S.I. No. 128/1997:

EUROPEAN COMMUNITIES DETAILED PROVISIONS ON THE CONTROL OF ADDITIVES, OTHER THAN COLOURS AND SWEETENERS FOR USE IN FOODSTUFFS) REGULATIONS, 1997

EUROPEAN COMMUNITIES DETAILED PROVISIONS ON THE CONTROL OF ADDITIVES, OTHER THAN COLOURS AND SWEETENERS FOR USE IN FOODSTUFFS) REGULATIONS, 1997

The Minister for Health in exercise of the powers conferred on him by Section 3 of the European Communities Act, 1972 (No. 27 of 1972) hereby makes the following Regulations for the purpose of giving effect to European Parliament and Council Directive 95/2/EC¹ on food additives, other than colours and sweeteners, for use in foodstuffs:

¹O.J No. L61, 18.3.1995, pp. 140

1. These Regulations may be cited as the European Communities (Detailed Provisions on the Control of Additives, other than Colours and Sweeteners, for use in Foodstuffs) Regulations, 1997.

2. These Regulations shall come into force on the 25th day of March, 1997.

3. (1) In these Regulations any reference to an article or Schedule shall, except where otherwise indicated, be construed as a reference to an article contained in these Regulations or, as may be, to the Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

(2) In these Regulations words and phrases shall have the same meaning as in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

4. (1) These Regulations make detailed provisions for the use in foodstuffs of the categories of food additives defined in sub-article (2). The general provisions for the use of these food additives are laid down in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

(2) For the purpose of these Regulations

( a ) 'preservatives' are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by micro-organisms;

( b ) 'antioxidants' are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes,

( c ) 'carriers', including carrier solvents, are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;

( d ) 'acids' are substances which increase the acidity of a foodstuff and/or impart a sour taste to it;

( e ) 'acidity regulators' are substances which alter or control the acidity or alkalinity of a foodstuff,

( f ) 'anti-caking agents' are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another;

( g ) 'anti-foaming agents' are substances which pre-vent or reduce foaming;

( h ) 'hulking agents' are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value;

( i ) 'emulsifiers' are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff;

( j ) 'emulsifying salts' are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components;

( k ) 'firming agents' are substances which make tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel;

( l ) 'flavour enhancers' are substances which enhance the existing taste and/or odour of a foodstuff;

( m ) 'foaming agents' are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;

( n ) gelling agents' are substances which give a foodstuff texture through formation of a gel,

( o ) 'glazing agents' (including lubricants) are substances which, when applied to the external surface of foodstuff, impart a shiny appearance or provide a protective coating;

( p ) 'humectants' are substances which pre-vent foodstuffs from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium;

( q ) 'modified starches' are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached:

( r ) 'packaging gases' are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container;

( s ) 'propellants' are gases other than air which expel a foodstuff from a container;

( t ) 'raising agents' are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;

( u ) 'sequestrants' are substances which form chemical complexes with metallic ions;

( v ) 'stabilisers' are substances which make it possible to maintain the physio-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff and include also substances which stabilise, retain or intensify an existing colour of a foodstuff; and

( w ) 'thickeners' are substances which increase the viscosity of a foodstuff.

(3) These Regulations do not apply to flour treatment agents, colours or sweeteners for use in foodstuffs for human consumption where

-- flour treatment agents, other than emulsifiers, are substances which are added to flour or dough to improve its baking quality, and

-- colours and sweeteners are as defined in and regulated by the European Communities (General Provisions on the Control of Additives, and in particular Colours and Sweeteners for use in Foodstuffs) Regulations, 1995 ( S.I. No. 344 of 1995 ).

(4) For the purposes of these Regulations the following are not considered as food additives:

( a ) substances used for treatment of drinking water as provided for in Directive 80/778/EEC ²

²O.J No. L 229. 30.8.1980. p. 11

( b ) products containing pectin and derived from dried apple pomace or peel of citrus fruits, or from a mixture of both, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (liquid pectin');

( c ) chewing gum bases;

( d ) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes,

( e ) ammonium chloride;

( f ) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten;

( g ) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts and having no additive function;

( h ) caseinates and casein; and

( i ) inulin.

5. (1) Only substances listed in Parts A, C, D and E of the Schedule may be used in foodstuffs for the purposes mentioned in Article 4(2).

(2) Subject to sub-articles (3) and (4), food additives listed in Part A of the Schedule are permitted in foodstuffs, for the purposes mentioned in Article 4(2), following the 'quantum satis' principle.

(3) Sub-article (2) does not apply in the case of foodstuffs listed in Part B of the Schedule.

(4) Except where specifically provided for, sub-article (2) does not apply to:

( a ) - unprocessed foodstuffs,

- honey as defined in Directive 74/409/EEC ³,

³O.J No. L 221. 12.8.1974. p. 11

- non-emulsified oils and fats of animal or vegetable origin,

- butter,

- pasteurised and sterilised (including UHT sterilisation) milk and cream (including skimmed, plain and semi--skimmed),

- unflavoured, live fermented milk products,

- natural mineral water as defined in Directive 80/777/EEC ⁴ and spring water,

⁴O.J No. L 229. 30.8. 1980. p. 1

- coffee (excluding flavoured instant coffee ) and coffee extracts,

- unflavoured leaf tea,

- sugars as defined in Directive 7¾3 7/EEC ⁵

⁵O.J No. L 356. 27.12.1973. p. 1

- dry pasta

- natural unflavoured buttermilk (excluding sterilised buttermilk);

( b ) food for infants and young children as referred to in the Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ) including foods for infants and young children not in good health; these foodstuffs are subject to the provisions of Part F of the Schedule; and

( c ) the foodstuffs listed in Part B of the Schedule which may contain only those food additives referred to in that Part and those food additives referred to in Parts C and D under the conditions specified therein.

(5) Food additives listed in Parts C and D of the Schedule may only used in the foodstuff's referred to in those Parts and under the conditions specified therein.

(6) Only those food additives listed in Part E of the Schedule may be used as carriers or carrier solvents for food additives and must be used under the conditions specified therein.

(7) The provisions of these Regulations shall also apply to the corresponding foodstuffs intended for particular nutritional uses in accordance with the Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ).

(8) Maximum levels indicated in the Parts to the Schedule refer to foodstuff's as marketed, unless otherwise stated.

6. (1) These Regulations shall be enforced and executed by each health board, established in accordance with the Health Act 1970 (No. 1 of 1970) in respect of its functional area through its authorised officers and/or the officers of the Minister for Health who are authorised officers for the purposes of these Regulations.

(2) For the purposes of these Regulations, "authorised officer" means:

( a ) an officer of the Minister for Health who is authorised in writing by the Minister for Health to be an authorised officer for the purposes of these Regulations; or

( b ) an officer of a health board who is authorised in writing by the Chief Executive Officer of the health board to be an authorised officer for the purposes of these Regulations

7. For the purposes of ensuring compliance with the Regulations, the control system established under the provisions of the Health (Official Control of Food) Regulations, 1996 ( S.I. No. 241 of 1996 ) shall apply.

8. (1) Where an authorised officer reasonably suspects or believes that a foodstuff or food additive does not comply with these Regulations, the authorised officer may seize and/or remove and/or detain such foodstuffs or food additive as being a foodstuff or food additive which is unfit for human consumption.

(2) With the consent in writing of the owner or person responsible for such foodstuff or food additive, an authorised officer may destroy or otherwise dispose of it so as to pre-vent its use for human consumption.

(3) An authorised officer who has seized any foodstuff or food additive in pursuance of the provisions of this article may, on giving notice in writing to the owner or person responsible for such foodstuff or food additive apply to a Judge of the District Court for an Order directing that such food or food additive be destroyed or otherwise disposed of as being a foodstuff or food additive which is unfit for human consumption.

(4) A Judge of the District Court to whom the application is made for an order under sub-article (3) of this article shall, if satisfied that such foodstuff or food additive does not comply with these Regulations, order that it be destroyed or otherwise disposed of after such period, not exceeding fourteen days, as may be specified in such order, as being a foodstuff or food additive which is unfit for human consumption and an officer shall destroy or dispose of it accordingly.

9. A person shall give to any authorised officer all reasonable assistance that the officer may require in the performance of his duties under these Regulations and such assistance shall include the giving of information relating to the composition and use of any foodstuff or food additive and the identity of the person from whom or the place from which any such foodstuff or food additive has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has been consigned or the manner in which it has otherwise been disposed of.

10. In any proceedings for an offence under these Regulations it shall be a defence for the person charged to show that the food in respect of which the offence is alleged to have been committed was intended for export and complied with the domestic food legislation of the importing country relevant to the alleged offence.

11. (1) Any person who contravenes any article or sub-article of these Regulations shall be guilty of an offence.

(2) A person guilty of an offence under these Regulations shall be liable on summary conviction to a Fine not exceeding £1.000 or at the discretion of the Court, to imprisonment for a term not exceeding 6 months or to both.

(3) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of a director, manager, secretary or other officer of the body corporate, the director, manager, secretary or other officer or any person purporting to act in such capacity shall, as well as the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished accordingly.

(4) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted within 12 months from the date of the offence.

12. An offence under these Regulations shall be prosecuted by the Minister for Health or by a health board in whose functional area the offence was committed.

13. (1) The following Regulations are hereby revoked:

Health (Antioxidant in Food) Regulations, 1973 ( S.I. No. 148 of 1973 ),

Health (Antioxidant in Food) (Amendment) Regulations, 1983 ( S.I. No. 61 of 1983 );

Health (Antioxidant in Food) (Amendment) Regulations, 1992 ( S.I. No. 69 of 1992 ),

Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) Regulations, 1994 ( S.I. No. 78 of 1994 );

Health (Preservatives in Food) Regulations, 1981 (S.I. No. 337 of 1981),

Health (Preservatives in Food) (Amendment) Regulations, 1989 ( S.I. No. 263 of 1989 );

Health (Preservatives in Food) (Amendment) Regulations, 1992 ( S.I. No. 66 of 1992 );

Health (Solvents in Food) Regulation, 1972 ( S.I. No. 340 of 1972 ); and

Health (Solvents in Food) (Amendment) Regulations. 1992 ( S.I. No. 70 of 1992 ).

(2) References in another instrument to any of the Regulations revoked under sub-article (1) shall be construed as references to these Regulations, as appropriate.

SCHEDULE

PART A

FOOD ADDITIVES GENERALLY PERMITTED FOR USE IN FOODSTUFFS NOT REFERRED TO IN ARTICLE 12 (3)

Notes

1. Substances on this list may be added to all foodstuffs with the exception of those referred to in Article 12(3) following the quantum satis principle.

2. The substances listed under numbers E 407 and E 440 may be standardised with sugars, on condition that this is stated in addition to the number and designation.

3. Explanation of symbols used:

* The substances E 290, E 93 8, E 939, E 94I, E 942 and E 948 may also be used in the foodstuffs referred to in Article 12 (3).

# The substances E410, E 412, E 415 and E 417 may not be used to produce dehydrated foodstuffs intended to rehydrate on ingestion.

PART B

FOODSTUFFS IN WHICH A LIMITED NUMBER OF ADDITIVES OF PART A MAY BE USED

¹O.J No. 228. 16.8.1973. p.23

Coca and chocolate products energy-reduced or with no added sugars are not covered by Schedule II

²O.J. No L 244. 30.9.1993, p.23

³O.J. No. L205. 13. 8. 1979. p. 5

¹ O.J. No L 24. 30.1.1976, p. 49

¹ O.J. No L 84. 27.3.1987. p. 1

² O.J. No L373. 31.12.1988. p.59

³ O.J. No L231.13.8.1992. p.1

⁴ O.J. No L 176, 3.7.1984. p.6

PART C

CONDITIONALLY PERMITTED PRESERVATIVES AND ANTIOXIDANTS

SECTION I

Sorbates, benzoates and p-hydroxybenzoates

Note

1. The levels of all substances mentioned above are expressed as the free acid.

2. The abbreviations used in the table mean the following:

3. The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

(¹) This entry docs not include dairy-based drinks.

(²) O.J. No L 84. 27. 3.1987, p. 1.

⁽¹⁾ O.J. No. L 186,30.6. 1989, p. 27

SECTION 2

Sulphur dioxide and sulphites

Note

1. Maximum levels are expressed as SO; in mg/kg or mg/l as appropriate and relate to the total quantity, available from all sources.

2. An SO₂ content of not more than 10 mg/kg or 10 mg/l is not considered to be pre-sent.

(¹) In edible parts.

SECTION 3

OTHER PRESERVATIVES

SECTION 4

OTHER ANTIOXIDANTS

Note

The * in the table refers to the proportionality rule: when combinations of gallates, BHA and BHT are used, the individual levels must be reduced proportionally.

PART D

OTHER PERMITTED ADDITIVES

The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

(¹) E only.

(¹) E 341 (ii) only.

(²) E 341 (iii) only.

(1) E 493 only (2) E 492 only

(¹) Asbestos free.

(²) E553b only.

PART E

PERMITTED CARRIERS AND CARRIER SOLVENTS

Notes

Not included in this list are:

1. Substances generally considered as foodstuffs:

2. Substances referred to in Article 1 1 (4);

3. Substances having primarily an acid or acidity regulator function, such as citric acid and ammonium hydroxide.

PART F

FOOD ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN

Note

Formulae and weaning foods for infants and young children may contain E 414 acacia gum (gum arabic) and E 551 silicon dioxide resulting from the addition of nutrient preparations containing not more than 10 g/kg of each of these substances, as well as E 421 mannitol when used as a carrier for vitamin B 12 (not less than I part vitamin B 12 to 1000 parts mannitol).

The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

SECTION 1

FOOD ADDITIVES PERMITTED IN INFANT FORMULAE FOR INFANTS IN GOOD HEALTH

Notes

1. For the manufacture of acidified milks, non-pathogenic L(+)lactic acid producing cultures may be used.

2. If more than one of the substances E 322 and E 471 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substance in that foodstuff.

SECTION 2

FOOD ADDITIVES PERMITTED IN FOLLOW-ON FORMULAE FOR INFANTS IN GOOD HEALTH

Note

1. For the manufacture of acidified milks, non-pathogenic L(+)lactic acid producing cultures may be used.

2. If more than one of the substances E 322 and E 471 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substance in that foodstuff.

3. if more than one of the substances E 407, E 410 and E 412 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substances together in that foodstuff.

SECTION 3

FOOD ADDITIVES PERMITTED IN WEANING FOODS FOR INFANTS AND YOUNG CHILDREN IN GOOD HEALTH

SECTION 4

FOOD ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN FOR SPECIAL MEDICAL PURPOSES

The tables in Sections 13 of Part F are applicable.

GIVEN under the official seal of the Minister for Health this 21st day of March, 1997.

MICHAEL NOONAN. T.D.

Minister for Health

EXPLANATORY NOTE

These Regulations are cited as the European Communities (Detailed Provisions on the Control of Additives, other than Colours and Sweeteners, for use in Foodstuffs) Regulations, 1997 and come into force on the 25th day of March, 1997.

These Regulations implement European Parliament and Council Directive 95/2/EC¹ on food additives, other than colours and sweeteners, for use in foodstuffs, which is commonly known as the "Miscellaneous Additives Directive"

These Regulations set out the detailed provisions which apply to the use in food for human consumption of the categories of food additive specified in Article 4(2). The general provisions which apply to these, and to all other food additives, are set out in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

¹O.J No. L 61. 18.3.1995. pp. 140