Nutrition and Health Claims

Nutrition and Health Claims: Update regarding the positive Lists, the „on hold“ Claims and EFSA Requirements for new Claim Applications Avv. Dr. Barbara Klaus:

Freitag, 18. Januar 13

27th September 2012 | © meyer. avvocati | rechtsanwälte | attorneys at law

Labelling, Presentation and Advertising of Foodstuffs Ban of misleading advertising (Art. 16 of Regulation (CE) No 178/2002) ÂŤThe labelling, advertising and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers.Âť

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Labelling, Presentation and Advertising of Foodstuffs GENERAL REQUIREMENTS FOR ALL FOODSTUFFS

SPECIFIC REQUIREMENTS FOR CERTAIN CATEGORIES. EXAMPLES:

► Labelling, presentation and advertising of foodstuffs Directive 2000/13/

► Food additives Regulation (EC) No

EC + national implementing laws + Regulation (EU) No 1169/2011 on the provision of food information to consumers Regulation (EC) No. 1169/2011 which contains the new EU food labeling rules thereby repealing the nutrition labeling (90/496/EEC) and food labeling (2000/13/EC) Directives and consolidating their provisions under one Regulation; it shall apply from 13 December 2014, with the exception of point (l) of Article 9(1) (nutrition labelling), which will apply from 13 December 2016, and Part B of Annex VI (relates to minced meat), which will apply from 1 January 2014

1333/2008

► Food supplements Directive 2002/46/EC ► Fortified foodstuffs Regulation (EC) No 1925/2006

► Foodstuffs for particular nutritional purposes Regulation (EC) 953/2009

► Nutrition labelling Directive 90/496/EEC of 24 September 1990 + national laws implementing laws + Regulation (EU) No 1169/2011 on the provision of food information to consumers.

►Cocoa and chocolate Directive 2000/36/

► Nutrition and health claims made on foods Regulation (EC) No 1924/2006

► Fruit

EC

juices Directive 2001/112/EC

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Specific Rules on Nutrition and Health Claims SCOPE (Recitals No 1, 2 of Regulation (EC) No 1924/2006) «An increasing number of foods labelled and advertised in the Community bear nutrition and health claims. In order to ensure a high level of protection for consumers and to facilitate their choice, products put on the market, including imported products, should be safe and adequately labelled. A varied and balanced diet is a prerequisite for good health and single products have a relative importance in the context of the total diet. Differences between national provisions relating to such claims may impede the free movement of foods and create unequal conditions of competition (...) It is therefore necessary to adopt Community rules on the use of nutrition and health claims on foods.»

(Recital No 3 of Regulation (EC) No 1924/2006) «General labelling provisions are contained in Directive 2000/13/EC (…). Directive 2000/13/EC generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food. This Regulation should complement the general principles in Directive 2000/13/EC and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.» dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Specific Rules on Nutrition and Health Claims SUBJECT MATTER (Art. 1 of Regulation (EC) No 1924/2006)

THIS REGULATION APPLIES: ► 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 ► limited application to non-prepackaged foodstuffs ► to trade marks, brand names or fancy names appearing in the labelling, presentation or advertising of a food ► to generic descriptors which have traditionally been used to indicate a particularity of a class of foods which could imply an effect on human health, such as “digestive” or “cough drops” (but derogations foreseen)

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Specific Rules on Nutrition and Health Claims ADMITTED ► NUTRITION CLAIM when listed in the Annex of Regulation (EC) No 1924/2006 Any claim that states, suggests or implies that a food has particular beneficial nutritional properties due to the energy it provides or does not provide; and/or the nutrients or other substances it contains or does not contain.

Examples: “source of calcium”; “high in fibre and low in fat”; “light”. ► HEALTH CLAIM when included in the lists of authorized so called “general function” health claims recently adopted by the Commission (Regulation (EU) No 432/2012 of 16 May 2012).

Any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. See interpretation of the term of “health claim” in CJEU judgment C-544/2010, 6 Sept. 2012.

Examples: “Calcium contributes to normal muscle function”; “Biotin contributes to normal functioning of the nervous system”; “Lactulose contributes to an acceleration of intestinal transit”. ► COMBINED NUTRITION AND HEALTH CLAIM Example: “Contains vitamin C which contributes to the normal function of the immune system.” dr. barbara klaus | 01/18/13

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Specific Rules on Nutrition and Health Claims ADMITTED ► REDUCTION OF DISEASE RISK CLAIM when authorized according to a EU procedure 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 Example: “Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease” BUT FORBIDDEN: HUMAN DISEASE CLAIMS Any claim that attributes to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties.

Example: “Plant stanol esters protect from osteoporosis”. ► CLAIMS ON CHILDREN'S DEVELOPMENT AND HEALTH when authorized according to a EU procedure Example: “Vitamin D is needed for the normal growth and development of bone in children.” dr. barbara klaus | 01/18/13

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Specific Rules on Nutrition and Health Claims ADMITTED ► CLAIMS WITH A REFERENCE TO OVERALL GOOD HEALTH AND/OR TO HEALTH RELATED WELL-BEING: No authorization needed but an authorized claim must be added (Article 10 (3) of Regulation (EC) No 1924/2006).

Example overall good health: “Contains healthy vitamin C” accompanied by an authorized health claim for vitamin C.

Shall be

Example health related well-being: “Contains vitamin C to stay fit” accompanied by an authorized health claim for vitamin C.

Shall be

► CLAIMS ON GENERAL WELL-BEING: No authorization needed as these claims are not within scope of Regulation (EC) No 1924/2006 Example: “Wellness and Beauty”, “With vitamin E and borage seed oil for the beauty from inside” BUT: CJEU Judgment C-544/2010, 6 Sept. 2012 Difficult to draw a borderline between the two concepts of health claim and general well-being claim dr. barbara klaus | 01/18/13

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CJEU Judgment C-544/2010, 6 Sept. 2012  Health claims are forbidden in the labelling of beverages containing more than 1.2% by volume of alcohol. A wine growers’ cooperative indicated in the labels of the bottles : “Mild edition – easily digestible”  description referred to general well-being.  CJEU stated that easily digestible accompanied by a reference to the reduced content of substances frequently perceived by consumers as being harmful, is a health claim:  the relationship that must exist between a food or one of its constituents and health must be understood in a broad sense.  it is sufficient that the preservation of a good state of health, despite the potentially harmful consumption, is suggested.  not only temporary effects but also long-term consumption must be taken into account.  in order to protect consumers, all claims related to alcoholic beverages, even if scientifically proven, must be considered as ambiguous and therefore forbidden.

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Different Authorization Procedure for Health Claims

Art. 13

The role of a nutrient or other substance in growth, development and the functions of the body psychological or behavioural functions 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

Art. 14

Reduction of disease risk claims Claims referring to children‘s development and health

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List of authorized General Function Health Claims (Regulation (EU) No 432/2012 of 16 May 2012) Main aim: ensure that health claims are truthful, clear, reliable and useful to the consumer and that they are based on and substantiated by generally accepted scientific evidence ► Article 13 (2) Regulation (EC) No 1924/2006: Member States provided the Commission with lists of claims as by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification ► Article 13 (3) Regulation (EC) No 1924/2006: European Commission’s duty to adopt a Community list of permitted claims and all necessary conditions for the use of these claims by 31 January 2010 at the latest AS A RESULT OF THIS PROCESS: ► On 16 May 2012 the European Commission issued the Regulation (EU) 432/2012 which provides a positive list of permitted health claims made on foods other than those referring to the reduction of disease risk and children’s development and health dr. barbara klaus | 01/18/13

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The long Journey of Regulation (EU) No 432/2012

44.000 Claims from Member States More than 10.000 similarities EFSA received a consolidated list

July 2011: 4637 claims subject to assessment 1548 botanicals

2758 claims assessed (60 %): ~ 222 claims About 25 % positive opinions

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List of authorized General Function Health Claims COMMISSION REGULATION (EU) No 432/2012 of 16 May 2012 (see also EU Commission - Questions and Answers on the list of permitted Health Claims on food products, 16.5.2012, Reference: MEMO/12/346)

 Permitted health claims published in Annex of Regulation (EU) No 432/2012  Permitted health claims are based on a scientific assessment by the European Food Safety Authority (EFSA) (Reference to EFSA Opinions indicated in the Annex of Regulation (EU) No 432/2012)

 BUT: Health claims inconsistent with generally accepted nutrition and health

principles were not authorized although positive EFSA assessment (i.e. effect of fats on the normal absorption of fat soluble vitamins and effect of sodium on the maintenance of normal muscle function). Recital 12: Use of these health claims would convey a conflicting and confusing message to consumers, because it would encourage consumption of those nutrients for which, on the basis of generally accepted scientific advice, European, national and international authorities inform the consumer that their intake should be reduced ambiguous or misleading claims dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

List of authorized General Function Health Claims COMMISSION REGULATION (EU) No 432/2012 of 16 May 2012

 Permitted claims include the wording and specific conditions of use of the

claims, and where applicable, conditions or restrictions of use and/or an additional statement or warning.

 EXAMPLE: • Wording: Betaine contributes to normal homocysteine metabolism.

•

Condition of use: The claim may be used only for food which contains at least 500 mg of betaine per quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 1,5 g of betaine.

•

Restrictions of use and/or additional statement or warning: In order to bear the claim information shall be given to the consumer that a daily intake in excess of 4 g may significantly increase blood cholesterol levels.

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Status of the Claims not in the permitted List  Claims actually not authorised for inclusion in the permitted list are inserted into the "Union Register" of nutrition and health claims making it clear why they are not authorised (see: http://ec.europa.eu/nuhclaims/).  Reasons for their non-authorisation:  Health claims submitted as “function claims” but that do not qualify as such.  Health claims not related to human health which cannot consequently be used on foods.  Health claims for combinations of substances where health claims are already authorised for some of the individual substances.  General Function Health Claims for which EFSA assessment or consideration by the Commission is not finalised. These include:  Health claims under further assessment = so called “on hold claims”.  Health claims subject to the individual authorisation procedure pending a decision = new claims under Article 13 (5) Regulation (EC) No 1924/2006.

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

On hold claims Deferred health claims:  REQUIRING FURTHER ASSESSMENT BY EFSA This group of substances is considered by EFSA to be insufficiently characterized for an assessment (e.g. probiotics).

 CLAIMS ON “BOTANICAL SUBSTANCES” Can be present in the composition of both Traditional Herbal Medicinal Products and in foods. Different treatment of the same herbal substance, depending on its use (food or medicinal product) creates discrimination and potential consumer confusion.

EFSA considers the data situation referred to these claims as being inadequate. For this reason such claims are situated in the interim area between unsubstantiated and eligible for auhorisation. Pending decision on how to address this issue.

REQUIRING FURTHER CONSIDERATION BY THE RISK MANAGER For a few claims it has not reached an agreement between Member States and European Commission. In particular, claims on caffeine received a positive EFSA assessment, but disputes on the health ground is still opened with Member States.

dr. barbara klaus | 01/18/13

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Application of Regulation (EU) No 432/2012  The regulation will apply from 14 December 2012. 

It is not still clear if Member States will establish a “transitory period”.

ITALY The Ministry of Health has prepared a draft communication:  Claims included in Regulation (EU) 432/2012, but not conforming to the wording of the Annex and used on products labeled before 14.12.12, are PERMITTED until 30.6.2014.  Rejected claims not included in Regulation (EU) 432/2012, used on products labeled before 14.12.12, are PERMITTED until June 2013.

OTHER PROPOSAL Give the possibility to market all those products with the “old claims” in the label at least while stocks last. dr. barbara klaus | 01/18/13

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Sanctions in Case of Infringement SANCTIONS IN CASE OF INFRINGEMENT OF HEALTH CLAIMS REGULATION Rules regarding unfair commercial practices set out in the Italian Consumer Code (implementation of Directive 2005/29/EC – Antitrust Authority). Rules regarding misleading advertising set out in the Italian Law on Food Labelling (D.Lgs. No 109/1992 = implemetation of Directive 2000/113/EC) – official control authorities. Draft Legislative Decree regarding sanctions in case of infringement if Regulation (EC) No 1924/2006 regarding health and nutrition claims.  Problem: delimitation of the competences of the administrative control authorities and the Antitrust Authority. FEDERALIMENTARE proposes to establish that only the administrative control authorities and not the Antitrust Authority are competent for inflicting fines.

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Health claims and the Italian Antitrust Authority Unfair commercial practice according to Italian Consumer Code ďƒ˜Article 21 (1) b): it is considered to be an unfair commercial practice, because misleading, if it contains false information and is therefore untruthful or in any way, including overall presentation, deceives or is likely to deceive the average consumer, even if the information is factually correct, in relation to elements such as the main characteristics of the product (such as health benefits and effects), and in either case causes or is likely to cause him to take a transactional decision that he would not have taken otherwise. ďƒ˜Article 22: A commercial practice shall be regarded as misleading if, in its factual context, taking account of all its features and circumstances and the limitations of the communication medium, it omits material information that the average consumer needs, according to the context, to take an informed transactional decision and thereby causes or is likely to cause the average consumer to take a transactional decision that he would not have taken otherwise (misleading omissions).

= Art. 6 (1) b of Directive 2005/29/EC

= Art. 7 of Directive 2005/29/EC

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Italian Antitrust Authority – Case-law Case PS20 – Danacol and Case PS649 – Pro-Active In these cases the health claims stating the reduction of cholesterol related to foodstuff added with phytosterols (Danacol and ProActiv) were considered as neglected and misleading because they do not indicate all the necessary elements for consumers in order to be aware of their economic choices. Argumentation of Antitrust Authority:  General principles of Regulation (EC) No 1924/2006: use of health claims should not be false, ambiguous or misleading or encourage excessive consumption or create or exploit fear in the consumer (Art. 3), so as to enable the average consumer to understand the beneficial effects as expressed in the claim (Art. 5).

These requirements relate not only to the single health claim indication, but to the whole advertising communication in the context of which the single claim is made.  It is considered misleading to create the expectation that it is possible eliminate or reduce risk factors related to hypercholesterolemia through the consumption of a food product the whose effectiveness is, by its nature, limited and partial.

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Italian Antitrust Authority – Case-law Case PS20 – Danacol and Case PS649 – Pro-Active Argumentation of Antitrust Authority:  Since they are not adequately highlighted the situations in which the recruitment of the product can be useful, limited to cases of mild hypercholesterolemia, and to what extent the consumption of this product may cause benefit, these methods of promoting the product integrates an unfair commercial practice as misleading consumers about the product properties (misleading omissions).  Therefore, the messages regarding health benefits are omissions and misleading within the meaning of Articles. 21 (1) b) and 22 of the Consumer Code, because due to their content and due to the absence of more comprehensive information regarding the effective use of the foodstuff (ProActiv), they are likely to deceive the average consumer, and cause him to take a transactional decision that he would not have taken otherwise.

dr. barbara klaus | 01/18/13

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Health claims and the Italian Antitrust Authority Unfair commercial practice according to Italian Consumer Code Article 21(3): It is considered to be an unfair commercial practice, in relation to products likely to harm the health and safety of consumers, to fail to state this likelihood such that consumers are induced to neglect to observe the normal standards of prudence and vigilance. Article 21(4): It is considered to be an unfair commercial practice, those that can reach children and adolescents and can also indirectly threaten their safety. These provisions may rise a breach of the EU law as they are considered only in Italy and not covered by Directive 2005/29/EC. CJEU Judgment C-261/07, 23 April 2009:  Directive 2005/29/EC fully harmonises rules on unfair commercial practices.  Directive precludes a prohibition of commercial practices by establishing a presumption of unlawfulness for practices other than those indicated in the Directive itself; without requiring a case by case assessment in order to establish whether or not they cause the average consumer to take a transactional decision that he would not have taken otherwise.

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Italian Antitrust Authority – Case-law Case PS2115 – Case Red Bull Advertising claim regarding Red Bull® Energy Drink which highlights the positive effects on driving performance during prolonged driving (health claim). Reference was made to a scientific study which proved that Red Bull has positive influence on cognitive performance and that it substantially increases the ability to concentrate and react. Argumentation of Antitrust Authority:  The message is structured in such a way as to leave the consumer believe that the normal rule of prudence - which is to stop when driving in a state of sleepiness - would be overcome by the results of precise studies and accredited by prestigious institutions.  The message, therefore, appears likely to cause the consumer to believe, in contrast to true, that the intake of the drink helps to overcome, in complete safety, sleepiness and that it is therefore possible to drive without the need to stop and rest, in conditions of tiredness; although in such a state the only possible advice is to stop and rest. dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Italian Antitrust Authority – Case-law Case PS2115 – Case Red Bull Argumentation of Antitrust Authority:  Therefore, the advertisement at issue reveals itself misleading about the characteristics and benefits of the drink, according to Article 21 (1) b) of the Consumer Code.  In addition, this advertising urges and reassures the consumer (drivers) to face situations of objective danger, such as driving in a state of sleepiness or long distance driving, only by relying on the characteristics and effects claimed for the product (cognitive performance and increase of concentration and reaction).  Therefore, the message in question, by failing to mention the risks arising from the proposed use of the product (i.e. car driving in a state of sleepiness) is likely to cause consumers to ignore the normal rules of prudence and vigilance, and therefore in violation of Article 21 (3) of the Consumer Code. dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Italian Antitrust Authority – Case-law ANTITRUST AUTHORITY CASE LAW CONCERNING HEALTH CLAIMS ARISING QUESTIONS

Has the economic operator an obligation to inform consumers about the risks that are not related to the product itself and / or its normal use? Does the economic operator violate the professional diligence (in the light of the applicable law), if it does not inform consumers of all the risks associated with each hypothetical behavior? What has the protection of safety and health of consumers to do in laws concerning exclusively the protection of their economic interests (ban of unfair commercial practises) ? Who is the average consumer?

dr. barbara klaus | 01/18/13

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Authorization of new “general function” health claims  Article 13(5) and Article 18 of Regulation (EC) No 1924/2006: Allow to submit new applications in order to authorize “general function” health claims (except those regarding disease risk reduction and child development or health under Article 14) based on newly developed scientific evidence and/or which include a request for the protection of proprietary data to the EU Register. These applications:

 Shall be submitted to the national competent authority of a Member State which shall acknowledge receipt of the application in writing within 14 days of its receipt.

The application shall include the data provided for in Article 15(3) and the reasons for the request.

 Shall be sent without delay to EFSA for a scientific assessment as well as to the Commission and the Member States for information. EFSA shall issue its opinion within a time limit of five months. Such time limit may be extended by up to one month supplementary information are necessary.

 If EFSA issues an opinion in favour of the inclusion of the claim, the Commission shall take a decision on the application within two months. dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Authorization of new “general function” health claims

Applications for authorisation of health claims - 3 key issues:  Sufficient characterisation of the food ?  Claimed effect sufficiently defined & is it a beneficial physiological effect?

 Relevant studies in humans available?

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Authorization of new “general function” health claims

Scientific and technical guidance  General guidance covering the principles applied by the NDA Panel in the evaluation of health claims:  General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal 2011;9(4):2135 [24 pp.].

 Specific guidances on the scientific requirements for health claims in selected areas:

 Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011, 9(4):1984 – April 2011

 Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.

EFSA Journal 2011;9(12):2474 – December 2011

 Guidance on the scientific requirements for health claims related to

appetite ratings, weight management, and blood glucose concentrations. EFSA Journal 2012;10(3):2604 – March 2012 dr. barbara klaus | 01/18/13

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EFSA Guidances  Guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. EFSA Journal 2012;10(5):2702 [13 pp.].

EFSA Journal 2012;10(5):2702 [13 pp.] – May 2012

 Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions.

EFSA Journal 2012;10(7):2816 [13 pp.] – July 2012

 Guidance on the scientific requirements for health claims related to physical performance released for public consultation.

EFSA Journal 2012;10(7):2817 [9 pp.] – July 2012

dr. barbara klaus | 01/18/13

Freitag, 18. Januar 13

Contact - Kontakt - Contatto

Avv. Dr. Barbara Klaus Lawyer and Lecturer in Food Law (European Institute of Public Administration Luxembourg / Business School del Sole 24 ORE Milan)

meyer. avvocati | rechtsanw채lte | attorneys at law Via Caradosso, 12 I - 20123 Milano Fon +39 02 43 51 42 21 Fax +39 02 43 41 69 82 E-Mail: klaus@klauslegal.com Internet: www.klauslegal.com

dr. barbara klaus | 01/18/13

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