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 phytostanol esters (Text with EEA relevance)
Modified by
Commission Regulation (EU) No 718/2013of 25 July 2013amending Regulation (EC) No 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters(Text with EEA relevance), 32013R0718, July 26, 2013
Commission Regulation (EC) No 608/2004of 31 March 2004concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffsOJ L 109, 6.5.2000, p. 29., as amended by Directive 2003/89/ECOJ L 308, 25.11.2003, p. 15., and in particular Article 4(2) and Article 6(7) thereof,Whereas:(1)Phytosterols, phytosterol esters, phytostanols and phytostanol esters reduce serum cholesterol levels but may also reduce the β-carotene levels in blood serum. Member States and the Commission therefore consulted the Scientific Committee on Food (SCF) about the effects of consumption of phytosterols, phytosterol esters, phytostanols and phytostanol esters from multiple sources.(2)The Scientific Committee on Food (SCF) in its opinion "General view on the long-term effects of the intake of elevated levels of phytosterols from multiple dietary sources, with particular attention to the effects on β-carotene" of 26 September 2002 confirmed the need to label phytosterols, phytosterol esters, phytostanols and phytostanol esters as specified in Commission Decision 2000/500/EC of 24 July 2000 on authorising the placing on the market of "yellow fat spreads with added phytosterol esters" as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the CouncilOJ L 200, 8.8.2000, p. 59.. The SCF also indicated that there was no evidence of additional benefits at intakes higher than 3 g/day and that high intakes might induce undesirable effects and that it was therefore prudent to avoid plant sterol intakes exceeding 3 g/day.(3)Products containing phytosterols/phytostanols should thus be presented in single portions containing either maximum 3 g or maximum 1 g of phytosterols/phytostanols, calculated as free phytosterols/phytostanols. Where this is not the case, there should be a clear indication of what constitutes a standard portion of the food, expressed in g or ml, and of the amount of phytosterols/phytostanols, calculated as free phytosterols/phytostanols, contained in such a portion. In all events, the composition and labelling of products should be such as to allow users to easily restrict their consumption to maximum 3 g/day of phytosterols/phytostanols through the use of either one portion containing maximum 3 g, or three portions containing maximum 1 g.(4)In order to facilitate consumer understanding it appears appropriate to replace on the label the word "phyto" with the word "plant".(5)Decision 2000/500/EC allows the addition of certain phytosterol esters to yellow fat spreads. It sets out specific labelling requirements in order to ensure that the product reaches its target group, namely people who want to lower their blood cholesterol levels.(6)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: