This is a chapter from the Bloomsbury Professional book Food Law, 3rd Edition, which takes account of significant changes in food and feed law and procedure made since 2000 pursuant to the European Commission White Paper on Food Safety. It examines the work of the Food Standards Agency and developments of wider relevance, such as the Human Rights legislation and the establishment of the Department for Environment, Food and Rural Affairs. Written in a straightforward and easy-to-use style, the 3rd edition of this practical book provides quick and easy access to the legislation that affects practitioners on a daily basis.
This chapter, the index and the table of contents are FREE to view, as a sample of the book's contents. To view the other chapters, please subscribe to Books online.
Table of Contents
11.1.1 This chapter deals with the related topics of food claims and nutrition. They overlap but are not co-extensive. Claims are made about matters other than nutrition. Nutritional legislation includes rules about the composition of food irrespective of how it is labelled.
In recent years Community legislation to protect consumers from misleading claims and unsafe health foods has developed considerably to supplement the long-established national safeguards in the Food Labelling Regulations 1996 and the Food Safety Act 1990. The original Council Directive 77/94/EEC which established a framework for the approximation of Member States' laws in relation to food claimed to be suitable for particular nutritional uses was replaced by Council Directive 89/398/EEC, which has been amended many times. As a result the Commission has begun the process of recasting Directive 89/398/EC to codify the text.[1] Directive 2002/46/EC has set down rules governing the production and marketing of food supplements and Regulation (EC) 1925/2006 has laid down rules on the addition of vitamins and minerals. The most important development has been Regulation (EC) 1924/2006 on nutrition and health claims. This has made provision for long awaited[2] rules to complement not only the prohibition in Art 2(1) of labelling Directive 2000/13/EC (on the use of information that could mislead the purchaser or attribute medicinal properties to food), but also now the more general prohibition in Art 16 of Regulation (EC) 178/2002 on labelling or other presentation that may mislead consumers).[3] Moreover, the Regulation has applied to health claims the requirement in Council Directive 90/496/EEC that makes nutritional labelling compulsory where nutrition claims appear on food.
The White Paper on a Strategy for Europe on Nutrition, Overweight and Obesity related health issues [4] stressed the importance of consumers having access to clear, consistent and evidence-based information. It was agreed that the effectiveness of nutrition labelling could be strengthened as a means to support the ability of consumers to choose a balanced diet, as it is an effective means of providing information to support health conscious food choices. The Commission is therefore proposing a Regulation of the European Parliament and of the Council on the provision of food information to consumers. The intention is to modernise, simplify and clarify the existing food labelling legislation. If it becomes law, the legislation will combine into one instrument Directive 2000/13/EC (described in ch 9) and Directive 90/496/EC (described in sections 11.4 and 11.5) and result in major changes in this area.[5]
This chapter considers:
(a) nutrition and health claims, in section 11.2;
(b) claims controlled by the Food Labelling Regulations, in section 11.3;
(c) prescribed nutrition labelling, in section 11.4;
(d) requirements for nutrition labelling given voluntarily, in section 11.5;
(e) other claims, in section 11.6;
(f) foodstuffs for particular nutritional uses, in section 11.7;
(g) food supplements, in section 11.8; and
(h) addition of vitamins and minerals, in section 11.9.
11.2.1 Food producers are often keen to make claims about the health and nutritional benefits of the food they produce. The difficulty for the consumers is to know what claims to believe. Directive 2000/13/EC prohibits any health claim relating to human diseases (see below at para 11.3.1) but this still leaves room for a variety of claims. Countries within the EU took different approaches to the consequent need to regulate health claims. In the United Kingdom, an exhortatory approach was adopted, with advice being given on good practice in complying with existing legislation in the FSA 1990, s 15 (see section 8.3 above) and the Food Labelling Regulations 1996, reg 40 and Sch 6 (see section 11.3 below). On the basis of a 1990 Food Advisory Committee report, guidelines on the most common nutritional claims were issued in 1999 by the Food Standards Agency. In addition, a group representing the interests of consumers, industry and enforcement officers[6] established a code of practice and agreed standards for a number of generic health claims about specific foods and blood cholesterol or heart health.
Recognising that existing discrepancies can 'act as a barrier to guaranteeing a high level of consumer public health protection, and can constitute obstacles to the free movement of foods and the proper functioning of the internal market' the Commission proposed a Regulation on Nutrition and Health Claims Made on Food.[7] There was also a desire to bring EC law in line with Codex Alimentarius guidance on claims[8]and ease trade outside the Union. As a result, Regulation (EC) 1924/2006, as amended, now regulates this area.[9] The Regulations came into force on 1 July 2007 but the transitional measures mean that there is a considerable lead in time for compliance by a number of pre-existing foods, products and claims.
Regulation (EC) 1924/2006 does not affect Directive 89/398/EC on foodstuffs for particular nutritional uses that remains in force (see below at para 11.7.1). The Regulation is executed and enforced by the Nutrition and Health Claims (England) Regulations 2007.
11.2.2 A 'claim' is defined as 'any message or representation that is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that food has a particular characteristic.' A 'nutrition claim' is 'any claim which states, suggest or implies that a food has particular beneficial nutritional properties due to: (a) the energy (calorific value) it (i) provides; (ii) provides at a reduced or increased rate; or (iii) does not provide; and/or (b) the nutrients or other substances it (i) contains; (ii) contains in reduced or increased proportions; or (iii) does not contain. As examples, the FSA Guidance, offers 'source of calcium', 'low fat', 'high fibre' and 'reduced salt'. A 'health claim' is defined as 'any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.' The FSA Guidance suggests that this would include 'calcium helps build strong bones' and that more general claims such as 'good for you' may also be health claims.
11.2.3 Title II of Regulation (EC) 1924/2004 prescribes general principles and conditions for the use of nutrition and health claims. Claims must not be false, ambiguous or misleading and must not encourage or condone excess consumption of a food. Suggestions that imply that a balanced diet cannot provide the necessary nutrients are not permitted. Where a health claim is made, nutrition labelling is obligatory as it is, under Directive 90/496, when a nutrition claim is made (see para 11.3.1 and section 11.4 below).
Subject to exemptions, food must also in particular comply with specific nutrient profiles in order to bear nutrition or health claims. The Commission is required to establish these profiles and related conditions by 19 January 2009.
11.2.4 The nutrition claims that can be made are restricted to those set out in the Annex in respect of which the product meets with the specific conditions of use. For example, 'sugars-free' can only be made where the product contains no more than 0.5g of sugars per 100g or 100 ml. The full list of authorised claims is Low Energy; Energy-reduced; Energy-Free; Low Fat, Fat-Free; Low Saturated Fat; Saturated Fat-Free; Low Sugars; Sugars-Free; With no added sugars; Low Sodium/Salt; Very Low Sodium/Salt; Sodium-Free or Salt-Free; Source of Fibre; High Fibre; Source of Protein; High Protein; Source of [Name of Vitamin/s] and/or [Name of Mineral/s]; High [Name of Vitamin/s] and/or [Name of Mineral/s]; Contains [Name of the Nutrient or other substance]; Increased [Name of the Nutrient]; Reduced [Name of the Nutrient]; Light/Lite; Naturally/Natural.
11.2.5 Health claims cannot be made that: (a) suggest that health could be affected by not consuming the food; (b) refer to the rate or amount of weight loss; or (c) make reference to recommendations of individual doctors or health professionals. Any health claim must be authorised and included in the list of authorised health claims. By 31 January 2008, a list of claims, with the relevant scientific justifications and conditions applying to them, had to be submitted by each Member State to the European Commission who, on the advice of the European Food Safety Authority (EFSA), must, by 31 January 2010 at the latest, adopt the Community list of permitted claims and conditions for their use.[10] A procedure for changes to the list is prescribed. Special provision is made in respect of applications for the listing of claims that refer to the reduction in the risk of disease[11] or to children's development and health and of claims based on new or emerging science.
11.2.6 The Commission is obliged to establish a publicly available Community Register of nutrition and health claims showing details of rejected claims, as well as the conditions and restrictions applying to authorised ones.
11.3.1 Until the enactment of Regulation (EC) 1924/2006, the core provisions of British law on claims in respect of food were in the Food Labelling Regulations 1996, regs 40 and 41, read with Schs 6 and 7. It is vital to bear in mind that, since 1 July 2007, any product put on the market must comply with the requirements of Regulation (EC) 1924/2006 unless it has the benefit of a transitional measure in Art 28. In particular, nutrition claims used before 1 January 2006 may, although not listed in the Annex of authorised claims, continue in use until 19 January 2010, subject to the provisions of the Food Labelling Regulations 1996 and the Food Safety Act 1990. The FSA Guidance on Regulation (EC) 1924/2006 provides comprehensive assistance on the transitional periods and their relationship with the 1996 Regulations.
Given that during the transitional periods the national legislation will remain in place, this section continues to explain the restrictions that they impose on the making of specific claims, while endeavouring, where appropriate, to direct the reader to Directive 1924/2006. As will be observed, of particular importance to these national provisions are the conditions imposed in respect of each 'nutrition claim'. This term is defined in the Regulations as meaning 'any statement, suggestion or implication in any labelling, presentation or advertising of a food that that food has particular nutritional properties, but does not include a reference to any quality or quantity of any nutrient where such reference is required by law'. In implementation of Art 2(2) of Council Directive 90/496/EEC (on the nutrition labelling of food), the Regulations require nutrition labelling to be given when a nutrition claim is made. As will be seen below, this is achieved in relation to the various nutrition claims, by requiring the food in question to be marked or labelled with the 'prescribed nutrition labelling'. The detailed provisions imported by the use of this term are explained later in section 11.4.
It should be noted that the requirements summarised in section 11.3 are subject to qualifications set out in reg 41(1)–(3) of the Food Labelling Regulations 1996. Thus, nothing in the provisions as to claims should be taken to prevent the dissemination of useful information or recommendations intended exclusively for persons having qualifications in dentistry, medicine, nutrition, dietetics or pharmacy[12]. In implementation of Art 6(2) of Directive 89/398/EEC, this provision is an exception to the prohibition on claims that a food has the property of preventing, treating or curing a human disease noted in para 11.3.2 below. Moreover, a reference to a substance in a list of ingredients or in any nutrition labelling does not of itself constitute a claim of a type considered below[13].
Finally, any condition that a food shall be labelled with the prescribed nutrition labelling shall not apply in the case of:
(a) a food (other than sold from a vending machine) which is not prepacked and that is sold to the ultimate consumer at a catering establishment, or
(b) a claim contained within generic advertising.
For food described at (a), elements of the prescribed nutrition labelling may nevertheless be given subject, mutatis mutandis, to compliance with relevant provisions described in section 11.4[14].
Also, reg 41(5) makes it clear that the regulations cannot prohibit or restrict a claim made in accordance with the conditions of Regulation (EC) 1924/2006 on nutrition and health claims made on foods (see above and para 11.2).
By virtue of reg 3(4) and (5) of the Food Labelling Regulations 1996, of the claims provisions described in sections 11.3 and 11.4, only those described in para 11.3.4 apply to natural mineral water (other than such water that has been artificially carbonated).
11.3.2 The Regulations wholly forbid the making, either expressly or by implication, of two kinds of claims in the labelling or advertising of food. The first of these is any claim that a food has tonic properties. However, the use of the word 'tonic' in the description 'Indian tonic water' or 'quinine tonic water' does not of itself constitute such a claim.
Secondly, in implementation of Art 2(1)(b) of the general food labelling Directive 2000/13/EC and Art 6(1) of the particular nutritional uses Directive 89/398/EEC, a claim that a food has the property of preventing, treating or curing a human disease or any reference to such a property is prohibited[16]. An exception is noted in para 11.3.1 above and the provision is subject to Directive 1924/2006 which, as explained in para 11.2.5 above, allows for the possibility of listing claims which refer to the reduction in the risk of disease.
11.3.3 A claim of a type described in paras 11.3.4–11.3.11 below shall not be made, either expressly or by implication, in the labelling or advertising of a food except in accordance with the stated appropriate conditions. Where a claim of two or more of these types is made, the conditions appropriate to each must be observed.
11.3.4 In implementation of Council Directive 89/398/EEC[18], claims that a food is suitable, or has been specially made for a particular nutritional purpose are subject to the conditions set out below. 'Particular nutritional purpose' is defined as the fulfilment of the particular nutritional requirements of:
(a) a person whose digestive processes are, or whose metabolism is disturbed, or
(b) a person whose physiological condition renders him able to obtain a special benefit from the controlled consumption of any substance in food, or
(c) infants or young children[19] in good health.
1. The food must be capable of fulfilling the claim.
2. The food must be marked or labelled with an indication of the particular aspects of its composition or manufacturing process that give the food its particular nutritional characteristics.
3. The food:
(a) must be marked or labelled with the prescribed nutrition labelling[20] and may be marked or labelled with further information in respect of either or both of:
(i) any nutrient or component of a nutrient (whether or not a claim is made in respect of such nutrient or component), or
(ii) any other component or characteristic which is essential to the food's suitability for its particular nutritional use, and
(b) when sold to the ultimate consumer, must be prepacked and completely enclosed by its packaging.
11.3.5 Although the Food Labelling Regulations 1996 still contain the provisions described here, it appears that the conditions prescribed by Regulation (EC) 1924/2006 in respect of 'Low energy' and 'Energy- reduced' claims now apply.
Claims that a food has a reduced or low energy value are, under the Food Labelling Regulations 1996, subject to the conditions set out below. There are two qualifications to this. First, the appearance of the words 'low calorie' on a container of soft drink in accordance with the conditions in Sch 11 to the Food Labelling Regulations 1996[21] does not of itself constitute a claim. Secondly, where a food is in concentrated or dehydrated form and is intended to be reconstituted by the addition of water or other substances, condition 2 below applies to the food when reconstituted as directed.
1. If the claim is that the food has a reduced energy value, the energy value of a given weight of the food, or of a given volume in the case of a liquid food, must not be more than three quarters of that of the equivalent weight, or volume, of a similar food in relation to which no such claim is made, unless the food is:
(a) an intense sweetener, or
(b) a product which consists of a mixture of an intense sweetener with other substances and which, when compared on a weight for weight basis, is significantly sweeter than sucrose.
2. If the claim is that the food has a low energy value:
(a) the energy value of the food must not be more than 167 kJ (40 kcal) per 100 g or 100 ml, as appropriate, unless the food is:
(i) an intense sweetener, or
(ii) a product which consists of a mixture of an intense sweetener with other substances and which, when compared on a weight for weight basis, is significantly sweeter than sucrose,
(b) the energy value of a normal serving of the food must not be more than 167 kJ (40 kcal), and
(c) in the case of an uncooked food which naturally has a low energy value, the claim must be in the form 'a low energy food' or 'a low calorie food' or 'a low joule food'.
3. The food must be marked or labelled with the prescribed nutritional labelling[22].
11.3.6 Although the Food Labelling Regulations 1996 still contain the provisions described here, it appears that the conditions prescribed by Regulation (EC) 1924/2006 in respect of 'Source of protein' and 'High protein' claims now apply.
Under the Food Labelling Regulations 1996, claims that a food, other than a food intended for babies or young children[23] which satisfy the conditions of the item described in para 11.3.4 above, is a source of protein are subject to the conditions set out below.
1. The quantity of the food that can reasonably be expected to be consumed in one day must contribute at least 12 g of protein.
2.
(1) If the claim is that the food is a rich or excellent source of protein, at least 20% of the energy value of the food must be provided by protein.
(2) In any other case at least 12% of the energy value of the food must be provided by protein.
3. The food must be marked or labelled with the prescribed nutritional labelling[24].
11.3.7 It appears that the conditions prescribed by Regulation (EC) 1924/2006 in respect of 'Source of vitamins' and 'High in vitamins' claims now apply, except as regards a generic claim 'contains vitamins'. In that case, if the claim was in use before 1 January 2006 it may, by virtue of the transitional provision in Art 28(3), continue to be used until 19 January 2010 subject to the conditions prescribed by the Food Labelling Regulations 1996.
Under the Food Labelling Regulations 1996, claims that a food other than a food intended for babies or young children[25] which satisfies the conditions of the item described in para 11.3.4 above, is a source of vitamins are subject to the conditions set out below. Table A referred to in this paragraph is in para 11.3.12.
A reference to a vitamin in the name of a food does not of itself constitute a claim of a type to which this item applies if the food consists solely of:
(i) vitamins, or
(ii) a mixture of vitamins and minerals, or
(iii) a mixture of vitamins, or vitamins and minerals, and a carrying agent, or
(iv) a mixture of vitamins, or of vitamins and minerals, and other substances sold in tablet, capsule or elixir form.
1.
(1) If the claim is not confined to named vitamins, every vitamin named in the claim must be a vitamin specified in column 1 of Table A below, and:
(a) where the claim is that the food is a rich or excellent source of vitamins, the quantity of the food that can reasonably be expected to be consumed in one day must contain at least one half of the recommended daily allowance of two or more of the vitamins specified in column 1 of Table A below, and
(b) in any other case, the quantity of the food that can reasonably be expected to be consumed in one day must contain at least one sixth of the recommended daily allowance of two or more of the vitamins specified in column 1 of Table A below.
(2) If the claim is confined to named vitamins, every vitamin named in the claim must be a vitamin specified in column 1 of Table A below, and:
(a) where the claim is that the food is a rich or excellent source of vitamins, the quantity of the food that can reasonably be expected to be consumed in one day must contain at least one half of the recommended daily allowance of every vitamin named in the claim, and
(b) in any other case, the quantity of the food that can reasonably be expected to be consumed in one day must contain at least one sixth of the recommended daily allowance of every vitamin named in the claim.
2. The food must be marked or labelled:
(a) in the case of a food to which nutrition labelling[26] relates:
(i) where the claim is in respect of unnamed vitamins (whether alone or together with named vitamins), then in respect of any of those unnamed vitamins that are listed in Table A, with the prescribed nutrition labelling[27] and, in addition, with a statement of the percentage of the recommended daily allowance for such vitamins as are contained in either a quantified serving of the food or, provided that the total number of portions contained in the sales unit of the food is stated, in one such portion of the food, and
(ii) where the claim is in respect of a named vitamin or of named vitamins (whether alone or together with unnamed vitamins), then in respect of that named vitamin or those named vitamins, with the prescribed nutrition labelling[28] and, in addition, with a statement of the percentage of the recommended daily allowance for such vitamins as are contained in either a quantified serving of the food or, provided that the total number of portions contained in the sales unit of the food is stated, in one such portion of the food, and
(b) in the case of food supplements or waters other than natural mineral waters, in respect of any vitamins, whether unnamed, named or both:
(i) with a statement of the percentage of the recommended daily allowance of those vitamins contained in either a quantified serving of the food or (provided that the food is prepacked) a portion of the food, and
(ii) where the food is prepacked, of the number of portions contained in the package,
and the name used in any such marking or labelling for any such vitamin shall be the name specified for that vitamin in column 1 of Table A in para 11.3.12.
11.3.8 It appears that the conditions prescribed by Regulation (EC) 1924/2006 in respect of 'Source of minerals' and 'High in minerals' claims now apply, except as regards a generic claim 'contains minerals'. In that case, if the claim was in use before 1 January 2006 it may, by virtue of the transitional provision in Art 28(3), continue to be used until 19 January 2010 subject to the conditions prescribed by the Food Labelling Regulations 1996.
Under the Food Labelling Regulations 1996, claims that a food other than a food intended for babies or young children[29] which satisfies the conditions of the item described in para 11.3.4 above, is a source of minerals are subject to the conditions specified below.
A claim that a food has a low or reduced level of minerals shall not be regarded as a claim of a type described in this item.
The note on the item summarised in para 11.3.7 above applies equally to this item with the substitution of the word 'mineral(s)' for 'vitamin(s)' and vice versa as appropriate. Table B referred to in this paragraph is in para 11.3.12.
The conditions are the same as those set out in the item described in para 11.3.7 above with appropriate substitution of the word 'mineral' for 'vitamin' and 'Table B' for 'Table A'.
11.3.9 It appears that Regulation (EC) 1924/2006 now applies so that use of this claim on the market before 1 January 2006 has the benefit of the transitional provision in Art 28(3) and may continue until 19 January 2010 subject to the conditions prescribed by the Food Labelling Regulations 1996.
Under the Food Labelling Regulations 1996, claims relating to the presence or absence of cholesterol[30] in a food are subject to the conditions set out below.
1. Subject to condition 3, the food must contain no more than 0.005% of cholesterol.
2. The claim must not be accompanied by a suggestion, whether express or implied, that the food is beneficial to human health because of its level of cholesterol.
3. If the claim relates to the removal of cholesterol from, or its reduction in, the food and condition 1 is not met, such claims shall only be made:
(a) as part of an indication of the true nature of the food,
(b) as part of an indication of the treatment of the food,
(c) within the list of ingredients, or
(d) as a footnote in respect of a prescribed nutrition labelling[31].
4. The food must be marked or labelled with the prescribed nutritional labelling[32].
11.3.10 Nutrition claims not dealt with under any of the items described in paras 11.3.4–11.3.9 above are subject to the conditions specified below.
1. The food must be capable of fulfilling the claim.
2. The food must be marked or labelled with the prescribed nutritional labelling[33].
11.3.11 By Art 5(3) of Regulation (EC) 1924/2006, nutrition and health claims must refer to the food ready for consumption in accordance with the manufacturer's instructions. This takes precedence over the Food Labelling Regulations 1996, but a claim of this kind used on the market before 1 January 2006 has the benefit of the transitional provision in Art 28(3) and may continue in use until 19 January 2010 subject to the conditions prescribed by the Food Labelling Regulations 1996.
These provide that, in the case of claims that a food has a particular value or conveys a particular benefit, the value or benefit must not be derived wholly or partly from another food that is intended to be consumed with the food in relation to which the claim is made.
11.3.12 The tables referred to in paras 11.3.7 and 11.3.8 above in relation to vitamins and minerals respectively are as follows:
Vitamin |
Recommended daily allowance |
Vitamin A |
1100 micro g |
Vitamin D |
5 micro g |
Vitamin E |
10 mg |
Vitamin C |
60 mg |
Thiamin |
1.4 mg |
Riboflavin |
0.16 mg |
Niacin |
111 mg |
Vitamin B6 |
2 mg |
Folacin |
200 micro g |
Vitamin B12 |
1 micro g |
Biotin |
0.15 mg |
Pantothenic acid |
6 mg |
Mineral |
Recommended daily allowance |
Calcium |
1100 mg |
Phosphorus |
1100 mg |
Iron |
14 mg |
Magnesium |
300 mg |
Zinc |
15 mg |
Iodine |
150 micro g |
Note: As a rule, a significant amount means 15% of the recommended daily allowance listed in respect of each vitamin and mineral specified in Table A and B above that is supplied by 100 g or 100 ml of a food, or per package of a food if the package contains only a single portion.
11.4.1 As noted in section 11.3, the Community requirement that nutrition labelling must be given where a nutrition claim appears is imposed by the condition that the food must be marked or labelled with the 'prescribed nutritional labelling'. Parts I and II of Sch 7 to the Food Labelling Regulations 1996 respectively set out the requirements for the presentation and the contents of prescribed nutritional labelling[34]. These provisions are summarised below.
It should be noted that Art 2(2) of nutrition labelling Directive 90/496, which these provisions implement, is applied directly by Art 7 of Regulation (EC) 1924/2006 so that nutrition labelling is required where a health claim is made, as well as where a nutrition claim is made (see para 11.2.3).
11.4.2 For the purposes of explanation, it will be clearer to deal first with the contents of prescribed nutritional labelling.
Subject to exceptions mentioned below for non-prepacked foods, prescribed nutrition labelling must consist of one of the two following groups of information:
(a) by the first alternative called 'group 1' by Directive 90/496/EEC, the information given must be the energy and the amounts of protein, carbohydrate and fat;
(b) by the second alternative called 'group 2' by Directive 90/496/EEC, the information given must be the energy and the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium.
Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information given must be in accordance with (b).
The amounts of any polyols, starch, mono-unsaturates, polyunsaturates, cholesterol and, if present in significant amounts, minerals or vitamins may also be included in the nutrition labelling and must be included where such is the subject of a nutrition claim. As a rule, 'a significant amount', in relation to vitamins or minerals, means 15% of the recommended daily allowance listed in respect of each vitamin or mineral specified in Table A or B in para 11.3.12 that is supplied by 100 g or 100 ml of a food, or per package of a food if the package contains only a single portion.
Where the amount of any mono-unsaturates, polyunsaturates or cholesterol is given with labelling in accordance with (a) above, the amount of saturates must also be included.
Where such is the subject of a nutrition claim, the prescribed nutrition labelling must also include the name and amount of any substance that belongs to, or is a component of, one of the nutrients already required or permitted to be included. As examples of components, the MAFF Guidance notes give fructose as a component of sugars and trans fatty acids as a component of fat.
In exercise of the derogation in Art 11 of Directive 90/496/EEC, the prescribed nutritional labelling that must be borne by non-prepacked food sold to ultimate consumers, other than at catering establishments, from vending machines and to catering establishments, is restricted to information about any nutrition claim, but information may be given voluntarily for any or all of the energy or nutrients listed in the Regulations.
11.4.3 The rules on the presentation of prescribed nutrition labelling are in Part I of Sch 7 to the Food Labelling Regulations 1996. Subject to the further provisions below, the order and manner of prescribed nutrition labelling must, where appropriate, be as follows:
energy value |
[x] kJ and [x] kcal |
||
protein |
[x] g |
||
carbohydrate |
[x] g |
||
of which: |
|||
—sugars |
[x] g |
||
—polyols |
[x] g |
||
—starch |
[x] g |
||
fat |
[x] g |
||
of which: |
|||
—saturates |
[x] g |
||
—mono-unsaturates |
[x] g |
||
—polyunsaturates |
[x] g |
||
—cholesterol |
[x] mg |
||
fibre |
[x] g |
||
sodium |
[x] g |
||
[vitamins] |
[x units] |
||
[minerals] |
[x units]. |
If there is also an obligation to give the name and amount of any substance that belongs to, or is a component of, an item already given, the substance or component must be listed immediately after the item to which it relates, thus:
[item] |
[x] g or mg |
||
of which: |
|||
— [substance or component] |
[x] g or mg. |
For [vitamins] and [minerals] there shall be substituted, as appropriate, the names of any vitamin or mineral listed in Table A or B listed in para 11.3.12 above.For [item] there shall be substituted the name of the relevant item [from the above list].
For [substance or component] there shall be substituted the name of the substance or component.
For [x ] there shall be substituted the appropriate amount in each case and, in respect of vitamins and minerals, such amounts:
(i) shall be expressed in the units of measurement specified in relation to the respective vitamins and minerals given in Table A or B listed in para 11.3.12 above, and
(ii) shall also be expressed as a percentage of the recommended daily allowance specified for such vitamins and minerals in those Tables.
In implementation of Art 6 of Directive 90/496/EEC, all amounts are required to be given per 100 g or 100 ml, as appropriate. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated. The amounts shall be as contained in the food sold to the ultimate consumer or to a catering establishment, or they may (if expressly said to be so) be such amounts as are contained in the food after the completion of such preparation in accordance with detailed instructions given for the preparation for consumption of the food.
The amounts shall be averages based, either alone or in any combination, on:
(i) the manufacturer's analysis of the food;
(ii) a calculation from the known or actual values of the ingredients used;
(iii) a calculation from generally established and accepted data,
and 'averages' means the figures which best represent the respective amounts of the nutrients that a given food contains, there having been taken into account seasonal variability, patterns of consumption and any other factor which may cause the actual amount to vary.
In implementation of Art 5 of Directive 90/496/EEC, the following conversion factors are required to be used for the purposes of calculating the energy value:
1 g of carbohydrate (excluding polyols) shall be deemed to contribute 17 kJ (4 kcal)
1 g of polyols shall be deemed to contribute 10 kJ (2.4 kcal)
1 g of protein shall be deemed to contribute 17 kJ (4 kcal)
1 g of fat shall be deemed to contribute 37 kJ (9 kcal)
1 g of ethanol shall be deemed to contribute 29 kJ (7 kcal)
1 g of organic acid shall be deemed to contribute 13 kJ (3 kcal)
1 gram of salatrims shall be deemed to contribute to 25kJ (6 kcal).
In implementation of Art 7 of Directive 90/496/EEC, any prescribed nutrition labelling is required to be printed together in one conspicuous place:
(a) in tabular form, with any numbers aligned, or
(b) if there is insufficient space to permit tabular listing, in linear form.
11.5.1 Paragraph 11.1.2 referred to the Community requirement that nutrition labelling, if given, must be given in accordance with specified rules. This requirement is to be found in Arts 2(1) and 4 of the nutrition labelling Directive 90/496/EEC and is implemented in Great Britain by reg 41(4) of and Sch 7 to the Food Labelling Regulations 1996.
As defined by the Food Labelling Regulations 1996, 'nutrition labelling', in relation to a food (other than a natural mineral water or other water intended for human consumption or any food supplement), means any information appearing on labelling (other than where it appears solely as part of a list of ingredients) and relating to energy value or any nutrient or to energy value and any nutrient, including any information relating to any substance which belongs to, or is a component of, a nutrient.
Where food is labelled voluntarily with nutrition labelling, the requirements for prescribed nutrition labelling[35] apply except in two express particulars. These are the requirements that[36]:
(a) the Group 2 information must be given where a nutrition claim is made for sugars, saturates, fibre or sodium; and
(b) the labelling must include the name and amount of any substance that belongs to, or is a component of, one of the nutrients required or permitted to be included, where such is the subject of a nutrition claim.
11.6.1 In addition to legislative requirements regarding claims in Regulation (EC) 1924/2006 and the Food Labelling Regulations 1996, mention should be made of certain non-statutory material that can constitute a guide to good practice and might be relevant in proceedings, for example, under s 15 of the FSA 1990[37].
Useful sources are to be found in guidance notes prepared by the Food Standards Agency and standards drawn up by the Codex Alimentarius Commission[38]. The work of the Codex Alimentarius Commission continues to contribute to the development of international food standards, not least in relation to labelling and nutrition claims.
This section considers non-statutory material on:
(a) claims that food is 'fresh', 'pure', natural' etc;
(b) claims about 'vegetarian' and 'vegan' food;
(c) claims concerning food assurance schemes.
11.6.2 The Food Standards Agency, following research, issued revised guidance in July 2008 on the 'Criteria for the use of the terms fresh, pure, natural, etc in food labelling.' The guidelines do not have the force of law .
The guidance gives revised definitions for the following marketing terms: 'original', 'traditional', 'authentic', 'real', 'fresh', 'pure', 'natural'[39] and 'farmhouse'. The original recommendations for the term 'homemade' have been maintained and guidance has also been added for the following terms: 'farmhouse (pâté)', 'hand-made', 'selected', 'quality', 'premium', 'finest', 'best', 'seasonal' 'style', 'wild' and 'type'.
The aim of the guidance is to help manufacturers, producers, retailers and caterers decide when to use such descriptions; to assist enforcement authorities to provide consistent advice about labelling; and to help consumers. The Food Standards Agency believes that by encouraging consistent and transparent labelling practices, consumers are better able to make an informed choice about the products they purchase.
In terms of general best practice, the guidance recommends that before any term is used the following points should be considered and applied where possible:
(a) foods should be sold without deceit and therefore should be labelled and advertised so as to enable a prospective purchaser to make a fair and informed choice, based on clear and informative labelling;
(b) a food must be able to fulfil the claim being made for it and therefore adequate information must be available to show that the claim is justified;
(c) where the use of the marketing term is potentially ambiguous or imprecise, the likely understanding of the 'average' consumer is a good benchmark; and
(d) claims should allow fair comparison and competition between products, sectors and traders.
As pictures etc have at least the same potential as words to mislead, the guidance stresses that it is important that as much attention is paid to background illustrations and pictures, as is to the written word. The labelling and presentation of food as a whole should be used in assessing whether a particular label or description is likely to be considered misleading. The guidance considers that it is not appropriate to use any marketing term unless its meaning is clear. Where any qualification or explanation is necessary to understand the meaning of the marketing term this should accompany the term and associated imagery.
11.6.3 There is no legal definition of 'vegetarian or 'vegan' but the Food Standards Agency has produced guidance on the use of these terms in food labelling. The Agency suggests that the term 'vegetarian' should not be applied to foods that are, or are made from, or with, the aid of products derived from animals that have died, have been slaughtered or animals that die as a result of being eaten. The term 'vegan' should not be applied to foods that are, or are made from or with the aid of animals or animal products. Products that use additives such as milk and eggs would be suitable to be labelled 'vegetarian' but not 'vegan'. It is important that the risk of contamination is avoided if the food is to be labelled appropriately.
11.6.4 Food assurance schemes are voluntary systems (with the exception of organic schemes that are regulated by Regulation (EC) 2092/91) which aim to verify that farmers and growers meet certain standards of production. Members of a scheme can use the scheme's logo on their produce and/or use a specific claim to advertise to consumers that the product has been produced to this standard. The Food Standards Agency has produced guidance on these schemes to try and ensure that the standards behind the schemes are communicated to the consumers as transparently as possible. The Agency recommends that minimum standards applied to the participating producers by an assurance scheme should be set by a board with a strong independent element, that producers should be regularly inspected and that clear procedures for dealing with non-compliance should be introduced and effectively implemented. It is considered to be important that consumers are made aware in what ways, if any, the scheme standards exceed the legal minimum.
11.7.1 Council Directive 89/398/EEC, as amended, provides a Community framework for provisions relating to foodstuffs intended for particular nutritional uses, often colloquially designated 'PARNUTS'. These products are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability[40]. As indicated in para 11.3.4[41], a particular nutritional use must fulfil the particular nutritional requirements of persons falling within one of three defined categories. Subject to any changes necessary to meet these criteria, the products must comply with mandatory provisions applicable to foodstuffs for normal consumption[42] as well as bearing the prescribed nutrition labelling.
A few substantive provisions in Directive 89/398/EEC have called for implementation by the Food Labelling Regulations 1996[43]. A key element is Art 4 that confers on the Commission power to draw up specific implementing provisions for six groups of foods for particular nutritional uses[44]. Specific Directives have been enacted for the following groups:
(a) infant formulae and follow-on formulae,
(b) processed cereal-based foods and baby foods for infants and young children,
(c) foods intended for use in energy-restricted diets for weight reduction, and
(d) dietary foods for special medical purposes.
In the context of the implementing Regulations, the requirements of these Directives are respectively summarised in paras 11.7.2–11.7.5 below.
Article 4(2) of Directive 89/398/EEC provides for the establishment of a list of substances that may be used in the manufacture of foods for particular nutritional uses. Lists were included in the specific Directives on infant formulae and follow-on formulae and on processed cereal-based foods and baby foods for infants and young children. The substances authorised for addition to other 'parnuts' foods are listed in Directive 2001/15/EC explained in para 11.7.6.
Additionally, Art 4a of Directive 89/398/EEC provides for the adoption of rules governing the use of terms concerning low-sodium foods and gluten-free foods[45].
For foodstuffs for particular nutritional uses which do not belong to one of the specified groups, Art 9 of Directive 89/398/EEC requires the national competent authority to be notified when a product is first placed on the market. The Notification of Food for Particular Nutritional Uses (England) Regulations 2007 confirm the Food Standards Agency as the competent authority and prohibit the sale of such products if the correct notification has not been given. The 2007 Regulations also enable the FSA, by written declaration, to suspend or restrict trade in specified products intended for a particular nutritional use where it has detailed grounds for establishing that the product does not comply with Art 1(2) of the Directive or endangers human life.
11.7.2 The Infant Formula and Follow-on Formula (England) Regulations 2007, as amended,[46] implement Commission Directive 2006/141/EC (on infant formulae and follow-on formulae), as amended, and Council Directive 92/52/EEC (on infant formulae and follow-on formulae intended for export to third countries) and are intended to ensure stricter controls on the promotion, labelling and compostion of infant formula and follow-on formula.[47]
For the purposes of the Regulations, 'infant formulae' are defined as foodstuffs intended for particular nutritional use by infants during the first few months of life, and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding and 'follow-on formulae' are defined as foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced, and constituting the principal liquid element in a progressively diversified diet of such infants.
The marketing of infant formula or follow-on formula is prohibited unless it complies with specified requirements as to composition, labelling, appearance and packaging. There are strict limits on the maximum levels of pesticides that may be present. Similar compositional restrictions are imposed on exports to third countries. Advertising of infant formula and follow-on formula is restricted and specified promotion of infant formula prohibited, so as not to discourage breastfeeding. Requirements are also laid down about the provision of information and education regarding infant and child feeding.
11.7.3 The Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 2003, as amended, implement Commission Directive 2006/125/EC (on processed cereal-based foods and baby foods for infants and young children), as amended.
For the purposes of the Regulations, 'processed cereal-based foods' are foods for particular nutritional use within specified categories of cereal products fulfilling the particular requirements of infants and young children in good health and intended for use by infants while they are being weaned, and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food and 'baby foods' are other foods for particular nutritional use fulfilling the same particular requirements. The Regulations do not, however, apply to baby food that is milk intended for young children.
The sale of processed cereal-based food and baby food is prohibited unless it is labelled and complies with specified requirements as to manufacture and composition, including restrictions on the addition of nutritional substances and nutrients and maximum limits for pesticide residues.
11.7.4 The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997, as amended, implement Commission Directive 96/8/EEC, as amended (on foods intended for use in energy-restricted diets for weight reduction).
The Regulations control specially formulated food intended for use in energy restricted diets for weight reduction, being food that complies with specified compositional requirements and which, when used as instructed by the manufacturer, replaces:
(a) the whole of the total diet; or
(b) one or more meals of the daily diet.
The controlled food must be sold under the name 'total diet replacement for weight control' or 'meal replacement for weight control', as appropriate, the use of those names being reserved to such food. The sale of the food is prohibited if it is not labelled with specified particulars, if reference is made to the rate or amount of weight loss that may result from its use and, in the case of food intended as a replacement for the whole daily diet, if all the components are not contained in the same package.
11.7.5 The Medical Food (England) Regulations 2000, as amended, implement Commission Directive 1999/21/EC, as amended (on foods for special medical purposes).
'Dietary foods for special medical purposes' are defined as a category of foods for particular nutritional uses specially processed or formulated and intended for dietary management of patients and intended to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two. Foods for special medical purposes are classified as (i) nutritionally complete foods with a standard formulation, (ii) nutritionally complete foods specific for a disease, disorder or medical condition or (iii) nutritionally incomplete foods. The Commission has confirmed that the definition is not intended to catch freely available products that are not aimed at patients with specific problems, other foods for particular nutritional uses and low birth weight formulae.
The implementing Regulations prohibit the marketing of dietary foods for special medical purposes unless they comply with specified compositional criteria, are sold under the prescribed name 'Food(s) for special medical purposes' and are labelled with mandatory particulars.
11.7.6 Directive 2001/15/EC (on substances that may be added for specific nutritional purposes in foods for particular nutritional uses) is implemented by the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002. The Regulations prohibit the sale of Parnuts foods (other than infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children) in the manufacture of which specified substances, failing to meet particular conditions, have been used for specific nutritional purposes.
11.8.1 The Food Supplements (England) Regulations 2003, as amended, implement Directive 2002/46/EC, as amended, on food supplements.[48] The Regulations define the term 'food supplement' as 'any food the purpose of which is to supplement the normal diet and which: (a) is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and (b) is sold in dose form.' The Regulations do not apply to medicinal products as defined by Directive 2001/83/EC. Regulation 2 prohibits the sale of a food supplement to the ultimate consumer unless it is prepacked. Food supplements may contain only vitamins and minerals listed in Sch 1, which are in the forms listed in Sch 2 and meet the relevant purity criteria (reg 5).
Labelling requirements, in addition to those prescribed by the Food Labelling Regulations 1996, are set out in regs 6 and 7. In particular, a food supplement must be labelled with the term 'food supplement', although this may be qualified by other required particulars. The FSA's guidance gives the example of 'Food Supplement – containing vitamins and minerals.'
In October 2003 the validity of the Regulations was challenged in the High Court on the basis that Directive 2002/46/EC was invalid. The High Court sought a preliminary ruling from the ECJ on this point and in 2005 the Directive was declared valid. The Regulations, therefore, remain good law.[49]
11.9.1 Regulation (EC) 1925/2006, on the addition of vitamins and minerals and certain other substances, lists the vitamins and minerals and the vitamin formulations and mineral substances that may be added to food.[50] Restrictions are imposed that prohibit the addition of vitamins and minerals to non-processed foods and beverages containing more than 1.2% by volume of alcohol. If a vitamin or mineral is added to food it is obligatory to provide nutrition labelling. The Regulations do not apply to mandatory addition of vitamins or minerals or where the addition is required by law. They also do not apply to vitamin and mineral food supplements or the use of substances for additive purposes, which continue to be controlled by separate legislation.
Additionally, Regulation (EC) 1925/2006 includes a procedure for the prohibition or restriction and for the listing of other substances having a nutritional or physiological effect, such as fibre and essential fatty acids, that may be added to foods or used in their manufacture under conditions that result in the ingestion of excessive amounts, or otherwise represent a risk to consumers.
The Commission is required to maintain a publicly available register of information listed under the Regulation.
Provision for the execution and enforcement of Regulation (EC) 1925/2006 is made by the Addition of Vitamins, Mineral and Other Substances (England) Regulations 2007.
[1] Proposal for a Directive of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses (Recast), COM (2008) 3 final.
[2] See, in particular, Directive 2000/13/EC, Art 2(2), which in fact dates back to its predecessor, Directive 79/112/EEC.
[3] With regard to the implementation of these provisions in domestic law, see paras 8.3.1 and 11.3.2 as to Directive 2000/13/EC, Art 2(1)(a) and (b); and paras 3.2.36- 3.2.37 as to Regulation (EC) 178/2002, Art 16.
[4] COM (2007) 279 final.
[5] Proposal for a Regulation of the European Parliament and of the Council on the provision of food information to consumers, COM (2008) 40 final.
[6] The Joint Health Claims Initiative set up in 1997.
[7] Proposal for a Regulation of the European Parliament and the Council on nutrition and health claims made on foods, COM (2003) 424.
[8] Codex Guidelines for Use of Nutrition and Health Claims, Codex Guidelines 23/1997, revised 2004. See also Nutrition labels and health claims: the global regulatory environment (WHO, 2004).
[9] The Food Standards Agency has prepared guidance, European Regulation (EC) 1924/2006 on nutrition and health claims made on foods: Food Standards Agency Guidance on Compliance, Version 1, April 2008. This is expected to be revised and updated prior to the expected adoption by 31 January 2010 of a list of authorised EC health claims.
[10] The Food Standards Agency website explains the UK list of potential health claims that it submitted to the EFSA on 30 January 2008.
[12] Food Labelling Regulations 1996, reg 41(1).
[13] Food Labelling Regulations 1996, reg 41(2).
[14] Food Labelling Regulations 1996, reg 41(3).
[15] Food Labelling Regulations 1996, reg 40(1) and Pt I of Sch 6.
[16] See case C-221/2000 Commission v Austria [2003] ECR I–1007.
[17] Food Labelling Regulations 1996, reg 40(2) and (3) and Pt II of Sch 6.
[19] By the Food Labelling Regulations 1996, reg 2(1), 'infants' is defined as children under the age of 12 months and 'young children' as children between one and three years.
[23] By the Food Labelling Regulations 1996, reg 2(1), 'young children' is defined as children between one and three years.
[25] By the Food Labelling Regulations 1996, reg 2(1), 'young children' is defined as children between one and three years.
[29] By the Food Labelling Regulations 1996, reg 2(1), 'young children' is defined as children between one and three years.
[30] Cheshire County County Council Fair Trading and Advice Service v Mornflakes Oats Ltd (1993) 157 JP 1011.
[34] In relation to the requirements of the 1996 Regulations that implement nutrition labelling Directive 90/496/EEC, Guidance Notes on Nutrition Labelling were issued by the Ministry of Agriculture, Fisheries and Food in May 1999. These notes precede the establishment of the Food Standards Agency but remain valid.
[39] As to the meaning of the word 'natural' used in relation to orange juice and strawberry jam, see respectively Amos v Britvic (1984) 149 JP 13; and case C-465/98 Darbo [2000] ECR I-2297. As to the use of the term 'natural' in relation to flavouring ingredients, see para 9.2.9 above.
[40] See case C-107/97 Ministère Public v Max Rombi [2000] ECR I-3367.
[41] The term considered in para 11.3.4 is 'particular nutritional purpose' used in the Food Labelling Regulations 1996, Sch 6, Pt II item 1. However that provision implements the definition of 'foodstuffs for particular nutritional uses' in Directive 89/398/EEC and the three categories of persons are in substance the same.
[42] See C-101/98 Union Deutsche Lebensmittelwerke GmbH v Schutzverband gegen Unwesen [1999] ECR I-8841.
[44] Regulation of additives permitted in foodstuffs intended for particular nutritional uses is reserved to the Council.
[45] The Commission is currently consulting on a draft Regulation concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten based on a Codex Alimentarius standard.
[46] The FSA has issued Guidance Notes on the Infant Formula and Follow-On Formula Regulations 2007, Revision 1, May 2008.
[47] In R (on the application of the Infant & Dietetic Food Association Ltd) v Secretary of State for Health, the Welsh Ministers [2008] EWHC 575 (Admin) the lack of transitional arrangements for bringing the Regulations into force with regard to labelling and packaging was successfully challenged. As a result the Regulations were amended to take account of this ruling and there is now a transitional period until 1 January 2010 as regards the labelling of infant formula and follow-on formula; and with regard to presentation in so far as it relates to the shape, appearance and packaging of infant formula and follow-on formula.
[48] The Food Standards Agency has issued Guidance Notes on Legislation implementing Directive 2002/46/EC on Food Supplements.
[49] Case C-154/04 R (on the application of Alliance for Natural Health) v Secretary of State for Health [2005] ECR I-6451, [2005] 2 CMLR 61.
[50] The Food Standards Agency has produced 'Guidance to Compliance', April 2008.