REFIT of the EU Nutrition and Health Claim regulation: Outcomes and perspectives
On 20 May 2020, the European Commission completed the Regulatory Fitness and Performance program (REFIT) 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 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, nutrient profiles, and on the other, 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, different objectives
Despite the 2009 deadline set in the NHCR, nutrient profiles have not yet been adopted. The purpose of the evaluation was therefore to assess whether they were warranted and adequate to ensure the objectives 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 concluded 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 evaluation of voluntary front of pack nutrition labelling such as the NutriScore.
Indeed, the objectives of such policies 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 emphasises that in the absence of nutrient profiles, consumers continue to be exposed to foods high in fat or sugar bearing health and nutrition claims.
Operators face an uneven level playing field as some of them, in anticipation of the adoption of nutrient profiles, re-labelled their products, removed the claims and reformulated them.
The complicated relation between food and medicine
The report concludes that the objectives 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 prevented 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. Legislation of THMPs whether the notion of “traditional use” is accepted, lack of coherence.
The report stated: “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 it will set nutrient profiles to restrict promotion of food high in salt, sugars and/or fat.
Katia Merten-Lentz is a partner at lawfirm Keller and Heckman and member of the FoodNavigator Expert Advisory Panel.