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

Status
Not Published
Public Enquiry End Date
31-Jan-2020
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
04-Nov-2019
Due Date
23-Mar-2020
Completion Date
25-Feb-2020

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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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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

(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)]

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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