Changes in labelling regime

1. Changes in labelling regime Patrick DEBOYSER Head of ‘Food Law & Biotechnology’ Health & Consumer Protection DG EUROPEAN COMMISSION Changes in labelling regime

2. Changes in labelling regime : overview • Changes already enacted: • Labelling of food containing meat (Directive 2001/101/EC) • Labelling of compound ingredients (Directive 2003/89/EC) • Labelling of allergenic substances (Directive 2003/89/EC) • Labelling of food containing quinine or caffeine (Directive … ) • Labelling of genetically modified (GM) food (Regulation 1829/2003) • Changes being considered by Council and Parliament: • Nutrition and health claims (Proposal COM(2003) …) • Changes being considered by the Commission • Nutrition labelling • General review of food labelling Changes in labelling regime

3. General labelling regime : Directive 2000/13/EC • Consolidates previous legislation • Objectives: • To ensure the smooth functioning of the internal market • To inform and protect consumers • Has been adopted as a model for labelling legislation in many countries around the world • Applies to all foods placed on the market but does not prevent rules applying to specific food • Applies to the labelling of food, and to certain aspects of presentation and advertising • Applies to food sold pre-packaged but not to food sold in bulk (not pre-packaged) and not to food sold by mass caterers (restaurants, etc.) Changes in labelling regime

4. General labelling requirements • Labelling may not mislead the purchaser to a material degree: • as to the characteristics of the food (e.g. in particular : nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production); • by attributing to the food effects or characteristics which it does not possess; • by suggesting that the food possess special characteristics when in fact all similar food possess such characteristics. • Labelling may not attribute to any food the property of preventing, treating or curing human disease, or refer to such properties. • A non-exhaustive list of claims, within the meaning of the two requirements above, the use of which must at all events be prohibited or restricted, shall be established by Council and Parliament. Changes in labelling regime

5. Mandatory labelling: requirements • The name of the food. • The list of ingredients. • The quantity of certain ingredients (QUID). • The net quantity of the food. • The date of durability or the ‘use by’ date. • Any special storage conditions or conditions of use. • The name and address of the manufacturer or packager, or of a seller established in the European Union. • The place of origin or provenance where failure to give it would mislead the consumer to a material degree. • Any instructions for usewhere they are needed. Changes in labelling regime

6. Mandatory labelling: derogations • Provided by Directive 2000/13/EC itself (e.g. butter, cheese…). • Provided in other EU legislation (e.g. fruit juices, fish…). • Community provisions applicable to specified food and not to food in general may provide for derogations in exceptional from the requirements to provide the list of ingredients and/or the date of minimum durability (not used so far). • Community provisions applicable to specified food and not to food in general may provide that other particulars must appear on the labelling (e.g. indication of quinine and caffeine content). • Where there are no Community provisions, Members States may, subject to approval by the Community, provide that other particulars must appear on the labelling. Changes in labelling regime

7. List of ingredients: overview • Very complex regime! • Includes all the ingredients of the food, in descending order of weight, as recorded at the time of their use in the manufacture of the product. • Many derogations: fresh fruits and vegetables, carbonated water, fermentation vinegars, cheese, butter, fermented milk, alcoholic beverages, compound ingredients… • Important modification introduced in 2003 (Directive 2003/89/EC) coming into force in 2005): • Allergenic substances must always be labelled! • Individual ingredients of compound ingredients must be labelled except in very specific circumstances! Changes in labelling regime

8. List of ingredients: allergenic substances (1) • Substances which cause allergies, intolerances or hypersensitivity must always be labelled. • List of these substances is provided in Annex IIIa of Directive 2000/13/EC: Cereals containing gluten Milk Crustaceans Nuts Eggs Celery Fish Mustard Peanuts Sesame seeds Soybeans Sulphur dioxide and all products thereof Changes in labelling regime

9. List of ingredients: allergenic substances (2) • Exemption may be granted (by the Commission) in respect of ingredients for which it has been scientifically established that they are not likely, under specific circumstances, to trigger allergenic reactions. • Where studies are currently being undertaken for that purpose, the Commission may grant exemption until completion of the said studies or 25 November 2007 at the latest, provided a notification has been made to the Commission prior to 25 November 2004. Changes in labelling regime

10. List of ingredients: compound ingredients • Abolition of the 25 % rule (whereby individual ingredients of compound ingredients constituting less than 25 % of the final product did not need to be indicated in the list of ingredients of the final product). • Ingredients of compound ingredients have to be listed except: • where the composition of the compound ingredient is defined in current Community legislation (e.g. jam) and the compound ingredient constitutes less than 2 % of the finished product; • where the compound ingredient consists of spices and/or herbs and the the compound ingredient constitutes less than 2 % of the final product; • where the compound ingredient is a food for which a list of ingredients is not required in Community legislation (e.g. cheese, butter…). Changes in labelling regime

11. List of ingredients: flexibility introduced • Fruits, vegetables and mushrooms: • when used in proprortions that may vary, and where none of them predominates, • may be grouped together in the list of ingredients under the designation « fruit », « vegetables » or « mushrooms » followed by the phrase « in varying proportions » and by a list of the fruit, vegetables or mushrooms present. • Ingredients constituting less than 2 % may be listed in a different order, after the other ingredients. • Where two ingredients are substitutable in the production of a product, they may be referred to by means of the phrase « contains … and/or … » provided that: • they represent less than 2 % of the finished product; • At least one of the two ingredients is present. Changes in labelling regime

12. List of ingredients: categories of ingredients • Annex I to Directive 2000/13/EC defines categories of ingredients which may be designated by the specific name of the category rather than by the specific name of the ingredient considered for inclusion in the list of ingredients (e.g. vegetable oil, fish…). • The category « … meat » was been recently added to that list (Directive 2001/101/EC): • the name(s) of the animal species must be included; • the maximum amount of fat and connective tissues contained in the ingredient designated by the category « … meat » is specified (e.g. for poultry: 25 % fat and 25 % connective tissue). • mechanically recovered meat is excluded, and must be labelled as such. • this only concerns meat which constitutes and ingredient of another food! Changes in labelling regime

13. Changes in labelling regime

14. Labelling of genetically modified (GM) food • New provisions (Regulation 1829/2003) have recently come into application (18 April 2004). • They provide for the mandatory labelling of all GM food and GM food ingredients which consist of, contain or are derived from a GMO, irrespective of: • any safety or nutritional consideration; • the is sometimes referred to as « labelling the method of production ». Changes in labelling regime

15. Labelling of GM food: examples • In practice, following labelling is typically required: • In the case of a food consisting of a GMO (e.g. Bt11 corn), the label shall bear « genetically modified corn » as the name of the product. • In the case of a food containing a GMO (e.g. Bt11 corn), the list of ingredient will include the terms « genetically modified corn ». • In the case of a food produced from a GMO (e.g. oil from Bt cotton seeds), the label shall bear « GM cotton seeds oil ». • In the case of a food containing an ingredient (e.g. oil from Bt cotton seeds), the list of ingredients will include the terms « GM cotton seeds oil ». Changes in labelling regime

16. Labelling of GM food: additional labelling • In addition, where a GM food (or ingredient) is different from its conventional counterpart as regards: • its composition • its nutritional value or nutritional effects • its intended use • its implications for the health of certain sections of the population this must be mentioned in the labelling provisions (Regulation 1829/2003) have recently come into application (18 April 2004). • In addition, where a food may give rise to ethical or religious concerns, this shall also be mentioned. • Where a GM food does not have a conventional counterpart, the labelling shall contain appropriate information about the nature and characteristics of the food. Changes in labelling regime

17. Labelling of GM food: scope • In contrast with the general labelling requirements (Directive 2000/13/EC) the provisions of Regulation 1829/2003 apply to all food, whether sold pre-packaged or not. • There are divergences as to the application of these provisions to food provided by mass caterers (e.g. restaurants, canteens, schools, prisons…). • According to the Commission, the provisions do not apply to food which is processed or prepared by mass caterers, but they do apply to food which are supplied to mass caterers and delivered as such to the final consumer. • Some Member States (e.g. Germany, France) consider that the provisions of Regulation 1829/2003 apply also to all food served by mass caterers to final consumers. • In practice, this divergence is of little practical importance as, under the Commission interpretation, Member States are allowed to extend the provisions of the Regulation to food sold by mass caterers to final consumers on their territory. Changes in labelling regime

18. Labelling of GM food: exemption • The provisions of Regulation 1829/2003 do not apply to the unintentional presence of GM material in conventional food provided that: • this presence is no higher than 0,9 % of any ingredient or of the food itself; • the operator is in a position to establish that this presence is adventitious or technically unavoidable (i.e. appropriate steps have been taken to avoid this presence. • The 0,9 % threshold may be lowered by the Commission through the comitology procedure. • The 0,9 % labelling threshold operates independently from the 0,5 % tolerance threshold for the adventitious presence of unauthorized GM material. However, as the case may be, any unauthorised GM material present will be counted against the 0,9 % labelling threshold. Changes in labelling regime

19. Labelling of GM food: controls • The control of the respect of the new labelling provisions has been greatly improved in three respects: • the precise labelling requirements applicable to any GM food will henceforth be specified in the authorization of the food; • a validated method of detection will be available for all GM food authorised in the EU, as validation of the detection method is now a prerequisite for the authorisation; • in addition to detection as well as in cases where no transgenic DNA or protein is detectable, controls will be based on the paper track (traceability). • Regulation 1830/2003 requires the mandatory traceability of GMOs and food derived from GMOs. The exemptions provided by this Regulation are based on and therefore similar to those laid down in respect of labelling by Regulation 829/2003. Changes in labelling regime

20. Changes in labelling regime

21. Nutrition and health claims • As consumers have become increasingly concerned about what they eat and how this affects their health, the food industry has responded by providing more detailed nutrition labelling and often making claims about the beneficial effects of certain foods. • The existing EU rules on labelling and nutrition labelling do not define conditions for the use of nutrition claims and do not allow health claims to be made. • Consumers can therefore be misled by claims that have not been properly substantiated. • The Commission submitted a proposal for a Parliament and Council Regulation on nutrition and health claims in July 2003. • The proposed Regulation will give legal security and address these issues by specifying the conditions for the use of nutrition and health claims, prohibiting certain claims and scientifically evaluating the use of claims in relation to the nutritional profile of foods. Changes in labelling regime

22. Nutrition claims • Nutrition claims, such as “low fat” or “high fibre”, refer to what is or is not contained in the product. • There are currently no legally binding conditions regulating the use of these claims. • The proposed Regulation aims to harmonise the use of such claims so that products claiming to be for example “high fibre” have a defined minimum amount of fibre per a defined unit (e.g. 6 g / 100g). • Furthermore, some claims may be misleading. For example a product claiming to be “90% fat free” may be stating correct facts but it is still misleading since it implies that it has a low fat content while in reality 10% fat represents a fairly high fat content. • The proposal includes an Annex listing the only nutrition claims that will be allowed and the conditions for using them. Changes in labelling regime

23. Health claims: general • Health claims refer to the potential health benefits that a food or a food component may bring to consumers. • It is currently prohibited to make any claims that are misleading to consumers, as well as any claim which refers to a human disease. • The proposal distinguishes between two types of health claims: • health claims regarding the role of a nutrient in normal body functions, which are uncontroversial and well established. Example: “Calcium plays an important role in strengthening thebones”. • health claims which are more novel Example: “Whole grain may keep your heart healthy” and claims referring to the reduction of a risk factor of a disease Example: “Regular consumption of whole grain may reduce the risk of heart disease” Changes in labelling regime

24. Health claims: authorisation • Well established health claims: • Within three years of the Regulation entering into force, the Commission will, on the basis of notifications by the Member States, make a positive list of such well established claims that will be permitted. • The list will be regularly updated to reflect progress in scientific knowledge and food technology. • Novel and disease risk related claims • Only claims that can be substantiated will be permitted on the EU level. • Operators wanting to make such claims will have to submit an application to the European Food Safety Authority (EFSA). • A decision on the acceptability of the claim will be taken by the Commission. • In some cases, the right to use the claim will be reserved for the applicant who has put the file together (reward of innovation). Changes in labelling regime

25. Prohibited nutrition and health claims • Some health claims will be prohibited irrespective of whether or not they could be substantiated: • vague claims referring to general wellbeing (e.g. "helps your body to resist stress", "preserves youth") • claims making reference to psychological and behavioural functions (e.g. “improves your memory” or “reduces stress and adds optimism”) • slimming or weight control claims (e.g. "halves/reduces your calories intake") • reference to and endorsement by doctors or health professionals • any claim suggesting that not eating the specified food might lead to health problems. • In addition, both nutrition and health claims will be prohibited in respect of alcoholic beverages above 1.2 %. Only claims referring to a reduction in alcohol or energy content, will be allowed. Changes in labelling regime

26. Nutritional profiles • The basic principle in nutrition is that there are no “good foods” and “bad foods” but rather “good diets” and “bad diets”. In a long-term varied diet all foods can be included. • However, foods bearing a nutrition or health claim will automatically be perceived as "good" foods by consumers. • The proposal therefore provides for the possibility of restricting the use of claims on some foods based on their nutritional profile. • The amount of total fat, saturates, sugar or salt are criteria for the nutritional profile of products, since scientific evidence shows a link between over-consumption of such nutrients and some chronic diseases (see WHA Resolution of last week). • Within 18 months of adoption of the Regulation, the Commission will evaluate nutritional profiles in close consultation with stakeholders and based on the opinion of the European Food Safety Authority (EFSA). Exemptions may be necessary for certain claims on foods depending on their role and importance in the diet of the population. Changes in labelling regime

27. Changes in labelling regime

28. Nutrition labelling • In the EU, nutrition labelling is currently only required where a nutrition claim is being made. In such case it must conform to the requirements laid down in Directive 90/496/EEC. • Where nutrition labelling is offered voluntarily, it must also conform to these requirements. • The European Commission is considering a proposal to make nutrition labelling compulsory on all pre-packaged food in the EU. • A wide consultation of stakeholder and Member States has been carried in 2003. • There appears to be support for requiring the mandatory disclosure of maximum 5-6 nutrition facts: total energy, total fats, saturated fats, total carbohydrates, sugars, and sodium/salt. • The Commission has now carrying an evaluation of the likely impact of such a measure, in particular small and medium companies. • A proposal to Parliament and Council may still be put forward before the end of 2004. Changes in labelling regime

29. Changes in labelling regime

30. General review of food labelling provisions • The Commission has engaged in a major review of the current food labelling provisions, with a view to: • updating, modernizing and simplifying them; • making labels clearer, more readable and better understandable to consumers; • reflecting changes in consumer expectations; • taking into account progress in communication means and technologies. • A preleminary evaluation has been undertaken. • This will constitute a major project for the new Commission. Changes in labelling regime

31. Changes in labelling regime

32. Issues of common interest • Improving consumer awareness of the presence of allergens in food • Addressing obesity: • prominence of energy-related (calorie) information in labelling • packaging/serving size information • importance of education (reading labels and acting upon them) • satiety claims assessment • How to improve consumer information – including nutrition information – on food which are not sold pre-packaged and those supplied by mass-caterers (restaurants, canteens…) Changes in labelling regime