(1)    These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006.

(2)    These Regulations come into force on 31st December 2006.

(3)    These Regulations apply in relation to England only.

(4)    In these Regulations “the principal Regulations” means the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002.

The principal Regulations are amended in accordance with regulations 3 to 5.

In regulation 2(1) (interpretation), in the definition of “Directive 2001/15”, after “Directive 2004/5/EC” insert “and Commission Directive 2006/34/EC”.

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

(b)    in the Section concerning Category 2 (minerals), under the heading “IRON” insert at the end

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

(1)    In so far as they apply in relation to England, the Notification of Marketing of Food for Particular Nutritional Uses (England and Wales) Regulations 2002 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 by authority of the Secretary of State

Caroline Flint

Minister of State,

Department of Health

20th November 2006

1    These Regulations, which apply in relation to England only, amend the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) 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).

4    These Regulations—

(a)    add certain substances to the list in the categories 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 category minerals 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 England to remove unnecessary wording from regulation 6 of those Regulations (regulation 6).

6    A full regulatory impact assessment of the effect that these Regulations will have on the costs of business has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directive 2006/34/EC are transposed in these Regulations. Copies may be obtained from the Nutrition Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.