Ewa Hudson, Head of Health & Wellness Research04.29.10
Euromonitor International recently published a global briefing titled “Impact of EFSA's Changing Legislation on Health and Wellness Food Claims.” The core objective of this report is to examine the impact of ongoing regulatory reform on the health and wellness food and beverage industry, through the lens of the European Food Safety Authority (EFSA) and its articles 13 and 14. Specifically, the report seeks to examine how a tighter EU regulatory framework will impact upon the product claims manufacturers are able to use and, ultimately, the performance of retail sales across the EU.
The last few years have seen significant changes in the EU legislative arena, with several major pieces of legislation coming to fruition and yet more on the horizon. These include the extremely protracted regulations on nutrition and health claims and fortification in 2007, followed by the new organic legislation in 2009. Over the next two to three years, attention will focus on overhauling the general labeling legislation, which will have an impact on all food manufacturers.
Between 2005 and 2009, the emphasis of health claims on health and wellness food and beverages, particularly for pre/probiotic yoghurts, other functional drinking and spoonable yoghurts, fortified/functional gum and nectars, as well as functional spreadable oils and fats, became more tightly focused, shifting away from general function and nutrition and more toward disease reduction. In 2005, disease reduction claims accounted for 46% of all claims, but by 2009 this figure had increased to 53%.
This is largely a reflection of the increasingly competitive market environment, where specific claims are a better 'hook' to gain the attention of consumers compared with broader ones relating to general function or nutrition. However, this trend toward specificity has also made many claims more vulnerable to EFSA's new regulatory regime.
Regulation 1924/2006: Nutrition & Health Claims on Foods
We are now more than two years into this regulation, although the real impact was arguably not experienced until October 2009 when EFSA started releasing opinions on health claims submitted under Article 13 of the regulation—the so-called generic health claims. The impact was significant. Of the first 500 opinions published, approximately two-thirds of the claims were rejected because they failed to establish the cause and effect relationship claimed, according to EFSA.
Many of the generic claims that have been found to be supported by scientific data are those that could be viewed as more 'traditional' ingredients—vitamins and minerals found in everyday foodstuffs, most of which have been subject to decades of research. Although the European population in general does not suffer from deficiencies in many of these nutrients because they are found in a normal balanced diet, it does give the green light to continued use of these claims.
Many of the ingredients that fell short of EFSA approval could be considered to be “less traditional.” In some cases the data submitted did not relate to the claimed substance; in others, animal or in vitro data could not be extrapolated to humans, or the human data provided was simply too weak to justify the claim for the general population. Notable outcomes include taurine's reputed energy-boosting properties, soy isoflavones and bone health and several 'mood-enhancing' ingredients.
Areas of significant public (and media) interest such as cholesterol reduction, gut health and joint health have also emerged with mixed results. Probably the most unexpected outcome of the first round of EFSA opinions was that over 170 probiotic strains submitted under Article 13 were found not to fulfill the claims relating to digestive health, mainly because the strains used for clinical studies were not deemed to be sufficiently characterized, leaving many recognized brands to re-think their marketing strategies. Of the probiotic claims submitted under Article 14, all are still under assessment.
Fish oils containing omega 3 fatty acids also took an unexpected battering in the area of joint health, a very long-standing “health assumption.” Submissions for DHA/EPA combinations were not found to be effective in maintaining healthy joints, although reduction of blood pressure and blood triglycerides was established. ALA omega 3 was also found to help reduce cholesterol.
Possibly the area of greatest private investment, cholesterol reduction in relation to plant stanols and plant sterols, has also been examined under Article 14. Both McNeil's plant stanols and Unilever's plant sterols were found to have a cholesterol-reducing effect and were granted the following claim: “Plant sterols/plant stanol esters have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease.” It is important to note that these approvals are exclusive to McNeil and Unilever because the data are proprietary to these companies. Therefore, although there are a plethora of plant sterol ingredients on the market, approved as novel foods, other companies cannot carry these claims without first obtaining approval under this particular regulation.
So what's next? Long overdue are the controversial nutrient profiles (supposed to be published by January 2009), which are still under discussion. These will no doubt impact more traditional nutrition claims when finally published. The Commission has also started to establish a register on its website of all approved and rejected health claims in line with the requirements of the regulation.
Regulation 1925/2006: Adding Vitamins, Minerals and Other Substances to Foods
The regulation on fortification has been somewhat dormant in terms of visible developments since it came into force in July 2007. For instance, only two new minerals have been added to the list of permitted substances, and the once feared annex III (list of substances under scrutiny) has remained completely empty, which is, of course, reassuring. However, 2010 will now see some action as two areas of significance are realized. The date for submitting dossiers for any vitamins and minerals not included in annex I or II has passed (19 January 2010), which means that any of these substances used in Member States until this date will now be banned unless subject to a dossier (these can continue to be used, subject to derogation, until 19 January 2014). In addition to this, EFSA will finally be launching a public consultation on dietary reference values for micronutrients based on its report on tolerable upper intake levels of vitamins and minerals published in 2006. This ties in with the terms of the regulation to set maximum levels of vitamins and minerals for fortification where there may be concerns for consumer safety (originally due to have been set by January 2009).
However, as with the claims regulation, fortified foods may still undergo some significant changes when the verdict on nutrient profiles is finally reached as fortified foods are often accompanied by nutrition/health claims. More immediately, there are likely to be fortified foods where generic health claims are already being removed following the first round of publications from EFSA, although nutrition claims relating to the level of fortification should be unaffected at this time.
Environment and Organic
The environment continues to play an important part in consumer buying decisions, and long-overdue changes to organic legislation were implemented in January 2009 with Regulation 834/2007. This included several key departures from the previous organic legislation, including:
• New standards laid down for aquaculture and seaweed, hunting and fishing (new details for viniculture are still awaiting clarification).
• The 70-95% category for organic foods has been abolished and all foods using the word “organic” in their sales description must be at least 95% organic.
• A legal threshold for adventitious GM contamination has been laid down in line with the regulations on genetically modified foods.
A new European Commission (EC) logo has been designed and must be displayed on all organic foods (those with more than 95% organic ingredients) produced in the EU—this was previously voluntary, with individual certification bodies’ logos often used instead.
For food manufacturers, this last point is of great significance—not only introducing the requirement to re-design every piece of organic packaging in Europe, but also encompassing two additional elements of the new code system for organic approval bodies and the indication of the origin of agricultural ingredients immediately below the logo.
There is a transition period for existing packaging until 1 January 2012, provided the product complies with all other requirements of the new organic regulation.
In more general terms, there is an overwhelming culture change within the food industry to implement more environmentally-friendly manufacturing systems, to reduce waste and carbon footprints. Although not currently regulated, it is an area where self-regulation has proved itself as consumers are increasingly looking to 'carbon labeling' as a new food quality indicator. Could this be regulated in the future? Anything is possible.
