health claims

New health claim on creatine approved by Lara Skoblikov

The European Commission has approved the health claim "Daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55". 

The claim may be used only for foods targeting adults over the age of 55, who are engaged in regular resistance training.

In order to use the claim, information shall be provided to the consumer that:

  1. The claim is targeting adults over the age of 55, who are engaged in regular resistance training,
  2. The beneficial effect is obtained with a daily intake of 3 g of creatine in conjunction with resistance training, which allows an increase in the workload over time and which should be performed at least three times per week for several weeks, at an intensity of at least 65 %-75 % of one repetition maximum load (repetition maximum load is the maximum weight or force an individual can exert in a single lift).

This is the second authorized health claim for creatine. In 2012, the European Commission approved "Creatine increases physical performance in successive bursts of short-term, high intensity exercise". Several other claims have been rejected, among which "Creatine improves mental attentiveness also in the elderly".

Italy: new fines of up to €40K for incompliant health claims by Sebastian MELCHOR

Italy has adopted new provisions on fines for not compliance with health and nutrition claim rules. The rules of the Decreto Legislativo foresee specific fines for different infringements of Regulation 1924/2006, and related legislation. 

Fines for unauthorized claims on alcoholic drinks vary from €5,000-€20,000, not including the nutrition declaration can carry a fine of €2,000 to €16,000. The highest fines, of up to €40,000, are foreseen for using claims which suggest that health could be affected by not consuming the food; claims which make reference to the rate or amount of weight loss or claims which make reference to recommendations of individual doctors or health professionals and unauthorized associations.

DECRETO LEGISLATIVO 7 febbraio 2017, n. 27

Trademark exception in Claims Regulation interpreted broadly by Sebastian MELCHOR

According to a recent ruling by the Court of Justice of the EU, the exception for trademarks laid down in Article 28(2) of the Claims Regulation also applies to product marketed as a medicinal product before 2005 and subsequently marketed as a foodstuff, provided that they had the same physical characteristics and bore the same trade mark or brand name.

Pursuant to Article 28(2), products bearing trademarks or brand names existing before 1 January 2005 which do not comply with that regulation may continue to be marketed until 19 January 2022, after which time the provisions of the Claims Regulation will apply.

German firm Nelsons was selling ‘Bach Flowers’ remedies as medicinal products using the trademark RESCUE, which was then registered for medicinal products. In 2007, Nelsons also registered RESCUE as a trademark for foodstuffs. A ruling by the Higher Regional Court in Hamburg, had held that ‘Bach flower’ remedies were not medicinal products, but foodstuffs. Following that judgment, Nelsons, began marketing the remedies at issue not as medicinal products, but as foodstuffs, without making any changes to them.

‘RESCUE DROPS’ and ‘RESCUE NIGHT SPRAY’ suggested to the consumers that the use of the Nelson remedies was recommended so they can be ‘rescued’ when facing certain health problems. As such, they were considered reference to general, non-specific benefits for overall good health and health-related well-being, within the meaning of Article 10(3) of the Clams Regulation.

The question was whether the exception in Article 28(2) was applicable in the situation at hand, where the trademark was used in products marketed as medicinal products that were only marketed as foodstuffs after 2005.

The Court ruled first that the term “products” in that provision refers to foodstuffs, since according to Article 2 of Regulation No 178/2002, to which Article 2(1)(a) of the Claims Regulation refers for the definition of ‘food’, that definition does not cover ‘medicinal products’.

Then, the Court went on to say that the products were “objectively” foodstuffs “both during the relevant period with regard to Article 28(2) of that regulation, that is before 1 January 2005, and now”. For that reason, they were classified as ‘products’ within the meaning of Article 28(2) of the Claims Regulation and the exception applied.

Judgment of the Court (Third Chamber) of 23 November 2016 In Case C‑177/15, Nelsons GmbH v Ayonnax Nutripharm GmbH, Bachblütentreff Ltd.

EFSA updates scientific guidance on claims on immune system and gastro-intestinal tract by Lara Skoblikov

EFSA has issued an extended Guidance on the scientific requirements for claims related to the immune system and gastro-intestinal tract. This guidance replaces the 2011 guidance on the scientific requirements for health claims related to gut and immune function.

An interesting topic discussed in the new Guidance is the differentiation between the principles applied to the evaluation of health claims based on the essentiality of nutrients and those applied to other claims. Several claims on vitamins and minerals and general immune function (e.g. vitamins C, D, A, B12, B6, zinc, copper, folate, iron, selenium) have received favorable opinions on the basis of the well-established biochemical role of such nutrients, and/or on deficiency symptoms involving the immune system. Interestingly,  For these claims, the NDA Panel did not review the primary scientific studies submitted and it did not weigh the evidence. 

This is in sheer contrast with EFSA's regular approach. In practice, favorable opinions are  issued only on the basis of human intervention studies which may be supported by a known mechanism of action. The new Guidance provides useful examples of applications that have been evaluated with a positive outcome to indicate the number, type and quality of studies that may be needed for substantiation of a claim, as well as examples of applications with an unfavorable outcome to illustrate the kind of shortcomings that can prevent the substantiation of certain claims.

 

 

ASA confirms Comparative Efficacy Claim falls outside of scope HCR by Lara Skoblikov

In its recent ruling, UK Advertising Standards Authority ASA confirmed that the statement "WORKS TWICE AS FAST AS ANY OTHER ENERGY GEL" falls outside the scope of Regulation 1924/2006 on nutrition and health claims and therefore does not need an authorization.

Indeed, it can be defended that claiming that a product "works twice as fast" does not per se suggest a relationship between the product and health, as per the definition of "health claim" in the Regulation. 

Similarly, EFSA has considered on numerous occasions that claiming that a nutrient has improved bioavailability does not refer to a relationship between a food/food constituent and health. 

This provides an opportunity to food business operators to use certain marketing claims without the need for an authorization. However, it should be done with great caution. In particular:

  • The statement should be substantiated with adequate evidence. In the case at hand, the defendant could provide a study which was considered flawed and had not compared the product with all other competitor products on the market. The ASA therefore considered the claim misleading and instructed the defendant to remove it from the labelling.
  • Claiming that a food or nutrient is capable of increasing the bioavailability of other nutrients is considered a health claim. For example, the claim "Vitamin C increases iron absorption" is an authorized health claim.
  • While the ASA did not take this into consideration in the ruling at hand, the claim "works twice as fast" could still imply an effect on health depending on the context. In fact, "works twice as fast as other energy gels" could suggest that the product provides twice as much energy. This could be considered a reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being in the sense of Article 10(3) of the Regulation and should be accompanied with a related specific permitted claim such as "contributes to normal energy-yielding metabolism", which is authorized for several nutrients.

 

Autocontrol backs the wrong horse by Lara Skoblikov

The Spanish self-regulatory agency for advertising Autocontrol issued a very questionable interpretation of the nutrition claim "no added sugars". Fortunately, it makes for a nice regulatory analysis.

The claim "no added sugars" was used on a custard product containing chocolate. According to the nutrition declaration, it contained 6 g of sugar/100 g. It was accompanied with the statement "contains naturally occurring sugars in the milk and chocolate".  Autocontrol considered that the nutrition claim was used in accordance with Regulation 1924/2006 on nutrition and health claims.

Let's have a closer look.

Pursuant to Regulation 1924/2006, "a claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’".

The Regulation distinguishes between sugars that are added to the food on one hand, and sugars naturally present in the food on the other hand. Autocontrol assumed, apparently without any careful consideration, that the sugar was "naturally present" in the chocolate. It considered that the product therefore did not contain any added mono- or disaccharides or any other food used for its sweetening properties in the sense of Regulation 1924/2006 and that the claim was lawfully used. 

Regulation 1924/2006 is however not an isolated instrument, but should always be read together with the rules in Regulation 1169/2011 on labelling, which lead us to a very different conclusion. 

Pursuant to Regulation 1169/2011, ‘ingredient’ means "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; residues shall not be considered as ‘ingredients".  A ´compound ingredient’ means "an ingredient that is itself the product of more than one ingredient".  

The designation 'chocolate' is reserved under EU law for products produced of cocoa and sugar. According to the above labelling definitions, it is a "compound ingredient", with sugar being one of its ingredients which is added during the manufacturing process. By using chocolate in a product, sugar is added as an ingredient, precluding the use of the claim "no added sugars".  

Sugar can also be naturally present in an ingredient, for example in milk or fruit. In this case, sugar is not an ingredient "used in the manufacture or preparation of a food" in the sense of Regulation 1169/2011, but already present in the raw material and a "no added sugars" claim would be possible, as long as it is used together with the statement "contains naturally occurring sugars".

The above conclusion is supported by the Codex Alimentarius Guidance for Use of Nutrition and Health Claims. Codex standards are not binding, but should be considered an important interpretation tool for EU legislation. The Guidance explains that a “no added sugars” claim may be made provided – among others – that “the food contains no ingredients that contain sugars as an ingredient (Examples: jams, jellies, sweetened chocolate, sweetened fruit pieces, etc.)”.

Autocontrol rulings do not have normative status, but can give useful guidance on how claims can be used. The present case is an example of how it can sometimes be wiser to perform your own assessment instead. 

 

EU approves new probiotic strain as novel food by Sebastian MELCHOR

The EU has recently authorized the marketing of heat-treated milk products fermented with probiotic strain Bacteroides xylanisolvens (DSM 23964), in what constitutes another probiotic approval as a novel food in the EU after Clostridium butyricum (CBM 588) was authorized last December 2014.

Whilst there is no positive list of individual strains which enjoy a probiotic status at EU level, EFSA  has adopted a “Qualified Presumption of Safety” concept which provides a generic assessment system for use within EFSA that, in principle, can be applied to all requests received for the safety assessments of microorganisms deliberately introduced into the food chain. QPS status informs on the safety of a microorganism and is used without prejudice to any other legal requirements. Therefore, the species granted with QPS status (e.g. L. acidophilus, L. brevis, L. casei, L. helveticus, L. plantarum, L. reuteri, L. rhamnosus, etc.) have been granted a presumption of safety[1].

According to the EU specifications, heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture. The description is “semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens”.

Some Member States have adopted positive lists of probiotics[2] and others have laid down certain conditions for naming specific strains as such[3].

There is no EU-wide definition of the terms “probiotic bacteria” or “probiotics”, nor has their use in food been regulated under EU regulations.

Ban on the use of “probiotics” still in place  

The use of the term “probiotics” for foods is currently subject to a de facto ban in the EU. The ban has its origin in the qualification of the term as a health claim in the Commission Guidance on Nutrition and Health Claims of December 14, 2007 as it is argued that the naming of this category of substances contains an implied health benefit. The ban has been severely criticized for the lack of a sound legal basis, and has had significant implications for the probiotic industry. In addition, it has been stated  the ban jeopardizes the right of consumers to access the necessary information to make choices in full knowledge of facts, by restricting the provision of information about the true nature of foods containing probiotics.

 - COMMISSION IMPLEMENTING DECISION (EU) 2015/1291 of 23 July 2015 authorising the placing on the market of heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964) as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council

[1]       Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal (2007) 587, 1-16.

[2]          See, inter alia, the publication of the Belgian Superior Health Council No. 8651: Probiotics and their implications for Belgian public health. Part 1: Microbiological characterization, of February 1, 2012.

[3]       See Italian Ministry of Health’s Guidelines on Probiotics (Linee guida sui probiotici, Ministero della Salute, Dipartimento Sanita Pubblica Veterinaria, Sicurezza alimentare e degli organi collegiali I direzione generale igiene e sicurezza degli alimenti e della nutrizione ufficio IV; Commissione unica per la dietetica e la nutrizione; Revisione 2011).

Botanical claims status upheld, EU Court rules by Sebastian MELCHOR

The decision of the European Commission to adopt a partial list of health claims and allow more than 2,000 botanical claims to continue to be used until EFSA completes their evaluation did not infringe EU law, according to a recent ruling of the General Court (the previous Court of First Instance of the EU).

The ruling dismissed an attempt by several trade associations and health food companies to annul Commission Regulation 432/2012 establishing a list of permitted health claims on several grounds relating to general principles of EU law.

In that regulation, the Commission authorised a partial list of 222 health claims. On the same date, it identified a list of more than 2,000 claims in respect of which the EFSA had not completed its evaluation or the Commission itself had not yet completed its consideration, and published that list on its webpage. According to the Commission, those on-hold health claims, which concerned, mainly  botanical substances, remained on hold and therefore could continue to be used in accordance with the transitional scheme provided for in Article 28(5) and (6) of Regulation No 1924/2006.

The applicants accused the Commission of not having a legal basis for splitting the authorisation procedure for health claims into several stages or for granting additional transitional measures to the claims put on hold. They also invoked an infringement of the principle of legal certainty as it was not possible to identify, with clarity and precision, the on-hold claims from those which have been rejected.

The Court remained unconvinced and rejected all arguments presented against the Commission’s way of action. It stated that there was nothing in Regulation 1924/2006 which suggested that the EU legislature sought to deprive the Commission of its discretionary power to establish that list on a gradual basis. Further, this  approach did not result in the adoption of several lists, as claimed by the applicants, but rather in the adoption of a single list which is added to gradually. It also stated that the Commission had set out “in a clear manner the reasoning behind its decision to adopt the list of permitted claims in stages, thereby enabling interested parties to understand the justification for that decision and the consequences thereof”.

A piece of advice to the Commission  

The Court also had a ‘better legislation’ tip for the Commission, and it stated that “it would have been desirable to adopt, for both the on-hold claims and the rejected claims, a list bearing a similar format to the list of permitted claims, annexed to Regulation No 432/2012, in order to make the task of identification easier for interested parties”. However,  the fact that the Commission adopted a different approach was not sufficient to support the applicants’ complaint of a lack of legal certainty.

More than 2,000 on-hold claims may be used under the responsibility of the food business operator, provided that they comply with the general principles established in Regulation 1924/2006 (mainly, that they are scientifically substantiated in the sense of Article 6 thereof) and the national provisions of the Member State where it is used.

Ruling of the General Court (Eighth Chamber), of 12 June 2015 in Case T‑296/12, The Health Food Manufacturers’ Association and others v Commission

‘Health Claim’ Definition to Be Interpreted Widely, EU Court Rules by Sebastian MELCHOR

In its first judgment on Regulation 1924/2006 on nutrition and health claims made on foods, the Court of Justice of the EU adopted a broad interpretation of the definition of “health claim” by ruling that claims for merely temporary or fleeting effects of a food on human health, such as in the claim "easily digestible", are indeed health claims (Case C-544/10 Deutsches Weintor).

A health claim is defined as any claim that states, suggests or implies that a relationship exists between food and health. The Court stressed that since this definition does not provide information as to whether that relationship must be direct or indirect, or as to its intensity or duration, the term relationship “must be understood in a broad sense”. 

Regulation 1924/2004 prohibits beverages containing more than 1.2% by volume of alcohol from carrying health claims. A German wine was described on its label as "easily digestible" accompanied by a reference to reduced acidity. The Court was asked in essence whether that amounted to a health claim.

It was argued that, since digestion had only temporary or fleeting effects, a description such as "easily digestible" was not a health claim because it did not imply that the beneficial nutritional or physiological effect led to a sustained improvement in physical condition.

The Court rejected that argument. It ruled that "health claim" covered not only an implication that health would improve as a result of consuming a food but also an implication that adverse or harmful effects on health which would otherwise accompany or follow such consumption were reduced or absent. Moreover, a health claim refers not only to the temporary or fleeting effects of a specific instance of consumption of a food but also to the effects of repeated, regular, even frequent consumption. 

A claim which suggests that a wine is readily absorbed and digested implies that the digestive system will not suffer, or will suffer little, and will remain relatively healthy and intact even after repeated consumption over an extended period of time. The claim might therefore suggest a sustained beneficial physiological effect (consisting in the preservation of a healthy digestive system) in contrast to other wines.

Demarcation “objective information” vs “health claims” unresolved

Contrary to the Opinion of the Advocate General Mazák delivered on 29 March 2012 on this matter, the Court did not embark on the heated discussion of whether objective, factual statements linking consumption of a food and effects on human health (e.g. “glucosamine is an essential component of cartilages”) fall under the definition of health claim. According to Mazák, whilst the definition of health claim “is framed in fairly general terms”, “for there to be a health claim within the meaning of [Regulation 1924/2006], the description must imply that the food concerned has … specific health benefit or beneficial physiological effect”.