PART 2Amendment of the 2019 Regulations

Amendment of Part 5 of the 2019 Regulations6.

(1)

Part 5 of the 2019 Regulations (amendment of EU tertiary legislation) is amended as follows.

(2)

In regulation 21 (amendment of Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses)—

(a)

in paragraph (2), in the inserted words, for “the United Kingdom” substitute “ Great Britain ”;

(b)

in paragraph (4), in the substituted words, for “, Food Standards Scotland or the Food Standards Agency” substitute “ or Food Standards Scotland ”.

(3)

In the regulations listed in paragraph (4), for “United Kingdom” in each place where those words appear, substitute “ Great Britain ”.

(4)

The regulations listed in this paragraph are —

(a)

regulation 22 (amendment of Commission Regulation (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health);

(b)

regulation 23 (amendment of Commission Regulation (EC) No 984/2009 of 21 October 2009 refusing to authorise certain health claims made on food, other than those referring to the reduction of disease risk and to children's development and health);

(c)

regulation 24 (amendment of Commission Regulation (EC) No 1024/2009 of 29 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health);

(d)

regulation 26 (amendment of Commission Regulation (EC) No 1167/2009 of 30 November 2009 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health);

(e)

regulation 31 (amendment of Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health);

(f)

regulation 32 (amendment of Commission Regulation (EU) No 957/2010 of 22 October 2010 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health);

(g)

regulation 35 (amendment of Commission Regulation (EU) No 1162/2010 of 9 December 2010 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children's development and health);

(h)

regulation 37 (amendment of Commission Regulation (EU) No 440/2011 of 6 May 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to children's development and health);

(i)

regulation 38 (amendment of Commission Regulation (EU) 665/2011 of 11 July 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk);

(j)

regulation 40 (amendment of Commission Regulation (EU) No 1160/2011 of 14 November 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk);

(k)

regulation 41 (amendment of Commission Regulation (EU) No 1170/2011 of 16 November 2011 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk);

(l)

regulation 44 (amendment of Commission Regulation (EU) No 378/2012 of 3 May 2012 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children's development and health);

(m)

regulation 48 (amendment of Commission Regulation (EU) No 1048/2012 of 8 November 2012 on the authorisation of a health claim made on foods and referring to the reduction of disease risk);

(n)

regulation 57 (amendment of Commission Regulation (EU) No 1135/2014 of 24 October 2014 on the authorisation of a health claim made on foods and referring to the reduction of disease risk);

(o)

regulation 59 (amendment of Commission Regulation (EU) No 1226/2014 of 17 November 2014 on the authorisation of a health claim made on foods and referring to the reduction of disease risk);

(p)

regulation 60 (amendment of Commission Regulation (EU) No 1228/2014 of 17 November 2014 authorising and refusing to authorise certain health claims made on foods and referring to the reduction of disease risk);

(q)

regulation 64 (amendment of Commission Regulation (EU) 2015/391 of 9 March 2015 refusing to authorise certain health claims made on foods and referring to children's development and health);

(r)

regulation 68 (amendment of Commission Regulation (EU) 2015/1052 of 1 July 2015 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk);

(s)

regulation 69 (amendment of Commission Regulation (EU) 2015/1886 of 20 October 2015 refusing to authorise certain health claims made on foods and referring to children's development and health);

(t)

regulation 74 (amendment of Commission Regulation (EU) 2016/372 of 15 March 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk);

(u)

regulation 78 (amendment of Commission Regulation (EU) 2016/1381 of 16 August 2016 refusing to authorise a health claim made on foods and referring to children's development and health);

(v)

regulation 79 (amendment of Commission Regulation (EU) 2016/1389 of 17 August 2016 authorising a health claim made on foods and referring to children's development and health);

(w)

regulation 80 (amendment of Commission Regulation (EU) 2016/1390 of 17 August 2016 refusing to authorise a health claim made on foods and referring to children's development and health);

(x)

regulation 82 (amendment of Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk);

(y)

regulation 83 (amendment of Commission Regulation (EU) 2017/236 of 10 February 2017 refusing to authorise a health claim made on foods and referring to the reduction of disease risk);

(z)

regulation 90 (amendment of Commission Regulation (EU) 2018/1555 of 17 October 2018 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk).

(5)

In regulation 43 (amendment of Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 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), in paragraph (3)(a)(ii), in the substituted words, for “ the United Kingdom ” substitute “Great Britain”.

(6)

In regulation 46 (amendment of Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health), after paragraph (3) insert—

“(4)

In the Annex, in the table (list of permitted health claims), after the second entry relating to “water” insert—

(a)

in the column entitled “Nutrient, substance, food or food category”, “Water-Soluble Tomato Concentrate (WSTC) I and II”;

(b)

in the column entitled “Claim”, “Water-Soluble Tomato Concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow”;

(c)

in the column entitled “Conditions of use of the claim”, “Information to the consumer that the beneficial effect is obtained with a daily consumption of 3 g WSTC I or 150 mg WSTC II in up to 250 ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid”;

(d)

in the column entitled “EFSA Journal number”, “2010; 8(7): 1689”.”.

(7)

In regulation 72 (amendment of Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes)—

(a)

omit paragraphs (2) to (4);

(b)

for paragraph (5) substitute—

“(5)

In Article 8 (specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants)—

(a)

in paragraph 1, for “a language easily understood by the consumers”, substitute “ English ”;

(b)

in paragraph 4, for “Member States”, substitute “ The appropriate authority ”;

(c)

after paragraph 6, insert—

“7.

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.”.

(c)

in paragraph (6), in the substituted Article 9—

(i)

in paragraph 1, for “the United Kingdom” substitute “ Great Britain ”;

(ii)

in paragraph 2, omit sub-paragraph (d) and the comma immediately preceding it;

(d)

after paragraph (7), insert—

“(8)

In Annex IV (name referred to in Article 4), for “respectively:” to the end of that Annex, substitute “ “Food for special medical purposes”.”.