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
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, and in particular Article 17(3) thereof,
OJ L 404, 30.12.2006, p. 9.
Whereas:
(1) Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
(2) Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.
(3) Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.
(4) The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
(5) Following an application from Cargill Incorporated, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006 and requesting the protection of proprietary data for one meta-analysis and for information pertaining to the production process of barley ‘betafiber’ (BarlivTM), the Authority was required to deliver an opinion on a health claim related to the effects of barley beta-glucans on lowering of blood cholesterol and reduced risk of (coronary) heart disease (Question No EFSA-Q-2011-00798). The claim proposed by the applicant was worded as follows: ‘Barley beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of (coronary) heart disease’.
Harland JI, 2011 (unpublished); Meta-analysis of the effects of barley beta-glucan on blood lipids.
The EFSA Journal (2011); 9(12):2470.
(6) On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2011 that a cause and effect relationship had been established between the consumption of barley beta-glucans and lowering of blood LDL-cholesterol concentrations. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims. The meta-analysis and information pertaining to the production process of barley ‘betafiber’ (BarlivTM), claimed by the applicant as proprietary, were not considered necessary by the Authority for reaching its conclusion. It is therefore considered that the requirement laid down in point (c) of Article 21(1) of Regulation (EC) No 1924/2006 is not fulfilled and accordingly, protection of proprietary data should not be granted.
(7) Following an application from Valens Int. d.o.o., submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of barley beta-glucans on lowering of blood cholesterol and reduced risk of (coronary) heart disease (Question No EFSA-Q-2011-00799). The claim proposed by the applicant was worded as follows: ‘Barley beta-glucan has been shown to reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of heart disease’.
The EFSA Journal (2011); 9(12):2471.
(8) On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2011 that a cause and effect relationship had been established between the consumption of barley beta-glucans and lowering of blood LDL-cholesterol concentrations. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims.
(9) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim should include certain particulars. Accordingly, those particulars should be set out in the Annex to this Regulation as regards the authorised claim and include, as the case may be, the revised wording of the claim, specific conditions of use of the claim, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the Authority.
(10) One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that wording and presentation are taken into account in that respect. Therefore where the wording of claims has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use indicated in the Annex to this Regulation.
(11) The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them,
HAS ADOPTED THIS REGULATION:

Article 1 1. The health claim listed in the Annex to this Regulation may be made on foods on the Great Britain market in compliance with the conditions laid down in that Annex.
Words in Art. 1(1) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 48(2)(a) (as amended by S.I. 2020/1476, regs. 1(2), 6(3)(4)(m)); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 1(2) omitted (E.W.S.) (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 48(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
Article 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 48(3); 2020 c. 1, Sch. 5 para. 1(1)
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 November 2012.
For the Commission
The President
José Manuel Barroso
ANNEX

Permitted health claim
Application — Relevant provisions of Regulation (EC) No 1924/2006	Applicant — Address	Nutrient, substance, food or food category	Claim	Conditions of use of the claim	Conditions and/or restrictions of use of the food and/or additional statement or warning	EFSA opinion reference
Article 14(1)(a) health claim referring to a reduction of a disease risk	Cargill Incorporated, acting through Cargill Health and Nutrition, c/o Cargill R & D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium	Barley beta-glucan	Barley beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.	Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of barley beta-glucan. The claim can be used for foods which provide at least 1 g of barley beta-glucan per quantified portion.		Q-2011-00798
	Valens Int. d.o.o., Kidričeva ulica 24b, SI-3000 Celje, Slovenia					Q-2011-00799