Contact

Robert Mack David Earnshaw David O’Leary CEO Chairman Director

Burson-Marsteller Brussels 37 Square de Meeûs, 1000 Brussels • Tel +32 2 743 66 11 • Fax +32 2 733 66 11 bmbrussels@bm.com • www.bmbrussels.eu

AA ffuullll ppllaattee ooff iissssuueess...... bbuutt ttoooo mmuucchh ttoo ddiiggeesstt?? September 2010

he safety, quality, labelling, nutritional value, marketing and origin of the food we eat are issues that have come increasingly under the spotlight in recent years. Disquiet over how we produce food, such as over the use of GMOs; the worrying rise in

obesity, especially among children; and unease about the truthfulness of marketing claims on food are all issues that have risen quickly and high up the political agenda across Europe.

The last decade has seen unprecedented political and legislative activity in Brussels as the EU has attempted to address these and other concerns expressed by EU citizens, by health and consumer groups, by Members of the European Parliament, and by member state governments.

Yet much of it is unfinished business: the debate over food labelling, re-opened in 2008, is ongoing; the regulation of health claims on foods is far from complete, nearly four years after legislation was agreed; the law on novel foods is in the process of being revised; and GMOs remain a perennial source of debate.

This Burson-Marsteller Insight looks at some of the items on the EU’s food policy agenda and their potential impact on industry and consumers, bringing together in a single summary the key issues in this increasingly controversial area of policy.

Health claims Tying up the myriad loose ends

APPROVAL OF HEALTH CLAIMS

More than six months after the stated deadline for the approval of a list of so-called ‘generic’ health claims on foods, the Commission is yet to approve even the first batch of claims. This approval is likely in the autumn – but will in many ways be the easy part of the process. Further batches of claims will be sent for Commission approval following the assessment of the European Food Safety Authority (EFSA) – and there is already a feeling in the Commission that the second batch, already evaluated by EFSA, will prove more difficult than the first.

The problems centre on a few key issues, including scientific criteria for the substantiation of claims, notably raising the critical question as to whether the criteria used by EFSA are appropriate to the assessment food, and the

pertinence of some studies for claims substantiation (for example, eligibility of proof obtained from studies on people who are ill). Closely linked to this is the issue of target populations, and more specifically, the extrapolation of the results from specific populations to the overall population.. Other issues include ‘insufficient characterisation’ of a food or ingredient and its health effect, and where to draw the borderline between foods and pharmaceuticals. To try to address these problems, EFSA has intensified its contact with companies, trade groups, and other stakeholders.

The Commission also faces difficulties about the legal use of claims as the various batches of claims are approved – and whether rejected claims are illegal immediately, or only after all four batches of claims have been assessed by EFSA and examined by the Commission.

Whatever happens, it is clear that the Regulation on nutrition and health claims, after an uneasy birth, is having a troubled infancy. There is almost certainly going to be a clamour from the food industry, as well as from health and consumer groups, for improvements to the law when the Commission reports on the situation regarding health claims, and the impact of the Regulation on dietary choices. This report is due to appear in 2012.

NUTRIENT PROFILES

After surviving a knife-edge parliamentary vote in June 2010 regarding their deletion from the Claims Regulation, nutrient profiles are now back on the agenda.

Profiles – which limit access to claims to those foods that have a healthy ‘profile’ in terms of salt, saturated fat and sugar content – have long been seen by critics as arbitrary, unscientific, and ‘nannying’. For supporters, they are an essential element of the law, stopping what they see as the absurdity of foods that are high in fat, salt or sugar from being able to be marketed as ‘healthy’.

Against this backdrop, the Commission has some difficult choices to make, which it will address in the autumn: will it allow ‘traditional’ foods, such as bread, to bear a

T

BBUURRSSOONN--MMAARRSSTTEELLLLEERR IINNSSIIGGHHTT

FFoooodd ppoolliiccyy iinn tthhee EEUU:: wwhheerree nneexxtt?? BURSON-MARSTELLER INSIGHT

E V I D E N C E - B A S E D C O M M U N I C A T I O N S

substantiated health claim regardless of its nutritional composition (for example, German bakers have pressed for the right to bear a health claim on traditional dark bread, despite its high salt content)? And how can ‘traditional’ products be defined?

It seems likely that meat and cheese will also be exempted, but then there is the question of setting thresholds for a series of product categories, such as dairy products, and cereals, where the interests of companies, health groups and producers will be keenly debated.

The Commission has a tough job to balance these interests – and to show that, following the reprieve for the concept of profiles, it can put this provision into practice. It is probable that the Commission will table a proposal to this effect in the autumn, hoping for agreement by mid-2011 (already more than two years behind schedule).

The approach looks set to be industry-friendly, to a point, disappointing many health campaigners. There are set to be exemptions for ‘traditional foods’; however, it is highly improbable that we will see claims on cake and chocolate. The system will be scientifically-grounded, based on the existing EFSA opinion. And the Commission will be frank with companies demanding the right to make claims on products that seem ostensibly ‘unhealthy’ – it wants manufacturers to be honest and realistic.

The Commission will also make use of ‘monitoring articles’ and highlight the two-year transition period as a way of persuading sceptics in the food industry to support its plans. Furthermore, the proposed setting of nutrient profiles by the World Health Organisation (WHO) and the US Food and Drug Administration (FDA) will heighten the sense that nutrient profiles are a concept that, while perhaps difficult to enforce, is here to stay.

Politically, the problems remain in Parliament – although the threshold to reject a Commission proposal implementing nutrient profiles is high, at 369 votes, according to the rules of the ‘regulatory procedure with scrutiny’. (The vote on nutrient profiles in June 2010 was tied 309-309.) Only a few member states are opposed to profiles, so we should see the adoption of the system within the next 12 to 18 months.

Labelling Full disclosure or too much information?

Following the first reading vote of the European Parliament in June 2010, the proposed Regulation on food information to consumers is now in the hands of the Council, for its first reading.

The original Commission proposal from January 2008 has been substantially amended in many of its key aspects – from a minimum font size on food labels, to the approach to front-of-pack labelling (including national schemes), to the rules for country of origin labelling. Given the fundamental changes, the Commission will draw up a revised proposal (taking into account Parliament’s amendments) before the Council begins its work. This could arrive in September or October 2010. A

Council position can be expected towards the end of the year – although some of the thorniest issues (such as the precise rules and application of country of origin labelling) are yet to be deeply considered by the member states.

The Council is set to take a cautious approach: it is highly unlikely to contradict the EP’s decision to adopt a limited front-of-pack labelling scheme, nor to re-instate the Commission’s plans to allow national schemes to co-exist. The future of one of the most well-known national schemes, the UK Food Standards Agency’s ‘traffic light’ scheme, is uncertain, and will probably be sacrificed by the new UK government.

Health and consumer groups – who complained about the intense industry lobbying on this proposal, and on the front-of-pack labelling provisions in particular – will not give up completely. However, it is highly improbable that the Council will take on board the traffic-light scheme, despite arguments that consumers prefer a colour-coded system.

On country of origin labelling, debate will continue about the types of foods that require mandatory labelling, and how this will affect the internal market. The Council seems less favourable to an ‘expansive’ approach that includes single-ingredient items as well as some processed goods. Instead, the member states currently favour a limited use of origin labelling, where its absence would mislead consumers (in line with the Commission’s original proposal). However, some member states are proposing alternative approaches, limiting origin labelling to meat, poultry, milk, fruit and vegetables. Some governments propose an extension of mandatory origin labelling to some ‘lightly-processed’ products, such as cooked meats and cheese.

In any case, there will be a number of issues to settle at second reading in 2011 – although without the intensity of debate that was seen in the Parliament’s first reading, given the rejection of traffic lights. An agreement by the end of next year seems probable – and it is expected to be one with which the food industry will be satisfied.

GMOs A new chapter in the never-ending story

The new Commissioner for Health and Consumer Policy, John Dalli has seen his first few months in office dominated by the issue of genetically-modified organisms (GMOs).

Less than one month into his new role, he approved the cultivation of BASF’s Amflora GM potato (albeit not for food production). This was the first such authorisation in the EU for twelve years.

Then, in July, he proposed a package of proposals to overhaul the EU’s GMO policy – in effect, proposing to grant member states the final say over whether GM crops are grown on their

E V I D E N C E - B A S E D C O M M U N I C A T I O N S

territory. Hence, Commissioner Dalli has proposed a new period of ‘co-existence’ in the EU that would allow member states to establish ‘GMO-free’ areas and to adopt stricter isolation measures to avoid an unintended presence of GMOs in other products. The 2001 Directive on the deliberate release of GMOs would also be modified, allowing member states to restrict GM crop cultivation on their territory based on socio-economic, ethical and moral grounds. This would resurrect the ‘fourth hurdle’ idea of the 1990s (adding a socio-economic/environmental hurdle to the scientific hurdles of safety, efficacy and quality), albeit with national rather than EU application – and therefore potentially diverse results.

This power could be activated after the scientific assessment has been conducted and authorisation granted – meaning that the approval of GMOs can continue as before. However, some environmental groups fear that the process will be accelerated, with cautious member states less determined to hold up the process, safe in the knowledge that they can block cultivation of any approved crop on their territory. Others are concerned that biotech companies will in practice launch lawsuits in countries that seek to ban approved GMOs for socio-economic, ethical or moral reasons, thereby quickly undermining the ‘fourth hurdle’ concept.

The biotech industry – and ardent Europeans – argue that the internal market, and indeed Europe’s ability to regulate in this area, will be damaged; the industry also argues that the decision represents a defeat for science-based policy making.

With many MEPs opposed (for diverse reasons), and a fairly even split among member states, the Commission’s hope for a first reading agreement on this issue early in 2011 looks optimistic. It seems that, in another form, Europe’s GMO impasse may continue.

Novel foods The attack of the clones?

While there seems to be general agreement on most of the planned changes to the EU’s Regulation on novel foods, one issue is holding up agreement: how to address the subject of food from cloned animals and their offspring.

The Commission proposal, launched in January 2008, aimed to streamline the procedure for approval of novel foods in the EU, creating a centralised process with scientific assessment by EFSA. However, the inclusion in the definition of foods derived from “non-traditional breeding techniques” – i.e. cloning – poisoned the well, and brought an intensively negative reaction from consumer groups, MEPs, and the media.

And yet while the Parliament’s rapporteur, Kartika Liotard (GUE/NGL, Netherlands) wants an agreement as soon as possible, as do the Commission and member states, the dossier is almost certain to go to conciliation. In essence, the

disagreement between the Council and the EP centres on the method, not the principle of opposing food from clones or their offspring: the Council fears a legal vacuum if such food is not included in the scope of the Regulation; the Parliament fears that to include it means to risk having food from clones safety assessed and then potentially approved.

Meanwhile, the Council opposes the Commission on the issue of whether ‘food from clones’ should encompass food from the naturally-produced offspring of clones. The Commission says no; member states disagree.

The Commission will now publish a non-legislative report on the issue, which should be ready by November (in time for a conciliation process). The aim is to understand what is on the market, the situation in the United States and elsewhere, and the particular problem of dealing with imports of semen from cloned bulls – which is much harder to regulate than the import of the bulls themselves.

This task will have been complicated by the news in August that meat and milk from cloned animals and their offspring has probably entered the food chain in the UK (although the debate focused as much on animal welfare as on food safety).

How to regulate food from cloned animals is set to be an issue that rages in the months to come – and will test the abilities of Commissioner Dalli, as well as Europe’s resolve to enforce moral and ethical barriers, as well as the precautionary principle, despite the use of food from the offspring of clones being permitted in other markets, such as in the US.

Food safety and innovation Dealing with potential threats, from farm to factory

Food safety at all stages of the production is another priority for Commissioner Dalli.

The Commissioner is preparing a comprehensive – and potentially controversial – proposal on animal health in 2011. As well as looking at issues relating to animal welfare, the plan will examine issues relating to food safety, such as slaughter and protection against animal diseases.

The second TSE (Transmissible Spongiform Encephalopathies) Roadmap, which looks at control of diseases such as Mad Cow disease and scrapie, will also be revised, following a consultation that has now closed. One proposal from the Commission is to tolerate use of processed animal proteins (PAP), but only inter-species – for example, no pig meal will be fed to pigs and ‘cannibalism will not be allowed’. The roadmap looks to build on the success of the first TSE roadmap, and lead eventually to the eradication of these diseases in animals in the EU.

Elsewhere, Bisphenol-A, or BPA, continues to be a source of controversy. The substance, used in some plastic bottles, has been a source of concern as it can, under some circumstances, ‘leak’ into food and beverage products. Some studies have indicated that it is a potential endocrine disruptor. While the EU waits for an EFSA opinion on BPA, some countries – such as France and Denmark – have taken steps to ban its use.

E V I D E N C E - B A S E D C O M M U N I C A T I O N S

Meanwhile, pending the opinion, the Commission is pressing manufacturers to use alternative technologies that are already employed elsewhere in the world.

Nanotechnology and its application in the food sector has been identified by the Commission as one of the key issues for the years to come. A recent consultation on ‘Towards a Strategic Nanotechnology Action Plan (SNAP) 2010-2015’ – which looks at various applications of nanotechnology – saw some scepticism about its use in food, with respondents favouring use of this science in areas such as information technology, aerospace, energy and material sciences. The next step will be a proposed guidance document from EFSA, due shortly – although it seems that public and political opinion (as displayed in a clear vote for a moratorium on its use, in the European Parliament in July) may be difficult to shift regarding the use of nanotech in food.

Other issues on the agenda

OBESITY PLATFORM

Despite the departure of Robert Madelin from DG Sanco, and some criticism about the effectiveness of the EU Platform for Action on Diet, Physical Activity and Health, Commissioner Dalli and the new Director-General, Paola Testori, seem keen to continue the work of this group, at least in the short term.

However, the Platform will come under pressure to demonstrate real progress towards its objective (to "contain or reverse the trend of sustained, acute EU-wide increase in overweight or obesity"), with industry and NGO members divided over the utility of the group, according to an evaluation report published in July. The Commission is certain to want to see better outcomes.

DIETETIC FOODS

A review of the long-standing Framework Directive on Foods for Particular Nutritional Uses (PARNUTS) was due in 2010, but has been delayed. The Commission is even considering repealing the law, which sets special rules for food types such as infant formula, gluten-free and lactose-free foods, foods for special medical purposes, and slimming foods. In many areas – such as sports foods – specific legislation has still not been agreed, despite a provision in the original 1989 Directive.

Problems with the definition of the scope of PARNUTS, the relationship of the legislation with other food laws (such as the Claims Regulation), and inconsistencies and administrative burdens in the ‘notification procedure’ mean the Commission is considering changes to simplify and harmonise the rules, while also ensuring that it only enacts rules where consumer health would be put at risk.

At the moment, the options include repeal of the framework law, partial repeal (keeping some of the specific category rules in place), a ‘positive list’, whereby only named categories of products can be marketed as ‘dietetic foods’, and a centralised (EFSA-led) notification process.

A decision on the chosen path could follow in late 2010 or early 2011.

Photo credits (Flickr CC):

{Guerrilla Futures | Jason Tester}; How can I recycle this; didbygraham; me'nthedogs; KevinLallier

One of the major shifts in power brought about by the Lisbon Treaty was the extension of co-decision (now known officially as the ‘ordinary legislative procedure’) to trade policy and agriculture. In some ways, there is more to this extension of co-decision to the common agricultural policy (CAP) than meets the eye.

Firstly, while the power of enacting laws falls to the Council and the EP, the day-to-day implementation of some areas of the CAP – including fixing prices, levies and aid - has shifted to the Council. This bucks the overall trend of the Treaty, which grants more implementing powers to the Commission.

Secondly, it represents a culture shift – notably for the European Commission. Most MEPs on the Agriculture Committee will be familiar with the inter-institutional negotiations that take place on a co-decision dossier from their work on other committees. However, DG Agriculture is faced with a new challenge – learning about the processes and politics of regular interaction with parliamentarians, and handling a tri-partite process as opposed to the old-style dialogue with the Council.

Furthermore, the extension of the Parliament’s budgetary powers, through the abolition of the distinction between ‘compulsory’ (including CAP spending) and ‘non-compulsory’ expenditure, is a significant shift that will allow MEPs to act on farming subsidies, a long-time grievance of many parliamentarians.

The next major step will be the publication in November of a Commission Communication on the future of the CAP, in which the Commissioner for Agriculture, Dacian Ciolos, is likely to propose a continuation of direct payments to farmers, but also to review the criteria in order to ensure a more balanced outcome.

Agricultural policy