Condensed Milk and Dried Milk (Wales) (Amendment) Regulations 2008 (S.I. No. 137 (W. 19) of 2008)

W E L S H S TAT U T O RY I N S T R U M E N T S 2008 No. 137 (W.19) FOOD, WALES The Condensed Milk and Dried Milk (Wales) (Amendment) Regulations 2008 EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which apply in relation to Wales, amend the Condensed Milk and Dried Milk (Wales) Regulations 2003 (S.I. 2003/3053, W.291) ("the 2003 Regulations"). They make provision for the implementation of Council Directive 2007/61/EC amending Directive 2001/114/EC relating to certain partly or wholly dehydrated preserved milk for human consumption (OJ No. L258, 4.10.2007, p.27). 2. These Regulations amend the definitions of partly dehydrated milk and totally dehydrated milk in the 2003 Regulations (regulation 3). 3. These Regulations also make certain amendments to the Notes to Schedule 1 of the 2003 Regulations, in particular amending Notes 1 and 3, introducing a new Note 4 and re-numbering the former Note 4 as Note 5 (regulation 4). 4. The Regulations make a consequential amendment to the Colours in Food Regulations 1995 (S.I. 1995/3124) (regulation 5) and to the Miscellaneous Food Additives Regulations (S.I. 1995/3187) (regulation 6). 5. A full regulatory assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff, CF10 1EW. O F F E RY N N A U S TAT U D O L C Y M R U 2008 Rhif 137 (Cy.19) BWYD, CYMRU Rheoliadau Llaeth Cyddwys a Llaeth Sych (Cymru) (Diwygio) 2008 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 Llaeth Cyddwys a Llaeth Sych (Cymru) 2003 (O.S. 2003/3053, Cy.291) ("Rheoliadau 2003"). Maent yn gwneud darpariaeth ar gyfer gweithredu Cyfarwyddeb y Cyngor 2007/61/EC sy'n diwygio Cyfarwyddeb 2001/114/EC ynghylch llaeth penodol wedi'i breserfio a'i ddadhydradu yn llwyr neu'n rhannol i'w fwyta neu i'w yfed gan bobl (OJ Rhif L258, 4.10.2007, t.27). 2. Mae'r Rheoliadau hyn yn diwygio'r diffiniadau o laeth wedi'i ddadhydradu'n rhannol a llaeth wedi'i ddadhydradu'n llwyr yn Rheoliadau 2003 (rheoliad 3). 3. Mae'r Rheoliadau hyn hefyd yn gwneud diwygiadau penodol i'r Nodiadau i Atodlen 1 o Reoliadau 2003, ac yn benodol maent yn diwygio Nodyn 1 a 3, yn cyflwyno Nodyn 4 newydd ac yn ailrifo'r Nodyn 4 blaenorol yn Nodyn 5 (rheoliad 4). 4. Mae'r Rheoliadau'n gwneud diwygiad canlyniadol i Reoliadau Lliwiau mewn Bwyd 1995 (O.S. 1995/3124) (rheoliad 5) ac i Reoliadau Ychwanegion Bwyd Amrywiol 1995(O.S. 1995/3187) (rheoliad 6). 5. Mae asesiad effaith rheoleiddiol llawn o'r effaith y bydd yr offeryn hwn yn ei gael ar gostau busnes a'r sector gwirfoddol ar gael gan yr Asiantaeth Safonau Bwyd, Llawr 11, Southgate House, Wood Street, Caerdydd, CF10 1EW. 1 O F F E RY N N A U S TAT U D O L C Y M R U 2008 Rhif 137 (Cy.19) BWYD, CYMRU Rheoliadau Llaeth Cyddwys a Llaeth Sych (Cymru) (Diwygio) 2008 Gwnaed 22 Ionawr 2008 Gosodwyd gerbron Cynulliad Cenedlaethol Cymru 24 Ionawr 2008 Yn dod i rym 22 Chwefror 2008 Mae Gweinidogion Cymru yn gwneud y Rheoliadau a ganlyn drwy arfer y pwerau a roddwyd gan adrannau 16(1)(e), 17(1) a 48(1) o Ddeddf Diogelwch Bwyd 1990(1). Yn unol ag adran 48(4A) o'r Ddeddf honno, maent wedi rhoi sylw i gyngor perthnasol a roddwyd iddynt gan yr Asiantaeth Safonau Bwyd. 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(2),cafwyd ymgynghori agored a thryloyw â'r cyhoedd yn ystod cyfnod paratoi a gwerthuso'r Rheoliadau hyn. W E L S H S TAT U T O RY I N S T R U M E N T S 2008 No. 137 (W.19) FOOD, WALES The Condensed Milk and Dried Milk (Wales) (Amendment) Regulations 2008 Made 22 January 2008 Laid before the National Assembly for Wales 24 January 2008 Coming into force 22 February 2008 The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16(1)(e), 17(1) and 48(1) of the Food Safety Act 1990(1). In accordance with section 48(4A) of that Act, they have had regard to relevant advice given by the Food Standards Agency. 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(2), there has been open and transparent public consultation during the preparation and evaluation of these Regulations. (1) 1990 p. 16. Amnewidiwyd adran 1(1) a (2) (diffiniad o "food") gan O.S. 2004/2990. Diwygiwyd adrannau 17 a 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. Trosglwyddwyd swyddogaethau 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) fel y'i darllenir gydag adran 40(3) o Ddeddf 1999. Yn rhinwedd adran 162 o Ddeddf Llywodraeth Cymru 2006 a pharagraffau 28 a 30 o Atodlen 11 iddi, mae swyddogaethau a roddwyd i Gynulliad Cenedlaethol Cymru yn arferadwy gan Weinidogion Cymru. (2) OJ Rhif L31, 1.2.2002, t.1. Diwygiwyd y Rheoliad hwnnw ddiwethaf gan Reoliad (EC) Rhif 575/2006 (OJ Rhif L100, 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 1999Act". Section 48 was also amended by S.I. 2004/2990. Functions 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 1999 Act. By virtue of section 162 of and paragraphs 28 and 30 of Schedule 11 to the Government of Wales Act 2006, functions conferred on the National Assembly for Wales are exercisable by the Welsh Ministers (2) OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Commission Regulation (EC) No. 575/2006 (OJ No. L100, 8.4.2006, p.3). Enwi, cymhwyso a chychwyn 1. Enw'r Rheoliadau hyn yw Rheoliadau Llaeth Cyddwys a Llaeth Sych (Cymru) (Diwygio) 2008, maent yn gymwys o ran Cymru a deuant i rym ar 22 Chwefror 2008. Diwygio Rheoliadau Llaeth Cyddwys a Llaeth Sych (Cymru) 2003 2. Diwygir Rheoliadau Llaeth Cyddwys a Llaeth Sych (Cymru) 2003(1) yn unol â rheoliadau 3 a 4. 3. Yn rheoliad 2 (dehongli), hepgorer y geiriau "yn uniongyrchol" o'r diffiniadau o "llaeth wedi'i ddadhydradu'n rhannol" a "llaeth wedi'i ddadhydradu'n llwyr". 4. Yn y Nodiadau i Atodlen 1 (cynhyrchion llaeth sydd wedi'u dadhydradu a'u preserfio yn rhannol neu'n llwyr a'u disgrifiadau neilltuedig) — (a) Yn lle Nodyn 1, rhodder y canlynol— "1. Ychwanegiadau a awdurdodir a deunyddiau crai: (a) Caiff unrhyw gynnyrch dynodedig gynnwys unrhyw sylwedd a ganiateir yn unol â Chyfarwyddeb y Cyngor 89/107/EEC ar gyd-ddynesiad cyfreithiau Aelod-wladwriaethau ynghylch ychwanegion bwyd yr awdurdodir eu defnyddio mewn bwydydd y bwriedir iddynt gael eu bwyta gan bobl(2) a fitaminau a mwynau yn unol â gofynion Rheoliad (EC) Rhif 1925/2006 Senedd Ewrop a'r Cyngor ar ychwanegu fitaminau a mwynau a sylweddau eraill penodol at fwydydd(3). (b) Dyma'r deunyddiau crai a awdurdodir at ddibenion addasu protein y cyfeirir ato yn Nodyn 4: (i) Anathreiddiad llaeth, sef y cynnyrch a geir wrth grynodi protein llaeth drwy drahidlo llaeth, llaeth rhannol sgim neu laeth llwyr sgim; (ii) Athreiddiad llaeth, sef y cynnyrch a geir drwy dynnu proteinau llaeth a braster llaeth allan o laeth, llaeth rhannol sgim neu laeth llwyr sgim drwy ei drahidlo; a Title application and commencement 1. The title of these Regulations is the Condensed Milk and Dried Milk (Wales) (Amendment) Regulations 2008, apply in relation to Wales and they come into force on 22 February 2008. Amendment of the Condensed Milk and Dried Milk (Wales) Regulations 2003 2. The Condensed Milk and Dried Milk (Wales) Regulations 2003(1) are amended in accordance with regulations 3 and 4. 3. In regulation 2 (interpretation), the word "directly" is omitted from the definitions of "partly dehydrated milk" and "totally dehydrated milk". 4. In the Notes to Schedule 1 (partly or wholly dehydrated preserved milk products and their reserved descriptions) — (a) For Note 1 substitute the following — "1. Authorised additions and raw materials: (a) Any designated product may contain any substance permitted pursuant to Council Directive 89/107/EEC on the approximation of laws of Member States concerning food additives authorised for use in foodstuffs intended for human consumption(2) and vitamins and minerals in accordance with the requirements of Regulation (EC) No. 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods(3). (b) Authorised raw materials for protein adjustment purposes referred to in Note 4 are as follows: (i) Milk retentate, which is the product obtained by concentrating milk protein by ultra filtration of milk, partly skimmed milk or skimmed milk; (ii) Milk permeate, which is the product obtained by removing milk proteins and milk fat from milk, partly skimmed milk or skimmed milk by ultra filtration; and (1) S.I. 2003/3053 (W.291). (2) OJ No. L40, 11.2.1989, p.27. This Directive was last amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L284, 31.10.2003, p.1). (3) OJ No. L404, 30.12.2006, p.26. 3 (1) O.S. 2003/3053 (Cy.291). (2) OJ Rhif L40, 11.2.1989, t.27. Diwgiwyd y Gyfarwyddeb hon ddiwethaf gan Reoliad (EC) Rhif 1882/2003 Senedd Ewrop a'r Cyngor (OJ Rhif L284, 31.10.2003, t.1). (3) OJ Rhif L404, 30.12.2006, t.26. (iii) Lactos, sydd yn ansoddyn naturiol mewn llaeth a geir fel arfer o faidd â'i gynnwys lactos anhydrus nad yw'n llai na 99.0% m/m ar sail sych. Gall fod yn anhydrus neu gynnwys un moleciwl o ddwr o grisialiad neu fod yn gymysgedd o'r ddwy ffurf.". (b) Yn Nodyn 3, yn lle'r indent cyntaf rhodder y canlynol — "3. Heb ragfarn i Reoliad (EC) Rhif 853/2004 Senedd Ewrop a'r Cyngor sy'n pennu rheolau hylendid penodol ar gyfer bwyd sy'n dod o anifeiliaid(1), llwyddir i breserfio'r cynnyrch dynodedig—". (c) Yn lle Nodyn 4, rhodder y canlynol— "4. Heb ragfarnu'r gofynion cyfansoddiadol a osodir yn y tabl uchod, caniateir addasu cynnwys y protein mewn llaeth i gynnwys isafswm o 34% yn ôl pwysau (wedi'i fynegi ar fater sych sy'n rhydd o fraster) drwy ychwanegu a/neu dynnu ansoddau llaeth yn y fath fodd fel na newidir y gymhareb o brotein maidd i'r casein yn y llaeth sy'n cael ei addasu.". (ch) Fel Nodyn 5 ychwaneger y canlynol — "5. Penderfynir y lefelau o fater sych, cynnwys lleithder, braster, swcros, asid lactig a lactadau a gweithgaredd ffosffatas yn y cynnyrch dynodedig yn unol â'r dulliau a osodir yng Nghyfarwyddeb 79/1067.". Diwygiadau canlyniadol 5. Yn Rheoliadau Lliwiau mewn Bwyd 1995(2), i'r graddau y maent yn gymwys o ran Cymru, ym mharagraff 6 o Atodlen 2, ar ôl yr ymadrodd "Directive 2001/114/EC" ychwaneger y geiriau "as amended by Directive 2007/61/EC(3)". 6. Yn Rheoliadau Ychwanegion Bwyd Amrywiol 1995(4), i'r graddau y maent yn gymwys o ran Cymru, yng ngholofn 1 o Atodlen 7, ar ôl yr ymadrodd "Partially dehydrated and totally dehydrated milk as defined in Directive 2001/114/EC" ychwaneger y geiriau "as amended by Directive 2007/61/EC(5)". (iii) Lactose, which is a natural constituent of milk normally obtained from whey with an anhydrous lactose content of not less than 99.0% m/m on a dry basis. It may be anhydrous or contain one molecule of water of crystallisation or be a mixture of both forms.". (b) In Note 3, for the first indent substitute the following — "3. Without prejudice to Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin(1), the preservation of the designated products shall be achieved—". (c) For Note 4 substitute the following — "4. Without prejudice to the compositional requirements set out in the table above, the protein content of milk may be adjusted to a minimum content of 34% by weight (expressed on fat-free dry matter) by the addition and/or withdrawal of milk constituents in such a way as not to alter the ratio of whey protein to casein in the milk being adjusted.". (d) As Note 5 add the following — "5. The levels of dry matter, moisture content, fat, sucrose, lactic acid and lactates and phosphatase activity in the designated products shall be determined in accordance with the methods set out in Directive 79/1067.". Consequential amendments 5. In the Colours in Food Regulations 1995(2), in so far as they apply in relation to Wales, in paragraph 6 of Schedule 2, after the expression "Directive 2001/114/EC" add the words "as amended by Directive 2007/61/EC(3)". 6. In the Miscellaneous Food Additives Regulations 1995(4), in so far as they apply in relation to Wales, in column 1 of Schedule 7, after the expression "Partially dehydrated and totally dehydrated milk as defined in Directive 2001/114/EC" add the words "as amended by Directive 2007/61/EC(5)". (1) OJ Rhif L139, 30.4.2004, t.55. Nodwyd y fersiwn a gywirwyd mewn corigendwm (OJ Rhif L226, 25.6.2004, t.22). Diwygiwyd y Rheoliad ddiwethaf gan Reoliad y Cyngor (EC) Rhif 1791/2006 (OJ Rhif L363, 20.12.2006, t.1). (2) O.S. 1995/3124, diwygiwyd gan O.S 2003/3053 (C.291) (3) OJ Rhif L258, 4.10.2007, t.27. (4) O.S. 1995/3187, diwygiwyd gan O.S 2003/3053 (C.291) (5) OJ Rhif L258, 4.10.2007, t.27. (1) OJ No. L139, 30.4.2004, p.55. The corrected version was set out in a corrigendum (OJ No. L226, 25.6.2004, p.22). The Regulation was last amended by Council Regulation (EC) No. 1791/2006 (OJ No. L363, 20.12.2006, p.1). (2) S.I. 1995/3124, as amended by SI 2003/3053 (W.291), there are other amending instruments but none that are relevant (3) OJ No. L258, 4.10.2007, p.27. (4) S.I. 1995/3187.as amended by S.I 2003/3053 (W.291) (5) OJ No. L258, 4.10.2007, p.27. 4 O dan awdurdod y Gweinidog dros Iechyd a Gwasanaethau Cymdeithasol, un o Weinidogion Cymru. 22 Ionawr 2008 Under authority of the Minister for Health and Social Services, one of the Welsh Ministers 22 January 2008 5 Gwenda Thomas W E L S H £3.00 W243/02/08 ON