EFSA’s health claim evaluation processKey impacts on the European Food & Drink Market

George Tsakraklides

What are Functional Foods?

A health claim is any statement used on product labels, marketing or advertising materials which implies benefits from the food or its components, e.g. vitamins, minerals, fiber, and ‘probiotic’ bacteria

Health claims are increasingly appearing on our food..

The definition of functional foods is still evolving. To some they are fortified foods, to others they include supplements, while to some they can be any food which can make a valid health claim and “provides a health benefit beyond basic nutrition”

So where do Functional Foods fall?

Unlike medicines, most of the concern is about false claimsWhereas in medicines the regulatory environment focuses on safety as well as efficacy, functional foods are so far considered a low-risk category

Functional foods exist in the evolving and still uncertain realm between Foods and Medicines

Medicines undergo multistep validation before entering the market, a process which on average takes between 10 and 15 years

..but the food industry is not allowed to make “medicinal” claims about foods

As the definition of functional foods takes shape, so does the regulatory environment

Directive 2001/83/EC of the European Parliament

Institute of Food TechnologistsNutrition.about.com

EFSA.europa.eu

A rapidly growing market

Rising public interest in healthy living and awareness that food is not only for energy or pleasure - but can serve specific health benefits - has led to a new and rapidly growing market.

15.119.7

Source: Leatherhead

31%

Global Functional Foods Market

(bn euros)

2007 2011

all inclusive estimate

155

UK 1998-2007Source: IGD Research

EFSA (European Food Safety Authority) is the EU’s risk assessor for food-related risk – providing scientific opinions and advice to:

• provide a sound foundation for European food policies and legislation

• support the European Commission, European Parliament and EU Member States in taking effective and timely risk management decisions

Its remit covers food and feed safety, animal health and welfare, nutrition, plant protection and plant health

Shortly after its formation, EFSA took on the ambitious task of regulating functional foods

EFSA Mission

“…So that the consumer is not misled by exaggerated or untruthful claims”

EFSA.europa.eu

Health claims made in relation to food products require authorization under Regulation EC 1924/2006 before they can be used in labeling and marketing

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) is responsible for verifying the scientific substantiation of the health claim. It presides over specialist Working Groups

Following ratification of the NDA Opinions by the EU Parliament, member states take on the task of enforcing the new law

The NDA panel and claims classification

Two broad categories of claims

• “general function and nutrition” - e.g. enhance immunity or learning ability, “low fat”, “source of omega-3 fatty acids” or “high in fiber”

• “disease reduction” - e.g. “Plant sterol have shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease”

Article 13

• Growth, development and body functions• Psychological or behavioural benefits• Sliming, weight control

Article 14

• Reduction in disease• Children’s development and health

Health Claims Evaluation - Key Milestones

2002 is established

2006 Nutrition and Health Claims Regulation (NHCR; No 1924/2006) enacted

2008 EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) begins work of evaluating submitted health claims, prioritizing claims under Article 13.1

2010 (March) last claims received

2011 (July) Panel’s last batch of its Register of Opinions published, consultation begins before critical vote in the European Parliament

2012 (January) the register of NDA opinions is presented and put to debate

(May) article 13 list register wins approval in European parliament by 60% vote and becomes law. Companies given till December 14 to comply

EFSA.europa.eu

The EFSA health claim evaluation Process in numbers

Herbals and Botanicals put on hold

ratification

44,000

4,637

27581548

consolidation exclusion decision

222 NDA

approved

Brussels

EFSA.europa.eu

An uneven decision

About 80% of claims were rejected. If Vitamins and Minerals are excluded, the rate approaches 95%

Intertek Cantox

Evaluation of claims for botanicals, has been put on hold as the EFSA has considered them “insufficiently characterised” and needs time to decide. These will continue to be allowed to be marketed for the time being, though it is at the discretion of member states. Confusion between THMPs (Traditional Herbal Medicinal Products) - which are allowed under separate regulation - and food products with similar ingredients could theoretically result in the same active ingredient being rejected and approved under separate regulations

Botanicals and microorganisms: lucky for now?

The losers

Probiotics were among the most high-profile as well as controversial casualties

Immunity claims, weight loss ingredients and antioxidants did not fare well in general

However overall rejections did not focus on specific categories but were based on the strength of evidence to support each claim

Ingredient Claim

Probiotics Bolster Immune systemGut microflora balance

Antioxidants Various

Omega-3 Cognitive development

Chewing gum Dental plaque reduction

Nutraingredients.comEFSA.europa.eu

The winners

Ingredient Claimed effect

Vitamins Various

Minerals Various

Live yoghurt Lactose digestion

Certain fibres Glucose , cholesterol, weight

Walnuts Blood vessel function

Meal replacement Weight control

Fatty acids Heart function

Xylitol, sorbitol Tooth mineralisation

CH/electrolyte drinks / creatine

Sports performance

Studying how EFSA came to its conclusions is quite important as it gives us an idea of what makes a successful health claim – and what companies should watch out for in the future

Nutraingredients.comEFSA.europa.eu

Full list of 222 approved claims in the official Journal of the European Union:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:136:FULL:EN:PDF

What matters to the EFSA’s NDA panel?

Relevant studies, properly designed and fit to purpose

Studies with humans subjects and, in the case of disease reduction claims, studies among healthy individuals who would be the target population as opposed to those having the disease. Glucosamine claims for preventing joint degeneration were rejected partly on the basis that research was done on people already suffering

Studies among relevant human populations

The link between cranberry juice consumption and decrease in Urinary Tract Infections was dismissed multiple times as results were based on in vitro studies as opposed to clinical trials among humans. Ironically Dutch-based Medical Brands won a much more significant Class II Medical Device claim in Germany which by mutual recognition allows marketing in EU27

Sound science

Nutraingredients.comEFSA.europa.eu

Nutraingredients.comEFSA.europa.eu

Lack of evidence for cause and effect was the reason for about 4 out of 5 rejections

Cantox

What matters to the EFSA’s NDA panel?

sufficient evidence to establish a link between the particular ingredient and the food

Identification of the active ingredient as well as the specific effect it has, as opposed to a general effect. A good example is the rejection of a link between water and avoiding dehydration. Although obvious, the claim was deemed as medicinal. It was also submitted under the wrong article

Sufficient characterisation of food constituent and effect

It is not enough e.g. to demonstrate that polyphenols in olive oil have antioxidant properties. The evidence must include an effect of olive oil consumption rather than polyphenols i.e. the actual food for which the claim is made

Specific claims with specific aims which can be tested

Nutraingredients.comEFSA.europa.euCantox

Nutraingredients.comEFSA.europa.eu

Wording is everything

Milk is the richest dietary source of calcium Milk is the richest dietary source of bio-available calcium

Helps maintain a healthy blood flow and benefits circulation

proposed

Helps maintain normal platelet aggregation

allowed

Biotin contributes to normal energy-yielding metabolism

Biotin contributes to healthy energy-yielding metabolism

We can expect future claims to be:

1) More specific and technical2) More difficult to decipher3) Less impactful4) More rational, less emotional

Final re-wordings illustrate EFSA’s commitment to the accurate and precise description of the specifically proven effect rather than what this means to the consumer - In order to minimise the potential for various interpretations as well as positive generalisations of the claimed effect on overall health

It is not only about the claim being made. It is about how it is worded

EFSA.europa.euNewhope360.comNutrisciences.com

Impacts – Current products

Current Products : challenging times ahead

1600 claim associations will be banned which means claims will be removed from packaging and other marketing. The food industry has until Dec 14th to comply

Expected fall in sales in products with rejected claims.

Brand names which themselves make a health claim may be under threat. Examples are Unilever’s Flora pro.activ and the iconic Slim-Fast brand. Jan 19, 2022 deadline for changing brand name if its health claim is not approved

Direct threat to brands

Decision on other claims has been postponed, leaving companies in the dark in terms of future planning. Some rejected claims can be resubmitted under other articles of the regulation. Others have been withdrawn

In limbo

Bbc.co.uk, just-food.com

EFSA.europa.eu

Impacts – Innovation

Lack of EFSA approval will rob manufacturers of the marketing messages that would have been the perfect ammunition for ingredients with newly-approved function

Less NPD and innovation

Nutraingredients.com

Innovation: limited options , increased competition

Although there will only be few new products that claim a “new function”, companies will try to maximise their take from the small new slice of the pie by including the new approved ingredients in as many products (existing or new) as possible

Limited new approvals may spark product “mutations”

More “All -rounders” and “blends”Lack of innovation and competition for the very few new approvals will intensify the trend of multi-functional foods , as manufacturers try to outcompete each other by providing extra features - giving rise to more “blends” that can “do it all”

Nutraingredients.com

Impacts - Marketing

There will be more scrutiny for claims to refer to specific effects of the ingredient rather than simplified generalisations. Marketers will have to tackle complicated scientific jargon and convert it to a message which sells e.g. Instead of anti-oxidant they may have to say “reduces oxidative stress”

The challenge of making science sound simple

Lost in translation

Ensuring that the meaning of the claim is not altered, overstated or understated upon translation will be a challenge for marketers working under the watchful eye of EU country authorities and the EFSA

New messages will walk a fine line between science fiction and sales targets

Renewed emphasis on “sound science” and limited new approvals to work will leave many with no choice but to re-package their old messages - but using new “buzzwords” – opening up the market for new consumer needs

New opportunities for future nutritional “buzzwords”

There are already signals from the EFSA that certain flexibility on the wording of claims will be allowed, recognising the challenge of communicating claims to consumers. Time will tell what exactly companies can “get away with”

Flexibility in wording

Opportunity to get creative?

Impact on Consumers – was it worth it?

New marketing messages will be more difficult to interpret as they focus on what the product does rather than what this means to the user. For those who have the knowledge, the new messages will be more useful than ever. For the majority who don’t, confusion will set in in the beginning

A new learning curve for consumers - but a new era for popular nutrition?

It has been argued that the removal of claims from packaging for many products will leave consumers in some instances with no information other than what is contained in the package. At the same time this may encourage some to rely on their own research and consult a variety of other sources, reliable or not

Left In the dark – or more empowered to seek info?

European Food Information Council

It is under debate whether consumers are now safer or not.. What is certain is that they will be challenged to learn more about what they eat.

Impact on Consumers – was it worth it?

Although rejections will receive little notice, approvals will be highlighted in the media and over-exploited by manufacturers, providing consumers with new information. The new wave of a small number of approvals may be an advertisement for the whole functional foods market - enough to potentially re-invigorate it, offset the negative effects of rejections and ensure demand and interest continue to grow

New approvals, products - is the Functional Foods market still alive?

Will product quality increase as a result of more careful research and validation? And if it does, will consumers be asked to pay the price?

Quality vs. price

What can companies do?

Provexis had to submit a 700-page dossier in support of its tomato extract which claims it improves blood circulation. The dossier addressed issues from the original, rejected application and had to specify:

The formulation of the extract to be usedProducts it can be used inEffective dosage and conditions of use

Invest in research and people

‘everything should be spelt out clearly – the health claim process is time consuming and costly, and we have learnt that a company should make every effort to communicate not just present but any potential conditions of use for their products ’

- Provexis COO

Larger companies will have more resource and money for “proper” research, complex dossiers and innovation

bbc.co.uk

What can companies do?

In this environment of increased scrutiny marketing departments will need to tread carefully and push their messaging to its legal limits

Create more subtle claims that do not require validation

Smaller companies will have to do the best with what they can claim already - as well as what they cannot claim anymore

Requirements are getting increasingly technical and detailed. Marketers will need to work more closely with the Food Scientists. The former advising on what sells, the latter advising on what can be claimed. Together they can formulate claims, agree on validation and finalise wording

Consult the scientists more

Small enterprises who cannot pay the legal and other fees for research and regulatory filing may seek the help of big companies, who will be happy to acquire manufacturing infrastructure in exchange for protection

Mergers and acquisitions may be the only option for some

EFSA’s health claim evaluation – the next day

• Make the most of approved claims by creating blends or other multi-functional foods

• Study the plethora of rejection case studies available

• Appeal or submit the same claim under a different article or even different regulation

• Pay attention to what is important to the NDA

• Create new claims which won’t be impossible and costly to support via research

• Invest in experts who can design sound scientific studies. Learn from pharma and other industries

• Conduct market research to understand customer needs

• Follow EFSA news in order to get in on the far and few opportunities for new claims as early as possible

• If possible, re-word or create more subtle claims that require no validation

• Re-brand or focus on other product strengths and USPs

• If necessary move from a product brand to an endorsed or corporate brand architecture model

• Educate consumers in order to promote your claims as well as your own brand

• Consult with the R&D more on claim strategy and wording early on in process

• Conduct market research to measure brand performance

• In the face of intense competition, review pricing strategy if needed

• Target customers better

• Shift attention to what sells

• Lure customers via promotions

• Turn attention to non-EU markets

• Consider whether product price should take into account the cost of research undertaken to support and develop it

R&D Marketing Sales

Approvedclaims

Rejectedclaims

Futureclaims

EU / GovernmentEFSA.europa.euEuropa.euEur-lex.europa.euFood Standards Agency (UK)Food Safety Authority of Ireland

General MediaBBC NewsGoogle NewsWikipedia

Specialist & B2B Media foodmanufacture.co.uknewhope360.comnutraceuticals worldNutrisciences.comNutraingriedients.comJust-food.comFnB newsFoodbev.comEufoodpolicy.comNutrition.about.comNutritionaloutlook.comNutrialphaeurope.com

Sources

NGOs / Non-Profit OrganisationsInstitute of Food TechnologistsEPHA European Public Health AllianceEuropean Food Information Council

ConferencesVitafoods EuropeIFT

Research OrganisationsMeyerBCC ResearchLeatherheadIGDIntertek Cantox

Special Interest GroupsAlliance for Natural Health

George is a scientist and market researcher at MM-Eye

sharp minds, safe handswww.mm-eye.com George Tsakraklides

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