2007/343/EC: Commission Decision of 15 May 2007 authorising the placing on the market of oil enriched with phytosterols/phytostanols as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2007) 2073)
Date: 2007-05-15
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, market approval, vegetable oil

17.5.2007

EN

Official Journal of the European Union

L 129/63

COMMISSION DECISION

of 15 May 2007

authorising the placing on the market of oil enriched with phytosterols/phytostanols as a novel
food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2007) 2073)

(Only the English text is authentic)

(2007/343/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:

(7)

(8)

addition of phytosterols/phytostanols is authorised. The
rules concerning the presentation and the labelling of
foods with added phytosterols/phytostanols apply.

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 added phytosterols/phytos-
tanols.

esters ensures

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

in this Decision are in
Standing
the

opinion

the

of

(1)

(2)

On 4 May 2005 the company Enzymotec made a request
to the competent authorities of the Netherlands to place
oil
enriched with phytosterols/phytostanols on the
market as a novel food or a novel food ingredient.

On 23 May 2006 the competent food assessment body
of the Netherlands issued its initial assessment report. In
the oil
that
report
enriched with
human
consumption.

it came to the conclusion that
for

phytosterols

safe

is

(3)

The Commission forwarded the initial assessment report
to all Member States on 29 May 2006.

(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)

raised

objections

risk
The
issues,
management
therefore there was no need to consult the European
Food Safety Authority (EFSA).

issues
assessment

concerned
risk

rather

than

of

HAS ADOPTED THIS DECISION:

Article 1

Oil enriched with phytosterols/phytostanols as specified in
Annex 1 may be placed on the market in the Community
as a novel food ingredient for use in the foods specified in
Annex 2.

Article 2

The products containing the novel
food ingredient 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 one portion per day) or a maximum of 1 g (in case of three
portions per day) of added phytosterols/phytostanols.

The amount of phytosterols/phytostanols added to a container
of beverages shall not exceed 3 g.

(6)

The authorisation of oil enriched with phytosterols/phy-
tostanols should only cover use in foods where the

Spicy sauces and salad dressings including mayonnaise shall be
packed as single portions.

(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 129/64

EN

Official Journal of the European Union

17.5.2007

This Decision is addressed to Enzymotec, 5 Hataasi ST, Ramat Gabriel Industrial Park, Migdal HaEmeq,
Israel 23 106.

Article 3

Done at Brussels, 15 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

17.5.2007

EN

Official Journal of the European Union

L 129/65

ANNEX I

Specifications of oil enriched with phytosterols/phytostanols

Definition:

Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.

Substance/Parameter

Content

Acylglycerol Distribution:

Free fatty acids (expressed as oleic acid)

Monoacylglycerols (MAG)

Diacylglycerols (DAG)

Triacylglycerols (TAG)

Phytosterol fraction:
β-sitosterol
β-sitostanol

campesterol

campestanol

stigmasterol

brassicasterol

other sterols/stanols

Others:

Moisture and volatile

Peroxide value (PV)

Trans fatty acids

Not more than 2 %

Not more than 10 %

Not more than 25 %

Making up the balance

Not more than 80 %

Not more than 15 %

Not more than 40 %

Not more than 5 %

Not more than 30 %

Not more than 3 %

Not more than 3 %

Not more than 0,5 %

< 5 meq/kg

Not more than 1 %

Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols

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 %.

L 129/66

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Official Journal of the European Union

17.5.2007

ANNEX II

Foods referred to in Article 1

Spreadable fats, as defined by Council Regulation (EC) No 2991/94 (1) Annex, points B and C, excluding cooking and
frying fats and spreads based on butter or other animal fat.

Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of
fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g
per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by
vegetable fat or protein.

Soya drinks.

Spicy sauces and salad dressings including mayonnaise.

(1) OJ L 316, 9.12.1994, p. 2.