IE
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
Table of Provisions (14)
Statutory Text (14 Articles)
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.
E NO
NAME
MAXIMUM LEVEL
E 270
Lactic acid (L(+)—form only)
quantum satis
E 330
Citric acid
quantum satis
E 306
Tocopherol-rich extract
]
E 307
Alpha-tocopherol
]
10 mg/l individually or in combination
E 308
Gamma-tocopherol
]
E 309
Delta-tocopherol
]
E 338
Phosphoric acid
In conformity with the limits set in Annex II to Directive 91/321/EEC
E 440
Pectins
5 g/l in acidified follow-on formulae only
E 322
Lecithins
1g/l
E 471
Mono-and di-glycerides
4g/l
E 407
Carrageenan
0.3 g/l
E 410
Locust bean gum
1g/l
E 412
Guar gum
1g/l
SECTION 3
FOOD ADDITIVES PERMITTED IN WEANING FOODS FOR INFANTS AND YOUNG CHILDREN IN GOOD HEALTH
ENO
NAME
FOODSTUFF
MAXIMUM LEVEL
E 170
Calcium carbonates
]
E 260
Acetic acid
]
E 261
Potassium acetate
]
E 262
Sodium acetate
]
E 263
Calcium acetate
]
E 270
Lactic acid *
]
quantum satis
E 296
Malic acid *
]
Weaning foods
(only for pH adjustment)
E 325
Sodium lactate *
]
E 326
Potassium lactate *
]
E 327
Calcium lactate *
]
E 330
Citric acid
]
E 331
Sodium citrates
]
E 332
Potassium citrates
]
E 333
Calcium citrates
]
E 507
Hydrochloric acid
]
E 524
Sodium hydroxide
]
E 525
Potassium hydroxide
]
E 526
Calcium hydroxide
]
* L(+)—form only
E 500
Sodium carbonates
]
quantum satis
E 501
Potassium carbonates
]
Weaning foods
(only as raising agents)
E 503
Ammonium carbonates
]
Individually or in combination expressed as ascorbic acid
E 300
L-ascorbic acid
]
Fruit- and vegetable -based drinks, juices and baby foods
0.3 g/kg
E 301
Sodium L-ascorbate
]
E 302
Calcium L-ascorbate
]
]
]
Fat-containing cereals, biscuits, rusks and baby foods
0.2 g/kg
E 304
L-ascorbyl palmitate
]
E 306
Tocopherol-rich extract
]
0 1 g/kg individually or in combination
E 307
Alpha-tocopherol
]
E 308
Gamma-tocopherol
]
E 309
Delta-tocopherol
]
E 338
Phosphoric acid
Weaning foods
1 g/kg as P
2
O
5
(only for pH adjustment)
E 339
Sodium phosphates
]
1 g/kg
individually or in combination expressed as P
2
O
5
E 340
Potassium phosphates
]
Cereals
E 341
Calcium phosphates
]
E 322
Lecithins
Biscuits and rusks
Cereal-based foods
Baby foods
]
]
]
10 g/kg
E 471
Mono and di-glycerides of fatty acids
]
]
E 472a
Acetic acid esters of mono and di-glycerides of fatty acids
]
]
]
Biscuits and rusks
Cereal-based foods
Baby foods
]
]
]
5 g/kg
individually or in combination
E 472b
Lactic acid esters of mono- and di-glycerides of fatty acids
]
]
]
E 472c
Citric acid esters of mono- and di-glycerides of fatty acids
]
]
]
E 400
Alginic acid
]
E 401
Sodium alginate
]
]
Desserts
Puddings
]
]
0.5 g/kg
individually or in combination
E 402
Potassium alginate
]
E 404
Calcium alginate
]
E 410
Locust bean gum
]
Weaning foods
10g/kg
individually or in combination
E 412
Guar gum
]
E 414
Acacia gum (gum arabic)
]
E 415
Xanthan gum
]
]
]
Gluten-free cereal-based foods
20 g/kg
individually or in combination
E 440
Pectins
]
E 551
Silicon dioxide
Dry cereals
2 g/kg
E 334
Tartaric acid *
]
E 335
Sodium tartrate *
]
E 336
Potassium tartrate *
]
Biscuits and rusks
5 g/kg
as a residue
E 354
Calcium tartrate *
]
E 450a
Disodium diphosphate
]
E 575
Glucono-delta-lactone
]
* L(+)—form only
E 1404
Oxidised starch
]
E 1410
Monostarch phosphate
]
E 1412
Distarch phosphate
]
E 1413
Phosphated distarch phosphate
]
]
E 1414
Acetylated distarch phosphate
]
]
Weaning foods
50g/kg
E 1420
Acetylated starch
]
E 1422
Acetylated distarch adipate
]
E 1450
Starch sodium octenyl succinate
]
]
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/EC
1
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).
1
O.J No. L 61. 18.3.1995. pp. 140
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 offoodstuff, 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
2
O.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
,
3
O.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,
4
O.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 73/437/EEC
5
5
O.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
S.I. No. 128 of 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/EC
1
on food additives, other than colours and sweeteners, for use in foodstuffs
1
O.J No. L61, 18.3.1995, pp. 140