2.—(1) The Foods for Special Medical Purposes (Scotland) Regulations 2000(1) are amended as follows.
(2) In regulation 2 (interpretation)—
(a)the existing text is renumbered as paragraph (1),
(b)after that paragraph, insert—
“(2) For the purposes of these Regulations, the Annex to the Directive is to be read as if, in paragraph 4, for “Directive 91/321/EEC and its subsequent modifications” there were substituted “Directive 2006/141/EC(2)”.”.
(3) For regulation 3 (restrictions on sale), substitute—
3.—(1) No person shall sell a dietary food in Scotland unless—
(a)its formulation, composition and instructions for use comply with the provisions of schedule 1;
(b)it is sold under the name “Food(s) for special medical purposes”; and
(c)it is labelled in accordance with schedule 2.
(2) When a dietary food is placed on the market—
(a)the manufacturer, or
(b)where the dietary food is manufactured outside of the United Kingdom, the importer,
shall notify the competent authority of the territories within the United Kingdom where the dietary food is being marketed by forwarding to it a model of the label used for that dietary food.
(3) The manufacturer or, as the case may be, the importer shall not sell a dietary food in Scotland unless they have provided the notification in accordance with paragraph (2).
(4) The competent authorities for the purposes of this regulation are, in respect of a dietary food manufactured in, or imported from outside the United Kingdom into—
(a)Scotland, Food Standards Scotland(3),
(b)England, the Secretary of State,
(c)Wales, the Welsh Ministers,
(d)Northern Ireland, the Food Standards Agency(4).”
(4) Into the Regulations, insert—
Regulation 3(1)(a)
1. The formulation of dietary foods shall be based on sound medical and nutritional principles. Their use, in accordance with the manufacturer’s instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data.
2. The dietary foods must comply with the compositional criteria specified in the Annex to the Directive.
Regulation 3(1)(c)
1. The labelling of dietary foods shall bear, in addition to the particulars provided for in Article 9 of Regulation (EU) No 1169/2011, the following particulars:
(a)the available energy value expressed in kJ and kcal, and the content of protein, carbohydrate and fat, expressed in numerical form, per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
(b)he average quantity of each mineral substance and each vitamin mentioned in the Annex present in the product, expressed in numerical form per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
(c)selectively the content of components of protein, carbohydrate and fat and/or of other nutrients and their components the declaration of which would be necessary for the appropriate intended use of the product, expressed in numerical form, per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
(d)information on the osmolality or the osmolarity of the product where appropriate;
(e)information on the origin and the nature of the protein and/or protein hydrolysates contained in the product.
2. The labelling shall in addition bear the following particulars, preceded by the words ‘important notice’:
(a)a statement that the product must be used under medical supervision;
(b)a statement whether the product is suitable for use as the sole source of nourishment;
(c)a statement that the product is intended for a specific age group, as appropriate;
(d)where appropriate a statement that the product poses a health hazard when consumed by persons who do not have the diseases, disorders or medical conditions for which the product is intended.
3. The labelling shall also include:
(a)the statement ‘For the dietary management of…’ where the blank shall be filled in with the diseases, disorders or medical conditions for which the product is intended;
(b)where appropriate a statement concerning adequate precautions and contra-indications;
(c)a description of the properties and/or characteristics that make the product useful in particular, as the case may be, relating to the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product;
(d)where appropriate a warning that the product is not for parenteral use.
4. The labelling shall bear instructions for the appropriate preparation, the use and the storage of the product after the opening of the container, as appropriate.
5. In this schedule—
“the Annex” means the Annex to the Directive, and
“Regulation (EU) No 1169/2011” means Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.”.
S.S.I. 2000/130, as amended by S.S.I. 2005/616, 2007/549, 2008/322, 2015/100 and 2018/392.
OJ No. L 401, 30.12.2006, p.1, last amended by Commission Delegated Regulation (EU) 2016/127 (OJ No. L 25, 2.2.2016, p.1).
Food Standards Scotland was established by section 1 of the Food (Scotland) Act 2015 (asp 1).
The Food Standards Agency was established by section 1 of the Food Standards Act 1999 (c.28).