Food Supplements (Wales) (Amendment) Regulations 2007 (S.I. No. 1076 (W. 114) of 2007)

NATIONAL ASSEMBLY FOR WALES S TAT U T O RY I N S T R U M E N T S 2007 No. 1076 (W.114) FOOD, WALES The Food Supplements (Wales) (Amendment) Regulations 2007 EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations amend the Food Supplements (Wales) Regulations 2003 which implement in Wales Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (OJ No. L183, 12.7.2002, p.51). These Regulations implement in Wales Commission Directive 2006 / 37 /EC (OJ No. L 94, 1.4.2006, p.32) amending Annex II to Directive 2002/46/EC as regards the inclusion of certain substances. 2. The 2003 Regulations prohibit the sale of a food supplement in the manufacture of which a vitamin or mineral has been used unless that vitamin or mineral is listed in Schedule 1 to those Regulations and is in a form listed in Schedule 2 (the positive lists), subject to a transitional provision (regulation 5 and Schedules to those Regulations). 3. These Regulations (a) add another form of the vitamin folate and another form of the mineral iron to the positive list in Schedule 2 to the 2003 Regulations (regulation 5) and make a consequential amendment (regulation 4); (b) update the definition of "Directive 2002/46/EC" in the 2003 Regulations (regulation 3). 4. A regulatory appraisal has been prepared for these Regulations and has been placed in the Library of the National Assembly for Wales together with a transposition note setting out how the main elements of Directive 2006/37/EC are transposed in these Regulations. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW. CYNULLIAD CENEDLAETHOL CYMRU O F F E RY N N A U S TAT U D O L 2007 Rhif 1076 (Cy.114) BWYD, CYMRU Rheoliadau Atchwanegiadau Bwyd (Cymru) (Diwygio) 2007 NODYN ESBONIADOL (Nid yw'r nodyn hwn yn rhan o'r Rheoliadau.) 1. Mae'r Rheoliadau hyn yn diwygio Rheoliadau Ychwanegion Bwyd (Cymru) 2003 sy'n gweithredu yng Nghymru Gyfarwyddeb 2002/46/EC Senedd Ewrop a'r Cyngor ar gyd-ddynesiad cyfreithiau'r Aelod-wladwriaethau ar atchwanegiadau bwyd (OJ Rhif L183, 12.7.2002, t.51). Mae'r Rheoliadau hyn yn gweithredu yng Nghymru Gyfarwyddeb y Comisiwn 2006/37/EC (OJ Rhif L94, 1.4.2006, t.32) sy'n diwygio Atodiad II i Gyfarwyddeb 2002/46/EC o ran cynnwys sylweddau penodol. 2. Mae Rheoliadau 2003 yn gwahardd gwerthu atchwanegiad bwyd y defnyddiwyd fitamin neu fwyn wrth ei gynhyrchu oni bai i'r fitamin hwnnw neu i'r mwyn hwnnw gael ei restru yn Atodlen 1 i'r Rheoliadau hynny ac oni bai ei fod ar ffurf a restrir yn Atodlen 2 (y rhestri cadarnhaol), yn ddarostyngedig i ddarpariaeth drosiannol (rheoliad 5 ac Atodlenni i'r Rheoliadau hynny). 3. Mae'r Rheoliadau hyn (a) yn ychwanegu ffurf arall ar y fitamin ffolad a ffurf arall ar y mwyn haearn at y rhestr gadarnhaol yn Atodlen 2 yn Rheoliadau 2003 (rheoliad 5) ac yn gwneud diwygiad canlyniadol (rheoliad 4); (b) yn diweddaru'r diffiniad o "Cyfarwyddeb 2002/46/EC" yn Rheoliadau 2003 (rheoliad 3). 4. Mae arfarniad rheoliadol wedi'i baratoi ar gyfer y Rheoliadau hyn a'i roi yn Llyfrgell Cynulliad Cenedlaethol Cymru ynghyd â Nodyn Trosi sy'n nodi sut y mae prif elfennau Cyfarwyddeb 2006/37/EC yn cael eu trosi yn y Rheoliadau hyn. Gellir cael copïau gan yr Asiantaeth Safonau Bwyd, Llawr 11, Southgate House, Caerdydd, CF10 1EW. 1 O F F E RY N N A U S TAT U D O L 2007 Rhif 1076 (Cy.114) BWYD, CYMRU Rheoliadau Atchwanegiadau Bwyd (Cymru) (Diwygio) 2007 Wedi'u gwneud 27 Mawrth 2007 Yn dod i rym 6 Ebrill 2007 Mae Cynulliad Cenedlaethol Cymru, drwy arfer y pwerau a roddwyd gan adrannau 16(1)(a) ac (e), 17(1), 26(1)(a) a (3) a 48(1) o Ddeddf Diogelwch Bwyd 1990(1) ac sydd bellach wedi'u breinio ynddo(2), ac wedi rhoi sylw yn unol ag adran 48(4A) o'r Ddeddf honno, i gyngor perthnasol a roddwyd gan yr Asiantaeth Safonau Bwyd ac ar ôl ymgynghoriad cyhoeddus agored a thryloyw wrth lunio'r Rheoliadau fel sy'n ofynnol gan Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a'r Cyngor(3) sy'n gosod egwyddorion a gofynion cyffredinol cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn gosod gweithdrefnau o ran materion diogelwch bwyd, yn gwneud y Rheoliadau canlynol. Enwi, cychwyn a chymhwyso 1. Enw'r Rheoliadau hyn yw Rheoliadau Atchwanegiadau Bwyd (Cymru) (Diwygio) 2007, deuant i rym ar 6 Ebrill 2007 ac maent yn gymwys o ran Cymru. S TAT U T O RY I N S T R U M E N T S 2007 No. 1076 (W.114) FOOD, WALES The Food Supplements (Wales) (Amendment) Regulations 2007 Made 27 March 2007 Coming into force 6 April 2007 The National Assembly for Wales, in exercise of the powers conferred by sections 16(1)(a) and (e), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990(1) and now vested in it(2), having had regard, in accordance with section 48(4A) of that Act, to relevant advice given by the Food Standards Agency, and after open and transparent public consultation during the preparation of the Regulations as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council(3) 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, makes the following Regulations. Title, commencement and application 1. The title of these Regulations is the Food Supplements (Wales) (Amendment) Regulations 2007, they will come into force on 6 April 2007 and apply in relation to Wales. (1) 1990 p. 16; amnewidiwyd adran 1(1) a (2) (diffiniad o "food") gan O.S. 2004/2990. Diwygiwyd adrannau 17 ac 48 gan baragraffau 12 a 21 yn eu trefn o Atodlen 5 i Ddeddf Safonau Bwyd 1999 (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 (1994 p.40), Atodlen 6 i Ddeddf 1999 ac O.S. 2004/2990. (2) Trosglwyddwyd swyddogaethau a oedd gynt yn arferadwy gan "the Secretary of State", i'r graddau yr oeddent 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 (1999 p.28). (3) OJ Rhif L31, 1.2.2002, t. 1. Diwygiwyd y Rheoliad hwnnw ddiwethaf o ran y dyddiad y cafodd y Rheoliadau hyn eu gwneud gan Reoliad y Comisiwn (EC) Rhif 575/2006 (OJ Rhif L 100, 8.4.2006, t.3). 2 (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 (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 (1994 c.40), Schedule 6 to the 1999 Act and S.I. 2004/2990. (2) Functions formerly exercisable by "the Secretary of State" 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 (1999 c.28). (3) OJ No. L31, 1.2.2002, p. 1. That Regulation was last amended as at the date these Regulations were made by Commission Regulation (EC) No. 575/2006 (OJ No. L 100, 8.4.2006, p.3). Diwygio Rheoliadau Ychwanegion Bwyd (Cymru) 2003 2. Diwygir Rheoliadau Ychwanegion Bwyd (Cymru) 2003(1) diwygio yn unol â rheoliadau 3 i 5. 3. Yn rheoliad 2(1) (dehongli) yn y diffiniad o "Cyfarwyddeb 2002/46" mewnosoder ar y diwedd ", fel y'i diwygiwyd gan Gyfarwyddeb y Comisiwn 2006/37/EC(2) sy'n diwygio Atodiad II i Gyfarwyddeb 2002/46/EC Senedd Ewrop a'r Cyngor o ran cynnwys sylweddau penodol". 4. Yn Atodlen 1 (fitaminau a mwynau y caniateir eu defnyddio wrth gynhyrchu ychwanegion bwyd), yn Adran 1 (fitaminau), yn lle "Asid ffolig" rhodder "Ffolad". 5. Yn Atodlen 2 (ffurf ar sylweddau fitamin a mwyn y caniateir eu defnyddio wrth gynhyrchu ychwanegion bwyd) (a) yn adran A (fitaminau), yn eitem 10 yn lle'r pennawd "ASID FFOLIG" rhodder "FFOLAD", ac o dan y pennawd (diwygiedig) hwnnw rhodder ar y diwedd "(b) calsiwm L methylffolad"; (b) yn adran B (mwynau) o flaen "Carbonad cwprig" mewnosoder "Bisglycinad fferus". Llofnodwyd ar ran Cynulliad Cenedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 1998(3). 27 Mawrth 2007 Llywydd y Cynulliad Cenedlaethol Amendment of the Food Supplements (Wales) Regulations 2003 2. The Food Supplements (Wales) Regulations 2003(1) are amended in accordance with regulations 3 to 5. 3. In regulation 2(1) (interpretation), in the definition of "Directive 2002/46" insert at the end ", as amended by Commission Directive 2006/37/EC(2) amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances". 4. In Schedule 1 (vitamins and minerals which may be used in the manufacture of food supplements), in Section 1 (vitamins), for "Folic acid" substitute "Folate". 5. In Schedule 2 (form of vitamin and mineral substances which may be used in the manufacture of food supplements) (a) in section A (vitamins), at item 10 for the heading "FOLIC ACID" substitute "FOLATE", and under that (revised) heading insert at the end "(b) calcium-L-methylfolate"; (b) in section B (minerals) before "Cupric carbonate" insert "Ferrous bisglycinate". Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(3). 27 March 2007 The Presiding Officer of the National Assembly (1) S.I. 2003/1719 (W. 186), to which there are amendments not relevant to these Regulations. (2) OJ No. L 94, 1.4.2006, p.32. (3) 1998 c.38. 3 (1) O.S. 2003/1719 (Cy. 186), y mae diwygiadau iddo nad ydynt yn gymwys i'r Rheoliadau hyn. (2) OJ Rhif L94, 1.4.2006, t.32. (3) 1998 p.38. D. Elis-Thomas £3.00 W0061/04/07 ON