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.

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.

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.

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.

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.

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.

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

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.

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