Updated ESSNA position paper on the Revision of the PARNUTS
Framework Directive (Directive 2009/39/EC)1
June 2010
ESSNA (European Specialist Sports Nutrition Alliance) was set up in 2003 to campaign for appropriate
European legislation on sports nutrition products. ESSNA is a pan-European organisation with 20 Members
representing a number of specialist sport nutrition businesses and trade associations with an interest in this field.
Our aim is to be the voice of the sports nutrition sector in Europe 2 which currently amounts to €3.45bn with a
growth rate around 7%+ per year 3.
The purpose of this paper is to provide the Commission and Member States with further comments relating to
the potential options as outlined in the recently updated Commission Working paper on the Revision of Council
Directive 2009/39/EC on foodstuffs intended for a particular nutritional uses (the ‘Framework’ or ‘PARNUTS
Directive’ on ‘dietetic foods’).
In particular, ESSNA is providing additional comments on the negative and positive impacts identified by the
Commission, as presented during the recent second stakeholder meeting in Brussels on the PARNUTS
Revision.
European Commission’s working document on potential options
ESSNA remains committed to the objectives that should be reached with this revision:
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maximum potential for innovation for safe sports nutrition products;
product safety;
the possibility to communicate to consumers the intended use/suitability of our products;
equal market access across Europe/maximum harmonisation/optimal functioning of the internal market;
legal certainty for our products;
a minimum of regulatory burden which ensures flexibility and clarity for all businesses; and
consistency with other pieces of relevant legislation.
These objectives ESSNA feels are encompassed by the Commission’s own objectives of Public Health
Protection, Simplification, Harmonisation and SME and Innovation.
This latest paper reflects a majority consensus which believes that the establishment of specific sports nutrition
legislation is no longer necessary as the creation of such a specific directive would not deliver the objectives
outlined above and because it becomes increasingly difficult to maintain that sports nutrition is clearly
distinguishable from general foods as the sector is moving more into mainstream. The paper also records a
minority position taken by one of our members (please find their comments on Option 2 and 3 in Annex 1). Our
Members see sports nutrition mostly as products that aim to provide their target audience with the right amount
of nutrients (and are formulated as such), at the right time, in a convenient format, while also providing that
target audience with the information needed, indicating the products suitability.
The majority of ESSNA Members would therefore prefer Option 2 (repeal of the PARNUTS Framework Directive
but maintain some of the vertical legislation). ESSNA prefers this option because through the repeal of
PARNUTS it will be clear which products need specific legislation for public health reasons, providing clarity for
the consumer.
1
OJ L 124, 20.05.2009, p.21;
“Europe” is EU-27;
3
Euromonitor from trade sources/national statistics, Note: Historic regional/global values are the aggregation of local currency country data
at current prices, Date Exported (GMT): 16/03/2009 16:53:56, 2009 Euromonitor International (data includes on trade sales).
2
Option 3 (PARNUTS remains but the scope of the legislation is limited to categories of dietetic foods on a
positive list with specific compositional and/or labelling rules) will not provide this clarity as interaction and
confusion with other existing legislation would remain. Revision objectives would as such not be met under this
option, while achievable under Option 2.
ESSNA also recognises that Option 1 (repeal of all PARNUTS legislation) does not appear to be a feasible
option as most of the products covered by vertical directives do benefit from the specific legislation they are
falling under. ESSNA does not think that this option will deliver the revision objectives.
Please find below our additional comments on the negative and positive impacts presented by the Commission.
ESSNA also includes the strengths and weaknesses identified previously which remain relevant.
Option 1- Repeal all the legislation on dietetic foods- (framework directive and all vertical
directives)
o
o
o
This option is based on the idea that the PARNUTS concept is no longer justified because of the
confusion, inconsistency and borderline cases it created.
All foods previously covered under PARNUTS legislation, including vertical legislation would fall under
general food law
There will be no EU specific compositional and labelling rules for products addressed to specific groups
of the population
The Commission’s View
Negative impacts:
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Public health: reduction in consumer protection; Higher risk of having inappropriate
products for vulnerable groups of the population
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Internal market: Potential national rules on public health grounds
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Price: Sales advantage of being dietetic product lost:
e.g diabetic chocolate versus no added sugar chocolate – (or potential benefit to consumers,
other industries) ?
Positive impacts:
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Consumer protection: no specific status to foods where it is not necessary
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Consumer information: no conflicting or confusing labels (suitability versus claim)
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Internal market: notification regime repealed, no need for multiple applications, no different
outcome between MS
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SMEs easier access to market
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Simplification: less rules to comply with

Innovation?
ESSNA’s comments on the Commission’s negative impacts:
 Public Health: ESSNA agrees with this assessment. Most products falling under existing vertical legislation
benefit from strict rules for reasons of public health. As such, ESSNA agrees that there is a higher risk of
inappropriate products reaching vulnerable groups of the population, if all PARNUTS legislation were to be
repealed.
 Internal Market: national legislation that could be permissible on public health grounds would indeed hamper
cross-border trade. However, ESSNA also agrees with the Commission’s reasoning that it would be difficult
to establish national rules for sports nutrition on public health grounds. Currently PARNUTS does allow for
national legislation to be established until such EU legislation is established (Article 12.2 PARNUTS
Framework Directive). In case of repeal therefore, national rules for sports nutrition could only be
established on the ground of public health. Seeing how the industry has evolved over the last decade, it is
questionable that this could be justified.
 Price: the repeal of all PARNUTS legislation will not affect the price for sports nutrition products. The sport
nutrition price is determined by the price of the ingredients and the production processes used to ensure the
quality of the products.
ESSNA’s comments on the Commission’s positive impacts:
 While ESSNA recognised the positive impacts, our Members strongly believe that the negative impact of not
providing public health protection to those consumers most vulnerable, outweighs the benefits of repealing
all PARNUTS legislation.
Previous ESSNA comments of relevance:
This option is not a feasible option as most of the products covered by existing vertical directives do benefit from
legislation.
Option 2- Repeal Framework directive but keep some or all vertical legislation
o
o
o
o
o
PARNUTS concept is no longer justified for the same reasons as outlined above
Products presenting high risk for certain groups of consumers and commercialised widely within the
EU would continue to be covered (some or all of the current vertical rules)
High risk means: if compositionally not adequate and/or insufficient information could be prejudicial
for health
EFSA would be involved in the setting of compositional criteria
Other categories of food currently covered by PARNUTS would fall under general food law
The Commission’s View
Negative impacts:
 Perceived reduction in consumer protection?
 Price advantage of being a dietetic product lost (see option 1)
Positive impacts:
Same as in option 1 +
 Consumer protection: same high level of protection maintained across the EU
 Consumer information: additional rules maintained when needed
 Internal market: no national rules needed
 Innovation?
General ESSNA Comments on Option 2:
 ESSNA’s Members do not think that specific sports nutrition rules are needed for the protection of public
health.
 ESSNA does however see great benefits in conveying the necessary information on sports nutrition products
through the suitability statement.
 ESSNA members do not consider their sport nutrition products as high risk products.
 Sport nutrition products are widely commercialised within and outside Europe.
ESSNA’s comments on the Commission’s negative impacts:
 Perceived reduction in consumer protection?: ESSNA does not think that this will be the case as those
products warranting specific compositional and labelling criteria on public health grounds, and only those
products, will be covered by such specific legislation. Therefore, ESSNA feels that the perception of
consumer protection will only increase as only those products needing protection will have the appropriate
legislation in place.
 Price: the repeal of the PARNUTS Framework Directive will not affect the price for sports nutrition products.
The sport nutrition price is determined by the price of the ingredients and the production processes used to
ensure the quality of the products.
 Loss of suitability statement: ESSNA also sees the loss of the suitability statement for those products no
longer covered by PARNUTS as a negative impact- see below.
 Additional negative impact: EFSA involvement in the setting of compositional criteria: while EFSA would
provide a scientific assessment, what guarantees are in place that the risk managers - Parliament,
Commission and Council- will not eventually take a political decision?
ESSNA’s comments on the Commission’s positive impacts:
 ESSNA agrees with the identified positive impacts.
 Internal market: ESSNA welcomes the Commission’s clarification that no national rules are needed as all
those rules needed for public health reasons are already maintained at EU level. ESSNA would like to see
more assurances in place as any future/ existing national legislation for sports nutrition will/is hampering the
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internal market on invalid grounds. As many ESSNA Members are SMEs, it proves a too expensive option
to challenge the national rules and the competent authority when such national rules are established.
Innovation: as long as no specific legislation would be established for sports nutrition, there would indeed be
sufficient room for innovation.
Previous ESSNA comments of relevance:
Strengths:
 This option would allow for product innovation as no restrictive compositional criteria would be set;
 No additional regulatory burdens are being set provided no specific sports nutrition directive would be
set;
 Currently the PARNUTS Framework Directive allows for the setting of national legislation for sports
nutrition as no specific vertical sports nutrition directive has been set. The repeal of PARNUTS could
potentially prevent Member States from the setting of national legislation (apart from public health
grounds- however the setting of national rules for sports nutrition on public health grounds seem
unfeasible if EU legislation for products needing public health protection will be set) and national sports
nutrition legislation on grounds of public health could potentially be repealed;
 Tools contained within the new Mutual Recognition Regulation could be used to ensure market access
across the EU.
Weaknesses and outstanding questions:
 More clarity/assurances is/are needed on whether Member States would indeed be restricted in the
setting of national legislation if the PARNUTS Framework were to be repealed;
 Those sports nutrition products that could not find a home under already existing specific legislation
such as Food Supplements, Fortified Food, would fall under general food law;
 No intended use statements could be made. These intended use/suitability statements are currently
used by our Members to communicate information about their products that the consumer finds
important and useful as it relates to their health;
 How would the Commission ensure that useful and important statements explaining the suitable use of
the products could continue to be made by sports nutrition companies if PARNUTS were repealed?;
 The new Mutual Recognition Regulation is still a young tool and its effectiveness/added value has not
yet been completely proven;
 The interaction of sports nutrition products with nutrient profiles remain problematic, this will only be
exacerbated if sports nutrition were to fall under general food law. While some indication has been
given that the Commission is looking into a solution for those products where the health claims that has
been approved by EFSA is linked to the nutrient that fails the nutrient profile, more assurances have to
be given that a solution will indeed be provided for this large category of products;
 More clarity is needed on the detail for this option.
Option 3- Revision of the Framework Directive limiting the scope of categories of dietetic foods
to a positive list with specific compositional criteria and/or labelling rules
o
o
o
o
o
o
PARNUTS concept would be maintained but the scope would be limited to a positive list of groups of
food with specific compositional and labelling rules
No notification procedure
Foods not included in the list would fall under general food law
Establishing the positive list: it would focus on the pre-existing five specific pieces of legislation
(including Foods for special medical purposes and slimming foods) and the necessity or not to
have specific legislation for other categories (the working document mentions VLCDs, as an
example of such a category)
The other categories (such as VLCDs) and future additional categories could be added to the
positive if justified in terms of :
 satisfying the definition
 having their own distinct composition and labelling requirements that go beyond the general
food safety and labelling requirements to ensure public health protection
 sufficient cross-border trade within the internal market to justify EU intervention
Once again, EFSA would be called upon for the setting of the compositional criteria where they
would need to be set
The Commission’s View
Negative impacts:
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Reformulation and label change: additional requirements (composition+ labelling information)
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Interaction with other legislation remains complex – similar foods different statements
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One product may be compositionally sufficient for suitability statement, another may not be but
may be successful in using a similar claim
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E.g. diabetic food and low sugar food (nutrition claim) 
suitable for intense muscular effort or enhances endurance
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SMEs barriers
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Innovation?
Positive impacts:
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Consumer protection: compositional standards ensure composition for the targeted audience
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Consumer information: additional information on labels (balanced against potential confusion)
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Harmonisation: single set of rules at EU level, legal certainty
General ESSNA Comments on Option 3:
 The scope of the positive list of PARNUTS products should not be extended to include sports nutrition for
the following reasons:
o Compliance with PARNUTS definition?:
 Special and distinguishable from normal foods (special composition or manufacturing
process): it becomes increasingly difficult to maintain that sports nutrition is clearly
distinguishable from general foods as the sector is moving more into mainstream.
 Intended for specific groups of the population and not for the general population: this is
indeed the case; the products are intended for people engaging in intense muscular effort
(sportsmen), especially when producing for semi/professional athletes.
 Satisfy the particular nutritional requirements of the persons for whom they are intended:
this is indeed the case.
o Having own distinct composition and labelling requirements that go beyond the general food safety
and labelling requirements to ensure public health protection: such requirements are not needed for
public health protection when it comes to sports nutrition. ESSNA does however recognise that
such public health protection grounds do exist for the pre-existing five specific pieces of legislation.
o Sufficient cross-border trade: this is indeed the case- see above.
ESSNA’s comments on the Commission’s negative impacts for products included in the scope:
 Reformulation and label change: if sports nutrition would be included on the positive list this would indeed be
a negative impact, very costly to the industry while not bringing any additional benefits of increased
consumer protection.
 Labels: if sports nutrition is not included in the scope, the industry loses the possibility to inform consumers
about the suitability of the product.
 Innovation: this would be hampered tremendously as the sports nutrition industry is driven by innovation and
development. Strict criteria would not provide any incentives for further innovation.
 EFSA involvement in the setting of compositional criteria: while EFSA would provide a scientific assessment,
what guarantees are in place that the risk managers - Parliament, Commission and Council- will not
eventually take a political decision?
 SME barriers to having specific sports nutrition legislation? If sports nutrition were to be included in the
scope, this option would time-consuming and increase the time it takes to develop a product and bring it to
the market.
ESSNA’s comments on the Commission’s positive impacts for products included in the scope:
 ESSNA agrees with the Commission’s assessment for other PARNUTS categories. However, for sports
nutrition, no additional consumer protection is gained from being included in the scope of the positive list.
 However, if included, sports nutrition products such as isotonic drinks could continue to make the suitability
statement.
Previous ESSNA comments of relevance:
Strengths:
 If sport nutrition products were to fall under the scope of the positive list, harmonisation across Europe
should be possible. Harmonisation would reduce basic product costs to the company;
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Sports products would have a clearer legislative home, which will give rise to legal certainty for products;
and
The scope of products falling under the legislation would be clarified and interpretation issues would be
minimised.
Weaknesses and outstanding questions:
 This option could result in complex and lengthy legislation containing specific and fixed compositional
criteria, which would jeopardise product innovation and product development, both of which are
imperative goals of the sports nutrition industry;
 This option would be time-consuming and increase the time it takes to develop a product and bring it to
the market;
 The majority of the sports nutrition industry has repeatedly stated that they do not want specific sports
nutrition legislation for the above reasons;
 The notification procedure contained in specific pieces of legislation may remain;
 The length of the legislative process would also mean that the final piece of legislation would no longer
reflect current research and product marketed, making it redundant and problematic for the industry;
 The Commission is not supportive of specific sports nutrition legislation; and
 Defining the scope of such a directive can be problematic. ESSNA’s view is that the scope should be
narrow and not too wide (e.g. covering all products associated with “sport” would be too wide).
Option 4- Amending the Framework Directive replacing the notification procedure to a prior
authorisation procedure
o
o
o
o
o
o
Products falling under existing vertical legislation would not need prior authorisation as they already
have to comply with set compositional and labelling requirements- e.g. a slimming product under
Directive 96/8/EC would not need prior authorisation
Products under PARNUTS without specific rules would need prior authorisation before the product is
placed on the market as dietetic foods
Notification procedure would disappear, the authorisation procedure would be an EU level
procedure requiring scientific input by EFSA
The procedure would consider the composition of the product in light of the claimed nutritional
purpose i.e. the exercise would be the assessment of the composition of the product (e.g. the levels
of nutrients and other substances) in relation to the suitability statement (e.g. suitable for lactating
women).
After submission for authorisation and before EFSA involvement, Member States would have to
decide whether the food is bearing a 'dietetic' suitability statement or a nutrition or health claim in
order to choose the appropriate procedure (prior-authorisation under the nutrition and health claim
Regulation or prior-authorisation under the dietetic food legislation).
If the process would lead to a negative opinion, the product could still be put on the market, but
without the statements.
The Commission’s View
Negative impacts:
 Simplification: duplication system with claims?
Difficulty in procedural choice for MS and industry (the MS would have to assess if the specific
statement would have to follow the claims procedure under NHCR or the suitability procedure)
 Lengthy procedure (1 year): any delays would be very costly for the industry
 Innovation? - would this option still allow for innovation?
 Trade- how would this be affected?
Positive impacts:
 Consumer protection: prior-authorisation ensure sufficient nutrients for the targeted audience
 Consumer information: additional information on labels (again, the Commission balances this against
potential confusion as health claims may cause continued confusion)
 Harmonisation: single set of rules at EU level, legal certainty (balanced against MS decision on the
procedure to apply)
ESSNA’s comments on the Commission’s negative impacts:
 Simplification: duplication with claims?: in addition to the negative impact identified, uniform application
would be difficult to maintain: while one MS might say that the to follow procedure would be the health
claims procedure, another MS may conclude that the relevant procedure should be the suitability procedure.
 Innovation and barriers to trade for SMEs: the lengthy procedure would mean that innovation would slow
down and could only be taken forward by big multinationals as SMEs will have to prioritise where they put
their resources- application or innovation. In addition, if EFSA would charge fees for this application, the
cost would be even higher, with no guarantees for return in investment (not even if EFSA would return a
positive opinion, as the risk manager - Parliament, Commission and Council- could still take the decision not
to follow the EFSA opinion).
 EFSA dossiers: sufficient guidance would have to be given in advance of the first dossier submission so that
the criteria for the type of science, and what assessment standards will apply will be clear to the submitter.
 More clarity is needed how only suitability statements on future products will be covered, as this provides no
guarantees for past statements. Therefore consumer information is not necessarily improved.
ESSNA’s comments on the Commission’s positive impacts:
 ESSNA agrees with the impact identified.
 ESSNA thinks the benefits from the additional information outweigh the confusion raised by the Commission.
 Only those products could carry a statement for which the composition is deemed appropriate in relation to
the statement.
Previous ESSNA comments of relevance:
Strengths:
 Consumer care and safety in sports nutrition could be maintained through the dossier approval;
 Product innovation would not necessarily be obstructed (although this depends on the level of
substantiation that would be required for a product to be authorised);
 This option would ensure that only products with adequate compositional formulation would be put onto
the market if they want to make suitability statements;
 Prior-authorisation would only be applicable for future products;
 Prior-authorisation would not be required for products covered by vertical legislation; and
 Could remove barriers to trade, as once a product’s statement is authorised on a centralised EU level,
all Member States would have to allow the respective product and accompanying statement on the
market.
Weaknesses and outstanding questions:
 An authorisation procedure could cause serious delays between product innovation and access to
market for the product, which in turn could give rise to additional and significant costs for the
manufacturer/distributor;
 It would be essential that all Member States accept and understand the harmonised prior-authorisation
procedural rules and follow the same rules and interpretation to reach the initial assessment decision
which determines the to follow procedure;
 The scope of the framework would remain unclear and inconsistencies with other pieces of legislation
would not be clarified, meaning that legal uncertainty would remain;
 In order to avoid similar problems to those that have occurred with the Nutrition and Health Claims
Regulation, it would be essential that the processes, including any appeal processes, are clearly outlined
and that the level of scientific evidence required in the dossier is clearly defined and agreed upon in
advance;
 Given recent experiences with the authorisation procedure under the Nutrition and Health Claims
Regulation, this option would put a disproportionate burden on the manufacturer/distributor due to
amongst other reasons the delays that arise during such procedures;
 Past experiences involving EFSA’s scientific input have shown it does not ensure consistency and have
also put immense pressure and time constraints on companies. Therefore, most of our Members do not
want to experience a repeat exercise;
 Would the above consideration not mean a duplication of the Nutrition and Health Claims exercise?
 Do EFSA/national competent authorities have the necessary resources and/or expertise to take this
procedure forward? Especially in light of the current health claims experience;
 No legal certainty is guaranteed as authorisation of products will not be guaranteed;
 This option may limit innovation.
Conclusion
As illustrated above, all of our Members are in agreement with the objectives that should be reached with this
revision:
 maximum potential for innovation for safe sports nutrition products;
 product safety;
 the possibility to communicate to consumers the intended use/suitability of our products;
 equal market access across Europe/maximum harmonisation/optimal functioning of the internal market;
 legal certainty for our products;
 a minimum of regulatory burden which ensures flexibility and clarity for all businesses; and
 consistency with other pieces of relevant legislation.
ESSNA Members believe that these objectives, based on the available information, cannot be reached by either
Option 1, or Option 4. The majority consensus believes that, based on the available information, these objective
could be reached by Option two, provided that no specific sports nutrition legislation containing compositional
and labelling requirements would be set, as there is no public health ground for this. The position paper also
acknowledges a minority opinion, which (provisionally) prefers to see the revision objectives reached through
Option 3, as within that Member’s organisation wider interests than sports nutrition are at stake.
ESSNA hopes that this additional feedback aids the Commission in reaching a compromise solution that would
bring maximum benefits to the greatest amount of stakeholders possible.
June 2010
Contact
ESSNA Secretariat
c/o The Whitehouse Consultancy
Southbank House
Black Prince Road
London SE1 7SJ
United Kingdom
+44 (0)20 7463 0668
www.whitehouseconsulting.co.uk
Annex 1
As mentioned in the introduction, this paper also reflects the minority opinion of one Member, for which wider
interests than just sports nutrition are at stake (infant formulae, foods for special medical purposes).
This opinion is aligned with the majority of the Members regarding the objectives to be reached with the
PARNUTS Revision and regarding Options 1 and 4. It differs from the majority consensus on Options 2 and 3.
Option 2- Repeal Framework directive but keep some or all vertical legislation
Strengths:
 Products such as Sports foods/article 11 will be placed on the market as foods for normal consumption,
with no notification, etc.
Weaknesses:
 The concept of a dietetic food would no longer exist;
 Industry loses the PARNUTS definition. The definition is our guarantee of specificity vis-à-vis food for
general consumption;
 We also risk losing the innovation clause;
 We risk losing the ability to provide information to Health Professionals (HP). In some PARNUTS
categories (infant formula) or countries (FSMP) information to the final consumer is prohibited, so
information to the HP is essential.
 This option carries the risk that categories such as Sports foods/article 9 products could lose the status
of PARNUTS. When regulations such as the Nutrition and Health Claims Regulation are fully applicable
(end of transitional periods, article 13 list of permitted claims published, etc.), it will become more and
more difficult to get food categories accepted as PARNUTS; and
 It is possible that some categories of products or that some of the legislation/rules could be revoked.
This situation is not clear.
Option 3- Revision of the Framework Directive limiting the scope of categories of dietetic foods
to a positive list with specific compositional criteria and/or labelling rules
Strengths:
 This option may provide for legislation for sports foods, depending on discussions within the EC and
member states; and
 The EC leaves open the possibility that additional categories could be added to the positive list at a later
date.
Weaknesses:
 Industry will lose categories of PARNUTS not currently covered by vertical legislation (e.g., sports foods,
toddler’s milks, premature formulae, foods for diabetics etc.);
 This option may limit innovation; and
 Adding new categories on to the positive list once it is set will be highly improbable.