The lofty aim of the 2006 EU Nutrition and Health Claims Regulation (1924/2006/EC) was to impose clearer, tighter and harmonised EU controls on the use of health and nutrition claims in food advertising and labelling. Years later, the first 222 officially approved health claims have appeared plus the 1600 that were rejected. Omar Bucchioni reports.
Topic: Food
Who: European Commission
When: May 2012
Where: UK
Law stated as at: 16 May 2012
What happened:
On 16 May 2012 the European Commission published a list of 222 health claims which have been officially approved by the European Food Safety Authority (EFSA).
The list has been published pursuant to the Nutrition and Health Claims Regulation (1924/2006/EC).
Food manufacturers will have a period of 6 months to adapt their practices to the new requirements since from the beginning of December 2012 all health claims in respect of foods that are not authorised or not on hold/under consideration will be prohibited.
All this is in spite of a pending decision of the European Ombudsman which is investigating the food claims assessment process and the opposition of industry groups e.g. the European Federation of Associations of Health Product Manufacturers (EHPM).
The EHPM argues that EFSA’s assessment process for general function claims is not in line with the proportionality foreseen by the regulation and that non-authorised claims should be put on hold until this issue is clarified and resolved. In addition, the 6 month transition period appears to be too short, expensive and impractical for food supplement manufacturers to implement label changes and sell through all their current stock.
It is the responsibility of the Member States’ authorities to enforce the rules on health claims. This should be a relatively easy task since all enforcement authorities will be able to rely on one list of authorised health claims and their conditions of use to verify if a claim is misleading or not.
Background information
Back in December 2006, the Council and the Parliament adopted a Regulation on nutrition and health claims made on foods.
In 2008, Member States submitted lists of about 44,000 health claims, which were consolidated by the Commission into a list of some 4,600.
By 2010 these claims were sent to the European Food Safety Authority (EFSA) which conducted a scientific assessment of whether the claims could be substantiated.
In June 2011 the EFSA finalised its main body of work for all health claims other than those on botanical substances.
In December 2011, Member States agreed to authorise the claims listed in the Annex to this Commission Regulation during the Standing Committee on the Food Chain and Animal Health.
Both the European Parliament and the Council considered this list under the scrutiny period, which ended with no objections on 27 April 2012.
In May 2012, the European Commission has adopted the 222 approved claims, which appear on the “EU Register of nutrition and health claims on foods”. This may be found on the European Commission’s website along with a list of the 1600 so far unsuccessful claims.
Other proposed claims are still undergoing the approvals procedure.
The aim
The new measures ensure that any claim made on foods’ labelling, presentation or marketing in the European Union is clear, accurate and based on evidence accepted by the whole scientific community.
Ultimately, these changes should assist consumers with making informed and meaningful choices and should facilitate the free circulation of foods bearing claims as any food company will be able to use the same claims on its products everywhere in the EU.
More specifically
Generally speaking, the use of health claims shall only be permitted if the food/constituent, for which the claim is made, has been shown to have a beneficial physiological effect. In assessing each claim, a scientific judgement is made as to whether the claimed effect is considered to be a beneficial physiological effect in the context of the specific claim, taking into account the population group for whom the claim is intended.
For function claims, a beneficial effect may relate to maintenance or improvement of a function.
For reduction of disease risk claims, “beneficial” refers to whether the claimed effect relates to the reduction (or beneficial alteration) of a risk factor for the development (onset) of a human disease (not to the reduction of the risk of disease).
Nutrition claims are only permitted if they are listed in the Annex of Regulation (EC) N°1924/2006 and are in conformity with the conditions set out in that Annex.
Nutrition claims
Here below are some examples of necessary conditions to meet in order to use nutrition claims:
Energy
LOW ENERGY – A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids. For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose), applies.
ENERGY-REDUCED – A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where the energy value is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.
ENERGY-FREE – A claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 4 kcal (17 kJ)/100 ml. For table-top sweeteners the limit of 0,4 kcal (1,7 kJ)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose), applies.
Fat
LOW FAT – A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3 g of fat per 100 g for solids or 1,5 g of fat per 100 ml for liquids (1,8 g of fat per 100 ml for semi-skimmed milk).
FAT-FREE – A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of fat per 100 g or 100 ml. However, claims expressed as ‘X % fat-free’ shall be prohibited.
LOW SATURATED FAT – A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1,5 g per 100 g for solids or 0,75 g/100 ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must not provide more than 10 % of energy.
SATURATED FAT-FREE – A claim that a food does not contain saturated fat, and any claim likely to have the same meaning for the consumer, may only be made where the sum of saturated fat and trans-fatty acids does not exceed 0,1 g of saturated fat per 100 g or 100 ml.
Sugars
LOW SUGARS – A claim that a food is low in sugars, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 5 g of sugars per 100 g for solids or 2,5 g of sugars per 100 ml for liquids.
SUGARS-FREE – A claim that a food is sugars-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of sugars per 100 g or 100 ml.
WITH NO ADDED SUGARS – A claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’.
Sodium/Salt
LOW SODIUM/SALT – A claim that a food is low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,12 g of sodium, or the equivalent value for salt, per 100 g or per 100 ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should not exceed 2 mg of sodium per 100 ml.
VERY LOW SODIUM/SALT – A claim that a food is very low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,04 g of sodium, or the equivalent value for salt, per 100 g or per 100 ml. This claim shall not be used for natural mineral waters and other waters.
SODIUM-FREE or SALT-FREE – A claim that a food is sodium-free or salt-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,005 g of sodium, or the equivalent value for salt, per 100 g.
Fibre
SOURCE OF FIBRE – A claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, 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 kcal.
HIGH FIBRE – A claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 kcal.
Protein
SOURCE OF PROTEIN – A claim that a food is a source of protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 12 % of the energy value of the food is provided by protein.
HIGH PROTEIN – A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 20 % of the energy value of the food is provided by protein.
HIGH PROTEIN – A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 20 % of the energy value of the food is provided by protein.
Vitamins/Minerals
SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] – A claim that a food is a source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 6 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods .
HIGH [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] – A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least twice the value of ‘source of [NAME OF VITAMIN/S] and/or [NAME OF MINERAL/S]’.
CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE] – A claim that a food contains a nutrient or another substance, for which specific conditions are not laid down in this Regulation, or any claim likely to have the same meaning for the consumer, may only be made where the product complies with all the applicable provisions of this Regulation, and in particular Article 5. For vitamins and minerals the conditions of the claim ‘source of’ shall apply.
Nutrients
INCREASED [NAME OF THE NUTRIENT] – A claim stating that the content in one or more nutrients, other than vitamins and minerals, has been increased, and any claim likely to have the same meaning for the consumer, may only be made where the product meets the conditions for the claim ‘source of’ and the increase in content is at least 30 % compared to a similar product.
REDUCED [NAME OF THE NUTRIENT] – A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar product, except for micronutrients, where a 10 % difference in the reference values as set in Directive 90/496/EEC shall be acceptable, and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable.
Omega 3
SOURCE OF OMEGA-3 FATTY ACIDS – A claim that a food is a source of omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 0,3g alpha-linolenic acid per 100g and per 100kcal, or at least 40mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and per 100kcal.
HIGH OMEGA-3 FATTY ACIDS – A claim that a food is high in omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 0,6g alpha-linolenic acid per 100g and per 100kcal, or at least 80mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and per 100kcal.
Mono/Poly/Unsaturated Fat
HIGH MONOUNSATURATED FAT – A claim that a food is high in monounsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 20% of energy of the product.
HIGH POLYUNSATURATED FAT – A claim that a food is high in polyunsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 20% of energy of the product.
HIGH UNSATURATED FAT – A claim that a food is high in unsaturated fat, and any claim likely to have the same meaning for the consumer may only be made where at least 70% of the fatty acids present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product.
Various
LIGHT/LITE – A claim stating that a product is ‘light’ or ‘lite’, and any claim likely to have the same meaning for the consumer, shall follow the same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food ‘light’ or ‘lite’.
NATURALLY/NATURAL – Where a food naturally meets the condition(s) laid down in this Annex for the use of a nutritional claim, the term ‘naturally/natural’ may be used as a prefix to the claim.
Health claims
Here below are some examples of claims and necessary conditions to meet in order to use health claims:
Winners-some of the authorised claims
Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children (information to the consumer that the beneficial effect is obtained with a consumption of 2-3g of chewing gum sweetened with 100% xylitol at least 3 times per day after the meals).
Calcium is needed for the maintenance of normal bones/teeth (the claim may be used only for food which is at least a source of calcium 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.);
Creatine increases physical performance in successive bursts of short-term, high intensity exercise. (The claim may be used only for food which provides a daily intake of 3 g of creatine. In order to bear he claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of creatine.The claim may be used only for foods targeting adults performing high intensity exercise);
Lactase enzyme – Lactase enzyme improves lactose digestion in individuals who have difficulty digesting lactose – (The claim may be used only for food supplements, with a minimum dose of 4500 FCC (Food Chemicals Codex) units with instructions to the target population to consume with each lactose containing meal Information shall also be given to the target population that tolerance to lactose is variable and they should seek advice as to the role of this substance in their diet.);
Water – Water contributes to the maintenance of normal regulation of the body’s temperature – (In order to bear the claim, information shall be given to the consumer that in order to obtain the claimed effect, at least 2,0 L of water, from all sources, should be consumed per day. The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC).
Water-Soluble Tomato Concentrate (WSTC) I and II – Water-Soluble Tomato Concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow – (Information to the consumer that the beneficial effect is obtained with a daily consumption of 3g WSTC I or 150 mg WSTC II in up to 250 ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid.)
Losers-some of the prohibited claims
Dietary fibre – Fibre helps to reduce fat absorption.
Fruit-rich diet – A diet rich in fruits can help to control body weight. – (Non-compliance with the Regulation because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.).
Mediterranean diet – ‘X’ fits in a Mediterranean diet. A Mediterranean style diet helps maintain heart health.
Sugar-free chewing gum- Beneficial to dental health; – safe for teeth; -promotes healthy teeth and gums; -helps protect teeth and gums; -helps to strengthen teeth and gums.
Probiotic – Bifidobacterium bifidum I-3426 – probiotic -helps to strenghten your body’s natural defences; -helps to strenghten the natural defenses; – helps to stimulate the immune system.
Vegetable-rich diet – A diet rich in vegetables helps control body weight.
Water Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance.
Why this matters:
This is an important step taken by the EU in relation to both nutrition and health claims for foods which affects both the food industry as well as the general public across the 27 EU territories. Food manufacturers using health claims on food labelling and in advertising are expected to comply with these new rules by the end of 2012. Authorities across the EU are expected to take responsibility and enforce such rules.
Will the food industry be ready for such a huge change within this very limited period of time given the pressure that is already experiencing under the current economic difficulties? Will there be an increase in pricing as a result of current not-compliant stocks (unsold by the end of the year) becoming illegal?
Without extending the remit of this article too far and providing that the European Ombudsman investigating the claims assessment process gives the all-clear, it looks like this is the way ahead.
Some useful links:
