Guide to Using NANDO Information System New Approach to Notified and Designated Organisations Last Update: 29/01/2015 Contents Overview 1 Consulting the Registrar 2 Country View .................................................................................................................. 3 Legislation View ............................................................................................................. 5 Body Number/Name View.............................................................................................. 9 Construction Products View......................................................................................... 11 Free Search ................................................................................................................. 14 Mutual Recognition Agreements (MRA) View ............................................................. 17 Notifying Authority/Notification Procedure View .......................................................... 19 Accreditation Body View .............................................................................................. 21 Glossary of Terms 22 Index 25 NANDO Information System (Europa) Contents • i Overview In order to trade within the EU, it is a legal requirement that products conform with the European legislation. CE - marking testifies of product conformance with the legislation and is delivered by duly accredited attestation organisations (known as "Bodies") within each Member State. This User Manual describes the NANDO Information System, the new online access point to consult regulatory information about such Bodies responsible for carrying conformity assessment procedures for products marketed in the European Union, and their respective competence areas. NANDO currently covers most published EU legislation, including the Construction Product Regulation (EU) No 305/2011 (CPR) and the 73/23/EEC Low Voltage Directive. NANDO Information System (Europa) Overview • 1 Consulting the Registrar IN THIS SECTION Country View Legislation View Body Number/Name View Construction Products View Free Search Mutual Recognition Agreements (MRA) View Notifying Authority/Notification Procedure View Accreditation Body View 3 5 9 11 14 17 19 21 Council Resolution of 7 May 1985 on a New Approach to technical harmonisation and standardization requires that Member States notify the Commission and the other Member States of the list of Bodies (that come under their jurisdiction and which therefore are established in their territory) which they have designated as competent to carry out conformity certification as required by specific EU legislations. The secured online application used by Member States to enter notification information is called NANDO-Input, while its counterpart, NANDO Information System, provides an efficient way to consult this information. The different consultation options available in the NANDO menu bar provide different views on the Body registrar. These will be detailed in this section: MENU DESCRIPTION Country Per country overviews of registered national Bodies. Legislation Cross-country overviews of Bodies notified under specific sections of a given legislation (Directive, Regulation, etc.). Body Consultation of the notified Body registrar sorted by notified Body number. Construction products Overview of Bodies notified either under the 89/106/EEC Construction Products Directive (CPD) (expired 01/07/2013) and/or under the Construction Product Regulation (EU) No 305/2011 (CPR). Free Search Notified Body search area. Mutual Recognition Agreements • European Bodies designated as assessment bodies to List of mutual recognition agreements (MRAs) involving either: conduct assessments on products to be placed on the market in specific third countries; • Non-EU bodies included in MRAs (i.e. Australia, Canada, Japan, New Zealand, the USA, or Switzerland) designated to assess, in line with EU legislation and in accordance with the provisions of the MRA, products to be placed on the EU market. Notifying Authority – Notification procedures Overview, names and addresses of Notifying Authorities in all Member States + downloadable HTML pages/ PDFs describing their respective notification procedures. Accreditation Body Overview of all national Accreditation Bodies, and details of the names, addresses and contact details. NANDO Information System (Europa) Consulting the Registrar • 2 NANDO Information System (Europa) Country View The Country menu provides per country overviews of national registered Bodies. ♦ To display a country overview 1. Select the Country option in the menu bar. Result: NANDO displays a list of countries for which Bodies have been notified, as well as countries for which Conformity Assessment Bodies (CABs) have been designated under Mutual Recognition Agreements (MRAs). Figure 1 – Country list 2. Click on the appropriate country name to display the corresponding list of registered Bodies. Result: The complete list of Bodies registered for the selected country is displayed. 3. You can further limit the list to a specific legislation using the filter box above the list: NANDO Information System (Europa) Consulting the Registrar • 3 NANDO Information System (Europa) 4. Each Body in the list is presented as a hyperlink. Click a hyperlink to view the full notification details of a Body in the list. Select the appropriate Body hyperlink to view its details Figure 2 – Country view NANDO Information System (Europa) Consulting the Registrar • 4 NANDO Information System (Europa) Legislation View The Legislation menu provides lists of Notified Bodies, as well as full details about the notified items in the selected Legislation and up-do-date overviews of the latest changes affecting Bodies under each legislation. Notified items are included in a multi-level tree structure where each branch of the tree represents a level, or structural division of that Legislation. Most Legislations have the following standard divisions, and you will have to select each level successively to find the related Body: Legislation Articles/Annexes Procedures Product families For example: The Construction Products Regulation (EU) No 305/2011 (CPR) has a more complex structure, involving items such as Decisions, AVCP systems, Intended uses, Harmonised standards, Body Functions, Levels, Position papers and EADs. The following sections are available in connection with the CPR Regulation: The list of technical specifications (i..e. horizontal specifications and harmonised standards) involved in Regulation (EU) No 305/2011. NANDO Information System (Europa) The list of European Assessment Documents used for assessing performance in relation to the essential characteristics of construction products – as foreseen by the Regulation. The list of position papers involved in the Regulation i.e. GNB – SG / GNB – AG documents. Consulting the Registrar • 5 NANDO Information System (Europa) ♦ To display a legislation overview 1. Select the Legislation menu. Result: NANDO displays a list of legislations for which Bodies have been notified. Figure 3 – Legislation overview 2. Click on the appropriate legislation to display its general structure. 3. ● If the selected legislation is not Regulation (EU) No 305/2011 Construction Products (CPR), you can further limit the list to a specific Procedure, Article/annex or Product using the filter box above the list: ● If the selected legislation is Regulation (EU) No 305/2011 - Construction Products (CPR), you can further limit the list by selecting a specific Decision and/or Product family. Result: NANDO Information System (Europa) The list of Bodies notified under the selected item is displayed. Each Body is presented as a hyperlink. Click a hyperlink to view the full notification details of a Body in the list. Consulting the Registrar • 6 NANDO Information System (Europa) Figure 4 – NBs for a selected legislation (non-construction related) ♦ To view and keep track of the latest changes to Bodies The RSS feed feature is a convenient way of keeping track of the latest changes affecting Bodies under one or more legislations. Per legislation, RSS provides up-to-date overviews on a daily basis. You may also decide to subscribe to one or more feeds. In this case, you will be able to access the desired change overview directly from the Feeds tab of your Internet Explorer Favorites Center. 1. Select the Legislation menu. 2. From the Legislation overview, click the desired legislation. Result: RSS icon next to the You are presented with an up-to-date list of changes to Bodies under the selected legislation: NOTE Please note that RSS lists are limited to the latest 10 changes – or the 50 changes if the selected directive is the CPD. Figure 5 – RSS overview NANDO Information System (Europa) Consulting the Registrar • 7 NANDO Information System (Europa) 3 The overview provides a short description of each change, including the Body name, type and identification number, the related Notifying Authority and country. The date mentioned tells you when the change took place, the most recent change being displayed at the top of the list. You can click on a Body to view the corresponding notification in a PDF format. 4. To subscribe to a displayed feed: – click the Subscribe to this feed hyperlink at the top of the desired RSS list: – confirm by clicking Subscribe in the popup window (the example below is from Internet Explorer): Result: NANDO Information System (Europa) The feed is now added to your feed list. You can access it anytime. You can use your Internet browser, any other RSScompatible browser or RSS aggregator to manage and access the subscribed feeds. If you are using Internet Explorer, for example, open your Favorites Center, and then clicking Feeds: Consulting the Registrar • 8 NANDO Information System (Europa) Body Number/Name View The Body menu provides lists of notified Bodies sorted by notified Body number, or by name. ♦ To display a Body overview 1. Select the Body menu. Result: The Body selection page provides different sections to select the Body based on the first character of its name, its type or Notified Body number range. The upper section is used to select the Body based on the first character of its name The middle section allows you to browse non-Notified Bodies by Body type, as well as withdrawn/expired/suspended Bodies or notifications The lower section allows you to select the Notified Body based on its number range Figure 6 – Body view 2. To find any type of Body based on its name, select the appropriate first letter of the name from the alphabet hyperlinks in the upper section as illustrated below, and then click on the appropriate Body to view its details. Or To find a Body which is not necessarily a Notified Body, select its type in the middle section (e.g. Approval Body, Competent Body, LVD Body, Technical Assessment Body, etc.), and then click on the appropriate Body to view its details. Or NANDO Information System (Europa) Consulting the Registrar • 9 NANDO Information System (Europa) If the searched body's notification has expired, if it has been suspended or withdrawn: i) select the Withdrawn/Expired/Suspended Notifications/NBs hyperlink: ii) select the legislation and searched status: Withdrawn/expired/suspended Bodies are signalled by their expired end of validity date between brackets, as illustrated above. All other items listed relate to expired notifications. Or To find a Notified Body based on its Notified Body number, select the appropriate number grouping in the lower section: 3. To view the detail of a Notified Body from the list, simply click on its hyperlink. Result: The full details of the selected Body are displayed: If successive versions exist for a Body, these are available for view by clicking the appropriate version hyperlink NANDO Information System (Europa) Consulting the Registrar • 10 NANDO Information System (Europa) Construction Products View The Construction products menu is dedicated to notifications concerning products intended to be used in buildings and building works construction. Up-to-date PDFs provide overviews of all Bodies that were notified either under the former 89/106/EEC Construction Products Directive (CPD) and/or under the new Construction Product Regulation (EU) No 305/2011 (CPR). You can also perform custom searches to find some specific Bodies notified under these legislative documents. ♦ To consult CPD-related notifications 1. Select the Construction products menu. Result: The Construction products main page appears: Figure 7 – Construction products main page 2. For a printer-friendly overview of all notifications under CPD, click the 'PDF' hyperlink next to '89/106/EEC Construction products (expired 01/07/2013)'. Or, To look for a specific CPD notification: – Click the '89/106/EEC Construction products (expired 01/07/2013)' hyperlink. – Either select a Decision in the unfiltered list, and then select a Product family. Or, Click on the appropriate structural element at the top of the page and drill down until you find the specific item for which Bodies have been notified. The CPD structure is as follows: The list of harmonised standards involved in the 89/106/EEC Directive NANDO Information System (Europa) The list of ETAGs involved in the Directive The list of ETAs involved in the Directive The list of Guidance Papers relating to the Directive Consulting the Registrar • 11 NANDO Information System (Europa) Result: The list of Bodies notified under the selected item is displayed. Each Body is presented as a hyperlink. Click a hyperlink to view the full notification details of a Body in the list. Figure 8 – Filtered list of Bodies notified under CPD ♦ To consult CPR-related notifications 1. Select the Construction products menu. Result: The Construction products main page appears: Figure 9 – Construction products main page 2. For a printer-friendly overview of all notifications under CPR, click the 'PDF' hyperlink next to 'Regulation (EU) No 305/2011 – Construction products'. Or, To look for a specific CPR notification: – Click the 'Regulation (EU) No 305/2011 – Construction products' hyperlink. NANDO Information System (Europa) Consulting the Registrar • 12 NANDO Information System (Europa) – Either select a Body directly in the unfiltered list. Or, Select a Decision (and a Product family) and click Search. Or, Click on the appropriate structural element at the top of the page until you find the specific item for which Bodies have been notified. The CPR structure is as follows: List of technical specifications involved in Regulation 305/2011 i.e. f horizontal specifications: f harmonised standards: The list of European Assessment Documents used for assessing performance in relation to the essential characteristics of construction products – as foreseen by the Regulation. The list of ETAGs used as EADs according to Article 66(3) of Regulation 305/2011 You can consult either: – (all) : the list of all Bodies notified in connection with the related harmonised standard, whether or not they were also specifically designated as competent to work away from their own test facilities under Article 46 of the CPR; Or – (art 46): a shorter list with only those Bodies who were also designated according to CPR Art. 46. Result: The list of Bodies notified under the selected item is displayed. Each Body is presented as a hyperlink. Click a hyperlink to view the full notification details of a Body in the list. Figure 10 – Filtered list of Bodies notified under CPR NANDO Information System (Europa) Consulting the Registrar • 13 NANDO Information System (Europa) Free Search The Free search feature provides advanced search options. Searches are based on a set of selected criteria that you can combine to limit the quantity of returned information. ♦ To perform a free search 1. Select the Free search menu. Result: The Free search page is displayed: Figure 11 – Free search 2. On the Free search page, enter one or more search criteria to find the searched Body/Bodies: NANDO Information System (Europa) Keyword On Bodies The full name of the searched Body, or just the beginning or any part of it. For example: To find a Body for which you are not sure whether the name starts with ‘Instituti’ or ‘Instituto’: type just ‘institut’, and NANDO will find both ‘Instituti’ and ‘Instituto'. Keyword On Legislations The reference or name of the specific legislation for which the search Body/Bodies has/have been notified. For example: – 88/378/EEC – Safety of toys – 97/23/EC Pressure equipment etc. Consulting the Registrar • 14 NANDO Information System (Europa) TIP Please note that there is not always uniformity in the way articles and annexes are formulated in legislations. For example, article 10 may be written "Art.10" in one legislation and "Article 10" in another legislation. Similarly, annex 3 may be written "Annex 3" in one legislation and "Annex III" in another legislation. Keyword On Articles/ Annexes Identification of the specific article or annex for which the searched Body/Bodies have been notified. For example: – Annex II – Article 10 – Annex VI Art.8, 2(c), 2nd indent – Annex IV, Part III - Module 1 etc. Keyword On Procedures Identification of the specific procedure for which the searched Body/Bodies has/have been notified. For example: – EC unit verification – Product quality assurance – Conformity to type etc. Keyword on Products Identification of the specific products for which the searched Body/Bodies has/have been notified. For example: – Weighing instruments – Active medical devices – Saws etc. Keyword On Horizontal technical competence Description of the specific 'horizontal' technical competences of the search Body/Bodies. This concerns the medical legislations (90/385/EEC, 93/42/EEC, and 98/79/EEC). The following search fields are only relevant in connection with the new Construction Products Regulation (EU) No 305/2011 (CPR): NANDO Information System (Europa) Keyword On Decisions Identification of the specific legislation of attestation of conformity for which the searched Body/Bodies has/have been notified. You can specify the decision number or any part of the full title of the legislation. For example: – 99/92/EC – wood-based beams – pipes etc. Keyword On Intended uses The intended use (or "essential characteristics") of the products for which the searched Body/Bodies has/have been notified. For example: – For uses subject to reaction to fire regulations – Energy conservation – Noise reduction etc. Keyword On AVCP system Identification of the system used for attesting the conformity of the products (i.e. 'AoC' with reference to CPD) or for assessing and verifying constancy of performance (i.e. 'AVCP' with reference to CPR) for which the searched Body/Bodies has/have been notified. Consulting the Registrar • 15 NANDO Information System (Europa) 6 AoC/AVCP systems are currently in use: System 1+ : Product conformity certification with audit testing. System 1 : Product conformity certification without audit testing. System 2+ : Factory production control (fpc) certification with continuous surveillance. System 2 : Factory production control (fpc) certification without surveillance. System 3 : Initial type testing. System 4 : Manufacturer’s tasks only. Keyword On Technical specification Reference or title of the technical specifications for which the searched Body/Bodies has/have been notified. For example: – EN 40-5:2002 – Lighting columns – EN 681-4:2000/A1:2002 – Fixed firefighting systems etc. Keyword On Bodies function Functional classification of the searched Body/Bodies. For example: – Product Certification Body – FPC Certification Body – Inspection Body – Test Laboratory The following search field is relevant only in connection with the Interoperability Directives (i.e. 96/48/EC, 2001/16/EC and 2008/57EC): Keyword On Technical Specifications for Interoperability Identification of technical specifications for associated to the searched interoperability directive. For example: – CCS Revision 4 - 2008/386/EC – ENE - 2002/733/EC – RST Corrig - NA – SRT - 2008/163/EC 3. NANDO Information System (Europa) Click Search at the bottom of the Free search page. Consulting the Registrar • 16 NANDO Information System (Europa) Mutual Recognition Agreements (MRA) View The Mutual Recognition Agreements feature provides up-to-date information on bodies involved in MRAs, i.e. • 'CABs from third countries' i.e. non-EU bodies included in MRAs (i.e. Australia, Canada, Japan, New Zealand, the USA, or Switzerland) designated to assess, in line with EU legislations and in accordance with the provisions of the MRA, products to be placed on the EU market. • 'EU CABs' i.e. European bodies designated as assessment bodies to conduct assessments on products to be placed on the market in specific third countries. When available, a hyperlink is also provided to the Official Journal describing the related MRAs. ♦ To view MRA information 1. Select the Mutual Recognition Agreements menu. Result: The Mutual Recognition Agreements (MRAs) overview is displayed: Figure 12 – Mutual Recognition Agreements overview NANDO Information System (Europa) Consulting the Registrar • 17 NANDO Information System (Europa) 2. You can further view: – a list of bodies from MRA countries which have been designated as CABs in Europe: click the desired CABs from (country) hyperlink: – a list of European bodies which have been designated as CABs in MRA countries: click the desired EU CABs hyperlink: – the Official Journal describing the MRA involving one of the countries in the list: The selected Official Journal will open in a new page on the Eur-Lex website. NANDO Information System (Europa) Consulting the Registrar • 18 NANDO Information System (Europa) Notifying Authority/Notification Procedure View The Notifying Authority feature provides an up-to-date list of Notifying Authorities in each Member State, with their names, addresses and notification procedures followed. ♦ To look up Notifying Authorities 1. Select the Notifying Authority – Notification procedures menu. Result: The Notifying Authority page is displayed: Figure 13 – Notifying Authority list 2. You can further limit the list by using the filter box above the list: 3. To view the detail of a Notifying Authority in the list, click on its hyperlink. NANDO Information System (Europa) Consulting the Registrar • 19 NANDO Information System (Europa) Result: The details of the selected Notifying Authority are displayed: A 'Notification procedures' section is available if the Notification Authority has provided information about its notification procedures. Click the HTML or PDF hyperlinks to view the details of a notification procedure. Specific documents describing certain notification procedures may be available as well: NANDO Information System (Europa) Consulting the Registrar • 20 NANDO Information System (Europa) Accreditation Body View The Accreditation Body feature provides an up-to-date list of national accreditation bodies (NAB), with their names, addresses and contact details. ♦ To look up Accreditation Bodies 1. Select the Accreditation Body menu. Result: The Accreditation Body page is displayed: Figure 14 – Accreditation Body list 2. To view the detail of an Accreditation Body in the list, click on its hyperlink. Figure 15 – Accreditation Body details NANDO Information System (Europa) Consulting the Registrar • 21 Glossary of Terms Accreditation Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. AoC Attestation of conformity. A system for attesting the conformity of products to European technical specifications. AVCP Assessment and Verification of Constancy of Performance. In order to ensure that the declaration of performance of a construction product is accurate and reliable, the performance should be assessed and the production in the factory should be controlled in accordance with an appropriate system of assessment and verification of constancy of performance of the construction product. Several systems could be chosen to be applied for a given construction product, in order to take into account the specific relationship of some of its essential characteristics to the basic requirements for construction works. CE - marking An official logo or symbol affixed to products as a declaration by the person responsible that the product conforms to all applicable Community provisions, and the appropriate conformity assessment procedures have been completed. The CE - marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, save where specific legislations require otherwise. Conformity assessment procedure Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled, for example procedures for sampling, testing and inspection, registration and approval. Denotification Formal total or partial withdrawal or suspension of a notification when the Commission considers that a Notified Body no longer conforms to the requirements or no longer fulfil its responsibilities. NANDO Information System (Europa) Glossary of Terms • 22 NANDO Information System (Europa) ETA (European Technical Approval) A favourable technical assessment of the fitness of a construction product for an intended use, based on the contribution made by this product to the fulfilment of the six Essential Requirements, as stated in the CPD for the construction works in which the product is installed. A manufacturer may apply for an ETA where there are no Harmonized Standards, where there are no recognized existing national standards to build on, or where a product deviates significantly from Harmonized Standards. A list of issued ETAs is maintained on the EOTA website at http://www.eota.be/html/issued_ETA.htm. ETAG (ETA Guideline) A document drafted by and for the EOTA Approval Bodies as a result of a mandate from the European Commission and EFTA. Its basic aim is to establish how Approval Bodies should evaluate the specific characteristics/requirements of a product or family of products. A list of endorsed ETAGs is maintained on the EOTA website, at http://www.eota.be/html/endorsed.htm. FPC Factory Production Control. GNB Group of Notified Bodies. Harmonised Standards European standards, which are adopted by European standards organisations, prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations, and follow a mandate issued by the Commission after consultation with the Member States. Harmonised standards in the meaning of the “New Approach” are deemed to exist when the European standards organisations formally present to the Commission the European standards elaborated or identified in conformity with the mandate. Inspection Bodies Bodies which inspect FPC procedures and report back to the FPC certification body who ultimately assess the results and issue the certificate. Notification An act whereby a Member State informs the Commission and the other Member States that a body meets the designated requirements, such as knowledge, experience, independence, resources, to conduct conformity assessments. Notified Body A certification organisation which the Competent Authority of a Member State designates to carry out one or more of the conformity assessment procedures described in the annexes of EU Legislations. A Notified Body must be qualified to perform all the functions set out in any annex for which it is designated. The designation may be restricted to specified types of devices and/or Annexes. SG NANDO Information System (Europa) Sector Group of Notified Bodies. Glossary of Terms • 23 NANDO Information System (Europa) Technical Assessment Body (TAB) An organisation that has been designated by a Member State as being entrusted with the establishment of draft European Assessment Documents and the issuing of European Technical Assessments in accordance with the Construction Products Regulation (EU) No 305/2011 (CPR). Technical regulation NANDO Information System (Europa) Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. Glossary of Terms • 24 Index Functions.............................................16 # G # 73/23/EEC .............................................. 1 89/106/EEC ............................................ 1 A Accreditation Bodies ........................... 21 Annexes .......................................... 5, 14 AoC ................................................. 5, 15 Article 46 ............................................. 13 Articles ............................................ 5, 14 AVCP .................................................... 5 B Bodies ................................................... 9 Body function ...................................... 16 Body Name ....................................... 2, 9 Body Number.................................... 2, 9 C CABs..................................................... 3 CE marking ........................................... 1 Conformity Assessment Bodies............ 3 Conformity to type............................... 15 Construction products..................... 2, 11 Construction Products Directive ........... 1 Country ............................................. 2, 3 CPD ......................................1, 2, 11, 15 CPR ..................................1, 2, 5, 11, 15 E EAD................................................. 5, 13 EC unit verification.............................. 15 ETA ........................................... 5, 11, 22 ETA guidelines...................................... 5 ETAG .............................................. 5, 22 Expired.................................................. 9 Expired Bodies.................................... 10 Expired notifications............................ 10 F Feeds .................................................... 7 FPC..................................................... 23 Free search..................................... 2, 14 NANDO Information System (Europa) GNB ....................................................23 H Harmonised standards........5, 11, 13, 23 Horizontal specifications .....................13 Horizontal Technical competence.......15 I Inspection Body...................................23 Intended uses......................................15 Interoperability Directives....................16 K Keyword on AoC System ....................15 Keyword on Articles or Annexes .........14 Keyword on Bodies .............................14 Keyword on Decisions ........................15 Keyword on Horizontal Technical competence.........................................15 Keyword on Intended uses .................15 Keyword on Legislations .....................14 Keyword on Procedures......................15 Keyword on Technical Specifications .16 L Legislations ...................................1, 2, 5 M MRAs ....................................................3 Mutual Recognition Agreements...........3 N NAB .....................................................21 NANDO-Input ........................................2 Notification procedures .......................19 Notifications.........................................23 Notified Bodies ................................2, 23 Notifying Authorities ......................17, 19 P Position papers .........................5, 11, 13 Procedure........................................5, 15 Index • 25 NANDO Information System (Europa) Product ....................................... 2, 5, 15 Product quality assurance .................. 15 R Regulation (EU) 305/2011 ............ 1, 2, 5 Regulations........................................... 2 RSS feeds............................................. 7 S Search ........................11, 14, 17, 19, 21 SG....................................................... 23 Suspended............................................ 9 System 1 ............................................. 15 System 1+........................................... 15 NANDO Information System (Europa) System 2 .............................................15 System 2+ ...........................................15 System 3 .............................................15 System 4 .............................................15 T Technical regulation............................23 Technical specifications ................13, 16 W Withdrawn .............................................9 Withdrawn Bodies ...............................10 Withdrawn notifications .......................10 Index • 26
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