Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2007 (W.S.I. No. 116 (W.7) 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. 116 (W.7) FOOD, WALES The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2007 EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which apply in relation to Wales, amend the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002 as amended ("the principal Regulations"). 2. These Regulations implement Commission Directive 2006/34/EC (OJ No. L83, 22.3.2006, p.14) amending the Annex to Directive 2001/15/EC as regards the inclusion of certain substances. 3. The principal Regulations apply to food for most particular nutritional uses (definition of "designated PNU food" in regulation 2(1) of those Regulations). Those Regulations restrict the sale of such food where there has been added to it for a specific nutritional purpose a substance falling within one of the following six categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides; choline and inositol. In such a case the substance must be listed under the relevant category in Schedule 1 or, as regards foods for special medical purposes, Schedule 1 or 2. There is a time-limited derogation as respects substances listed in Schedule 3 (regulation 3(5) of those Regulations). CYNULLIAD CENEDLAETHOL CYMRU O F F E RY N N A U S TAT U D O L 2007 Rhif 116 (Cy.7) BWYD, CYMRU Rheoliadau Bwyd at Ddefnydd Maethol Neilltuol (Ychwanegu Sylweddau at Ddibenion Maethol Penodol) (Cymru) (Diwygio) 2007 NODYN ESBONIADOL (Nid yw'r nodyn hwn yn rhan o'r Rheoliadau.) 1. Mae'r Rheoliadau hyn, sy'n gymwys o ran Cymru, yn diwygio Rheoliadau Bwyd at Ddefnydd Maethol Neilltuol (Ychwanegu Sylweddau at Ddibenion Maethol Penodol) (Cymru) 2002 fel y'i diwygiwyd ("y prif Reoliadau"). 2. Mae'r Rheoliadau hyn yn rhoi ar waith Gyfarwyddeb y Comisiwn 2006/34/EC (OJ Rhif L83, 22.3.2006, t.14) sy'n diwygio'r Atodiad i Gyfarwyddeb 2001/15/EC o ran cynnwys sylweddau penodol. 3. Mae'r prif Reoliadau yn gymwys i fwyd ar gyfer y rhan fwyaf o ffyrdd penodol o'i ddefnyddio'n faethol (ceir diffiniad o "bwyd DMN dynodedig" yn rheoliad 2(1) o'r Rheoliadau hynny). Mae'r Rheoliadau hynny yn cyfyngu ar werthu bwydydd o'r fath pan fo sylwedd sy'n cwympo o fewn un o'r chwe categori canlynol wedi cael ei ychwanegu ato at ddiben maethol penodol: fitaminau; mwynau; asidau amino; carnitin a thawrin; niwcelotidau; colin ac inositol. Mewn achos o'r fath rhaid i'r sylwedd fod wedi'i restru o dan y categori perthnasol yn Atodlen 1 neu, yn achos bwydydd at ddibenion meddygol arbennig, yn Atodlen 1 neu 2. Mae yna randdirymiad ag iddo derfyn amser yn achos sylweddau a restrir yn Atodlen 3 (rheoliad 3(5) o'r Rheoliadau hynny). 1 4. Mae'r Rheoliadau hyn (a) yn ychwanegu sylweddau penodol at y rhestr yn y categorïau fitaminau a mwynau y ceir eu hychwanegu at ddibenion maethol penodol at fwydydd DMN dynodedig (heb unrhyw derfyn amser) (rheoliad 4); (b) yn ychwanegu sylwedd yn y categori mwynau at y rhestr o sylweddau y ceir eu hychwanegu at ddibenion maethol penodol at fwydydd at ddibenion meddygol arbennig (heb unrhyw derfyn amser) (rheoliad 5); (c) yn diweddaru'r diffiniad o "Cyfarwyddeb 2001/15" (rheoliad 3). 5. Mae'r Rheoliadau hyn hefyd diwygio Rheoliadau Hysbysiadau o Farchnata Bwyd at Ddibenion Maethol Penodol (Cymru a Lloegr) 2002 i'r graddau y maent yn gymwys o ran Cymru er mwyn dileu geiriau dianghenraid o reoliad 6 o'r Rheoliadau hynny (rheoliad 6). 6. Mae arfarniad rheoliadol wedi'i baratoi ar gyfer y Rheoliadau hyn ac wedi'i roi yn llyfrgell Cynulliad Cenedlaethol Cymru, ynghyd â chopi o'r nodyn trosi sy'n ymwneud â'r Rheoliadau hyn. Gellir hefyd gael copïau oddi wrth yr Asiantaeth Safonau Bwyd, Llawr 11, Southgate House Caerdydd CF10 1EW. 4.These Regulations (a) add certain substances to the list in the categories of vitamins and minerals which may be added for specific nutritional purposes in designated PNU foods (without any time limit) (regulation 4); (b) add a substance in the minerals category to the list of substances which may be added for specific nutritional purposes in foods for special medical purposes (without any time limit) (regulation 5); (c) update the definition of "Directive 2001/15" (regulation 3). 5. These Regulations also amend the Notification of Marketing of Food for Particular Nutritional Uses (England and Wales) Regulations 2002 in so far as they apply in relation to Wales to remove unnecessary wording from regulation 6 of those Regulations (regulation 6). 6. A full regulatory appraisal has been prepared for these Regulations and has been placed in the Library of the National Assembly for Wales along with a copy of the transposition note relating to these Regulations. Copies are also available from the Food Standards Agency, 11th Floor, Southgate House, Cardiff CF10 1EW. 2 O F F E RY N N A U S TAT U D O L 2007 Rhif 116 (Cy.7) BWYD, CYMRU Rheoliadau Bwyd at Ddefnydd Maethol Neilltuol (Ychwanegu Sylweddau at Ddibenion Maethol Penodol) (Cymru) (Diwygio) 2007 Wedi'u gwneud 23 Ionawr 2007 Yn dod i rym 25 Ionawr 2007 Mae Cynulliad Cenedlaethol Cymru yn gwneud y Rheoliadau a ganlyn drwy arfer y pwerau a roddwyd gan adrannau 16(1)(f), 17(1), 26(3) a 48(1) o Ddeddf Diogelwch Bwyd 1990(1) ac sydd bellach wedi'u breinio ynddo ef(2). Mae Cynulliad Cenedlaethol Cymru wedi ystyried cyngor perthnasol a roddwyd gan yr Asiantaeth Safonau Bwyd fel sy'n ofynnol gan adran 48(4A) o'r Ddeddf honno. Cafwyd ymgynghori agored a thryloyw â'r cyhoedd yn ystod cyfnod paratoi'r Rheoliadau 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(3). S TAT U T O RY I N S T R U M E N T S 2007 No. 116 (W.7) FOOD, WALES The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2007 Made 23 January 2007 Coming into force 25 January 2007 The National Assembly for Wales makes the following Regulations in exercise of the powers conferred by sections 16(1)(f), 17(1), 26(3) and 48(1) of the Food Safety Act 1990(1) and now vested in it(2). The National Assembly for Wales has had regard to relevant advice given by the Food Standards Agency as required by section 48(4A) of that Act. There has been 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 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(3). (1) 1990 c. 16; section 1(1) and (2) (definition of "food") was substituted by S.I. 2004/2990; section 53(2) was amended by Schedule 6 to the Food Standards Act 1999 (1999 c.28) and S.I. 2004/2990. (2) Functions of the Secretary of State under the Food Safety Act 1990, so far as exerciseable 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. 672). (3) OJ No. L31, 1.2.2002, p. 1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4). 3 (1) 1990 c. 16; amnewidiwyd adran 1(1) a (2) (y diffiniad o "food") gan O.S. 2004/2990; diwygiwyd adran 53(2) gan Atodlen 6 i Ddeddf Safonau Bwyd 1999 (1999 p.28) ac O.S. 2004/2990. (2) Trosglwyddwyd swyddogaethau'r Ysgrifennydd Gwladol o dan Ddeddf Diogelwch Bwyd 1990, i'r graddau y maent yn arferadwy mewn perthynas â Chymru, i Gynulliad Cenedlaethol Cymru gan Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 1999 (O.S. 672). (3) OJ Rhif L31, 1.2.2002, t. 1. Diwygiwyd y Rheoliad hwnnw ddiwethaf gan Reoliad (EC) Rhif 1642/2003 Senedd Ewrop a'r Cyngor (OJ Rhif L245, 29.9.2003, t.4). Enwi, cychwyn, cymhwyso a dehongli 1.-(1) Enw'r Rheoliadau hyn yw Rheoliadau Bwyd at Ddefnydd Maethol Neilltuol (Ychwanegu Sylweddau at Ddibenion Maethol Penodol) (Cymru) (Diwygio) 2007. (2) Daw'r Rheoliadau hyn i rym ar 25 Ionawr 2007. (3) Mae'r Rheoliadau hyn yn gymwys o ran Cymru. (4) Yn y Rheoliadau hyn ystyr "y prif Reoliadau" yw Rheoliadau Bwyd at Ddefnydd Maethol Neilltuol (Ychwanegu Sylweddau at Ddibenion Maethol Penodol) (Cymru) 2002(1). Diwygio'r prif Reoliadau 2. Diwygir y prif Reoliadau yn unol â rheoliadau 3 i 5. 3. Yn rheoliad 2(1) (dehongli), yn y diffiniad o "Cyfarwyddeb 2001/15", ar ôl "Cyfarwyddeb 2004/5/EC" mewnosoder "a Chyfarwyddeb y Comisiwn 2006/34/EC(2)". 4. Yn Atodlen 1 (sylweddau y ceir eu hychwanegu at ddibenion maethol penodol at fwyd DMN dynodedig) (a) yn yr Adran sy'n ymwneud â Chategori 1 (fitaminau), yn lle'r pennawd "FOLIC ACID" rhodder "FOLATE", ac o dan y pennawd (diwygiedig) hwnnw mewnosoder ar y diwedd "- calcium-L-methylfolate"; (b) yn yr Adran sy'n ymwneud â Chategori 2 (mwynau), o dan y pennawd "IRON" mewnosoder ar y diwedd "- ferrous bisglycinate". 5. Yn Atodlen 2 (sylweddau ychwanegol y ceir eu hychwanegu at ddibenion maethol penodol at fwydydd at ddibenion meddygol arbennig) mewnosoder ar y dechrau "Categori 2: Mwynau magnesium L-aspartate". Title, commencement, application and interpretation 1.-(1) The title of these Regulations is the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2007. (2) These Regulations come into force on 25 January 2007. (3) These Regulations apply in relation to Wales. (4) In these Regulations "the principal Regulations" means the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002(1). Amendment of the principal Regulations 2. The principal Regulations are amended in accordance with regulations 3 to 5. 3. In regulation 2(1) (interpretation), in the definition of "Directive 2001/15", after "Directive 2004/5/EC" insert "and Commission Directive 2006/34/EC(2)". 4. In Schedule 1 (substances which may be added for specific nutritional purposes in designated PNU foods) (a) in the Section concerning Category 1 (vitamins), for the heading "FOLIC ACID" substitute "FOLATE", and under that (revised) heading insert at the end "- calcium-L methylfolate"; (b) in the Section concerning Category 2 (minerals), under the heading "IRON" insert at the end "- ferrous bisglycinate". 5. In Schedule 2 (additional substances which may be added for specific nutritional purposes in foods for special medical purposes) insert at the beginning "Category 2. Minerals magnesium L-aspartate". (1) O.S. 2002/2939 (Cy.280), a ddiwygiwyd gan O.S. 2004/1012 (Cy.109); y mae offerynnau diwygio eraill i'w cael, ond nid oes yr un ohonynt yn berthnasol. (2) OJ Rhif L83, 22.3.2006, t.14. (1) S.I. 2002/2939 (W.280), amended by S.I. 2004/1012 (W.109); there are other amending instruments but none is relevant. (2) OJ No. L83, 22.3.2006, p.14. 4 Diwygio'r Rheoliadau Hysbysiadau o Farchnata Bwyd at Ddibenion Maethol Penodol (Cymru a Lloegr) 2002 6.-(1) I'r graddau y maent yn gymwys o ran Cymru, diwygir Rheoliadau Hysbysiadau o Farchnata Bwyd at Ddibenion Maethol Penodol (Cymru a Lloegr) 2002(1) yn unol â pharagraff (2). (2) Yn rheoliad 6 (cymhwyso amrywiol ddarpariaethau o Ddeddf Diogelwch Bwyd 1990) hepgorer y geiriau ", unless the context otherwise requires,". Llofnodwyd ar ran Cynulliad Cenedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 1998(2) 23 Ionawr 2007 Llywydd y Cynulliad Cenedlaethol Amendment of the Notification of Marketing of Food for Particular Nutritional Uses (England and Wales) Regulations 2002. 6.-(1) In so far as they apply in relation to Wales, the Notification of Marketing of Food for Particular Nutritional Uses (England and Wales) Regulations 2002(1) are amended as specified in paragraph (2). (2) In regulation 6 (application of various provisions of the Food Safety Act 1990) omit the words ", unless the context otherwise requires,". Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(2) 23 January 2007 The Presiding Officer of the National Assembly (1) O.S. 2002/333. (2) 1998 p.38. (1) S.I. 2002/333. (2) 1998 c.38. 5 D. Elis-Thomas £3.00 W460/01/07 ON