In December 2006 EU decision makers adopted Regulation (EC) No 1924/2006 on the use of nutrition and health claims for foods. This Regulation lays down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs.
One of the key objectives of this Regulation is to ensure that any claim made on a food label in the EU is clear and substantiated by scientific evidence.
In the following, frequently asked questions about the Health Claims Regulation as well as its further implication for the conduct of evidence based food studies are provided.
What is the aim of the Regulation?
The aim of the Regulation on health and nutrition claims is to ensure that consumers are not misled by unsubstantiated, exaggerated or untruthful claims about foodstuffs.
What exactly is a Health Claim?
A health claim is any statement on labels, advertising or other marketing products that health benefits can result from consuming a given food. Health claims are prohibited unless they are authorised by the EU Commission in accordance to Regulation (EC) No 1924/2006 and included in a list of permitted claims.
There are two types of claims, namely “unspecific” and “specific” claims. However, ALL health-related claims have to be approved by the European Commission before use.
Unspecific claims are referring to general, non-specific advantages of nutrients or foodstuffs for health in general or health-related well-being. The reference to an unspecific claim is prohibited (according to Art 10(3) Regulation (EC) No 1924/2006) unless authorized by the Commission and included in a list of permitted claims. In the course of the commencement of the Regulation, a lot of health claims have been refused by the Commission and consequently will be prohibited in the future.
The health claims which have been approved and registered can be found in in Commission Regulation (EU) No 432/2012, and can be used by the community. The presentation of a health claim on a label is always optional.
For instance, one registered claim for biotin is “Biotin contributes to normal energy-yielding metabolism.” The claim may be used only for food which is at least a source of biotin as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Specific claims are in general those with a more precise description of the health effect, e.g. “Prevention of hair loss”. However, the decision whether a claim is specific or not falls under the jurisdiction of courts and is therefore exposed to a certain subjective nature. For example “Give your memory a boost” was considered as specific, whereas “For brain, nerves, concentration, and memory” was determined to be unspecific.
Like unspecific claims, also the specific ones have to be approved - if not already registered in the list (or registered in the list with similar words).
Once registered, they can be found in the listing of Regulation (EU) No 432/2012, unless they refer to the reduction of a disease risk and to children’s development and health (Art 14 (EC) No 1924/2006). Claims, which in general refer to the reduction of disease risk, underlie an individual authorisation (as defined in Art 14-18 (EC) No 1924/2006). Here, the European Commission published an EU Register for authorised, as well non-authorised health claims.
Notably, the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect (Art 14(2) (EC) No 1924/2006).
What products will be covered by the Health Claims Regulation?
The regulation would apply to any food (also food supplements) or drink product produced for human consumption to be sold on the EU/ Member States’ market. The proposed new rules do not cover cosmetics, medicine or pet food products.
Are there Health Claims which are prohibited?
Article 7(3) of Regulation (EU) No 1169/2011 states: food information to consumers shall not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties.
This is important especially for food supplements, which due to their "dosed form“ come close to so-called presentation drugs.
Furthermore, according to Art 12 (EC) No 1924/2006, there is a total ban for the following claims:
- Claims which suggest that health could be affected by not consuming the food.
- Claims which make reference to the rate or amount of weight loss.
- Claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11 (EC) No 1924/2006.
Health Claims are an optional mention, but they entail mandatory details
In Art 10 (EC) No 1924/2006 special conditions are defined. These are that health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:
- Statement indicating the importance of a varied and balanced diet and a healthy lifestyle
- The quantity of the food and pattern of consumption required to obtain the claimed beneficial effect
- Where appropriate, a statement addressed to persons who should avoid using the food
- An appropriate warning for products that are likely to present a health risk if consumed to excess
The Conduct of Evidence based Scientific Studies with Foodstuffs
According to the Regulation, health claims should be only authorised for use in the Community after a scientific assessment of the highest possible standard, which is carried out by the European Food Safety Authority (EFSA).
As health claims can be complex from a scientific (methodological) point of view, the EFSA saw an urgent need for the definition of special criteria to substantiate health claims.
For this reason, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA Panel) published a general guidance document firstly in March 2011 (EFSA NDA Panel, 2011a), which was superseded by a later version in 2015 (EFSA NDA Panel, 2015).
This guidance document aims to explain the general scientific principles applied by the NDA Panel for the evaluation of all health claims and outlines a series of steps for the compilation of applications.
What do I have to consider when performing a study with foodstuffs?
It is not within the scope of the guidance to provide detailed instructions on the design of scientific studies or on the statistical analyses of the results. These should rely on general scientific knowledge.
The applicant of the Claim has to make sure that the respective study is designed and performed to the best scientific standard as confirmed by the experts in the relevant field. In addition, they should follow the EFSA defined statistical reporting and other guidelines published by scientific bodies.
Requirements for the scientific substantiation of studies:
- Pertinent human (interventional and observational) studies are an absolute requirement for the scientific substantiation of health claims, and pertinent human efficacy studies are at the top of the hierarchy that informs decisions on substantiation;
- Assessing evidence for a cause and effect relationship and for consistency of the effect (or the association) across studies in a study group which is representative of the target population;
- Generally accepted methods for the assessment of the outcome variable(s) of interest in vivo in humans have to be provided.
However, there is no pre-established rule how many or which types of studies are needed for substantiation. The reproducibility of the effect of the food/constituent, as indicated by the consistency of the findings and the biological plausibility of the effect also need to be considered.