2006/59/EC: Commission Decision of  24 January 2006  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  (notified under document number C(2006) 115)   (Text with EEA relevance)
Date: 2006-01-24
Institutions: European Commission
Subjects: bread, food additive, food inspection, foodstuffs legislation, health risk, labelling, market approval, marketing standard, rye

3.2.2006

EN

Official Journal of the European Union

L 31/21

COMMISSION DECISION

of 24 January 2006

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

(notified under document number C(2006) 115)

(Only the Finnish and Swedish texts are authentic)

(Text with EEA relevance)

(2006/59/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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 ingredients (1), and in particular
Article 7 thereof,

Whereas:

(1)

(2)

(3)

On 21 September 2000 Karl Fazer Ltd made a request to
the competent authorities of Finland to place foods with
added phytosterols on the market as novel
foods or
novel food ingredients.

On 29 January 2001 the competent authorities of
Finland issued their initial assessment report.

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

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 unde-
sirable effects and that it was therefore prudent to avoid
plant sterol intakes exceeding 3 g/day.

Furthermore, the SCF, in its opinion on applications for
approval of a variety of plant sterol enriched foods of 5
March 2003, reiterated its concerns about cumulative
intakes from a wide range of foods with added phytos-
terols. However, at the same time the SCF confirmed
with regard to the application of Oy Karl Fazer Ab
that
the addition of phytosterols to a wide range of
bakery products was safe.

In order to meet the concerns on cumulative intakes of
from different products Oy
phytosterols/phytostanols
Karl Fazer Ab consequently agreed to reduce
the
original application to rye bread.

Commission Regulation (EC) No 608/2004 of 31 March
2004 (2) concerning the labelling of
foods and food
ingredients with added phytosterols, phytosterol esters,
phytostanols and/or phytostanol
that
consumers receive the information necessary in order
to avoid excessive intake of additional phytosterols.

esters ensures

(7)

(8)

(9)

(4)

The Commission forwarded this initial assessment report
to all Member States on 13 March 2001.

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

(10)

The Standing Committee on the Food Chain and Animal
the
Health has not
given a
Commission therefore submitted a proposal
to the
Council on 22 August 2005 in accordance with Article
the Council Decision 1999/468/EC (3),
5(4) of
the
Council being required to act within three months.

favourable opinion;

(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

(11) However, the Council has not reacted within the required
time-limit; a Decision should now be adopted by the
Commission,

(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 97, 1.4.2004, p. 44.
(3) OJ L 184, 17.7.1999, p. 23.

L 31/22

EN

Official Journal of the European Union

3.2.2006

HAS ADOPTED THIS DECISION:

(in case of three portions per day) of added phytosterols/phy-
tostanols.

Article 1

Article 3

Foods and food ingredients as described in Annex I with added
phytosterols/phytostanols as specified in Annex II 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
easily be divided into portions that contain either a maximum
of 3 g (in case of one portion per day) or a maximum of 1 g

This Decision is addressed to Oy Karl Fazer Ab, Fazerintie 6,
FIN-00941 Helsinki.

Done at Brussels, 24 January 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

3.2.2006

EN

Official Journal of the European Union

L 31/23

ANNEX I

PRODUCTS REFERRED TO IN ARTICLE 1

Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and
≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added.

ANNEX II

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.