Trends in Food Science & Technology 28 (2012) 15e22

Review

* Corresponding author.

0924-2244/$ - see front matter � 2012 Elsevier Ltd. All rights reserved.http://dx.doi.org/10.1016/j.tifs.2012.06.006

Nutrition and health

claims: An

enforcement

perspective

Ajay Patel*, Chris Smith,

Tim Knowles and Yin-Ling LinDepartment of Food, Consumer and Technology,

Hollings Faculty, Manchester Metropolitan University,

Old Hall Lane, Manchester M14 6HR, UK (Tel.: D44(0) 161 247 2752; e-mail: a.k.patel@mmu.ac.uk)

In the March 2011 edition of this journal, there appeared an

overview of the regulation of health and nutrition claims

(Gilsenan, 2011) with particular reference to the Regulation

on Nutrition and Health Claims made on Foods (EC, 1924/

2006). From the issue of regulation arises the equally impor-

tant next question of how such regulation might be enforced.

This article examines the role played by enforcement in the

control of nutrition and health claims. The article examines

the prospects for enforcement of the regulation with reference

to enforcement theory and practice and previous decisions

concerning health and nutrition claims, with particular

emphasis on the UK.

The use of nutrition and health claims is common (Caswell

et al. 2003). An illustration of the extent of the part played by

health and nutrition claims is provided by a survey of the Irish

food market in 2007. The survey found that some 47% of foods

featured a nutrition claim and some 18% a health claim (Lalor

et al., 2010). Nutrition and health claims for food can help

consumers make well informed choices in relation to their

diet (Leathwood et al. 2007). Prior to the regulation there

was no harmonised legislation explicitly governing the use

of health and nutrition claims in the EU. Member states of

the EU were left to control such claims at national level. In

the UK there was no regulation specific to health and nutrition

claims relating to food; only general control of misleading

advertising applicable to all goods and services (see Table 1

below).

In some member states the control of health and nutrition

claims was the subject of self-regulatory initiatives such as

the Joint Health Claims Initiative in the UK and the Swedish

Food Sector’s Code of Practice on health claims in the label-

ling and marketing of food products. Experience with the

national codes has informed the implementation of the regula-

tion (Asp & Bryngelsson, 2007).

Whereas the regulation has provided a comprehensive

approach to the control of health and nutrition claims, the

same cannot be said for enforcement which remains a matter

for member states. The lack of effective enforcement or the dif-

ferences in the approaches of the member states may jeopar-

dise the aims of the regulation of facilitating cross border

trade and providing a high level of consumer protection.

Enforcement of general food law in the UKWhile the making of policy and law remains at EU level theresponsibility for enforcement in the UK is largely ceded tolocal authorities and specific central agencies. There areover 400 local authorities in the UK and primary responsi-bility for enforcement of food law lies with their tradingstandards and environmental health departments, some-times combined into a single Regulatory Servicesdepartment.

Although general responsibility for food law enforce-ment rests with local authorities, there are reserved dutiesheld by central agencies. Until recently the principal centralagency was the Food Standards Agency (FSA).

Other agencies of central government which have re-sponsibilities for enforcement for specific areas of foodlaw include the Pesticides Safety Directorate, the Veteri-nary Medicines Directorate and the Egg Marketing Inspec-torate; all within the Department for Environment, Foodand Rural Affairs (DEFRA) with responsibilities that arealigned with their titles.

Enforcement and penalties under the Nutrition andHealth Claims Regulations 2007

The Nutrition and Health Claims Regulations 2007(NHCRs) implement the Regulation on Nutrition andHealth Claims (EC, 1924/2006) into the UK law. Section4 of the NHCRs makes the following provision for enforce-ment; “each port health authority within its district and

16 A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

each food authority within its area shall execute and en-force the provisions of these Regulations and of the Regu-lation”. The competent authorities are identified in theRegulations as the Food Standards Agency, the port author-ity and the food authority in section 3 (NHCR, 2007). Abreach of the provisions of the regulation is a criminaloffence which may be tried either in the magistrates’ orcrown court. The penalty on summary conviction is a fineup to the statutory maximum and or three months’ impris-onment. The penalty on indictment is up to two yearsimprisonment and/or a fine.

The relationship between local and centralgovernment food law enforcement

Until its dissolution the FSA retained an overarchingmonitoring and supervisory role in relation to enforcement:

“Under the Food Standards Act 1999 the Agency hasa package of statutory powers to strengthen enforcementof food standards, and to ensure national objectives are de-livered.” Such powers included; the ability to set standardsof performance in relation to enforcement of food law andmonitor the performance of enforcement authorities.

In the Comprehensive Spending Review of 2010 thegovernment announced its intention to dismantle the FSAand divided its responsibilities between the Department ofHealth and the Department for Environment, Food and Ru-ral Affairs. The Local Government Association now playsthe function previously fulfilled by Local Government Reg-ulation, previously Local Authorities Coordinators of Reg-ulatory Services (LACORS), as the coordinating body inrelation to various consumer protection functions includingfood safety. It gives advice and guidance to local authoritiesand the FSA on enforcement issues.

Duties of local authoritiesAs with the EFSA policy, contained in its guidance doc-

ument of 2010 (EFSA, 2010), enforcement of food law inthe UK has typically focussed on food safety. This is unsur-prising in the light of the immediate and serious risks pre-sented by food borne illness. As such, enforcement of foodsafety law has rested with Environmental Health whereasenforcement of the Regulation falls to Trading Standardsas the nature of the risk is economic rather than health.

Inspection of food premises forms an important part ofthe strategy of food law enforcement by local authorities.In this respect the Food Standards Act 1999 provides localauthorities with wide powers to inspect any stage of theproduction or sale of food and to take a sample. Althoughlocal authority responsibility for enforcement of food lawis often expressed as a duty; for example, a local authoritymust investigate every consumer complaint about food, en-forcement action may include a range of measures fromwarnings, improvement notices, prosecutions and closureof a business. Also local authorities’ food safety officerswill take a risk-based approach to inspection and enforce-ment taking a more frequent and interventionist attitude

in proportion to the risk presented by the food producer/supplier.

Generally the failure to enforce the law leads to the po-tential for abuse and consequent loss of confidence in legalrules (Landes & Posner, 1974). Specific rules that are notenforced may do harm by leading subjects to lose respectfor legal rules in general. Although the passing of legisla-tion may have a symbolic value and deterrent effect, thelack of rigorous enforcement will have a wearying effecton the regulation (Polinsky & Shavell, 1999).

From the initial proposal on nutrition and health claimsin 2003, the European Commission acknowledged that suchclaims “are often not properly enforced.” As a result,“Consumers can therefore be misled by claims that havenot been properly substantiated. The proposed Regulationwill give legal security and address these issues by specify-ing the conditions for the use of nutrition and healthclaims.” (EC, 2003). There is an implicit acknowledgementthat the failure to enforce nutrition claims may be the resultof the lack of specific legislation and, therefore, clarity inthe law. The paucity of cases in this area may be further ev-idence of this failure. Regulation 1924/2006, may providesuch clarity to allow effective enforcement. Whether thiswill happen or whether there may be other reasons forthe lack of enforcement would involve a review and analy-sis of the opinions of enforcers.

In extrapolating economic theory to enforcement, thekey problem which arises is that the benefits of enforce-ment are diffuse and are enjoyed by all. The benefit offood law enforcement is an economic good like any other.However as with “public” goods generally, “no ‘markettype’ solution exists to determine the level of expenditureon public goods” (Tiebout, 1956). In this respect the bene-fits of food law enforcement are allocated in a non-optimalway when compared to other goods.

Enforcement options and the factors affectingenforcement choices

Various studies have examined the relationship betweenthe economic, political and social forces in understandingthe regulation of businesses (Gunningham et al., 2005). Indetermining the enforcement actions of a local authority,these studies provide some general insights into the en-forcement of food law by Trading Standards Officers(TSOs).

One of the notable trends in regulation across a range ofsectors from financial services to food safety has been to-wards a risk-based approach. The approach has influencedfood law enforcement as well. The Scientific Committee ofthe European Food Safety Authority (EFSA) has developedguidance for performing risk-benefit assessment for food(EFSA, 2010). However the document is concerned onlywith human health risks and does not address social, eco-nomic and other considerations. A risk-based approachmay be defined as, “systemised decision making frame-works and procedures to prioritise regulatory activities

17A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

and deploy resources principally relating to inspection andenforcement based on an assessment of the risks that regu-lated firms pose to the regulator’s objectives” (Black,2002). The risk-based approach is promoted as a transparentand coherent approach to regulation and by focussing onthe areas that present the greatest risks, it may provide anefficient allocation of resources. The risk-based approachwas put into practice following Sir Phillip Hampton’s2005 review Reducing administrative burdens: effectiveinspections and enforcement. In the final report the reviewadopts the principle that; “regulators, and the regulatorysystem as a whole, should use comprehensive risk assess-ment to concentrate resources on the areas that need themmost” (Hampton, 2005). The attraction of a risk-based ap-proach where responses are determined by the logic of riskanalysis is obvious but there are potential shortcomings ofthe approach, in particular that of, “the challenges of regu-lation to which regulators have to respond vary across thedifferent regulatory tasks of detection, response develop-ment, enforcement, assessment, and modification”(Black& Baldwin, 2010).

In relation to health and nutrition claims one of the fac-tors which may have led to a significant level of unsub-stantiated claims prior to the passing of the regulation,may be due to uncertainty about the legal position. Thegreater the latitude in relation to the precise legal positionthe more scope there is for interpretation by providers totheir own full advantage. On a more generous and less dis-trustful reading, suppliers may genuinely be unaware oftheir legal duties or be mistaken as to the existence and ap-plication to their own enterprise of these regulations(Hutter, 2001).

The food industry comprises a large variety of differenttypes of businesses ranging from the multinational con-glomerate encompassing complex distribution and licens-ing arrangements to the small direct producer forexample, farmer. Smaller businesses can find compliancewith their regulatory obligations more difficult; througha lack of resources or the failure to understand what is re-quired from them (Yapp & Fairman, 2006).

Trading Standards Officers represent the first line of re-sponse to the enforcement of the Regulation. They interpretthe law in statutes, cases and procedure and translate it intoaction on the frontline (Hutter, 2008). Trading StandardsOfficers enjoy a high level of discretion about how to im-plement the law in relation to individual businesses. Theevidence shows that regulators generally deploy this discre-tion flexibly (Hawkins, 2002). Regulators including Trad-ing Standards Officers make use of a range or “menu” ofenforcement options available to them. These may rangefrom education and advice, to agreement on a course ofaction or undertakings as well as court action. The mainobjective of enforcement action is for securing compliance“both through the remedy of existing problems and, aboveall, the prevention of others” (Hutter, 2008). The possibilityof the use of a range of options raises questions about the

nature of enforcement, its purpose and at what point thatpurpose is achieved:

“The preferred methods to achieve these ends are co-operative and conciliatory. So where compliance is lessthan complete, and there is good reason for it being incom-plete, persuasion, negotiation and education are the primaryenforcement methods. Accordingly, compliance is not nec-essarily regarded as being immediately achievable; rather itmay be seen as a long-term aim. The use of formal legalmethods, especially prosecution, is regarded as a last resort,something to be avoided unless all else fails to secure com-pliance. Indeed, the importance of legal methods lies in themystique surrounding their threatened or possible userather than their actual use” (Hutter, 2008).

There are a number of reasons why action on enforce-ment does not necessarily mean taking legal action. Thegeneral way in which regulations and law, particularlyEuropean regulations, are drafted can make taking legal ac-tion difficult for enforcers (Baldwin & Sunkin, 1995;Kagan & Scholz, 1984). Enforcers may consider that infor-mal action such as advice and guidance may be more effec-tive and may provide a more efficient way to utilise theirresources than prosecution or other legal action (Hawkins,2002).

The local level at which Trading Standards operate andthe discretion that is afforded to TSOs with a local authoritywill lead to differences in the way in which the same law isenforced by different departments. A key factor in this var-iation will be the availability of resources, particularly thedepartment’s budget and staff numbers (Hampton, 2005).The question of what resources are available for enforce-ment of health and nutrition claims may be affected notonly by the resources available to the department as a wholebut also to the allocation of those resources to various as-pects of the many responsibilities of TSOs. Notwithstand-ing risk analysis and a scientific approach, in decidingwhat action to take, a TSO will also be affected by theirown personal and intuitive assessment about the nature ofthe breach and its potential impact (Tebbutt et al., 2007).Formal action may only follow where an incident is viewedas so serious as to warrant legal action or that the TSO feelsthat informal action will not lead to a positive responsefrom the business involved.

While the local aspect of Trading Standards enforcementis seen by many as one of its great strengths in providingregional accountability, the structural organisation of localauthorities with the incorporation of elected councillorsopens up the system to political interference. In this respect,the concept of representational democracy and ideologi-cally driven support for a particular policy represent con-trasting facets of the same issue.

The range of matters that fall within the duties of TSOsto enforce is extremely wide. The broad areas covered are;“economic recovery, environmental protection, improvedhealth, community safety” (TSI, 2011). The day-to-daywork may include policing of; age restricted sales,

18 A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

counterfeit goods, overloaded vehicles, weights and mea-sures and food related inspections. The expertise requiredto effectively monitor such a broad variety of activity is in-creasingly technical and more demanding. This leads toa TSO, like their EHO cousins, having to become a “Jackof all trades” and inevitably “a master of none” (Hutter,2008). The extent of this feature as a problem will vary be-tween authorities. Large metropolitan authorities will beable employ and develop specialist teams but smaller au-thorities where there are fewer employees, will need toadopt several functions and provide a more generalised ap-proach to their role.

Businesses play an increasing role in influencing the reg-ulation of enforcement of law in general and this also ap-plies to the activities of TSOs. There has been a shift infocus from the traditional role of the state regulator asa strict legal enforcer and prosecutor to that of educatorand advisor. In making this shift, TSOs have needed to be-come more attuned to the needs of the businesses that theyoversee. This is evidenced in the consultation process sanc-tioned and even required by central government, sometimesas part and parcel of a broader deregulation agenda. Suchan agenda is frequently the focus of lobbying activitiesby industry groups and public relations firms. In relationto the influence of one business on another, large busi-nesses, particularly supermarkets, can exert considerableinfluence on those smaller food businesses for whom thesupermarket represents their distribution channel(Balsevich et al., 2003).

Enforcement policy and enforcement action byTrading Standards

The way in which TSOs seek to carry out their enforce-ment duties is a matter of public record for the purposes ofopenness, consistency, accountability and transparency.Some local authorities publish the details of the enforce-ment policy on their web sites and such policies are col-lated on the web site of the Trading Standards Institute(TSI). Local authorities are required to conform with man-datory reforms aimed at removing unjustified differences inenforcement approaches between regions. Therefore theenforcement policy of local authorities should be similar.

The legal underpinning for enforcement policy is pro-vided by the Legislative and Regulatory Reform Act 2006and further guidance is bestowed by the principles in theEnforcement Concordat and the Regulator’s ComplianceCode.

The Home Authority Principle means that a businessbased in a single authority that has outlets and does busi-ness outside that authority is subject to the jurisdiction ofits home authority rather than that of another authoritywhere it has a branch or where the business is done.

Local councils help businesses operating in the UK tocomply with legislation by providing advice, guidanceand information. Businesses will generally build up a rela-tionship with, and receive advice and information from, one

particular council. This is “usually the local council wherethe business is based, but not exclusively.” LocalGovernment Regulation (formerly LACORS) (LGR, 2011).

In its consultation Empowering and Protection Con-sumers Consultation on institutional changes for provisionof consumer information, advice, education, advocacyand enforcement (BIS, 2011) the government has soughtviews on the proposal aimed at “clarifying its responsibilityto tackle cross-boundary threats”. The consultation recog-nises the limitations of the Home Authority Principle andin particular the problems of the risks of taking enforce-ment action and the lack of expertise. The consultation ac-knowledges the need to reduce the disincentive forindividual authorities to take on more complex or riskycases (of which enforcement of NHCRs might be an exam-ple), say by creating an indemnity fund. It goes on to dis-cuss how an individual Trading Standards departmentmight become a designated lead authority with expertisein a particular sector, for example the enforcement ofNHCRs.

At the investigation stage, TSOs are required to take ac-count of the relevant legislation including the Police andCriminal Evidence Act 1984, Criminal Procedure andInvestigations Act 1996, Regulation of InvestigatoryPowers Act 2000 and the Human Rights Act 1998. Investi-gating officers are also required to follow codes of practicedealing with interviewing witnesses and disclosing evi-dence. The nature of Trading Standards prosecution workwould suggest that it is concerned with the criminal processand while the Nutrition and Health Claims Regulations2007 (NHCR, 2007) create offences for breaches, onemight enquire as to the suitability of dealing with breachesby reference to criminal proceedings.

Actual enforcement e cases and regulatory decisionsThe regulation allows member states to implement their

own enforcement regimes. Case law and non-statutory en-forcement such as the Advertising Standards Authority pro-vide useful guidance on enforcement (Gilsenan, 2011).

Cases prior to the regulationPrior to the regulation coming into force, the relevant

law applied to goods and services generally and it wasnot specific to health and nutrition claims for food (seeTable 1). It required that consumers were not misled(Ruffell, 2003).

There are only two English cases where courts have con-sidered health claims prior to the regulations coming intoforce. Both cases are unreported in official court reportsand the records of them are from press articles. Both casesinvolve cereal manufacturers.

The first case Cheshire County Council v Mornflake OatsLimited 1993 involves Mornflakes Oats’ claims made forheart health on the packaging for porridge oats. The claimmade was that eating porridge oats as part of a low caloriediet could reduce blood cholesterol and therefore reduce the

Table 1. Showingthe rules applicable to nutrition and health claims.

Applicable law Applies to all goodsand services

Applies to foodand drink only

Applies to food anddrink in relation to healthand nutrition claims only

Consumer Protection from Unfair TradingRegulations 2008

Business Protection from MisleadingMarketing Regulations 2008

Food Safety Act 1990

Nutrition and Health Claims Regulations 2007

Advertising Standards Associationvoluntary/co-regulatory codesThe UK Code of Non-broadcast Advertising,Sales Promotion and Direct Marketing (CAP Code)Press, print, posters, online

The UK Code of Broadcast Advertising(BCAP Code)Broadcast only

19A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

risks from heart disease. In that case the high court held theinformation on the box had to be taken as a whole and thatthe claim was in effect a medicinal claim for MornflakeOats. The claim that porridge oats could “treat, help preventor cure a disease” was a precise claim which may only beused for medicines and not foods unless they have beenproven to deliver such benefits. As such the claim wasmade in contravention of the Food Labelling Regulations1996. The legal position may be different now.

In the second case, Shropshire Trading Standards vNestle UK Limited 2000, Nestle was prosecuted for claimsmade for its Shredded Wheat breakfast cereal. The wordingon the packaging of Shredded Wheat stated: “Coronaryheart disease.it’s the UK’s single biggest killer.theBritish Heart Foundation suggests the following to reducethe risks of CHD; cut down on fat and salt; eat more fi-bre.take part in a healthy heart campaign and start alongthe way to a healthier heart.cut down on fat.ShreddedWheat is 98% fat free with no added sugar.cut down onsalt.Shredded Wheat has no added salt.eat morefibre.Shredded Wheat is a great source of bran fibre.”

The magistrate commented that it was “clear beyonddoubt that the statements about Shredded Wheat attachedto each of the campaign steps invite an irresistible inferencethat eating Shredded Wheat will reduce the risk of coronaryheart disease”.

Nestle was found guilty and fined £2500 and ordered topay costs of £13,601 for contravening the Food Safety Act

1990 and the Food Labelling Regulations. It pleaded notguilty by claiming that the food could in fact prevent, treator cure a human disease (FLM, 2000).

The case was decided at magistrates’ court level;therefore in spite of its significance for the regulationof food, it does not provide a binding precedent for futurecourts.

In 2011 St Helens Trading Standards successfully pros-ecuted Bodyscoop Limited in what is thought to be the firstaction under the NHCRs. The magistrates’ court imposeda fine of £12,000 on Bodyscoop and the director wasordered to pay the same amount. The prosecution con-cerned diet pills that were ineffective and caused mildstomach upset. St Helens Trading Standards took actionin response to complaints from consumers.

Advertising Standards Authority (ASA) adjudicationsThe above court cases are significant. However the re-

ports of the decisions provide little in the way of guidanceabout the courts’ approach to health and nutrition claims asthere are no published judgements. Perhaps more enlighten-ing are the decisions of the Advertising Standards Author-ity, in particular the ASA decision on Danone Actimel. TheASA has upheld four complaints about health claims madeby Danone in the period 2006e2009. In 2009 the ASA pro-vided the most comprehensive account of its investigationand on its rationale.

20 A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

In 2009 the ASA received a complaint about a televisionadvertisement for Danone “Actimel” which made theclaim; “Actimel. Scientifically proven to help supportyour kids’ defences”. The claim was challenged by a com-plaint that questioned whether such a claim could be sub-stantiated under the British Code of Advertising Practicesection 8.3.1:

8.3.1 Accuracy in food advertising

� 8.3.1(a)Nutrition claims (e.g. “high in vitamin C”) or healthclaims (e.g. “aids a healthy digestion”) must be sup-ported by sound scientific evidence. Advertising mustnot give a misleading impression of the nutritional orhealth benefits of the product as a whole and factual nu-trition statements should not imply a nutritional orhealth claim that cannot be supported.

Danone claimed Actimel would support the humanbody’s natural defence system against common infections.Danone provided the ASA with the body of scientific evi-dence on which it relied. The studies, it claimed, showeda positive effect for Actimel overall.

The ASA, in consultation with a nutrition expert, con-sidered the scientific studies. The first, by Guerin-Dananet al., did not consider health effects and therefore itwas discounted (Guerin-Danan et al. 1998). Two furtherstudies were deemed unsuitable as evidence for the ben-efits of Actimel for the general population as they werecarried out on hospitalised children in India. Two studiesby Pedone et al., were examined. The 1999 study, useda sample size that was too small to show the effect onthe incidence of diarrhoea in the subjects (Carosellaet al. 1999). In both of the studies the mean ages of thechildren were 6 and 15.5 months and this was consideredby the ASA to be “lower than the target group of schoolage children suggested by the ad.” The portion sizes ofthe children in the study were larger than the recommen-ded serving of one 100 g pot of Actimel per day. Furtherobservations by the ASA on the evidence included the in-consistency between the studies and where research wascarried out on children who suffered from allergic condi-tions. This meant that the results of the study “could notnecessarily be extrapolated to apply to normal, healthychildren”(Giovannini et al., 2007). Where there wereapparent benefits among those who consumed Actimelthese were not statistically significant when comparedto the control groups.

In conclusion, the ASA found that “the evidence did notsupport the claim made in the ad that ‘a serving of Actimelwas scientifically proven to support the defences of normal,healthy school aged children against common, everydaychildhood infections’”. And finally “[W]we therefore con-cluded that the ad was misleading.”

The ASA has published guidance in this area for mar-keters entitled Guidance on health therapies and evidence

Q and A and a help note; Substantiation for health, beautyand slimming claims based on cases that it has adjudicated.

The role of the European Food Safety Authority and itsimpact on courts and the ASA

Under the regulation a claim which is permitted underArticle 13.1 and which therefore appears on the pendinglist of approved claims may be used in the promotion offood. For a claim to be permitted under Article 13.1 itmust be underpinned by generally accepted scientific evi-dence. ‘General function’ health claims that refer to a nutri-ent or substance in growth fall under 13.1. Article 13.5deals with ‘new function’ or proprietary health claims.The approval is provided by the European Commissionand member states but based on the scientific opinions ofEFSA as to whether the claim is substantiated.

Since the regulation came into force in 2007, some ofthe responsibility which previously rested with the ASAhas eased or been made simpler by the creation of the ap-proved claims list. Therefore the question of whether to up-hold a complaint may be determined by reference to the listof approved claims rather than by a fresh inquiry into theevidence.

The Dietetic Products, Nutrition and Allergies (NDA)panel of EFSA has rejected the vast majority of the healthclaims submitted (Gilsenan, 2011). In carrying out this as-sessment, EFSA has adopted a quasi-judicial function.EFSA’s role is to independently assess whether the under-pinning evidence substantiates a claim. In this respect,EFSA bears responsibility for deciding whether the evi-dence supports a health claim and issuing an opinion.The outcome may be likened to that of a decision of a courtor the ASA in that the positive opinion regarding a claim, ifapproved by the Commission and member states will deter-mine whether a prospective promotional communicationcan be used by a food business. In this way the opinion pro-vides guidance and influences future behaviour. Underpin-ning the system there seems to be a belief that science isunequivocal and that EFSA can somehow remove the re-sponsibility for decisions from the administrators andcourts.

EFSA received some 44,000 ‘general function’ healthclaims from under Article 13.1 from individual memberstates of the EU for approval. Some 44,000 claims weresubmitted and this unwieldy list was whittled down to4637 by removing the inevitable duplication. EFSA hasprovided 341 opinions on 2758 general function healthclaims (EFSA, 2012).

When considering the evidence, EFSA decides if a causeand effect relationship is established, this is “a scientific as-sessment to the highest standard”(Gilsenan, 2011). But be-fore this can be determined there are three key preliminaryquestions that need to be addressed:

i) Is the food on which the claim is made sufficientlydefined and characterised?

21A. Patel et al. / Trends in Food Science & Technology 28 (2012) 15e22

ii) Is the claimed effect sufficiently defined and is it a ben-eficial physiological effect?

iii) Whether a cause and effect relationship has been estab-lished (for which human data are compulsory)?

In each case there must be a positive answer to all threequestions. In line with the ASA approach shown in theActimel ruling “well conducted human studies are centralto the claim substantiation. Human studies must be well de-signed, be of high quality and must be representative of thetarget population to which the claim is intended. They mustbe sufficiently powered, address confounding factors anduse valid biomarkers for the claimed effect”(Gilsenan,2011).

Some 80% of Article 13.1 proposed claims have beenrejected by the Panel. The quality of the evidence providedin support of claims has been variable, ranging from theBible, Wikipedia to peer reviewed scientific journals. Ofthose claims that have been rejected they include those re-lating to probiotic, antioxidant and glycaemic response. Alljoint health claims have been rejected as the evidence hasinvolved studies carried out using patients with osteoarthri-tis and their conclusions could not be applied to the generalhealthy population (Gilsenan, 2011). In contrast, claims re-lating to the consumption of calcium and child bone growthhave been approved.

Notwithstanding the question of scientific evaluation,there are five general principles which must be followedin relation to all health and nutrition claims. The claimmust not:

i) be false or ambiguousii) give rise to doubt about the safety and or the nutritional

adequacy of other foodsiii) encourage excess consumptioniv) state, suggest or imply that a balanced and varied diet

cannot provide appropriate quantities of nutrients ingeneral

v) refer to changes in bodily functions which could giverise to fear in consumers.

The decision making of the Panel differs from adjudica-tion by a self-regulatory body like the ASA or a court insome important respects. The process has very much beena case of “learning by doing”, not something that regulatorsor courts do or at least admit. The guidance to substantia-tion is evolving and EFSA has also committed to more di-alogue with stakeholders by consultation.

Court cases often arise as a result of ambiguity in thelaw. The result of the Article 13.1 procedure of adoptingpermitted claims or a “white list” may be that there isless ambiguity and that consequently there will be evenfewer cases. This will have implications for enforcementwhich should also involve a preliminary check by authori-ties to enquire whether a claim is among the permittedclaims. On one view this should be a more straightforward

exercise and remove the ambiguity and simplify the judge-ment that may then need to be made. In spite of this recentcourt decisions seem to indicate a less than supine attitudeof the courts; “In two decisions dated 12 March 2008(MD2008, p 533) and 11 September 2008 (MD2008 p1344), the Higher Court of Schleswig addressed the issueof prior effect of the Community list. The court held thatthe inclusion of a health claim on the list had no legal effectand that the list merely contained proposals” (Meisterernst,2010).

Challenges under the regulation where they are mademay involve a challenge of the procedure used by EFSAfor review and about other parts of the Regulation.

However it is “imperative that the Commission and theMember States, as the responsible risk managers and the in-stitutions entitled to decide on the authorisation of healthclaims, regain control over the interpretation and applica-tion of the Regulation” (Meisterernst, 2010).

A salutary lesson on the risks of making a false claimcan be seen from the case of Dannon in the US wherethe claim that Activia yogurt was “clinically” and “scientif-ically” proven to regulate digestion and boost immune sys-tems resulted in a settlement where Dannon agreed to pay$45m to affected consumers. Whilst redress by class ac-tions is a relatively immature area of litigation in Europe,there has been significant pressure from consumer groupsand the European Parliament to provide direct remediesfor consumers in the context of the EU Unfair CommercialPractices Directive as implemented by the CPRs (EU,2009).

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