Nutrition and health claims
1. Can all substances (melatonin, for example) with permitted health claims be used in foodstuffs?
– The authorisation of a health claim does not affect e.g. the classification decisions made by national medicines authorities or the novel food status of foodstuffs.
The starting point in the use of health claims is that the scientific evidence given to substantiate the claims needs to be subjected to a prior approval process. Until this has been done, the claim may not be used in the labelling or marketing of food. The European Food Safety Authority EFSA assesses the scientific evidence behind the health claims and the wording of the claims. After discussions between the Commission and the member states, claims are either authorised or rejected by a Commission Regulation.
The assessment process of health claims does not involve any consideration of whether the substances to which the claims pertain should be classified as foodstuffs or medicines in the member states. National medicines authorities still have the right and the responsibility to decide on which substances are classified as medicines in each country. The authorisation of health claims does not affect this. This is specifically emphasised in Commission Regulation (EU) 432/2012, under which 222 health claims were authorised: (17) The addition of substances to or the use of substances in foodstuffs is governed by specific Union and national legislation, as is the classification of products as foodstuffs or medicinal products. Any decision on a health claim in accordance with Regulation (EC) No 1924/2006 such as inclusion in the list of permitted claims referred to in Article 13(3) thereof does not constitute an authorisation to the marketing of the substance on which the claim is made, a decision on whether the substance can be used in foodstuffs, or a classification of a certain product as a foodstuff.
This means that although the assessment of health claims only concerns the claimed effect on health, foodstuffs have to be safe. Operators in the food business always have to ensure that the foodstuffs they manufacture, have manufactured or distribute do not involve health risks.
People often wonder how health claims used on foods can be authorised for a substance classified as a medicine. The practical reason for this is that the classification of medicines can vary a lot from one member state to another. Melatonin, for example, is not classified as a medicine in all the member states; in some its use has been permitted in foodstuffs. Such a member state has submitted a health claim application pertaining to melatonin for assessment. This health claim application has been assessed according to the same principles as all the other applications. Since it has been found in the assessment process that there is scientific evidence substantiating the health claim, the claim has been authorised. The authorisation does not, however, affect the classification decisions made by national medicines authorities.
2. The transitional period for certain Article 13(1) non-authorised health claims ended on 14 December 2012. May any remaining stock be sold after this date?
The Regulation (EU) 432/2012 regarding Article 13(1) claims, or ‘functional health claims’, took effect on 14 December 2012. This means that no non-authorised functional health claims rejected by the Commission may be used in the marketing of foods after this date. The Register of authorised and non-authorised health claims is available on the Commission's web site at: http://ec.europa.eu/nuhclaims/. The Regulation does not permit the sale of any remaining stock after the expiry of the transitional period if the product packaging carries non-authorised health claims. Since the piece of legislation involved in an EU Regulation, no exemptions are allowed from the stipulated transitional period by ways of national laws. If the food business operator wishes to sell the remaining stock of products whose packaging displays non-authorised health claims after the expiry of the transitional period, such claims should be covered with stickers, etc.
In Finland, responsibility for regulatory control under the Food Act rests with municipalities, and this include control of compliance with the Regulation on nutrition and health claims. However, municipal food supervisors are free to use discretion on a case-by-case basis in accordance with the principle of proportionality. Evira is not in a position to grant any extensions for amending labelling displaying non-authorised health claims.
3. What health claims can be made for substances of plant origin?
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. 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.
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.
Evira 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’).
4. Are the supplementary statements required under Article 10(2) of the Regulation on Nutrition and Health Claims also applicable to food supplements?
Under Section 5 of the Food Supplement Decree, food supplement packing is to be labelled to read: “The food supplement is not to be used as a substitute for a balanced diet." Article 10(2) of the Regulation (EU) No. 1924/2006 on nutrition and health claims stipulates, in turn, that whenever a health claim is used in marketing food, the labelling – or in the absence of labelling – the presentation must include a statement indicating the importance of a varied and balanced diet and a healthy lifestyle. The position adopted by the working party appointed by the Commission is that while the requirement of the Food Supplement Decree for such a statement is not a substitute for the requirement set out in the Regulation, the two can be combined. No exact EU-wide uniform wording has been determined. Evira holds that the following wording, for example, meets the requirements of both the Food Supplement Decree and Article 10(2)a: “The food supplement is no substitute for a varied and balanced diet and a healthy lifestyle.” If preferred, the message can be split into two separate sentences.
5. Has Evira prohibited the use of superfood term?
– No, Evira has not prohibited the use of this term. Evira has, however, concluded that if this term is used in the marketing of foodstuffs, it shall be accompanied by a health claim that specifies the health effect.
The justification for this is that pursuant to Article 10(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods, reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14. (Last modified on 9.11.2011).
6. Can public figures or individual persons be used in marketing to tell about the health effects of foods?
– Pursuant to Article 5 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods, the use of nutrition and health claims shall only be permitted if the presence, absence or reduced content in a food or category of food of a nutrient or other substance has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence. The adequacy of the scientific evidence is evaluated by the European Food Safety Authority EFSA.
Marketing based on the experiences of individual consumers can be considered to be misleading, as the experiences of an individual consumer cannot be considered to fulfil the requirement of the Regulation for generally accepted scientific evidence. If on the other hand, the scientific evidence used to substantiate the claim has been evaluated and the claim has been approved for use, there is no obstacle to an individual consumer, whether a public figure or an ordinary consumer, telling about it in an advertisement.
However, health claims which make reference to recommendations of individual doctors or health professionals are always prohibited pursuant to Article 12 of the Claim Regulation.(Last modified 9.11.2011)
7. Can a medicinal property be attributed to food, if it has been scientifically proven?
– Products marketed as foods may not be presented as having medicinal properties, even if this could be substantiated with scientific evidence. If such claims are desired to be made for a product, Finnish Medicines Agency Fimea must be asked to classify the product.
This is based on Section 9 of the Food Act (23/2006) which states that food must not be presented as having properties related to prevention, treatment or curing of human diseases and such information may not be referred to, i.e. medicinal claims may not be made for food. Medicinal claims are only permitted to be made for medicines. This is not a new requirement; the use of medicinal claims in the marketing of foods has been prohibited for decades.(Last modified 9.11.2011)
8. Why has Evira already intervened in the marketing of food although the European Commission has not yet published a list of approved and rejected health claims?
Marketing control is part of Evira's normal field of activity. During both 2011 and 2012, Evira sent about 30 calls for action and requests for clarification to operators regarding claims that violate food regulations. For the most part, the calls for action and requests for clarification have pertained to medicinal marketing of foods. Medicinal claims are always forbidden in the marketing of foods. However, Evira has so far not taken action in relation to the so-called Article 13 health claims; the European Commission is expected to publish a list of approved and rejected claims pursuant to Article 13 in early 2012.
Closer control of health claims will be introduced in autumn 2013 when Evira will launch an instructive project for the control of health claims in collaboration with local control authorities.
Pursuant to Section 9 of the Food Act (23/2006), food must not in food packaging, presentation and advertising, or in some other way in connection with marketing be presented as having properties related to prevention, treatment or curing of human diseases and such information may not be referred to. Medicinal claims are only permitted to be made for medicines. This is not a new requirement; the use of medicinal claims in the marketing of foods has been prohibited for decades.
The use of health claims is governed by Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods. The so-called Article 13 claims are health claims that describe the role of a nutrient or other substance in growth, development and the functions of the body, psychological and behavioural functions, or weight control.
European Food Safety Authority EFSA has since 2008 evaluated the scientific evidence presented to substantiate health claims. The European Commission is about to publish in the first part of 2012, based on EFSA's evaluations, a list of approved and rejected health claims pursuant to Article 13. The use in marketing of a health claim rejected by the European Commission shall be discontinued within six months.
At present, health claims pursuant to Article 13 may still be used at the operator's own responsibility, even if EFSA has evaluated the evidence substantiating the claim to be inadequate. For this reason Evira has not so far intervened in the use of such claims in the marketing of foods. However, the calls for action and requests for clarification that Evira has sent to operators in relation to marketing that violates food regulations have reminded operators of their obligation to ensure that the health claims used in marketing comply with the requirements of Claim Regulation (EC) No. 1924/2006. (Last modified 9.11.2011)
9. What type of information about health effects of foods can be given to health professionals?
– Pursuant to Section 9 of the Food Act (23/2006), food must not in food packaging, presentation and advertising, or in some other way in connection with marketing be presented as having properties related to prevention, treatment or curing of human diseases and such information may not be referred to. Medicinal claims are only permitted to be made for medicines.
The Food Act is applied to food and the conditions in which it is handled, and to food business operators and food control at all stages in the production, processing and distribution of food (Chapter 2). As the Act is applied at all stages of the distribution of food, Evira interprets this to mean that no medicinal properties may be attributed to food even in marketing targeted at professionals.
Nutrition and Health Claim Regulation (EC) No. 1924/2006 is applied to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer (Article 1). A common EU level interpretation of the application of the Claim Regulation to marketing targeted at professionals has so far not been made. The interpretation adopted by Evira is that the Claim Regulation is also applied to marketing targeted at professionals, if the marketing materials are targeted at final consumers or professionals will forward the marketing information either in writing or orally to the final consumer. Evira will draw up more specific guidelines, as necessary, if an EU level interpretation is issued of this matter. (Last modified 9.11.2011)
10. Have medicinal claims been previously permitted?
The presentation of medicinal claims in the marketing of foods has been prohibited as misleading since the Food Act of 1941. Food control authorities have in connection with their control activities intervened in the medicinal marketing of foods since 1980s. The previous Food Act passed in 1995 specifically stipulated that it is prohibited to present food as having properties related to prevention, treatment or curing of human diseases or to refer to such information. Thus, the same legislative principles have applied for decades. (Last modified 9.11.2011)
11. Is it permissible to market foodstuffs by telling about its effects on health?
Nutrition and health claims may be used in the marketing of foods under the conditions laid down in the Regulation (EC) No 1924/2006 on nutrition and health claims adopted in 2007. The main rule is that the claimed effect shall be beneficial in nutritional or physiological terms, as established by generally accepted scientific evidence. Health claims require pre-authorisation.
12. What is a nutrition claim?
– A nutrition claim states that a food has particular beneficial nutritional properties in terms of energy amount, nutrients or other substances. Examples of nutrition claims include "reduced salt", "light" and "high in fibre".
Only the nutrition claims included in the List in the Annex to the Regulation on nutrition and health claims may be used in the EU. The use of a nutrition claim always requires the indication of the nutritional value in the labelling.
13. What is a health claim?
– A health claim states that a relationship exists between health and the food. The claim must be substantiated by scientific evidence, the adequacy of which is assessed by EFSA (European Food Safety Authority).
Health claims include so-called functional claims related to growth, development and the functions of the body, claims that refer to psychological and behavioural functions as well as claims that describe slimming or weight control. Claims that refer to the reduction of disease risk and claims that refer to children's development and health are also health claims.
The use of a health claim also requires the indication of the nutritional value in the labelling.
14. Are some claims prohibited?
– Yes. No foods may be marketed using medicinal claims, which refer to prevention, treatment or curing of human diseases. The recommendations of individual physicians or health care professionals are prohibited in marketing. As health claims must be substantiated by generally accepted scientific evidence, the experience of individual users may not be used in marketing either.
It is also prohibited to market a food product stating that health could be affected by not consuming the product. Claims which make reference to the rate or amount of weight loss, such as "6 kg in 3 days", are prohibited in the marketing of weight control products. In Evira's opinion references to the reduction of waist circumference or size of clothes are also prohibited.
15. Must pre-authorisation be sought for health claims?
– Yes. Health claims used on the market at present are currently being assessed in the EU. EFSA assesses the scientific substantiation for the claims.
Authorities in EU countries have gathered a list of the health claims used in the different countries. Operators in the food sector have also directly applied for the authorisation from the European Commission for claims of a certain type. The Commission will publish a list of claims authorised on the basis of EFSA's opinion, and of the conditions for their use.
The list is to be published in phases during 2010 and 2011. Once assessed, only claims that have been authorised may be used and then only in compliance with the conditions set out for their use. Claims that are still under the assessment procedure may be used on the conditions described in question 15.
16. Can new health claims be submitted for inclusion in the list of authorised claims after January 2010?
– Yes. Health claims substantiated by newly developed scientific evidence can be submitted to EFSA for assessment also after 31 January 2010. An Application Guide is provided on EFSA's web site.
17. What kind of foods can be marketed as "source of fibre" or "high in fibre"?
– A nutrition claim that a food is a ’source of fibre’ may only be made where the product contains at least 3 g of fibre per 100 g or at least 1.5 g of fibre per 100 kcl. The claim ’high in fibre’ may be made where the product contains at least 6 g/100 g or at least 3 g/100 kcal.
18. Can foods be marketed with low glycemic index?
– On certain conditions, yes. Reference to the glycemic index is considered a health claim, which means that the operator wishing to use it in marketing must apply for the inclusion of the claim in EU's list of authorised health claims. Naturally the product must also contain carbohydrates that are digested slowly by the body.
19. Can foods be marketed with the claim ’cholesterol-free?
– No, because ‘cholesterol-free’ is not included in the list of authorised nutrition claims in the Annex to the Regulation on nutrition and health claims. By contrast, the claims ‘low saturated fat’ or ‘no saturated fat’ can be used provided the product fulfils the conditions set out for such products.
20. Can foods be marketed with the claim ‘reduces cholesterol’?
– This type of a health claim is considered to be a claim referring to reduction of disease risk, as high cholesterol is known to be a risk factor in coronary artery disease. The claim has to be included in the list of authorised health claims for it to be used in marketing.
Claims referring to the cholesterol-reducing effects of plant sterols and plant stanols are authorised health claims.
21. Can foods be marketed with indications such as ’varied food’ or ’for a healthy diet’?
– No, because such indications refer to the nutritional properties of the product in a too unspecific and general manner. Also, they are not included in the list of authorised nutrition claims.
22. Can foods be marketed with the claim ’contains lactic acid bacteria’?
– Yes, provided that the content of lactic acid bacteria in the product is so high that it has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific data. This claim is a nutrition claim.
23. May the Heart symbols be used on food packaging after 30 January 2010?
– The Heart symbol of the Finnish Heart Association is considered to be a nutrition claim and an application has been filed for authorisation pursuant to the Regulation on nutrition and health claims has been filed.
24. When and where is the list of authorised health claims to be published?
– Decisions on the authorisation of individual health claims are published in the Official Journal of the European Union. A list of authorised health claims is published on the web site of the European Commission.