Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 (W.S.I. No. 2591 (W. 255) of 2013)

O F F E R Y N N A U S T A T U D O L C Y M R U BWYD, CYMRU Rheoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd (Cymru) 2013 NODYN ESBONIADOL (Nid yw’r nodyn hwn yn rhan o’r Rheoliadau) 1. Mae’r Rheoliadau hyn, sy’n gymwys i Gymru, yn darparu ar gyfer gweithredu a gorfodi Rheoliadau canlynol yr UE— (a) Rheoliad (EC) Rhif 2065/2003 Senedd Ewrop a’r Cyngor ynghylch cyflasynnau mwg a ddefnyddir neu a fwriedir i’w defnyddio mewn bwydydd neu arnynt (OJ Rhif L309, 26.11.2003, t.1); (b) Rheoliad (EC) Rhif 1332/2008 Senedd Ewrop a’r Cyngor ynghylch ensymau bwyd (OJ Rhif L354, 31.12.2008, t.7); (c) Rheoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ynghylch ychwanegion bwyd (OJ Rhif L354, 31.12.2008, t.16); (d) Rheoliad (EC) Rhif 1334/2008 Senedd Ewrop a’r Cyngor ynghylch cyflasynnau a chynhwysion bwyd penodol ac iddynt briodweddau cyflasyn i’w defnyddio mewn bwydydd ac arnynt (OJ Rhif L354, 31.12.2008, t.34). 2. Mae’r Rheoliadau hyn hefyd yn gweithredu Cyfarwyddeb 2009/32/EC Senedd Ewrop a’r Cyngor ynghylch cyd-ddynesiad cyfreithiau’r Aelod wladwriaethau ynghylch toddyddion echdynnu a ddefnyddir wrth gynhyrchu deunyddiau bwyd a chynhwysion bwyd (OJ Rhif L141, 6.6.2009, t.3). 3. Mae’r Rheoliadau hyn yn dirymu, yn gyfan gwbl neu’n rhannol, y Rheoliadau a ganlyn— (a) Rheoliadau Toddyddion Echdynnu mewn Bwyd 1993 (O.S. 1993/1658); W E L S H S T A T U T O R Y I N S T R U M E N T S FOOD, WALES The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which apply to Wales, provide for the execution and enforcement of the following EU Regulations — (a) Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods (OJ No. L309, 26.11.2003, p.1); (b) Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes (OJ No. L354, 31.12.2008, p.7); (c) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ No. L354, 31.12.2008, p.16); (d) Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods (OJ No. L354, 31.12.2008, p.34). 2. These Regulations also implement Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ No. L141, 6.6.2009, p.3). 3. These Regulations revoke, in whole or in part, the following Regulations — (a) The Extraction Solvents in Food Regulations 1993 (S.I. 1993/1658); 2013 Rhif 2591 (Cy. 255) 2013 No. 2591 (W. 255) 2 (b) Rheoliadau Cyflasynnau Mwg (Cymru) 2005 (O.S. 2005/1350 (Cy.98)); (c) Rheoliadau Bwyd (Atal Defnyddio E 128 Red 2G fel Lliw Bwyd) (Cymru) (Rhif 2) 2007 (O.S. 2007/23315 (Cy.186)); (d) Rheoliadau Ensymau Bwyd (Cymru) 2009 (O.S. 2009/3377 (Cy.299)); (e) Rheoliadau Ychwanegion Bwyd (Cymru) 2009 (O.S. 2009/3378 (Cy.300)); (f) Rheoliadau Cyflasynnau mewn Bwyd (Cymru) 2010 (O.S. 2010/1198 (Cy.2922)). 4. Mae’r Rheoliadau hyn, yn Rhan 2, yn darparu mai trosedd, yn ddarostyngedig i unrhyw drefniadau trosiannol sy’n gymwys, yw torri gofynion penodol yn y canlynol neu ddefnyddio cynnyrch neu osod ar y farchnad gynnyrch sy’n torri gofynion penodol yn y canlynol— (a) Rheoliad (EC) Rhif 1333/2008 ynghylch ychwanegion bwyd (rheoliad 3 a Thabl 1 o Atodlen 1); (b) Rheoliad (EC) Rhif 1334/2008 ynghylch cyflasynnau bwyd a bwydydd ac iddynt briodweddau cyflasyn (rheoliad 4 a Thabl 1 o Atodlen 2); (c) Rheoliad (EC) Rhif 2065/2003 ynghylch cyflasynnau mwg (rheoliad 5 a Thabl 1 o Atodlen 3); a (d) Rheoliad (EC) Rhif 1332/2008 ynghylch ensymau bwyd (rheoliad 6 a Thabl 1 o Atodlen 4). 5. Mae’r Rheoliadau hyn hefyd yn darparu yn Rhan 2 y caiff swyddog awdurdodedig o awdurdod gorfodi, yn achos mathau penodol o ddiffyg cydymffurfio, o ran labelu, gyflwyno hysbysiad gwella sy’n ei gwneud yn ofynnol i gamau penodol gael eu cymryd, ac yn niffyg hynny y bydd trosedd wedi ei gyflawni (rheoliad 7 a Thabl 2 o Atodlenni 1 i 4). Caiff person y cyflwynir hysbysiad gwella iddo apelio yn ei erbyn i lys ynadon (rheoliad 8). 6. Mae Rhan 3 o’r Rheoliadau hyn yn gweithredu Cyfarwyddeb 2009/32/EC ynghylch toddyddion echdynnu, drwy wneud y canlynol yn benodol— (a) pennu’r amgylchiadau lle nad yw’r rheolaethau ar doddyddion echdynnu yn gymwys (rheoliad 10); (b) diffinio beth yw toddydd echdynnu a ganiateir (rheoliad 11); (c) gwahardd unrhyw berson rhag defnyddio toddydd echdynnu heblaw toddydd echdynnu a ganiateir, fel y’i diffinnir, wrth gynhyrchu bwyd (rheoliad 12); (b) The Smoke Flavourings (Wales) Regulations 2005 (S.I. 2005/1350 (W.98)); (c) The Food (Suspension of the Use of E128 Red 2G Food Colour) (Wales) Regulations 2007 (S.I. 2007/23315 (W.186)); (d) The Food Enzymes (Wales) Regulations 2009 (S.I. 2009/3377 (W.299)); (e) The Food Additives (Wales) Regulations 2009 (S.I. 2009/3378 (W.300)); (f) The Flavourings in Food (Wales) Regulations 2010 (S.I. 2010/1198 (W.2922)). 4. These Regulations, in Part 2, provide that it is an offence, subject to any applicable transitional arrangements, to contravene or to use or place on the market a product that contravenes specified requirements of — (a) Regulation (EC) No 1333/2008 relating to food additives (regulation 3 and Table 1 of Schedule 1); (b) Regulation (EC) No 1334/2008 relating to food flavourings and foods with flavouring properties (regulation 4 and Table 1 of Schedule 2); (c) Regulation (EC) No 2065/2003 relating to smoke flavourings (regulation 5 and Table 1 of Schedule 3); and (d) Regulation (EC) No 1332/2008 relating to food enzymes (regulation 6 and Table 1 of Schedule 4). 5. These Regulations also provide in Part 2 that in the case of certain types of non-compliance, relating to labelling, an authorised officer of an enforcement authority may serve an improvement notice requiring specified steps to be taken, failing which an offence will be committed (regulation 7 and Table 2 of Schedules 1 to 4). A person served with an improvement notice may appeal against it to a magistrates court (regulation 8). 6. Part 3 of these Regulations implement Directive 2009/32/EC relating to extraction solvents, in particular by — (a) specifying the circumstances where the controls on extraction solvents do not apply (regulation 10); (b) defining what constitutes a permitted extraction solvent (regulation 11); (c) prohibiting any person from using an extraction solvent other than a permitted extraction solvent, as defined, in the production of food (regulation 12); 3 (d) gwahardd unrhyw berson rhag gosod ar y farchnad doddydd echdynnu nad yw’n doddydd echdynnu a ganiateir neu nad oes gwybodaeth benodol yn cyd-fynd ag ef ar y pecyn, y cynhwysydd neu’r label (rheoliadau 13 a 14). 7. Mae’r Rheoliadau hyn yn Rhan 4 — (a) yn dynodi’r Asiantaeth Safonau Bwyd fel yr awdurdod cymwys at ddibenion ceisiadau am awdurdodi cyflasyn mwg (rheoliad 15); (b) yn rhoi’r ddyletswydd o orfodi’r Rheoliadau hyn i awdurdodau bwyd (rheoliad 16); (c) yn darparu ar gyfer y gosb uchaf y gall person fod yn agored iddi o’i gollfarnu am drosedd o dan y Rheoliadau hyn (rheoliad 17); (d) yn darparu, lle’r ardystir bod bwyd yn fwyd y mae’n drosedd ei osod ar y farchnad, y trinnir y bwyd at ddibenion adran 9 o Ddeddf Diogelwch Bwyd 1990 fel petai’n methu â chydymffurfio â gofynion diogelwch bwyd (rheoliad 18); ac (e) yn cymhwyso, ag addasiadau penodol, amryw o ddarpariaethau Deddf Diogelwch Bwyd 1990 at ddibenion y Rheoliadau hyn (rheoliad 19). 8. Mae’r Rheoliadau hyn yn Rhan 5 — (a) yn gwneud mân ddiwygiad i Reoliadau Labelu Bwyd 1996 (rheoliad 20); a (b) yn dirymu offerynnau penodol yn gyfan gwbl neu’n rhannol (rheoliad 21 ac Atodlen 5). 9. Ystyriwyd Cod Ymarfer Gweinidogion Cymru ar gynnal Asesiadau Effaith Rheoleiddiol mewn perthynas â’r 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. (d) prohibiting any person from placing on the market an extraction solvent that is not a permitted extraction solvent or which is not accompanied by certain information on the packaging, container or label (regulations 13 and 14). 7. These Regulations in Part 4 — (a) designate the Food Standards Agency as the competent authority for the purposes of applications for authorisation of a smoke flavouring (regulation 15); (b) assign the duty of enforcing these Regulations to food authorities (regulation 16); (c) provide for the maximum penalty to which a person may be liable on conviction for an offence under these Regulations (regulation 17); (d) provide that, where food is certified as being food which it is an offence to place on the market, the food will be treated for the purposes of section 9 of the Food Safety Act 1990 as failing to comply with food safety requirements (regulation 18); and (e) apply, with certain modifications, various provisions of the Food Safety Act 1990 for the purposes of these Regulations (regulation 19). 8. These Regulations in Part 5 — (a) make a minor amendment to the Food Labelling Regulations 1996 (regulation 20); and (b) revoke certain instruments in whole or in part (regulation 21 and Schedule 5). 9. The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations. 4 O F F E R Y N N A U S T A T U D O L C Y M R U BWYD, CYMRU Rheoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd (Cymru) 2013 Mae Gweinidogion Cymru yn gwneud y Rheoliadau a ganlyn drwy arfer y pwerau a roddir gan adrannau 16(1)(a),(e) ac (f),17(1) a (2), 26(1), (2)(e) ac (f) a (3), a 48(1) o Ddeddf Diogelwch Bwyd 1990(1) ac sydd bellach wedi eu breinio ynddynt hwy(2), fel y’u darllenir gyda pharagraff 1A o Atodlen 2 i Ddeddf y Cymunedau Ewropeaidd 1972(3). Yn unol ag adran 48(4A) o Ddeddf Diogelwch Bwyd 1990, maent wedi rhoi sylw i gyngor perthnasol a roddwyd gan yr Asiantaeth Safonau Bwyd. W E L S H S T A T U T O R Y I N S T R U M E N T S FOOD, WALES The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16(1)(a),(e) and (f),17(1) and (2), 26(1), (2)(e) and (f) and (3), and 48(1) of the Food Safety Act 1990(1) and now vested in them(2),as read with paragraph 1A of Schedule 2 to the European Communities Act 1972(3). In accordance with section 48(4A) of the Food Safety Act 1990, they have had regard to relevant advice given by the Food Standards Agency. 2013 No. 2591 (W. 255) 2013 Rhif 2591 (Cy. 255) (1) 1990 c. 16. Section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990. Sections 17 and 48 were amended by paragraphs 12 and 21 respectively of Schedule 5 to the Food Standards Act 1999 (c.28), “the 1999 Act”. Section 48 was also amended by S.I. 2004/2990. Section 26(3) was amended by Schedule 6 to the 1999 Act. Section 53(2) was amended by paragraph 19 of Schedule 16 to the Deregulation and Contracting Out Act 1994 (c.40), Schedule 6 to the 1999 Act, S.I. 2004/2990 and S.I. 2004/3279. (2) Functions of “the Ministers”, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the Food Standards Act 1999 (c.28), and subsequently transferred to the Welsh Ministers by paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c.32). (3) 1972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51) and amended by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7). (1) 1990 p.16. Amnewidiwyd adran 1(1) a (2) (diffiniad “food”) gan O.S. 2004/2990. Diwygiwyd adrannau 17 a 48 gan baragraffau 12 a 21 yn y drefn honno o Atodlen 5 i Ddeddf Safonau Bwyd 1999 (p.28), “Deddf 1999”. Diwygiwyd adran 48 hefyd gan O.S. 2004/2990. Diwygiwyd adran 26(3) gan Atodlen 6 i Ddeddf 1999. Diwygiwyd adran 53(2) gan baragraff 19 o Atodlen 16 i Ddeddf Dadreoleiddio a Chontractio Allan 1994 (p.40), Atodlen 6 i Ddeddf 1999, O.S. 2004/2990 ac O.S. 2004/3279. (2) Trosglwyddwyd swyddogaethau “the Ministers”, i’r graddau y maent yn arferadwy o ran Cymru, i Gynulliad Cenedlaethol Cymru gan Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 1999 (O.S. 1999/672) fel y’i darllenir gydag adran 40(3) o Ddeddf Safonau Bwyd 1999 (p.28), a’u trosglwyddo wedyn i Weinidogion Cymru gan baragraff 30 o Atodlen 11 i Ddeddf Llywodraeth Cymru 2006 (p.32). (3) 1972 p.68. Mewnosodwyd paragraff 1A o Atodlen 2 gan adran 28 o Ddeddf Diwygio Deddfwriaethol a Rheoleiddiol 2006 (p.51) a’i ddiwygio gan Ran 1 o’r Atodlen i ddeddf yr Undeb Ewropeaidd (Diwygio) 2008 (p.7). Made 7 October 2013 Laid before the National Assembly for Wales Coming into force 31 October 2013 Gwnaed 7 Hydref 2013 Gosodwyd gerbron Cynulliad Cenedlaethol Cymru 9 Hydref 2013 Yn dod i rym 31 Hydref 2013 9 October 2013 5 Mae’r Rheoliadau hyn yn gwneud darpariaeth at ddiben a grybwyllir yn adran 2(2) o Ddeddf y Cymunedau Ewropeaidd 1972 ac mae’n ymddangos i Weinidogion Cymru ei bod yn hwylus i unrhyw gyfeiriad at Erthygl neu Atodiad i unrhyw rai o offerynnau’r UE a bennir yn rheoliad 2(4) gael ei ddehongli fel cyfeiriad at yr Erthygl honno neu’r Atodiad hwnnw fel y’u diwygiwyd o dro i dro. Yn unol â gofynion Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a’r Cyngor sy’n gosod egwyddorion cyffredinol a gofynion cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn gosod gweithdrefnau o ran materion diogelwch bwyd(1), cafwyd ymgynghoriad cyhoeddus agored a thryloyw wrth i’r Rheoliadau hyn gael eu paratoi a’u gwerthuso. RHAN 1 Rhagarweiniol Enwi, cymhwyso a chychwyn 1. Enw’r Rheoliadau hyn yw Rheoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd (Cymru) 2013, maent yn gymwys o ran Cymru a deuant i rym ar 31 Hydref 2013. Dehongli 2.—(1) Yn y Rheoliadau hyn — ystyr “awdurdod bwyd” (“food authority”) yw — (a) cyngor sir; a (b) cyngor bwrdeistref sirol; ystyr “Cyfarwyddeb 2009/32” (“Directive 2009/32”) yw Cyfarwyddeb 2009/32/EC Senedd Ewrop a’r Cyngor ynghylch cyd-ddynesiad cyfreithiau’r Aelod-wladwriaethau ynghylch toddyddion echdynnu a ddefnyddir wrth gynhyrchu deunyddiau bwyd a chynhwysion bwyd(2); ystyr “y Ddeddf” (“the Act”) yw Deddf Diogelwch Bwyd 1990; (1) OJ Rhif L31, 1.2.2002, t.1. Diwygiwyd y Rheoliad hwn ddiwethaf gan Reoliad y Comisiwn (EC) Rhif 596/2009 Senedd Ewrop a’r Cyngor sy’n addasu nifer o offerynnau sy’n ddarostyngedig i’r weithdrefn y cyfeirir ati yn Erthygl 251 o’r Cytuniad i Benderfyniad y Cyngor 1999/468/EC o ran y weithdrefn reoleiddiol gyda chraffu: Addasiad i’r weithdrefn reoleiddiol gyda chraffu Rhan Pedwar (OJ Rhif L188, 18.7.2009, t.14). (2) OJ Rhif L141, 6.6.2009, t.3. Diwygiwyd yr offeryn hwn gan Gyfarwyddeb y Comisiwn 2010/59/EU (OJ Rhif L225, 27.8.2010, t.10). These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Welsh Ministers that it is expedient for any reference to an Article of or an Annex to any of the EU instruments specified in regulation 2(4) to be construed as a reference to that Article or that Annex as amended from time to time. As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1), there has been open and transparent public consultation during the preparation and evaluation of these Regulations. PART 1 Introductory Title, application and commencement 1. The title of these Regulations is the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013, they apply in relation to Wales and come into force on 31 October 2013. Interpretation 2.—(1) In these Regulations — “the Act” (“y Ddeddf”) means the Food Safety Act 1990; “Directive 2009/32” (“Cyfarwyddeb 2009/32”) means Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients(2); “Regulation 2065/2003” (“Rheoliad 2065/2003”) means Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke (1) OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Commission Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny – Part Four (OJ No. L188, 18.7.2009, p14). (2) OJ No. L141, 6.6.2009, p.3. This instrument was amended by Commission Directive 2010/59/EU (OJ No. L225, 27.8.2010, p.10). 6 ystyr “Rheoliad 2065/2003” (“Rheoliad 2065/2003”) yw Rheoliad (EC) Rhif 2065/2003 Senedd Ewrop a’r Cyngor ynghylch cyflasynnau mwg a ddefnyddir neu a fwriedir i’w defnyddio mewn bwydydd neu arnynt(1); ystyr “Rheoliad 1332/2008” (“Rheoliad 1332/2008”) yw Rheoliad (EC) Rhif 1332/2008 Senedd Ewrop a’r Cyngor ynghylch ensymau bwyd (2); ystyr “Rheoliad 1333/2008” (“Rheoliad 1333/2008”) yw Rheoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ynghylch ychwanegion bwyd(3), fel y’i darllenir gyda’r canlynol — (c) Rheoliad y Comisiwn (EU) Rhif 1129/2011 sy’n diwygio Atodiad II i Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor drwy sefydlu rhestr i’r Undeb o ychwanegion bwyd(4), (d) Rheoliad y Comisiwn (EU) Rhif 1130/2011 sy’n diwygio Atodiad III i Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ynghylch ychwanegion bwyd drwy sefydlu rhestr i’r Undeb o ychwanegion bwyd i’w defnyddio mewn ychwanegion bwyd, ensymau bwyd, cyflasynnau bwyd a maetholion(5), ac (e) Rheoliad y Comisiwn (EU) Rhif 231/2012 sy’n nodi manylebau ar gyfer ychwanegion bwyd a restrir yn Atodiadau II a III i Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor(6); ystyr “Rheoliad 1334/2008” (“Rheoliad 1334/2008”) yw Rheoliad (EC) Rhif 1334/2008 Senedd Ewrop a’r Cyngor ynghylch cyflasynnau a chynhwysion bwyd penodol ac iddynt briodweddau cyflasyn bwyd i’w defnyddio mewn bwydydd ac arnynt(7), fel y’i darllenir gyda Rheoliad y Comisiwn (EU) Rhif 873/2012 ynghylch mesurau trosiannol sy’n ymwneud â rhestr yr Undeb o gyflasynnau a deunyddiau (1) OJ Rhif L309, 26.11.2003, t.1. Diwygiwyd yr offeryn hwn gan Reoliad (EC) Rhif 596/2009 Senedd Ewrop a’r Cyngor (OJ Rhif L188, 18.7.2009, t.14). (2) OJ Rhif L354, 31.12.2008, t.7. Diwygiwyd yr offeryn hwn ddiwethaf gan Reoliad y Comisiwn (EU) Rhif 1056/2012 (OJ Rhif L313, 13.11.2012, t.9). (3) OJ Rhif L354, 31.12.2008, t.16. Diwygiwyd yr offeryn hwn ddiwethaf gan Reoliad y Comisiwn (EU) Rhif 510/2013 (OJ Rhif L150, 4.6.2013, t.17). (4) OJ Rhif L295, 12.11.2011, t.1. (5) OJ Rhif L295, 12.11.2011, t.178. (6) OJ Rhif L83, 22.3.2012, t.1. Diwygiwyd yr offeryn hwn ddiwethaf gan Reoliad y Comisiwn (EU) Rhif 497/2013 (OJ Rhif L143, 30.5.2013, t.20). (7) OJ Rhif L354, 31.12.2008, t.34. Diwygiwyd yr offeryn hwn ddiwethaf gan Reoliad Gweithredu’r Comisiwn (EU) Rhif 545/2013 (OJ Rhif L163, 15.6.2013, t.15). flavourings used or intended for use in or on foods(1); “Regulation 1332/2008” (“Rheoliad 1332/2008”) means Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes(2); “Regulation 1333/2008” (“Rheoliad 1333/2008”) means Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives(3), as read with — (a) Commission Regulation (EU) No 1129/2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives(4), (b) Commission Regulation (EU) No 1130/2011 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food additives for use in food additives, food enzymes, food flavourings and nutrients(5), and (c) Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council(6); “Regulation 1334/2008” (“Rheoliad 1334/2008”) means Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods(7), as read with Commission Regulation (EU) No 873/2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) 1334/2008 of the European Parliament and of the Council(8); (1) OJ No. L309, 26.11.2003, p.1. This instrument was amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No. L188, 18.7.2009, p.14). (2) OJ No. L354, 31.12.2008, p.7. This instrument was last amended by Commission Regulation (EU) No 1056/2012 (OJ No. L313, 13.11.2012, p.9). (3) OJ No. L354, 31.12.2008, p.16. This instrument was last amended by Commission Regulation (EU) No. 510/2013 (OJ No. L150, 4.6.2013, p.17). (4) OJ No. L295, 12.11.2011, p.1. (5) OJ No. L295, 12.11.2011, p.178. (6) OJ No. L83, 22.3.2012, p.1. This instrument was last amended by Commission Regulation (EU) No. 497/2013 (OJ No. L143, 30.5.2013, p.20). (7) OJ No. L354, 31.12.2008, p.34. This instrument was last amended by Commission Implementing Regulation (EU) No 545/2013 (OJ No. L163, 15.6.2013, p.15). (8) OJ No. L267, 2.10.2012, p.162. 7 ffynhonnell a nodir yn Atodiad I i Reoliad (EC) 1334/2008 Senedd Ewrop a’r Cyngor(1); ystyr “Rheoliadau’r UE” (“the EU Regulations”) yw Rheoliad 2065/2003, Rheoliad 1332/2008, Rheoliad 1333/2008 a Rheoliad 1334/2008; ystyr “swyddog awdurdodedig” (“authorised officer”) yw unrhyw berson sydd wedi ei awdurdodi mewn ysgrifen, naill ai yn gyffredinol neu’n benodol, gan awdurdod bwyd i weithredu mewn materion sy’n codi o dan y Rheoliadau hyn. (2) Mae i ymadroddion eraill a ddefnyddir yn y Rheoliadau hyn ac y defnyddir yr ymadroddion Saesneg cyfatebol yn offerynnau’r UE sydd wedi eu rhestru ym mharagraff (4) yr un ystyr yn y Rheoliadau hyn ag sydd i’r ymadroddion Saesneg cyfatebol yn yr offerynnau hynny. (3) Mae unrhyw gyfeiriad yn y Rheoliadau hyn at Erthygl neu Atodiad i unrhyw rai o offerynnau’r UE a restrir ym mharagraff (4) yn gyfeiriad at yr Erthygl honno neu’r Atodiad hwnnw fel y’u diwygiwyd o dro i dro. (4) Offerynnau’r UE yw Cyfarwyddeb 2009/32, Rheoliad 2065/2003, Rheoliad (EC) Rhif 1331/2008 Senedd Ewrop a’r Cyngor yn sefydlu gweithdrefn awdurdodi gyffredin ynglŷn ag ychwanegion bwyd, ensymau bwyd a chyflasynnau bwyd(2), Rheoliad 1332/2008, Rheoliad 1333/2008 a Rheoliad 1334/2008. (5) Pan aseinir unrhyw swyddogaethau o dan y Ddeddf— (a) drwy orchymyn o dan adran 2 o Ddeddf Iechyd y Cyhoedd (Rheoli Clefydau) 1984(3), 1984(3), i awdurdod iechyd porthladd; neu (b) drwy orchymyn o dan adran 6 o Ddeddf Iechyd y Cyhoedd 1936(4), i gyd-fwrdd ardal ardal unedig; mae unrhyw gyfeiriad yn y Rheoliadau hyn at awdurdod bwyd i’w ddehongli, i’r graddau y mae’n ymwneud â’r swyddogaethau hynny, fel cyfeiriad at yr awdurdod y maent wedi eu haseinio felly iddo. “authorised officer” (“swyddog awdurdodedig”) means any person who is authorised in writing, either generally or specially, by a food authority to act in matters arising under these Regulations; “food authority” (“awdurdod bwyd”) means — (d) a county council; and (e) a county borough council; “the EU Regulations” means Regulation 2065/2003, Regulation 1332/2008, Regulation 1333/2008 and Regulation 1334/2008. (2) Other expressions used in these Regulations and in the EU instruments listed in paragraph (4) have the same meaning in these Regulations as they do in those instruments. (3) Any reference in these Regulations to an Article of or Annex to any of the EU instruments listed in paragraph (4) is a reference to that Article or Annex as amended from time to time. (4) The EU instruments are Directive 2009/32, Regulation 2065/2003, Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings(1), Regulation 1332/2008, Regulation 1333/2008 and Regulation 1334/2008. (5) Where any functions under the Act are assigned — (a) by an order under section 2 of the Public Health (Control of Disease) Act 1984(2), to a a port health authority; or (b) by an order under section 6 of the Public Health Act 1936(3), to a joint board for a united district; any reference in these Regulations to a food authority is to be construed, so far as relating to those functions, as a reference to the authority to which they are so assigned. (1) OJ No. L354, 31.12.2008, p.1. This instrument is implemented by Commission Regulation (EU) No. 234/2011 (OJ No. L64, 11.03.2011, p.15) and that Regulation has been amended by Commission Implementing Regulation (EU) No. 562/2012 (OJ No. L168, 28.06.2012, p.2). (2) 1984 c.22; section 7(3)(d) was substituted by paragraph 27 of Schedule 3 to the Food Safety Act 1990 (1990 c.16). (3) 1936 c.49; section 6 is to be read with paragraph 1 of Schedule 3 to the Food Safety Act 1990. (1) OJ Rhif L267, 2.10.2012, t.162. (2) OJ Rhif L354, 31.12.2008, t.1. Rhoddwyd yr offeryn hwn ar waith gan Reoliad y Comisiwn (EU) Rhif 234/2011 (OJ Rhif L64, 11.03.2011, t.15) ac mae’r Rheoliad hwnnw wedi ei ddiwygio gan reoliad Gweithredu’r Comisiwn (EU) Rhif 562/2012 (OJ Rhif L168, 28.06.2012, t.2). (3) 1984 p.22; amnewidiwyd adran 7(3)(d) gan baragraff 27 o Atodlen 3 i Ddeddf Diogelwch Bwyd 1990 (p.16). (4) 1936 p.49; mae adran 6 i’w darllen gyda pharagraff 1 o Atodlen 3 i Ddeddf Diogelwch Bwyd 1990. 8 RHAN 2 Ychwanegion, cyflasynnau ac ensymau bwyd Trosedd torri gofynion yr UE ynghylch ychwanegion bwyd 3. Mae unrhyw berson sy’n torri unrhyw rai o ddarpariaethau Rheoliad 1333/2008 a bennir yng ngholofn gyntaf Tabl 1 o Atodlen 1, fel y’i darllenir gyda mesurau trosiannol a geir yn y Rheoliad hwnnw neu sydd i’w darllen gydag ef, neu sy’n defnyddio neu’n gosod ar y farchnad gynnyrch sy’n methu cydymffurfio ag unrhyw rai o’r darpariaethau hynny, yn cyflawni trosedd. Trosedd torri gofynion yr UE ynghylch cyflasynnau, gan gynnwys cyflasynnau mwg 4. Mae unrhyw berson sy’n torri unrhyw rai o ddarpariaethau Rheoliad 1334/2008 a bennir yng ngholofn gyntaf Tabl 1 o Atodlen 2, fel y’i darllenir gydag Erthygl 4 (sylweddau cyflasu sydd wrthi’n cael eu gwerthuso) o Reoliad Gweithredu’r Comisiwn (EU) Rhif 872/2012 yn mabwysiadu’r rhestr o sylweddau cyflasu y darperir ar ei chyfer gan Reoliad (EC) Rhif 2232/96 Senedd Ewrop a’r Cyngor(1) a chyda mesurau trosiannol a geir yn Rheoliad 1334/2008 neu sydd i’w darllen gydag ef, neu sy’n defnyddio neu’n gosod ar y farchnad gynnyrch sy’n methu cydymffurfio ag unrhyw rai o’r darpariaethau hynny, yn cyflawni trosedd. 5. Mae unrhyw berson sy’n torri unrhyw rai o ddarpariaethau Rheoliad 2065/2003 a bennir yng ngholofn gyntaf Tabl 1 o Atodlen 3, neu sy’n defnyddio neu’n gosod ar y farchnad gynnyrch sy’n methu cydymffurfio ag unrhyw rai o’r darpariaethau hynny, yn cyflawni trosedd. Trosedd torri gofynion yr UE ynghylch ensymau bwyd 6. Mae unrhyw berson sy’n torri unrhyw rai o ddarpariaethau Rheoliad 1332/2008 a bennir yng ngholofn gyntaf Tabl 1 o Atodlen 4, fel y’i darllenir gydag Erthyglau 18 a 24 (mesurau trosiannol) neu sy’n defnyddio neu’n gosod ar y farchnad gynnyrch sy’n methu cydymffurfio ag unrhyw rai o’r darpariaethau hynny, yn cyflawni trosedd. (1) OJ Rhif L267, 2.10.2012, t.1. PART 2 Food additives, flavourings and enzymes Offence of contravening EU requirements on food additives 3. Any person who contravenes, or who uses or places on the market a product that fails to comply with, any of the provisions of Regulation 1333/2008 specified in the first column of Table 1 of Schedule 1, as read with transitional measures contained in or to be read with that Regulation, commits an offence. Offence of contravening EU requirements on flavourings, including smoke flavourings 4. Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions of Regulation 1334/2008 specified in the first column of Table 1 of Schedule 2, as read with Article 4 (flavouring substances under evaluation) of Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council(1) and with transitional measures contained in or to be read with Regulation 1334/2008, commits an offence. 5. Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions of Regulation 2065/2003 specified in the first column of Table 1 of Schedule 3 commits an offence. Offence of contravening EU requirements on food enzymes 6. Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions of Regulation 1332/2008 specified in the first column of Table 1 of Schedule 4, as read with Articles 18 and 24 (transitional measures), commits an offence. (1) OJ No. L267, 2.10.2012, p.1. 9 Hysbysiadau gwella – cymhwyso is-adrannau (1) a (2) o adran 10 o Ddeddf Diogelwch Bwyd 1990 7.—(1) Mae is-adrannau (1) a (2) o adran 10 o’r Ddeddf (hysbysiadau gwella) yn gymwys at ddibenion y Rheoliadau hyn gyda’r addasiadau a ganlyn. (2) Yn lle is-adran (1), rhodder— “(1) If an authorised officer of an enforcement authority has reasonable grounds for believing that a person is failing to comply with a provision of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 specified in paragraph (1A), the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)— (a) state the officer’s grounds for believing that the person is failing to comply with the relevant provision; (b) specify the matters which constitute the person’s failure so to comply; (c) specify the measures which, in the officer’s opinion, the person must take in order to secure compliance; and (d) require the person to take those measures, or measures that are at least equivalent to them, within such period as may be specified in the notice. (1A) Any EU provision specified in the first column of Table 2 of— (a) Schedule 1; (b) Schedule 2; (c) Schedule 3; or (d) Schedule 4; or (e) regulation 13(2)”. Apelio yn erbyn hysbysiad gwella – cymhwyso is adrannau (1) a (6) o adran 37 ac adran 39 o Ddeddf Diogelwch Bwyd 1990 8.—(1) Mae is-adrannau (1) a (6) o adran 37 o’r Ddeddf (apelio) yn gymwys at ddibenion y Rheoliadau hyn gyda’r addasiadau a ganlyn— (a) yn lle is-adran (1), rhodder— “(1) Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice under section 10(1), as applied and modified by rheoliad 7 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013, may appeal to a magistrates court.”; a Improvement notices – application of subsections (1) and (2) of section 10 of the Food Safety Act 1990 7.—(1) Subsections (1) and (2) of section 10 of the Act (improvement notices) apply for the purposes of these Regulations with the following modifications. (2) For subsection (1), substitute— “(1) If an authorised officer of an enforcement authority has reasonable grounds for believing that a person is failing to comply with a provision of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 specified in paragraph (1A), the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)— (a) state the officer’s grounds for believing that the person is failing to comply with the relevant provision; (b) specify the matters which constitute the person’s failure so to comply; (c) specify the measures which, in the officer’s opinion, the person must take in order to secure compliance; and (d) require the person to take those measures, or measures that are at least equivalent to them, within such period as may be specified in the notice. (1A) Any EU provision specified in the first column of Table 2 of— (a) Schedule 1; (b) Schedule 2; (c) Schedule 3; or (d) Schedule 4; or (e) regulation 13(2)”. Appeal against improvement notice – application of subsections (1) and (6) of sections 37 and section 39 of the Food Safety Act 1990 8.—(1) Subsections (1) and (6) of section 37 of the Act (appeals) apply for the purposes of these Regulations with the following modifications— (a) for subsection (1), substitute— “(1) Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice under section 10(1), as applied and modified by regulation 7 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013, may appeal to a magistrates court.”; and 10 (b) yn is-adran (6), yn lle “(3) or (4)”, rhodder “(1), (3) or (4)”. RHAN 3 Toddyddion echdynnu Rheolaethau ar doddyddion echdynnu 9. Yn y Rhan hon mae unrhyw gyfeiriad at Erthygl neu Atodiad â rhif yn gyfeiriad at yr Erthygl honno neu’r Atodiad hwnnw yng Nghyfarwyddeb 2009/32. 10. Nid yw darpariaethau’r Rhan hon yn gymwys i unrhyw doddydd echdynnu— (a) a ddefnyddir wrth gynhyrchu unrhyw ychwanegion bwyd, fitaminau neu unrhyw ychwanegion maethol eraill, oni bai bod yr ychwanegion bwyd, y fitaminau neu’r ychwanegion maethol eraill hynny wedi eu rhestru yn Atodiad I; neu (b) y bwriedir ei allforio y tu allan i’r Undeb Ewropeaidd. 11. Yn y Rhan hon ystyr “toddydd echdynnu a ganiateir” yw — (a) toddydd echdynnu— (i) a restrir yn Atodiad I, (ii) a ddefnyddir yn unol â’r amodau defnyddio ac o fewn unrhyw derfynau uchaf ynglŷn â gweddillion a bennir yn yr Atodiad hwnnw, (iii) nad yw’n cynnwys swm sy’n beryglus yn wenwynegol o unrhyw elfen neu sylwedd, (iv) nad yw, yn ddarostyngedig i unrhyw eithriadau sy’n deillio o feini prawf penodol ynglŷn â phurdeb, yn cynnwys mwy nag 1 mg/kg o arsenig neu fwy nag 1 mg/kg o blwm, a (v) sy’n bodloni gofynion Erthygl 3(c) o ran y meini prawf ynglŷn â phurdeb; neu (b) dŵr y gall sylweddau sy’n rheoleiddio asidedd neu alcalinedd fod wedi eu hychwanegu iddo; neu (c) sylweddau bwyd sydd â phriodweddau toddydd. 12. Ni chaiff unrhyw berson ddefnyddio unrhyw doddydd echdynnu nad yw’n doddydd echdynnu a ganiateir yn doddydd echdynnu wrth gynhyrchu bwyd. 13.—(1) Ni chaiff unrhyw berson osod ar y farchnad— (b) in subsection (6), for “(3) or (4)”, substitute “(1), (3) or (4)”. PART 3 Extraction solvents Controls on extraction solvents 9. In this Part any reference to a numbered Article or Annex is a reference to that Article of or Annex to Directive 2009/32. 10. The provisions of this Part do not apply to any extraction solvent — (a) used in the production of any food additives, vitamins or any other nutritional additives, unless such food additives, vitamins or other nutritional additives are listed in Annex I; or (b) intended for export outside the European Union. 11. In this Part “permitted extraction solvent” means — (a) an extraction solvent that — (i) is listed in Annex I, (ii) is used in accordance with the conditions of use and within any maximum residue limits specified in that Annex, (iii) does not contain a toxicologically dangerous amount of any element or substance, (iv) subject to any exceptions deriving from specific purity criteria, does not contain more than 1 mg/kg of arsenic or more than 1 mg/kg lead, and (v) meets the requirements of Article 3(c) as regards purity criteria; or (b) water to which substances regulating acidity or alkalinity may have been added; or (c) food substances which possess solvent properties. 12. No person may use as an extraction solvent in the production of food any extraction solvent that is not a permitted extraction solvent. 13.—(1) No person may place on the market — 11 (a) toddydd echdynnu nad yw’n doddydd echdynnu a ganiateir; na (b) unrhyw fwyd ac ynddo neu arno doddydd echdynnu wedi ei ychwanegu nad yw’n doddydd echdynnu a ganiateir. (2) Ni chaiff unrhyw berson osod ar y farchnad doddydd echdynnu nad yw’n bodloni gofynion rheoliad 14. 14.—(1) Yn ddarostyngedig i baragraff (2), rhaid i’r wybodaeth a ganlyn ymddangos ar y pecyn, y cynhwysydd neu’r label — (a) yr enw masnachol fel y’i nodir yn Atodiad I; (b) awgrym clir bod y deunydd o ansawdd sy’n addas i’w defnyddio at echdynnu bwyd neu gynhwysion bwyd; (c) cyfeiriad a all gael ei ddefnyddio i adnabod y swp neu’r lot; (d) enw neu enw busnes a chyfeiriad y gweithgynhyrchydd neu’r paciwr neu enw neu enw busnes a chyfeiriad gwerthwr sydd wedi ei sefydlu yn nhiriogaeth yr UE; (e) y swm net ar ffurf unedau o gyfaint; ac (f) os oes angen hynny, yr amodau storio arbennig neu’r amodau defnyddio. (2) Caniateir i’r manylion a bennir yn is-baragraffau (c), (d), (e) ac (f) o baragraff (1) ymddangos fel arall ar y dogfennau masnach sy’n cyfeirio at y swp neu’r lot y maent i’w cyflenwi gydag ef wrth eu dosbarthu neu cyn eu dosbarthu. (3) Rhaid i’r wybodaeth a bennir ym mharagraff (1) fod yn hawdd i’w weld, yn glir i’w ddarllen ac yn annileadwy. (4) Caniateir i’r wybodaeth a bennir ym mharagraff (1) gael ei darparu mewn mwy nag un iaith, ond rhaid i un o leiaf o’r ieithoedd hynny fod yn hawdd i’r prynwr ei deall oni bai bod mesurau eraill wedi eu cymryd i sicrhau bod y prynwr yn cael gwybod am yr wybodaeth benodedig. RHAN 4 Gweinyddu a gorfodi Awdurdodau cymwys 15. Yr Asiantaeth Safonau Bwyd yw’r awdurdod cymwys at ddibenion Erthygl 7 o Reoliad 2065/2003. (a) an extraction solvent that is not a permitted extraction solvent; or (b) any food having in it or on it an added extraction solvent that is not a permitted extraction solvent. (2) No person may place on the market an extraction solvent that does not meet the requirements of regulation 14. 14.—(1) Subject to paragraph (2), the following information must appear on the packaging, container or label — (a) the commercial name as indicated in Annex I; (b) a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients; (c) a reference by which the batch or lot may be identified; (d) the name or business name and address of the manufacturer or packer or of a seller established in the territory of the EU; (e) the net quantity given as units of volume; and (f) if necessary, the special storage conditions or conditions of use. (2) The particulars specified in subparagraphs (c), (d), (e) and (f) of paragraph (1) may alternatively appear on the trade documents relating to the batch or lot which are to be supplied with, or prior to, the delivery. (3) The information specified in paragraph (1) must be easily visible, clearly legible and indelible. (4) The information specified in paragraph (1) may be provided in more than one language, but at least one of those languages must be easily understood by the purchaser unless other measures have been taken to ensure that the purchaser is informed of the specified information. PART 4 Administration and enforcement Competent authorities 15. The competent authority for the purpose of Article 7 of Regulation 2065/2003 is the Food Standards Agency. 12 Awdurdodau gorfodi 16. Dyletswydd pob awdurdod bwyd yw gweithredu a gorfodi’r Rheoliadau hyn a Rheoliadau’r UE yn ei ardal neu ei ranbarth. Troseddu a chosbi 17.—(1) Mae unrhyw berson sy’n torri rheoliad 12 neu 13(1) yn cyflawni trosedd. Condemnio bwyd 18. Os bydd dadansoddydd bwyd yn ardystio bod unrhyw fwyd yn fwyd y mae’n drosedd ei osod ar y farchnad, rhaid trin y bwyd hwnnw at ddibenion adran 9 o’r Ddeddf (y caniateir i fwyd gael ei atafaelu a’i ddifa ar orchymyn ynad heddwch odani) fel bwyd sy’n methu cydymffurfio â gofynion diogelwch bwyd. Cymhwyso amryw o ddarpariaethau Deddf Diogelwch Bwyd 1990 19.—(1) Mae’r darpariaethau a ganlyn yn y Ddeddf yn gymwys at ddibenion y Rheoliadau hyn gyda’r addasiad bod unrhyw gyfeiriad yn y darpariaethau hynny at y Ddeddf neu at Ran ohoni i’w ddehongli fel cyfeiriad at y Rheoliadau hyn — (a) adran 20 (troseddau oherwydd bai person arall); (b) adran 21 (amddiffyniad diwydrwydd dyladwy)(1) gyda’r addasiad— (i) bod is-adrannau (2) i (4) yn gymwys o ran trosedd o dan reoliad 3, 4, 5, 6, 7(4) neu 17(1) fel y maent yn gymwys o ran trosedd o dan adran 14 neu 15, a (ii) y bernir bod y cyfeiriadau yn is-adran (4) at “sale” yn cynnwys cyfeiriadau at “placing on the market”; (c) adran 30(8) (sy’n ymwneud â thystiolaeth ddogfennol); (d) adran 35(1) (cosbi troseddau)(2), i’r graddau y mae’n ymwneud â throseddau o dan adran 33(1) fel y’i cymhwysir gan baragraff (3)(b); Enforcement authorities 16. It is the duty of each food authority within its area or district to execute and enforce these Regulations and the EU Regulations. Offences and penalties 17.—(1) Any person who contravenes regulation 12 or 13(1) commits an offence. Condemnation of food 18. Where any food is certified by a food analyst as being food which it is an offence to place on the market, that food shall be treated for the purposes of section 9 of the Act (under which food may be seized and destroyed under an order of a justice of the peace) as failing to comply with food safety requirements. Application of various provisions of the Food Safety Act 1990 19.—(1) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part of it is to be construed as a reference to these Regulations — (a) section 20 (offences due to fault of another person); (b) section 21 (defence of due diligence)(1) with the modification that — (i) subsections (2) to (4) shall apply in relation to an offence under regulation 3, 4, 5, 6, 7(4) or 17(1) as they apply in relation to an offence under section 14 or 15, and (ii) in subsection (4) the references to “sale” are deemed to include references to “placing on the market”; (c) section 30(8) (which relates to documentary evidence); (d) section 35(1) (punishment of offences)(2), in so far as it relates to offences under section 33(1) as applied by paragraph (3)(b); (1) Section 21 was amended by S.I. 2004/3279. (2) Section 35(1) is amended by the Criminal Justice Act 2003 (c.44), Schedule 26, paragraph 42, from a date to be appointed. (1) Diwygiwyd adran 21 gan O.S. 2004/3279. (2) Diwygiwyd adran 35(1) gan Ddeddf Cyfiawnder Troseddol 2003 (p.44), Atodlen 26, paragraff 42, o ddyddiad sydd i’w bennu. (2) Mae unrhyw berson sy’n euog o drosedd o dan reoliad 3, 4, 5, 6 neu 17(1) yn agored o’i gollfarnu’n ddiannod i ddirwy heb fod yn fwy na lefel 5 ar y raddfa safonol. (2) Any person guilty of an offence under regulation 3, 4, 5, 6 or 17(1) is liable on summary conviction to a fine not exceeding level 5 on the standard scale. 13 (g) adran 36A (troseddau gan bartneriaethau Albanaidd)(2). (2) Mae’r darpariaethau a ganlyn yn y Ddeddf yn gymwys at ddibenion y Rheoliadau hyn gyda’r addasiad bod unrhyw gyfeiriad yn y darpariaethau hynny at y Ddeddf i’w ddehongli fel pe bai’n cynnwys cyfeiriad at Reoliadau’r UE a’r Rheoliadau hyn— (a) adran 3 (rhagdybio bod bwyd wedi ei fwriadu i bobl ei fwyta) gyda’r addasiad y bernir bod y cyfeiriadau at “sold” a “sale” yn cynnwys cyfeiriadau at “placed on the market” a “placing on the market” yn y drefn honno; (b) adran 33(1) (rhwystro etc. swyddogion); (c) adran 33(2), gyda’r addasiad y bernir bod y cyfeiriad at “any such requirement as is mentioned in subsection (1)(b) above” yn gyfeiriad at unrhyw ofyniad o’r fath a grybwyllir yn yr is-adran honno fel y’i cymhwysir gan is-baragraff (b); a (d) adran 44 (amddiffyn swyddogion sy’n gweithredu’n ddidwyll). (3) Mae adran 34 o’r Ddeddf (terfyn amser ar gyfer erlyniadau) yn gymwys i droseddau o dan y Rheoliadau hyn fel y mae’n gymwys i droseddau y gellir eu cosbi o dan adran 35(2) o’r Ddeddf. RHAN 5 Cyffredinol Diwygiadau canlyniadol ac eraill 20. Yn rheoliad 2(1) (dehongli) o Reoliadau Labelu Bwyd 1996(3), yn y diffiniad o “the additives regulations” hepgorer yr ymadrodd “the Food Additives (Wales) Regulations 2009,”. (e) section 35(2) and (3)(1), in so far as it relates to offences under section 33(2) as applied by paragraph (2)(c); (f) section 36 (offences by bodies corporate); and (g) section 36A (offences by Scottish partnerships)(2). (2) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act is to be construed as including a reference to the EU Regulations and these Regulations — (a) section 3 (presumption that food is intended for human consumption) with the modification that the references to “sold” and “sale” are deemed to include references to “placed on the market” and “placing on the market” respectively; (b) section 33(1) (obstruction etc. of officers); (c) section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” is deemed to be a reference to any such requirement as is mentioned in that subsection as applied by sub-paragraph (b); and (d) section 44 (protection of officers acting in good faith). (3) Section 34 of the Act (time limit for prosecutions) applies to offences under these Regulations as it applies to offences punishable under section 35(2) of the Act. PART 5 General Consequential and other amendments 20. In regulation 2(1) (interpretation) of the Food Labelling Regulations 1996(3), in the definition of “the additives regulations” omit the expression “the Food Additives (Wales) Regulations 2009,”. (1) Section 35(3) was amended by S.I. 2004/3279. (2) Section 36A was inserted by the Food Standards Act 1999 (c.28), Schedule 5, paragraph 16. (3) S.I. 1996/1499. Relevant amending instruments are S.I. 2010/2817 and 2012/2619. (1) Diwygiwyd adran 35(3) gan O.S. 2004/3279. (2) Mewnosodwyd adran 36A gan Ddeddf Safonau Bwyd 1999 (p.28), Atodlen 5, paragraff 16. (3) O.S. 1996/1499. Offerynnau diwygio perthnasol yw O.S. 2010/2817 a 2012/2619. (e) adran 35(2) a (3)(1), i’r graddau y mae’n ymwneud â throseddau o dan adran 33(2) fel y’i cymhwysir gan baragraff (2)(c); (f) adran 36 (troseddau gan gyrff corfforaethol); ac 14 Y Gweinidog Iechyd a Gwasanaethau Cymdeithasol, Gweinidog, un o Weinidogion Cymru Minister for Health and Social Services, one of the Welsh Ministers Mark Drakeford 7 October 20137 Hydref 2013 Revocations 21. The instruments listed in the first column of Schedule 5 are revoked to the extent specified in the second column. Dirymu 21. Dirymir yr offerynnau a restrir yng ngholofn gyntaf Atodlen 5 i’r graddau a bennir yn yr ail golofn. 15 ATODLEN 1 Rheoliadau 3 a 7 Darpariaethau penodedig yn Rheoliad 1333/2008 Tabl 1 Y ddarpariaeth yn Rheoliad 1333/2008 Y pwnc Erthygl 4.1 (fel y’i darllenir gydag Erthyglau 11.3 ac 11.4, 12, 13.2 a 18.1(a), 18.2 a 18.3) Gofyniad mai dim ond ychwanegion bwyd a gynhwysir yn y rhestr yn Atodiad II i Reoliad 1333/2008 a osodir ar y farchnad fel y cyfryw, ac y’u defnyddir yn unol ag unrhyw amodau a bennir yn yr Erthyglau hynny a’r Atodiad hwnnw. Erthygl 4.2 (fel y’i darllenir gydag Erthyglau 12, 13.2 a 18.3) Gofyniad mai dim ond ychwanegion bwyd a gynhwysir yn y rhestr yn Atodiad III i Reoliad 1333/2008 y caniateir eu defnyddio mewn ychwanegion bwyd, ensymau bwyd, cyflasynnau bwyd a maetholion a hynny o dan yr amodau defnyddio a bennir yn yr Atodiad hwnnw. Erthygl 4.5 Gofyniad bod rhaid i ychwanegion bwyd gydymffurfio â’r manylebau y cyfeirir atynt yn Erthygl 14 o Reoliad 1333/2008. Erthygl 5 Gwaharddiad ar osod ar y farchnad ychwanegion bwyd neu fwyd sy’n cynnwys ychwanegion bwyd, os nad yw defnyddio’r ychwanegyn bwyd yn cydymffurfio â Rheoliad 1333/2008. Erthygl 11.2 Gofyniad bod rhaid defnyddio ychwanegion bwyd yn unol ag egwyddor quantum satis pan nad oes lefel uchaf rhifiadol wedi ei phennu ar gyfer yr ychwanegyn o dan sylw. Erthygl 15 Gwaharddiad ar ddefnyddio ychwanegion bwyd mewn bwydydd nas prosesir ac eithrio fel y darperir yn Atodiad II i Reoliad 1333/2008. Erthygl 16 Gwaharddiad ar ddefnyddio ychwanegion bwyd mewn bwydydd ar gyfer babanod a phlant ifanc (gan gynnwys bwydydd dietegol i fabanod a phlant ifanc at ddibenion meddygol arbennig) ac eithrio fel y darperir yn Atodiad II i Reoliad 1333/2008. Erthygl 17 Gofyniad bod rhaid defnyddio dim ond y lliwiau bwyd hynny a restrir yn Atodiad II i Reoliad 1333/2008, at ddibenion marcio iechyd ar gig neu gynhyrchion cig, lliwio addurniadol ar blisgyn wyau neu stampio plisgyn wyau. Erthygl 18.1(b) (fel y’i darllenir gydag Erthygl 18.2) Gofyniad na chaiff ychwanegion bwyd fod yn bresennol mewn bwyd yr ychwanegwyd ychwanegyn bwyd, ensym bwyd neu gyflasyn bwyd ato, onid yw’r ychwanegyn yn un a ganiateir yn yr ychwanegyn, yr ensym neu’r cyflasyn o dan Reoliad 1333/2008, ei fod wedi ei gludo drosodd i’r bwyd drwy gyfrwng yr ychwanegyn, yr ensym neu’r cyflasyn, ac nad oes iddo swyddogaeth dechnolegol yn y bwyd terfynol. 16 Erthygl 18.1(c) (fel y’i darllenir gydag Erthygl 18.2) Gofyniad na chaiff ychwanegion bwyd fod yn bresennol mewn bwydydd sydd i’w defnyddio yn unig i baratoi bwyd cyfansawdd, oni fydd y bwyd cyfansawdd yn cydymffurfio â Rheoliad 1333/2008. Erthygl 18.4 Gofyniad na chaniateir defnyddio ychwanegion bwyd yn felysyddion mewn bwydydd cyfansawdd sydd heb siwgrau ychwanegol, bwydydd cyfansawdd ynni is sydd heb siwgrau ychwanegol, bwydydd cyfansawdd ynni is, bwydydd dietegol cyfansawdd a fwriedir ar gyfer dietau calorïau isel, bwydydd cyfansawdd gwrth-gariogenig a bwydydd cyfansawdd sydd ag oes silff estynedig, oni fydd y melysydd yn un a ganiateir yn unrhyw un o gynhwysion y bwyd cyfansawdd. Erthygl 26.1 Gofyniad bod rhaid i gynhyrchwyr a defnyddwyr ychwanegion bwyd hysbysu’r Comisiwn ar unwaith ynghylch unrhyw wybodaeth wyddonol neu dechnegol newydd a allai effeithio ar yr asesiad o ddiogelwch yr ychwanegyn bwyd o dan sylw. Tabl 2 Y ddarpariaeth yn Rheoliad 1333/2008 Y pwnc Erthygl 21.1 (fel y’i darllenir gydag Erthygl 22) Gofyniad bod rhaid i ychwanegion bwyd na fwriedir eu gwerthu i’r defnyddwyr terfynol gael eu labelu, yn unol ag Erthygl 22 o Reoliad 1333/2008, yn weladwy, yn glir i’w darllen ac yn annileadwy mewn iaith a ddeellir yn hawdd gan y prynwyr. Erthygl 23.1 (fel y’i darllenir gydag Erthygl 23.2 and 23.5) Gwaharddiad ar farchnata ychwanegion bwyd, a werthir yn unigol neu’n gymysg â’i gilydd a/neu’n gymysg â chynhwysion bwyd eraill, ac y bwriedir eu gwerthu i’r defnyddwyr terfynol, oni ddangosir gwybodaeth benodedig ar eu pecynnau. Erthygl 23.3 (fel y’i darllenir gydag Erthygl 23.5) Gofyniad bod y labeli ar felysyddion pen bwrdd sy’n cynnwys polyolau a/neu aspartame a/neu halen aspartame – acesulfame yn cynnwys rhybuddion penodedig Erthygl 23.4 Gofyniad bod rhaid i weithgynhyrchwyr melysyddion pen-bwrdd drefnu, drwy fodd priodol, fod yr wybodaeth ar gael sy’n angenrheidiol er mwyn i ddefnyddwyr eu defnyddio’n ddiogel. Erthygl 24.1 (fel y’i darllenir gydag Erthygl 24.2) Gofyniad y dylai labeli’r bwyd sy’n cynnwys y lliwiau a restrir yn Atodiad V gynnwys yr wybodaeth ychwanegol a bennir yn yr Atodiad hwnnw. Erthygl 26.2 Gofyniad bod cynhyrchwyr a defnyddwyr ychwanegion bwyd, ar gais y Comisiwn, yn ei hysbysu ynghylch y defnydd gwirioneddol o’r ychwanegyn bwyd o dan sylw 17 ATODLEN 2 Rheoliadau 4 a 7 Darpariaethau penodedig yn Rheoliad 1334/2008 Tabl 1 Y ddarpariaeth yn Rheoliad 1334/2008 Y pwnc Erthygl 4 Gofyniad bod rhaid i’r defnydd ar gyflasynnau bwyd neu gynhwysion bwyd ac iddynt briodweddau cyflasyn beidio â pheri risg i ddiogelwch na chamarwain y defnyddiwr. Erthygl 5 Gwaharddiad ar osod cyflasynnau nad ydynt yn cydymffurfio neu fwyd nad yw’n cydymffurfio ar y farchnad. Erthygl 6.1 (fel y’i darllenir gyda Rhan A o Atodiad III) Gwaharddiad ar ychwanegu sylweddau penodol a bennwyd fel y cyfryw mewn bwydydd. Erthygl 6.2 (fel y’i darllenir gyda Rhan B o Atodiad III) Gofyniad na ddylai sylweddau penodol sy’n bresennol yn naturiol mewn cyflasynnau neu gynhwysion bwyd ac iddynt briodweddau cyflasyn fod yn uwch na lefelau penodedig mewn bwydydd cyfansawdd o ganlyniad i ddefnyddio cyflasynnau neu gynhwysion bwyd ac iddynt briodweddau cyflasyn. Erthygl 7.1 (fel y’i darllenir gyda Rhan A o Atodiad IV) Gwaharddiad ar ddefnyddio deunyddiau ffynhonnell penodol i gynhyrchu cyflasynnau neu gynhwysion bwyd ac iddynt briodweddau cyflasyn. Erthygl 7.2 (fel y’i darllenir gyda Rhan B o Atodiad IV) Cyfyngiadau ar ddefnyddio cyflasynnau neu gynhwysion bwyd ac iddynt briodweddau cyflasyn a gynhyrchir o ddeunyddiau ffynhonnell penodol. Erthygl 10 Cyfyngiad ar osod ar y farchnad neu ddefnyddio cyflasynnau a deunyddiau ffynhonnell sydd heb eu cynnwys ar restr yr Undeb. Erthygl 19.2 Gofyniad bod rhaid i gynhyrchydd neu ddefnyddiwr cyflasyn a gymeradwywyd sy’n cael ei baratoi drwy ddulliau cynhyrchu neu drwy ddefnyddio deunyddiau cychwynnol sy’n sylweddol wahanol i’r rhai a gynhwyswyd yn yr asesiad risg gyflwyno’r data angenrheidiol i’r Comisiwn i ganiatáu gwerthusiad o ran y dull cynhyrchu neu’r priodweddau diwygiedig cyn marchnata’r cyflasyn. Erthygl 19.3 Gofyniad ar weithredwyr busnesau bwyd i hysbysu’r Comisiwn ar unwaith os cânt wybod am unrhyw wybodaeth wyddonol neu dechnegol newydd a allai effeithio ar asesiad diogelwch sylwedd cyflasu. Tabl 2 Y ddarpariaeth yn Rheoliad 1334/2008 Y pwnc Erthygl 14.1 (fel y’i darllenir gydag Erthyglau 15 ac 16) Gofynion ynghylch labelu cyflasynnau na fwriedir eu gwerthu i’r defnyddiwr terfynol. Erthygl 17 (fel y’i darllenir gydag Erthyglau 15.1(a) ac (16) Gofynion ynghylch labelu cyflasynnau y bwriedir eu gwerthu i’r defnyddiwr terfynol. 18 ATODLEN 3 Rheoliadau 5 a 7 Darpariaethau penodedig yn Rheoliad 2065/2003 Tabl 1 Y ddarpariaeth yn Rheoliad 2065/2003 Y pwnc Erthygl 4.2 Gwaharddiad ar farchnata cyflasyn mwg nad yw ar y rhestr o gyflasynnau mwg awdurdodedig, neu unrhyw fwyd y mae cyflasyn mwg o’r fath yn bresennol ynddo neu arno. Erthygl 4.2 Gwaharddiad ar farchnata cyflasyn mwg awdurdodedig, neu unrhyw fwyd y mae cyflasyn mwg o’r fath yn bresennol ynddo neu arno, ac eithrio yn unol ag unrhyw amodau defnyddio a osodwyd yn yr awdurdodiad. Erthygl 5.1, yr is-baragraff cyntaf Gwaharddiad ar ddefnyddio pren wedi ei drin, oni ellir dangos drwy dystysgrif neu ddogfennaeth briodol nad yw’r sylwedd a ddefnyddir i drin y pren yn peri sylweddau a allai fod yn wenwynig wrth iddo ymlosgi. Erthygl 5.1, yr ail is-baragraff Gofyniad bod rhaid gallu dangos drwy ddogfennaeth neu dystysgrif y cydymffurfiwyd â’r gwaharddiad ym mharagraff cyntaf Erthygl 5.1 Erthygl 5.2, y frawddeg gyntaf Gofyniad bod rhaid cydymffurfio â’r amodau yn Atodiad 1 wrth gynhyrchu cynhyrchion sylfaenol (cyddwysiadau mwg sylfaenol neu ffracsiynau tar sylfaenol) Erthygl 5.2, yr ail frawddeg Gwaharddiad ar ddefnyddio’r cyfnod olewaidd annhoddadwy mewn dŵr wrth gynhyrchu cyflasynnau mwg. Erthygl 9.4 Gofyniad bod rhaid i ddeiliad awdurdodiad neu unrhyw weithredydd busnes bwyd arall, sy’n defnyddio cynnyrch awdurdodedig, neu gyflasyn mwg deilliedig a gynhyrchir o gynnyrch awdurdodedig, gydymffurfio ag unrhyw amodau neu gyfyngiadau sydd ynghlwm wrth yr awdurdodiad Erthygl 9.5 Gofyniad bod rhaid i ddeiliad awdurdodiad hysbysu’r Comisiwn am unrhyw wybodaeth wyddonol neu dechnegol newydd sy’n ymwneud â chynnyrch awdurdodedig, ac a allai ddylanwadu ar werthuso diogelwch y cynnyrch awdurdodedig hwnnw Tabl 2 Y ddarpariaeth yn Rheoliad 2065/2003 Y pwnc Erthygl 13.1 Gofyniad bod rhaid i weithredwyr busnesau bwyd sicrhau y trosglwyddir yr wybodaeth benodedig i’r gweithredydd busnes bwyd sy’n derbyn y cynnyrch pan osodir y cynnyrch ar y farchnad am y tro cyntaf Erthygl 13.2 Gofyniad, yn sgil gosod cynnyrch ar y farchnad am y tro cyntaf, fod rhaid i weithredwyr busnesau bwyd sy’n gosod y cynhyrchion ar y farchnad drosglwyddo’r wybodaeth benodedig yn Erthygl 13.1 i’r gweithredwyr busnes bwyd sy’n derbyn y cynnyrch, bob tro y rhoddir y cynnyrch ar y farchnad 19 ATODLEN 4 Rheoliadau 6 a 7 Darpariaethau penodedig yn Rheoliad 1332/2008 Tabl 1 Y ddarpariaeth yn Rheoliad 1332/2008 Y pwnc Erthygl 4 Gofyniad na chaniateir gosod ensymau bwyd ar y farchnad fel y cyfryw na’u defnyddio mewn bwydydd oni bai eu bod yn ymddangos yn rhestr yr Undeb o ensymau awdurdodedig y darperir ar ei chyfer yn Erthygl 17 ac yn unol â’r manylebau a’r amodau defnyddio penodedig. Erthygl 5 Gwaharddiad ar osod ar y farchnad ensymau bwyd nad ydynt yn cydymffurfio neu fwydydd sy’n cynnwys ensymau o’r fath nad ydynt yn cydymffurfio â Rheoliad 1332/2008 a’i fesurau gweithredu. Erthygl 14.1 Gofyniad bod rhaid i gynhyrchydd neu ddefnyddiwr ensym bwyd hysbysu’r Comisiwn ar unwaith am unrhyw wybodaeth wyddonol neu dechnegol newydd a allai effeithio ar ei asesiad diogelwch. Erthygl 14.2 Gofyniad bod rhaid i gynhyrchydd neu ddefnyddiwr ensym bwyd a gymeradwywyd sy’n cael ei baratoi drwy ddulliau cynhyrchu neu drwy ddefnyddio deunyddiau cychwynnol sy’n wahanol i’r rhai a gynhwyswyd yn yr asesiad risg gyflwyno’r data angenrheidiol i’r Comisiwn i ganiatáu gwerthusiad o ran y dull cynhyrchu neu’r priodweddau diwygiedig cyn marchnata’r ensym. Tabl 2 Y ddarpariaeth yn Rheoliad 1332/2008 Y pwnc Erthygl 10.1 (fel y’i darllenir gydag Erthygl 11) Gofynion ynghylch labelu ensymau a pharatoadau bwyd na fwriedir eu gwerthu i’r defnyddiwr terfynol. Erthygl 12.1 Gofynion ynghylch labelu ensymau a pharatoadau bwyd y bwriedir eu gwerthu i’r defnyddiwr terfynol. ATODLEN 5 Rheoliad 21 Dirymu Enw’r offeryn Graddfa’r dirymu Rheoliadau Toddyddion Echdynnu mewn Bwyd 1993 (O.S. 1993/1658) Y Rheoliadau cyfan Rheoliadau Toddyddion Echdynnu mewn Bwyd (Diwygio) 1995 (O.S. 1995/1440) Y Rheoliadau cyfan Rheoliadau Toddyddion Echdynnu mewn Bwyd (Diwygio) 1998 (O.S. 1998/2257) Y Rheoliadau cyfan 20 Rheoliadau Toddyddion Echdynnu mewn Bwyd (Diwygio) (Cymru) 2011 (O.S. 2011/1849 (Cy.199)) Y Rheoliadau cyfan Rheoliadau Cyflasynnau Mwg (Cymru) 2005 (O.S. 2005/1350 (Cy.98)) Y Rheoliadau cyfan Rheoliadau Bwyd (Atal Defnyddio E 128 Red 2G fel Lliw Bwyd) (Cymru) (Rhif 2) 2007 (O.S. 2007/2315 (Cy.186)) Y Rheoliadau cyfan Rheoliadau Ensymau Bwyd 2009 (O.S. 2009/3377 (Cy.299)) Rheoliadau 3, 4, 5, 6, 7(2)(b) ac 8 Rheoliadau Ychwanegion Bwyd (Cymru) 2009 (O.S. 2009/3378 (Cy.300)) Pob darpariaeth ac eithrio rheoliadau 1, 2, 18(4) a 19 Rheoliadau Ychwanegion Bwyd (Cymru) (Diwygio) 2011 (O.S. 2011/655 (Cy.93)) Y Rheoliadau cyfan Rheoliadau Ychwanegion Bwyd (Cymru) (Diwygio) (Rhif 2) 2011 (O.S. 2011/1450 (Cy.172)) Y Rheoliadau cyfan Rheoliadau Ychwanegion Bwyd (Cymru) (Diwygio) a Thoddyddion Echdynnu mewn Bwyd (Diwygio) (Cymru) (O.S. 2012/1198 (Cy.148)) Y Rheoliadau cyfan Rheoliadau Cyflasynnau mewn Bwyd (Cymru) 2010 (O.S. 2010/2922 (Cy.243)) Pob darpariaeth ac eithrio rheoliadau 1, 2 a 7. © h Hawlfraint y Goron 2013 Argraffwyd a chyhoeddwyd yn y Deyrnas Unedig gan The Stationery Office Limited o dan awdurdod ac arolygiaeth Carol Tullo, Rheolwr Gwasg Ei Mawrhydi ac Argraffydd Deddfau Seneddol y Frenhines. SCHEDULE 1 Regulations 3 and 7 Specified provisions of Regulation 1333/2008 Table 1 Provision of Regulation 1333/2008 Subject matter Article 4.1 (as read with Articles 11.3 and 11.4, 12, 13.2 and 18.1(a), 18.2 and 18.3) Requirement that only food additives included in the list in Annex II to Regulation 1333/2008 be placed on the market as such and that they be used in accordance with any conditions specified in those Articles and that Annex. Article 4.2 (as read with Articles 12, 13.2 and 18.3) Requirement that only food additives included in the list in Annex III to Regulation 1333/2008 may be used in food additives, food enzymes, food flavourings and nutrients and under the conditions of use specified in that Annex. Article 4.5 Requirement that food additives comply with the specifications referred to in Article 14 of Regulation 1333/2008. Article 5 Prohibition on placing on the market of food additives or food containing food additives if the use of the food additive does not comply with Regulation 1333/2008. Article 11.2 Requirement to use food additives in accordance with the quantum satis principle where no maximum numerical level fixed for the additive concerned. Article 15 Prohibition on use of food additives in unprocessed foods except where provided for in Annex II to Regulation 1333/2008. Article 16 Prohibition on use of food additives in foods for infants and young children (including dietary foods for infants and young children for special medical purposes) except where provided for in Annex II to Regulation 1333/2008. Article 17 Requirement to use only food colours listed in Annex II to Regulation 1333/2008 for the purpose of health marking meat or meat products, decorative colouring of eggshells or stamping of eggshells. Article 18.1(b) (as read with Article 18.2) Requirement that food additives be present in food to which a food additive, food enzyme or food flavouring has been added, only if the additive is permitted in the additive, enzyme or flavouring under Regulation 1333/2008, has been carried over to the food via the additive, enzyme or flavouring and has no technological function in the final food. Article 18.1(c) (as read with Article 18.2) Requirement that food additives be present in foods to be used solely in the preparation of a compound food only if the compound food complies with Regulation 1333/2008. 21 Article 18.4 Requirement that food additives be used as sweeteners in compound foods with no added sugars, energy reduced compound foods with no added sugars, energy reduced compound foods, compound dietary foods intended for low calorie diets, non cariogenic compound foods and compound foods with an increased shelf life only if the sweetener is permitted in any of the ingredients of the compound food. Article 26.1 Requirement that producers and users of food additives inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the food additive concerned. Table 2 Provision of Regulation 1333/2008 Subject matter Article 21.1 (as read with Article 22) Requirement that food additives not intended for sale to the final consumer be labelled, in accordance with Article 22 of Regulation 1333/2008, visibly, clearly legibly and indelibly and in a language easily understandable to purchasers. Article 23.1 (as read with Article 23.2 and 23.5) Prohibition on marketing of food additives sold singly or mixed with each other and/or other food ingredients and intended for sale to the final consumer unless their packaging contains specified information. Article 23.3 (as read with Article 23.5) Requirement that the labelling of table-top sweeteners containing polyols and/or aspartame and/or aspartame – acesulfame salt bear specified warnings. Article 23.4 Requirement that manufacturers of table top sweeteners make available by appropriate means the information necessary to allow safe use by consumers. Article 24.1 (as read with Article 24.2) Requirement that labelling of the food containing the colours listed in Annex V should contain the additional information specified in that Annex. Article 26.2 Requirement that producers and users of food additives, at the request of the Commission, inform it of the actual use of the food additive concerned. 22 SCHEDULE 2 Regulations 4 and 7 Specified provisions of Regulation 1334/2008 Table 1 Provision of Regulation 1334/2008 Subject matter Article 4 Requirement that the use of flavourings or food ingredients with flavouring properties does not pose a safety risk or mislead the consumer. Article 5 Prohibition on the placing on the market of non-compliant flavourings or non-compliant food. Article 6.1 (as read with Part A of Annex III) Prohibition on adding certain specified substances as such in foods. Article 6.2 (as read with Part B of Annex III) Requirement that certain substances naturally present in flavourings or food ingredients with flavouring properties should not exceed specified levels in compound foods as a result of the use of flavourings or food ingredients with flavouring properties. Article 7.1 (as read with Part A of Annex IV) Prohibition on the use of certain source materials to produce flavourings or food ingredients with flavouring properties. Article 7.2 (as read with Part B of Annex IV) Restrictions on the use of flavourings or food ingredients with flavouring properties produced from certain source materials. Article 10 Restriction on the placing on the market or use of flavourings and source materials that are not included on the Union list. Article 19.2 Requirement that a producer or user of an approved flavouring that is prepared by production methods or using starting materials significantly different from those included in the risk assessment must submit the necessary data to the Commission to allow an evaluation with regard to the modified production method or characteristics before marketing the flavouring Article 19.3 Requirement on food business operators to inform the Commission immediately if they become aware of any new scientific or technical information that might affect the assessment of the safety of a flavouring substance. Table 2 Provision of Regulation 1334/2008 Subject matter Article 14.1 (as read with Articles 15 and 16) Requirements for the labelling of flavourings not intended for sale to the final consumer. Article 17 (as read with Articles 15.1(a) and 16) Requirements for the labelling of flavourings intended for sale to the final consumer. 23 SCHEDULE 3 Regulations 5 and 7 Specified provisions of Regulation 2065/2003 Table 1 Provision of Regulation 2065/2003 Subject matter Article 4.2 Prohibition on marketing a smoke flavouring not on the list of authorised smoke flavourings, or any food in or on which such a smoke flavouring is present Article 4.2 Prohibition on marketing an authorised smoke flavouring, or any food in or on which such a smoke flavouring is present, otherwise than in accordance with any conditions of use laid down in the authorisation Article 5.1, first subparagraph Prohibition on using treated wood, unless it can be demonstrated by appropriate certification or documentation that the substance used in treatment does not give rise to potentially toxic substances during combustion Article 5.1, second subparagraph Requirement to be able to demonstrate by documentation or certification that the prohibition in the first paragraph of Article 5.1 has been observed Article 5.2, first sentence Requirement to observe conditions in Annex I during production of primary products (primary smoke condensates or primary tar fractions) Article 5.2, second sentence Prohibition on the use of water-insoluble oily phase during the production of smoke flavourings Article 9.4 Requirement that an authorisation holder or any other food business operator using an authorised product, or a derived smoke flavouring produced from an authorised product, must comply with any conditions or restrictions attached to the authorisation Article 9.5 Requirement that an authorisation holder inform the Commission immediately of any new scientific or technical information relating to an authorised product which might influence the assessment of its safety Table 2 Provision of Regulation 2065/2003 Subject matter Article 13.1 Requirement that food business operators ensure the specified information is transmitted to the receiving food business operator when the product is first placed on the market Article 13.2 Requirement that following the first placing on the market, on each subsequent occasion that the product is placed on the market, food business operators placing products on the market transmit the information specified in Article 13.1 to the receiving food business operators 24 SCHEDULE 4 Regulations 6 and 7 Specified provisions of Regulation 1332/2008 Table 1 Provision of Regulation 1332/2008 Subject matter Article 4 Requirement that food enzymes may not be placed on the market as such or used in foods unless they appear in the Union list of authorised enzymes provided for in Article 17 and in accordance with the prescribed specifications and conditions of use. Article 5 Prohibition on placing on the market of non compliant food enzymes or foods containing such enzymes which do not comply with Regulation 1332/2008 and its implementing measures. Article 14.1 Requirement that a producer of user of a food enzyme shall inform the Commission immediately of any new scientific or technical information that might affect its safety assessment. Article 14.2 Requirement that a producer or user of an approved food enzyme that is prepared by production methods or using starting materials significantly different from those included in the risk assessment must submit the necessary data to the Commission to allow an evaluation with regard to the modified production method or characteristics before marketing the enzyme. Table 2 Provision of Regulation 1332/2008 Subject matter Article 10.1 (as read with Article 11) Requirements for labelling of food enzymes and preparations not intended for sale to the final consumer. Article 12.1 Requirements for labelling of food enzymes and preparations intended for sale to the final consumer. SCHEDULE 5 Regulation 21 Revocations Name of instrument Extent of revocation The Extraction Solvents in Food Regulations 1993 (S.I. 1993/1658) The whole Regulations The Extraction Solvents in Food (Amendment) Regulations 1995 (S.I. 1995/1440) The whole Regulations The Extraction Solvents in Food (Amendment) Regulations 1998 (S.I. 1998/2257) The whole Regulations 25 The Extraction Solvents in Food (Amendment) (Wales) Regulations 2011 (S.I. 2011/1849 (W.199)) The whole Regulations The Smoke Flavourings (Wales) Regulations 2005 (S.I. 2005/1350 (W.98)) The whole Regulations The Food (Suspension of the Use of E128 Red 2G Food Colour) (Wales) Regulations 2007 (S.I. 2007/2315 (W.186)) The whole Regulations The Food Enzymes Regulations 2009 (S.I. 2009/3377 (W.299)) Regulations 3, 4, 5, 6, 7(2)(b) and 8 The Food Additives (Wales) Regulations 2009 (S.I. 2009/3378 (W.300)) All provisions except regulations 1, 2, 18(4) and 19 The Food Additives (Wales) (Amendment) Regulations 2011 (S.I. 2011/655 (W.93)) The whole Regulations The Food Additives (Wales) (Amendment) (No.2) Regulations 2011 (S.I. 2011/1450 (W.172)) The whole Regulations The Food Additives (Wales) (Amendment) and the Extraction Solvents in Food (Amendment) (Wales) Regulations 2012 (S.I. 2012/1198 (W.148)) The whole Regulations The Flavourings in Food (Wales) Regulations 2010 (S.I. 2010/2922 (W.243)) All provisions except regulations 1, 2 and 7. 26 © Crown copyright 2013 Printed and Published in the UK by the Stationery Office Limited under the authority and superintendence of Carol Tullo, Controller of Her Majesty’s Stationery Office and Queen’s Printer of Acts of Parliament. O F F E R Y N N A U S T A T U D O L C Y M R U BWYD, CYMRU Rheoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd (Cymru) 2013 W E L S H S T A T U T O R Y I N S T R U M E N T S FOOD, WALES The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 ONW1749/10/13 2013 No. 2591 (W. 255) 2013 Rhif 2591 (Cy. 255) £5.75