Nutrition and health claims in the European Union in 2022

| 03 September 2022 | By Nuala Collins, BSc, Dip PgCert, Hans Verhagen, PhD 
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Nutrition and well being claims are extensively used on meals labels and should positively affect client perceptions and intentions to purchase meals. Regulation (EC) 1924/2006 on diet and well being claims goals to make sure claims are clear, scientifically substantiated, and helps shoppers to make knowledgeable choices. The European Commission (EC) is working to introduce a legislative proposal on nutrient profiles in 2022 to limit the usage of claims on meals excessive in saturated fats, sugar, or salt. The EC should additionally discover a answer to the inequality within the scientific substantiation of nonbotanical versus botanical claims.
 
Keywords – claims, well being, diet, Regulation 1924/2006
 

Introduction

Functional meals embrace meals with enhancements, similar to decreasing damaging features (e.g., decrease in energy, sugar, sodium) in addition to the incorporation of different constituents (e.g., nutritional vitamins, minerals, plant sterols, probiotics, prebiotics). Functional meals with well being claims had been among the many first claims used on meals labels within the Nineteen Eighties, whereas right now, diet claims are extra extensively used. In the EU, the target of Regulation (EC) 1924/2006,¹ which was launched in 2007, is to make sure that any diet and well being declare made in industrial communication to shoppers or well being professionals (by labelling, presentation, or promoting) is obvious and correct. A declare is outlined as “any message or illustration, which isn’t obligatory below Community or nationwide laws, together with pictorial, graphic, or symbolic illustration, in any type, which states, suggests or implies {that a} meals has specific traits.”¹ There are two classes of claims on meals within the EU: diet claims and well being claims (Figure 1). Nutrition claims consult with what a meals accommodates: content material claims and comparative claims. Health claims consult with what a meals does and consult with basic perform claims, claims associated to a discount of illness danger, and claims associated to the expansion and improvement of youngsters. Nutrition and well being claims are generally used on meals product labels to positively affect shoppers notion of the product and to steer them to buy meals with claims.^2,3
 
Figure 1. Overview of diet and well being claims within the EU below Regulation (EC) 1924/2006^1,a

^aHealth claims in yellow require submission of an software file and its scientific information could also be protected for five years from the date of authorization.
 

Nutrition claims

Under Article 2 of Regulation (EC) 1924/2006, a diet declare is outlined as any declare that states, suggests, or implies a meals has a specific diet property in relation to the power, vitamins, and different substances it accommodates, in larger or decrease quantities, or by no means.
 
Currently, there are 30 diet claims permitted (Table 1). Any meals enterprise operator can use a diet declare on a meals label offered the circumstances to make a declare are glad as outlined in Annex 1 of Regulation (EC) 1924/2006.
 

 

Health claims

There are 4 principal sorts of well being claims within the EU:
 

• General, nonspecific well being claims. These sorts of claims consult with well being or well-being (Article 10). They should be supported by a associated particular Article 13 or 14 well being declare near the final declare or suitably signposted, for instance, with an asterisk.⁵

 

• Health claims aside from these referring to the discount of illness danger (Article 13). These can relate to the expansion, improvement, and features of the physique; to psychological and behavioral features; or to slimming or weight-control. (However, claims that consult with the speed or quantity of weight reduction should not allowed). Article 13(1) perform claims are based mostly on “typically accepted scientific information;” whereas Article 13(5) claims are based mostly on newly developed scientific information.

 

• Reduction of illness danger claims (Article 14 1a). These claims also needs to bear a press release indicating that the illness to which the declare is referring has a number of danger elements and that altering one in all these danger elements might or might not have a useful impact.

 

• Children’s progress and improvement (Article 14 1b). These claims are supported by scientific research in kids. There are 12 licensed well being claims⁶ for youngsters’s progress and improvement. Food merchandise for youngsters can’t bear grownup claims.

 
Health claims on meals should be supported by scientific proof. Regulation 1924/2006 states that “Health claims ought to solely be licensed to be used within the Community after a scientific evaluation of the best attainable normal. In order to make sure harmonized scientific evaluation of those claims, the European Food Safety Authority [EFSA] ought to perform such assessments.”
 
By January 2008, a complete of 4,637 well being declare proposals had been submitted by the EU member states based mostly on Article 13(1) standards for perform claims. These proposals didn’t require a full substantiation file, solely the submission of related scientific references.
 
Applicants should submit a proper file for Article 13(5) and Article 14 (1.a and 1.b) claims. To inform an software, the EFSA has developed a steering for the preparation and presentation of a well being declare software,⁷ which incorporates data on the brand new presubmission part, launched as a part of the Transparency Regulation (EU) 2019/1381.⁸ To additional improve transparency within the dealing with of well being declare functions, the EFSA has additionally printed administrative steering⁹ for the processing of regulated merchandise, together with well being claims.

When evaluating a well being declare file, the EFSA evaluates the extent to which:
 

• The meals/constituent is outlined/characterised,
• The claimed impact is “useful to human well being,” and
• Scientific proof of a cause-and-effect relationship is established.

 
A damaging reply in any of the three steps signifies the declare shouldn’t be appropriate for authorization. Points 1 and three are easy, however for level 2 (useful to human well being), the EFSA has printed a sequence of steering paperwork¹² on the scientific necessities for well being claims associated to:
 

• Functions of the nervous system, together with psychological features;
• Physical efficiency;
• Bone, joints, pores and skin, and oral well being;
• Appetite rankings, weight administration, and blood glucose concentrations;
• The immune system, the gastrointestinal tract, and defence in opposition to pathogenic microorganisms; and
• Antioxidants, oxidative harm, and cardiovascular well being.

 
The EFSA evaluates every well being declare software, and the result’s printed as a scientific opinion. To date, EFSA has evaluated over 3,000 well being claims. An overview of the present state of the analysis course of is proven in Table 2. The conclusions of an EFSA scientific opinion evaluating a well being declare could be:
 

• A cause-and-effect relationship has been established,
• There is inadequate proof to ascertain a cause-and-effect relationship, or
• A cause-and-effect relationship has not been established.

 

After finalization of a scientific opinion by the EFSA, it’s as much as the EC and member states to determine on authorization of a well being declare. Only well being claims that carry the conclusion “a cause-and-effect has been established” qualify for authorization. With some exceptions (e.g., glucose and cognition, lactose and gastrointestinal discomfort, and caffeine in relation to alertness, consideration, and train), well being claims that had been thought-about by the EFSA as “scientifically substantiated” have been licensed. The EU Register of Nutrition and Health Claims lists all permitted diet claims and all licensed and nonauthorized well being claims.⁶
 

Evolution in the usage of claims

The sorts of claims on meals packaging have developed over time. Immune well being claims and cholesterol-lowering well being claims had been primarily used within the Nineteen Eighties, when practical meals first grew to become obtainable.¹³ However, client analysis has proven a desire for diet claims over well being claims, and meals labels now replicate that client desire (Table 3). The in depth use of diet and well being claims on meals labels worldwide suggests meals companies take into account them a aggressive benefit. Some meals classes, greater than others, similar to yoghurts¹⁴ and breakfast cereals,¹⁵ make vital use of diet and well being claims.
 

 

Contemporary points

In May 2020, the EC accomplished its analysis of the regulation on diet and well being claims¹⁶ and a few points round diet and well being claims haven’t been resolved up to now, such because the setting of “nutrient profiles” and well being claims round “botanicals.”

 
The authentic intention was that nutrient profiles (NPs) can be set by January 2009 to guard shoppers from being misled by claims on merchandise excessive in saturated fats, salt, and sugar. However, the NPs have nonetheless not been established. Many completely different NPs are used globally. They have been used for various functions: To prohibit the promotion of unhealthy meals to kids, to make sure meals merchandise that bear a diet or well being declare are wholesome, and to judge the dietary high quality of meals to underpin front-of-pack diet labelling (FoPNL).
 
A synthesis of the traits of quite a few NPs has been accomplished utilizing a visible arrow mannequin,¹⁷ developed in 2008 and revised and up to date to incorporate nutrient profiles for FoPNL.^18,19 The EC’s Farm to Fork Strategy²⁰ states that NPs will probably be set to limit the promotion of meals excessive in vitamins similar to salt, sugars, and/or fats as foreseen within the diet and well being claims regulation. A legislative proposal to revise present laws on meals data to shoppers is anticipated to be accomplished by the tip of 2022.
 
The EFSA have offered scientific recommendation²¹ to help the EC within the improvement of NPs and FoPNL. The recommendation outlines the vitamins of public well being significance within the EU inhabitants food regimen, vitamins, and nonnutrients (power and fiber) to be thought-about by a nutrient profiling mannequin, and the contribution of meals teams to nationwide diets for EU populations and subgroups. The EFSA panel said that the identical scientific issues might underpin the setting of nutrient profiling fashions for each the restriction of well being claims and entrance of pack diet labelling functions. The ultimate determination will probably be made by the EC in session with member states.
 
Regarding botanical well being claims for vegetation and their preparations, there are “on maintain” well being claims which have but to be reviewed by the EFSA and licensed by the EC. Although many vegetation have a historical past of being consumed, they don’t have the scientific substantiation required by the EFSA to help a licensed well being declare. In apply, “on maintain” means some botanical well being claims are utilized in meals as a result of danger managers and nationwide guidelines allow them within the member state. The EC acknowledges that it may very well be applicable to have in mind the precise state of affairs of vegetation and/or their preparations, which have a protracted conventional historical past of use linked to well being advantages.¹¹ While this isn’t resolved, 2,078 claims¹¹ on botanical substances can be utilized together with a disclaimer that the well being declare has not been evaluated and offered it isn’t a medicinal substance within the member state.
 
Another modern situation issues micro-organisms. To date, not a single well being declare from the various functions on “probiotics” has been licensed, aside from an impact on the digestion of lactose. Some member states^22,23 interpret the regulation to permit the usage of the time period “probiotic.” It is now used, for instance, as a basic well being declare on yoghurt or fermented milk merchandise and supported by a selected Article 13(1) well being declare referring to improved lactose digestion (offered the merchandise meet the situation of use relating to lactobacillus delbrueckii subsp. bulgaricus and streptococcus thermophilus focus).
 
Finally, the checklist of well being claims within the EU Register have been retained by the UK since its exit from the EU and at the moment are on the Great Britain Nutrition and Health Claims Register. New functions for well being claims are validated by the Department of Health and Social Care in England. The software is then handed to the United Kingdom Nutrition and Health Claims Committee, which follows an method much like the EFSA’s relating to scientific evaluation. Although the UK regulatory procedures are completely different, the scientific necessities for brand new claims are much like these of the EU.²⁴
 

Acronyms and abbreviations
EC, European Commission; EFSA, European Food Safety Authority; EU, European Union; FoPNL, front-of-pack diet labelling; NP, nutrient profile; UK, United Kingdom.

 
About the authors
Nuala Collins, BSc, Dip PgCert, works as lead for the Food Reformulation Task Force, Ireland. She has virtually 35 years’ expertise in dietetics, dietary science, meals allergy, and meals regulation. Collins has labored in scientific settings and within the meals trade having certified as a dietician from Trinity College, Dublin, Ireland. She is presently working towards a grasp’s diploma in meals regulatory affairs, a collaborative postgraduate programme between Ulster University (UK) and University College Dublin (Republic of Ireland). She could be contacted at [email protected]
 
Hans Verhagen, PhD, is a board-certified toxicologist and board-certified nutritionist with greater than 39 years {of professional} expertise in meals security and diet. Verhagen has labored at universities in Nijmegen, Maastricht, Ulster, and Copenhagen; in contract analysis and trade; for the Netherland’s National Institute for Public Health and the Environment; and for EFSA from 2015-2020. From 2006-2015, he was a member of the EFSA-NDA panel engaged on well being claims and novel meals. Verhagen is presently a visiting professor on the University of Ulster, Northern Ireland, and on the Technical University Denmark. Since 2020, he has been proprietor and marketing consultant of Food Safety & Nutrition Consultancy. He could be contacted at [email protected]; [email protected]; and [email protected]
 
Citation Collins N, Verhagen H. Nutrition and well being claims within the European Union in 2022. Regulatory Focus. Published on-line 3 September 2022. https://www.raps.org/news-and-articles/news-articles/2022/9/nutrition-and-health-claims-in-the-european-union
 
References
All references accessed and/or verified 26 August 2022.

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