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Food Safety

Evaluation of the Regulation on nutrition and health claims


Regulation (EC) No 1924/2006 on nutrition and health claims made on foods governs the use of these claims in the labelling, presentation and advertising of foods.

It aims at enabling consumers to make healthier choices by protecting them from misleading information and ensuring a level playing field for food businesses to operate within the single market.

Evaluations and Fitness Checks are tools that are used to implement the Regulatory Fitness and Performance programme (REFIT). REFIT is a rolling programme to keep the entire stock of EU legislation under review and ensure that it is 'fit for purpose'; that regulatory burdens are minimised and that all simplification options are identified and applied.

On 20 May 2020, the Commission completed the Evaluation of the Regulation on nutrition and health claims, which was announced in its Better Regulation Communication of 19 May 2015.


Since its adoption in 2006, the implementation of the Regulation remains incomplete. Nutrient profiles, that had to be set by January 2009, have not been established and health claims on plants and their preparations used in foods are not yet fully regulated.

In addition, the situation in relation to health claims on plants and their preparations has led to a broader reflection regarding the use of plants and their preparations used in foods.

This evaluation focuses on nutrient profiles and health claims on plants and their preparations added to foods. It also considers the more general regulatory framework for the use of such substances in foods since it is closely related to the use of health claims.

This evaluation covers the period 2005 to 2018 and the 27 EU Member States and the United Kingdom (since the United Kingdom was still a Member of the European Union during the period covered by the evaluation).

The Roadmap

The Commission published a Roadmap, on 8 October 2015, on the Evaluation of the EU Nutrition and Health Claims legislation. This Roadmap defines the purpose, content and scope of the evaluation. Moreover, it sets out the main evaluation criteria to be addressed:

  • Effectiveness (Have the objectives been met?)
  • Efficiency (What are the costs and benefits involved?)
  • Coherence (Does the policy complement other actions or are there contradictions?)
  • Relevance (Is EU action still relevant?)
  • EU added value (Can or could similar changes have been achieved at national level, or does EU action provide a clear added value?)

Stakeholders could submit their feedback on the roadmap via a dedicated webpage. Feedback received during the first four weeks after publication of the roadmap was considered in the design of the evaluation.

The extent to which feedback received after that period could be taken into account was determined by the progress made in the evaluation process.

Feedback received on the roadmap may be accessed here.


An evaluation is defined as an evidence-based judgement of the extent to which an intervention has:

  • Been effective and efficient,
  • Been relevant given the needs and its objectives,
  • Been coherent both internally and with other EU policy interventions, and;
  • Achieved EU added-value.

Hence, the collection of evidence, data and information constitutes a crucial part of an evaluation exercise. To support the data gathering for this evaluation, the Commission assigned to the Food Chain Evaluation Consortium (FCEC) to carry out an external study. This study was launched in May 2016 and was completed in June 2018.

The study methodology envisaged the extensive consultation of all stakeholders directly or indirectly affected by these issues, including EU countries' competent authorities, business operators, consumers and other non-business interest groups, to ensure a higher quality and a more credible evaluation.

The consultation strategy for this evaluation included a combination of consultation methods and tools, including:

Online survey of EU-28 Member State Competent authorities

Agra CEAS Consulting launched an online survey to the Member State Competent Authorities. The online survey can be consulted at the following links:

Online survey of EU stakeholders

In the framework of this evaluation, Agra CEAS Consulting launched an on-line survey of organisations representing stakeholders, including consumers, relevant business operators, and public health interest groups, whether set up at EU or national level.

The questionnaire of this survey was only addressed to business associations or other non-business stakeholder organisations, whether active at EU or national or regional level.

However, it was not intended to be completed by individual companies. SMEs were covered by another survey, through the Europe Enterprise Network SME Panel.

The weblink to access the survey was not respondent-specific and could be accessed by any potential respondent.

The PDF version of the questionnaire can be accessed at the following links:

The questionnaire was available in English only.

SME survey consultation

The SME survey, which targeted individual small and medium enterprises (SMEs), including micro-enterprises, was launched via the Europe Enterprise Network SME Panel.

This consultation aimed at allowing, in the context of this evaluation, to assess how easy it has been for SMEs to comply with the legislation and whether, in comparison with their limited staff and turnover, any disproportionate costs incurred. This consultation run for eight weeks.

The questionnaires of the surveys can be consulted below:

Online public consultation via the website 'Your Voice in Europe'

The consultation was based on a questionnaire with closed questions and it aimed at collecting the views of citizens. See the Your Voice website.

In-depth interviews and case studies

The in-depth interviews aimed at further investigating, clarifying and analysing elements that came up in the online surveys. They were conducted with key stakeholders both at Member states' level and at EU level.

Interviews were carried out also with selected third countries. The case studies aimed at providing more in-depth investigation on certain of the issues (thematic focus) under study.

Stakeholders' and Member States' workshops

Two sets of one-day workshops, with stakeholders and Member States were held at the beginning and at the end of the consultation process.

These meetings took place in the context of the Working Group of the Advisory Group on the Food Chain and Animal and Plant Health (stakeholders) and the Working Group on nutrition and health claims (Member States).

  • First workshop (21 June 2016): the purpose was to get exploratory feedback on the main issues under study and inform participants of the scope and process of the evaluation, in particular of the data collection needs and what was expected of them during the main phase, to allow from an early stage to prepare and coordinate data collection at their end.
  • Second workshop (26/27 October 2017): the purpose of these workshops was to present the findings of the analysis of the external study, in particular the aggregate results of the targeted surveys, and to stimulate further discussions/exchange on these, as well as to validate these findings.

Additional information and all relevant documentation can be accessed via the "Advisory Group - Food Chain and Animal and Plant Health" webpage.

Staff Working Document - Key findings

The staff working document of this evaluation was published on 20 May 2020, together with the list of appendices.

The staff working document draws on the work conducted by the external contractor and the Commission services, it summarises the analysis to the evaluation questions, and it presents the conclusions of the evaluation process.

Nutrient Profiles

Overall, the evaluation findings show that the specific objective pursued by the setting of nutrient profiles is still pertinent and necessary to meet the objective of the Claims Regulation, which is a high level of consumer protection. Therefore, the setting of nutrient profiles needs to be further considered.

Health claims on plants and their preparations and the more general regulatory framework concerning the use of plants in foods.

Overall, the evaluation findings show that in the current situation the objectives of the Claims Regulation are not fully attained. Furthermore, the current rules of the Claims Regulation do not take into account the specific situation of plants and/or their preparations, which have a long traditional history of use linked to health benefits.

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 Traditional Herbal Medicinal Products on the same plant substances.

In the light of the shortcomings highlighted above about the smooth functioning of the internal market and the possible openness to the notion of 'traditional use' to substantiate health claims on plants and their preparations, there are merits for further studying the potential harmonisation of the field of plants and their preparations, including the safety aspect.

Next steps

The results of this evaluation will be used to inform the Commission's reflection on these topics.