2006/58/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 pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council  (notified under document number C(2006) 42)   (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

L 31/18

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Official Journal of the European Union

3.2.2006

II

(Acts whose publication is not obligatory)

COMMISSION

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 pursuant to Regulation (EC) No 258/97 of the European Parliament
and of the Council

(notified under document number C(2006) 42)

(Only the Finnish and Swedish texts are authentic)

(Text with EEA relevance)

(2006/58/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:

On 24 September 2001 Pharmaconsult Oy Ltd (formerly
MultiBene Health Oy Ltd) made a request to the compe-
tent 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.

(1)

(2)

(3)

(4)

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

(8)

(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).

(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)

(7)

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 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 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 Phar-
maconsult Oy consequently agreed to reduce
the
original application on bakery products exclusively to
rye bread.

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Official Journal of the European Union

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(9)

(10)

Commission Regulation (EC) No 608/2004 of 31 March
2004 concerning the labelling of foods and food ingre-
dients with added phytosterols, phytosterol
esters,
phytostanols and/or phytostanol esters (1), ensures that
consumers receive the information necessary in order
to avoid excessive intake of additional phytosterols.

The Standing Committee on the Food Chain and Animal
the
given a
Health has not
Commission therefore submitted a proposal
to the
Council on 22 August 2005 in accordance with Article
the Council Decision 1999/468/EC (2),
5(4) of
the
Council being required to act within three months.

favourable opinion;

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

called the products, may be placed on the market
Community.

in the

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 one portion per day) or maximum 1 g (in
case of three portions per day) of added phytosterols/phytos-
tanols.

Article 3

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

HAS ADOPTED THIS DECISION:

Done at Brussels, 24 January 2006.

Article 1

Foods and food ingredients as described in Annex I with added
phytosterols/phytostanols as specified in Annex II, hereinafter

For the Commission

Markos KYPRIANOU
Member of the Commission

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

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Official Journal of the European Union

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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.