oSIST prEN 17444:2020
(Main)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 - 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
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
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 supplementsDopingprävention 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 dopantesTa 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
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 DopingsubstanzenThis 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
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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 foodsupplements ........................................................................................................................................... 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.---------------------- Page: 5 ----------------------
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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.---------------------- Page: 6 ----------------------
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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.---------------------- Page: 7 ----------------------
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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 sweetenersNote 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 supplements3.6
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
(WADA) which is updated, at least annuallyNote 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 marketNote 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)]
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 substances4.1 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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