Health claims made on plants and their preparations

The process of assessing and authorising health claims related to substances of plant origin is still under way in the EU because the European Commission is currently deliberating on whether traditional use should be accepted as evidence to a greater extent than in the past.

A total of about 2,000 claims are currently awaiting scientific assessment by the EFSA and/or a decision by the European Commission. Since the assessment and authorisation process is still under way, the Article 13(1) claims - functional health claims - on which data were submitted to EFSA for evaluation in January 2008 but on which no decision has yet been passed by the Commission may be used in the marketing of foods with due regard to the general requirements set out in the nutritional and health claims regulation.

However, the claims shall comply with the Claims Regulation and the national provisions applied to claims.

  • Claims can be made using the same or an equivalent wording as the wording with which authorisation has been applied for the claim.
  • The conditions of use of the claim shall be fulfilled in the food on which the claim is used.
  • The food package shall carry the labelling required under legislation pertaining to claims.
  • In addition to labelling, the use of the claim in marketing shall also be taken into consideration.
  • If the health claim, which is still under consideration, is a medicinal claim or a claim prohibited by virtue of Article 3 or 12 of the Claims Regulation, Finnish Food Authority interprets it to not be a health claim compliant with the Claims Regulation and the claim may not be used in the labelling or marketing of food.

The food business operator is liable to demonstrate that the claim used in the marketing of food is either found in the list of claims already authorised at http://ec.europa.eu/nuhclaims/ or to show that the transitional period applicable to the claim. Otherwise the claim may not be used in the marketing of food.

Finnish Food Authority recommends the wording given in the Regulation. If the food business operator wishes to use some other wording, he should make sure that the claim is understood by the consumer in the same way. It should be pointed out that the wording may not be stronger than the authorised wording of the claim (e.g. ‘maintains normal level’ as opposed to ‘reduces’).

Health claims referred to in Article 13(1) that are still under consideration

Claims submitted to the EFSA for evaluation are listed in the following register available on EFSA’s web site. http://registerofquestions.efsa.europa.eu/roqFrontend/questionsList.jsf (Enter the substance involved (name in English/Latin) in the Keyword field and ‘Health Claims Art. 13/2’ in the Food Sector Area field.

If the register displays 'Under Consideration' in the Status field for a given claim, it is still awaiting assessment by EFSA. If the status is ‘Finished’, EFSA has issued its opinion but there may still be no Commission decision on the claim. If a decision has been issued by the Commission, the claim is displayed in the register of authorised and non-authorised claims maintained by the Commission: http://ec.europa.eu/nuhclaims/ For example, final decisions have been issued by the Commission on certain berry juices and fruit.

If the claim has been rejected by the Commission, it may not be used in the marketing of foods beyond 14 December 2012. However, if no decision has yet been issued by the Commission, the claim may be used in marketing for the time being.

Claims awaiting EFSA’s evaluation and/or Commission decision are listed as ID numbers in the pdf file on the Commission web site at: http://ec.europa.eu/nuhclaims/ (”Some function claims for which the assessment by EFSA or the consideration by the Commission is not finalised.”). The ID number is identical with the four-digit code appearing in the Subject field after a search of the EFSA register. A detailed list of the wordings of the retrieved claims is available on EFSA’s web site at http://www.efsa.europa.eu/en/topics/topic/article13.htm in ”Database of health claims submitted to EFSA for evaluation” halfway through site.

Page last updated 11/9/2018