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 health claims are broadly used on meals labels and could positively affect client perceptions and intentions to purchase meals. Regulation (EC) 1924/2006 on diet and health 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 use of claims on meals excessive in saturated fats, sugar, or salt. The EC should additionally discover a answer to the inequality in the scientific substantiation of nonbotanical versus botanical claims.
 

Keywords – claims, health, diet, Regulation 1924/2006
 

Introduction

Functional meals embody meals with enhancements, reminiscent of lowering destructive facets (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 health claims have been amongst the first claims used on meals labels in the Eighties, whereas right now, diet claims are extra broadly used. In the EU, the goal of Regulation (EC) 1924/2006,¹ which was launched in 2007, is to make sure that any diet and health declare made in business communication to shoppers or health professionals (by labelling, presentation, or promoting) is evident and correct. A declare is outlined as “any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic, or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics.”¹ There are two classes of claims on meals in the EU: diet claims and health claims (Figure 1). Nutrition claims discuss with what a meals incorporates: content material claims and comparative claims. Health claims discuss with what a meals does and discuss with common operate claims, claims associated to a discount of illness danger, and claims associated to the progress and growth of kids. Nutrition and health 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 health claims in 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 selected diet property in relation to the power, vitamins, and different substances it incorporates, 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 supplied the circumstances to make a declare are glad as outlined in Annex 1 of Regulation (EC) 1924/2006.
 

Health claims

There are 4 principal kinds of health claims in the EU:
 

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

• Health claims apart from these referring to the discount of illness danger (Article 13). These can relate to the progress, growth, and features of the physique; to psychological and behavioral features; or to slimming or weight-control. (However, claims that discuss with the fee or quantity of weight reduction should not allowed). Article 13(1) operate claims are based mostly on “generally accepted scientific data;” 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 an announcement 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 could or could not have a useful impact.

• Children’s progress and growth (Article 14 1b). These claims are supported by scientific research in kids. There are 12 licensed health claims⁶ for youngsters’s progress and growth. 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 should only be authorized for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonized scientific assessment of these claims, the European Food Safety Authority [EFSA] should carry out such assessments.”
 
By January 2008, a complete of 4,637 health declare proposals have been submitted by the EU member states based mostly on Article 13(1) standards for operate 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 steerage for the preparation and presentation of a health declare software,⁷ which incorporates data on the new presubmission part, launched as a part of the Transparency Regulation (EU) 2019/1381.⁸ To additional improve transparency in the dealing with of health declare functions, the EFSA has additionally revealed administrative steerage⁹ for the processing of regulated merchandise, together with health claims.

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

 

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

 
A destructive reply in any of the three steps signifies the declare isn’t appropriate for authorization. Points 1 and 3 are simple, however for level 2 (useful to human health), the EFSA has revealed a collection of steerage paperwork¹² on the scientific necessities for health claims associated to:
 

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

 
The EFSA evaluates every health declare software, and the result’s revealed as a scientific opinion. To date, EFSA has evaluated over 3,000 health 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 health declare may 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 health declare. Only health 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), health claims that have been thought of 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 health claims.⁶

 

Evolution in the use of claims

The kinds of claims on meals packaging have developed over time. Immune health claims and cholesterol-lowering health claims have been primarily used in the Eighties, when practical meals first turned obtainable.¹³ However, client analysis has proven a choice for diet claims over health claims, and meals labels now replicate that client choice (Table 3). The intensive use of diet and health claims on meals labels worldwide suggests meals companies contemplate them a aggressive benefit. Some meals classes, greater than others, reminiscent of yoghurts¹⁴ and breakfast cereals,¹⁵ make vital use of diet and health claims.
 

 

Contemporary points

In May 2020, the EC accomplished its analysis of the regulation on diet and health claims¹⁶ and some points round diet and health claims haven’t been resolved thus far, reminiscent of the setting of “nutrient profiles” and health claims round “botanicals.”

 

The unique intention was that nutrient profiles (NPs) could 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 totally 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 health 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 likely be set to limit the promotion of meals excessive in vitamins reminiscent of salt, sugars, and/or fats as foreseen in the diet and health claims regulation. A legislative proposal to revise current laws on meals data to shoppers is anticipated to be accomplished by the finish of 2022.

 

The EFSA have supplied scientific recommendation²¹ to help the EC in the growth of NPs and FoPNL. The recommendation outlines the vitamins of public health significance in the EU inhabitants weight loss plan, vitamins, and nonnutrients (power and fiber) to be thought of by a nutrient profiling mannequin, and the contribution of meals teams to nationwide diets for EU populations and subgroups. The EFSA panel acknowledged that the identical scientific concerns might underpin the setting of nutrient profiling fashions for each the restriction of health claims and entrance of pack diet labelling functions. The last choice will likely be made by the EC in session with member states.

 

Regarding botanical health claims for crops and their preparations, there are “on hold” health claims which have but to be reviewed by the EFSA and licensed by the EC. Although many crops have a historical past of being consumed, they don’t have the scientific substantiation required by the EFSA to help a certified health declare. In observe, “on hold” means some botanical health claims are used in meals as a result of danger managers and nationwide guidelines allow them in the member state. The EC acknowledges that it could possibly be applicable to take note of the particular scenario of crops and/or their preparations, which have a protracted conventional historical past of use linked to health advantages.¹¹ While this isn’t resolved, 2,078 claims¹¹ on botanical substances can be utilized in mixture with a disclaimer that the health declare has not been evaluated and supplied it’s not a medicinal substance in the member state.

 

Another modern concern issues micro-organisms. To date, not a single health declare from the many functions on “probiotics” has been licensed, apart from an impact on the digestion of lactose. Some member states^22,23 interpret the regulation to permit the use of the time period “probiotic.” It is now used, for instance, as a common health declare on yoghurt or fermented milk merchandise and supported by a selected Article 13(1) health declare referring to improved lactose digestion (supplied the merchandise meet the situation of use relating to lactobacillus delbrueckii subsp. bulgaricus and streptococcus thermophilus focus).

 

Finally, the record of health claims in 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 health 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 just like the EFSA’s relating to scientific evaluation. Although the UK regulatory procedures are totally different, the scientific necessities for brand new claims are just 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 nearly 35 years’ expertise in dietetics, dietary science, meals allergy, and meals regulation. Collins has labored in scientific settings and in the meals business having certified as a dietician from Trinity College, Dublin, Ireland. She is at present 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 may be contacted at nualacollins.foodfacts@gmail.com
 
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 business; 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 health claims and novel meals. Verhagen is at present a visiting professor at the University of Ulster, Northern Ireland, and at the Technical University Denmark. Since 2020, he has been proprietor and advisor of Food Safety & Nutrition Consultancy. He may be contacted at h.verhagen@ulster.ac.uk; FSNConsultancy@hotmail.com; and hansver@food.dtu.dk
 
Citation Collins N, Verhagen H. Nutrition and health claims in 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.

1. European Commission. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on diet and health claims made on meals. Last up to date 29 November 2012. https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924
2. Kaur et al. A scientific evaluation, and meta-analyses, of the affect of health-related claims on dietary selections. Int J Behav Nutr Phys Act. Published on-line 17 July 2017. https://doi.org/10.1186/s12966-017-0548-1
3. Oostenbach LH, et al. Systematic evaluation of the affect of diet claims associated to fats, sugar and power content material on meals selections and power consumption. BMC Public Health. Published 15 October 2019. https://doi.org/10.1186/s12889-019-7622-3
4. European Commission. What is a diet declare? Not dated. https://ec.europa.eu/food/safety/labelling-and-nutrition/nutrition-and-health-claims/nutrition-claims_en
5. Case C‑524/18. Judgment, 30 January, 2020. https://curia.europa.eu/juris/document/document.jsf;jsessionid=223376B5870582323C1826F45E769453?text=&docid=222888&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=35185397
6. European Commission. EU Register: Nutrition and health claims made on meals (v.3.6). https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/
7. European Food Safety Authority. Scientific and technical steerage for the preparation and presentation of a health declare software. EFSA J. 2021;19(3):6554. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6554              
8. Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU danger evaluation in the meals chain [incl. amendments]. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1381&from=EN
9. European Food Safety Authority. Administrative steerage for the processing of functions for regulated merchandise (replace 2021). Dated 3 March 2021. https://www.efsa.europa.eu/en/supporting/pub/en-6471
10. [Behind paywall] Verhagen H, van Loveren H. Status of diet and health claims in Europe by mid 2015. ). Trends Food Sci Technol. 2016;56:39-45. https://www.sciencedirect.com/science/article/abs/pii/S0924224415301321
11. European Commission. Regulation (EC) No 1924/2006 on diet and health claims made on meals with regard to nutrient profiles and health claims made on crops and their preparations and of the common regulatory framework for his or her use in meals [staff working document and executive summary of evaluation. Dated 20 May 2020. https://ec.europa.eu/food/system/files/2020-05/labelling_nutrition-claims_swd_2020-96_sum_en.pdf
12. European Food Safety Authority. Nutrition applications: Regulations and guidance. https://www.efsa.europa.eu/en/applications/nutrition/regulationsandguidance
13. [Behind paywal] Hilliam M. The marketplace for practical meals. Int Dairy J. 1998;8(5-6):349-353. https://doi.org/10.1016/S0958-6946(98)00057-0
14. Cruz-Casarrubias C. Estimated results of the implementation of the Mexican warning labels regulation on the use of health and diet claims on packaged meals. Int J Behav Nutr Phys Act. Published on-line 10 June 2021. https://doi.org/10.1186/s12966-021-01148-1 
15. Vermote M, et al. Nutritional content material, labelling and advertising and marketing of breakfast cereals on the Belgian market and their reformulation in anticipation of the implementation of the nutri-score front-of-pack labelling system. Nutrients. Published 25 March 2020. https://doi.org/10.3390/nu12040884
16. European Commission. Evaluation of the regulation on diet and health claims. https://ec.europa.eu/food/safety/labelling-and-nutrition/nutrition-and-health-claims/evaluation-regulation-nutrition-and_en
17. Verhagen H, van den Berg H. A easy visible mannequin to check current nutrient profiling schemes. Food Nutr Res. 2008.  https://foodandnutritionresearch.net/index.php/fnr/article/view/1117/4380
18. van der Bend D, et al. A easy visible mannequin to check current front-of-pack nutrient profiling schemes. Eur J Nutr Food Safety. 2014;4(4):429-534. http://www.sciencedomain.org/abstract.php?iid=513&id=30&aid=5399  
19. van der Bend DLM, Lissner L. Differences and similarities between front-of-pack diet labels in Europe: A comparability of practical and visible facets. Nutrients. Published on-line 14 March 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471039/
20. European Commission. Farm to fork technique. 2020. https://ec.europa.eu/food/system/files/2020-05/f2f_action-plan_2020_strategy-info_en.pdf
21. European Food Safety Authority. Scientific recommendation associated to nutrient profiling for the growth of harmonised necessary front-of-pack diet labelling and the setting of nutrient profiles for proscribing diet and health claims on meals. Dated 2022. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7259  
22. [In Spainish] Probióticos en los alimentos. Dated 27 October 2020. https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/subdetalle/probioticos.htm
23. [In Italian] Probiotici e prebiotici. Current as of seven July 2021. https://www.salute.gov.it/portale/temi/p2_6.jsp?area=Alimenti%20particolari%20e%20integratori&id=1426&lingua=italiano&menu=integratori
24. [UK] Department of Health and Social Care. Guidance on diet and health claims on meals. Last up to date 10 November 2021. https://www.gov.uk/government/publications/nutrition-and-health-claims-guidance-to-compliance-with-regulation-ec-1924-2006-on-nutrition-and-health-claims-made-on-foods