Doping prevention in sport - Good development and manufacturing practices aimed at preventing the presence of prohibited substances in food intended for sportspeople and food supplements

This document sets out the requirements relative to the development and manufacture of food intended for sports people and food supplements to reduce the risk of the presence - without fully guarantying the absence - of substances prohibited by the World Anti-Doping Agency (WADA) [5].
This document specifies a framework of good practices with the objective of preventing the presence of substances prohibited in sport in food intended for sports people and food supplements.
This document does not lead to any form of product endorsement.
This document excludes the so-called “energy drinks”.

Dopingprävention im Sport - Gute Praxis bei der Entwicklung und Herstellung zur Vermeidung von Dopingsubstanzen für Nahrungsergänzungsmittel und Sport-Lebensmittel

Dieses Dokument legt die Anforderungen an die Entwicklung und Herstellung von Sportlernahrung und Nahrungsergänzungsmitteln fest, um das Risiko zu senken, dass von der Welt-Anti-Doping-Agentur (WADA) [4] verbotene Substanzen vorhanden sind.
Dieses Dokument legt einen Rahmen für gute Praktiken fest, mit dem Ziel zu verhindern, dass im Sport verbotene Substanzen in Sportlernahrung und Nahrungsergänzungsmitteln enthalten sind.
Dieses Dokument führt zu keiner Form von Produktanerkennung.
Dieses Dokument behandelt keine sogenannten "Energydrinks".

Prévention du dopage dans le sport - Bonnes pratiques de développement et de fabrication visant à prévenir la présence de substances interdites dans les denrées alimentaires destinées aux sportifs et les compléments alimentaires

Le présent document présente les exigences relatives au développement et à la fabrication des denrées alimentaires destinées aux sportifs et des compléments alimentaires, en vue de limiter le risque de présence de substances interdites par l’Agence mondiale antidopage (AMA) [4].
Le présent document spécifie un cadre de bonnes pratiques dont l’objectif est de prévenir la présence de substances interdites dans le sport, dans les denrées alimentaires destinées aux sportifs et dans les compléments alimentaires.
Le présent document ne conduit, en aucun cas, à une quelconque autorisation de produits.
Sont exclues du présent document les boissons dites « énergisantes ».

Preprečevanje uporabe nedovoljenih snovi v športu - Dobre prakse za razvoj in proizvodnjo z namenom preprečevanja prisotnosti prepovedanih snovi v hrani za športnike in v prehranskih dopolnilih

General Information

Status
Published
Public Enquiry End Date
31-Jan-2020
Publication Date
02-Mar-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Mar-2021
Due Date
06-May-2021
Completion Date
03-Mar-2021

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SLOVENSKI STANDARD
SIST EN 17444:2021
01-april-2021
Preprečevanje uporabe nedovoljenih snovi v športu - Dobre prakse za razvoj in
proizvodnjo z namenom preprečevanja prisotnosti prepovedanih snovi v hrani za
športnike in v prehranskih dopolnilih

Doping prevention in sport - Good development and manufacturing practices aimed at

preventing the presence of prohibited substances in food intended for sportspeople and

food supplements
Dopingprävention im Sport - Gute Praxis bei der Entwicklung und Herstellung zur
Vermeidung von Dopingsubstanzen für Nahrungsergänzungsmittel und Sport-
Lebensmittel
Prévention du dopage dans le sport - Bonnes pratiques de développement et de

fabrication visant à prévenir la présence de substances interdites dans les denrées

alimentaires destinées aux sportifs et les compléments alimentaires
Ta slovenski standard je istoveten z: EN 17444:2021
ICS:
67.040 Živilski proizvodi na splošno Food products in general
SIST EN 17444:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 17444:2021
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SIST EN 17444:2021
EN 17444
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 67.040
English Version
Doping prevention in sport - Good development and
manufacturing practices aimed at preventing the presence
of prohibited substances in food intended for sportspeople
and food supplements

Prévention du dopage dans le sport - Bonnes pratiques Dopingprävention im Sport - Gute Praxis bei der

de développement et de fabrication visant à prévenir la Entwicklung und Herstellung zur Vermeidung von

présence de substances interdites dans les denrées Dopingsubstanzen für Nahrungsergänzungsmittel und

alimentaires destinées aux sportifs et les compléments Sport-Lebensmittel
alimentaires
This European Standard was approved by CEN on 20 December 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17444:2021 E

worldwide for CEN national Members.
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SIST EN 17444:2021
EN 17444:2021 (E)

Contents Page

European foreword ............................................................................................................................................ 3

Introduction .......................................................................................................................................................... 4

1 Scope .......................................................................................................................................................... 6

2 Normative references .......................................................................................................................... 6

3 Terms and definitions ......................................................................................................................... 6

4 Prohibited substances ......................................................................................................................... 9

4.1 General requirements ......................................................................................................................... 9

4.2 Particular requirements applicable to food intended for sportspeople and food

supplements ........................................................................................................................................... 9

5 Good development and manufacturing practices ..................................................................... 9

5.1 General requirements ......................................................................................................................... 9

5.1.1 General...................................................................................................................................................... 9

5.1.2 Selection of ingredients .................................................................................................................... 10

5.1.3 Selection of suppliers of ingredients ........................................................................................... 10

5.1.4 Competence of personnel ................................................................................................................ 10

5.1.5 Help box for competence of personnel ....................................................................................... 10

5.1.6 Premises and production tools ...................................................................................................... 10

5.1.7 Help box for premises and production tools ............................................................................ 11

5.1.8 Document control ............................................................................................................................... 11

5.2 Specific requirements ....................................................................................................................... 11

5.2.1 General.................................................................................................................................................... 11

5.2.2 Composition/formulation of products ........................................................................................ 11

5.2.3 Commitment with suppliers ........................................................................................................... 11

5.2.4 Help box for commitment with suppliers .................................................................................. 12

5.2.5 Traceability ........................................................................................................................................... 12

5.2.6 Cross-contamination or external contamination .................................................................... 12

5.2.7 Help box for cross-contamination or external contamination ........................................... 13

5.2.8 End product analysis plan ............................................................................................................... 13

5.3 Management of nonconformities .................................................................................................. 14

5.3.1 Identification of nonconformities ................................................................................................. 14

5.3.2 Management of internally detected nonconformities ........................................................... 14

5.3.3 Management of externally detected nonconformities .......................................................... 14

6 Information intended for users ..................................................................................................... 15

Annex A (informative) Example of good employee training and practices ................................ 16

Bibliography ....................................................................................................................................................... 18

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SIST EN 17444:2021
EN 17444:2021 (E)
European foreword

This document (EN 17444:2021) has been prepared by Technical Committee CEN/TC 453 “Dietary

supplements and sports food free of doping substances”, the secretariat of which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by August 2021, and conflicting national standards shall be

withdrawn at the latest by August 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,

Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,

Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North

Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United

Kingdom.
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SIST EN 17444:2021
EN 17444:2021 (E)
Introduction

Doping prevention is based on various targeted actions, intended for sportspersons at all levels and their

environment. One of these doping prevention actions is ensuring that people participating in sport

activities, either during training or competition, do not ingest doping substances through their diet, in

particular by means of food intended for sportspeople and food supplements.

This document has been designed to provide manufacturers with a framework to minimize the risk of the

presence of prohibited substances in food intended for sportspeople and food supplements. Such a risk

cannot be eliminated entirely, and no company should be making claims to this affect, however there are

a number of processes companies can put in place to reduce the risk of the presence of prohibited

substances.

Indeed, in a context of trade globalization and the underlying development of transnational ordering on

the Internet, it is now possible for sportspeople to order and import foods from countries outside the

European Union (EU). In addition, various studies show that food intended for sportspeople and food

supplements may contain doping substances resulting from unintentional contamination or voluntary

additions of substances prohibited by the World Anti-Doping Agency [4], may give positive results in anti-

doping tests and can induce adverse effects for health. Given the side effects of doping substances on

health, which is one of the criteria for their prohibition, the prevention of doping by contamination of

foods intended for sportspeople and food supplements is an important public health issue. This issue

concerns all sportspeople, including recreational sports practitioners.

Various publications addressing contamination of food intended for sportspeople and food supplements

highlight the presence of prohibited substances (mainly anabolic agents, or stimulants). These substances

are included in the Prohibited List published and revised annually by the WADA [4]. Such substances are

harmful to health causing mainly cardiovascular adverse effects, such as myocardial infarction,

arrhythmia or coronary artery disease, neurotoxicity, hepatotoxicity, etc.

This document falls within the framework of the measures laid down at international level by the Council

of Europe and by United Nations Educational, Scientific and Cultural Organization (UNESCO)

respectively:

— the Council of Europe's Anti-Doping Convention of 1989 [5] of which Article 4 provides for the

possibility of adopting administrative measures to restrict the availability of doping agents in sport;

— UNESCO's 2005 International Convention against Doping in Sport [6] of which Article 10 requires

that:

“States Parties, where appropriate, shall encourage producers and distributors of nutritional

supplements to establish best practices in the marketing and distribution of nutritional supplements,

including information regarding their analytic composition and quality assurance.”

Manufacturers applying this document are strongly encouraged to comply with the requirements of other

standards, in particular those of EN ISO 22000 on food safety management [1] (which includes Hazard

Analysis Critical Control Point (HACCP) principles) and as applicable those of EN ISO 9001 on quality

management [2].

Thanks to the support offered jointly by the CEN and by the interested parties in preparation of this

document, there is a clear emphasis on the importance of encouraging companies responsible for the

development and manufacture of food supplements and food intended for the sportspeople with the

intention of excluding the substances prohibited by WADA [4] and protecting consumers.

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SIST EN 17444:2021
EN 17444:2021 (E)

This document should work towards and support any other European, national laws or regulations in the

area of doping in sport.

Quality assurance can be improved by carrying out testing, audit, certification process, etc.

The following standard has been developed to promote good manufacturing practices specifically with

consideration to substances prohibited in sport.
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SIST EN 17444:2021
EN 17444:2021 (E)
1 Scope

This document sets out the requirements relative to the development and manufacture of food intended

for sportspeople and food supplements to reduce the risk of the presence of substances prohibited by the

World Anti-Doping Agency (WADA) [4].

This document specifies a framework of good practices with the objective of preventing the presence of

substances prohibited in sport in food intended for sportspeople and food supplements.

This document does not lead to any form of product endorsement.
This document excludes the so-called “energy drinks”.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
sport

all forms of physical activity which, through casual or organised participation, aim at expressing or

improving physical fitness and mental well-being, forming social relationships or obtaining results in

competition at all levels

[SOURCE: Council of Europe Committee of Ministers Recommendation No. R (92) 13 Rev of the committee

of Ministers to Members States on the revised European Sports Charter [7]]
3.2
sportsperson
sportspeople
person(s) who participate(s) in sport
3.3
ingredient

any substance or product, including flavourings, food additives and food enzymes, and any constituent of

a compound ingredient, used in the manufacture or preparation of a food and still present in the finished

product, even if in an altered form

[SOURCE: Regulation (EC) n° 1169/2011 of the European Parliament and of the Council of 25 October

2011, Article 2 [2f], modified [8]]
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SIST EN 17444:2021
EN 17444:2021 (E)
3.4
foodstuff

food including drink, chewing gum and any substance, including water, intentionally incorporated into

the food during its manufacture, preparation or treatment

[SOURCE: Regulation (EC) n° 178/2002 of the European Parliament and of the Council of 28 January

2002, Article 2 [9]]

Note 1 to entry: It means any substance or product, whether processed, partially processed or unprocessed,

intended to be, or reasonably expected to be ingested by humans.

Note 2 to entry: It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and

without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.
3.5
food supplement

foodstuff the purpose of which is to supplement the normal diet and which are concentrated sources of

nutrients or other substances with a nutritional or physiological effect, alone or in combination marketed

in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of

powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders

designed to be taken in measured small unit quantities

[SOURCE: Directive 2002/46/EC of the European Parliament and of the council of 10 June 2002, Article

2 [a] [10]]

Note 1 to entry: Food supplements are divided into three categories: those containing energetic macronutrients

(e.g. proteins, carbohydrates), micronutrients (e.g.: vitamins, minerals including trace elements) and substances

with physiological effects (e.g.: amino acids, creatine, botanicals).
3.6
energy drink

water based flavoured drink containing a mixture of different compounds, most often caffeine, taurine,

glucuronolactone and B vitamins, and sugars or sweeteners

Note 1 to entry: They can also contain plant extracts, such as guarana and ginseng. Energy drinks are presented as

cans, shots, ready-to-drink or powder forms.

Note 2 to entry: Energy drinks should not be confused with those known as “sports drinks” which are designed to

be used specifically before, during and/or after exercise or sports. Typically, sport drinks are used to replace

electrolytes (essential minerals) and macronutrients. They are used to replace water lost in sweat or used up during

exercise activity.
3.7
food intended for sportspeople

all food products which target sportspeople, irrespective of the EU legislation under which they are

placed on the market

Note 1 to entry: They are designed to optimize gains from training, enhance recovery within and between workouts

and events, achieve and maintain an ideal body weight and composition. The labelling of food intended for

sportspeople is clear in explaining the right conditions for product consumption. They particularly include products

bearing authorized health claims that are related to sport and physical activity according to articles 13.1 and 13.5

of Regulation (EC) n°1924/2006 [11].

Note 2 to entry: Food intended for sportspeople is not defined in EU legislation.

Note 3 to entry: Food intended for sportspeople includes sports drinks.
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EN 17444:2021 (E)
3.8
nonconformity
means presence in the end product of a substance prohibited in sport
3.9
organisation

entity involved in the manufacture, research and/or development, and marketing of food intended for

sportspeople and/or food supplements
3.10
processed products
foodstuffs resulting from the processing of unprocessed products

Note 1 to entry: These products may contain ingredients that are necessary for their manufacture or to give them

specific characteristics.

[SOURCE: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004

on the hygiene of foodstuffs, Article2, o) [12]]
3.11
unprocessed products

foodstuffs that have not undergone processing, and includes products that have been divided, parted,

severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen,

deep-frozen or thawed

[SOURCE: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004

on the hygiene of foodstuffs, Article 2, n) [12]]
3.12
prohibited substances

substances stated in the prohibited list and its statements managed by WADA which is updated, at least

annually

Note 1 to entry: Manufacturers should be aware that some ingredients potentially contain naturally occurring

prohibited substances and therefore, should take action in order to eliminate the risk of prohibited substances in

sport.
3.13
WADA monitoring program

program established by WADA regarding substances which are not on the Prohibited List, but which are

monitored in order to detect patterns of misuse in sport

Note 1 to entry: Substances that will be monitored are published every year by WADA.

Organisations are obliged to refer to the List in force at the time of manufacture of their products.

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SIST EN 17444:2021
EN 17444:2021 (E)
4 Prohibited substances
4.1 General requirements

The organization shall know the prohibited substances as defined in 3.12. For this purpose, top

management shall retain the version in force of the Prohibited List and its summary of major

modifications and explanatory notes [13].

Considering the complexity of the Prohibited List which contains “open” sections (including other

substances than those specifically listed by name, with a similar chemical structure or similar biological

effects) and which does not expressly name all the prohibited substances (especially in sections S1.1.b,

S1.2, S2, S3, S4, S5 and S6.b), the manufacturers need specific expertise in the anti-doping domain to assist

them to meet the 5.1.1 requirements. This expertise can be based on either internal or external resources.

Top management shall ensure that this updated information is communicated to all personnel concerned

with research, development and/or manufacture, to suppliers of ingredients and to subcontractors.

4.2 Particular requirements applicable to food intended for sportspeople and food

supplements

By means of an internal and/or external audit, the organization shall periodically (e.g.: annually) evaluate

the risks of introducing contaminants during manufacture. The audit should be based on a HACCP type

analysis and should apply to all food intended for sportspeople and food supplements at the time of their

design and their manufacture, in such a way as to identify the critical points for quality control.

5 Good development and manufacturing practices
5.1 General requirements
5.1.1 General

Implementation of research, good development and/or manufacturing practices is essential in the

preparation of food intended for sportspeople and food supplements.

Good practices arise from requirements conventionally implemented by organisations in the framework

of either regulatory food safety requirements or voluntary approaches in terms of quality management.

As well as general requirements on the provision of appropriate means and resources, they include

specific requirements for control of the processes of development and manufacture of food intended for

sportspeople and food supplements in order to reduce the risk of prohibited substances in the end

product.

For the design and manufacture of food intended for sportspeople and food supplements, with the

intention of reducing the risk of prohibited substances in sport, the organization shall ensure in particular

provision of the appropriate means and resources in terms of:
— ingredients;
— suppliers of ingredients;
— personnel;
— premises and production tools;
— document control.
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EN 17444:2021 (E)
5.1.2 Selection of ingredients

The organization shall select dedicated ingredients for the manufacture of food intended for sportspeople

and food supplements.
For each ingredient, it shall determine:

1) those which do not contain any of the prohibited substances defined in the Prohibited List in force at

the time of acceptance (see 4.1);

2) those likely to contain or to give rise to the presence of a prohibited substance, such as some plant

extracts (e.g. Nelumbo nucifera contains higenamine, which is in the Prohibited List);

3) those containing a prohibited substance.

The organization shall specify, in the technical data sheet for the ingredients, to which category they

belong.

When ingredients categorized in 2) and 3) are used on the site of manufacture, the organization shall put

in place an appropriate traceability system enabling assurance that any cross contamination is avoided.

5.1.3 Selection of suppliers of ingredients

The organization shall identify the suppliers of the ingredients described in 5.1.2 likely to meet the

specific requirements described in 5.2.3.

The organization shall inform the selected suppliers in accordance with the requirements described in

4.1.
5.1.4 Competence of personnel

Top management shall identify the relevant personnel involved in all stages of the development and

manufacturing (e.g.: supply chain, blending, packing, quality department, etc.).

Relevant personnel shall receive information on the prohibited substances (see 3.12), from the

commencement of employment and periodically (at least annually).

In addition, specific training (see Annex A for additional information) shall be provided to relevant

personnel in order to prevent cross-contamination. Its effectiveness shall be verified regularly, at least

annually.

The organization shall ensure that relevant personnel have access to the appropriate documents (see

3.12).
5.1.5 Help box for competence of personnel

Initial prohibited substances information shall be supplied for example by a booklet provided to any new

personnel involved in all stages of the development and manufacturing.
The organization shall define and deliver a training plan.

To verify the effectiveness of the training, the organization may rely on a MCQ (Multiple Choice Question)

system or an interview with the quality representative.
5.1.6 Premises and production tools

Premises and production tools shall be designed, built, used and maintained in order to protect products

against internal and/or external contamination.
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EN 17444:2021 (E)
5.1.7 Help box for premises and production tools

Premises and production tools may for example be reflected in the following practices:

— the forward flow principle if the premises and equipment permit this;
— appropriate layout of the premises;
— secure access points to prevent external intrusions;
— separation of storage locations for ingredients from those for end products;

— identification and listing of critical control point (CCP) related to cross-contamination (surfaces,

equipment, etc.).
5.1.8 Document control

As part of the organization's document control, top management shall access the WADA website and

examine the Prohibited List that will be in force.

This Prohibited List shall be circulated internally and to suppliers. The organization shall retain a record

of this circulation.
Any document no longer valid shall be collected and archived.
5.2 Specific requirements
5.2.1 General

The organization shall carry out an evaluation of the causes likely to give rise to the presence of

prohibited substances. The organization should base this evaluation on the critical points identified for

quality control during the periodic evaluation audit (4.2).

If risk of contamination has been identified, the organization shall put in place appropriate actions to

minimize this risk.
5.2.2 Composition/formulation of products

Food intended for sportspeople and food supplements shall only be prepared using ingredients not

containing prohibited substances (3.12) and complying with the requirements stated in 5.1.2.

5.2.3 Commitment with suppliers

The organization shall require selected suppliers to comply with a specification containing the following

information relating to its anti-doping approach:
— the ingredient(s);
— the existence of a traceability system;

— a contractual commitment by the supplier specifying for each ingredient, the presence, absence or

risk of presence of prohibited substances (3.12);

— a commitment by the supplier to inform the organization of any modification in preparation of the

ingredient;
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SIST EN 17444:2021
EN 17444:2021 (E)
5.2.4 Help box for commitment with suppliers

The supplier commitment may be a specification jointly signed by both parties or a supplier certificate.

Modifications to an ingredient may be for example changes in:
— growing or harvesting practices for the plant selected;
— the variety;
— the geographical origin;
— the manufacture process;
— storage and preservation procedures.
5.2.5 Traceability

The organization shall implement a specific traceability system to enable identification of end product

batches, customers and relations with inputs and suppliers. EC Regulation n°178/2002 [9] defines

requirements to implement a traceability system.

For end products, the organization shall put in place a system for preservation and storage of marketed

batches samples.

Each batch in its commercial packaging shall be sampled and the samples preserved and stored in a

sample library for at least the Best
...

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