Commission Delegated Regulation (EU) 2016/128Show full title

Article 8 U.K. Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants

1. All mandatory particulars for food for special medical purposes developed to satisfy the nutritional requirements of infants shall appear in [F1 English].

2. The labelling, presentation and advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall not include pictures of infants, or other pictures or text which may idealise the use of the product.

However, graphic representations for easy identification of the product and for illustrating methods of preparation shall be permitted.

3. The labelling, presentation and advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall be designed in such a way that it enables consumers to make a clear distinction between such products and infant formula and follow-on formula, in particular as to the text, images and colours used, so as to avoid any risk of confusion.

4. Advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall be restricted to publications specialising in baby care and scientific publications.

[F2 The appropriate authority] may further restrict or prohibit such advertising. Such advertising shall contain only information of a scientific and factual nature.

The first and second subparagraphs shall not prevent the dissemination of information exclusively intended for health care professionals.

5. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of food for special medical purposes developed to satisfy the nutritional requirements of infants directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.

6. Manufacturers and distributors of food for special medical purposes developed to satisfy the nutritional requirements of infants shall not directly provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts.

7. [F3 In this Article “appropriate authority” means—

(a) in respect of food developed in England, the Secretary of State;

(b) in respect of food developed in Wales, the Welsh Ministers;

(c) in respect of food developed in Scotland, the Scottish Ministers.]

Textual Amendments

F1 Word in Art. 8(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 72(5)(a) (as substituted by S.I. 2020/1476, regs. 1(2), 6(7)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 8(4) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 72(5)(b) (as substituted by S.I. 2020/1476, regs. 1(2), 6(7)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 8(7) inserted by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 72(5)(c) (as substituted by S.I. 2020/1476, regs. 1(2), 6(7)(b)); 2020 c. 1, Sch. 5 para. 1(1)