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2014 Set to Present the Greatest Regulatory Hurdle in a Generation to Food in the EU

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2014 is already presenting the greatest regulatory hurdle that the food industry has faced in a generation. The Food Information for Consumers Regulation requires virtually every single food label in the EU to be changed. While manufacturers and retailers are still trying to get to grips with the ever moving feast of ‘guidance’ and implementation legislation proliferating at the moment, the consumer is going to be faced with labels that are already drawing enquiry and criticism, particularly for those that suffer from food allergies and intolerances.

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. Nutritional 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, graphical 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. The UK has wasted no time in launching a system that utilises the GDA scheme favoured by most manufacturers, combined with the traffic light scheme as previously championed by the Food Standards Agency. The majority of UK retailers have signed up to the scheme, along with many manufacturers, but several influential companies have opted out. The rest of Europe has not taken too kindly to the scheme either – Italy is particularly concerned that it will directly harm the sale of many traditional products such as meats and cheeses, and appears to be supported in its position by several other Member States. There is a genuine issue of lack of consistency with other EU markets, and if appeals to the European Commission are successful, the scheme could yet fail.

Another key wellbeing area that will be changed under the new legislation is the labelling of allergens. Currently, allergens tend to be highlighted to the consumer in an ‘allergen box’ underneath the ingredients list. Under the new legislation, the allergens will be required to be highlighted in the ingredients list, and the allergen boxes will no longer contain anything more than a signpost to check the ingredients list. It is also returning to the pure letter of the law concerning cereals containing gluten – the actual name of the cereal (eg wheat, barley etc) will be highlighted, rather than an indication that the product contains gluten. This is likely to cause mass confusion for consumers, and could potentially put certain consumer groups at risk as allergen boxes in their current format provide a quick and easy checkpoint during the shopping process. To top off the subject of allergens, ‘may contain’ labelling remains unchanged, which many allergic consumers would probably identify as being the most essential element to resolve.

This regulation is still very much an evolving and maturing process. Unlike virtually any other piece of legislation before it, we are very unlikely to receive formal guidance because it is simply too complex for any one authoritative body to understand at the coal face of food businesses. This does not bode well for enforcement and equality across the EU.

Regulation 1924/2006 on Nutrition and Health Claims Made on Foods

14 December 2012 came and went, and with it the coming into force of regulation 432/2012, the list of so-called generic health claims under Article 13.1 of the nutrition and health claims regulation. A list of just 222 positive claims and 1,719 rejections, which has been added to in a limited fashion, brings the current numbers to 229 approved and 1,875 non-authorised. Whilst manufacturers have already made a good use out of numerous authorised claims, especially in the areas of cardiovascular and brain health with omega 3, energy boosting with caffeine, and bone health with calcium and vitamin D, probiotics are seen as the biggest victim as the word "probiotic" has been banned from food labels altogether.

The published regulation was intended to bring a final cut-off date for non-authorised claims, and in the main for foodstuffs this is generally the case. However, a sweep of food supplements and in particular foods for sports nutrition reveals an awful lot of products are still carrying specifically non-authorised claims. Enforcement seems to be targeting larger companies, especially through advertising, but internet sales and smaller health food outlets are still falling below the radar.

Alongside this, there is still no progress on nutrient profiles. Will there ever be nutrient profiling? The longer the time elapses from repeatedly missed deadlines, the more unlikely it feels that the Commission will ever square this circle.

The seven new claims that were authorised are published in regulations 536/2013 and 1018/2013, and include DHA and EPA for normal triglyceride levels and blood pressure; fructose and alpha-cyclodextrin and the reduction of post-prandial glycaemix responses; dried prunes/plums and regular bowel function and carbohydrate and maintenance of normal brain function. The carbohydrate claim is particularly interesting as it was hotly debated as to whether carbohydrate claims could be used responsibly and correctly interpreted by consumers – as a consequence this claim comes with a requirement for the food to also comply either with the ‘low sugar’ or ‘no added sugar’ criteria.

Also addressed in regulation 536/2013 is the question of claims on hold. There are over 2,000 claims on botanical substances awaiting assessment. The Commission is still attempting to establish how claims should be handled in relation to the nutrition and health claims regulation and the traditional/herbal medicinal products directive. No timeframe has been given for this issue to be resolved, but claims which have not been subject to a negative opinion from EFSA are permitted for continued use. In the same boat are claims on caffeine, very low calorie diets and reduced lactose. Very low calorie and reduced lactose will be re-visited once the new regulation on foods for specific groups (replacing the old PARNUTS directive) has bedded in. Caffeine, however, has been subject to positive opinions relating to endurance, alertness and cognitive function and mental and physical stimulation, but these have not yet been passed into regulation. There is still some concern among Member States as to the target market and protection of vulnerable consumers, which needs to be resolved before these claims can be approved. However, in the meantime, caffeine (and low-cal, reduced lactose) claims that have previously been in use can continue to be used.

Article 13.5, covering claims based on new scientific data, now includes five authorisations, four of which are authorised with a proprietary period of five years. These are: slowly digestible starch from Mondelez International, reformulated acidic soft drinks for maintenance of tooth mineralisation from GlaxoSmithKline, water soluble tomato concentrate for normal platelet aggregation from Provexis and cocoa flavonoids for the elasticity of blood vessels and normal blood flow from Barry Callebaut. The most recent authorisation, not subject to a proprietary five-year period, is based on sugar beet fibre and the increase of faecal bulk – foods must comply with the definition for ‘high fibre’ foods to carry this claim.

There are now 51 rejections in this category. The latest raft of rejections in late 2013, which included glucosamine for maintenance of joint cartilage and diacylglycerol oil for weight loss, carry a transition period until May 2014 to be removed from the market. All other rejected claims under Article 13.5 are no longer subject to a transition period.

Article 14.1(a) claims covering the reduction of disease risk have had two new approvals in the past 12 months, bringing the total to nine authorised and 15 rejected. The new claims both relate to barley beta-glucans and reducing cholesterol and risk of coronary heart disease.

Article 14.1(b) on children’s health and development has had no further approvals since 2012. However, four positive EFSA opinions have been published which should be passed into legislation. These are the effect of iodine on thyroid function and cognitive function, vitamin C and increased non-haem iron absorption and iron and haemoglobin formation.

In nutrition claims, the previously vetoed ‘no added salt’ claim was finally approved, although the ‘now with less...’ claim remains off limits.

It has also finally come to pass that Member States have put their heads together to draw up guidance to allow for flexibility in the wording of health claims to make them more consumer friendly. This guidance specifically discourages quoting excerpts from EFSA opinions, and changing words that fundamentally alter a claim (such as ‘supports’ to ‘stimulates’), but does permit flexibility where wording is adapted to have the same meaning for the consumer as the approved claim. This is good news for the industry, but may not turn out to be as flexible as some might have hoped.

Foods for Special Groups Replaces PARNUTs

After many years of debate over what is or is not a PARNUT, the Commission has finally done away with the uncertainty (and the different interpretations of the Member States) and slimmed down the dietetic area under new regulation 609/2013 on foods for special groups. It includes only foods for infants and young children, foods for special medical purposes and total diet replacement for weight control. It therefore removes from scope:

  • Gluten-free/very low gluten - already defined by regulation 41/2009, and will subsequently be encompassed by the regulation on food information for consumers
  • Milk-based drinks for young children (1-3 years, so-called ‘growing up milk’) and
  • Foods for sports people
  • Foods intended for energy-restricted diets for weight control - foods carrying these claims will fall under the scope of the health claims regulation

The regulation will apply from 20 July 2016.

Novel Foods and Foods from Cloned Animals

After innumerable years of discussion, drafting and rejection, we finally have a package of proposals that will replace the Novel Food Regulation in its current form. The main concern with the NFR has always been that it was seen to stifle innovation by its stringency, and created a significant barrier to the introduction of exotic foods with many years of safe consumption into the EU. This new proposal addresses the following key issues:

  • Centralised authorisation procedure to ensure a level playing field across the EU and a reduced approval process time
  • Special approval process for foods with a safe history of use outside the EU
  • Exclusivity period for foods developed using new technologies – such products may be granted a five-year protection period for exclusive marketing

The subject of cloning has finally been placed into its own legislative framework, with two draft directives covering the farming of cloned animals for the purposes of producing food, wool, skin or fur and the placing on the market of food produced from cloned animals. In both cases, the farming practice and placing on the market of food is proposed to be banned. The legislation proposes a review of this situation five years down the line, which will take into account innovation in cloning techniques and animal welfare and changes in consumer perception.

Summarising, 2014/2015 will be one to watch as Regulation on Food Information unfolds. Will consumers prefer the new nutrition labelling and front of pack schemes? How will allergen labelling shape up over the next couple of years? Will we see any progress in novel foods after several previously unsuccessful attempts? And what will become of probiotic claims – is the foreseeable future going to see developments in getting any of these approved?

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