Foodlaw-Reading

Dr David Jukes, The University of Reading, UK

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Last updated: 11 April, 2017

Nutrition and Health Claims Legislation in the EU

On this page:
  • EU Law - Links to the original text, amendments and a consolidated version
  • Approved Health Claims - Listing of Regulations providing approval to submitted health claims

EU Law

Summary

After many years of discussion and dispute, EU controls were adopted in 2006 by Regulation (EC) No 1924/2006. This started to apply from July 2007 but elements became effective at various later dates and some aspects are still not operating.

The regulation provides the following definitions:

The Regulation contains an Annex which lists the permitted nutrition claims and the conditions which must be met if they are to be used. Subject to the provisions of the Regulation, these are generally available for use by any food meeting the stated conditions. Only authorised health claims can be used. The types of claims which can be authorised are set out in Articles 13 and 14 of the Regulation and it provides the procedures for gaining approval and for the establishment of a Register of Health Claims.

Since all authorised claims had to be substantiated by an assessment of the scientific evidence supporting the claim (performed by the European Food Safety Authority (EFSA)), the process of adopting the list of authorised claims has taken a considerable time. A large number of claims relating to 'botanicals' have still not been assessed. Another difficulty has been the provision, included in Article 4(1) of the Regulation, for the adoption of 'nutrient profiles' which would prevent the use of claims on foods considered to have an unhealthy profile - no profiles have yet been adopted. An overview of the process is shown in the following figure:

For a larger version of this figure, see: Figure: Claims

Access to the EU Legal Documents

As amended by:

Consolidated Text: A copy of the consolidated text incorporating the amendments is available. See: Consolidated Text (December 2014)

For more details about the legislation, supporting documents, approvals and procedures see:

The Commission has established an on-line EU Register of Nutrition and Health Claims which shows:

  • Permitted nutrition claims and their conditions of use
  • Authorised health claims, their conditions of use and applicable restrictions, if any;
  • Non-authorised health claims and the reasons for their non-authorisation;
  • EU legal acts for the specific health claims;

Health Claims

Article 13 Claims - Function claims

This article provides for the approval of health claims which describe or refer to:

(a) the role of a nutrient or other substance in growth, development and the functions of the body; or
(b) psychological and behavioural functions; or
(c) without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet.

These may be approved following a simplified procedure if they are

(i) based on generally accepted scientific evidence; and
(ii) well understood by the average consumer.

The first list of authorised claims (containing 222 claims) was published in 2012 and has been amended to add additional authorisations.

Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ L136, 25.5.2012, p1)

As amended by:

A consolidated version of Regulation 432/2012 is available. See: Commission Regulation (EU) No 432/2012 (September 2016).

The Register shows a total of 239 authorised Article 13 claims (of which 6 are restricted due to proprietary data) and 1,983 non-authorised Article 13 claims (April 2017).

Note: Function claims for 'botanicals' have not yet progressed and remain outside the scope of the approved register of claims. Approximately 1,500 such claims were submitted for approval.

Article 14(1)(a) - Reduction of disease risk claims

These are defined as 'any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease'. These may be approved following the application of the standard approval process. These are being approved and listed in individual Regulations as follows. Additional Regulations provide details of rejected claims - these are not listed here.

The Register shows a total of 14 authorised Article 14(1)(a) claims and 24 non-authorised Article 14(1)(a) claims (April 2017 ).

Article 14(1)(b) - Claims referring to children's development and health.

These may be approved following the application of the standard approval process. These are being approved and listed in individual Regulations as follows. Additional Regulations provide details of rejected claims - these are not listed here.

The Register shows a total of 12 authorised Article 14(1)(b) claims and 44 non-authorised Article 14(1)(b) claims (April 2017 ).

This page was first provided on 14 July 2016
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