The firm of Nutrisciences advises and represents the food industry in matters related to food law and the sciences surrounding its application. This includes provisions related to labelling; health claims, and the broader issues surrounding the successful marketing of functional foods, beverages and dietary supplements. Read more...
On 5th December at the latest meeting of the Standing Committee. In a press release from the Commission they current status and details of the health claims voted into law and those awaiting a final decision, what will happen re enforcement etc are discussed….More to follow!
SOURCE: http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/11/868
The 29th of September 2011 see the final adoption by the European Commission (EC) of the Food Information for Consumers Regulation (FIR). After some 8 years in the making the process has finally come to a conclusion despite concerns in as late as May of this year of a collapse due to issues over Country of Origin labelling.
The new labelling rules will enter into force 20 days after their publication in the Official Journal of the EU (i.e. end of November). Food business operators will then have 3 years to adapt to most of the mandatory labelling provisions. For nutrition labelling, two scenarios have to be distinguished:
1. Businesses already providing nutrition labelling will have a 3-year transition period.
2. Businesses that never provided nutrition labelling will have a 5-year transition period.
The regulation will have a selection of impacts on current labelling requirements.
Further detail can be found at:
http://tinyurl.com/6a4vhmd
After 3 long years the 13.1 list of health claims have been reviewed by EFSA’s NDA panel….see there comments here!
http://www.efsa.europa.eu/en/press/news/110728.htm
In EFSA 5th batch released today some of the sports nutrition markets biggest ingredients have taken a pounding. The following is a brief overview of the opinions on this batch of health claims as they relate to the weight loss and sports nutrition industry…..
Sports Nutrition outcomes:
HMB – Rejected
RIBOSE – Rejected
SODIUM PHOSPHATE – Rejected
L-GLUTAMINS -Rejected
CASEIN HYDROLYSATES – Rejected outside of general protein claims
CREATINE – Rejected for memory & Attention
CARBS + Electrolytes – Approved with specific formulation requirements for hydration and performance
SODIUM – Accepted for muscle function
L-CARNITINE – Rejected
ASTAXANTHIN -Rejected
Weight management outcomes:
PHASEOLAMINE – Rejected
L-CARNITINE – Rejected
CAPSAICIN – Rejected
5-HTP- Rejected
MCT – Rejected
And the story continues….
According to a recent communication from the EC, member states will be allowed to forward for further EFSA assessment claims made on micro-organism (not sufficiently characterised). Furthermore, claims for which EFSA concluded that “the evidence provided is insufficient to establish cause and effect relationship” rather than “a cause and effect relationship has not been established” will be allowed to submit new evidence.
Three months has been allowed for the submission of new data following member states contacting stakeholders for additional evidence. New submissions opened on the first of June and will close 30th September 2011 as an extension to the process described in Article 13(2) and 13(3).
Member states will have until 31 October to complete their validation of submissions and administrative checks and forward the submissions to the Commission services.
In an adjudication by the UK’s Advertising Standards Authority (ASA) on the 6th April on of the UK’s largest vitamin companies Vitabiotics Ltd was challenged over b-vitamin and product based health claims. The claims included:
Challenge of the claim
The complainant challenged whether the claims in ads that recent research had shown that B vitamins could help maintain brain function and mental performance was misleading, because they understood that the research referred to did not support that conclusion.
Response to challenge by Vitabiotics
Vitabiotics Ltd (Vitabiotics) said, as one of the country’s largest and most respected vitamin supplement companies, they strived to ensure all of their marketing communications were accurate and fully compliant with the CAP Code.
Vitabiotics provided a copy of the research referred to in the ad, but said they did not make the claim in either ad that recent research had shown that B vitamins could help maintain brain function and mental performance. They said the statement on the pack “to help maintain brain function and performance” referred to the Neurozan Plus product as a whole, and not the mention of the research news. They argued that no conclusion or claim at all was made in relation to the research news and said the claim “Also includes the specific B vitamins reported in ground-breaking research” referred to the fact that the nutrients found in Neurozan had been positively featured in recent research.
Vitabiotics said, regardless of the arguments they had put forward, no further ads would feature the claims unless they were deemed acceptable by the ASA.
Assessment
The ASA noted that Vitabiotics did not believe the ads made any claims about the effect of B vitamins on brain function and mental performance. However, we considered that the claims “To help maintain Brain Function & Performance.” and the related marketing text would be interpreted by readers to mean that B vitamins could help maintain brain function, performance and memory, and that that was supported by recent, pioneering research.
We noted that the study provided by Vitabiotics was a randomised, double-blinded, controlled trial which assessed whether supplementation with high doses of folic acid (vitamin B9) and vitamins B6 and B12 could slow the accelerated rate of brain atrophy in those with mild cognitive impairment (MCI). We noted the 168 study participants were all aged over 70 and had a diagnosis of MCI, and that some participants had other health concerns such as diabetes and history of strokes, and we therefore considered that the study was unsuitable to support claims likely to be understood as referring to the normal, healthy adult population. Notwithstanding that, while we noted the study concluded that supplementation with those B vitamins over the course of two years could slow the rate of brain atrophy in elderly subjects with MCI, we also noted that the study was not powered to assess the effect of the treatment on cognition or cognitive decline. We therefore also considered that the study was not suitable to support claims relating to brain function or mental performance.
We therefore concluded that the implied claims that recent research had shown that B vitamins could help maintain brain function and performance had not been substantiated and were misleading.
Ruling by ASA
Ad must not appear again in its current form. We told Vitabiotics not to repeat the implied claims about B-vitamins and recent research.
Source: Adjudication of the ASA Council
*To help maintain Brain Function & Performance
*Neurozan Plus contains NEURO-SPECIFIC MICRO-NUTRIENTS including phosphatidylserine, 5 HTP, Co-Q10, vit D3, B complex and zinc to help maintain cognitive function and mental performance.
[CHALLENGED CLAIM]
The complainant challenged whether the claims in ads that recent research had shown that B vitamins could help maintain brain function and mental performance was misleading, because they understood that the research referred to did not support that conclusion.
[RESPONSE BY VITABIOTICS TO THE CHALLENGE]
Vitabiotics Ltd (Vitabiotics) said, as one of the country’s largest and most respected vitamin supplement companies, they strived to ensure all of their marketing communications were accurate and fully compliant with the CAP Code. T
Vitabiotics provided a copy of the research referred to in the ad, but said they did not make the claim in either ad that recent research had shown that B vitamins could help maintain brain function and mental performance. They said the statement on the pack “to help maintain brain function and performance” referred to the Neurozan Plus product as a whole, and not the mention of the research news. They argued that no conclusion or claim at all was made in relation to the research news and said the claim “Also includes the specific B vitamins reported in ground-breaking research” referred to the fact that the nutrients found in Neurozan had been positively featured in recent research.
Vitabiotics said, regardless of the arguments they had put forward, no further ads would feature the claims unless they were deemed acceptable by the ASA.
[ASSESSMENT]
The ASA noted that Vitabiotics did not believe the ads made any claims about the effect of B vitamins on brain function and mental performance. However, we considered that the claims “To help maintain Brain Function & Performance.” and the related marketing text would be interpreted by readers to mean that B vitamins could help maintain brain function, performance and memory, and that that was supported by recent, pioneering research.
We noted that the study provided by Vitabiotics was a randomised, double-blinded, controlled trial which assessed whether supplementation with high doses of folic acid (vitamin B9) and vitamins B6 and B12 could slow the accelerated rate of brain atrophy in those with mild cognitive impairment (MCI). We noted the 168 study participants were all aged over 70 and had a diagnosis of MCI, and that some participants had other health concerns such as diabetes and history of strokes, and we therefore considered that the study was unsuitable to support claims likely to be understood as referring to the normal, healthy adult population.
Notwithstanding that, while we noted the study concluded that supplementation with those B vitamins over the course of two years could slow the rate of brain atrophy in elderly subjects with MCI, we also noted that the study was not powered to assess the effect of the treatment on cognition or cognitive decline. We therefore also considered that the study was not suitable to support claims relating to brain function or mental performance.
We therefore concluded that the implied claims that recent research had shown that B vitamins could help maintain brain function and performance had not been substantiated and were misleading.
[RULING BY ASA]
Ad must not appear again in its current form. We told Vitabiotics not to repeat the implied claims about B-vitamins and recent research.
Source: Adjudication of the ASA Council
Recently the updated Dutch Choices logo called ‘Ik Kies Bewust’ was presented to the public. On the basis of criteria that define maximum levels of nutrients as fat, added sugar and salt, products are entitled to carry the Choices logo on the front of the package. Important to note is that this decision is based on the relative healthiness of a food. So, foods which are better in nutritional quality than other foods in the same category may get a Choices logo. The green logo does this for necessary basic food groups such as vegetables, meals and dairy products and the blue one for the remaining food categories like snacks. These logos emphasize the positive nutritional aspects to consumers as no products are presented in a negative frame. Not all products joined the Choices initiative, which may explain why the Heinz ketchup does not have a logo and the bebo omega light (see picture below).
Nutrition logos which also present the negative nutritional qualities of a food exist as well, the most well-known example is the British Traffic Light logo with its green, amber and red symbols. For example, a red traffic light shows that the food contains a high level of one of the key ingredients fat, sugar, and salt and should be eaten occasionally. The more green traffic lights, the healthier the choice. Proponents argue that front of pack labels are effective in helping consumers make healthier choices. Furthermore, Vyth and colleagues found that the Choices logo initiative has influenced food manufacturers to reformulate existing products and develop new products with a healthier product composition.
There are opponents as well. For example, food politician Marion Nestle and nutrition expert David Ludwig are less positive about nutrition logos. ‘Healthier foods are not necessarily healthy’, they state in their paper in which they make a case for an outright ban for front-of-pack nutrition labels as they mislead consumers. Particularly nutrition logos such as the Choices logos have been criticised for creating a too simplifying contrast between good and bad foods. A recent study among 520 consumers by Andrews and colleagues showed that ‘seal of approval’ type logos as the Choices logo are perceived as more healthful than food with a traffic light logo or no logo. Other studies find that for some consumers the nutrition logos feel as an intrusion; an unpleasant attempt to control their food behaviour. For example, the French consumer association sees a traffic light system as incompatible with the French food culture. For the French no red traffic light to spoil the pleasure of eating.
Considerable research exists on consumer comprehension of nutrition logos and nutrition profiling methodologies. Unfortunately, less is known about real use in practice and whether these logos actually lead to better diet quality and health. That is not easy to find out as there are many factors that influence consumers’ food choices and nutrition labelling is just one of them.
SOURCE: http://foodintakecontrol.blogspot.com/2011/03/new-healthy-food-logo-in-netherlands.html
& Nutrisciences Ltd & http://www.ikkiesbewust.nl/
According to a recent adjudication by the Advertising Standards Authority (ASA) it seems that a US style disclaimer can help you avoid issues related to implied claims.
Following a complaint against the name “Optiflex Glucosamine” that the product efficacy could not be substantiated the ASA ruled that:
Upon Copy Advices recommendation, Healthspan had ensured that Optiflex advertising was accompanied by a prominent disclaimer stating “Not clinically proven to optimise flexibility”. Because of that, we considered that consumers would not be misled by the product name, and concluded that the ad was not misleading on that point.
However, according to a quick search of UK patents it seems the ASA and its ruling may not be 100% in its interpretation of the regulations. Firstly the trademark is registered as “Optiflex” (UK trademark case: 2437205) and not “Optiflex Glucosamine”. Secondly, the ASA had adopted the Nutrition & Health Claims Regulation (1924/2006) into its CAP code of advertising practice. It has also stated on many occasions that it will look towards the opinions of EFSA as part of its adjudication process. As such under 1924/2006 article 1(3) shows trademarks covering an implied health claim are subject to the terms of the regulation in as much as they must also carry an authorised nutrition or health claim where it is used. The regulation mentions nothing about a the use of a disclaimer to allow trademark use.
However there is another caveat which may allow the implied claims suggested by the name “Optiflex glucosamine”. Under article 28 (2) relating to transitional measures products bearing trademarks are allowed to continue to be sold until 19th January 2022. Sounds great? However, this is only for those products existing on the market before 1st January 2005. Optiflex was filed in November 2006 and not registered until august 2008. So would not meet the conditions of the regulation.
Given the trademark does not meet the conditions of the exemptions under 1924/2006 and glucosamine claims have been rejected by EFSA does this ASA decision mean they are now not following the opinions of EFSA as part of their assessment process? Is this because the decisions have not been made law? Or is it because they missed the issues described above.
If it is the former it looks like we may be allowed to make any implied claims as long as we use a US style disclaimer stating not clinically proven?
Source: http://www.asa.org.uk/ASA-action/Adjudications/2011/2/Healthspan-Ltd/TF_ADJ_49786.aspx
In a presentation to the Association of the European Self-Medication Industry (AESGP) Conference Brussels 2 February 2011 – Vittorio Silano suggests that and addition to the framework of Directive 2002/46/EC could be the way forward for botanicals.
According to Silano, “This would require the adoption of an hoc Regulation providing for a positive list of safe botanical species and plant parts (including ,where necessary, relevant specifications) and of applicable harmonized descriptions of science-based intended uses, also recognizing the value of tradition.” In relation to adding nutrients other than vitamins and minerals to 2002/46/EC he stated, “I am quite convinced that for traditional botanical food supplements we have reached that stage and that in about two years of intensive work we could achieve such an objective”.
Also interesting was his opinions regarding the efficacy of botanical food supplements with regards to the Nutrition & Health Claims Regulation (1924/2006) which has recently removed botanicals from its assessment. Silano stated that, “unfortunately, regulation 1924/2006 had not taken into account then peculiarity of traditional botanical food supplements”. Implying that maybe as part of EFSA NDA panel approach to assessment traditional history of use should have been included in some cases.
What influence this will have on the future decision on how to assess botanicals within the framework of the NHCR is not known.
I would suggest the potential solution to the current botanical debacle is a splitting of traditional botanical food supplements for assessment under the NHCR and traditional botanical medicinal products entering a system of assessments such as the THMPD.
According to a recent communication to the Commission by the Minister for Public Health, Welfare and Sports a draft decree has been laid down rules for the approval of a “food choice logo” representing foods which have and EFSA (and parliament) health claim approval.
An Extension to the Nutrition & Health Claims regulation
Regulation (EC) 1924/2006 harmonises the legal provisions of the Member States with respect to nutritional and health claims. A food choice logo as defined in the draft decree is within the scope of the concept of a nutritional claim as referred to in Article 2, second paragraph, 4 °, of Regulation (EC) 1924/2006. Nutritional claims approved for the entire European Union as well as the relevant conditions are included in the Annex to Regulation (EC) 1924/2006. However, the rules applying to the use of the logo are valid only within the Netherlands. In light of this, the logo cannot be included in the Annex to Regulation (EC) 1924/2006.
However, Article 23 of Regulation (EC) 1924/2006 accords Member States of the European Union the competence to adopt new legislation within the scope of that Regulation. The present draft decree exercises that competence. This has a twofold consequence.
The first consequence is that the draft decree cannot be adopted until after a successful notification procedure as referred to in Article 23 of Regulation (EC) 1924/2006.
The second consequence will be that the logo used and the rules for its application will also need to be notified separately in due course, in accordance with the aforementioned Article 23. Only after successful completion of the notification procedure may the Minister approve the logo.
The draft decree contains a clause on mutual recognition.
A great idea for consumer choice?
Ensuring a healthy composition of foodstuffs has attracted more and more attention in recent years, not only from governments but from consumers, producers and traders. This attention has resulted in the development of logos designed to indicate that a particular foodstuff has a healthier composition than other foods in a particular product group. These logos for foodstuffs will make it easier for consumers to make the “healthier choice”. Some relevant characteristics in this respect are: energy content, saturated fats, trans fats, added sugar, dietary fibre and salt.
In the Netherlands, two logos are currently in use. Both these logos have the same objective, but their application is based on different sets of criteria.
The Netherlands has welcomed the creation of these logos, whose use is voluntary, but only as an intermediate step towards a single logo for foodstuffs. This is the only way to prevent confusion for consumers. Consequently, representatives of both logo organisations have begun consultations as of October 2008, also at the request of the Dutch government, with the aim of joining the two logos together.
The government’s policy aims at stimulating healthy nutrition for the largest possible proportion of the Dutch population. In line with this policy is a broadly used logo facilitating the selection of healthier foods.
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