This article was published on Food Navigator on the 6th of August.

What does the EC’s fitness and performance check on Nutrition and Health Claims regulation suggest?

On 20 May 2020, the European Commission completed the REFIT [1] Evaluation of the Regulation (EC) n°1924/2006 on Nutrition and Health claims (the NHCR). Even though the EU Commission concluded that the Regulation remains ‘fit for purpose’, it is clear from the report [2] that the NHCR needs a refresh.

The purpose of this REFIT Evaluation was to assess two important parts of the NHCR: on the one hand the nutrient profiles and on the other hand the health claims made on plants and their preparations. The aim was to provide an evidence-based judgement of the extent to which the EU regulation has been effective, efficient, coherent and relevant as well as has allowed to achieve EU added-value.

Nutrient Profiles and nutrient profiling, similar approach but different objectives

Despite the 2009 deadline set in the NHCR, nutrient profiles [3] have not yet been adopted. The purpose of the evaluation was therefore to assess whether they were warranted and adequate to ensure the objectives [4] of the NHCR.

Most importantly, it concerned the specific objective  to avoid a situation where nutrition or health claims mask the overall nutritional status of a food product, possibly misleading consumers trying to make healthy choices.

The report concludes that nutrient profiles are generally still coherent and required to achieve EU added value. The specific objectives pursued by the nutrient profiles remain relevant, even though other politics have emerged in the recent year, such as the mandatory nutrition declaration or the multiplication of voluntary front of pack nutrition labelling such as the Nutriscore.

Indeed, the objectives of such politics differ from the setting of nutrient profiles as they were not designed to restrict the use of claims.

However, the effectiveness and efficiency are doubtful. The report emphasizes that in the absence of nutrient profiles, consumers continue to be exposed to foods high in fat or sugar bearing health and nutrition claims. [5]

Operators face an uneven level playing field as some of them, in anticipation of the adoption of nutrient profiles, re-labeled their products, removed the claims and reformulated them.

Health claims on plants and their preparations or the complicated relation between food and medicine

The report concludes that, the objectives [6] pursued by the Regulation remain fully relevant today. The general food regulatory framework concerning the use of plants, and notably Article 8 of the Fortified Food Regulation (EC) n°1925/2006 ensure fairly effectively the safety related to the use of certain plant substances which could represent a potential risk for the consumer.

However,  the current situation where most of the claims related to plant and their preparations have been put ‘on hold’ is an issue. The uncertainty related to the future of the ‘on hold’ lists of claims has hindered innovation. In addition, the lack of recognition of the specificity of plant as well as the absence of consideration for evidence based on traditional use have prevent a full achievement of the objectives of the NHCR.

According to the report, it is also not coherent to have harmonized rules on health claims while in most cases the use of plants is governed by national rules.

Plants and their preparations are often borderline between the world of food (supplements) and medicine (Traditional Herbal Medicinal Products) – an appreciation made by Member States triggering possible classification issues that may impact the smooth function of the internal market.

At EU level, the fact that plants and their preparation are not subject to similar scientific assessment is not coherent either. The discrepancy between the NHCR that provides for a scientific assessment of the “highest possible standard” which, in this specific case, include human intervention studies – and the legislation of THMPs whether the notion of “traditional use” is accepted, lack of coherence thus:

“it could be appropriate to explore the notion of ‘traditional use’ in the efficacy assessment of health claims on plants and their preparations used in foods together with the effects of the co-existence, on the EU market, of THMPs on the same plant substances”

Therefore, even though the question of the classification would remain under the remit of Member States, the adoption of positive or a negative list of plants would be a real EU added-value and would help improve the situation with regard to safety and the smooth functioning of the internal market .

The results of this evaluation will fuel the Commission’s reflection on how to refresh the NHCR which remains, globally, “fit for purpose”. An insight into the future work of the Commission can already be found in the Farm to Fork Strategy published at the same time as the report. The Commission already announced for 2022 the setting of nutrient profiles to restrict promotion of food high in salt, sugars and/or fat.

[1] Regulatory Fitness and Performance program

[2] See: https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-claims_swd_2020-95_part-1.pdf

[3] “nutrient profiles are thresholds of nutrients such as fat, salt and sugars in foods, above which nutrition claims would be limited and health claims prohibited, thus preventing a positive health message on food  high in these  nutrients” (Report page 5)

[4] The general objectives of the NHCR were notably to achieve a high level of consumer protection (prevent notably misleading information), improving the free movement of goods, increasing the legal certainty for economics operator, ensuring fair competition for food business operators within the internal market and promoting and protection innovation in the area of food.

[5] See notably Tables 3 and 4 of the Report New food products and drink with claims exceeding the nutrient profile thresholds set out in the Commission’s draft legal act of 2009 on setting the criteria for nutrient profiles, 2005 to 2017.

[6] The specific objectives pursued by the NHCR in relation to health claim on plants and their preparation is to ensure the effective functioning of the internal market whilst providing a high level of consumer protection