Proposal for a Council Decision authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2005-07-28
Institutions: European Commission
Subjects: bread, food additive, foodstuff, foodstuffs legislation, health policy, human nutrition, marketing, rye

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.07.2005 
COM(2005) 340 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of rye bread with added phytosterols/phytostanols 
as novel foods or novel food ingredients under Regulation (EC) No 258/97 of 
the European Parliament and of the Council 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

On  24  September  2001  Pharmaconsult  Oy  Ltd.  (formerly  MultiBene  Health  Oy  Ltd.) 
submitted, under Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel 
food  ingredients,  a  request  to  the  competent  authorities  of  Finland  for  the  placing  on  the 
market of phytosterols. 

The initial assessment report from Finland concluded that the phytosterols are safe for human 
consumption.  However,  other  Member  States  raised  reasoned  objections  to  their  placing  on 
the market as novel foods or novel food ingredients. Therefore an authorisation Decision via 
comitology  procedure  was  required  in  accordance  with  Article  7  (1)  of  Regulation  (EC) 
No 258/97.  

In the view of the Member States’ objections the Commission requested an opinion from the 
former Scientific Committee on Food (SCF), which was delivered on 4 April 2003. The SCF, 
in its opinion on the application from MultiBene (now Pharmaconsult Oy Ltd.) for approval 
of plant sterol-enriched foods, came to the conclusion that the addition of phytosterols is safe, 
provided that the daily consumption does not exceed 3g.  

Furthermore, the SCF, in its opinion “General view on the longterm 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  indicated  that  there  was  no  evidence  of 
additional  benefits  at  intakes  higher  than  3  g/day  but  that  high  intakes  might  induce 
undesirable effects and that it was therefore prudent to avoid plant sterol intakes exceeding 3 
g/day.  

Against this background, a draft Commission Decision authorising the placing on the market 
of  rye  bread  with  added  phytosterols/phytostanols  as  novel  foods  or  novel  food  ingredients 
was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health,  on 
30 April 2004, for vote. Six Member States voted in favour, six Member States voted against 
and three Member States abstained. 

The Committee failed to deliver, by qualified majority, an opinion on the draft submitted by 
the Commission. Consequently, pursuant to Article 13 (4) b) of Regulation (EC) No 258/97 
and  in  accordance  with  Article  5  of  Council  Decision  1999/468/EC,  the  Commission  must 
now submit to the Council a proposal relating to the measures to be taken, the Council having 
three  months  in  which  to  act  by  a  qualified  majority,  and  inform  the  European  Parliament, 
which may consider appropriate to take a position in accordance with Article 8 of the above 
Decision. 

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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of rye bread with added phytosterols/phytostanols 
as novel foods or novel food ingredients under Regulation (EC) No 258/97 of 
the European Parliament and of the Council 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community,  

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council 
of  27  January  1997  concerning  novel  foods  and  novel  food  ingredients1,  and  in  particular 
Article 7 thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

On 24 September 2001 Pharmaconsult Oy Ltd. (formerly MultiBene Health Oy Ltd.) 
made a request to the competent authorities of Finland for placing phytosterols on the 
market; 

On  17  January  2002  the  competent  authorities  of  Finland  issued  their  initial 
assessment report; 

In their initial assessment report, Finland’s competent food assessment body came to 
the conclusion that the phytosterols/stanols are safe for human consumption; 

The  Commission  forwarded  the  initial  assessment  report  to  all  Member  States  on 
5 March 2002; 

(5)  Within  the  60  day  period  laid  down  in  Article  6  (4)  of  the  Regulation,  reasoned 
objections  to  the  marketing  of  the  product  were  raised  in  accordance  with  that 
provision; 

(6) 

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 
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;  

1 

OJ L 43, 14.2.1997, p. 1. 

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(7) 

(8) 

(9) 

Furthermore, the SCF, in its opinion on an application from MultiBene for approval of 
plant  sterol-enriched  foods  of  4  April  2003,  reiterated  its  concerns  about  cumulative 
intakes  from  a  wide  range  of  foods  with  added  phytosterols.  However,  at  the  same 
time  the  SCF  confirmed  that  the  addition  of  phytosterols  to  a  wide  range  of  bakery 
products was safe; 

In order to meet the concerns on cumulative intakes of phytosterols/phytostanols from 
different  products  Pharmaconsult  Oy  consequently  agreed  to  reduce  the  original 
application on bakery products exclusively to rye bread; 

Commission  Regulation  (EC)  N°  608/20042  concerning  the  labelling  of  foods  and 
food  ingredients  with  added  phytosterols,  phytosterol  esters,  phytostanols  and/or 
phytostanol  esters  ensures  that  consumers  receive  the  information  necessary  in  order 
to avoid excessive intake of additional phytosterols; 

(10)  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  has  not  given  a 

favourable opinion. 

HAS ADOPTED THIS DECISION:  

Article 1 

Foods and food ingredients as described in Annex 1 with added phytosterols/phytostanols as 
specified  in  Annex  2,  hereinafter  called  the  products,  may  be  placed  on  the  market  in  the 
Community. 

Article 2 

The products shall be presented in such a manner that they can be easily divided into portions 
that contain either maximum 3 g (in case of 1 portion per day) or maximum 1 g (in case of 
three portions per day) of added phytosterols/phytostanols. 

Article 3 

This Decision is addressed to Pharmaconsult Oy, Riippakoivunkuja 5, FIN - 02130 Espoo. 

Done at Brussels, [...] 

For the Council 
The President 

2 

OJ L 97, 1.4.2004, p. 44. 

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ANNEX 1 

Products referred to in Article 1 

Rye bread that contains ≥ 50% (wholemeal rye flour, whole or cracked rye kernels and rye 
flakes); ≤ 30 % wheat; ≤ 5 % added sugar but no fat added. 

ANNEX 2 

Specifications of phytosterols and phytostanols for the addition to foods and food 
ingredients 

Definition: 

Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may 
be presented as free sterols and stanols or esterified with food grade fatty acids. 

Composition (with GC-FID or equivalent method): 

< 80% β-sitosterol 

< 15% β-sitostanol 

< 40% campesterol 

< 5% campestanol 

< 30% stigmasterol 

< 3% brassicasterol 

< 3% other sterols/stanols 

Contamination/Purity (GC-FID or equivalent method) 

Phytosterols  and  phytostanols  extracted  from  sources  other  than  vegetable  oil  suitable  for 
food  have  to  be  free  of  contaminants,  best  ensured  by  a  purity  of  more  than  99%  of 
the phytosterol/phytostanol ingredient. 

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