Health and Nutritional Claims Regulation 2003/0165

In 2003, the European Commission issued proposals to harmonise the rules on health and nutritional claims. This has been greatly debated and a common position was finally reached on 16 May 2006.

The proposed Regulation aims to give legal certainty 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. As a regulation it will be directly applicable to all Member States after it comes into force.

The Council of Ministers is expected to vote on this Regulation in September. It could then come into force before the year is out and be applied six month afterwards, from around April 2007.

Applicability

The Regulation applies to nutrition and health claims made in commercial communications whether in the labelling, presentation or advertising of foods to be deliveries as such to the final consumer. It shall also apply in respect of foods intended for supply of mass caterers eg restaurants and schools and includes food supplements and natural mineral waters. (There are some derogations for labelling provisions for non-prepackaged foodstuffs such as fruit and vegetables.)

A trademark brand name or fancy name that may be construed as nutrition or health claim may be used without undergoing the authorisation procedure provided that is accompanied by a related nutrition or health claim in that labelling presentation or advertising which complies with the provisions of the Regulation.

Generic descriptors that have been traditionally used for a class of foods which could imply an effect on human health may be authorised on application by the food business operators concerned e.g. cough sweets and digestives.

Prohibited Health & Nutritional Claims

• Claims and information that is not clear, accurate or substantiated will not be permitted.
• Alcohol above 1.2% may not make a health or nutritional claim except in relation to reduced energy or alcohol – There has been debate as to why qualified health claims cannot be made for alcoholic beverages such as red wine that has proven health giving properties in moderation.
• Claims which suggest that health could be affected by not consuming the food.
• Claims which make reference to the rate or amount off weight loss – however slimming and weight control claims are permitted.
• Claims that refer to recommendations of a particular doctor or health professional - but health-related organisations may be referred to, it was understood that for charities in particular this was an important revenue for them.
• Medicinal claims remain prohibited.

Nutritional Claims

These are all included in an annex to the Regulation. This appears to be a clear cut and straight forward addition to the legislation, whilst some may disagree with where the lines have been drawn it looks like it may be genuinely helpful to industry and marketing. However, all is not so easy as Article 4 has survived:

Nutrient Profile - (Article 4)

This states that a nutrition claim can only be used if it fits a certain nutritional profile (i.e. below a certain salt, fat and/or sugar level). These nutritional profiles will be set by Commission and Member States through Comitology procedure, based on the opinion of the European Food Safety Authority (EFSA), within 24 months of the Regulation entering into force.

A slight amendment to Article 4 was agreed between Council and Parliament prior to the vote, whereby a nutrition claim will still be permitted if only one nutrient (e.g. salt, sugar or fat) exceeds the limit of the nutritional profile. However, the high level of this substance must be clearly marked on the label, close to and with the same prominence as the claim. e.g. “rich source of vitamin c high in sugar”. If two substances exceed the limit of the nutritional profile then no claim may be made.

This assessment of individual foods as opposed to diet is contrary to most nutritionalists’ thinking and may therefore reduce the incentive to make food that has high levels of salt, fat and/or sugar healthier.

HEALTH CLAIMS

Article 10 – Health claims will only be permitted if the following information is included.

• A statement indicating the importance of a varied and balanced diet and healthy lifestyle;
• The quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
• Where appropriate, a statement to persons who should avoid the food; and
• Appropriate warnings for products that are likely to present a health risk if consumed to excess.

The last two points would be expected under general food safety requirements in any event.

Health claims, other than those referring to the reduction of disease risk and to children’s development and health will be included on a “register”. This is a list of claims based on accepted scientific evidence and well understood by the “average consumer”. This register of authorised health claims will be compiled 3 years after implementation of the Regulation. This will allow manufacturers who wish to introduce a product with a particular health claim to simply consult the register in order to know the rules to be observed and not to have to go through the authorisation process itself

• This register or list of health claims will include
• The role of a nutrient or other substance in bodily functions;
• Psychological and behavioural functions; or
• Slimming or weight control

which are ‘indicated’ in the list. i.e. the wording is not spelled and so there is some flexibility which is positive for the market.

Disease Risk Reduction and Children’s Development and Health Claims (Article 14)

Disease risk reduction and children’s development and health claims must go through a specific authorisation process (Articles 15-18) for inclusion in a community list.

Reduction of disease risk claims must 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.

Authorisation Process

Any novel health claims, disease risk reduction and children’s health and development claim will have to be examined by the EFSA and approved on a case-by-case basis.

Guidance is to be produced to assist small and medium sized enterprises, but the costs associated with the compilation and submission of a dossier have been estimated as, as much as £100,000 (€147,000) per product, (plus possible fees for EFSA to review it) and this could be prohibitive for SMEs.

Health claims authorised on the basis of proprietary data shall be recorded in a separate annex to the Register. It will be recorded with this approval the fact that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant. This right extends for 5 years unless and until the Commission takes a decision on whether a claim could be or could have been included in the list without the submission of data designated as proprietary.

Timing of Authorisation Process

When a producer lodges an application, EFSA must give its opinion within 5 months. If the Agency demands further information from the applicant in relation to a disease risk reduction or children’s health and development claim, a further 2 months is allowed. If further information is requested in relation to a novel health or proprietary this information must be provided within 15 days and a further 1 month may be added to the process.

There is 30 days for comments to the Commission from both parties and the public after publication of the EFSA’s opinion.

If the EFSA opinion on the claim is positive, the Commission will take a decision on whether or not to authorise it after simple consultation of Members States within 2 months. However, if EFSA gives a negative Opinion, the standard Comitology procedure will be used to decide whether or not to authorise the claim i.e. Member State experts will vote on a Commission proposal in the Standing Committee on the Food Chain and Animal Health. There is no time limit for this (however if action is to be taken by qualified majority this must be done within 3 months from the date of referral.)

Transitional Periods

• Nutritional Content - 2 years if on market 1 January 2006
• Health Claim - 3 years if on market 1 January 2006
• Trade Mark - 15 years (previously 10 years) but only if on market 1 January 2005
• Nutrient Profiling - 24 months from implementation
• Data Protection - 5 years - unless EFSA decides it is a generic claim.

ANNEX TO REGULATION - Nutrition claims and conditions applying to them

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 40kcal (170kJ)/100g for solids or more than 20kcal (80kJ)/100ml for liquids. For table-top sweeteners the limit of 4kcal (17kJ)/portion, with equivalent sweetening properties to 6g 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 4kcal (17kJ)/100ml. For table-top sweeteners the limit of 0,4kcal (1,7kJ)/portion, with equivalent sweetening properties to 6g of sucrose (approximately 1 teaspoon of sucrose), applies.

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 3g of fat per 100g for solids or 1,5g of fat per 100ml for liquids (1,8g of fat per 100ml 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 0,5g of fat per 100g or 100ml. 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 1,5g per100g for solids or 0,75g/100ml 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 0,1g of saturated fat per 100g or 100ml.

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 5g of sugars per 100g for solids or 2,5g of sugars per 100ml 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 0,5g of sugars per 100g or 100ml.

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".

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 0,12g of sodium, or the equivalent value for salt, per 100g or per 100ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should not exceed 2mg of sodium per 100ml.

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 0,04g of sodium, or the equivalent value for salt, per 100g 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 0,005g of sodium, or the equivalent value for salt, per 100g.

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 3g of fibre per 100g or at least 1,5g of fibre per 100kcal.

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 6g of fibre per 100g or at least 3g of fibre per 100kcal.

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.

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 7 of Regulation (EC) No .../... of the European Parliament and of the Council of ... 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.

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.

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.