Offerynnau Statudol Cymru
2024 Rhif 741 (Cy. 102)
Bwyd, Cymru
Rheoliadau Ychwanegion Bwyd a Bwydydd Newydd (Awdurdodiadau a Diwygiadau Amrywiol) a Chyflasynnau Bwyd (Dileu Awdurdodiadau) (Cymru) 2024
Gwnaed
5 Mehefin 2024
Gosodwyd gerbron Senedd Cymru
7 Mehefin 2024
Yn dod i rym
28 Mehefin 2024
Mae Gweinidogion Cymru yn gwneud y Rheoliadau hyn drwy arfer y pwerau a roddir gan—
Erthyglau 7(4) a (5) a 14A(2)(b) o Reoliad (EC) Rhif 1331/2008 Senedd Ewrop a’r Cyngor sy’n sefydlu gweithdrefn awdurdodi gyffredin ar gyfer ychwanegion bwyd, ensymau bwyd a chyflasynnau bwyd(1);
Erthyglau 12(1) a 32A(3)(b) o Reoliad (EU) 2015/2283 Senedd Ewrop a’r Cyngor ar fwydydd newydd(2).
Mae Gweinidogion Cymru wedi ceisio cyngor gan yr Asiantaeth Safonau Bwyd ac wedi rhoi sylw i’r cyngor hwnnw, fel sy’n ofynnol gan Erthygl 7(4) a (5) o Reoliad (EC) Rhif 1331/2008 (mewn perthynas â Rhannau 2 a 3 o’r Rheoliadau hyn)(3).
Ymgynghorwyd fel sy’n ofynnol gan Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a’r Cyngor sy’n gosod egwyddorion a gofynion cyffredinol cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn gosod gweithdrefnau o ran materion diogelwch bwyd(4).
RHAN 1Cyflwyniad
Enwi, rhychwant, cymhwyso a dod i rym
1.—(1) Enw’r Rheoliadau hyn yw Rheoliadau Ychwanegion Bwyd a Bwydydd Newydd (Awdurdodiadau a Diwygiadau Amrywiol) a Chyflasynnau Bwyd (Dileu Awdurdodiadau) (Cymru) 2024.
(2) Mae’r Rheoliadau hyn—
(a)yn rhychwantu Cymru a Lloegr;
(b)yn gymwys o ran Cymru;
(c)yn dod i rym ar 28 Mehefin 2024.
PART 2Ychwanegion Bwyd
Diwygio Rheoliad (EC) Rhif 1333/2008
2. Mae Rheoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ar ychwanegion bwyd(5) wedi ei ddiwygio yn unol ag Atodlen 1.
Diwygio Rheoliad y Comisiwn (EU) Rhif 231/2012
3.—(1) Yn Rheoliad y Comisiwn (EU) Rhif 231/2012 sy’n gosod manylebau ar gyfer ychwanegion bwyd a restrir yn Atodiadau II a III i Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor(6), mae’r Atodiad wedi ei ddiwygio fel a ganlyn.
(2) Ar y dechrau, ar gyfer “Note: Ethylene oxide may not be used for sterilising purposes in food additives” rhodder—
“Restrictions on ethylene oxide in food additives
Ethylene oxide may not be used for sterilising purposes in food additives.
Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide*), irrespective of origin, in food additives listed in Annexes 2 and 3 to Regulation (EC) No 1333/2008 or mixtures of those food additives, must not exceed 0.1 mg/kg.
* ethylene oxide + (0.55 × 2-chloroethanol)”.
(3) Yn y cofnodion ar gyfer pob un o’r ychwanegion a ganlyn, hepgorer y rhes sy’n ymwneud ag “Ethylene oxide” —
(a)E 431 Polyocsiethylen (40) stearad;
(b)E 432 Polyocsiethylen sorbitan monolawrad (Polysorbad 20);
(c)E 433 Polyocsiethylen sorbitan monoolead (Polysorbad 80);
(d)E 434 Polyocsiethylen sorbitan monopalmitad (Polysorbad 40);
(e)E 435 Polyocsiethylen sorbitan monostearad (Polysorbad 60);
(f)E 436 Polyocsiethylen sorbitan tristearad (Polysorbad 65);
(g)E 1209 Copolymer impiedig o bolyfinyl alcohol-polyethylen glycol;
(h)E 1521 Polyethylen glycol.
(4) Mae Atodlen 2 yn gwneud darpariaeth mewn perthynas â’r fanyleb ar gyfer E 960b glycosidau stefiol o eplesu (Yarrowia lipolytica).
(5) Mae Atodlen 3 yn gwneud darpariaeth mewn perthynas â’r fanyleb ar gyfer E 960c(ii) rebaudiosid M, AM a D a gynhyrchir drwy drosi glycosidau stefiol puredig iawn o echdyniad dail Stevia ag ensymau.
RHAN 3Cyflasynnau Bwyd
Diwygio Rheoliad (EC) Rhif 1334/2008
4.—(1) Yn Rheoliad (EC) Rhif 1334/2008 Senedd Ewrop a’r Cyngor ar gyflasynnau a chynhwysion bwyd penodol â phriodoleddau cyflasu sydd i’w defnyddio mewn bwydydd ac ar fwydydd(7), mae Atodiad 1 (rhestr ddomestig o gyflasynnau a deunyddiau ffynhonnell) wedi ei diwygio fel a ganlyn.
(2) Yn Rhan A (rhestr ddomestig o sylweddau cyflasu), yn Adran 2, yn Nhabl 1, hepgorer y cofnodion ar gyfer y sylweddau cyflasu a ganlyn—
(a)Rhif FL(8) “07.030” enw cemegol “1-(4-Methoxyphenyl) pent-1-en-3-one”;
(b)Rhif FL “07.046” enw cemegol “Vanillylidene acetone”;
(c)Rhif FL “07.049” enw cemegol “1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one”;
(d)Rhif FL “07.206” enw cemegol “4-(2,3,6-Trimethylphenyl)but-3-en-2-one”;
(e)Rhif FL “07.258” enw cemegol “6-Methyl-3-hepten-2-one”;
(f)Rhif FL “10.034” enw cemegol “5,6-Dihydro-3,6-dimethylbenzofuran-2(4H)-one”;
(g)Rhif FL “10.036” enw cemegol “5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one”;
(h)Rhif FL “10.042” enw cemegol “3,4-Dimethyl-5-pentylidenefuran-2(5H)-one”;
(i)Rhif FL “10.043” enw cemegol “2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone”;
(j)Rhif FL “10.046” enw cemegol “Hex-2-eno-1,4-lactone”;
(k)Rhif FL “10.054” enw cemegol “Non-2-eno-1,4-lactone”;
(l)Rhif FL “10.060” enw cemegol “2-Decen-1,4-lactone”;
(m)Rhif FL “10.170” enw cemegol “5-Pentyl-3H-furan-2-one”;
(n)Rhif FL “13.004” enw cemegol “Allyl 2-furoate”;
(o)Rhif FL “13.034” enw cemegol “3-(2-furyl)acrylaldehyde”;
(p)Rhif FL “13.043” enw cemegol “Furfurylidene-2-butanal”;
(q)Rhif FL “13.044” enw cemegol “4-(2-Furyl)but-3-en-2-one”;
(r)Rhif FL “13.046” enw cemegol “3-(2-Furyl)-2-methylprop-2-enal”;
(s)Rhif FL “13.066” enw cemegol “3-Acetyl-2,5-dimethylfuran”;
(t)Rhif FL “13.103” enw cemegol “2-Butylfuran”;
(u)Rhif FL “13.137” enw cemegol “3-(2-Furyl)-2-phenylprop-2-enal”;
(v)Rhif FL “13.150” enw cemegol “3-(5-Methyl-2-furyl)prop-2-enal”.
Darpariaeth drosiannol
5.—(1) Mae’r paragraff hwn yn gymwys i sylweddau cyflasu y cyfeirir atynt yn rheoliad 4(2)(a) i (v) ynghyd â bwyd sy’n eu cynnwys a oedd—
(a)yn bresennol yn y Deyrnas Unedig ac a oedd wedi, neu y gallent fod wedi, eu gosod yn gyfreithlon ar y farchnad ym Mhrydain Fawr cyn diwedd 27 Mehefin 2024, neu
(b)ar dramwy i Brydain Fawr cyn diwedd 27 Mehefin 2024, ac y gallent fod wedi eu mewnforio neu eu symud i mewn i Brydain Fawr yn gyfreithlon a’u gosod ar y farchnad ar y dyddiad hwnnw.
(2) Caiff sylweddau cyflasu a bwyd y mae paragraff (1) yn gymwys iddynt, hyd at eu dyddiad parhauster lleiaf neu eu dyddiad ‘defnyddio erbyn’, gael eu rhoi ar y farchnad ac, yn ôl y digwydd, eu hychwanegu at fwyd arall.
(3) Caiff bwyd sy’n cynnwys un neu ragor o’r sylweddau cyflasu y mae paragraff (1) yn gymwys iddynt, hyd at ei ddyddiad parhauster lleiaf neu ei ddyddiad ‘defnyddio erbyn’, gael ei roi ar y farchnad ac, yn ôl y digwydd, ei ychwanegu at fwyd arall.
(4) Yn y rheoliad hwn—
mae i “dyddiad ‘defnyddio erbyn’” (“‘use by’ date”) yr un ystyr ag “‘use by’ date” yn Erthygl 24 o Reoliad (EU) Rhif 1169/2011 Senedd Ewrop a’r Cyngor ar ddarparu gwybodaeth am fwyd i ddefnyddwyr(9);
mae i “dyddiad parhauster lleiaf” (“date of minimum durability”) yr un ystyr â “date of minimum durability” yn Rheoliad (EU) Rhif 1169/2011 Senedd Ewrop a’r Cyngor ar ddarparu gwybodaeth am fwyd i ddefnyddwyr(10).
(5) Mae i ymadroddion Cymraeg eraill a ddefnyddir yn y rheoliad hwn sy’n cyfateb i ymadroddion Saesneg a ddefnyddir yn Rheoliad (EC) Rhif 1334/2008 Senedd Ewrop a’r Cyngor ar gyflasynnau a chynhwysion bwyd penodol â phriodoleddau cyflasu sydd i’w defnyddio mewn bwydydd ac ar fwydydd yr un ystyr â’r ymadroddion hynny yn y Rheoliad hwnnw.
RHAN 4Bwydydd Newydd
Diwygio Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470
6. Mae Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470 sy’n sefydlu rhestr yr Undeb o fwydydd newydd yn unol â Rheoliad (EU) 2015/2283 Senedd Ewrop a’r Cyngor ar fwydydd newydd(11) wedi ei ddiwygio yn unol ag Atodlenni 4 i 8.
Jayne Bryant
Y Gweinidog Iechyd Meddwl a’r Blynyddoedd Cynnar, o dan awdurdod Ysgrifennydd y Cabinet dros Iechyd a Gofal Cymdeithasol, un o Weinidogion Cymru
5 Mehefin 2024
Rheoliad 2
ATODLEN 1Diwygio’r rhestr ddomestig o ychwanegion bwyd sydd wedi eu cymeradwyo i’w defnyddio mewn bwydydd yn Atodiad 2 i Reoliad (EC) Rhif 1333/2008
Diwygio Rheoliad (EC) Rhif 1333/2008
1. Yn Rheoliad (EC) Rhif 1333/2008, mae Atodiad 2 (rhestr ddomestig o ychwanegion bwyd sydd wedi eu cymeradwyo i’w defnyddio mewn bwydydd) wedi ei ddiwygio fel a ganlyn.
Darpariaeth yn ymwneud ag ychwanegu E 960b (glycosidau stefiol o eplesu) ac E 960c(ii) (rebaudiosid M, AM a D a gynhyrchir drwy drosi glycosidau stefiol puredig iawn o echdyniad dail Stevia ag ensymau) at y rhestr ddomestig
2. Yn Rhan B (rhestr o’r holl ychwanegion), ym mharagraff 2 (melysyddion), yn y tabl, ar ôl y cofnod ar gyfer “E 960a” (glycosidau stefiol o Stevia) mewnosoder y cofnod a ganlyn—
| “E 960b | Steviol glycosides from fermentation”. |
3. Yn Rhan C (diffiniadau o grwpiau o ychwanegion), ym mharagraff 5 (ychwanegion eraill y caniateir eu rheoleiddio yn gyfun), yn is-baragraff (v)—
(a)yn y testun o flaen y tabl, yn lle “E 960a and E 960c: Steviol Glycosides” rhodder “E 960a - E 960c: Steviol glycosides”;
(b)yn y tabl, ar ôl y cofnod ar gyfer “E 960a” (glycosidau stefiol o Stevia) mewnosoder y cofnod a ganlyn—
| “E 960b | Steviol glycosides from fermentation”. |
4. Yn Rhan E (ychwanegion bwyd awdurdodedig ac amodau defnyddio mewn categorïau bwyd), yn y tabl, yn lle “E 960a and E 960c”, ym mhob lle y mae’n digwydd, rhodder “E 960a – E 960c”.
Darpariaeth yn ymwneud â defnydd awdurdodedig newydd, a diwygio defnydd awdurdodedig presennol, ar gyfer E 476 (polyglyserol polyrisinolead)
5. Yn Rhan E (ychwanegion bwyd awdurdodedig ac amodau defnyddio mewn categorïau bwyd), yn y tabl—
(a)yng nghategori 03 (iâ bwytadwy), ar ôl y cofnod ar gyfer “E 473-474” (esterau swcros o asidau brasterog – swcroglyseridau) mewnosoder y cofnod a ganlyn—
| “E 476 | Polyglycerol polyricinoleate | 4000 | except sorbets”; |
(b)yng nghategori 12.6 (sawsiau), yn lle’r cofnod ar gyfer “E 476” (polyglyserol polyrisinolead) rhodder—
| “E 476 | Polyglycerol polyricinoleate | 4000 | only emulsified sauces with a fat content of less than 20% | |
| E 476 | Polyglycerol polyricinoleate | 8000 | only emulsified sauces with a fat content of 20% or more”. |
Diwygiadau amrywiol
6. Yn Rhan E (ychwanegion bwyd awdurdodedig ac amodau defnyddio mewn categorïau bwyd), yn y tabl—
(a)ar ddiwedd categori 05.1 (cynhyrchion coco a siocled), yn y lle priodol, mewnosoder y troednodyn a ganlyn—
| “(1): The additives may be added individually or in combination”; |
(b)yng nghategori 05.2 (melysion eraill gan gynnwys microfelysion ar gyfer puro’r anadl)—
(i)yn y trydydd cofnod ar gyfer “Group IV” (polyolau), yn lle “only cocoa or dried fruit-based, milk or fat-based sandwich spreads,” rhodder “sandwich spreads made with a base of cocoa, milk, dried fruit or fat;”;
(ii)yn y cofnod cyntaf ar gyfer “E 960a – E 960c” (glycosidau stefiol) fel y’i diwygir gan baragraff 4 o’r Atodlen hon, yn lle “only cocoa or dried-fruit-based” rhodder “only cocoa or dried fruit based”;
(iii)yn yr ail gofnod ar gyfer “E 960a – E 960c” (glycosidau stefiol) fel y’i diwygir gan baragraff 4 o’r Atodlen hon, yn lle “only cocoa, milk, dried-fruit-based or fat-based sandwich spreads,” rhodder “sandwich spreads made with a base of cocoa, milk, dried fruit or fat;”;
(c)yng nghategori 05.4 (addurniadau, caenau a llenwadau, ac eithrio llenwadau wedi eu seilio ar ffrwythau a gwmpesir gan gategori 4.2.4), yn yr ail gofnod ar gyfer “E 960a – E 960c” (glycosidau stefiol) fel y’i diwygir gan baragraff 4 o’r Atodlen hon, yn lle “only cocoa or dried-fruit-based,” rhodder “only cocoa or dried fruit based;”.
Rheoliad 3(4)
ATODLEN 2Diwygio’r Atodiad i Reoliad (EU) Rhif 231/2012 ar gyfer ychwanegu manyleb ar gyfer E 960b glycosidau stefiol o eplesu (Yarrowia lipolytica)
1. Yn Rheoliad y Comisiwn (EU) Rhif 231/2012, mae’r Atodiad (manylebau ar gyfer ychwanegion bwyd) wedi ei ddiwygio fel a ganlyn.
2. Ar ôl y cofnod ar gyfer “E 960a” (glycosidau stefiol o Stevia), mewnosoder y cofnod a ganlyn—
“E 960b STEVIOL GLYCOSIDES FROM FERMENTATION (YARROWIA LIPOLYTICA)
| Synonyms | |||
| Definition | Steviol glycosides from Yarrowia lipolytica consist of a mixture predominantly composed of rebaudioside M, with some rebaudioside D, and smaller amounts of rebaudioside A and rebaudioside B. The manufacturing process comprises two main phases. The first phase involves fermentation of a non-toxigenic non-pathogenic strain of Yarrowia lipolytica VRM that has been genetically modified with heterologous genes to overexpress steviol glycosides. Removal of biomass by solid-liquid separation and heat treatment is followed by concentration of the steviol glycosides. The second phase involves purification by employing ion-exchange chromatography, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95% of rebaudiosides M, D, A, and B. Viable cells or the DNA of Yarrowia lipolytica VRM must not be detected in the food additive. | ||
| Chemical name | Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Rebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid Rebaudioside D: 13-[(2- O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3- O-β-D-glucopyranosyl-β-D-glucopyranosyl ester | ||
| Molecular formula | Trivial name | Formula | Conversion factor |
| Rebaudioside A | C 44H 70O 23 | 0.33 | |
| Rebaudioside B | C 38H 60O 18 | 0.40 | |
| Rebaudioside D | C 50H 80O 28 | 0.29 | |
| Rebaudioside M | C 56H 90O 33 | 0.25 | |
| Molecular weight and CAS number | Trivial name | CAS Number | Molecular weight (g/mol) |
| Rebaudioside A | 58543-16-1 | 967.01 | |
| Rebaudioside B | 58543-17-2 | 804.88 | |
| Rebaudioside D | 63279-13-0 | 1129.15 | |
| Rebaudioside M | 1220616-44-3 | 1291.29 | |
| Assay | Not less than 95% of rebaudioside M, rebaudioside D, rebaudioside A, and rebaudioside B on the dried basis. | ||
| Description | White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5% sucrose equivalency) | ||
| Identification | |||
|---|---|---|---|
| Solubility | Freely soluble to slightly soluble in water | ||
| pH | Between 4.5 and 7.0 (1 in 100 solution) | ||
| Purity | |||
| Total ash | Not more than 1% | ||
| Loss on drying | Not more than 6% (105 °C, 2h) | ||
| Residual solvent | Not more than 5000 mg/kg ethanol | ||
| Arsenic | Not more than 0.1 mg/kg | ||
| Lead | Not more than 0.1 mg/kg | ||
| Cadmium | Not more than 0.01 mg/kg | ||
| Mercury | Not more than 0.05 mg/kg | ||
| Residual protein | Not more than 20 mg/kg | ||
| Microbiological criteria | |||
| Total (aerobic) plate count | Not more than 1000 CFU/g | ||
| Yeast | Not more than 100 CFU/g | ||
| Moulds | Not more than 100 CFU/g | ||
| Escherichia coli | Negative in 1g | ||
| Salmonella spp. | Negative in 25g”. | ||
Rheoliad 3(5)
ATODLEN 3Diwygio’r Atodiad i Reoliad (EU) Rhif 231/2012 ynghylch ailrifo ychwanegyn E 960c(i) (E 960c yn flaenorol) ac ar gyfer ychwanegu manyleb ar gyfer E 960c(ii) rebaudiosid M, AM a D a gynhyrchir drwy drosi glycosidau stefiol puredig iawn o echdyniad dail Stevia ag ensymau
1. Yn Rheoliad y Comisiwn (EU) Rhif 231/2012, mae’r Atodiad (manylebau ar gyfer ychwanegion bwyd) wedi ei ddiwygio fel a ganlyn.
2. Ym mhennawd y cofnod ar gyfer “E 960c” (rebaudiosid M a gynhyrchir drwy addasu glycosidau stefiol o Stevia ag ensymau) yn lle “E 960c” rhodder “E 960c(i)”.
3. Ar ôl y cofnod ar gyfer “E 960c(i)”, fel y’i diwygir gan baragraff 2 o’r Atodlen hon, mewnosoder y cofnod a ganlyn—
“E 960c(ii) REBAUDIOSIDE M, AM AND D PRODUCED VIA ENZYMATIC CONVERSION OF HIGHLY PURIFIED STEVIOL GLYCOSIDES FROM STEVIA LEAF EXTRACTS
| Synonyms | |||
| Definition | Steviol glycosides produced via enzymatic conversion of highly purified steviol glycosides (rebaudioside A or stevioside) from Stevia leaf extracts are composed predominantly of rebaudioside M, rebaudioside D, and rebaudioside AM. Rebaudiosides D, M and AM are produced via enzymatic conversion of highly purified steviol glycoside (rebaudioside A or stevioside) extracts (95% steviol glycosides) obtained from Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by genetically modified strains of Escherichia coli (pPM294, pFAH170, and pSK041) that facilitate the transfer of glucose from sucrose and UDP-glucose to steviol glycosides via glycosidic bonds. After removal of the enzymes by solid-liquid separation and heat treatment, the purification involves concentration of the steviol glycosides by resin adsorption, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95 % of total steviol glycosides, including one or more of rebaudiosides D, M and AM. Viable cells or DNA of Escherichia coli (pPM294, pFAH170, and pSK041) must not be detected in the food additive. | ||
| Chemical Name | Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3- O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside AM: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester | ||
| Molecular formula | Trivial name | Formula | Conversion factor |
| Rebaudioside M | C 56H 90O 33 | 0.25 | |
| Rebaudioside D | C 50H 80O 28 | 0.29 | |
| Rebaudioside AM | C 50H 80O 28 | 0.29 | |
| Molecular weight and CAS Number | Trivial name | CAS Number | Molecular weight (g/mol) |
| Rebaudioside M | 1220616-44-3 | 1291.29 | |
| Rebaudioside D | 63279-13-0 | 1129.15 | |
| Rebaudioside AM | 2222580-26-7 | 1129.15 | |
| Assay | Not less than 95 % of steviol glycosides on the dried basis, including one or more of rebaudiosides D, M and AM. | ||
| Description | White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5 % sucrose equivalency) | ||
| Identification | |||
|---|---|---|---|
| Solubility | Freely soluble to slightly soluble in water | ||
| pH | Between 4.5 and 7.0 (1 in 100 solution) | ||
| Purity | |||
| Total ash | Not more than 1 % | ||
| Loss on drying | Not more than 6 % (105 °C, 2h) | ||
| Residual solvent | Not more than 5000 mg/kg ethanol | ||
| Arsenic | Not more than 0.015 mg/kg | ||
| Lead | Not more than 0.2 mg/kg | ||
| Cadmium | Not more than 0.015 mg/kg | ||
| Mercury | Not more than 0.07 mg/kg | ||
| Residual protein | Not more than 5 mg/kg”. | ||
Rheoliad 6
ATODLEN 4Diwygio’r rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 ar gyfer awdurdodi protein wedi ei hydroleiddio’n rhannol o haidd a ddisbyddwyd (Hordeum vulgare) a reis a ddisbyddwyd (Oryza sativa) fel bwyd newydd
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Astaxanthin-rich oleoresin from Haematococcus pluvialis algae” mewnosoder y cofnod a ganlyn—
| “Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) | Specified food category Bread and similar products Fine bakery wares Breakfast cereals Margarines and similar Butter and margarine/oil blends Pasta and rice (and other cereal)-based dishes Fried or extruded cereal, seed, and root-based products Fruit/vegetable spreads and similar Confectionary including chocolate Dairy imitates Milk and dairy products Dessert sauces/ toppings Syrups (molasses and other syrups) Meat analogues Soups (marketed as such or reconstituted as instructed by the manufacturer) Stock cubes and granules (bouillon base) Gravy ingredients Savoury sauces Condiments (including table-top formats) Hummus Nut/seeds paste/emulsion/mass Energy drinks Carbohydrate-rich energy food products for sports people Protein and protein components for sports people Meal replacement for weight control | Maximum levels 15 g/100 g 15 g/100 g 30 g/100 g 10 g/100 g 10 g/100 g 30 g/100 g 30 g/100 g 30 g/100 g 15 g/100 g 50 g/100 ml (beverages) 50 g/100 g (products other than beverages) 50 g/100 ml (beverages) 50 g/100 g (products other than beverages) 15 g/100 g 15 g/100 g 30 g/100 g 15 g/100 g 15 g/100 g 10 g/100 g 10 g/100 g 10 g/100 g 30 g/100 g 20 g/100 g 90 g/100 ml 30 g/100 g 90 g/100 g 90 g/100 g | The designation of the novel food on the labelling of food containing it is “partially hydrolysed protein from spent barley and rice”. | Included in the list on 28 June 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Evergrain LLC, 1 Busch Place, St. Louis, Missouri 63118, USA. During the period of data protection, partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) is authorised for placing on the market, within Wales, only by Evergrain LLC unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Evergrain LLC. The data protection will expire at the end of 27 June 2029.” |
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3. Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Astaxanthin-rich oleoresin from Haematococcus pluvialis algae” mewnosoder y cofnod a ganlyn—
| “Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) | Description/Definition Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) is an off-white powder, produced by concentration of proteins from a mixture of barley and rice from the mash step of beer production using a series of enzymatic hydrolysis and mechanical purification steps. |
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| Characteristics/Composition Protein (dry basis): ≥ 85% Moisture: < 8% Total Carbohydrates: < 10% Fat: < 2% Ash: < 8% | |
| Heavy metals Arsenic: < 0.1 mg/kg Cadmium: < 0.1 mg/kg Lead: < 0.2 mg/kg Mercury: < 0.1 mg/kg | |
| Microbiological criteria Aerobic plate count: < 30,000 CFU/g Coliforms: < 10 CFU/g Yeast and mould: < 50 CFU/g Salmonella spp.: Negative in 25 g Escherichia coli: < 10 CFU/g Staphylococcus aureus: < 10 CFU/g Listeria spp.: Negative in 25 g CFU: Colony Forming Units”. |
Rheoliad 6
ATODLEN 5Diwygio’r rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 ar gyfer awdurdodi asidau brasterog wedi eu setyleiddio fel bwyd newydd
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Calanus finmarchicus oil” mewnosoder y cofnod a ganlyn—
| “Cetylated fatty acids | Specified food category Food supplements as defined in the Food Supplements (Wales) Regulations 2003(12) for persons aged 18 years or above | Maximum levels 2.1 g/day | The designation of the novel food on the labelling of food containing it is “cetylated fatty acids preparation”. The labelling of food supplements must bear a statement that they should not be consumed by persons under 18 years of age. | Included in the list on 28 June 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Pharmanutra S.p.A, Via Delle Lenze 216/b, 56122 Pisa, Italy. During the period of data protection, cetylated fatty acids is authorised for placing on the market, within Wales, only by Pharmanutra S.p.A unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmanutra S.p.A. The data protection will expire at the end of 27 June 2029.” |
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3. Yn Nhabl 2, (manylebau), ar ôl y cofnod ar gyfer “Calanus finmarchicus oil” mewnosoder y cofnod a ganlyn—
| “Cetylated Fatty Acids | Description/Definition The novel food is a mixture of 70 – 80% cetylated fatty acids which are produced from the reaction of cetyl alcohol with myristic acid and oleic acid. Characteristics/Composition Physical status at 25°C: Solid Colour (APHA Colour): ≤ 600 Acid value (mg KOH/g): ≤ 5 Iodine value (I 2g/100g): 30 – 50 Saponification value (mg KOH/g): 130 – 150 Hydroxyl value (mg KOH/g): ≤ 20 Ester content (%): 70 – 80 Cetyl oleate (%): 22 – 30 Cetyl myristate (%): 41 – 56 Triglycerides (%): 22 – 25 Microbiological criteria Total aerobic microbial count (CFU/g): ≤ 1000 Yeasts and moulds (CFU/g): ≤ 100 APHA: American Public Health Association KOH: potassium hydroxide CFU: Colony Forming Units”. |
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Rheoliad 6
ATODLEN 6Diwygio’r rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 ar gyfer awdurdodi 3-ffwcosyl-lactos (3-FL) (a gynhyrchir gan straen deilliannol o Escherichia coli K-12 DH1) fel bwyd newydd
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” mewnosoder y cofnod a ganlyn—
| “3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) | Specified food category Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products Unflavoured fermented milk-based products Flavoured fermented milk-based products including heat-treated products Cereal bars Infant formula and follow-on formula as defined in Regulation (EU) No609/2013 (13) Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food for special medical purposes as defined in Regulation (EU) No609/2013 Total diet replacement for weight control as defined in Regulation (EU) No609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 intended for infants (persons under the age of 1 year (12 months)) and young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 excluding food supplements for infants and young children | Maximum levels 2.0 g/l 2.0 g/l (beverages) 4.0 g/kg (products other than beverages) 2.0 g/l (beverages) 12.0 g/kg (products other than beverages) 25.0 g/kg 2.0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 2.0 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 12.0 g/kg (products other than beverages) In accordance with the particular nutritional requirements of the persons for whom the products are intended 2.0 g/l (beverages) 25.0 g/kg (products other than beverages) 1.25 g/l 2.0 g/day 4.0 g/day | The designation of the novel food on the labelling of food containing it is “3-fucosyllactose”. The labelling of food supplements intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added 3-fucosyllactose is consumed on the same day. | Included in the list on 28 June 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, 2970 Hørsholm, Denmark. During the period of data protection, 3-fucosyllactose is authorised for placing on the market, within Wales, only by Glycom A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 27 June 2029.” |
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3. Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” mewnosoder y cofnod a ganlyn—
| “3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) | Description/Definition 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose on a dry matter basis obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1. Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose Chemical formula: C18H32O15 Molecular mass: 488.44 Da CAS No: 41312-47-4 Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) – Specified saccharides (includes 3-FL, D-lactose, L-fucose, and 3-fucosyllactulose): ≥ 92.0 % (w/w) Assay (water-free) – 3-FL: ≥ 90.0 % (w/w) L-Fucose: ≤ 1.0 % (w/w) D-Lactose: ≤ 5.0 % (w/w) 3-Fucosyllactulose: ≤ 1.5 % (w/w) Sum of other carbohydrates: ≤ 5.0 % (w/w) pH in 5% solution (20°C): 3.2 – 7.0 Water: ≤ 6.0 % (w/w) Ash, sulphated: ≤ 0.5 % (w/w) Acetic acid (relevant for crystallised 3-FL): ≤ 1.0 % (w/w) Residual protein by Bradford assay: ≤ 0.01 % (w/w) Residual endotoxins: ≤ 10 EU/mg Heavy metals Lead: ≤ 0.1 mg/kg Arsenic: ≤ 0.2 mg/kg Mycotoxins Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: absent in 10g Salmonella spp.: absent in 25g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: absent in 25g Cronobacter spp.: absent in 10g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g EU: Endotoxin Units CFU: Colony Forming Units”. |
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Rheoliad 6
ATODLEN 7Diwygio’r rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 ar gyfer awdurdodi cymysgedd lacto-N-ffwcopentaos I (LNFP-I) a 2’-ffwcosyl-lactos (2’-FL) fel bwyd newydd
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Lactitol” mewnosoder y cofnod a ganlyn—
| “Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture | Specified food category Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products Unflavoured fermented milk-based products Flavoured fermented milk-based products including heat-treated products Cereal bars Infant formula and follow-on formula as defined in Regulation (EU) No609/2013 Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No609/2013 Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food for special medical purposes as defined in Regulation (EU) No609/2013 Total diet replacement for weight control as defined in Regulation (EU) No609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months)) and young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 excluding supplements for infants and young children | Maximum levels of LNFP-I 1.0 g/l 1.0 g/l (beverages) 2.0 g/kg (products other than beverages) 1.0 g/l (beverages) 10.0 g/kg (products other than beverages) 10.0 g/kg 1.5 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 1.0 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 8.33 g/kg (products other than beverages) 1.2 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 10.0 g/kg (products other than beverages) In accordance with the particular nutritional requirements of the persons for whom the products are intended 2.0 g/l (beverages) 20.0 g/kg (products other than beverages) 1.0 g/l 1.5 g/day 3.0 g/day | The designation of the novel food on the labelling of food containing it is “lacto-N-fucopentaose I and 2’-fucosyllactose mixture”. The labelling of food supplements intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added lacto-N-fucopentaose I (LNFP-I) or 2’-fucosyllactose (2’-FL) is consumed on the same day. The labelling of food supplements must bear a statement that they should not be consumed if food with added lacto-N-fucopentaose I (LNFP-I) or 2’-fucosyllactose (2’-FL) is consumed on the same day. | Included in the list on 28 June 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, 2970 Hørsholm, Denmark. During the period of data protection, lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) is authorised for placing on the market, within Wales, only by Glycom A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 27 June 2029.” |
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3. Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Lactitol” mewnosoder y cofnod a ganlyn—
| “Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture | Description/Definition Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture is a purified carbohydrate powder or agglomerate obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1 containing at least 75% of LNFP-I and 2’-FL of dry matter, where ≥ 50% is LNFP-I (dry weight) and ≥ 15% is 2’-FL (dry weight). Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) Specified saccharides (includes LNFP-I, 2’-FL, lacto- N-tetraose, difucosyl-D-lactose, 3-fucosyllactose, D-lactose, L-fucose and 2’-fucosyl-lactitol, LNFP-I fructose isomer, and 2’-fucosyl-D-lactulose): ≥ 90.0 % (w/w) Assay (water-free) – LNFP-I and 2’-FL: ≥ 75.0 % (w/w) Assay (water-free) – LNFP-I: ≥ 50.0 % (w/w) Assay (water-free) – 2’-FL: ≥ 15.0 % (w/w) Lacto- N-tetraose: ≤ 5.0 % (w/w) 3-Fucosyllactose: ≤ 1.0 % (w/w) Sum of L-Fucose and 2’-fucosyl-lactitol: ≤ 1.0 % (w/w) D-Lactose: ≤ 10.0 % (w/w) Difucosyl-D-lactose: ≤ 2.0 % (w/w) LNFP-I fructose isomer: ≤ 1.5 % (w/w) 2’-Fucosyl-D-lactulose: ≤ 1.0 % (w/w) Sum of other carbohydrates: ≤ 6.0 % (w/w) pH in 5% solution (20°C): 4.0–7.0 Water: ≤ 8.0 % (w/w) Ash, sulphated: ≤ 0.5 % (w/w) Residual protein by Bradford assay: ≤ 0.01 % (w/w) Heavy metals Arsenic: ≤ 0.2 mg/kg Mycotoxins Residual endotoxins: ≤ 10 EU/mg Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: Absent in 10g Salmonella spp.: Absent in 25 g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: Absent in 25g Cronobacter spp.: Absent in 10g EU: Endotoxin Units CFU: Colony Forming Units”. |
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Rheoliad 6
ATODLEN 8Cywiro cofnodion presennol yn y rhestr o fwydydd newydd yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
Cywiro’r cofnod yn Nhabl 1 ar gyfer “Bovine milk basic whey protein isolate”
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), yn lle’r cofnod ar gyfer “Bovine milk basic whey protein isolate” rhodder—
| “Bovine milk basic whey protein isolate | Specified food category Infant formula as defined in Regulation (EU) No609/2013 Follow-on formula as defined in Regulation (EU) No609/2013 Total diet replacement for weight control as defined in Regulation (EU) No609/2013 Food for special medical purposes as defined in Regulation (EU) No609/2013 Food supplements as defined in the Food Supplements (Wales) Regulations 2003 | Maximum levels 30 mg/100 g (powder) 3.9 mg/100 ml (reconstituted) 30 mg/100 g (powder) 4.2 mg/100 ml (reconstituted) 300 mg/day 30 mg/100g (powder formula for infants (persons under the age of 1 year (12 months)) during first months of life until the introduction of appropriate complementary feeding) 3.9 mg/100ml (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding) 30 mg/100g (powder formula for infants when appropriate complementary feeding is introduced) 4.2 mg/100ml (reconstituted formula for infants when appropriate complementary feeding is introduced) 58 mg/day for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) 380 mg/day for children and adolescents (persons aged 3 years (36 months) up to 18 years of age) 610 mg/day for persons aged 18 years or above 25 mg/day for infants (persons under the age of 1 year (12 months)) 58 mg/day for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) 250 mg/day for children and adolescents (persons aged 3 years (36 months) up to 18 years of age) 610mg/day for persons aged 18 years or above | The designation of the novel food on the labelling of food containing it is “Milk whey protein isolate”. The labelling of food supplements must bear a statement, as appropriate, that they should not be consumed by infants (persons under the age of 1 year)/infants or young children (persons under the age of 3 years)/infants, children or adolescents (persons under the age of 18 years).” |
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Cywiro’r fanyleb yn Nhabl 2 ar gyfer “Xylo-oligosaccharides”
3. Yn Nhabl 2 (manylebau), yn y cofnod ar gyfer “Xylo-oligosaccharides”, yng ngholofn 2 (nodweddion/cyfansoddiad), ar ôl y rhes yn ymwneud â “Moisture (%)” mewnosoder y rhes a ganlyn—
| “Dry material (%) | - | - | 70 – 75”. |
NODYN ESBONIADOL
(Nid yw’r nodyn hwn yn rhan o’r Rheoliadau)
Mae’r Rheoliadau hyn yn gwneud darpariaeth, o ran Cymru, ynghylch awdurdodiadau cynhyrchion bwyd rheoleiddiedig.
Gwneir Rhan 2 o’r Rheoliadau hyn (rheoliadau 2 a 3 ac Atodlenni 1 i 3) drwy arfer pwerau yn Rheoliad (EC) Rhif 1331/2008 sy’n sefydlu gweithdrefn awdurdodi gyffredin ar gyfer ychwanegion bwyd, ensymau bwyd a chyflasynnau bwyd (EUR 2008/1331). Mae rheoliad 2 ac Atodlen 1 yn diweddaru, o ran Cymru, y rhestr ddomestig o ychwanegion bwyd sydd wedi eu cymeradwyo i’w defnyddio mewn bwydydd yn Atodiad 2 i Reoliad (EC) Rhif 1333/2008 ar ychwanegion bwyd (EUR 2008/1333). Mae rheoliad 3 ac Atodlenni 2 a 3 yn diwygio, o ran Cymru, Reoliad y Comisiwn (EU) Rhif 231/2012 sy’n gosod manylebau ar gyfer ychwanegion bwyd a restrir yn Atodiadau II a III i Reoliad (EC) Rhif 1333/2008 (EUR 2012/231).
Mae’r diwygiadau a wneir yn Rhan 2 o’r Rheoliadau hyn yn darparu ar gyfer—
awdurdodi, o ran Cymru, osod ar y farchnad a defnyddio’r ychwanegyn bwyd E 960b glycosidau stefiol o eplesu (Yarrowia lipolytica);
awdurdodi, o ran Cymru, ddull cynhyrchu newydd ar gyfer ychwanegyn awdurdodedig sy’n bodoli eisoes: E 960c glycosidau stefiol a gynhyrchir yn ensymatig. Mae’r fanyleb ar gyfer y dull cynhyrchu sy’n bodoli eisoes yn yr Atodiad i EUR 2012/231 wedi ei hailrifo’n E 960c(i). Mae’r fanyleb ar gyfer y dull cynhyrchu newydd wedi ei mewnosod fel “E 960c(ii) rebaudioside M, AM and D produced via enzymatic conversion of highly purified steviol glycosides from Stevia leaf extracts”;
awdurdodi, o ran Cymru, ddefnydd newydd (iâ bwytadwy) ar gyfer yr ychwanegyn bwyd E 476 polyglyserol polyrisinolead, a diwygio defnydd awdurdodedig sy’n bodoli eisoes (sawsiau);
cyflwyno uchafswm terfyn gweddillion o 0.1 mg/kg ar gyfer gweddillion ethylen ocsid sy’n gymwys i bob ychwanegyn bwyd awdurdodedig;
mân gywiriadau amrywiol i Atodiad 2 i EUR 2008/1333.
Gwneir Rhan 3 o’r Rheoliadau hyn hefyd drwy arfer pwerau yn EUR 2008/1331. Mae rheoliad 4 yn dileu, o ran Cymru, 22 o sylweddau cyflasu o’r rhestr ddomestig o sylweddau cyflasu awdurdodedig yn Atodiad 1 i Reoliad (EC) Rhif 1334/2008 ar gyflasynnau a chynhwysion bwyd penodol â phriodoleddau cyflasu sydd i’w defnyddio mewn bwydydd ac ar fwydydd (EUR 2008/1334). Mae rheoliad 5 yn gwneud darpariaeth drosiannol i ganiatáu i gynhyrchion sy’n bodoli eisoes sy’n cynnwys y sylweddau hyn barhau i gael eu marchnata a’u defnyddio tan eu dyddiad parhauster lleiaf (dyddiad ‘ar ei orau cyn’) neu ddyddiad ‘defnyddio erbyn’.
Gwneir Rhan 4 o’r Rheoliadau hyn (rheoliad 6 ac Atodlenni 4 i 8) drwy arfer pwerau yn Rheoliad (EU) 2015/2283 ar fwydydd newydd (EUR 2015/2283). Mae Rhan 4 yn diweddaru, o ran Cymru, y rhestr o fwydydd newydd awdurdodedig yn yr Atodiad i Reoliad Gweithredu’r Comisiwn (EU) 2017/2470 sy’n sefydlu rhestr yr Undeb o fwydydd newydd (EUR 2017/2470)—
Mae Atodlen 4 yn mewnosod cofnod newydd, sy’n awdurdodi rhoi ar y farchnad brotein wedi ei hydroleiddio’n rhannol o haidd a ddisbyddwyd (Hordeum vulgare) a reis a ddisbyddwyd (Oryza sativa) fel bwyd newydd i’w ddefnyddio yn y categorïau bwyd penodedig.
Mae Atodlen 5 yn mewnosod cofnod newydd, sy’n awdurdodi rhoi ar y farchnad asidau brasterog wedi eu setyleiddio fel bwyd newydd i’w ddefnyddio mewn atchwanegiadau bwyd ar gyfer oedolion yn unig.
Mae Atodlen 6 yn mewnosod cofnod newydd, sy’n awdurdodi rhoi ar y farchnad 3-ffwcosyl-lactos (3-FL) (o straen o Escherichia coli K-12 DH1) fel bwyd newydd i’w ddefnyddio yn y categorïau bwyd penodedig.
Mae Atodlen 7 yn mewnosod cofnod newydd, sy’n awdurdodi rhoi ar y farchnad gymysgedd lacto-N-ffwcopentaos I (LNFP-I) a 2’-ffwcosyl-lactos (2’-FL) fel bwyd newydd i’w ddefnyddio yn y categorïau bwyd penodedig.
Mae Atodlen 8 yn cywiro gwallau mewn cofnodion presennol—
Yn Nhabl 1 yn unig, disodlir y cofnod presennol ar gyfer “bovine milk basic whey protein isolate” er mwyn mynd i’r afael â gwallau fformadu yn y cofnod presennol.
Yn Nhabl 2 yn unig, diwygir y fanyleb ar gyfer Sylo-oligosacaridau er mwyn ychwanegu’r paramedr ar gyfer “Dry material (%)”, a oedd ar goll o’r cofnod presennol.
Ystyriwyd Cod Ymarfer Gweinidogion Cymru ar gynnal Asesiadau Effaith Rheoleiddiol mewn perthynas âʼr Rheoliadau hyn. O ganlyniad, ystyriwyd nad oedd yn angenrheidiol cynnal asesiad effaith rheoleiddiol o’r costau a’r manteision sy’n debygol o ddeillio o gydymffurfio â’r Rheoliadau hyn.
EUR 2008/1331, a ddiwygiwyd gan O.S. 2019/860, 2022/1351. Diwygiwyd O.S. 2019/860 gan O.S. 2020/1504. Diffinnir y termau “domestic list”, “prescribe” ac “appropriate authority” yn Erthygl 2 o EUR 2008/1331. Diffinnir y term “sectoral food law” yn Erthygl 1(2) o EUR 2008/1331. Mewn perthynas â Rhan 2 o’r Rheoliadau hyn, mae Erthygl 7(5) o EUR 2008/1331 yn gymwys yn unol ag Erthyglau 10(3), 14 a 30(4) o Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ar ychwanegion bwyd (EUR 2008/1333). Mewn perthynas â Rhan 3 o’r Rheoliadau hyn, mae Erthygl 7(4) o EUR 2008/1331 yn gymwys yn unol ag Erthygl 11(3) o Reoliad (EC) Rhif 1334/2008 Senedd Ewrop a’r Cyngor ar gyflasynnau a chynhwysion bwyd penodol â phriodoleddau cyflasu sydd i’w defnyddio mewn bwydydd ac ar fwydydd (EUR 2008/1334).
EUR 2015/2283, a ddiwygiwyd gan O.S. 2019/702; mae offerynnau diwygio eraill ond nid yw’r un ohonynt yn berthnasol. Diwygiwyd O.S. 2019/702 gan O.S. 2020/1504. Diffinnir y termau “prescribe”, “appropriate authority” a “list” yn Erthygl 3 o EUR 2015/2283. Mae Erthygl 12(1) o EUR 2015/2283 yn gymwys yn unol ag Erthyglau 9 a 27(1) o’r Rheoliad hwnnw.
Diffinnir y term “Authority” yn Erthygl 2(3) o EUR 2008/1331.
EUR 2002/178, a ddiwygiwyd gan O.S. 2019/641; mae offerynnau diwygio eraill ond nid yw’r un ohonynt yn berthnasol.
EUR 2008/1333; yr offerynnau diwygio perthnasol yw O.S. 2019/860, 2023/343 (Cy. 50). Diwygiwyd O.S. 2019/860 gan O.S. 2020/1504.
EUR 2012/231; yr offerynnau diwygio perthnasol yw O.S. 2019/860, 2023/343 (Cy. 50). Diwygiwyd O.S. 2019/860 gan O.S. 2020/1504.
EUR 2008/1334; yr offerynnau diwygio perthnasol yw O.S. 2019/860, 2023/343 (Cy. 50). Diwygiwyd O.S. 2019/860 gan O.S. 2020/1504.
Rhif adnabod unigryw a ddyrannwyd gan Awdurdod Diogelwch Bwyd Ewrop o dan system wybodaeth yr UE am gyflasynnau, “FLAVIS”.
EUR 2011/1169; yr offerynnau diwygio perthnasol yw O.S. 2019/529, 778, 2020/1627. Diwygiwyd O.S. 2019/529 gan O.S. 2020/1501.
Diffinnir y term “date of minimum durability of a food” yn Erthygl 2(2)(r) o EUR 2011/1169 ond gweler hefyd Erthyglau 9(1)(f) a 24.
EUR 2017/2470; yr offerynnau diwygio perthnasol yw O.S. 2019/702, 2022/575 (Cy. 133), 2023/343 (Cy. 50).
O.S. 2003/1719 (Cy. 186), y mae diwygiadau iddo nad ydynt yn berthnasol i’r Rheoliadau hyn.
EUR 2013/609, a ddiwygiwyd gan O.S. 2019/651, 2023/28. Diwygiwyd O.S. 2019/651 gan O.S. 2020/1476, 2023/28.