Warning labels on plant sterols and stanols products

Phytosterol
Phytosterol (Photo credit: Wikipedia)

According to Art. 1 of the EU Regulation No. 718/2013, amending Regulation (EC) No. 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters,

“Article 2 of Regulation (EC) No 608/2004, point 3 is replaced by the following:

‘3. there shall be a statement that the product is not intended for people who do not need to control their blood cholesterol level.’

The precedent form of expression of the statement was positive. Now the European legislator intends to reinforce the provision with the strongest negative expression “the product is not intended for people who do not need to control their blood cholesterol level”.

Basically, it’s more a rewording than a real modification.

The rationale of the decision, is strictly related to the approval of Art. 13 and 14 claims for

” (3)The voluntary inclusion of nutrition or health claims on food labels is governed by 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 (4). Accordingly, 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 (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 (6) and Commission Regulation (EU) No. 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (7) have authorised health claims relating to the reduction and maintenance of blood cholesterol with respect to foods containing plant sterols and plant stanols, subject to certain conditions of use.

(4) Regulation (EC) No 983/2009 authorised, under certain conditions of use, the following health claims: ‘Plant sterols have been shown to lower/reduce blood choles­terol. High cholesterol is a risk factor in the development of coronary heart disease’ 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’.

(5) Regulation (EU) No 384/2010 authorised, under certain conditions of use, the following 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.’
(6) Regulation (EU) No 432/2012 authorised, under certain conditions of use, the following health claim: ‘Plant
sterols/stanols contribute to the maintenance of normal blood cholesterol levels’.

(7) The wording of the authorised health claims in combination with the mandatory statement relating to the target group laid down in Regulation (EC) No. 
608/2004 could potentially lead consumers who do not need to control their blood cholesterol level to use the product. Therefore, with a view to ensure consistency of the information provided on the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters, it is appro­priate to amend the mandatory statement laid down in Regulation (EC) No 608/2004 while ensuring that its wording serves adequately the informative purpose for which it was initially introduced.”

About the transitional measures, should be enlightened the Art. 2:

“Food and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters placed on the market or labelled prior to 15 February 2014 which do not comply with the requirements of this Regulation may be marketed until the stocks of the foods are exhausted”

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