2004 No. 105
Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Amendment) Regulations (Northern Ireland) 2004
Made
Coming into operation
The Department of Health, Social Services and Public Safety1 in exercise of the powers conferred on it by Articles 15(1)(f), 16(1), 25(3), 26(3) and 47(2) of the Food Safety (Northern Ireland) Order 19912 and of all other powers enabling it in that behalf, having had regard in accordance with Article 47(3A) of the said Order to relevant advice given by the Food Standards Agency and after consultation both as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council3 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 and in accordance with Article 47(3) and (3B) of the said Order, hereby makes the following Regulations:
Citation, commencement and interpretation1
1
These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Amendment) Regulations (Northern Ireland) 2004 and shall come into operation on 1st April 2004.
2
In these Regulations “the principal Regulations” means the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) Regulations (Northern Ireland) 20024.
Amendment of the principal Regulations
2
The principal Regulations shall be amended in accordance with regulations 3 to 7.
3
In regulation 2(1) (interpretation), in the definition of “Directive 2001/15” there shall be inserted at the end, “as amended by Commission Directive 2004/5/EC5 and as read with Commission Directive 2004/6/EC6 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products”.
4
In regulation 3 (restrictions on sale) –
a
in paragraph (1) there shall be inserted at the beginning “Subject to paragraph (5),”;
b
in paragraph (2), for “paragraph (1)” there shall be substituted “this regulation”; and
c
there shall be inserted at the end the following paragraph –
5
The restrictions in paragraph (1) shall not apply until 1st January 2007 in the case of a substance falling within one of the categories mentioned in paragraph (2) and listed under that category in Schedule 3 if –
a
the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance in the manufacture of any designated PNU food; and
b
that substance was used in the manufacture of a food for a particular nutritional use which was on sale in the European Community on 11th February 2004.
5
In Schedule 1 (substances which may be added for specific nutritional purposes in designated PNU foods) –
a
there shall be inserted in Category 2 (Minerals) under the heading “CALCIUM” after the entry “– oxide”, the entry “– sulphate”; and
b
there shall be inserted in Category 4 (Carnitine and taurine) after the entry “L-carnitine hydrochloride” the entry “L-carnitine-L-tartrate”.
6
For Schedule 2 (additional substances which may be added for specific nutritional purposes in foods for special medical purposes) there shall be substituted the contents of Schedule 1.
7
After Schedule 2 there shall be inserted as Schedule 3 the contents of Schedule 2.
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 11th March 2004.
SCHEDULE 1REVISED SCHEDULE 2 TO BE SUBSTITUTED IN THE PRINCIPAL REGULATIONS
SCHEDULE 2ADDITIONAL SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN FOODS FOR SPECIAL MEDICAL PURPOSES
Category 3. Amino acids
Substance
Conditions of use
L-arginine-L-aspartate
L-aspartic acid
L-citrulline
glycine
L-lysine-L-aspartate
L-lysine-L-glutamate
L-proline
L-serine
N-acetyl-L-cysteine
N-acetyl-L-methionine
Shall not be used except in foods intended for persons over 1 year of age.
For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used.
SCHEDULE 2NEW SCHEDULE 3 TO BE INSERTED IN THE PRINCIPAL REGULATIONS
SCHEDULE 3SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS IN ACCORDANCE WITH THE DEROGATION IN REGULATION 3(5)
Category 1. Vitamins
VITAMIN E:
D-alpha tocopheryl polyethylene glycol 1000 succinate
Category 2. Minerals
BORON:
boric acid
sodium borate
CALCIUM:
amino acid chelate
pidolate
MAGNESIUM:
amino acid chelate
pidolate
IRON:
ferrous hydroxide
ferrous pidolate
amino acid chelate
COPPER:
amino acid chelate
ZINC:
amino acid chelate
MANGANESE:
amino acid chelate
SELENIUM:
enriched yeast
CHROMIUM:
amino acid chelate
(This note is not part of the Regulations.)