Annexes to COM(2016)402 - Food intended for sportspeople - Main contents
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| dossier | COM(2016)402 - Food intended for sportspeople. |
|---|---|
| document | COM(2016)402  |
| date | June 15, 2016 |
Taking into account that no specific composition requirements have been set for sports food classified as food intended for particular nutritional uses, only the above mentioned requirements apply in respect to their composition.
After 20 July 2016, a sports food classified as food intended for particular nutritional uses will be considered under horizontal rules of food law either as a food supplement, where it falls under the definition of Directive 2002/46/EC or, in accordance with Regulation (EC) No 1925/2006, as a fortified food.
In the case of fortified food, Article 6(6) of Regulation (EC) No 1925/2006 states that vitamins and minerals added to the food should be present at least in a 'significant amount' according to the definition laid down in Regulation (EU) No 1169/2011. In sports food, vitamins and minerals are sometimes added at lower level than that 'significant amount', to ensure that the composition of the product best addresses the requirements of the body when carrying out a particular sports activity. In that context, it should be taken into account that Regulation (EC) No 1925/2006 provides for the possibility of granting a derogation to the requirement of the ‘significant amount’ in justified cases for certain categories of food. Consequently, there is an appropriate basis in place under Regulation (EC) No 1925/2006 which would allow that sports food classified nowadays as food intended for particular nutritional uses could continue to contain less than the significant amount of vitamins and minerals after 20 July 2016.
With respect to the addition of substances other than vitamins and minerals, no harmonisation took place up to now for fortified foods under Regulation (EC) No 1925/2006 and for food supplements under Directive 2002/46/EC. Hence, Member States have the possibility to introduce national rules in this respect, in compliance with Articles 34 to 36 of the Treaty on the Functioning of the European Union 54 , as to any other food products today classified as food supplements or fortified foods. Where Member States intend to adopt such rules, Articles 11 and 12 of Regulation (EC) No 1925/2006 apply. The situation is similar regarding maximum level of vitamins and minerals where harmonisation has not taken place either. After 20 July 2016, when sports food classified previously as food intended for particular nutritional uses will be governed by horizontal rules, such national provisions will apply to sports food.
6.4.Aspects related to the notification required by national competent authorities
Article 11(1) of Directive 2009/39/EC requires notification for foods intended for particular nutritional uses which do not belong to one of the groups listed in Annex I to the Directive. Annex I lists those specific groups of foodstuffs intended for particular nutritional uses for which it was required to lay down specific provisions. Although sports food is listed in this Annex, no specific rules have been adopted. For this reason, different approaches have been introduced by Member States regarding notification, some requiring this for sports food classified as food intended for particular nutritional uses and some not.
After 20 July 2016, sports food previously classified as food intended for particular nutritional uses will have to comply with horizontal rules on food supplements or fortified foods. For food supplements and fortified foods, Member States may require notification for monitoring purposes. Whether a possible re-notification requirement for sports food previously classified as food intended for particular nutritional uses will be requested will depend on the decision of the Member States. Differences in this respect might be expected; however it should be noted that, already in the context of Directive 2009/39/EC, notification is not considered as a significant administrative burden for operators 55 .
6.5.Additional aspects
After 20 July 2016, all sports food will have the same legal status. This would foster competition between manufacturers and, at the same time, would positively influence the competitiveness of the sector concerned. This can positively affect the price of sports food. There might be however some negative implication on the competitiveness of the specific sector of sports food manufacturers currently operating under Directive 2009/39/EC that would lose its specific position.
Re-labelling and re-notification costs (if obligations for such notifications are introduced) will not be significant, but additional costs stemming from certain reformulation of sports food considered today as food intended for particular nutritional uses might appear in order to comply with the requirements of Regulation (EC) No 1925/2006 56 , 57 , 58 . Additional costs for sports food currently placed on the market under Directive 2009/39/EC can also be expected in the context of applications for authorisation of health claims. Changes in the enforcement practices of the competent authorities compared to the current situation are not expected 59 .
7. Summary of national competent authorities' and interested parties' positions
The majority of national competent authorities believe that the existing horizontal rules of food law are either quite suitable or very suitable for regulating sports food 60 . Six national competent authorities have recognised the need for specific rules for sports food 61 .
Operators are clearly divided on the question whether specific legislation is necessary for sports food or whether sports food should be governed by horizontal rules of food law 62 .
An industry group in favour of specific provisions would like to ensure, through the introduction of specific definition, composition and information requirements for sports food, that such food products are clearly distinguishable from normal food. According to this group, under the current horizontal rules of food law, the quality of the product, including its safety and suitability for the target group and the proper communication on sports food, cannot be guaranteed, in particular as far as Regulation (EC) No 1924/2006 on nutrition and health claims is concerned. The position expressed by this group states that this would discourage innovation since the authorisation of new health claims may be beyond the means of operators 63 .
On the contrary, another industry group considers that the applicable horizontal rules of food law are sufficient to govern the different aspects (e.g. food safety, composition, and information) related to sports food and that the absence of specific legislation prevents 'legislation shopping'. In their opinion, sports food is not addressed to particular groups of vulnerable people but is intended to the wide range of population carrying out sports activity for different purposes (e.g. athletes for professional purposes, lifestyle and recreational users for health and wellbeing purposes). This group of operators believes that the introduction of specific rules, including a definition for sports food, could lead to excessive provisions which would negatively impact innovation 64 . However, this group of operators considers that some specific aspects, in particular regarding nutrition and health claims, are not adequately addressed under the horizontal rules of food law.
It is a general concern of food business operators that legislation, either of horizontal or specific nature, should adequately allow the provision of relevant information for sports food with particular attention to the nutritional characteristics and the intended use. There is also agreement that certain measures introduced at national level, for example in relation to food supplements and fortified foods, can lead to barriers in the Internal Market and would negatively influence cross-border trade in the EU 65 .
Finally, it should be mentioned that food business operators have raised the issue of the use of doping substances. However, this is not relevant to the European food legislation and should be addressed on the basis of international and voluntary standards 66 .
8. Conclusion
There are clear indications that sport has become mainstream in the general population. Consequently, people carrying out sports activity can hardly be characterised as a specific vulnerable group of consumers but rather as a target group of the general population who is protected at an appropriate level by horizontal legislation.
In view of the growing completion of the horizontal rules of food law which took place in the last years, an appropriate legislative framework is in place to ensure that sports food classified nowadays as food intended for particular nutritional uses can remain on the market and can operate. The horizontal rules of food law provide the necessary safeguards for these products in terms of food safety, food composition, consumer information and legal certainty. As a result, not only all sports food products will be subject to the same legal requirements but they will have the same level of harmonisation as other foods falling under the horizontal rules of food law. It is expected that, through the simplification and clarification of the legal framework applicable for sports food, legal certainty will be enhanced and the current fragmentation based on the different legal frameworks reduced.
From this analysis, it can be concluded that there is no necessity for specific provisions for food intended for sportspeople. Nevertheless, sports food may include some element of specificity and the analysis in this report shows that this may have to be taken into account by the Commission in the application and implementation of the horizontal rules, so that such specificities can be adequately addressed. The Commission will ensure proper application of horizontal legislation and monitor the developments after 20 July 2016.
(1)
OJ L 181, 29.6.2013, p. 35.
(2)
OJ L 124, 20.5.2009, p. 21.
(3)
Council Directive on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, OJ L 186, 30.6.1989, p.27.
(4)
Study on food intended for Sportspeople – Final Report – Food Chain Evaluation Consortium (FCEC) - http://ec.europa.eu/food/safety/labelling_nutrition/special_groups_food/sportspeople/index_en.htm .
(5)
EFSA, Technical report on Scientific and technical assistance on food intended for sportspeople, approved on 24.09.2015, http://www.efsa.europa.eu/en/supporting/pub/871e .
(6)
The SCF Report concluded that the "concept of a well-balanced diet is the basic nutritional requirement for athletes". It further explained that "taking the aspects of intense muscular exercise in consideration (…) individuals can benefit from particular foods and food ingredients beyond the recommended dietary guidelines for the general population" and gave some advice on the nature and essential composition of sports food 28.02.2001 http://ec.europa.eu/food/fs/sc/scf/out64_en.pdf .
(7)
For the purpose of the consumer survey, the definition of sportspeople included the requirement to consume sports food at least once in the last year, FCEC Study, Section 3.3.1.
(8)
FCEC Study, Section 3.3.1.
(9)
FCEC Study, Section 3.1.1.1.
(10)
FCEC Study, Section 3.1.1.2, Table 3.1.
(11)
There are certain cases of borderline products which can be used by and might give the impression to be of interest for sportspeople. Still, because of their targeting of the general population, such borderline products were not considered as sports food when analysing the market in the context of the FCEC Study, FCEC Study, Section 3.1.1.3.
(12)
FCEC Study on the basis of data from Euromonitor, Section 3.2.1.1.
(13)
The largest Member State markets were: (1) UK (EUR 732m), (2) Spain (EUR 491m), (3) Germany (EUR 452m), (4) Italy (EUR 358m), (5) Sweden (EUR 185m), (6) Netherlands (EUR 153m) and (7) France (EUR 128m), FCEC Study on the basis of data from Euromonitor, Section 3.2.1.1.
(14)
FCEC Study, Section 3.2.1.1.
(15)
"The most suitable method identified for estimating the number of FISP [food intended for sportspeople] products on the market is based on innovation. According to industry interviewees, innovation at EU level in terms of new products represents between 8% and 12% of the products on the market in a given year.", FCEC Study, Section 3.1.1.4.
(16)
FCEC Study, Section 3.1.1.4.
(17)
FCEC Study, Section 3.1.1.5, Table 3.4.
(18)
FCEC Study, Section 3.1.3.
(19)
Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, OJ L 124, 20.5.2003, p. 36.
(20)
FCEC Study, Section 3.2.1.4, Table 3.13.
(21)
FCEC Study, Section 3.3.2, Figure 3-7.
(22)
FCEC Study, Section 3.3.2.
(23)
Other marketing techniques used in relation to sports food are: sponsoring of sports events, endorsement by famous sportspeople, specialised press advertising, mainstream media, world-of-mouth advertising, web marketing and internet communication, FCEC Study, Section 3.3.3.
(24)
28% list of ingredients, 19% expected results/effects, 18% consumption instructions, 14% side effects, 13% warnings on potential overdoses and 9% use of natural ingredients/procedures in the preparation, FCEC Study, Section 3.3.3, Figure 3-8.
(25)
FCEC Study, Section 3.3.3, Figure 3-9.
(26)
FCEC Study, Section 3.3.1.
(27)
FCEC Study, Section 3.3.1.1.
(28)
68% of sportspeople consume sports food in relation to sport activities, compared to just 15.6% of lifestyle users, FCEC Study, Section 3.3.1.1, Figure 3-3.
(29)
FCEC Study, Section 3.3.1.2.
(30)
57.7% of lifestyle users use sports food neither in the context of sport nor physical activity and this is only the case in 16.1% of sportspeople, FCEC Study, Section 3.3.1.1, Figure 3-3.
(31)
15.9% of sportspeople indicated that they consume sports food in relation to physical effort other than sport, compared to 26.7% of lifestyle users, FCEC Study, Section 3.3.1.1, Figure 3-3.
(32)
FCEC Study Annexes, Consumer Survey, Section 6.5, Figure 6-9.
(33)
20% of performance boosting products and 14.6% of protein-based products are consumed by lifestyle users in relation to wellness and health. Taste preferences have been indicated as the most important reason behind consumption of sports drink products (24% of lifestyle users and 9.4% of sportspeople; percentages which confirm and justify the efforts operators make to mainly innovate in terms of taste and flavours). Taste preferences have been indicated by 11.5% of lifestyle users as the reason for consumption of sport energy bars, compared to 4.8% of sportspeople, who mainly consume these products in relation to energy increase (27%) and energy recovery (24%), FCEC Study Annexes, Consumer Survey, Section 6.5, Figure 6-9.
(34)
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, OJ L 404, 30.12.2006, p. 9.
(35)
FCEC Study, Section 3.3.3.
(36)
FCEC Study, Section 3.3.3, FCEC Study, Annexes, Consumer Survey, Section 6.10, Table 6.3.
(37)
FCEC Study, Section 3.3.3, Figure 3-9.
(38)
FCEC Study, Annexes, Consumer Survey, Section 6.11, Table 6.4.
(39)
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1.
(40)
FCEC Study, Section 3.4.1.1.
(41)
Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, OJ L 109, 6.5.2000, p. 29.
(42)
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, p. 18.
(43)
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on addition of vitamins and minerals and of certain other substances to foods, OJ L 404, 30.12.2006, p. 26.
(44)
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, OJ L 183, 12.7.2002, p. 51.
(45)
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, OJ L 43, 14.2.1997, p. 1.
(46)
Regulation (EU) No 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, OJ L 327, 11.12.2015, p. 1.
(47)
European Commission, 2011, Proposal for a Regulation of the European Parliament and of the Council on food intended for infants and young children and on food for special medical purposes, COM (2011) 353.
(48)
Commission Staff Working Paper, Impact Assessment Accompanying the Document "Proposal for a Regulation of the European Parliament and of the Council on food intended for infants and young children and food intended for special medical purposes",
http://ec.europa.eu/food/safety/docs/labelling_nutrition-special_groups_food-impact_assessment_en.pdf .
(49)
FCEC Study, Section 3.3.4.1.
(50)
Claims relevant for sportspeople on caffeine are under discussion. EFSA Panel on Dietetic Products, Nutrition and Allergies, 2011, Scientific Opinion on a list of health claims pursuant to Article 13(1) (EC) No 1924/2006, EFSA Journal 2011;9(4):2054; EFSA Panel on Dietetic Products, Nutrition and Allergies, 2015, Scientific Opinion on the safety of caffeine, EFSA Journal 2015:13(5):4102
(51)
FCEC Study, Section 3.3.4.1.
(52)
EFSA Scientific and technical assistance on food intended for sportspeople, 29.09.2015, http://www.efsa.europa.eu/en/supporting/pub/871e .
(53)
Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses, OJ L 269, 14.10.2009, p. 9.
(54)
OJ C 326, 26.10.2012, p. 47.
(55)
FCEC Study, Section 4.2.1.1.
(56)
Operators reported one-off relabeling cost for sports food previously placed as dietetic food on the market. It was also reported that operators periodically re-label their products, FCEC Study, Section 4.2.1.1.
(57)
The need to reformulate could also stem from some national provisions, e.g. maximum levels of vitamins and minerals in food supplements which will only affect sports food when Directive 2009/39/EC is repealed, FCEC Study, Section 4.2.1.1.
(58)
Such costs might have a higher proportional impact on SMEs than on larger players, FCEC Study, Section 4.2.2.
(59)
On the basis of the survey carried out amongst national competent authorities, 41% of them did not foresee any changes to enforcement practices under this option and 18% only minor changes. Eight competent authorities (36% of respondents) foresee moderate changes under this option and one of them major changes, FCEC Study, Section 4.4.2.1.
(60)
FCEC Study, Section 4.4.1.1.
(61)
FCEC Study, Section 4.1.2.1.
(62)
These differences can be observed throughout the whole FCEC Study.
(63)
FCEC Study, Section 4.2.3.
(64)
FCEC Study, Section 4.2.3.
(65)
FCEC Study, Section 4.1.2.2.
(66)
Study on doping prevention, European Commission, 12. December 2014,
http://bookshop.europa.eu/en/study-on-doping-prevention-pbNC0514065/