89 tal-1994

L.N. 119 or 1994

H)OD. DRUGS AND DRINKING WATER ACT

(CAP.13!)

IN uercise of the powers conferred by section 12 of tile Food,

Drugs and Drinkill& Waler Act , the Minister for Home Affairs and

Social Development, on the advice of the Food Standards Board, has

made Ihe following regulations

I . (I) llK"SC regulations may be cited as the Additives in Food

Regulations . 1994.

(2)

Regulations I, 2, 3 and 7 and the relative First and

Second Schedules shall come into force on Ihe day following lhedale of

publication of tht$C l'e8llIatiom, and regulations 4, 5 and 6 shall come

inlo force on the 1st July, 1995.

Regulation 2 ( I)

CATEGO RIES OF FOOD ADD111VES

Colour

Preservative

An lio(l~idan t

Emulsifier

Emulsifying 5<111

Th ickener

Gelllng A2ent

Stabilise r 0)

Flavour enhancer

Acid

Acidity regulator (2)

Anti~king agent

Modified !t&rell

SwcetellC r

Raising a~nt

Anli·foaming uent

Glazing agent (J)

Flour treatment agent

Firming agent

Hum«tant

Sequestrant (0)

En:tyme (. ) , 5)

Bulking age nt

Prope llant ga! and packaging gas

( ') This eategory al§O oomprises fOlm $tabilisen .

(2) These can act as two-way acidity reBulaton.

(l) These 5ub!;ta nccs include lubricanl$.

(4) Inclusion of these terms in this list is without prejudice to any future deci5ion or

mention thereof in the labelling of foodstuff!; intended for the finll consumer.

(S) Only those used 15 additives.

SECO ND SCHEDULE

Regulation 3 (3)

GENERALCRrrERIA FOR THE USE OF FOOD ADD111VES

I . Food additives may be approved only provided that

there may be demonstrated a reasonable t« lInological need I nd the

purpose cannot be ach ieved by otbt: r mel ns wllich are eoooomically I nd

technologically pnctiClble ,

they present no hazard to the health of the consumer al the level of use

proposed , ~ far ascan be juci,ed on the scientifIC evidence available ,

B 55"

they do not misle ad the COnSUme r.

-

2. 1llc use of food additives maybe oonsiderw only WMTe there iscvidcnce that

tile proposed use o f the additive oould have demo nstra ble advantages o f benefit 10 the

oonsumer, in olher WOrds;1 is ncoessary 10 C:SUlblish the Q5e for what is oommonly

referred 10 &5 ~lIeedH. The use of food additives mould serve one or more of the

purposes set OUt from points (a) 10 (d) be low. and o nly where those purpos.cs cannot be

achieved by other means whieb are eoonomicaUy and technologically praaicable and

do not presen t a haurd to the heal th of the oonsumer

(I) 10 preserve the nutritio nal quality of the food : a n intentional red\lCtion in

the putritional quali ty of a food would be j1,l$Iificd only where the food does no(

constitute Ilignificanl item in a normal die l o rwllere the addili~ is necessary for

the production of foods for groups of consumers having ~I dietary needs;

(b) 10 provide rleCl:$SaI)' ingredients o r constituents for foods manufactured

for groups of consumers having special dieta ry needs ;

(<;) 10 enhance the keeping quality or stability of a food or IQ improve its

organoleptic properties. provided that this does 1101 so change the nature,

substance or qu.aJiry of lhe food IQ 10 de<:eive lhe COll$llme r ;

(d) to provide aids in manufaelure, processin • • preparation . treatment,

pact;ng, tran!pOrt or storage of food. provided thatlhe additive is not used 10

disguise the effects of the use of faulty raw materials or of undesirable (including

unhygienic) practices o r techniques during the COUT5e of any of these activities .

1. Food lIdditivesshaU at all times comply with the approved mteria Of purily,

Approval for food additives shall

4. (a) specify the foods\ufb to which these additives may be added and the

conditions under which they may be: added ;

be limited to the lowest level of use neeessary to achieve the desired

(b)

effect;

(c) lake inlo account any acceptable daily inta~e. or equivalenl asscssment

establiShed for the food addi tive and the probable daily intake of it from all

sourca. Where the food addi tive is to be UKd in foods eaten by !ipCcial groups of

consumeR. account should be taken of the possible daily intake of the food

additive by consumen in those groups .

S. Any food additive o r any derivatives thereof, which are used in food must have

heen full y sub)ected to appropriate toxicological tesling and evaluation wi th a view 10

assessing any p:JMible harmful effeets.

Such evaluation mu~t also take into lICIXIun t an )' tu mul ative, sync:rgiSlic or

potentialing effect of its use Ind the phenomenon of huma n intolerance toSUbstl1lCCS

foreign 10 the humin body .

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( I) These regulations $hall apply 10 food additives Ihe

various CIItcgories of whicb are lisled in the Rnl Schedule to the5e

regulations , and which are U$ed , or intended to be used , as jn~nls

during the manufacture or prepanotion of food and an still pre$eIU ill

the final product, even ifln altered form .

(2) For the pul'pOSe$ of IlIcK regulations, "food additive"

means any !lUbstance nol normally consumed as a food in itself and not

oonnatty used as a c:harac:teristio.: ingredient of food whether or not il bas

Duuitivt: ... llK, tbe intentional addilion o f whicb to food for a

tedtnolo&kal purpose in the manufK\ure , processing, preparation,

treatmenl, packaging, transpan or lilorage o f IiUdI food resu llB, or may

be reasonably expeeted to result, in il o r its by· products beooming

directly or indirectly. component of wc:h foods..

(1) Tbc:se regulations ihall DOl apply 10

(a> processing aids, which means any substance , not

consumed as a food ingredient by itself, which is intentionally IISed

in the pmc:euin, o f raw materials, foods or their ingredicnt& 10

fulfiLl a cen ain ledtnological purpose during treatment or

processing and which may result in the unintentional but

tec:hnkally unavoidable presenee of residues of the substance or its

derivatives in the final product , always provided that such residues

do DOl present any health risk and do DOl havt: any technological

effect on the finished product

(b) substances u$ed in the protection of plants a nd plant

products in confonnity with the European Community rules

relating to plant health;

(c) fiaYOllrinp for use in foodstuffs , fallin, within the IOOpC

of Cotmcil Directi .. e 8813881EEC of the European Community;

(d)

subslaneel added to foodstuffs as nutrients.

(I) OoIy food additives listed under rcaulalions as may from _

time 11,1 time be published in respect of anycalegoriel of additives listed -

in the Finl Schedu le tu theR regulations may be used ;n the

manufacture ur preparation of food, and such use shall be subject 10 the

oonditionsof use specified in any such othe r regUlations to be made .

(2) lbe indusion of a food additive in one of the categories in

such Schedule shall be un the basis of the principal fUllction normally

associated with the food additive in question. HOwCYi:r , lhe allocation

of an additive 10 a particularalegorydoes not exclude the possibility of

such additive being authorised for several functions.

(3) Food additives shall5atisfy general criteria laid down in

- -. -,- " .....

the Serond Schedule tQ these regulations.

... ( I ) Food add itives nOI intended for sa le IQ the ultimate

b_.

ronsumer may be marketed only if their paf,;kagin, ur container bean

the folklwina information , which must be conspicuous. dearly lepble

and inde lible

~.

(I) for food add itives sold singly or mixed with each other ,

fareach additive , the nameofsu.ch addi tive as may be laid down by

any applicable European Community provi$i0n5 and its EEC

number or serial number, or, in the .bsc:nce of .ny such provision,

a de$cription of the additive that is sufficien tly precise: to enable it

10 be distinguished frain additives wit h which it could beoonfused,

in desceooing order of the proportion by weight in the total

Provided that when OI/K:r substances or materials or food

ingredients are inoorporated in any food additive or additives, to

faci litate Itorage, 1oII1e, Itandardisation , dilution or dissolutiol' of

such additive or additives, there shall be included the Ramc of the

additive and an iRdieat;on of each oomponent in descending order

of the proportion by weight in the total ;

either the statement "/or we in/ood"

(b)

or the statement "nSlricled use in/ood"

Or a more specir..: reference to its intended food use ;

(c) the special conditions of storagt: and use: if omission

the reof would preclude appropriate use of the additive ;

(d) the dicection$ fo r U$C , if the omission thereof would

preclude appropriate U$C of the additive ;

(e)

I mark identi fying the batch or lot;

(f) the name o r business name and address of the

manufacturer or paekager, or of a sc:ller;

(g) an indication of the percentage of any component which

is subject to a quaRlilative limitation in a food or adequate

cn mpositional infannation to enable the purchaser to com ply with

any European Community provision applicable 10 the food . Where

the IoIIme quantitative limitation applies to a group of components

used singly (K in c:ombination. the combined pcroentage may be

given as a single figure;

(h) the net quantity; and

(i) any other information as may be req uested under

I't'lulations published in re5pcCt of specific food additives.

(2) Notwith$tanding the provisions of paragraph ( I) of thit.

regulation, the information required unde r the proviso 10 sub-

puagnph (a), and under subparagraph$ (d), (e) , (f) and (g) of the $lid

paragraph may appear merely on the documents I't'laling 10 the

consignment which are to be supplied with or prior 10 the delivery,

provided that the indication Minumkd fo r tIu manuflXtuu offoodsruffs

ond noI fOT T(rail solt " appeara on a conspicuous part of the packaging or

OOI'1lainer of the prodllCl in qucstiOll.

Food addi tives inlended f(K sale 10 the ultimate consume r may

be marketed only if their packaging or comBinera bear the following

infomu tion, whidt mUSI be conspicuous, d early legible and indelible

(a) the name under whi<:h the product is sold. Sudt name

shall be conslituted by the name laid down by any European

Cqmmunity provisions applying 10 the product in question plus its

EEC number or se rial number . or. in the absence of such

provisions. by a description of the product that is sufficiently

precise loenable it to be distinguished from produdS with which il

could be confused: and

(b) the date of minimum durability within the meaninggiven

in the Labell ing and Presentation ofFood$tuffs Regulations. 1992;

"d

(c) the information required under sub· paragraphs (a) to (f).

( h) and (i) of patlllgraph (I) of regulation 4 of these regulations .

The parti(:ulafl referred to in regulations " and S of these

regulationnhall atlcast appear in one of the offlciallanguagcs of Mal la.

and the provisions of regulation IOof the Labelling and Presentation of

Food$tufb Regulalions, 1992 in respect of uemptions shall likewise

apply.

No person may import. sell, kccp for sale. or suppl y by way of

c:ompensation or otherwise , any food additive or any food containi ng

such addllive in either case unlcss in compliance with the provisions of

these regulalions.