1 Standardisation The tool to prove compliance with legal requirements… Dr Fred Foubert, Centexbel, Belgium

2 The players  Manufacturers, producers, distributors  Users, consumers (consumer associations)  Authorities  European  Member State Authorities  Standardisation bodies  Conformity assessment bodies (notified bodies)  less explicit role than in specific Directives  no CE marking obligation

3 The role of standards in the GPSD  Initial considerations (1)  disparities in requirements lead to barriers to trade and to distortion of competition  necessity to establish safety requirements for any product placed on the market  safety assessment shall take all relevant aspects into account, with special attention for vulnerable groups (children, elderly people…)  GPSD is complementary to specific directives  risks not addressed by the other directives can be taken into account

4 The role of standards  Initial considerations (2)  importance to establish European voluntary standards covering certain products and risks  presumption of conformity principle  standards to be established under mandates set by the EU Commission  general outline of requirements  harmonised standards, published in the OJEC  other standards or normative documents may also be used

5 The role of standards  Initial considerations (3)  independent certification by recognised conformity assessment bodies may be used  adequate information is also an obligation

6 The GPSD  Art. 1.1 – The purpose of the directive is to ensure that products placed on the market are safe.  Art. 1.2 – Where products are subject to specific safety requirements imposed by Community legislation, the Directive shall apply only to the aspects and risks or categories of risks not covered by those requirements.

7 The GPSD  Art. 2 (b) Safety of a product takes into account  foreseeable conditions of use, including duration  putting into service, installation  maintenance  Hence requirements shall address  product characteristics  composition,  packaging,  instructions for assembly, installation, maintenance  effect on other products  product presentation, labelling, warnings, instructions for use and safe disposal  consumer categories at risk (children, elderly people)

8 Ways to prove compliance – Art. 3.2  a product is deemed safe when:  it meets national law requirements on H&S  of the MS where it is marketed  in the absence of Community provisions  a product is presumed safe when:  it conforms to voluntary national standards  transposing European standards  published in the OJEC (harmonized standards)

9 Ways to prove compliance – Art. 3.3  Other possible elements to take into account in the absence of legislation or harmonized standards:  voluntary national standards from ENs (non- harmonized)  national standards (MS where product is marketed)  Commission recommendations  product safety codes – sector related  state of the art and technology  reasonable consumer safety expectations

10 Safeguard clause – Art. 3.4  Member States have the right to take measures  to impose restrictions on products being placed on the market  if these products are dangerous  despite proof of conformity

11 Procedure for harmonized standards – Art. 4.1  The Commission – assisted by a committee – determines the requirements to ensure products will meet the general safety requirement  The Commission calls on the European standardisation bodies to draw up standards (mandate)  European standardisation bodies adopt standards in accordance with cooperation guidelines EU-CEN  Commission reports to EP every three years on progress and future work

12 Publication of harmonized standards – Art. 4.2  The Commission publishes the references of mandated (harmonized) standards in the OJEC  Publication in the OJEC of standards adopted before the entry into force of the Directive is possible  If a standard does not ensure compliance with the general safety requirement, it can be withdrawn in whole or in part  Commission decisions are taken after consulting the advisory committee – Member States are notified of the decision

13 A standard is…  A technical document  established by consensus  approved by a recognized body  for common and repeated use  provides rules, guidelines or characteristics for activities or their results  aims at the achievement of the optimum degree of order in a given context  Source: ISO/IEC Guide

14 Who makes standards?  on a company or sector level  multinational companies (cars, aircraft)  branch organisations (e.g. EDANA)  on a national level  national standardisation bodies: MSZT, BSI, DIN, AFNOR  in Europe 1 standardisation body per country  US more sector oriented  on a European level  CEN: Comité Européen de Normalisation  European Union + Switzerland, Iceland, Norway  on an international level  ISO: International Standards Organisation  more than 100 countries

15 Types of normative documents: European  European documents  European standard (EN)  approved by a weighted voting procedure  three linguistic versions: E, F, D  translation into other languages possible, but not mandatory  becomes a national standard in all CEN countries  reference: MSZ EN xxxxx-x:yyyy

16 Types of normative documents: European  European Technical Specification (CEN/TS – old: ENV)  approved by a weighted voting procedure  not necessarily available in all languages  no obligation to make it a national standard  reference: CEN/TS xxxxx-x:yyyy  provisional document for three years

17 Types of normative documents: European  CEN Technical Report  approved by simple majority  no obligation for three linguistic versions  no obligation to make it a national standard  informative document (recommendations, inventory of knowledge)  reference: CEN/TR xxxxx-x:yyyy

18 Types of normative documents: international  International documents (ISO)  similar to CEN (standard, technical specification, technical report)  exists in E, F  no obligation to adopt them as national standards  reference: ISO xxxxx-x:yyyy  EN ISO standards  MSZ EN ISO xxxxx-x:yyyy

19 The Vienna Agreement  Agreement between CEN and ISO to avoid duplication of work  One of the organisations takes the lead (depends on availability of expertise)  Voting occurs in parallel and in accordance with the rules of each organisation  Decision to be taken for each individual work item  ISO takes the lead for amendments or revision of standards  leads to a shift of activity from CEN to ISO

20 Standardisation structures  Structures are similar in CEN and ISO  Technical committee (TC)  scope: fairly broad (e.g. floor coverings, plastics, ….)  decisions on work programme  national delegates (representatives of a national mirror committee)  Subcommittee (SC)  Working group (WG)  very specific scope e.g. terry towel fabrics  work items allocated by parent TC  do the actual standardisation work  experts (selected for their knowledge, but also represent national interests)  Task groups, ad hoc groups etc. (informal)

21 The standardisation process

22 The standardisation process  Draft stage – public enquiry  WG drafts the standard and decides when it is ready for public enquiry  in principle in all languages (often only in E)  draft receives a reference number  a period of 5 months to give everyone the opportunity to make comments  in practice the draft is discussed in the relevant mirror committee  a second enquiry (2 months) may be necessary  enquiry ends with a comments report, forwarded to the WG

23 The standardisation process  Formal vote stage  WG discusses comments and replies to each one  A final draft is made, taking accepted comments into account  TC approves release for formal vote  Formal vote = weighted vote  Pass criteria  71 % of votes positive and  more countries in favour than against

24 The standardisation process: weighting of votes GermanyDIN29 UKBSI29 FranceAFNOR29 ItalyUNI29 SpainAENOR27 PolandPKN27 NetherlandsNEN13 GreeceELOT12 Czech RepCSNI12 BelgiumIBN12 HungaryMSZT12 PortugalIPQ12 SwedenSIS10 AustriaON10 SwitzerlandSNV10 SlovakiaSUTN7 DenmarkDS7 FinlandSFS7 NorwayNSF7 IrelandNSAI7 LithuaniaLST7 LatviaLVS4 SloveniaSIST4 EstoniaEVS4 CyprusCYS4 LuxembourgSEE4 MaltaMSA3 IcelandIST3

25 The standardisation process  Approval and publication  approved text is finalized (editorial comments)  final text is released by CEN for publication by national standardisation bodies  national standardisation bodies  make standard available (printing, catalogue, web site)  within 6 months after release by CEN  withdraw conflicting national standards  for harmonized standards: see legislation  Review/revision  after 5 years or sooner, if necessary

26 Standards and legislation  European New Approach Directives  only general H&S requirements in Directive  specify attestation of conformity rules (certification schemes)  encourage use of harmonized European standards  technical translation of requirements  made on explicit request of the EU Commission (mandate)  presumption of conformity (publication in OJEC)  ZA-annex is link between standard and Directive  often lead to CE marking  conformity marking, not a quality mark

27 Standards and legislation  Examples  89/106 Construction Products Directive  ca. 150 harmonized standards  89/686 Personal Protective Equipment Directive  ca. 300 harmonized standards  93/42 Medical Devices Directive  ca. 250 harmonized standards  2001/95 General Product Safety Directive  10 standards - furniture - child care articles

28 Standards in support of the GPSD (1)  EN :1996  Furniture - Cribs and cradles for domestic use – Part 1: Safety requirements  EN : 1996  Furniture - Cribs and cradles for domestic use - Part 2: Test methods

29 Standards in support of the GPSD (2)  EN 12586:1999  Child care articles – Soother holder - Safety requirements and test methods (amended 2002)  EN : 2002  Child use and care articles – Soothers for babies and young children - Part 1: General safety requirements and product information  EN : 2002  Child use and care articles – Soothers for babies and young children - Part 2: Mechanical requirements and tests  EN : 2002  Child use and care articles – Soothers for babies and young children – Part 3: Chemical requirements and tests  EN 1466: 2004  Child care articles – Carry cots and stands – Safety requirements and test methods

30 Standards in support of the GPSD (3)  EN ISO 9994:2002  Lighters. Safety specifications (ISO 9994:2002)  EN 14059:2002  Decorative oil lamps - Safety requirements and test methods

31 Searching for standards  Standards are protected by copyright  Web sites of standardisation institutes  CEN:  ISO:  Hungary:

32 Live-link  A system operated by ISO, CEN and all major national standardisation bodies  most standardisation bodies have their own Live- link system  password protected  per TC or WG  all types of working documents: agendas, minutes of meetings, resolutions, drafts, …  can be downloaded by authorised users  uploading by TC or WG secretary

33 The future  Standardisation has proven to be a good tool to prove compliance with legal requirements  growing number of standards to underpin European Directive provisions  Growing internationalisation of standards  increasing importance of ISO and Vienna Agreement  A speedier standardisation process  3 year rule  live-link