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23 January 2013
In November 2012 the Swiss Federal Council adopted a revision of health claims legislation in order to harmonise it with EU law. The revision - which became effective on January 1 2013 - is intended to prevent the creation of new barriers to trade and to provide consumers with the same information that is available in the European Union. Instead of the approximately 30 claims currently admissible, more than 200 generic health claims will be available. The ban on health claims for slimming products has also been revoked.
A 'health claim' is any message or representation, in any form - including pictorial, graphic or symbolic - which states, suggests or implies that a particular relationship exists between a food category, a food or one of its constituents, and health - for example, 'calcium is needed for the maintenance of normal bones'. Nutrition claims, by contrast, are claims that state, suggest or imply that a food has particular beneficial properties - for example, 'low fat' or 'with no added sugars'.
In Switzerland, nutrition and health claims have been regulated by the Ordinance on the Labelling and Advertising of Food since March 2008. The relevant provisions closely follow the EU Regulation on Nutrition and Health Claims Made on Foods (1924/2006).
This regulation provides for the prohibition principle with the reservation of permission. Accordingly, health claims are, in principle, prohibited unless they:
EU member states were required to provide the European Commission with national lists of health claims by January 31 2008. The lists were scientifically assessed by the European Food Safety Authority. It was intended that, after consulting the authority, the commission would adopt the Community list of permitted claims and all necessary conditions for the use of these claims, by January 31 2010 at the latest. However, as the national lists contained more than 4,600 different health claims, implementation of the regulation triggered numerous discussions. The initial Community list with 222 health claims was finally adopted on May 16 2012 (Regulation 432/2012 - establishing a list of permitted health claims made on food, other than those referring to the reduction of disease risk and children's development and health). More than 1,600 existing claims were not approved for the Community list, which has had significant implications for product positioning strategies. Some other health claims - namely those concerning certain plant or herbal substances (botanicals) - have been put on hold and are still awaiting review by the European Food Safety Authority.
The Community list applies from December 14 2012. From this date, only authorised claims and on-hold claims are permitted. The authorised health claims, their conditions of use and applicable restrictions, if any, as well as the non-authorised health claims and reasons for their non-authorisation can be viewed in the Community Register.(1) For example, for water, the claims 'water contributes to the maintenance of normal physical and cognitive functions' and 'water contributes to the maintenance of normal regulation of the body's temperature' are authorised and hence permissible. In contrast, claims that 'water is an essential nutrient for life' or 'water helps all body functions to work properly' are no longer lawful, as the European Food Safety Authority considered that the claimed effects were not sufficiently defined and therefore could not be assessed. For biotin, seven health claims were authorised, in particular concerning the relationship between biotin and normal hair, skin and mucous membranes, normal energy-yielding and macronutrient metabolism, as well as normal functioning of the nervous system. By contrast, biotin may no longer be advertised as being necessary for healthy hair, teeth, bones, skin and nails.
Swiss health claims legislation
Under the Ordinance on the Labelling and Advertising of Food, health claims were previously permissible if they:
By amending the ordinance in March 2008, the regime was changed. During the transitional period the use of previously valid health claims is still allowed. However, it is advisable to keep an eye on the health claims that were not authorised by the European Union and, if required, to stop using them in Switzerland, since they were often rejected due to a lack of scientific substantiation or because they did not refer to a specific nutrient, substance, food or food category (but rather the product itself). At the end of the transitional period, health claims may be used only if they are listed in Annex 8 of the ordinance or if they have been individually authorised by the Federal Office of Public Health and fulfil the general requirements of Article 29c and following of the ordinance (ie, labelling and advertising requirements). Annex 8 contains a positive list of generic health claims permissible in Switzerland. However, these generic health claims may be used before the transitional period expires, provided that the general requirements of Article 29c and following and the specific conditions for the health claim are met. The Federal Office of Public Health authorises health claims that are not listed in Annex 8 if they are substantiated by scientific evidence and are not misleading.
In the November 2012 revision of the ordinance the transitional period was extended until December 31 2013. From 2014 onwards, products with previously valid health claims may be sold to consumers only until stocks are exhausted. Starting January 1 2014, products with previously valid health claims cannot be placed on the market or be advertised with previously valid health claims.
Harmonisation with EU Law
Nutrition claims under Swiss law are already regulated coherently with EU law. The revision of the Ordinance on the Labelling and Advertising of Food concerns health claims only and leads to a harmonisation of Annex 8 with the Community list. The approximately 30 health claims so far authorised in Annex 8 are extended to more than 200 generic health claims. For instance, for vitamin B12, only the health claim 'vitamin B12 is necessary for blood formation' was hitherto listed in Annex 8. By contrast, the new version of Annex 8 lists a wide range of health claims. In addition to the corresponding claim 'vitamin B12 contributes to normal red blood cell formation', seven other generic health claims, such as 'vitamin B12 contributes to the reduction of tiredness and fatigue' or 'vitamin B12 contributes to normal functioning of the nervous system', are available. The revision thus allows for a choice of health claim most suited to the product's target group without having to go through the Federal Office of Public Health authorisation procedure.
The claims for activated charcoal, lactulose, melatonin and Monascus purpureous (red yeast rice) were not taken over, as in Switzerland they fall under therapeutic products legislation rather than food law. In addition to the health claims provided for in the Community list, Annex 8 contains a health claim for the relationship between folate and the development of the neural tube of an unborn child. Further, claims concerning fluoridated and iodised table salt are still possible pursuant to the Ordinance on the Addition of Essential or Physiologically Beneficial Substances to Foods.
The new version of Annex 8 does not contain a health claim for every nutrient, substance, food or food category which was hitherto foreseen in the previous version of Annex 8 (eg, oligofructose and inulin). Neither were all health claims taken over into the new version. Further, the specific requirements of some health claims have changed - for example, health claims for vitamins were previously permissible if at least 30% of the recommended daily allowance for adults was contained in a daily ration. Under the new version of Annex 8, vitamin health claims may be used only for food which, at the expiry date, contains at least 15% of the recommended daily allowance per 100 grams or 100 millilitres, or per package if the package contains only a single portion. This is also a harmonisation with EU law, but it may cause a previously lawful use of health claims to become prohibited.
The revision to the Ordinance on the Labelling and Advertising of Food entered into force on January 1 2013. The health claims listed in the new version of Annex 8 may be used if the general requirements of Articles 29c and following and the specific conditions of the claim are met. Once the transitional period has expired, Articles 29c and following will apply without restriction, so that only health claims in Annex 8 or those authorised by the Federal Office of Public Health will be permissible, but not previously valid health claims. The same transitional regime applies to health claims listed in the former version of Annex 8. For instance, the health claim 'vitamin A is necessary for normal growth' may be used until the end of 2013. However, after this date authorisation by the Federal Office of Public Health will be necessary, as the health claim is not contained in the new version of Annex 8. By way of another example, for inulin Annex 8 has so far listed the health claim 'inulin has a positive effect on intestinal flora'. However, the European Food Safety Authority has rejected all inulin-related health claims, because the food constituents - inulin-type fructans - were not sufficiently characterised in relation to the claimed effects. There are no inulin-related health claims in the Community list or, accordingly, in the new version of Annex 8. Hence, the inulin-related health claims provided for in the previous version of Annex 8 may be used until the end of the transitional period, after which authorisation will be required. To what extent the rejection of a health claim by the European Food Safety Authority will have a prejudicial effect on the authorisation practice of the Federal Office of Public Health is uncertain. However, since the European Food Safety Authority has, in general, scientifically assessed the health claims, it is likely that such health claims will be authorised in exceptional cases only. In view of the significant changes to legislation, food companies are strongly advised to verify whether the health claims they use still comply with the new Swiss legislation.
No Cassis de Dijon principle for health claims
Given the autonomous introduction of the Cassis de Dijon principle in Switzerland, products which have lawfully entered the EU market can, in principle, freely circulate in Switzerland without prior approval. However, there are special provisions relating to food. Given the so far overly complex legal framework in the European Union, health claims are excluded from the Cassis de Dijon principle during a transition period. In the course of the revision to the Ordinance on Food and Basic Commodities, the transition period was extended until December 31 2013. Until then, the use of health claims in the Swiss market is exclusively governed by the Ordinance on the Labelling and Advertising of Food.
Health claims for slimming products
Article 10(2)c of the Ordinance on Food and Basic Commodities was amended from January 1 2013. The previous version prohibited, among other things, references of any kind that indicated or gave the impression that a certain food product was a slimming product. The ban was, to an extent, relaxed by the specialised food products legislation. In the new version of Article 10, the ban on health claims for slimming products was also abolished for normal food products.
This change was necessary to avoid inconsistencies with the revised Ordinance on the Labelling and Advertising of Food, as the health claims that promote a slimming or weight-control effect were taken over in Annex 8 (eg, 'glucomannan in the context of an energy restricted diet contributes to weight loss' or 'substituting one daily meal of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss').
For health claims on slimming products, the same rules apply as for other health claims. Until the end of the transitional period on December 31 2013, they are permissible if they comply with the requirements for previously valid health claims. However, the health claims in Annex 8 may be used from January 1 2013 if the general requirements of Article 29c and following of the Ordinance on the Labelling and Advertising of Food are fulfilled. When the transitional period expires, only the generic health claims contained in Annex 8 or those authorised by the Federal Office of Public Health may be used, provided that they do not make reference to the rate or amount of weight loss (eg, 'glucomannan helps you lose two pounds a week' will not be authorised).
The EU Community list of May 2012 provides comprehensive regulation of generic health claims. About 200 applications are pending and it is unclear how the approximately 2,000 applications relating to botanicals will be handled. Completion of the review process was put on hold in September 2010. Currently, it is under discussion whether to adapt the regulatory scheme for botanical health claims, as otherwise most claims would probably be disallowed, or whether to exclude botanicals from the scope of application of the EU Regulation on Nutrition and Health Claims made on Foods. Until a final decision has been reached, botanicals are subject to the respective national law of the EU member states in accordance with the regulation's transitional rules. The Federal Office of Public Health will follow the developments and may make further adjustments to Annex 8 as necessary. It is also possible that the Swiss transitional period will be extended for botanicals.
If no health claim has been authorised for a product, or previously valid health claims are no longer available, the question of appropriate reaction emerges. In the European Union, the following trends have become apparent:
These considerations could also be of interest to Swiss food companies.
For further information on this topic please contact Markus Frick and Manuel Bigler at Walder Wyss & Partners Ltd by telephone (+41 44 498 98 98), fax (+41 44 498 98 99) or email (firstname.lastname@example.org or email@example.com).
(1) See http://ec.europa.eu/nuhclaims/.
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