# Commission Regulation (EU) No 686/2014Show full title

Commission Regulation (EU) No 686/2014 of 20 June 2014 amending Regulations (EC) No 983/2009 and (EU) No 384/2010 as regards            the conditions of use of certain health claims related to the lowering effect of plant sterols and plant stanols on blood            LDL-cholesterol (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 686/2014                     

# of 20 June 2014

# amending Regulations (EC) No 983/2009 and (EU) No 384/2010 as regards the conditions of use of certain health claims related                        to the lowering effect of plant sterols and plant stanols on blood LDL-cholesterol                     

# (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(1), and in particular Article 17(3) thereof,                        

Whereas:

(1)Regulation (EC) No 1924/2006 provides that applications for authorisations of health claims are to be sent to the national                              competent authority of the respective Member State. The national competent authority is to forward those applications to the                              European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’. The Authority is to give an opinion on                              the health claim and to forward it to the Commission who is to decide on the authorisation of the health claim taking into                              account the opinion delivered by the Authority.

(2)Pursuant to Article 16(4) of Regulation (EC) No 1924/2006, an opinion of the Authority in favour of authorising a health claim                              may include specific conditions of use of the claim.

(3)The authorisation of health claims may be amended following a request by the applicant or user according to Article 19(1)                              of Regulation (EC) No 1924/2006 or following an opinion of the Authority issued on its own initiative or following a request                              from a Member State or from the Commission according to Article 19(2) of Regulation (EC) No 1924/2006.

(4)Following the opinion of the Authority, based on a request of the Commission and a similar request from France, regarding                              the possibility to indicate a quantitative effect in health claims related to the lowering effects of plant sterols/plant                              stanol esters on blood LDL-cholesterol (Question No EFSA-Q-2009-00530 and Q-2009-00718)(2), the Commission amended, by Regulation (EU) No 376/2010(3), the conditions of use of two health claims related to the lowering effects of plant sterols and plant stanol esters on blood                              cholesterol, as laid down in Commission Regulation (EC) No 983/2009(4), by indicating a quantitative effect. Moreover, based on the same opinion of the Authority, the Commission authorised, by                              Regulation (EU) No 384/2010(5), a health claim related to the lowering effects of plant sterols/plant stanol esters on blood LDL-cholesterol, establishing                              conditions of use related to the indication of a quantitative effect.

(5)Following an application from Raisio Nutrition Ltd, 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 lowering effects of plant stanols as plant                              stanol esters on blood LDL-cholesterol concentrations (Question No EFSA-Q-2011-00851)(6). The claim proposed by the applicant was worded as follows: ‘The daily consumption of 3 g plant stanols in ester form has                              been shown to reduce blood cholesterol by 12 %. High cholesterol is a risk factor in the development of coronary heart disease’.                              The applicant further requested that the minimum duration to obtain the effect be stated to be one to two weeks, and that                              an authorisation be given for claims for an extended range of foods, including yellow fat spreads, dairy products, cheese,                              rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat-based milk                              drinks.

(6)On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States                              on 16 May 2012, that plant stanol esters at a daily intake of 3 g (range 2,7-3,3 g) lower blood LDL-cholesterol by 11,4 %                              (95 % Confidence Interval (CI): 9,8-13,0), and that the minimum duration required to achieve the maximum effect of plant stanol                              esters on blood LDL-cholesterol lowering is two to three weeks. Moreover, the Authority concluded that while plant stanol                              esters added to foods such as margarine-type spreads, mayonnaise, salad dressings and to dairy products such as milk, yoghurts                              including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the extent of the                              cholesterol-lowering effect of plant stanols added to other food formats is less well established.

(7)Unilever PLC and Unilever NV submitted an application pursuant to Article 19 of Regulation (EC) No 1924/2006, for the modification                              of the conditions of use of the health claims related to the lowering effects of plant sterols and plant stanols on blood                              LDL-cholesterol (Question No EFSA-Q-2011-01241)(7). The modification concerns the magnitude of the lowering effect on blood LDL-cholesterol (7-12 %) for a daily intake of plant                              sterols and plant stanols between 1,5 and 3 g. The applicant further requested that the minimum duration to obtain the effect                              be stated to be one to two weeks.

(8)On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States                              on 16 May 2012, that plant sterols and plant stanol esters at a daily intake of 3 g (range 2,6-3,4 g) lower blood LDL-cholesterol                              by 11,3 % (95 % Confidence Interval (CI): 10,0-12,5), and that the minimum duration required to achieve the maximum effect                              of plant sterols and plant stanols on LDL-cholesterol is two to three weeks. The Authority also noted in its assessment that                              plant sterols and plant stanols at daily intakes ranging from 1,5 to 3 g have a similar efficacy on lowering blood LDL-cholesterol.

(9)The conditions of use of the authorised health claims on plant sterols, plant stanol esters and plant sterols/plant stanol                              esters, as laid down in Regulations (EC) No 983/2009 and (EU) No 384/2010, provide that reference to the magnitude of the                              cholesterol-lowering effect of those substances may be made for foods falling within certain categories. According to those                              conditions, when reference is made to the magnitude of the cholesterol-lowering effect, consumers are to be informed that                              plant sterols and/or plant stanol esters at daily intakes ranging from 1,5 to 2,4 g lower blood LDL-cholesterol by 7 % to                              10 % within two to three weeks. Since new evidence has shown that an additional effect is achieved with higher intakes of                              those substances of up to 3 g per day, it is necessary to amend those conditions of use as regards the consumer information                              on the magnitude of the effect and the required daily intake, taking into account the scientific opinions of the Authority.

(10)In order to ensure that the claims authorised by Regulations (EC) No 983/2009 and (EU) No 384/2010 do not confuse or mislead                              the consumer, the conditions of use concerning consumer information on the magnitude of the cholesterol-lowering effect should                              be set in a coherent way. Since plant sterols and plant stanols at daily intakes ranging from 1,5 to 3 g have a similar efficacy,                              it is appropriate to indicate the same magnitude of the effect for plant sterols, plant stanol esters and plant sterols/plant                              stanol esters. Commission Regulation (EC) No 608/2004(8) provides that the consumption of more than 3 g of plant sterols and plant stanols should be avoided. It is therefore appropriate                              to only provide ranges of intakes up to 3 g in the conditions of use.

(11)Regulations (EC) No 983/2009 and (EU) No 384/2010 should therefore be amended accordingly.

(12)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.

(13)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health,

HAS ADOPTED THIS REGULATION:

## Article 1U.K.Amendments to Regulation (EC) No 983/2009

Annex I to Regulation (EC) No 983/2009 is amended as follows:

the first entry (concerning the health claim: ‘Plant sterols have been shown to lower/reduce blood cholesterol. High cholesterol                              is a risk factor in the development of coronary heart disease’), is amended as follows:                           

the text in the fifth column (conditions of use of the claim) is replaced by the following:

‘Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols. Reference                                          to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products,                                          mayonnaise and salad dressings. When referring to the magnitude of the effect, the range “7 % to 10 %” for foods that provide                                          a daily intake of 1,5-2,4 g plant sterols or the range “10 % to 12,5 %” for foods that provide a daily intake of 2,5-3 g plant                                          sterols and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer.’;                                    

the text in the seventh column (EFSA opinion reference) is replaced by the following:

‘Q-2008-085                                    

Q-2009-00530 and Q-2009-00718                                    

Q-2011-01241’;                                    

the second entry (concerning the health claim: ‘Plant stanol esters have been shown to lower/reduce blood cholesterol. High                              cholesterol is a risk factor in the development of coronary heart disease’) is amended as follows:                           

the text in the fifth column (conditions of use of the claim), is replaced by the following:

‘Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant stanols. Reference                                          to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products,                                          mayonnaise and salad dressings. When referring to the magnitude of the effect, the range “7 % to 10 %” for foods that provide                                          a daily intake of 1,5-2,4 g plant stanols or the range “10 %-12,5 %” for foods that provide a daily intake of 2,5-3 g plant                                          stanols and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer.’;                                    

the text in the seventh column (EFSA opinion reference) is replaced by the following:

‘Q-2008-118                                    

Q-2009-00530 and Q-2009-00718                                    

Q-2011-00851                                    

Q-2011-01241.’                                    

## Article 2U.K.Amendments to Regulation (EU) No 384/2010

The first entry of Annex I to Regulation (EU) No 384/2010 (concerning the health claim: ‘Plant sterols and plant stanol esters                     have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart                     disease’) is amended as follows:                  

the text in the fifth column (conditions of use of the claim) is replaced by the following:

‘Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols/stanols. Reference                                 to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products,                                 mayonnaise and salad dressings. When referring to the magnitude of the effect, the range “7 % to 10 %” for foods that provide                                 a daily intake of 1,5-2,4 g plant sterols/stanols or the range “10 % to 12,5 %” for foods that provide a daily intake of 2,5-3                                 g plant sterols/stanols and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer.’;                           

the text in the seventh column (EFSA opinion reference) is replaced by the following:

‘Q-2008-779                           

Q-2009-00530 and Q-2009-00718                           

Q-2011-01241.’                           

## Article 3U.K.Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 June 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

1

OJ L 404, 30.12.2006, p. 9.                           

2

*EFSA Journal* 2009; 1175, 1-9.                           

3

Commission Regulation (EU) No 376/2010 of 3 May 2010 amending Regulation (EC) No 983/2009 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 (OJ L 111, 4.5.2010, p. 3).                           

4

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 (OJ L 277, 22.10.2009, p. 3).                           

5

Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims                              made on foods and referring to the reduction of disease risk and to children's development and health (OJ L 113, 6.5.2010, p. 6).                           

6

*EFSA Journal* 2012; 10(5):2692.                           

7

*EFSA Journal* 2012; 10(5):2693.                           

8

Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added                              phytosterols, phytosterol esters, phytostanols and/or phystostanol esters (OJ L 97, 1.4.2004, p. 44).