CEN
  Workshop agreement-CWA (http//www.cenorm.be/stand
  ardization/tech_bodies/workshop/otherthanICT/ws8.
  htm).
• Since 2000 the White Paper on food safety (COM
  (99) 719) presented by the European Commission,
  and now the regulation on the European Food
  Safety Authority and food safety (Regulation (EC)
  N 178/2002 of 28 January 2002 JOCE L 31
  1/02/2002) gave the opportunity to CEN to offer
  its support

27

• Since 1999 CEN has followed the discussions of
  the Kangaroo Group composed of Members of the
  European Parliament, Commission, Council and
  industry, by
• presenting the European standardization in the
  food area and participating in
• meetings where European food law is concerned
• The development of European food standardization
  is one of the priority actions of CEN.

28

• The development of European food standardization
  implies the organization of the awareness of CEN
  work in this field (e.g. December 2001 and June
  2002 issues of the CEN Networking on food and
  materials in contact with food -http//www.cenorm.
  be/news/newsletter.htm),
• a general recognition of its wide possibilities
  (test methods, specifications, quality,
  guidelines) and its involvement in the ongoing
  international work of the Codex Alimentarius.

29

• On proposal of the European Commission the Codex
  Alimentarius Commission adopted the five CEN
  methods for the detection of irradiated food as
  General Codex Methods for the Detection of
  Irradiated Foods4 at its 24th session of 2-7 July
  2001 in Geneva.
• The Codex Alimentarius Commission also revoked
  the European Regional Standard for vinegar
  (http//www.codexalimentarius.net/cac24/alinorm014
  1/bodye.htm).

30

• The work programme of CEN in the field of food
  covers now more than 410 work items and will
  increase with the work of TC 338 Cereals and
  cereals products and TC 327 Animal feeding
  stuffs based on mandate M/315 on animal feeding
  stuffs.
• CEN is aiming the recognition of the European
  Commission supporting areas of standardization
  where CEN can assist the European legislation.

31

• 1. FRUIT JUICES/UTENSILS IN CONTACT WITH
  FOOD/FOOD ANALYSIS/MILK/ OILSEEDS-VEGETABLE AND
  ANIMAL FATS AND OILS/ANIMAL FEEDING
  STUFFS,CEREALS-CEN/SS C10 Starches, CEN/SS C01
  Food products
• 2. GENETICALLY MODIFIED ORGANISMS
• 3. COMMITTE OF EXPERTS OF METHODS OF ANALYSIS
  (CEC)
• 4. EN 1784,1785,1786,1788/1996 and EN 17872000
  made by CEN TC 275 - Food Analysis - Horizontal
  methods

32
II- ELEMENTS FOR A CEN STRATEGY

• The development of European standardization can
  benefit from an agreed strategy resulting from
  initiatives taken by the CEN National Members and
  CMC at European and international level.
• Many CEN National Members have already developed
  national standards (analytical methods or
  specifications) for agricultural and food
  products, as well as in the field of food
  hygiene.
• CEN National Members supported CEN via the
  adoption of standards and the important progress
  of the CEN work programme for food.

33

• AFNOR, DIN and NEN are the most interested CEN
  National Members in the development of European
  food standardization.
• CEN National Members can take initiatives and
  make proposals to CEN which can be part of the
  CEN Strategy both at European and international
  level.

34
1. Elements for a CEN strategy at European level

• European standards already contribute to the
  quality and the safety of food (e.g. irradiated
  food, aflatoxins, listeria mycotogenes,
  genetically modified organisms).
• Initiatives can result from the development of
  the European legislation for the safety of food
  and the reference to European standards.

35

• The European Food Safety Authority and general
  principles of food law Regulation (EC) N178/2002
  of the European Parliament and of the Council of
  28 January 2002 on the general principles and
  requirements of food law and the European food
  Safety Authority- OJEC L N31 2002-02-01 p 1
• The European Food Safety Authority is entrusted
  with a number of key tasks such as independent
  scientific advice on all aspects to food safety,
  communication and dialogue with consumers on food
  safety and health issues as well as networking
  with national agencies and scientific bodies.

36

• The tasks of the authority essentially
  concentrate on risk assessment and risk
  communication.
• Risk management - including legislation and
  control - remains the responsibility of the
  Commission.
• It is proposed that CEN will establish a formal
  co-operation with the European Food Safety Agency
  when operating in 2002.

37

• The Community principle has been to move away
  from product specific requirements to horizontal
  legislation covering broad aspects as food
  additives, contaminants, labelling, etc.
• The legislation has in certain sectors been
  linked to the results from international
  harmonization works as that of CODEX
  Alimentarius, including regional standards (EC
  Regulation 178/2002 Art 13- International
  standards).
• In the field of industrial products the
  principles of the New Approach has been applied.

38

• In the food sector this has been a non-issue and
  the food authorities have not been prepared to
  reduce their national inspections/control systems
  and deregulate.
• It is not politically realistic to assume that
  the New Approach principles will be accepted as
  such in the food sector.
• However the question remains if there are
  elements which could be taken over by the food
  sector.
• It would be logical to enter into a dialogue with
  the Commission, industry and the National
  Standards Bodies to identify possible elements.

39

• Development of European standards in the food
  sector
• European Food Directives/new Regulation will
  lead to an increased need for
• - common validated analytical methods in order
  ensure necessary comparison of test results
• - developing sampling methods
• - methods for confirmation of test results (based
  on the general provisions of the EN 45 000 series
  of standards) and,
• - guidance documents based on the new regulation
  on hygiene (Hazard analysis and critical control
  points).

40

• The Joint Research Centre (Food products and
  consumer goods Unit- Ispra) provides
• validated methods which serve the various CEN
  working groups (GMOs, mycotoxins,
• materials in contact with food). Reference to
  European standards is already used by
• the Commission for the official control of
  foodstuffs, and some contaminants (see
• Annex). The European Commission, DG SANCO, also
  provided some information on

41

• European standardization in the field of the
  detection of irradiated foods
• http//europa.eu.int/comm/food/fs/sfp/fi07_en
  .htlm) and
• materials in contact with food
  (http//europa.eu.int/comm/food/fs/sfp/food_contac
  t/index_en.htlm- see practical
• guide, chap III CEN).
• The European Commission makes use of European
  Standardization when needs are identified on a
  casual basis.
• It would be necessary to broaden the dialogue
  with the European Commission including a wider
  range of possible interested parties.

42
2. Elements for a CEN strategy at international
level

• CEN policy with the International Standardization
  Organization (ISO) is based on the Vienna
  Agreement, on a case by case basis, and there is
  a need for evaluation of ISO standards in view of
  their enhancement to European standards (e.g. ISO
  151612001
• Guidelines on the application of ISO 90012000
  for the food and drink industry).
• Around 500 ISO standards were already published
  for a wide range of agricultural food products
  mainly prepared by ISO TC 34 Agricultural food
  product (methods of analysis, cereals, fruits
  and derived products, butter, ice cream, spices
  and condiments, tea, coffee, cocoa).

43

• At international level, the European Commission
  and CEN National Members via the national
  governmental delegations can propose European
  standards to the Codex Alimentarius Commission.
• AFNOR and DIN participate in national delegations
  of some Codex Committees (Food Additives and
  contaminants, methods of analysis and sampling,
  Codex Alimentarius Commission).
• On behalf of DIN the German delegation
• proposed to the Codex Committee on food
  additives and contaminants (Rotterdam-11-15 March
  2002) to endorse as Codex methods European
  standards elaborated by CEN TC 275 (CX/FAC 02/31
  Add.1).

44

• Since some years TC 275 has participated
  informally to the Inter-Agency meetings (IAM),
  preceding the meetings of Codex Committees on
  methods of analysis and sampling.
• Taking into account the growing interest for
  European standards at this level, it is necessary
  for CEN to establish a formal contact with the
  Codex Alimentarius.
• CEN can also participate in EC initiatives for
  international co-operation (e.g.
• ASEM/Asiatic countries and future food issues).

45

• III PROPOSAL FOR AN ACTION PLAN
• An action plan is proposed taking due account of
  already ongoing CEN activities in
• the field and the framework strategy as shown
  before. The aim is to complete a
• process which started in 1988 which should lead
  CEN to optimize its existing work
• and standards as well as to offer a full set of
  standards. The following action plan is
• proposed

46

• National Standards Bodies are invited to
  consult nationally on possible projects
• and to report to CMC by December 2002. Standards
  and guides on food hygiene
• should be considered as a source of possible
  projects for CEN.
• CMC takes up a broad consultation of the
  European Commission on possible
• references to European standards or projects to
  assist EU Regulation.
• CMC will propose a co-operation with the
  European Food Safety Authority by end
• 2002 subject to a possible formal agreement in
  2003.

47

• CMC organizes a survey with major stakeholders
  in the process to inquire on
• possible assistance from standardization in the
  food chain (food industry, retailers,
• and consumers) by end 2002.
• National Standards Bodies are invited to make
  proposals to CMC on the basis of
• ISO TC 34 standards and work programme (and
  possible others like ISO TC 47 )
• by December 2002 in order to prepare a plan for
  launching PQs on ISO standards
• in the framework of the Vienna Agreement.
• CMC will initiate a co-operation with the Codex
  Alimentarius by end 2002 .subject
• to a possible formal agreement and request for
  observer status in 2003.

48

• CMC will prepare a web site on European food
  standardization by end 2002 with
• the view to provide a global information on the
  role of standardization
• organizations in relation to the food area in
  2003.
• CMC will report to BT on the progress of
  actions by March 2003 subject to a final
• report to BT by end 2003.
• ANNEX
• References to European standards in European food
  legislation
• Examples of references to European standards
• in European food legislation

49

• Commission recommendation of 25 January 2002
  concerning a coordinated
• programme for the official control of foodstuffs
  for 2002 (2002/66/EC)(JOL 26
• 30 01 2002 p 8)
• -In the preamble (3) ,reference to EN 45000
  series and EN ISO 17025 2000
• concerning the general requirements for the
  competence of testing and calibration
• laboratories
• - Art 6.2 Sampling and method of analysis,
  reference to,
• .ISO 6579
• (in CEN TC 275 work programme under prEN 6579
  Microbiology of food and animal
• feeding stuffs- Horizontal method for the
  detection of Salmonella (ISO/DIS
• 65792000)

50

• .EN/ISO 16654
• (Microbiology of food and animal feeding stuffs-
  Horizontal method for the detection of
• Escherichia coli 0157)
• .EN/ISO 11290-1
• (Microbiology of food and animal feeding stuffs-
  Horizontal method for the detection
• and enumeration of Listeria monocytogenes- Part
  1 Detection method)
• .EN/ISO 11290-2
• (Microbiology of food and animal feeding stuffs-
  Horizontal method for the detection
• and enumeration of listeria monocytogenes- Part
  2 Enumeration method)

51

• -Annex I reference to the CEN standards on GMO
  testing under development in CEN
• TC 275 WG11 - Genetically modified foodstuffs-
  Six projects are currently under
• development.
• EFTA Surveillance Authority
• Recommendation of the EFTA Surveillance Authority
  N 228/01/COL of 2 July
• 2001 on a coordinated programme for the official
  control of foodstuffs for 2001
• (JOL 6 10 01 2002 p 65)
• -Preamble (3) Reference to EN 45000 series
• - Part B Bacteriological quality of smoked fish,
  6. 2 Method, Reference to EN/ISO
• 11290-1 and ISO/EN 11290-2.

52

• Commission Recommendation of 18 April 2001
  concerning a coordinated
• programme for the official control of foodstuffs
  for 2001 (2002/337/EC) (JOL
• 120 28 04 2001 p 41)
• -In the preamble (3) reference to EN 45000 series
• -Art 6 Bacteriological quality of smoked fish,
  6.2 Method, Reference to EN/ISO 11290-
• 1 and EN/ISO 11290-2.
• Commission Directive 2001/22/EC of 8 March 2001
  laying down the sampling
• methods and the methods of analysis for the
  official control of the levels of
• lead, cadmium, mercury and 3- MCPD in foodstuffs
  (JOL 77 16 03 2001 p 14)

53

• - Annex II 2. Specific sample preparation
  procedures for lead, cadmium and mercury,
• Reference to the procedures described in the CEN
  Standard Foodstuffs-
• Determination of trace elements- indicated in the
  references of the directive under a)
• 'Draft Standard prEN 13804, Foodstuffs-
  Determination of Trace Elements-
• Performance Criteria and General Considerations'
  CEN Rue de Stassart 36, B- 1050
• Brussels

54

• -Annex II 3.1 HORRATr/RSDr , Reference in
  references footnote c) to 'Method of
• Analysis to determine 3-Monochloropropane -1-2-
  Diol in Food and Food ingredients
• using Mass Spectrometric Detection , submitted to
  CEN TC 275 and AOAC
• Council Directive 93/99/EEC of 29 October 1993
  on the subject of additional
• measures concerning the official control of
  foodstuffs (JOL 290 24 11 1993 p
• 14)

55

• -Art 3.1 Reference to EN 45001 now replaced by EN
  ISO 17025
• -Art 3.2 (a) Reference to EN 45002
• (General criteria for the assessment of testing
  laboratories)
• -Art 3.3 Reference to EN 45003
• (Calibration and testing laboratory accreditation
  system- General requirements for
• operation and recognition)
• Mch/2002

56

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60
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62
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67
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68

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69

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70
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71

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  ???????? ??????? (??????)

72

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73

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74

• 2 . ??????? ????????? ????????? ???????
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  (??????) ???????.

75

• 4. ???? ??????? ????????? ????????
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• 6. ??????? ??????? ??????? (??????)
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  ????? ?????? ?? ???? ??? 40 ????? ???????

76

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77

• 7 . ??????? ??????? ???????? ?????????
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  ??????? 100 ??????.
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• 9 . ??????? ?????? ??????
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  ???? ??? ?????? ????????? ????????.

78

• 10 . ??????? ????????? ?????? ??????? (FDA)
  ????? ????? ?????? ??????? ????????? FDA ?? ???
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  ?????? ??????.
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  ????? ?? ???? ??? 60 ??? ????? ?????? ?????? ??
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  1992? ??? 185 ????? ????? ??? 1994? ???? ???? ???
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  ???? ??????? ????????? ????????? ?? ????? ??????.

79

• ????? ????? ???????? ?? ??????? ????????
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  ???????? ?????? ???????? ??? 1996.
• ?? ????? ???????? ????? ???? ????? ?? ?????
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