Regulations relating to foods for infants, young children and children (R. No. 1130 of 1984)

REG ULATIO NS RELATING TO FO O DSTUFFS FO R INFANTS, YO UNG CH ILDREN AND C HILDREN P ubl i shed under Government Not i ce No. R. 1130 of 8 June 1984 As amen ded b y: Government Not ice No. R . 2542 of 15 November 1985 (with effect from: 15 May 1986) T he Mi n is t e r o f Health and W elfare, in terms of section 15(1) of the Foodstuffs, Cosmetics and Disinfectants A ct , 19 7 2 (A ct 5 4 o f 1 9 72 ) , h as m ade t he reg u la t i on s co n ta i n ed i n t h e S ch edu l e h eret o . S CHEDULE D ef i n i t i on s 1 . In t h es e reg u la t i on s “the Act” shall mean the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 o f 1 9 72 ) , an d an y w ord to which a meaning has been ascribed in the Act shall bear such m ean in g an d , u n les s i n con s is t ent wi t h t h e co n tex t— “ca n ned fo o dstuff for infants and young children” shall mean a foodstuff, whether in a ready-to eat fo rm or i n a dry form requiring reconstitution with water only, packed in a hermetically sealed p ack age an d in t end ed p r im ari l y fo r us e d u r in g the infant’s normal weaning period and for the p ro g res s i ve ad ap ta t i on of i n fant s an d y o un g ch i ld ren t o o rdi n ary foo d st u ffs; “ch i l dren” s ha l l m ean pers on s fro m t h e ag e o f t h ree y ears u p to t he age of 1 0 y ears ; “fo o d a d di t iv e” s ha l l m ean any su b stance not normally consumed as a foodstuff, intentionally add ed t o a fo od s tu ff fo r a t ech no l og i cal (including organoleptic) purpose, but shall not include s ub s t an ces add ed t o fo o ds t u ffs for t he p urp os e of enh anc i n g t he nutritional value thereof; “gl u ten free” s ha l l mean that the total nitrogen content of the gluten- containing cereals used in die p ro d uc t do es n o t ex ceed 0 , 0 5 g /1 0 0 g of s uch cerea l s o n a d ry m at t e r b asi s ; “hermet i ca l l y s ea l ed package” shall mean an unopened package which cannot be opened without t he b reak in g or dam ag i n g o f s u ch p ack ag e or of the seal, adhesive label or other part thereof or a t tachm ent t here to wh i ch fo rm s an ai r -t i gh t cl o su re an d i s im p erv i ou s t o li q u id ; “i nf a nt” s ha l l m ean a p erso n u n der t he ag e of 1 2 m on t hs ; “i nf a nt fo rmu l a” s ha l l m ean a foodstuff based on milk of cows or other animals and/or on other w ho l es om e co n stituents of animal origin, including fish, or plant origin, in liquid or powdered form i nt en ded fo r us e , w h ere neces s ary , as i nfan t feedi n g i n order to meet the normal nutritional requ i rem en t s o f in fant s ; 2 “pro ces s ed cereal -b as ed f o od stuf f” shall mean a foodstuff prepared primarily from one or more m il l ed cerea l p roducts and/or legumes (pulses), including sesame, arachis and soybean, intended to s up p l em en t t he di e t of t he i nfan ts and yo u ng chi l d ren , an d t h e t e rm s ha l l i n cl u d e— (a) d ry cerea ls , t ha t is foo d s tuffs based on cereals and/or legumes (pulses), processed to low m oi s tu re co n ten t an d s o fragmented as to permit dilution with water, milk or some other s ui t abl e li q u id or, as in the case of preparations such as pasta, used after cooking in boiling w at er o r ot h er l i qu i ds ; (b) s i mp le o r co mp o si t e cooked flours of cereals, that is foodstuffs which have been cooked in a way t h a t d i st i n gu i sh es t h em as fo ll o ws : ( i ) P ar t i al l y co o ked fl o urs req u ir i n g a secon d sh o rt coo k i ng befo re u se ; ( i i) coo k ed fl ou rs, for i mm ed i a te u se , as s uch not requiring any further cooking b efo re u s e; and ( i ii ) d ex t r in i s ed flo u rs, t he s tarch content of which has in part been transformed into d ex t r in b y h ea t t rea t ment ; (c ) enzy me t rea t ed flo u rs of cereals, that is flours prepared with enzymes, the starch content of w hi ch h as b een t ran sfo rmed i n t o d ext r i n, mal t od ext r i n, mal t os e an d glucose; (d) p as t a , t h at i s fo o ds t uffs prepared from milled cereal products and suitable for weaning p er i o d; and (e ) rus k s an d b i scu i ts , t ha t is cereal-based foodstuffs produced by baking which may be used e i th er d i rec t l y o r, a fte r pulverisation, with the addition of water or milk or other suitable l i qu i d, and mi l k b i s cu i t s con s i st i n g m ai n l y o f cereals and containing milk solids; “serv in g ”, in rel a t io n to a fo o ds t uff, sh a l l m ean a reas o nab l e quantity of food suitable for con s um p ti o n as par t o f a m eal b y i nfan ts o r y o un g ch i ld ren o r ch i ld ren ; “su g ar” s ha l l m ean sucrose, glucose (or dextrose), fructose (or levulose), maltose, lactose, sorbitol, m an n it o l an d x yl i t ol ; an d “yo u ng chi l dren” s ha l l m ean pers on s fro m t h e age of 12 months up to the age of three years. P ro h ib i t io n o n th e s a l e o f certa i n F oo d stu f f s fo r I n f an ts a nd Yo u ng Ch i ld ren 2 . N o p ers o n s h al l se l l an y i n fan t fo rmu l a— (a) t he com p os i t io n o f wh ich d o es not comply with the minimum and maximum levels of v it ami n s , m i neral s in an available form, choline, proteins and linoleate, per 100 available k il o j ou l es, as s p ec i fied in Annex A: Provided that nutrients other than the vitamins and m in era l s li s t ed in Annex A may be added to any such formula in amounts based on levels o f s u ch n ut r i en t s i n hu man mi l k, p ro v i ded the usefulness thereof can be scientifically p ro v ed; (b) i n t h e p roces si n g o f which water is used which contains more than 10 mg/Ρ of nitrate as N (equ i va l ent t o 4 5 m g/Ρ No 3 ) ; (c ) w hi ch— (aa) con t a in s— ( i ) p at h o gen ic mi cro-o rg an is m s and / o r t o xi n s t h ereo f; ( i i) add ed h o rm o nes , an ti b i ot i cs o r o t h er ant i mi crob i al substances; 3 ( i ii ) m ore of any ch emi ca l s u bs t an ce registered in terms of section 3 (2) of t he F er t i li zers, Farm Feeds, Agricultural Remedies and S tock Remedies A ct , 19 4 7 (A ct 3 6 o f 1 9 47 ) , than the tolerances laid down by the Act; ( i v) m ore th an 0 , 2 m g/ k g o f lead in the ready-to-eat form of such formula or m ore th an 0 , 5 m g/kg of lead in the dehydrated concentrated form of such fo rm ul a ; (v) any foo d ad d it i v e, except t h os e s p eci fied in column II of Annex B, com p ly i ng with the conditions and not exceeding the limits laid down in col u mn I II ; (bb ) i s n o t p ack ed i n a h erm eti ca ll y sea l ed pack ag e . 3. N o p ers o n s h al l se l l an y cann ed fo o ds t uff for i nfan ts and y ou n g chi l d ren— (a) w hi ch— ( i ) con t a in s ad d ed n ut r i en t s, u nl es s t h e u s efu lness thereof can be scientifically p ro v ed; ( i i) con t a in s an y n i t ri t es i n such foodstuffs prepared with meat, except where bacon o r h am i s a con s ti t u ent thereof, in which case the nitrite content shall not exceed 2 0 m g/ k g; ( i ii ) d oes no t co mp l y w i t h t he requ i rem en ts laid down in regulation 2(b) and (c); (b) t he t ot a l so d iu m co nt en t o f wh ich exceeds 200 mg Na+/100 g on the ready-to-eat basis: P ro v i ded t h a t n o table salt (NaCΡ) shall be added to such products having a fruit base or to s uch pro du c t s i n ten ded sp eci fi cal l y as in troductory foodstuffs or as dessert products. 4 . (1) N o p ers o n s h al l se l l an y o f th e fol l ow i ng as products intended for infants and young chi l d ren : (a ) D ry cerea ls , si m pl e or composite cooked flours of cereals, enzyme-treated flours o f ce rea l s an d p ast a ; o r (b) rus k s an d b i scu i ts ; i f t h e s o d iu m co nt en t exceeds, in the case of (a), 100 mg/100 g of the ready-to-eat product and , in t he cas e of (b) 3 00 mg / 1 00 g o f th e pro du c t as so l d. (2) (a ) W h ere an y p ro d uc t i n (1 ) (a ) and (b) of this regulation is intended to be mixed w it h wat er b efo re co ns u mp tion, the minimum protein content shall be not less t han 15 p er cen t o n a dry weight basis and the quality of the protein shall be not l ess t han 7 0 per cen t o f th a t o f cas e in . (b) Mi l k bi s cu i t s s h al l co n t ai n not less than 10 per cent mass/mass milk proteins. (3) In ad di t i on t o t h e raw ingredients mentioned in paragraphs (a), (d) and (e) of the definition o f “ p ro cess ed cerea l-b as ed fo o ds t uff” in regulation 1, the following ingredients only, w here ap pro pr i a t e, may be add ed t o d ry cerea l s, p as t a , ru sk s an d bi s cu i t s: (a ) P ro t e in con cen t rates and other high-protein ingredients suitable for consumption b y i n fan t s an d young children: Provided that essential amino acids shall be added o nl y in s uch am ou n t s as m ay b e n eces s ary for the purpose of improving the p ro t e in q ua l i ty and th a t o n l y n at u ral L- fo rms of amino acids shall be used; (b) s al t ( so d iu m ch l or i d e) ; (c ) m il k an d m i l k p ro d uc t s ; 4 (d) egg s ; (e ) m eat ; ( f) fa ts and oi l s ; (g) frui t s an d v ege t ab l es; (h) s ug ars (n ut r i ti v e carbo h yd rat e sw eet en ers ) ; ( i ) m al t ; ( j ) h on ey; (k) coco a (o nl y i n p ro d uc t s to be con s um ed aft er n in e months of age and at a m ax i mu m l eve l of 5 % m/ m o n a d ry b asi s ) ; ( l ) p ot a t oes ; an d (m) s t arches , i n c lu d i ng en zym e-m odified starches and starches treated by physical m ean s. L ab ell i n g req u iremen ts 5 . T he req u iremen t s s p ecified in paragraphs (1), (2) and (3) of this regulation are supplementary to the o th er l ab el l i ng req u iremen t s l a id d ow n b y th e Act . (1) T he l ab e l o f an y in fant form ul a sh a ll b ear t he fol l o wi n g i nfo rmat i on : (a ) T he head in g “N ut r i t io n In form at i o n”, re fl ect i ng — ( i ) an i n di ca ti o n o f th e mas s o r v o l um e o f a serving of the ready-to-eat p ro d uc t , if n ot g iv en e l s ew here on th e lab e l; ( i i) t he energ y con t ent , to the nearest kilojule, of 100mΡ of the ready-to-eat p ro d uc t : ( i ii ) t he amo u nt o f ch oline, and the amount of each of the vitamins, minerals and o th er nu t r ien ts , referred to in regulation 3 and Annex A, present in 1 00 mΡ o f t h e read y- t o -eat p rod u ct ; ( i v) w hat percen t ag e o f t he RD A s p ec i fed i n A nn ex C each o f th e u nd erment i o ned nu t ri ents represents, if present in 100mΡ of the ready t o-eat p rod u ct in amounts of more than 2 per cent, listed in the following o rd er : V it ami n A; P ho s ph o ru s ; V it ami n D; Mag n es i um ; V it ami n E; P ot as si u m; V it ami n K1 ; S od i um ; V it ami n C; C hl o ri d e ; V it ami n B1 ; I ron ; V it ami n B2 ; C op p er ; N ico t in e ac i d; Iod i n e; B io t i n; Man g an ese ; F ol i c aci d; Z in c ; P an t ot h eni c ac i d ; F lu o r id e ; 5 V it ami n B6 ; C hro mi u m; V it ami n B1 2 ; S el en iu m; C al c i um ; Mo l y bd enu m; (v) t he amo u nt s in g ram s o f the proteins, carbohydrates and fats present in 1 00 g o f th e read y- t o-eat product: Provided that the type of sugar shall b e m en t io n ed s ep arat e l y i n t h e l i s t o f in g red i en t s . (b) t he s ou rces o f t h e p rot e i ns men ti o n ed i n t h e l i st o f i n gred ien t s. (c ) D irec ti o ns fo r— ( i ) p rep ara t i on and us e , including the application of sterilised equipment; ( i i) t he s t orage and keep in g before and after the package has been opened. (d) A n i n di cat i o n o n t h e main panel, in both official languages and in letters at least 4 ,0 mm i n h ei g h t, t ha t breast feed i ng s ho u ld b e t h e fi rs t cho i ce . (e ) I f t h e fo rmu l a co nt a i ns neither milk nor any milk product, the words “Free from m il k an d m i l k p ro d uc t s ”. ( f) I f t h e fo rmu l a co nt a i ns more than 0,25 mg Iron (Fe) per 100 available kilojules, t he w ord s “ i nfan t fo rm u la w it h Iro n”. (g) I f t h e fo r rnu l a co nt a i ns gl u t en , an i nd i ca t i on o f t h e p res en ce t hereo f. (h) I f t h e fo rmu l a co nt a i ns t he max i mu m con centration of NaC1 as specified in A nn ex A , t h e fo l lo w in g on the main panel in both official languages in letters at l eas t 2, 0 mm i n he i ght: “W arning: Do not add salt/W aarskuwing: Moenie sout b yv o eg n ie . ”. (2) T he l ab e l o f an y cann ed foodstuff for infants and young children shall reflect the following i nfo rmat i on : (a ) In t h e case o f an y n u tr i ent add ed i n accord an ce w ith regulation 3 (a) (i)— ( i ) t he h ead i ng “N u tr i t i on In fo rm ati o n ”; ( i i) an i n di ca ti o n o f th e mas s o r v o l um es o f a se rvi n g; ( i ii ) t he amo u nt s of add ed n u tr i ent s presen t i n a serving when packed: P ro v i ded t h a t— (a) t he t ot a l pro te i n, carbohydrate and fat values shall be indicated i n g ram s ; an d (b) each ty p e o f ad d ed s ug ar s h al l b e n am ed s epara te l y; ( i v) an i n di ca ti o n o f w hat percentage of the RDA specified in Annex C each o f t h e ad ded nu t r ien ts represen t s w hen packed . (b) D irec ti o ns fo r— ( i ) p rep ara t i on and us e ; an d ( i i) s t orage and keep in g before an d aft e r t h e p ackage has been opened. (c ) In t h e case o f cann ed b eet root and spinach intended as foodstuffs for infants, the fo ll o wi n g i n st ru ct i o n i n both official languages in letters not less than 2 mm in h ei g h t: “ Do no t us e before the age of 12 weeks/Moenie voor die ouderdom van 1 2 w ek e geb rui k n i e .”. (d) I f t h e fo o ds t uff con t a in s th e maxi m um co n cen t ra tion NaC1 as specified in regu l at i o n (3 )(b ) , t h e fo ll o wing on the main panel in both official languages in l e tt e r s n ot l ess than 2,0 mm in height: “W arning: Do not add salt/ W aarskuwing: Mo en ie s ou t by v oeg n i e .”. 6 (e ) I f s u ch fo od st uffs co n t ai n s n o gluten, the words “gluten free”, clearly stated on t he l abe l . (3) T he l ab e l o f an y pro ces s ed cereal-based foodstuff intended for infants and young children s ha l l bear t h e fo l lo w in g i n form at i o n: (a ) In t h e case o f ad ded nu t r ien ts t he u sefu ln es s o f which can be scientifically p ro v ed— ( i ) t he h ead i ng “N u tr i t i on In fo rm ati o n ”; ( i i) an i n di ca ti o n o f th e mas s o r v o l um e o f a s e rv i ng ; ( i ii ) t he amo u nt s presen t i n a s e rvi n g w hen packed : P rovided that— (a) t he t ot a l pro te i n and fat values shall be indicated in grams; and (b) each ty p e o f su g ar s ha ll be named separately and not as part of any carb oh y dra t e v a lu es ; ( i v) an i n di ca ti o n o f wh at percentage of the RDA specified in Annex C each o f t h e ad ded nu t r ien ts represen t s. (b) D irec ti o ns fo r— ( i ) t he p repara ti o n an d u s e o f th e fo o ds t u ff; and ( i i) t he s t orage and keep in g before and after the package has been opened. (c ) I f s u ch fo od s tu ff co n ta i n s more than 15 per cent protein, a direction stating that w at e r , m il k or fo rm ul a may be us ed fo r d i l ut i o n o r m i xi ng . (d) I f t h e fo o ds t uff con cern ed co ntains less than 15 per cent protein and the quality t hereof i s l es s t h an 70 p er cen t of t ha t of case i n, a direction containing the fo ll o wi n g s t at emen t o r wo rds of a similar meaning: “Milk or a formula, but no w at er , s h al l be u sed fo r dilution or mixing in accordance with medical advice”. (e ) I f s u ch fo od s tu ff contains no gluten, the words “gluten-free” clearly visible on the l abe l . ( f) I f t h e fo o ds t uff concerned contains the maximum amount of NaC1, the following o n t he mai n p an e l i n bo t h o ffic ial languages in letters not less than 2,0 mm in h ei g h t: “W a r n in g : Do no t ad d salt/W aarskuwing: Moenie sout byvoeg nie.”. 6 . T he pro v is i o ns of regu l at i o ns 2 (b ) , 2 (c ) an d 5 (3)(e) apply also to any foodstuff purporting or represen t ed to be i nt en ded fo r co n su m pt i on b y ch il d ren . 7 A NN EX A A mount s per 100 ava ilable ki lo joules N ut r ient M inimum M ax imum Vitamins Vitamin A. . . .. . . . . .. . . . . .. . . . . .. . . . . . Vitamin D. . . .. . . . . .. . . . . .. . . . . .. . . . . . Vitamin E (a-tocopherol compounds) Ascorbic acid (Vitamin C). . . .. . . . . .. Thiamine (Vitamin B1). . . .. . . . . .. . . . . Riboflavin (Vitamin B2) . . . .. . . . . .. . . Nicotinamide. . . .. . . . . .. . . . . .. . . . . .. . . Vitamin B6 (2). . . .. . . . . .. . . . . .. . . . . .. . . Fo lic acid. . . .. . . . . .. . . . . .. . . . . .. . . . . .. Pantothenic acid. . . .. . . . . .. . . . . .. . . . . . Vitamin B12 (Cyanocobalamin). . . .. . *Vitamin K1. . . .. . . . . .. . . . . .. . . . . .. . . . Biotin (Vitamin H). . . .. . . . . .. . . . . .. . . Mine rals Sodium (Na). . . .. . . . . .. . . . . .. . . . . .. . . Potassium (K). . . .. . . . . .. . . . . .. . . . . .. . Chloride (Cl). . . .. . . . . .. . . . . .. . . . . .. . . Calcium (Ca)(3). . . .. . . . . .. . . . . .. . . . . .. Phosphorus (P) (3). . . .. . . . . .. . . . . .. . . . . Magnesium (Mg). . . .. . . . . .. . . . . .. . . . . *Iron (Fe) . . . .. . . . . .. . . . . .. . . . . .. . . . . . Iodine (I) . . . .. . . . . .. . . . . .. . . . . .. . . . . .. *Copper (Cu). . . .. . . . . .. . . . . .. . . . . .. . . *Zink (Zn). . . .. . . . . .. . . . . .. . . . . .. . . . . . *Manganese (Mn). . . .. . . . . .. . . . . .. . . . Choline. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . Protein (4). . . .. . . . . .. . . . . .. . . . . .. . . . . .. Fat (5). . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. Linoleate (4). . . .. . . . . .. . . . . .. . . . . .. . . . 60 I .E. or 18 µg expressed as reti nol. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. 10 I.E.. . . .. . . . . .. . . . . .. . . . . .. . . . . .. 0 . 7 I .E. /g linoleic acid but in no case less than 0,15 I.E. /100 avai lable kilojoules. . . .. . . . . .. . . . . .. . . . 1,9 mg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. 10 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . 14 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . 60 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . 9 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 1 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 70 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . 0,04 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . . 1 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 0,4 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 5 mg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 20 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 14 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 12 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 6 mg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 1,4 mg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. 0,25 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . 1,2 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 14 µg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . 0,12 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . 1,2 µg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 1,7 mg. . . .. . . . . .. . . . . .. . . . . .. . . . . .. 0,43 g . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 0,8 g. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . 70 mg . . . .. . . . . .. . . . . .. . . . . .. . . . . .. 120 I.E. of 37 µg expressed as r e tino l 19. I .E. N ot spec if ie d N ot spec if ie d N ot spec if ie d No t spe cif ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d 12 m g 50 m g 35 m g N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d N ot spec if ie d 0 ,96 g 1 ,5 g N ot spec if ie d * O nly in the c hela ted f o rm . ( 1 ) O r pe r g r a m o f po lyunsa tu ra te d f a t ty a cid s , e xp re ssed a s l inole ic a c id. ( 2 ) For m u la e with a higher protein content than 0,43 g protein/100 kJ shall contain a minimum of 15 µg Vitamin B6 per gram of p r ote in. ( 3 ) T he Ca:P ra t io sha ll no t be le ss tha n 1 ,2 :1 a nd not m or e tha n 2,0 :1. (4) ( i ) T he nutr i t iona l qua li ty sha ll be equivalent to that of casein or a greater quantity of other protein in proportion to its b iolog ic a l va lue. T he qua l i ty o f the p r o te in sha l l be no t le ss tha n 85 pe r ce n t of tha t o f c a se in . ( i i) I solated amino acids shall be added to an infant formula for the sole purpose of improving its nutritional value for infants. E ssential amino acids may be added for the purpose of improving the protein quality. Provided that they shall be only in amounts nec e ssa r y f o r suc h pu r pose a nd tha t on ly na tu r a l L - f o rm s o f a mino a c id s sha l l be u se d . ( 5 ) T he p roduct shal l con tain l ino le ic a cid in the f o r m o f g lyc e r ide s . A NN EX B I II III F oodstuf f F ood addit ive C onditions and maximum level in 100 mΡ o f the ready-to-eat product I n fa n t f o r mu la Antiox idants L-Ascorbyl palmitate. . . .. . . . . .. . . . . Tocopherols, concentrate. . . .. . . . . .. pH-adjus t ing age nts Potassium carbonate. . . .. . . . . .. . . . . . Potassium citrate . . . .. . . . . .. . . . . .. . . Potassium hydrogen carbonate. . . .. 1 mg K n o t to e xc e e d 145 m g 8 Canne d f oods tuf fs for in fa n ts, y oung children a nd c hi ld r en Sodium carbonate . . . .. . . . . .. . . . . .. . Sodium citrate. . . .. . . . . .. . . . . .. . . . . . Sodium hydrogen carbonate. . . .. . . . Citric acid . . . .. . . . . .. . . . . .. . . . . .. . . . L ( + ) Lactic acid . . . .. . . . . .. . . . . .. . L ( + ) Lactic acid producing cultures Emuls if ie rs Lecithin. . . .. . . . . .. . . . . .. . . . . .. . . . . .. Mono- and diglycerides . . . .. . . . . .. . T hic kene rs Carrageenan . . . .. . . . . .. . . . . .. . . . . .. . Distarch phosphate. . . .. . . . . .. . . . . .. Distarch phosphate, acetylated. . . .. Distarch phosphate phosphated . . . . Hydroxypropyl starch . . . .. . . . . .. . . . Guar gum. . . .. . . . . .. . . . . .. . . . . .. . . . . Locust bean gum . . . .. . . . . .. . . . . .. . . pH-adjusting agents . . . .. . . . . .. . . . . . Calcium hydroxide. . . .. . . . . .. . . . . .. Potassium hydroxide . . . .. . . . . .. . . . . Sodium hydroxide. . . .. . . . . .. . . . . .. . pH-adjusting agents . . . .. . . . . .. . . . . . N a no t to exc e ed 35 m g G ood ma nuf a c tu ring practice 0 , 5 g 0 , 4 g 0 , 03 g in regular milk- and soy based liquid infant formulae only , 0,1 g in hydroly sed protein and/or a mino a c id - based liquid infant f o rm u la e on ly 0 , 5 g singly or in combination in soy -base infant formulae only 2 , 5 g singly or in combination in hyd rolysed protein and/or amino a cid-based liquid infant formulae only 100 m g G ood ma nuf a c tu ring practice Provided that the limits for Na and K spe cified in Annex A shall not be e xce e ded Conditions and maximum levels in 100 g of the ready -to-eat product 5 9 Acetic acid. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . Calcium carbonate. . . .. . . . . .. . . . . .. . . . . .. Potassium hydrogen carbonate. . . .. . . . . . L ( + ) Lactic acid . . . .. . . . . .. . . . . .. . . . . .. Sodium carbonate . . . .. . . . . .. . . . . .. . . . . .. Sodium hydrogen carbonate. . . .. . . . . .. . . Citric acid and Na salt. . . .. . . . . .. . . . . .. . . Antiox idant L-Ascorbic acid and its Na and K salts . L-ascorby l palmitate. . . .. . . . . .. . . . . .. . . . . Alpha-Tocopherol. . . .. . . . . .. . . . . .. . . . . .. Tecopherol concentrate, mixed. . . .. . . . . . Emuls if ie rs Lecithin. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. . Mono- and diglycerides . . . .. . . . . .. . . . . .. Flav ourants Ethy l vanillin . . . .. . . . . .. . . . . .. . . . . .. . . . . . Natural and nature identical flavourants Vanillin . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. . Vanillia extract . . . .. . . . . .. . . . . .. . . . . .. . . . T hic kene rs Distarch adipate, acety lated. . . .. . . . . .. . . Distarch glycerol . . . .. . . . . .. . . . . .. . . . . .. . Distarch glycerol, acety lated. . . .. . . . . .. . L-Ascorbyl palmitate. . . .. . . . . .. . . . . .. . . . Alpha-Tocopherol. . . .. . . . . .. . . . . .. . . . . .. Tocopherols, concentrate, mixed. . . .. . . . 500 m g G ood ma nuf a c tu ring practice 200 m g T he to ta l sodium content of the p r oduct n o t to exceed 200 mg 500 mg, the sodium content not to e xc e e d 200 m g 500 mg/kg, expressed as ascorbic a cid , the total sodium content not to e xc e e d 200 m g 200 m g/kg f a t 300 m g/kg f a t , s ing ly o r in c om b ina t ion 500 m g 1 500 mg /100 g f a t 7 mg Good manufacturing practice, only in c a nne d foodstuffs for young c hi ld r en a nd c hi ld r en 7 mg G ood ma nuf a c tu ring practice 200 m g/kg f a t 300 m g/kg fa t , sing ly o r in c om b ina t ion Emuls if ie rs Lecithin. . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. . Mono- and diglycerides . . . .. . . . . .. . . . . .. Enzy mes Malt carbohydrates. . . .. . . . . .. . . . . .. . . . . . Flav ourants Ethy l vanillin . . . .. . . . . .. . . . . .. . . . . .. . . . . . Natural and nature identical flavourants Vanillin . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . .. . Vanilla-extract. . . .. . . . . .. . . . . .. . . . . .. . . . . 1 500 mg G ood ma nuf a c turing practice 7 mg on a re a dy - to-eat basis Good manufacturing practice, only in c e r ea l- base d foodstuffs for y oung c h i ldr e n a nd children 7 mg on a re a dy - to-eat basis G ood ma nuf a c tu ring practice 10 A NN EX C R EC OMM EN DED DA ILY DIETA R Y A LLOWA NC ES ( R DA ) I n fa n ts Child r en U n it 0 , 0–0 ,5 y r 0 , 5–1 ,0 y r 1–3 y r 4–6 y r 7–10 y r Energy*. . . .. . . . . .. . . . . .. Protein. . . .. . . . . .. . . . . .. . . V ita m in A- a ct iv ity: (1) Vitamin A. . . .. . . . . .. (2) Retinol-equivalent . . Vitamin D. . . .. . . . . .. . . . . Vitamin E-activity . . . .. . Ascorbic acid (Vit. C). . . Biotin (Vit. H). . . .. . . . . .. Fo lic acid. . . .. . . . . .. . . . . . Pantothenic acid. . . .. . . . . Nicotinic acid (Vit. B3). . Riboflavin (Vit. B2). . . .. kJ g I U µg RE I U µg I U m g Ψ TE m g µg µg m g m g m g 480 /kg body mass 2 . 2/kg body mass 2200 420 400 10 4 .5 3 35 35 30 2 6 0 .4 440 /kg body mass 2 . 0/kg body mass 2000 400 400 10 6 4 35 50 45 3 8 0 .6 5600 23 2000 400 400 10 7 .5 5 45 65 100 3 9 0 .8 7100 30 2500 500 400 10 9 6 45 85 200 4 11 1 .0 10000 34 3500 700 400 10 10.4 7 45 120 300 5 16 1 .4 * A ppr ox ima tely 4,2 kilo j ou le s = 1 c a lor ie I n fa n ts Child r en U nit 0 , 0–0 ,5 y r 0 , 5–1 ,0 y r 1–3 y r 4–6 y r 7–10 y r Tiamin (Vit. B1). . . .. . . . . .. . . Py ridoxine (Vit. B6). . . .. . . . . Cyanocobalamin (Vit. B12). . Vitamin K. . . .. . . . . .. . . . . .. . . Calcium. . . .. . . . . .. . . . . .. . . . . Phosphorus. . . .. . . . . .. . . . . .. . Iodine. . . .. . . . . .. . . . . .. . . . . .. . Iron. . . .. . . . . .. . . . . .. . . . . .. . . . Magnesium. . . .. . . . . .. . . . . .. . Copper . . . .. . . . . .. . . . . .. . . . . . Zinc . . . .. . . . . .. . . . . .. . . . . .. . . Potassium. . . .. . . . . .. . . . . .. . . Sodium. . . .. . . . . .. . . . . .. . . . . . Chloride. . . .. . . . . .. . . . . .. . . . . Manganese . . . .. . . . . .. . . . . .. . Fluoride. . . .. . . . . .. . . . . .. . . . . Chromium. . . .. . . . . .. . . . . .. . . Selenium. . . .. . . . . .. . . . . .. . . . Molybdenum. . . .. . . . . .. . . . . . m g m g µg µg m g mg µg m g m g m g m g m g m g m g m g m g m g m g m g 0 .3 0 .3 0 .5 12 360 240 40 10 50 0 .7 3 925 350 700 0 .7 0 .5 0 .04 0 .04 0 .06 0 . 5 0 . 6 1 . 5 15 540 360 50 15 70 1 .0 5 1275 750 1200 1 .0 1 .0 0 .06 0 .06 0 .08 0 .7 0 .9 2 .0 25 800 800 70 15 150 1 .5 10 1650 975 1500 1 .5 1 .5 0 .08 0 .08 0 .1 0 .9 1 .3 2 .5 30 800 800 90 10 200 2 .0 10 2325 1350 2100 2 .0 2 .5 0 .12 0 .12 0 .15 1 .2 1 .6 3 .0 50 800 800 120 10 250 2 .5 10 3000 1800 2775 3 .0 2 .5 0 .2 0 .2 0 .3