SIST EN 17444:2021
(Main)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
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
Standards Content (Sample)
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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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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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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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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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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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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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
1
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.
1
Organisations are obliged to refer to the List in force at the time of manufacture of their products.
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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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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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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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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
...
SLOVENSKI STANDARD
oSIST prEN 17444:2020
01-februar-2020
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 sports people and
food supplements
Dopingprävention im Sport - Nahrungsergänzungsmittel und Sportnahrung frei von
Dopingsubstanzen - Bewährte Verfahren bei der Entwicklung und Herstellung zur
Vermeidung von Dopingsubstanzen
Prévention du dopage dans le sport Compléments alimentaires et aliments pour sportifs
exempts de substances dopantes Bonnes pratiques de développement et de fabrication
visant l'absence de substances dopantes
Ta slovenski standard je istoveten z: prEN 17444
ICS:
67.040 Živilski proizvodi na splošno Food products in general
oSIST prEN 17444:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17444:2020
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oSIST prEN 17444:2020
DRAFT
EUROPEAN STANDARD
prEN 17444
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2019
ICS
English Version
Doping prevention in sport - Good development and
manufacturing practices aimed at preventing the presence
of prohibited substances in food intended for sports
people and food supplements
Prévention du dopage dans le sport¿ Compléments Dopingprävention im Sport -
alimentaires et aliments pour sportifs exempts de Nahrungsergänzungsmittel und Sportnahrung frei von
substances dopantes ¿ Bonnes pratiques de Dopingsubstanzen - Bewährte Verfahren bei der
développement et de fabrication visant l'absence de Entwicklung und Herstellung zur Vermeidung von
substances dopantes Dopingsubstanzen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 453.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17444:2019 E
worldwide for CEN national Members.
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oSIST prEN 17444:2020
prEN 17444:2019 (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 principles . 9
4.2 Particular principles applicable to food intended for sports people and food
supplements . 9
5 Good development and manufacture 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 . 11
5.1.7 Help box for premises and production tools . 11
5.1.8 Documents 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
A.1 General. 16
A.2 Example from a Preventive Control Plan . 16
Bibliography . 18
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European foreword
This document (prEN 17444:2019) 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 document is currently submitted to the CEN Enquiry.
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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 sports people and food supplements.
This standard 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 sports people to order and import foods from countries outside the EU.
Additionally, various studies show that food intended for sports people and food supplements may
contain doping substances and consequently lead to 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 sports
people and food supplements is an important public health issue. This issue concerns all sports people,
including recreational sports practitioners.
Various publications addressing contamination of food intended for sports people 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 World Anti-Doping Agency
(WADA). Such substances are harmful to health causing mainly cardiovascular adverse effects as
myocardial infarction, arrhythmia or coronary artery disease, neurotoxicity, hepatotoxicity, etc.
This standard falls within the framework of the measures laid down at international level by the Council
of Europe and by UNESCO respectively.
— the Council of Europe's - Anti-Doping Convention of 1989 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 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 Standard are strongly encouraged to comply with the requirements of other
standards, in particular those of ISO 22000 on food safety management (which includes HACCP
principles) (Hazard Analysis Critical Control Point) and as applicable those of ISO 9001 on quality
management.
Thanks to the support offered jointly by the CEN and by the interested parties in preparation of this
Standard, 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 sports people with the
intention of excluding the substances prohibited by the World Anti-Doping Agency (WADA) [5] and
protecting consumers.
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This standard 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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1 Scope
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”.
2 Normative references
There are no terms and definitions 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 http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
energy drink
drink containing a mixture of different compounds, most often caffeine, taurine, glucuronolactone and B
vitamins, and sugars or sweeteners
Note 1 to entry: They may also contain plant extracts, such as guarana and ginseng. Energy drinks are presented as
cans, shots, ready-to-drink or powder forms as they are not designed for sport people
Note 2 to entry: These beverages 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, these products are used to replace
electrolytes (essential minerals) and macronutrients. They are used to replace water lost in sweat or used up during
exercise activity. Conversely, energy drinks are for general energy whenever the user feels they need that effect.
These products are most likely only used prior to sports/exercise by a small minority of users and may often not be
suitable for sports activities (lacking, for example, electrolytes). The marketing of sports drinks is clear in explaining
the right conditions for product consumption. It may also encourage people to engage in more sporting and physical
activity, and generally lead more active, and healthy lives. Consumers understand that sports drinks will only help
them if they choose to be active, but will not support inactive or passive lifestyles. Formulation wise, energy drinks
are typically based on sugar and caffeine (although there are sugar-free versions) and may also contain ingredients
such as taurine and glucuronolactone. These are designed to be consumed at any time of day, when in need of a
“boost”, therefore they could be taken around exercise but that is not the main focus.
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3.2
foodstuff
food includes drink, chewing gum and any substance, including water, intentionally incorporated into the
food during its manufacture, preparation or treatment. 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
[SOURCE: Regulation (EC) n° 178/2002 of the European Parliament and of the Council of 28 January
2002, Article 2]
3.3
food supplement
means a 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 [1]]
Note 1 to entry: The 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).
3.4
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, modified]
3.5
organisation
entity involved in the manufacture, research and/or development, and marketing of food intended for
sports people and/or food supplements
3.6
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, Article 1, o)]
3.7
processing
any action that substantially alters the initial product, including heating, smoking, curing, maturing,
drying, marinating, extraction, extrusion or a combination of those processes
[SOURCE: Regulation (EC) No 852/2004, Article 2, m)]
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3.8
prohibited substances
substances stated in the prohibited list and its statements managed by the World Anti-Doping Agency
1
(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.
3.9
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]
3.10
food intended for sports people
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 sports
people 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).
Note 2 to entry: Food intended for sports people is not defined in EU legislation.
Note 3 to entry: food intended for sports people includes sports drinks.
3.11
sportsperson
sports people
person(s) who participate(s) in sport
3.12
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, Article 2, n)]
1
Organisations are obliged to refer to the List in force at the time of manufacture of their products.
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3.13
WADA monitoring program
program established by the World Anti-Doping Agency (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
4 Prohibited substances
4.1 General principles
The organization shall know the prohibited substances as defined in 3.8. For this purpose, top
management shall retain the version in force of the Prohibited List and its summary of major
modifications and explanatory notes [4].
Considering the complexity of the Prohibited List which contains “open” sections (including other
substances than those specifically listed by name, with
...
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