2008/36/EC: Commission Decision of 10 January 2008 authorising the placing on the market of rice drinks with added phytosterols/phytostanols as novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 6)
Date: 2008-01-10
Institutions: European Commission
Subjects: beverage, food inspection, foodstuffs legislation, market approval, rice

11.1.2008

EN

Official Journal of the European Union

L 8/15

COMMISSION DECISION

of 10 January 2008

authorising the placing on the market of rice drinks with added phytosterols/phytostanols as novel
food under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2008) 6)

(Only the Finnish and Swedish texts are authentic)

(2008/36/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)

On 12 October 2004 the company Teriaka Ltd. Paulig
Group made a request to the competent authorities of
Finland to place rice drinks with added phytosterols on
the market as a novel food or novel food ingredient.

On 12 January 2005 the competent food assessment
body of Finland issued its initial assessment report. In
that report
the rice
drinks with added phytosterols are safe for human
consumption.

it came to the conclusion that

(3)

The Commission forwarded the initial assessment report
to all Member States on 31 January 2005.

(4) Within the sixty day-period laid down in Article 6(4) of
Regulation (EC) No 258/97 reasoned objections to the
marketing of the product were raised in accordance with
that provision.

(5)

(6)

Therefore the European Food Safety Authority (EFSA)
was consulted on 28 October 2005.

On 15 February 2006 EFSA adopted the ‘Statement of
the Scientific Panel on dietetic Products, Nutrition and
Allergies on a request from the Commission related to
a novel
food application on rice drinks with added
phytosterols’.

(7)

(8)

(9)

(10)

In the statement the panel came to the conclusion that
there is no reason to believe that the introduction of rice
drinks with added phytosterols/phytostanols will increase
the risk of overconsumption of phytosterols.

On the basis of the scientific assessment, it is established
that
rice drinks with added phytosterols/phytostanols
comply with the criteria laid down in Article 3(1) of
Regulation (EC) No 258/97.

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

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Rice drinks with added phytosterols/phytostanols as specified in
the Annex may be placed on the market in the Community as a
novel food.

Article 2

1.
Rice drinks referred to in Article 1 shall be presented in
such a manner that they can be easily divided into portions that
contain either a maximum of 3 g (in case of 1 portion/day) or a
maximum of 1 g (in case of 3 portions/day) of added phyto-
sterols/phytostanols.

The amount of phytosterols/phytostanols added to a

2.
container of rice drinks shall not exceed 3 g.

(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.

L 8/16

EN

Official Journal of the European Union

11.1.2008

This Decision is addressed to Teriaka Ltd., Siirakuja 3, 01490 Vantaa, Finland.

Article 3

Done at Brussels, 10 January 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

11.1.2008

EN

Official Journal of the European Union

L 8/17

ANNEX

Specifications of phytosterols and phytostanols for the addition to rice drinks

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.