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23.12.2011 Official
Journal
of
the
European
Union L
343/121
COMMISSION IMPLEMENTING DECISION
of 21 December 2011
authorising the placing on the market of a novel chewing gum base as a novel food ingredient
under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2011) 9680)
(Only the English text is authentic)
(2011/882/EU)
THE EUROPEAN COMMISSION,
novel food ingredient’ ( 2 ) came to the conclusion that the
novel chewing gum base was safe at the proposed
Having regard to the Treaty on the Functioning of the European
conditions of use and the proposed levels of intake.
Union,
(7)
The novel chewing gum base complies with the criteria
laid down in Article 3(1) of Regulation (EC) No 258/97.
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 (
(8) The
measures
provided
for
in
this
Decision
are
in

1 ), and in particular
Article 7 thereof,
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Whereas:
HAS ADOPTED THIS DECISION:
(1) On
10
October
2007
the
company
Revolymer
Ltd
made
Article 1
a request to the competent authorities of the Netherlands
to place a novel chewing gum base on the market as a
The novel chewing gum base as specified in the Annex may be
novel food ingredient.
placed on the market in the Union as a novel food ingredient
for the use in chewing gums up to a maximum of 8 %.
(2) On
23
April
2009
the
competent
food
assessment
body
of the Netherlands issued its initial assessment report. In
Article 2
that report it came to the conclusion that the novel
The designation of the novel chewing gum base authorised by
chewing gum base can safely be used as a food
this Decision on the labelling of the foodstuff containing it shall
ingredient.
be ‘gum base (1,3-butadiene, 2-methyl-homopolymer, maleated,
esters with polyethylene glycol mono-Me ether)’.
(3) The
Commission
forwarded
the
initial
assessment
report
to all Member States on 30 April 2009.
Article 3
This Decision is addressed to Revolymer Ltd, 1 Newtech Square,
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of Deeside Industrial Park, Deeside, Flintshire CH5 2NT, United
Regulation (EC) No 258/97 reasoned objections to the
Kingdom.
marketing of the product were raised in accordance with
that provision.
Done at Brussels, 21 December 2011.
(5) Therefore
the
European
Food
Safety
Authority
(EFSA)
was consulted on 2 July 2010.
For the Commission
(6) On
25
March
2011,
EFSA
in
the
‘Scientific
Opinion
on
John DALLI
the safety of a “novel chewing gum base (REV-7)” as a
Member of the Commission
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) EFSA Journal 2011; 9(4):2127.

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L 343/122
EN
Official Journal of the European Union
23.12.2011
ANNEX
Specifications of the novel chewing gum base
Description
The novel food ingredient is a synthetic polymer (patent number WO2006016179). It has a white to off-white colour.
It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic
anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).
Molecular structure of MPEG grafted PIP-g-MA
Characteristics of mono methoxy polyethylene glycol
Moisture less
than
5
%
Ash less
than
5
mg/kg
Residual anhydride less
than
15
μmol/g
Polydispersity index less
than
1,4
Isoprene less
than
0,05
mg/kg
Ethylene oxide less
than
0,2
mg/kg
Free maleic anhydride less
than
0,1
%
Total oligomeres (less than 1 000 Dalton) not
more
than
50
mg/kg
Impurities from raw materials
Ethylene glycol less
than
200
mg/kg
Diethylene glycol less
than
30
mg/kg
Monoethylene glycol methyl ether less
than
3
mg/kg
Diethylene glycol methyl ether less
than
4
mg/kg
Triethylene glycol methyl ether less
than
7
mg/kg
1,4-Dioxane less
than
2
mg/kg
Formaldehyde less
than
10
mg/kg

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