Health and Wellness Legislation in the EU
In regulatory terms, 2012 has already been a very busy year in the EU. Industry is busily preparing to comply with the new Food Information for Consumers Regulation (FIR) alongside the recently formalised positive list of generic health claims, which offers opportunities industry-wide but also finally closes the door on many long-used health claims.
Regulation 1924/2006 on nutrition and health claims made on foods
Without doubt, the most long awaited aspect of this legislation was the publication of the Article 13.1 list of approved generic health claims. Regulation 432/2012 was published on 16 May 2012, giving the food industry until 14 December 2012 to ensure that all claims are compliant with the approved list – just 222 claims. Claims made on foods after this date that are not in compliance with the regulation will be liable to enforcement action. This should not come as a great surprise to the food industry as the opinions of EFSA (European Food Safety Authority) have been published for some time, but there was no cut-off date for non-compliant claims until this regulation was formalised. Some 1,719 claims have been categorised as non-authorised under Article 13.1. Authorised claims are largely limited to vitamins and minerals, some essential fatty acids and fibre. Non-authorised claims controversially include all probiotic claims.
This final formalisation of the generic claims into law would appear to give the green light to the use of all authorised claims on appropriate foods, although one of the unresolved elements of the regulation is nutrient profiles. The absence of nutrient profiles could potentially result in claims made on ‘inappropriate’ foods (for example vitamin claims on high sugar confectionery), and some areas of industry feel that they are working in a very difficult position concerning the re-branding of products using authorised claims, only for that to potentially be threatened should profiling emerge over the next couple of years. The European Commission reported earlier this year that nutrient profiling will be reconsidered after the publication of Regulation 432/2012. Well, that time is now, so one to watch in the near future.
Article 13.5, covering claims based on new scientific data, still includes just one authorisation for water soluble tomato concentrate I & II for normal platelet aggregation and healthy blood flow. The 26 rejections in this category include some general wellbeing claims, some probiotic digestive health and respiratory tract health claims and several claims related to reducing hunger, appetite, body fat, waist circumference and resculpting body shape.
Article 14.1(a) claims covering the reduction of disease risk have so far resulted in seven authorisations and 15 rejections. There are only two key areas of health covered
by the authorisations – reduction of cholesterol and its association with coronary heart disease (plant sterols, plant stanols, plant sterol esters, plant stanol esters and oat beta-glucan) and reduction of dental carries/tooth demineralisation with sugar-free chewing gum and xylitol. Interestingly, the reduction of cholesterol claim was not authorised for soy protein in spite of its previously accepted benefit in this area. Reduction of urinary tract infection (UTI) claims were not approved for Ocean Spray cranberry juice or a food supplement containing cranberry extract (Uroval), but the company Medical Brands has recently achieved an approved medical claim for cranberry and UTI under the Medical Devices Regulation. Other non-authorised claims include water related to reduced dehydration and concomitant performance reduction, Actimel L casei in reducing Clostridium difficile and diarrhoea and added calcium to fruit juices to reduce dental carries.
Article 14.1(b) on children’s health and development saw 11 authorisations and 36 rejections. However, the authorised claims are limited – five relate calcium, vitamin D, phosphorus and protein to bone development. DHA (Docosahexaenoic acid) is approved in three claims for brain and visual development for infants, and iodine and ALA/LA (alpha-linolenic acid/linoleic acid) both contribute towards normal growth and iron for cognitive development. All other claims related to brain development, cognitive function, concentration, learning, relaxation, immune support and digestive health were not authorised. The dairy ‘3-a-day’ claim for maintaining healthy body weight and dental health was also rejected, as was the Kinder chocolate claim helping children to grow. All probiotic claims for children were also rejected.
Claims authorised or rejected under Article 13.5 or 14.1 were published under various regulations and are also subject to a 6-month cut-off period for non-authorised claims. All of the claims (including Article 13.1) can be found on the European Commission’s register of health claims http://ec.europa.eu/nuhclaims/. It should be remembered that authorised claims are still subject to use only in compliance with other factors laid down in the claims regulation. These include appropriate nutrition labelling, use of required accompanying statements, generic health statements backed up by related authorised claims and appropriate warnings for over-use/avoidance. The European Commission is currently drafting guidelines on the implementation of these rules. There are still claims being considered by EFSA and the EC for which transition periods for those that may be rejected have yet to be established.
For nutrition claims, there was much controversy over the rejection of two new claims by MEPs early in 2012. The claims on ‘percentage less’, eg ‘now with 15% less sugar’ and ‘no added salt’, were vetoed as Parliament felt that these claims would be confusing to consumers and would essentially reward unhealthy products with claims. The European Commission and food industry, on the other hand, feel that the ability to highlight gradual reformulations, as opposed to the sometimes unachievable jump to ‘low’ products with a 30% reduction in eg sugar or fat, would be beneficial to consumers in making healthier choices.
Vitamins and minerals and other substances added to foods and food supplements
While there continues to be no progress on the key outstanding topic concerning these two particular pieces of legislation – the setting of maximum levels of vitamins and minerals for fortification or food supplements where there may be concerns for consumer safety – steps have been taken concerning the first substances to be considered under Article 8 of Regulation 1925/2006 on fortification. Article 8 covers substances which may be prohibited, restricted or placed under Commission scrutiny. The European Commission has passed on its first request from a Member State to EFSA for assessment of Ephedra species and yohimbe (Pausinystalia yohimbe). At present, Directive 2002/46 on food supplements very specifically covers only vitamins and minerals, and in 2008 the Commission declared that the inclusion of other substances in the directive was not considered necessary. It will be worth noting whether, if the two substances under assessment are placed into Annex III of Regulation 1925/2006, this has any impact on the food supplements directive.
Regulation on Food Information for Consumers (Food Labelling)
Regulation 1169/2011 on food information for consumers was finally published at the close of 2011, completely overhauling food labelling and bringing it into the format of a regulation for the first time. One of the key features of the regulation will be the mandatory nutrition labelling on almost all pre-packed foods from 13 December 2016, within a new prescribed format. This means that although a very high percentage of foods already carry voluntary nutrition labelling according to Directive 90/496, all of these foods will be required to change their packaging to comply with new format and content. Foods that are already accompanied by a nutrition panel must also comply with the changes by 13 December 2014, a full two years before other foods not already carrying voluntary labelling. The nutrition panel will now mandatorily consist of energy, fat, saturates, carbohydrate, sugars, protein and salt (note the removal of fibre and the movement of protein further down the panel), with voluntary provision for monounsaturates, polyunsaturates, polyols, starch, fibre and vitamins and minerals. Information will be provided per 100g/ml and may also be provided as a percentage of the reference intakes, which are laid out in Annex XIII. Nutrition information per portion may also be provided, and there is provision for the European Commission to look into setting portion sizes within the legislation, although the scale of this task is undeniably huge and is therefore not subject to any deadline.
The regulation also allows for the provision of nutritional information on the front of pack (so-called FOP labelling). It was long thought that the European Commission would actually dictate the format that this was to take, favouring the extensively used ‘GDA’ scheme. In fact, the regulation only dictates that front of pack labelling, if used, must include energy (must always be declared per 100g/ml) with or without the following nutrients – fat, saturates, sugars and salt. All FOP declarations may also be according to the percentage reference intakes or per portion. Additional forms such as colour coding, graphic or symbolic forms are also permitted. Member States must monitor use of FOP and the Commission will produce a report on the potential need for regulated measures by December 2017. Therefore, aside from prescribing the nutrients and mandatory energy declaration, harmonisation of FOP labelling is no further forward. The UK has taken this opportunity to once again consult on the potential for one uniform scheme, as other countries may also undertake to do.
Other issues that the regulation mandates that the European Commission is to review include the possible mandatory declaration of trans fats (already the subject of many years of debate), the notorious ‘may contain’ labelling for allergens, ‘vegetarian/vegan’ labelling and setting reference intakes for specific population groups, including children.
At this time, the new organic regulation 835/2007 has had time to bed in, and it is now mandatory for organic food (at least 95% organic) to carry the prescribed EU logo, which may exist alongside other organic logos. Also in March 2012, detailed rules for organic wines were published in Regulation 203/2012, and shall apply from 1 August 2012. Other organic news is that the EU and US have set up a trade agreement for organic foods. This means that foods certified as organic in the EU may be exported to the US without the need for re-certification, and vice versa. This is a welcome agreement, not only in lifting trade barriers but also improving consumer confidence in the status of imported organic products.
Novel foods and foods from cloned animals
The novel foods regulation has been in place since 1997, and has long been considered a stifling element on innovation, for everything from newly engineered food ingredients to traditional foods from non-EU countries. This is of particular interest in the health and wellness arena as many exotic fruits are found to offer health opportunities, but with two onerous regulations to gain approval (novel foods and health claims) it is often insurmountable to bring them to market. A review of the regulation has been underway for many years, with a revised regulation proposed in 2008. This was rejected in March 2011 when the European Parliament and Council failed to reach agreement at what was expected to be the final stage of the process. Current status suggests there is likely to be a new draft published in 2013 alongside a draft regulation for food products from cloned animals. Food ingredients developed from nanotechnology fall within the current novel foods regulation, and the European Commission is mandated to consider the necessity for specific labelling for such ingredients under the Food Information Regulation. It is also hoped that the new draft will offer a more accessible route to approval for traditional foods from outside the EU.
In summary, it is all systems go for the health and wellness industry with the formalisation of generic health claims, the transition to new format nutrition labelling and a more relaxed than anticipated approach to front of pack labelling. Nutrient profiles and portion sizes are still looming in the background but are so long overdue that any short-term activity seems unlikely.