HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 210/14
EN
Official Journal of the European Union
7.8.2012
COMMISSION IMPLEMENTING DECISION
of 3 August 2012
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 and repealing
Commission Implementing Decision 2011/882/EU
(notified under document C(2012) 5406)
(Only the English text is authentic)
(2012/461/EU)
THE EUROPEAN COMMISSION,
(8) Article 2 of Implementing Decision 2011/882/EU
provided that the designation of the novel chewing
Having regard to the Treaty on the Functioning of the European
gum base authorised thereby on the labelling of the
Union,
foodstuff containing it shall be ‘gum base (1,3-butadiene,
2-methyl-homopolymer, maleated, esters with poly
Having regard to Regulation (EC) No 258/97 of the European
ethylene glycol mono-Me ether)’.
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients ( 1 ), and in particular
Article 7 thereof,
(9) However,
while
the
full
chemical
name
provides
for
a
clear and unambiguous designation of the substance, its
Whereas:
length might dominate the labelling of the foodstuff

containing it. As chewing gum is frequently sold in
packages with limited space on the surface for labelling,
(1) On
10
October
2007
the
company
Revolymer
Ltd
made
it would be appropriate to provide a shorter alternative
a request to the competent authorities of the Netherlands
for the labelling.
to place a novel chewing gum base on the market as a
novel food ingredient.
(10) The
Chemical
Abstract
Service
(CAS)
registry
numbers
(2) On
23
April
2009
the
competent
food
assessment
body
(CAS No) are an international standard for the desig
of the Netherlands issued its initial assessment report. In
nation of chemicals, which provides equivalent
that report it came to the conclusion that the novel
information to that of the chemical name as regards
chewing gum base can safely be used as a food
the nature of the substance.
ingredient.
(3) The
Commission
forwarded
the
initial
assessment
report (11) It is therefore appropriate to allow the use of the CAS
to all Member States on 30 April 2009.
registry number for the designation of the novel chewing
gum base authorised by Implementing Decision
(4) Within
the
60
days
period
laid
down
in
Article
6(4)
of
2011/882/EU on the labelling of the foodstuff containing
Regulation (EC) No 258/97 reasoned objections to the
it as an alternative to the full chemical name.
marketing of the product were raised in accordance with
that provision.
(12) The
Annex
could
have
caused
misunderstandings
as
in
its
(5) Therefore
the
European
Food
Safety
Authority
(EFSA)
title it provided only a part of the chemical name.
was consulted on 2 July 2010.
Furthermore the CAS No should be given in the Annex.
(6) On
25
March
2011,
EFSA
in
the
‘Scientific
Opinion
on
the safety of a “novel chewing gum base (REV-7)” as a
(13) Therefore,
it
appears
appropriate
to
repeal
and
replace
Implementing Decision 2011/882/EU by a new
novel food ingredient’ ( 2 ) came to the conclusion that the
Decision with the abovementioned modifications.
novel chewing gum base was safe at the proposed

conditions of use and the proposed levels of intake.
(14) The
measures provided for in this Decision are in
(7) The
novel
chewing
gum
base
complies
with
the
criteria
accordance with the opinion of the Standing
laid down in Article 3(1) of Regulation (EC) No 258/97
Committee on the Food Chain and Animal Health,
and therefore Commission Implementing Decision
2011/882/EU of 21 December 2011 authorising the
placing on the market of a novel chewing gum base as
HAS ADOPTED THIS DECISION:
a novel food ingredient under Regulation (EC) No
258/97 of the European Parliament and of the Coun
cil ( 3 ) was adopted.
Article 1
The novel chewing gum base as specified in the Annex may be
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) EFSA Journal 2011; 9(4):2127.
placed on the market in the Union as a novel food ingredient
( 3 ) OJ L 343, 23.12.2011, p. 121.
for the use in chewing gum up to a maximum of 8 %.

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EN
7.8.2012 Official
Journal
of
the
European
Union L
210/15
Article 2
The designation of the novel chewing gum base authorised by this Decision on the labelling of the foodstuff
containing it shall be ‘gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with
polyethylene glycol mono-Me ether)’ or ‘gum base (including CAS No: 1246080-53-4)’.
Article 3
Implementing Decision 2011/882/EU is hereby repealed.
Article 4
This Decision is addressed to Revolymer Ltd, 1, NewTech Square, Deeside Industrial Park, Deeside, Flintshire,
CH5 2NT, United Kingdom.
Done at Brussels, 3 August 2012.
For the Commission
John DALLI
Member of the Commission

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L 210/16
EN
Official Journal of the European Union
7.8.2012
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).
CAS No 1246080-53-4
Molecular structure of MPEG grafted PIP-g-MA
Characterisitics of 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether/
CAS No 1246080-53-4
Moisture less
than
5
%
Aluminium less
than
3
mg/kg
Lithium less
than
0,5
mg/kg
Nickel less
than
0,5
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
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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Document Outline

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