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
  • Regulation (EU) No 1169/2011 of the European Parliament and of the Councilof 25 October 2011on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004(Text with EEA relevance), 32011R1169, November 22, 2011
  • 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)
Article 1This Regulation shall apply to foods and food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters.
Article 2For labelling purposes, phytosterol, phytosterol ester, phytostanol and phytostanol ester shall be designated respectively by the terms "plant sterol", "plant sterol ester", "plant stanol" or "plant stanol ester" or their plural form, as appropriate.Without prejudice to the other requirements of Community or national law concerning the labelling of foodstuffs, the labelling of foods or food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters shall contain the following:1.in the same field of vision as the name under which the product is sold there shall appear, easily visible and legible, the words: "with added plant sterols/plant stanols";2.the amount of added phytosterols, phytosterol esters, phytostanols or phytostanol esters content (expressed in % or as g of free plant sterols/plant stanols per 100 g or 100 ml of the food) shall be stated on the list of ingredients;3.there shall be a statement that the product is not intended for people who do not need to control their blood cholesterol level;4.there shall be a statement that patients on cholesterol lowering medication should only consume the product under medical supervision;5.there shall be an easily visible and legible statement that the product may not be nutritionally appropriate for pregnant and breastfeeding women and children under the age of five years;6.advice shall be included that the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels;7.in the same field of vision as the particular required under point 3 above, there shall be a statement that the consumption of more than 3 g/day of added plant sterols/plant stanols should be avoided;8.there shall be a definition of a portion of the food or food ingredient concerned (preferably in g or ml) with a statement of the plant sterol/plant stanol amount that each portion contains.
Article 3Foods and food ingredients with added phytostanol esters already on the market in the Community or "yellow fat spreads with added phytosterol esters" that were authorised by Commission Decision 2000/500/EC produced from six months after entry into force of this Regulation shall comply with the labelling provisions of Article 2.
Article 4This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Article 1This Regulation shall apply to foods and food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters.
Article 2For labelling purposes, phytosterol, phytosterol ester, phytostanol and phytostanol ester shall be designated respectively by the terms "plant sterol", "plant sterol ester", "plant stanol" or "plant stanol ester" or their plural form, as appropriate.Without prejudice to the other requirements of Community or national law concerning the labelling of foodstuffs, the labelling of foods or food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters shall contain the following:1.in the same field of vision as the name under which the product is sold there shall appear, easily visible and legible, the words: "with added plant sterols/plant stanols";2.the amount of added phytosterols, phytosterol esters, phytostanols or phytostanol esters content (expressed in % or as g of free plant sterols/plant stanols per 100 g or 100 ml of the food) shall be stated on the list of ingredients;3.there shall be a statement that the product is not intended for people who do not need to control their blood cholesterol level;4.there shall be a statement that patients on cholesterol lowering medication should only consume the product under medical supervision;5.there shall be an easily visible and legible statement that the product may not be nutritionally appropriate for pregnant and breastfeeding women and children under the age of five years;6.advice shall be included that the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels;7.in the same field of vision as the particular required under point 3 above, there shall be a statement that the consumption of more than 3 g/day of added plant sterols/plant stanols should be avoided;8.there shall be a definition of a portion of the food or food ingredient concerned (preferably in g or ml) with a statement of the plant sterol/plant stanol amount that each portion contains.
Article 3Foods and food ingredients with added phytostanol esters already on the market in the Community or "yellow fat spreads with added phytosterol esters" that were authorised by Commission Decision 2000/500/EC produced from six months after entry into force of this Regulation shall comply with the labelling provisions of Article 2.
Article 4This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.