guidance

Food Additives Legislation

GUIDANCE NOTES

For further information on these guidance notes, contact:

Food Additives Unit

Chemical Safety and Toxicology Division

Food Standards Agency

Aviation House

125 Kingsway

London WC2B 6NH

Further copies of these guidance notes are available from: Food Standards Agency Publications:

tel 0845 606 0667

email foodstandards@https://www.wendangku.net/doc/e817474624.html,

Contents

Page Chapter 1

General guidance notes on food additives legislation2

Chapter 2

Guidance notes on the Sweeteners in Food Regulations 1995

(as amended)9

Chapter 3

Guidance notes on the Colours in Food Regulations 1995

(as amended)17

Chapter 4

Guidance notes on the Miscellaneous Food Additives

Regulations1995 (as amended)38

These guidance notes on food additives legislation have been

produced by the Food Standards Agency with the aim of

providing informal guidance. They should be read in conjunction

with the appropriate legislation and should not be taken as an

authoritative interpretation of the law, as only the courts have the

power to interpret statutory provisions.

A broad overview of the UK provisions is provided in Section 1,

General guidance notes. Section 1 also draws attention to points

of detail common to the three Statutory Instruments discussed.

Separate guidance notes for each of the three Statutory

Instruments can be found in subsequent sections of this booklet.

As these cover only unique points of detail, it is important for the

separate guidance notes to be read in conjunction with the

general guidance notes.

The guidance in Section 2 has been revised to reflect

amendments to the principal Regulations by the Sweeteners in

Food (Amendment) Regulations 1996, 1997, 1999 and 2001.

The guidance in Section 3 has been revised to reflect

amendments to the principal Regulations by the Colours in Food

(Amendment) Regulations 2000 and 2001.

The guidance in Section 4 has been revised to reflect

amendments to the principal Regulations by the Miscellaneous

Food Additives (Amendment) Regulations 1997, 1999, 2001 and

2001 (No. 2)

Chapter 1: General guidance

notes on food

additives legislation

Introduction

1.In 1995, three sets of Regulations were introduced in

England, Scotland and Wales to control the use of the principal

classes of food additives. These cover sweeteners, colours and

‘miscellaneous’ additives such as preservatives, antioxidants,

emulsifiers, stabilisers and carrier solvents. Similar controls were

introduced in Northern Ireland. The relevant Statutory Instruments

and their amendments to date are listed below:

i)the Sweeteners in Food Regulations 1995, as amended by the

Sweeteners in Food (Amendment) Regulations 1996, 1997,

1999, 2001* and 2002*

ii)the Colours in Food Regulations 1995, as amended by the Colours in Food (Amendment) Regulations 2000 and 2001*

iii)the Miscellaneous Food Additives Regulations 1995, as amended by the Miscellaneous Food Additives (Amendment)

Regulations 1997, 1999, 2001 and 2001 (No. 2)*

References to the above Statutory Instruments should also be taken

as covering the legislation in Northern Ireland and, from 2000

onwards, the separate Regulations in England, Scotland, Wales and

Northern Ireland.

*Separate amending provisions apply in England, Scotland, Wales and

Northern Ireland.

2.This section, the General guidance notes, provides a broad

overview of the UK provisions as well as drawing attention to points

of detail common to the three Statutory Instruments. Separate

guidance notes for each of the three Statutory Instruments can be

found in subsequent sections of this booklet. As these cover only

unique points of detail, it is important for the separate guidance

notes to be read in conjunction with these general ones. The

guidance notes for colours are more substantial than the other two.

3.The Statutory Instruments implement both European Parliament and Council, and Commission Directives controlling specific classes of food additives. These were adopted under Council Directive 89/107/EEC. This so-called Framework Directive sets out the basis for controls on food additives authorised for use in foodstuffs intended for human consumption (OJL 40, 11.2.89, pp. 27–33). The subsequent Directives form part of the Single Market initiative and more fully harmonise member states’ national controls on the use of certain classes of food additives, to the benefit of both traders and consumers. Consumer safety is maintained, since safety in use and technological need are prerequisites for all food additives authorised for use by these measures.

Scope of the legislation

4.The principal provisions of each of the Statutory Instruments stipulate:

?which food additives are permitted for use and for sale direct to the consumer

?specific purity criteria (i.e. specifications) for permitted additives ?conditions of additive use including the setting of maximum levels for certain additives

Food additives used primarily for colouring and sweetening are covered by the Colours in Food Regulations 1995 and the Sweeteners in Food Regulations 1995 respectively. The Miscellaneous Food Additives Regulations 1995 cover additives that are used primarily as acids; acidity regulators; anti-caking agents; anti-foaming agents; antioxidants; bulking agents; carriers and carrier solvents for colours, sweeteners and miscellaneous additives; emulsifiers; emulsifying salts; firming agents; flavour enhancers; flour treatment agents; foaming agents; gelling agents; glazing agents; humectants; modified starches; packaging gases; preservatives; propellants; raising agents; sequestrants; stabilisers; and thickeners. The term ‘food additive’ is defined in each of the three Statutory Instruments. Each class of food additives is defined in the relevant Statutory Instrument.

5.Some solvents and certain classes of miscellaneous additives are not controlled by specific legislation although the general consumer safety provisions contained within the Food Safety Act 1990 apply. This issue is discussed further in paragraphs 12–16 of the guidance notes on the Miscellaneous Food Additives Regulations 1995 in Section 4 of this booklet. The additives Regulations, like the Directives they implement, are applicable generally to all foods, including those intended for particular nutritional uses in accordance with Directive 89/398/EEC (PARNUTS). The amendment to the Food Additives Framework

Directive has, however, allowed member states to maintain national laws prohibiting the presence of certain additives in specific foods considered to be traditional. Non-traditional versions of the same foods are allowed to contain food additives, provided their presence and use is permitted by the additive legislation. No UK products are involved, but of course there are implications for exporters.

6.Apart from a specific provision implemented by the Sweeteners in Food Regulations 1995 concerning additional labelling requirements for table-top sweeteners, the legislation does not contain any provisions for the labelling of the presence of additives in food. It does, however, update the legislation covering the labelling of food additives sold as such.

7.The practice of using substances, such as titanium dioxide, to act as tracers for monitoring purposes is outside the scope of the food additive legislation since this is not an additive function.

8.The Statutory Instruments have been made under the Food Safety Act 1990 and relevant provisions within the Act are applicable. Control of the food additives concerned is by means of a positive list system. Many additives are only permitted in certain foodstuffs, and then only up to specified maximum levels.

9.Enforcement is carried out by local food authorities, with provisions on penalties and condemnation of food included in the legislation. A defence in relation to exports exists, as explained in paragraph 12.

10.Under the legislation, the purpose for which the additive is used determines which rules apply. For instance, sorbitol is commonly known for its sweetening properties and, where it is used in that capacity, it is controlled by the Sweeteners in Food Regulations 1995. However, sorbitol may also be used as a humectant and in such instances the requirements of the Miscellaneous Food Additives Regulations 1995 apply.

11.Responsibility for enforcement and interpretation of the law rests with UK enforcement authorities, UK Law Courts and, ultimately, the European Court of Justice (ECJ). The relevant Directives, however, provide for disputes over specific interpretation issues to be resolved, if necessary, by reference to the EC’s Standing Committee on the Food Chain and Animal Health (formerly the Standing Committee for Foodstuffs), for example in respect of unresolved queries over the interpretation of food categories. Such action can only be instigated by the European Commission or by appropriate authorities in member states. In the UK, this would normally be the Food Standards Agency. These provisions concerning the Standing Committee on the Food Chain and Animal Health may be found within the principal Directives themselves and not within the UK Regulations, because it is unnecessary for them to be implemented in the UK by national legislation.

12.For products that do not comply with the UK legislation on food additives and which are intended for export, there are two aspects that can be used in defence in any legal proceedings.

i)For all exports, it will only be a defence if the person charged

can prove that the products were intended for export to a country with analogous legislation on food additives, and that the products concerned comply with that legislation. Thus, where no such analogous legislation exists, the legal requirement is for the products concerned to comply with the UK additives legislation.

ii)For exports to other member states, it will only be a defence if the person charged can, in addition, prove that the legislation of that country complies with relevant Community law on additives.

The instances where use of this defence can be made will be very limited, since only in rare and specific cases will other member states have such legislation that differs from that in the UK. This defence is in fact intended to cover instances where a member state has made a temporary authorisation within its own territory in accordance with Article 5 of the Food Additives Framework Directive (89/107/EEC). This provision allows such temporary authorisations while the justifying scientific evidence is considered at Community level in order to allow a decision to be taken on whether or not to apply the authorisation throughout the EC.

Key points of common interest to all three statutory instruments

Implementing legislation

13.Each of the Statutory Instruments implements a European Parliament and Council Directive, which lists the permitted food additives and their condition of use. They also implement Commission Directives laying down the purity criteria for the additives concerned, by a simple reference to the title of those Directives.

14.All three Statutory Instruments include, in Regulation 2, a statement to the effect that expressions not defined in the Regulations have the same meaning as they have in the relevant Directive. Where the expressions are not found in the relevant Directive, they will automatically have the same meaning as in the Food Safety Act 1990 under which the Regulations are made.

Quantum satis

15.There are instances in the Regulations where no numerical maximum level is specified for additive use. This is because there is no need on safety grounds to set a maximum level. Rather, a level of quantum satis(QS) is set. QS is defined in the Regulations and means that additives shall be used in the food concerned in accordance with good manufacturing practice. This means that it must not be used at a level higher than is necessary to achieve the intended purpose and must not be used in a way that misleads the consumer.

Carry-over provisions

16.All three sets of Regulations include carry-over provisions. These apply to most foods permitted to contain food additives by those Regulations, but not to those specially prepared for infants and young children. These provisions permit the presence of a permitted food additive in a compound food, to the extent that the food additive is allowed by the relevant Regulations in one of the ingredients of the compound food. They also provide for permitted food additives to be present in foods (such as intermediary products), in which they would not otherwise be permitted, provided that those foods are to be used solely in the preparation of a compound food that will conform to the relevant Regulations. Food categories

17.All three Statutory Instruments list a number of food categories. Apart from where reference is made to a particular EU food compositional Directive, these have not been defined. This is to allow a necessary degree of flexibility to accommodate differences in the types of food products consumed in different member states. However, as the three Directives were negotiated separately without common categorisation, the food categories are not always directly comparable. While the categories are for the most part self-explanatory, there may be instances where clarification is necessary as regards the position of a certain food product. For example, some foods may meet the description of more than one category. The separate guidance notes for each Statutory Instrument in the later sections of this booklet provide some help here but, if required, further guidance should be sought from local trading standards officers or environmental health officers. A final point to note here is that the food categories have been devised purely to control food additive use and do not have any implications for the labelling of food.

Untranslated food categories

18.There are instances throughout the Directives where some food categories have not been translated into all the various EC languages. This is reflected in the Regulations, for example saucisses de Strasbourg and kippers in the Colours in Food Regulations 1995 and mostarda di frutta in the Miscellaneous Food Additives Regulations 1995. In these instances, the intention is that the relevant additives are only permitted in these speciality products.

Maximum level or maximum usable dose

19.All three Statutory Instruments restrict the level at which certain additives may be present in food. The level is called the ‘maximum level’ or, in the case of the Sweeteners in Food Regulations 1995, the ‘maximum usable dose’ and this has two meanings:

i)The level in the food as ready to eat, taking into account any

instructions for use. This rule applies to the entire Sweeteners in Food Regulations 1995, the Colours in Food Regulations 1995 and to three of the Schedules in the Miscellaneous Food Additives Regulations 1995. For example, the quantity (on a weight for volume basis) of a permitted sweetener in a bottle of concentrated squash may be at a higher level than that quoted in the Sweeteners in Food Regulations 1995. This is acceptable provided there are instructions for dilution such that, at the point the product is ready to drink, the level of the permitted sweetener is no greater than the maximum level permitted by the Regulations. It should be noted that in the UK, cooking, where applicable, is considered not to be a further instruction for use. The effect of cooking on the level of additives in a product differs according to a number of variable factors. Therefore, if it were considered to be a further instruction for use, it would make observance and uniform enforcement of the Regulations impossible.

ii)In all other cases in the Miscellaneous Food Additives Regulations 1995, the level relates to the food as sold.

20.Within a production run of a food, the level of food additives present may vary slightly between individual products. While it is recognised that some variation within a batch might occur, the onus is upon manufacturers to ensure that maximum permissible additive levels are observed for each of the individual products.

Categories of food additives subject to harmonised EC controls that fall outside the scope of the Food Additives Framework Directive 89/107/EC

Flavourings

21.It should be noted that controls also exist for the flavourings category of additives. The Flavourings in Food Regulations 1992 were introduced to implement specific provisions of Directive 88/388/EEC concerning flavourings for use in foodstuffs and to source materials for their production. The Regulations define categories of flavourings to be controlled, lay down limits for certain undesirable substances that are present in some flavourings, and set down labelling requirements for business and retail sales of flavourings sold as such. The Regulations were amended in 1994 when additional labelling requirements were set down relating to retail sales.

22.In addition, EC Regulation 2232/96 (which applies in the UK without the need for further implementation) lays down a Community procedure that will eventually lead to a positive list of permitted flavouring substances following a programme of evaluation. Currently, these substances are being evaluated at European Union (EU) level. This is a developing area and advice on the latest position can be obtained from the Food Standards Agency. See the front of this document for the address of the Food Additives Unit.

Extraction solvents

23.The Extraction Solvents in Food Regulations 1993 implement the provisions of Council Directive 88/344/EEC, which sets out a positive list of extraction solvents. Only those products on the list can be used in the Community. Maximum residue limits for each extraction solvent are laid down and, for some, specific conditions of use apply. The Regulations lay down specifications of purity and prescribe labelling requirements for extraction solvents. These Regulations were amended in 1995 and 1998. Firstly, they were amended to permit the use of an additional substance (cyclohexane) in the preparation of flavourings. Secondly, they were amended to delete two substances (butyl acetate and methyl-propan-1-ol) from the positive list, to reduce the maximum residue level for hexane and to clarify its conditions of use, and to add a new extraction solvent (1,1,1,2-tetrafluorethane or ‘TFE’) to the list.

Chapter 2: Guidance notes on the

Sweeteners in Food

Regulations 1995

(as amended)

Introduction

1.The notes in this section cover only those aspects of food

additives legislation that are specific to the Sweeteners in Food

Regulations 1995 as amended. References throughout these notes

should be taken as also covering the parallel legislation in Scotland,

Wales and Northern Ireland. For a complete overview, these notes

should be read in conjunction with the General guidance notes (see

Section 1 of this booklet), which cover points common to all

additives legislation. Manufacturers should be aware that the use of

sweeteners has implications for the labelling of their products. They

should therefore also consult the Food Labelling Regulations 1996

and their accompanying guidance notes.

Scope of the regulations

2.The Sweeteners in Food Regulations 1995 implement

provisions contained within two EC Directives:

3.i)European Parliament and Council Directive 94/35/EC on

sweeteners for use in foodstuffs (OJL 237, 10.9.94, pp.

3–12) as amended by Council Directive 96/83/EC (OJL 48,

19.2.97, pp. 16–19)

ii) Commission Directive 95/31/EC laying down specific

criteria of purity concerning sweeteners for use in foodstuffs

(OJL 178, 28.7.95, pp. 1–19) as amended by Directives

98/66/EC (OJL 257, 19.9.98, p. 35), 2000/51/EC (OJL

198, 4.8.2000 pp. 41–43) and 2001/52/EC (OJL 190,

12.7.2001 pp. 18–20)

The Sweeteners in Food Regulations 1995:

?define ‘sweetener’

?list the permitted sweeteners and, by cross-reference, the purity criteria with which they must comply

?set down conditions of use for sweeteners in food

?control the sale of sweeteners direct to the public (table-top sweeteners) and specify additional labelling requirements for these products

?prohibit the sale and use of sweeteners, and the sale of food containing sweeteners that do not comply with these provisions

The Sweeteners in Food (Amendment) Regulations 1996rectify an error in the wording of Regulation 3(2) of the Sweeteners in Food Regulations 1995.

The Sweeteners in Food (Amendment) Regulations 1997:

?extend the use of sweeteners already permitted by the principal Regulations to certain additional categories of food

?add certain technical provisions to bring the principal Regulations into line with the Colours in Food Regulations 1995 and the Miscellaneous Food Additives Regulations 1995, for example on ‘carry-over’ (see paragraph 8)

?amend the title of the food category ‘vitamins and dietary preparations’ (see paragraph 22)

The Sweeteners in Food (Amendment) Regulations 1999:

?amend a reference to Directive 95/31 so as to cover its amendment by Directive 98/66/EC that changed the specification for isomalt (E953)

?bring up to date references to the 1995 Regulations in other Regulations

The Sweeteners in Food (Amendment) (England) Regulations 2001:

?amend a reference to Directive 95/31 so as to cover its amendment by Directive 2000/51/EC that changed the specification for mannitol (E421) and maltitol syrup (E965 (ii))?bring up to date references to the 1995 Regulations in other Regulations

The Sweeteners in Food (Amendment) (England) Regulations 2002:

?amend a reference to Directive 95/31 so as to cover its amendment by Directive 2001/52/EC that changed the specification for mannitol (E421) and acesulfame K (E951). This corrects earlier purity criteria for mannitol in Directive 2000/51/EC that were found to contain an error and were therefore not implemented in the UK.

?give two-year temporary national authorisation to market the sweetener ‘sucralose’ in England

?bring up to date references to the 1995 Regulations in other Regulations

General philosophy of Directive 94/35/EC on sweeteners for use in foodstuffs

4.For sweeteners to be included in this Directive they first had to comply with the general criteria set out in Annex II of the Food Additives Framework Directive 89/107/EEC (OJL 40, 11.2.89, pp. 27–33). Under these criteria, food additives may only be approved if it has been demonstrated that they perform a useful purpose, are safe and do not mislead the consumer. The recitals of Directive 94/35/EC on sweeteners for use in foodstuffs further explain that the use of sweeteners to replace sugar is justified for the production of: i)energy-reduced foods

ii)non-cariogenic foods (i.e. foods that are unlikely to cause tooth decay)

iii)foods without added sugars, for the extension of shelf life through the replacement of sugar and for the production of dietetic products

Definition of sweetener

(Regulation 2(1))

5.For the purposes of these Regulations, a sweetener is defined as a food additive that is used or intended to be used either to impart a sweet taste to food or as a table-top sweetener. Table-top sweeteners are products that consist of, or include, any permitted sweeteners and are intended for sale to the ultimate consumer, normally for use as an alternative to sugar. Foods with sweetening properties, such as sugar and honey, are not additives and are excluded from the scope of this legislation. The Sweeteners in Food Regulations 1995 do not apply where a substance listed as a permitted sweetener is used for purposes other than sweetening, for example where sorbitol is used as a humectant in accordance with the Miscellaneous Food Additives Regulations 1995 and parallel Northern Ireland legislation.

Permitted sweeteners

(Regulations 2(1), 3(1), 4(a) and Schedule 1)

6.The only sweeteners permitted for sale to the ultimate consumer or for use in or on food are those listed in Schedule 1 to the Regulations whose specific purity criteria are in compliance with that stated in the annex to Directive 95/31/EC.

Foods allowed to contain permitted sweeteners (Regulations 3(2), 3(3) and Schedule 1)

7.Permitted sweeteners are only allowed to be used in or on foods that fall within one of the categories listed in Schedule 1 to the Regulations. A maximum usable dose for each permitted sweetener, varying according to the food category, is also specified within Schedule 1 and this must be respected. The use of two or more sweeteners in a single food is permitted, provided suitable categories exist and the maximum level for each individual sweetener is observed. The sale of foods that do not comply with these provisions is illegal.

Sweeteners in compound foods – carry-over (Regulation 2(1) (amended 1997) and Regulation 5A)

8.The Regulations have been amended to include provisions on carry-over (Regulation 5A) to bring them into line with the GB Regulations on Colours and Miscellaneous Food Additives. These provisions allow the presence of a permitted sweetener in a compound food, to the extent that the sweetener is allowed by the Regulations in one of the ingredients of the compound food. However, the definition of ‘compound foods’ in Regulation 2(1) means that permitted sweeteners are only allowed in the following compound foods:

i)those with no added sugar or that are energy-reduced

ii)dietary foods intended for a low-calorie diet (excluding those specifically prepared for infants and young children)

iii)those with a long shelf life

The Regulations also provide for what is commonly known as ‘reverse carry-over’. This means permitted sweeteners can be present in foods (such as intermediary products) in which they would not otherwise be permitted, provided that these foods are to be used solely in the preparation of a compound food that will conform to the Regulations.

Foods not allowed to contain sweeteners (Regulation 3(4) (amended 1997) and Regulation 5)

9.The use of sweeteners is prohibited in any foods for infants and young children. This is specified in Council Directive 89/398/EEC on the approximation of the laws of the member states

relating to foodstuffs intended for particular nutritional uses (OJL 186, 30.6.89, pp. 27–32) and this prohibition now includes foods for infants and young children not in good health. The sale of such products containing sweeteners is also prohibited. Foods for infants and young children, generally known as ‘baby foods’, include foods specially prepared for infants and young children who are in good health; or whose digestive processes or metabolism is disturbed; or who have a special physiological condition where they would be able to obtain benefit from controlled consumption of certain substances in foods. For the purposes of this prohibition, Regulation 2(1) defines ‘infants’ as children under the age of 12 months and ‘young children’ as children aged between one and three years. These definitions reflect those given in Article 1(2) of Directive 91/321/EEC on infant formulae and follow-on formulae (OJL 175, 4.7.91, pp. 35-49) that are made under Directive 89/398/EEC.

The terms ‘maximum usable dose’ and

‘quantum satis’

(Regulations 2(3)(c) and 2(3)(d))

10.These expressions are explained in the General Guidance Notes, Section 1, paragraphs 19 and 15 respectively.

The terms ‘with no added sugar’ and

‘energy-reduced’

(Regulations 2(3)(a) and 2(3)(b))

11.Many of the categories listed in Schedule 1 to the Regulations are described as ‘with no added sugar’ or ‘energy-reduced’. The final product must comply with the definitions of these terms and the effect is to limit further the type of foods in which sweeteners may be used. However, the actual terms ‘with no added sugar’ or ‘energy-reduced’ are not required by these Regulations to be used in the labelling of such products. Whatever description is used for those products must be in accordance with the Food Labelling Regulations 1996.1

1Guidance notes on the interpretation of the Food Labelling Regulations are available at https://www.wendangku.net/doc/e817474624.html,/multimedia/pdfs/guidnot1.pdf

12.‘Energy-reduced’ foods are foods with an energy value reduced by at least 30% compared with the original or a similar food. The legislation does not define the precise basis for this comparison, but wherever possible it should be by reference to one or more products that are currently on the market. If it is not possible to identify a comparable product that is currently on the market, the comparison could be made on the basis of previously marketed products. In an extreme case where it is not possible to identify an actual product, the comparison might be made with a hypothetically equivalent product, the composition of which is based on the use of sucrose rather than permitted sweeteners. Additional labelling requirements for table-top sweeteners

(Regulation 4(b))

13.The Regulations include labelling requirements that apply to table-top sweeteners only. In addition to the requirements contained within existing UK labelling legislation, table-top sweeteners must include on their labels the phrase:

‘[Name of sweetener(s)]-based table-top sweetener’

Furthermore, where table-top sweeteners contain polyols and/or aspartame, the following phrases must also be included on their labels:

for polyols – ‘excessive consumption may induce laxative effects’

for aspartame – ‘contains a source of phenylalanine’

For the purposes of these Regulations, polyols are considered to be sorbitol and sorbitol syrup (E420(i) and (ii)), mannitol (E421), isomalt (E953), maltitol and maltitol syrup (E965(i) and (ii)), lactitol (E966) and xylitol (E967).

Food categories

(Schedule 1 (amended 1997))

14.As the food categories are not defined (see the discussion in paragraph 17 of the General guidance notes, Section 1 of this booklet), there will always be a need for a certain amount of interpretation. The purpose of this section of the guidance notes is to provide an explanation of some of the less obvious food categories.

Energy-reduced fruit and vegetable preparations

15.In addition to covering energy-reduced fruit and vegetable preparations not covered elsewhere, this category would also include baked beans in sauce, but only those meeting the energy-reducing definition.

Sauces

16.Dressings would also be included here.

Products intended for particular nutritional uses

17.This would include products specially prepared for diabetics. Snacks: certain flavours of ready-to-eat, pre-packed, dry, savoury starch products and coated nuts

18.The maximum levels relate to those found in the final snack product as opposed to in the flavouring. In addition to coated nuts, this category would include savoury-flavoured potato products such as crisps, sticks and puffs as well as swollen or puffed cereal products such as maize sticks and popcorn. The flavours covered include those with a sweet/sour flavour profile, such as prawn cocktail, Worcester sauce, tomato sauce, spicy chicken, chilli and tangy sauce.

Essoblaten

19.This untranslated category has been included for a German product very similar to UK ice-cream wafers. UK ice-cream cones and wafers are listed separately as ‘cornets and wafers, for ice-cream, with no added sugar’.

Beers with a minimum acidity content of 30 milli-equivalents expressed as NaOH

Bière de table/Tafelbier/Table beer (original wort content less than 6%) except for Oberg?riges Einfachbier

Brown beers of the oud bruin type

20.The Agency is not aware of any current major production of these beers in the UK. ‘Acid’ beers are produced in Belgium and may contain cherries, cherry juice or cherry extract. Bière de table and Tafelbier are understood to be low-alcoholic-strength beers produced in Belgium, France and Germany. Oud bruin beers are fairly heavy dark-brown Dutch beers.

Feinkostsalat

21.This untranslated category has been included for a German speciality that consists of a prepared salad in a sauce. Use of sweeteners enables the salad to stay crisp for longer, thereby extending its shelf life.

Food supplements/diet integrators based on vitamins and/or mineral elements, syrup-type or chewable

22.This category has been changed from the rather broad category of ‘vitamins and dietary preparations’ to more accurately reflect the needs of the market.

Gaseosa

23.This category was introduced to cover a Spanish carbonated soft drink. Products classified under this category are expected to be labelled as such.

Home-brew kits for alcoholic beverages

24.This category is not included in Directive 94/35/EC as amended by Directive 96/83/EC. While some of these types of products may fall within the alcoholic beverage categories, others will not and thus for those there is no legal provision allowing sweeteners to be mixed in with their ‘active ingredients’. This problem was recognised late in the EC discussions. The solution foreseen at the time was for the sweeteners to be in a separate sachet from the other ingredients, thereby being a direct sale of an additive to a consumer. In these instances appropriate labelling rules must be observed, including those on consumer sales of food additives as laid down in the Food Additives Labelling Regulations 1992.

Chapter 3: Guidance notes on the

Colours in Food

Regulations 1995

(as amended)

Introduction

1.The notes in this section cover only those aspects of food

additives legislation that are specific to the Colours in Food

Regulations 1995. References throughout these notes are to those

Regulations as amended and should be taken as covering the

parallel Northern Ireland legislation and, from 2000, separate

Regulations in England, Scotland, Wales and Northern Ireland. For

a complete overview, these notes should be read in conjunction

with the General guidance notes (see Section 1 of this booklet),

which cover points common to all the additives legislation.

Scope of the regulations

2.The Colours in Food Regulations 1995 implement provisions

contained within two EC Directives:

i)European Parliament and Council Directive 94/36/EC on colours

for use in foodstuffs (OJ L 237, 10.9.94, pp 13–29)

ii)Commission Directive 95/45/EC (OJ L 226, 22.9.95, pp. 1–45) as amended by Commission Directives 1999/75/EC (GJ No.

L206, 5.8.1999, p. 19) and 2001/50/EC (OJ L 190, p.14,

12.7.2001), laying down specific purity criteria concerning

colours for use in foodstuffs

The Colours in Food Regulations 1995:

?define ‘colour’

?list the permitted colours and, by cross-reference to the relevant Directives, the purity criteria with which they must comply

?set down conditions of use for colours in food

?control the sale of colours direct to the public and prohibit the sale and use of colours and the sale of food containing colours

that do not comply with these provisions

General philosophy on the use of colours in food 3.The colours listed in the Regulations are included on the basis of the general criteria set down in Annex II of the Food Additives Framework Directive (89/107/EEC). As with all other additives used in food, colours may only be used if they perform a useful purpose, are safe and do not mislead the consumer. The recitals of the Colours Directive 94/36/EC state that colour may be used to:

i)reinforce colours already present in food

ii)restore the original appearance of food whose colour has been affected by processing, storage, etc.

iii)make food visually appealing and give colour to otherwise colourless food

There is general agreement that basic and unprocessed food should not be coloured. (For a discussion of the definitions of the food categories, see paragraph 17 of the General guidance notes, Section 1 of this booklet.)

Definition of colour

(Regulation 2(1))

4.Colours add or restore colour in a food. They are not substances that are normally consumed as foods by themselves or used as characteristic ingredients of foods. This Regulation is not intended to catch products such as fruit juices (for example, elderberry juice added to yoghurt) or tomato concentrates. These would be regarded as ingredients, to be labelled as such, even when added principally for colouring purposes.

5.The key to determining whether or not a substance is deemed

a colour under the Regulations is whether a substance has undergone ‘selective extraction’ for the prime function of colouring (Regulation 2(1)(b)). For example, dried spinach used in the manufacture of pasta verdi is not deemed a colour, but is regarded as an ingredient as the colour pigments (the chlorophyll) in the spinach are not selectively chosen. If the chlorophyll pigments are ‘selectively extracted’ from the spinach to perform a colouring function and added to the pasta, then these are regarded as colours and fall under the scope of the Regulations – chlorophylls (E140) are listed in Schedule 1. Saffron is allowed because it has a primary aromatic effect in addition to its secondary colouring effect and thus is outside the scope of the Regulations. Crocin has to be extracted from saffron by some physical or chemical means and automatically falls under the definition of colour, but is not permitted as it is not listed in Schedule 1 of the Regulations. A further example is that of