
2022 Rhif 575 (Cy. 133)
Bwyd, Cymru
Rheoliadau Bwydydd Newydd (Awdurdodiadau) a Chyflasynnau Mwg (Addasu Awdurdodiadau) (Cymru) 2022
Gwnaed 24 Mai 2022
Gosodwyd gerbron Senedd Cymru 27 Mai 2022
Yn dod i rym yn unol â rheoliad 1(3) a (4)

Mae Gweinidogion Cymru yn gwneud y Rheoliadau a ganlyn drwy arfer y pwerau a roddir gan Erthyglau 12(1) a 32A(3) o, ac yn unol ag Erthyglau 9 a 27(1) o, Reoliad (EU) 2015/2283 Senedd Ewrop a’r Cyngor ar fwydydd newydd; ac Erthygl 11(4) o Reoliad (EC) Rhif 2065/2003 Senedd Ewrop a’r Cyngor ar gyflasynnau mwg a ddefnyddir neu y bwriedir iddynt gael eu defnyddio mewn bwydydd neu arnynt.

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, ymgynghorwyd yn agored ac yn dryloyw â’r cyhoedd wrth lunio a gwerthuso’r Rheoliadau hyn.
RHAN 1 Cyflwyniad
Enwi, rhychwant, cymhwyso a chychwyn
1 

(1) Enw’r Rheoliadau hyn yw Rheoliadau Bwydydd Newydd (Awdurdodiadau) a Chyflasynnau Mwg (Addasu Awdurdodiadau) (Cymru) 2022.
(2) Mae’r Rheoliadau hyn—
(a) yn rhychwantu Cymru a Lloegr;
(b) yn gymwys o ran Cymru.
(3) Daw Rhannau 1 a 3 o’r Rheoliadau hyn i rym ar 18 Mehefin 2022.
(4) Daw Rhan 2 o’r Rheoliadau hyn i rym ar 30 Mehefin 2022.
RHAN 2 Bwydydd Newydd
Diwygio 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
2 
Yn 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, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio yn unol ag Atodlenni 1 i 5.
RHAN 3 Cyflasynnau Mwg
Diwygio Rheoliad Gweithredu’r Comisiwn (EU) Rhif 1321/2013 sy’n sefydlu rhestr yr Undeb o gynhyrchion cynradd a awdurdodir i greu cyflas mwg i’w defnyddio yn y modd hwnnw mewn bwydydd neu arnynt a/neu i gynhyrchu cyflasynnau mwg deilliedig
3 
Yn Rheoliad Gweithredu’r Comisiwn (EU) Rhif 1321/2013 sy’n sefydlu rhestr yr Undeb o gynhyrchion cynradd a awdurdodir i greu cyflas mwg i’w defnyddio yn y modd hwnnw mewn bwydydd neu arnynt a/neu i gynhyrchu cyflasynnau mwg deilliedig, mae’r Atodiad (rhestr ddomestig o gyflasynnau mwg awdurdodedig) wedi ei ddiwygio yn unol â rheoliadau 4 i 8.
Addasu’r awdurdodiad ar gyfer “Scansmoke PB 1110”
4 
Yn yr awdurdodiad ar gyfer “Scansmoke PB 1110” (cod unigryw “SF-001”), yng ngholofn 2, yn lle’r cofnodion sy’n cyfateb i “Name of the authorisation holder” ac “Address of the authorisation holder” rhodder—“
proFagus GmbH
Uslarer Strasse 3037194 BodenfeldeGERMANY”
Addasu’r awdurdodiad ar gyfer “Zesti Smoke Code 10”
5 
Yn yr awdurdodiad ar gyfer “Zesti Smoke Code 10” (cod unigryw “SF-002”), yng ngholofn 2, yn lle’r cofnodion sy’n cyfateb i “Name of the authorisation holder” ac “Address of the authorisation holder” rhodder—“
Kerry Group Plc
Prince’s StreetTraleeCo. Kerry, V92 EH11IRELAND”
Addasu’r awdurdodiad ar gyfer “SmokEz C-10”
6 
Yn yr awdurdodiad ar gyfer “SmokEz C-10” (cod unigryw “SF-005”), yng ngholofn 2, yn lle’r cofnodion sy’n cyfateb i “Name of the authorisation holder” ac “Address of the authorisation holder” rhodder—“
Kerry Group Plc
Prince’s StreetTraleeCo. Kerry, V92 EH11IRELAND”
Addasu’r awdurdodiad ar gyfer “SmokEz Enviro-23”
7 
Yn yr awdurdodiad ar gyfer “SmokEz Enviro-23” (cod unigryw “SF-006”), yng ngholofn 2, yn lle’r cofnodion sy’n cyfateb i “Name of the authorisation holder” ac “Address of the authorisation holder” rhodder—“
Kerry Group Plc
Prince’s StreetTraleeCo. Kerry, V92 EH11IRELAND”
Addasu’r awdurdodiad ar gyfer “TradismokeTM A MAX”
8 
Yn yr awdurdodiad ar gyfer “TradismokeTM A MAX” (cod unigryw “SF-007”), yng ngholofn 2, yn lle’r cofnodion sy’n cyfateb i “Name of the authorisation holder” ac “Address of the authorisation holder” rhodder—“
J. Rettenmaier & Söhne GmbH + CO KG
Holzmühle 173494 RosenbergGERMANY”
Lynne Neagle
Y Dirprwy Weinidog Iechyd Meddwl a Llesiant, o dan awdurdod y Gweinidog Iechyd a Gwasanaethau Cymdeithasol, un o Weinidogion Cymru
24 Mai 2022
ATODLEN 1
Diwygio amodau defnyddio a manylebau cymysgedd 2’-Ffwcosyl-lactos/Deuffwcosyl-lactos (2’FL/DFL) fel bwyd newydd
Rheoliad 2
1 
Yn Nhabl 1 (bwydydd newydd awdurdodedig), yn y cofnod ar gyfer “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)”, yng ngholofn 2 (yr amodau y caniateir defnyddio’r bwyd newydd odanynt), ar y diwedd mewnosoder yr amod defnyddio a ganlyn—“
Milk-based drinks and similar products intended for young children 1.2 g/L in the final product ready for use marketed as such or reconstituted as instructed by the manufacturer”.
2 
Yn Nhabl 2 (manylebau), yn y cofnod ar gyfer “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)”, yng ngholofn 2 (manylebau)—
(a) yn yr adran sydd â’r pennawd “Description/Definition”, yn lle’r geiriau o “amorphous powder” hyd at “spray drying” rhodder “powder or agglomerates thereof that is produced by a microbial process”;
(b) yn yr adran sydd â’r pennawd “Characteristics/Composition”, yn lle “Lactose and Fucose” rhodder “D-Lactose, L-Fucose, and 3-Fucosyllactose”.
ATODLEN 2
Awdurdodi olew Schizochytrium sp. (FCC-3204) fel bwyd newydd
Rheoliad 2
1 
Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Schizochytrium sp. (ATCC PTA-9695) oil” mewnosoder y cofnod a ganlyn—
"Schizochytrium sp. (FCC-3204) oil Specified food category Maximum levels of DHA The designation of the novel food on the labelling of the foodstuffs containing it is “Oil from the microalgae Schizochytrium sp.”.The labelling of food supplements containing  Schizochytrium sp. (FCC-3204) oil must bear a statement that they should not be consumed by infants and children under 3 years of age."  
Food Supplements as defined in the Food Supplements (Wales) Regulations 2003, excluding food supplements for infants and children under 3 years of age 1g/day
Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013
2 
Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Schizochytrium sp. (ATCC PTA-9695) oil” mewnosoder y cofnod a ganlyn—
"Schizochytrium sp. (FCC-3204) oil Description/Definition:The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp.Composition:Acid value: ≤ 0.5 mg KOH (potassium hydroxide)/g  Peroxide value (PV): ≤ 5.0 meq (milliequivalent)/kg oil  Moisture and volatiles: ≤ 0.05 %  Unsaponifiables: ≤ 4.5 %  Trans-fatty acids: ≤ 1.0 %  Docosahexaenoic acid (DHA): ≥ 32.0 %  P-anisidine value: ≤ 10".
ATODLEN 3
Awdurdodi olew Schizochytrium sp. (WZU477) fel bwyd newydd
Rheoliad 2
1 
Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Schizochytrium sp. (T18) oil” mewnosoder y cofnod a ganlyn—
"Schizochytrium sp. (WZU477) oil Specified food category Maximum levels of DHA The designation of the novel food on the labelling of the foodstuffs containing it is “Oil from the microalgae Schizochytrium sp.”.  Included in the list on 30 June 2022.This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Progress Biotech BV, Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands.During the period of data protection, Schizochytrium sp. (WZU477) oil is authorised for placing on the market within Wales only by Progress Biotech BV 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 Progress Biotech BV.The data protection ends at the end of 29 June 2027."
Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013  In accordance with Regulation (EU) No 609/2013
2 
Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Schizochytrium sp. (T18) oil” mewnosoder y cofnod a ganlyn—
"Schizochytrium sp. (WZU477) oil Description/Definition:  The novel food is an oil produced from the strain WZU477 of the microalgae Schizochytrium sp.  Composition: Acid value: ≤ 0.5 mg KOH (potassium hydroxide)/g  Peroxide value (PV): ≤ 5.0 meq (milliequivalent)/kg oil  Moisture and volatiles: ≤ 0.05 %  Unsaponifiables: ≤ 4.5 %  Trans-fatty acids: ≤ 1.0 %  Docosahexaenoic acid (DHA): ≥ 32.0 %  P-anisidine value: ≤ 10".
ATODLEN 4
Awdurdodi rhoi ar y farchnad halen sodiwm 3’-Sialyl-lactos (3’-SL) (ffynhonnell ficrobaidd) fel bwyd newydd
Rheoliad 2
1 
Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Selenium-containing yeast (Yarrowia lipolytica) biomass” mewnosoder y cofnod a ganlyn—
"3’-Sialyllactose (3’-SL) sodium salt (microbial source) Specified food category Maximum levels (expressed as 3’-Sialyllactose) The designation of the novel food on the labelling of the foodstuffs containing it is “3’-Sialyllactose sodium salt”.  The labelling of food supplements containing 3’-Sialyllactose sodium salt must bear a statement that they should not be consumed: a) if foods containing added 3’-Sialyllactose sodium salt are consumed the same day;b) by infants and young children.   Included in the list on 30 June 2022.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 Alle 4, DK-2970 Horsholm, Denmark.During the period of data protection, 3’-Sialyllactose sodium salt 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 ends at the end of 29 June 2027."
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 0.25 g/L
Flavoured fermented milk-based products including heat-treated products 0.25 g/L (beverages)2.5g/kg (products other than beverages) 
Unflavoured fermented milk-based products  0.25 g/L (beverages)0.5 g/kg (products other than beverages)
Beverages (flavoured drinks, excluding drinks with a pH less than 5)   0.25 g/L
Cereal bars  2.5g/kg
Infant formula as defined in Regulation (EU) No 609/2013   0.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation (EU) No 609/2013 0.15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 0.15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.1.25 g/kg (products other than beverages)
Milk-based drinks and similar products intended for young children   0.15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013   0.5 g/L (beverages)5g/kg (products other than beverages)
Food for special medical purposes as defined in Regulation (EU) No 609/2013  In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (Wales) Regulations 2003,  excluding food supplements for infants and young children 0.5 g/day
2 
Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Selenium-containing yeast (Yarrowia lipolytica) biomass” mewnosoder y cofnod a ganlyn—
"3’-Sialyllactose (3’-SL) sodium salt (microbial source) Description:3’-Sialyllactose (3’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 3’-sialyl-lactulose, and sialic acidSource: Genetically modified strain of Escherichia coli K-12 DH1 Definition:Chemical formula: C23H38NO19Na Chemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-Dglucose, sodium saltMolecular mass: 655.53 DaCAS No 128596-80-5 Characteristics/Composition: Appearance: White to off-white powder or agglomerateSum of 3’-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): ≥ 90.0 % (w/w)3’-Sialyllactose sodium salt (% of dry matter): ≥ 88.0 % (w/w)D-Lactose: ≤ 5.0 % (w/w)Sialic acid: ≤ 1.5 % (w/w)3’-Sialyl-lactulose: ≤ 5.0 % (w/w)Sum of other carbohydrates: ≤ 3.0 % (w/w)Moisture: ≤ 8.0 % (w/w)Sodium: 2.5 – 4.5 % (w/w)Chloride: ≤ 1.0 % (w/w)pH (20 °C, 5 % solution): 4.5 -6.0 Residual protein: ≤ 0.01 % (w/w) Microbiological criteria:Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella sp.: Absence in 25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units."
ATODLEN 5
Awdurdodi rhoi ar y farchnad halen sodiwm 6’-Sialyl-lactos (6’-SL) (ffynhonnell ficrobaidd) fel bwyd newydd
Rheoliad 2
1 
Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (fel y’i mewnosodir gan baragraff 1 o Atodlen 4 i’r Rheoliadau hyn) mewnosoder y cofnod a ganlyn—
"6’-Sialyllactose (6’-SL) sodium salt (microbial source) Specified food category Maximum levels (expressed as 6’-Sialyllactose) The designation of the novel food on the labelling of the foodstuffs containing it is “6’-Sialyllactose sodium salt”.  The labelling of food supplements containing 6’-Sialyllactose sodium salt must bear a statement that they should not be consumed:  a) if foods containing added 6’-Sialyllactose sodium salt are consumed the same day;b) by infants and young children.   Included in the list on 30 June 2022.This inclusion is authorised based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Glycom A/S, Kogle Alle 4, DK-2970 Horsholm, Denmark.During the period of data protection, 6’-Sialyllactose sodium salt 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 ends at the end of 29 June 2027."
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 0.5 g/L 
Unflavoured fermented milk-based products 0.5 g/L (beverages)2.5 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products 0.5 g/L (beverages)5.0 g/kg (products other than beverages)
Beverages (flavoured drinks, excluding drinks with a PH less than 5) 0.5 g/L 
Cereal bars 5.0 g/kg  
Infant formula as defined in Regulation (EU) No 609/2013 0.4 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined in Regulation (EU) No 609/2013 0.3 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 0.3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer2.5 g/kg (products other than beverages) 
Milk based drinks and similar products intended for young children 0.3 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 1.0 g/L (beverages)10.0 g/kg (products other than beverages)
Food for special medical purposes as defined under Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food supplements as defined in the Food Supplements (Wales) Regulations 2003, excluding food supplements for infants and young children 1.0 g/day
2 
Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (fel y’i mewnosodir gan baragraff 2 o Atodlen 4 i’r Rheoliadau hyn) mewnosoder y cofnod a ganlyn—
"6’-Sialyllactose (6’-SL) sodium salt (microbial source) Description:6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acidSource: Genetically modified strain of Escherichia coli K-12 DH1 Definition:Chemical formula: C23H38NO19NaChemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltMolecular mass: 655.53 DaCAS No 157574-76-0 Characteristics/Composition:Appearance: White to off-white powder or agglomerateSum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94.0 % (w/w)6’-Sialyllactose sodium salt (% of dry matter): ≥ 90.0 % (w/w)D-Lactose: ≤ 5.0 % (w/w)Sialic acid: ≤ 2.0 % (w/w)6’-Sialyl-lactulose: ≤ 3.0 % (w/w)Sum of other carbohydrates: ≤ 3.0 % (w/w)Moisture: ≤ 6.0 % (w/w)Sodium: 2.5-4.5 % (w/w)Chloride: ≤ 1.0 % (w/w)pH (20 °C, 5 % solution): 4.5-6.0 Residual protein: ≤ 0.01 % (w/w) Microbiological criteria:Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/gEnterobacteriaceae: ≤ 10 CFU/g Salmonella sp.: Absence in 25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units."