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29.8.2013 Official
Journal
of
the
European
Union L
230/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 816/2013
of 28 August 2013
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council as regards the use of Neutral methacrylate copolymer and Anionic methacrylate
copolymer in solid food supplements and the Annex to Commission Regulation (EU)
No 231/2012 as regards the specifications for Basic methacrylate copolymer (E 1205), Neutral
methacrylate copolymer and Anionic methacrylate copolymer
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Applications
for
authorisation
of
the
use
of
Anionic
methacrylate copolymer and Neutral methacrylate
copolymer as glazing agents in solid food supplements
Having regard to the Treaty on the Functioning of the European
were submitted on 25 and 27 April 2009 and were
Union,
made available to the Member States.
Having regard to Regulation (EC) No 1333/2008 of the
(5) The
European
Food
Safety
Authority
evaluated
the
safety
European Parliament and of the Council of 16 December
of Neutral methacrylate copolymer
( 4 ) and Anionic
2008 on food additives (
methacrylate copolymer (

1 ), and in particular Article 10(3),

5 ) when used as food additives
Article 14 and Article 30(5) thereof,
and concluded that their use in solid food supplements at
the proposed use levels is not of a safety concern.
Having regard to Regulation (EC) No 1331/2008 of the
European Parliament and of the Council of 16 December
(6)
There is a technological need for the use of Neutral
2008 establishing a common authorisation procedure for
methacrylate copolymer and Anionic methacrylate
food additives, food enzymes and food flavourings (
copolymer in solid food supplements. Neutral metha

2 ), and in
particular Article 7(5) thereof,
crylate copolymer is intended to be used as a
sustained-release glazing agent. Sustained-release formu
lations allow the continuous dissolution of a nutrient
Whereas:
over a defined time. Anionic methacrylate copolymer is

intended to be used as a glazing agent to protect the
stomach against irritating ingredients and/or to protect
sensitive nutrients against disintegration by the gastric
(1) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
acid. It is therefore appropriate to authorise the use of
Union list of food additives approved for use in foods
both food additives in solid food supplements and to
and their conditions of use.
assign E 1206 as E-number to Neutral methacrylate
copolymer and E 1207 as E-number to Anionic metha
crylate copolymer.
(2) Commission
Regulation
(EU)
No
231/2012
( 3 ) lays down
specifications for food additives including colours and
sweeteners that are listed in Annexes II and III to Regu
(7) Commission
Regulation
(EU)
No
1129/2011
( 6 ) auth
lation (EC) No 1333/2008.
orised the use of Basic methacrylate copolymer
(E 1205) in solid food supplements and Regulation
(EU) No 231/2012 sets out the specifications for that
(3) Those
lists
may
be
updated
in
accordance
with
the
food additive, including the maximum levels for
common procedure referred to in Article 3(1) of Regu
arsenic, lead, mercury and copper. Those specifications
lation (EC) No 1331/2008, either on the initiative of the
should be updated to take into account the maximum
Commission or following an application.
levels for lead, mercury and cadmium in food
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 4 ) EFSA Journal 2010; 8(7):1655.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 5 ) EFSA Journal 2010; 8(7):1656.
( 3 ) OJ L 83, 22.3.2012, p. 1.
( 6 ) OJ L 295, 12.11.2011, p. 1.

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L 230/2
EN
Official Journal of the European Union
29.8.2013
supplements as set out in Commission Regulation (EC)
copolymer (E 1206) and Anionic methacrylate
No 1881/2006 of 19 December 2006 setting maximum
copolymer (E 1207) is a 30 % dispersion of the dry
levels for certain contaminants in foodstuffs ( 1 ).
substance in water.
(11) Regulation
(EC) No 1333/2008 and Regulation (EU)
(8) Maximum
level
of
arsenic
in
food
supplements
has
not
No 231/2012 should therefore be amended accordingly.
been set at the Union level. However, specific levels are
laid down in the laws of Member States. Therefore, it is
(12) The
measures
provided
for
in
this
Regulation
are
in
appropriate to update specifications of Basic methacrylate
accordance with the opinion of the Standing
copolymer (E 1205) in Regulation (EU) No 231/2012 as
Committee on the Food Chain and Animal Health and
regards arsenic to take into account the laws of Member
neither the European Parliament nor the Council has
States.
opposed them,
(9) Maximum
level
of
copper
in
food
supplements
has
not HAS ADOPTED THIS REGULATION:
been set at the Union level and there is no indication of
copper presence at toxicologically significant levels in
Article 1
Basic methacrylate copolymer (E 1205). It is therefore
Annex II to Regulation (EC) No 1333/2008 is amended in
appropriate to delete copper from the purity section
accordance with Annex I to this Regulation.
for Basic methacrylate copolymer (E 1205) in Regulation
(EU) No 231/2012.
Article 2
The Annex to Regulation (EU) No 231/2012 is amended in
(10) Specifications
should
be
adopted
for
Neutral
methacrylate
accordance with Annex II to this Regulation.
copolymer (E 1206) and Anionic methacrylate
copolymer (E 1207). The purity criteria for arsenic,
Article 3
lead, mercury and cadmium should follow the same
approach as those for Basic methacrylate copolymer (E
This Regulation shall enter into force on the twentieth day
1205) and the maximum levels should take into account
following that of its publication in the Official Journal of the
that the commercial form of Neutral methacrylate
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 364, 20.12.2006, p. 5.

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29.8.2013 Off
ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) In Part B, the following entries for E 1206 and E 1207 are inserted in point 3 ‘Additives other than colours and sweeteners’, after the entry for E 1205 Basic methacrylate copolymer:
EN
‘E 1206 Neutral
methacrylate
copolymer

E 1207 Anionic
methacrylate
copolymer’
(2) In Part E, the following entries are inserted in food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, after the entry for
E 1205 Basic methacrylate copolymer:
‘E 1206 Neutral
methacrylate
copolymer 200
000
E 1207 Anionic
methacrylate
copolymer 100
000’
icial
Jour
nal
of
the
European
Union
L
230/3

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L 230/4
EN
Official Journal of the European Union
29.8.2013
ANNEX II
The Annex to Regulation (EU) No 231/2012 is amended as follows:
(1) The purity section of the entry for E 1205 (Basic methacrylate copolymer) is replaced by the following:
‘Purity
Loss of drying Not
more
than
2,0
%
(105
°C,
3
h)
Alkali value 162-198
mg
KOH/g
of
dried
substance
Sulphated ash Not
more
than
0,1
%
Residual monomers Butylmethacrylate
<
1
000
mg/kg
Methyl methacrylate < 1 000 mg/kg
Dimethylaminoethyl methacrylate < 1 000 mg/kg
Solvent residues propan-2-ol
<
0,5
%
Butanol < 0,5 %
Methanol < 0,1 %
Arsenic Not
more
than
1
mg/kg
Lead Not
more
than
3
mg/kg
Mercury Not
more
than
0,1
mg/kg
Cadmium Not
more
than
1
mg/kg’
(2) The following entries for E 1206 and E 1207 are inserted after the entry for E 1205 (Basic methacrylate copolymer):
‘E 1206 NEUTRAL METHACRYLATE COPOLYMER
Synonyms
Ethyl acrylate methyl methacrylate polymer; Ethyl acrylate, methyl
methacrylate polymer; Ethyl acrylate, polymer with methyl metha
crylate; Methyl methacrylate, ethyl acrylate polymer; Methyl metha
crylate, polymer with ethyl acrylate
Definition
Neutral methacrylate copolymer is a fully polymerised copolymer of
methyl methacrylate and ethyl acrylate. It is produced using a process
of emulsion polymerisation. It is manufactured by redox initiated poly
merisation of the monomers ethyl acrylate, methyl methacrylate by
using a free radical donor redox initiator system stabilised with poly
ethylene glycol monostearyl ether and vinylic acid/sodium hydroxide.
Residual monomers are removed by means of water vapour distillation.
CAS No 9010-88-2
Chemical name Poly(ethylacrylate-co-methyl
methacrylate)
2:1
Chemical formula Poly[(CH 2 :CHCO 2 CH 2 CH 3 )-co-(CH 2 :C(CH 3 )CO 2 CH 3 )]
Weight average molecular weight Approximately
600
000
g/mol
Assay/Residue on evaporation 28,5–31,5
%
1 g dispersion is dried in an oven for 3 hours at 110 °C.
Description Milky-white
dispersion
(the
commercial
form
is
a
30
%
dispersion
of
the dry substance in water) of low viscosity with a faint characteristic
odour.

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EN
29.8.2013 Official
Journal
of
the
European
Union L
230/5
Identification
Infrared absorption spectroscopy Characteristic
of
the
compound
Viscosity
Max. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)
pH-value 5,5–8,6
Relative density (at 20 °C) 1,037–1,047
Solubility The
dispersion
is
miscible
with
water
in
any
proportion.
The
polymer
and the dispersion are freely soluble in acetone, ethanol and isopropyl
alcohol. Not soluble when mixed with 1 N sodium hydroxide in a ratio
of 1:2.
Purity
Sulphated ash Not
more
than
0,4
%
in
the
dispersion
Residual monomers
Total of monomers (sum of methyl methacrylate and ethyl acrylate):
not more than 100 mg/kg in the dispersion
Residual emulsifier Polyethylene
glycol
monostearyl
ether
(macrogol
stearyl
ether
20)
not
more than 0,7 % in the dispersion
Solvent residues
Ethanol not more than 0,5 % in the dispersion
Methanol not more than 0,1 % in the dispersion
Arsenic Not
more
than
0,3
mg/kg
in
the
dispersion
Lead Not
more
than
0,9
mg/kg
in
the
dispersion
Mercury Not
more
than
0,03
mg/kg
in
the
dispersion
Cadmium Not
more
than
0,3
mg/kg
in
the
dispersion
E 1207 ANIONIC METHACRYLATE COPOLYMER
Synonyms Methyl
acrylate,
methyl
methacrylate,
methacrylic
acid
polymer;
Metha
crylic acid, polymer with methyl acrylate and methyl methacrylate
Definition
Anionic methacrylate copolymer is a fully polymerised copolymer of
methacrylic acid, methyl methacrylate and methyl acrylate. It is manu
factured in aqueous medium by emulsion polymerisation of methyl
methacrylate, methyl acrylate and methacrylic acid using a free
radical initiator stabilised with sodium lauryl sulphate and polyoxy
ethylene sorbitan monooleate (polysorbate 80). Residual monomers
are removed by means of water vapour distillation.
CAS No 26936-24-3
Chemical name Poly
(methyl
acrylate-co-methylmethacrylate-co-methacrylic
acid)
7:3:1
Chemical formula Poly[(CH 2 :CHCO 2 CH 3 )-co-(CH 2 :C(CH 3 )CO 2 CH 3 )-co-(CH 2 :C(CH 3 )
COOH)]
Weight average molecular weight Approximately
280
000
g/mol
Assay/Residue on evaporation 28,5–31,5
%
1 g of the dispersion is dried in an oven for 5 hours at 110 °C.
9,2–12,3 % methacrylic acid units on dry substance.
Description Milky-white
dispersion
(the
commercial
form
is
a
30
%
dispersion
of
the dry substance in water) of low viscosity with a faint characteristic
odour.

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L 230/6
EN
Official Journal of the European Union
29.8.2013
Identification
Infrared absorption spectroscopy Characteristic
of
the
compound
Viscosity
Max. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)
pH-value 2,0–3,5
Relative density (at 20 °C) 1,058–1,068
Solubility The
dispersion
is
miscible
with
water
in
any
proportion.
The
polymer
and the dispersion are freely soluble in acetone, ethanol and isopropyl
alcohol. Soluble when mixed with 1 N sodium hydroxide in a ratio of
1:2. Soluble above pH 7,0.
Purity
Acid value 60–80
mg
KOH/g
of
dried
substance
Sulphated ash Not
more
than
0,2
%
in
the
dispersion
Residual monomers
Total of monomers (sum of methacrylic acid, methyl methacrylate and
methyl acrylate): not more than 100 mg/kg in the dispersion
Residual emulsifiers Sodium
lauryl
sulphate
not
more
than
0,3
%
on
the
dry
substance
Polysorbate 80 not more than 1,2 % on the dry substance
Solvent residues
Methanol not more than 0,1 % in the dispersion
Arsenic Not
more
than
0,3
mg/kg
in
the
dispersion
Lead Not
more
than
0,9
mg/kg
in
the
dispersion
Mercury Not
more
than
0,03
mg/kg
in
the
dispersion
Cadmium Not
more
than
0,3
mg/kg
in
the
dispersion’

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