HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
27.11.2012 Official
Journal
of
the
European
Union L
327/49
COMMISSION IMPLEMENTING DECISION
of 22 November 2012
authorising the placing on the market of dihydrocapsiate as a novel food ingredient under
Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2012) 8391)
(Only the English text is authentic)
(2012/726/EU)
THE EUROPEAN COMMISSION,
(8) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
Having regard to the Treaty on the Functioning of the European
Committee on the Food Chain and Animal Health,
Union,
Having regard to Regulation (EC) No 258/97 of the European
HAS ADOPTED THIS DECISION:
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients ( 1 ), and in particular
Article 7 thereof,
Article 1
Whereas:
Dihydrocapsiate as specified in the Annex I may be placed on

the market as a novel food ingredient for the uses defined and
at the maximum levels established in Annex II, and without
(1) On
6
August
2010
the
company
Ajinomoto
Co.
Inc., prejudice to the provisions of Regulation (EC) No 1925/2006
Japan made a request to the competent authorities of
of the European Parliament and of the Council ( 3 ), Directive
the United Kingdom to place dihydrocapsiate on the
2009/39/EC of the European Parliament and of the Council ( 4 )
market as novel food ingredient.
and Directive 2009/54/EC of the European Parliament and of
the Council ( 5 ).
(2) On
10
March
2011
the
competent
food
assessment
body
of the United Kingdom issued its initial assessment
report. In this report it came to the conclusion that
Article 2
dihydrocapsiate will not present a health risk to
consumers.
The designation of dihydrocapsiate authorised by this Decision
on the labelling of the foodstuffs containing it shall be ‘Dihy
drocapsiate’.
(3) The
Commission
forwarded
the
initial
assessment
report
to all Member States on 13 April 2011.
Article 3
(4) Within
the
60
day
period
laid
down
in
Article
6(4)
of
Regulation (EC) No 258/97 reasoned objections were
This Decision is addressed to Ajinomoto Co. Inc., 15-1,
raised in accordance with that provision.
Kyobashi, Chuo-ku, 1-choume, 104-8315, Tokyo, Japan.
(5) Therefore
the
European
Food
Safety
Authority
(EFSA)
was consulted on 9 November 2011.
Done at Brussels, 22 November 2012.
(6) On
28
June
2012
in
their
‘Scientific
opinion
on
dihydro
capsiate’ ( 2 ) EFSA came to the conclusion that dihydro
capsiate is safe under the proposed uses and use levels.
For the Commission
(7) Dihydrocapsiate
complies
with
the
criteria
laid
down
in
Maro EFOVI
Article 3(1) of Regulation (EC) No 258/97.
Vice-President
( 3 ) OJ L 404, 30.12.2006, p. 26.
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 4 ) OJ L 124, 20.5.2009, p. 21.
( 2 ) EFSA Journal 2012; 10(7):2812.
( 5 ) OJ L 164, 26.6.2009, p. 45.

---

L 327/50
EN
Official Journal of the European Union
27.11.2012
ANNEX I
SPECIFICATIONS OF DIHYDROCAPSIATE
Definition
Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid.
Following the esterification dihydrocapsiate is extracted with n-hexane.
The enzyme Lipozyme 435 was approved by the Danish Veterinary and Food Administration.
Description: Viscous colourless to yellow liquid
Chemical formula: C 18 H 28 O 4
Structural formula:
CAS No: 205687-03-2
Physical-chemical properties of dihydrocapsiate
Dihydrocapsiate more
than
94
%
8-Methylnonanoic acid less
than
6
%
Vanillyl acohol less
than
1
%
Synthesis related substances less
than
2
%

---

EN
27.11.2012 Official
Journal
of
the
European
Union L
327/51
ANNEX II
USES OF DIHYDROCAPSIATE
Food category Maximum
use
levels
Cereal bars 9
mg/100
g
Biscuits, cookies and crackers 9
mg/100
g
Rice based snacks
12 mg/100 g
Carbonated drinks, dilutable drinks, fruit juice based drinks 1,5
mg/100
ml
Vegetable drinks 2
mg/100
ml
Coffee based drinks, tea based drinks 1,5
mg/100
ml
Flavoured water — still 1
mg/100
ml
Precooked oatmeal cereal 2,5
mg/100
g
Other cereals 4,5
mg/100
g
Ice cream, dairy desserts 4
mg/100
g
Pudding mixes (ready to eat) 2
mg/100
g
Products based on yoghurt 2
mg/100
g
Chocolate confectionery 7,5
mg/100
g
Hard candy
27 mg/100 g
Sugar-free gum 115
mg/100
g
Whitener/creamer
40 mg/100 g
Sweeteners 200
mg/100
g
Soup (ready to eat) 1,1
mg/100
g
Salad dressing
16 mg/100 g
Vegetable protein 5
mg/100
g
Ready to eat meals
3 mg/meal
Replacement meals
Meal replacement drinks 1
mg/100
ml

---

Document Outline

• �

---