(1)(2)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/1
II 
(Non-legislative acts) 
REGULATIONS  
  
COMMISSION REGULATION (EU) No 10/2011
of 14 Janu ary 
2011
on plastic materials and articles intended to come into contact with food
(Text with EEA relevance)
THE 
EUROPEAN 
COMMISSION,
Having regard to the Treaty on  the Functioning of the European 
Union,
Having 
regard 
to Regulation 
(EC) 
No 1935/2004 of the E uropean 
Parliamen t 
and 
of the Coun cil 
of 27 Octob er 
2004 on 
materials 
and 
articles in tended 
to come in to 
contact 
with food an d 
repeal­
ing 
Directives 80/590/E EC 
and 
89/109/EEC
(1) OJ L 338, 13.11.2004, p. 4., and in particular 
Article 
5(1)(a), (c), (d), (e), (f), (h), (i) an d 
(j) thereof,
After consulting 
the European 
Food Safety Authority,
Whereas:
(1) Regulation (EC) No  1935/2004 lays down  the general 
principles 
for elimin ating 
the differen ces 
between 
the laws 
of the Memb er
 States as reg ards
 food contact materials. 
Article 5(1) of that Reg ulation 
provides for the adoption of 
specific measures for g roups 
of materials an d 
articles an d 
describes
 in detail the procedure for the authorisation of 
substances 
at EU 
level when  
a specific measure provides 
for a list of authorised sub stances.(2) This Regulation is a specific measure within  the meaning 
of 
Article 5(1) of Reg ulation 
(EC) 
No 1935/2004. This 
Regulation
 should estab lish
 the specific rules for plastic 
materials an d
 articles to b e
 applied for their safe use an d
 
repeal Commission  
Directive 2002/72/E C 
of 6  August 
2002 
on plastic materials an d
 articles in tended
 to come 
into 
contact 
with foodstuffs
(2) OJ L 220, 15.8.2002, p. 18..
(3) Directive 2002/72/E C sets out basic rules for the man ufac­
ture 
of plastic materials an d 
articles. The Directive has b een 
substantially
 amended
 6 times. For reason s
 of clarity the 
text should b e
 consolidated
 and
 redundant
 and
 obsolete
 
parts removed.
(4) In the past Directive 2002/72/E C and its amendments have 
been
 transposed
 into
 national
 legislation
 without an y
 
major adaptation . 
For transposition 
into 
national 
law usu­
ally a time period of 12 mon ths
 is necessary.
 In
 case of 
amending 
the lists of mon omers 
and 
additives in  
order to 
authorise n ew 
substances 
this transposition 
time leads to a 
retardation  
of the authorisation  
and 
thus slows down  
inno­
vation. 
Therefore it seems appropriate to adopt rules on  
plastic
 materials an d
 articles in form of a Reg ulation
 
directly applicab le 
in 
all Member 
States.(1)L 12/2 EN Official Journ alof the EuropeanUnion 15.1.2011
(5) Directive 2002/72/E C applies to materials an d articles 
purely 
made of plastics an d 
to plastic g askets 
in 
lids. In 
the 
past these were the main  
use of plastics on  
the market. 
However, 
in 
recent 
years, besides 
materials an d 
articles 
purely made of plastics, plastics are also used in  
combina­
tion 
with other materials in  
so called multi-material multi-
layers. Rules on the use of vin yl
 chloride mon omer
 laid 
down in Coun cil
 Directive 78/142/E EC
 of 30  January
 
1978 on the approximation of the laws of the Memb er
 
States relatin g 
to materials an d 
articles which con tain 
vinyl 
chloride 
monomer 
and 
are intended 
to come in to 
contact 
with 
foodstuffs
(1) OJ L 44, 15.2.1978, p. 15. already apply to all plastics. Therefore it 
seems appropriate to exten d 
the scope of this Reg ulation 
to 
plastic layers in  
multi-material multi-layers.
(6) Plastic materials an d articles may b e composed of differen t 
layers 
of plastics held tog ether 
by 
adhesives. Plastic mate­
rials and
 articles may also b e
 printed
 or coated with an 
organic 
or inorganic 
coating. 
Printed 
or coated plastic 
materials an d
 articles as well as those held tog ether
 by
 
adhesives should b e
 within the scope of the Reg ulation.
 
Adhesives, coatin gs
 and
 printing
 inks
 are not
 necessarily
 
composed of the same sub stances
 as plastics. Reg u
lation 
(EC)
 No 1935/2004 foresees that for adhesives, coatin gs
 
and 
printing 
inks 
specific measures can  
be 
adopted. There­
fore plastic materials an d 
articles that are printed, coated or 
held together 
by 
adhesives should b e 
allowed to con tain 
in 
the
 printing,
 coating
 or adhesive layer other substances 
than 
those authorised at E U 
level for plastics. Those layers 
may be 
subject 
to other E U 
or national 
rules.
(7) Plastics as well as ion  exchange resins, rubbers and sili­
cones
 are macromolecular sub stances
 obtained
 by
 poly­
merisation processes. Reg ulation
 (EC)
 No  1935/2004 
foresees that for ion  
exchange 
resins, 
rubbers 
and 
silicones 
specific
 measures can b e
 adopted. As those materials are 
composed of differen t
 substances
 than plastics and have 
different
 physico-chemical properties specific rules for 
them need 
to apply an d 
it should b e 
made clear that they 
are not 
within 
the scope of this Reg ulation.
(8) Plastics are made of mon omers and other startin g sub­
stances 
which are chemically reacted to a macromolecular 
structure, the polymer, which forms the main structural 
component
 of the plastics. To the polymer additives are 
added to achieve defin ed
 technological
 effects. The poly­
mer as such is an  
inert 
high 
molecular weig ht 
structure. As substances 
with a molecular weig ht 
above 1 
000 Da usu­
ally cannot
 be
 absorbed
 in the body
 the poten tial
 health 
risk from the polymer itself is min imal.
 Potential
 health 
risk 
may occur from n on- 
or incompletely 
reacted mon o­
mers
 or other startin g
 substances
 or from low molecular 
weight 
additives which are tran sferred 
into 
food via mig ra­
tion
 from the plastic food con tact
 material. Therefore 
monomers, 
other startin g 
substances 
and 
additives should 
be 
risk 
assessed an d 
authorised b efore 
their use in  
the 
manufacture 
of plastic materials an d 
articles.
(9) The risk assessmen t of a substance to be performed b y the 
European
 Food Safety Authority (herein after
 the Author­
ity) should cover the sub stance
 itself, relevan t
 impurities 
and 
foreseeable 
reaction 
and 
degradation 
products in  
the 
intended 
use. The risk  
assessmen t 
should cover the poten ­
tial
 migration
 under
 worst foreseeab le
 conditions
 of use 
and 
the toxicity. Based on  
the risk 
assessmen t 
the authori­
sation 
should if n ecessary 
set out specification s 
for the sub ­
stance
 and
 restriction s
 of use, quan titative
 restriction s
 or 
migration 
limits to en sure 
the safety of the fin al 
material or 
article.
(10) No rules have yet b een set out at E U level for the risk 
assessmen t 
and 
use of coloran ts 
in 
plastics. Therefore their 
use should remain  
subject 
to national 
law. That situation  
should 
be 
reassessed at a later stag e.
(11) Solvents used in the manufacture of plastics to create a 
suitable 
reaction 
environment 
are expected to b e 
removed 
in the man ufacturing
 process as they are usually volatile. 
No rules have yet b een
 set out at E U
 level for the risk 
assessmen t 
and 
use of solven ts 
in 
the manufacture 
of plas­
tics. Therefore their use should remain  
subject 
to national 
law. 
That situation  
should be 
reassessed at a later stag e.
(12) Plastics can  also be made of syn thetic or natural occurring 
macromolecular
 structures which are chemically reacted 
with other startin g 
substances 
to create a modified macro­
molecule. Syn thetic 
macromolecules used are often  
inter­
mediate
 structures which are n ot
 fully polymerised. 
Potential 
health risk  
may occur from the mig ration 
of non-
or 
incompletely 
reacted other startin g 
substances 
used to 
modify the macromolecule or an  
incompletely 
reacted 
macromolecule. Therefore the other startin g 
substances 
as 
well as the macromolecules used in  
the manufacture 
of 
modified macromolecules should b e
 risk assessed an d
 
authorised b efore
 their use in the man ufacture
 of plastic 
materials an d 
articles.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/3
(13) Plastics can  also be made by micro-org anisms that create 
macromolecular
 structures out of startin g
 substances
 by
 
fermentation 
processes. The macromolecule is then  
either 
released to a medium or extracted. Poten tial 
health risk  
may 
occur from the mig ration 
of non- 
or incompletely 
reacted
 starting
 substances,
 intermediates
 or by-products
 
of the fermen tation 
process. In 
this case the fin al 
product 
should be 
risk 
assessed an d 
authorised b efore 
its use in 
the 
manufacture 
of plastic materials an d 
articles.
(14) Directive 2002/72/E C contains different lists for mon o­
mers 
or other startin g 
substances 
and 
for additives autho­
rised for the man ufacture 
of plastic materials an d 
articles. 
For monomers, 
other startin g 
substances 
and 
additives the 
Union 
list is now 
complete, this mean s 
that only 
sub­
stances
 authorised at E U
 level may b e
 used. Therefore a 
separation  
of monomers 
or other startin g 
substances 
and 
of 
additives in  
separate lists due to their authorisation  
sta­
tus is no
 longer
 necessary.
 As certain substan ces
 can be
 
used both 
as monomer 
or other startin g 
substances 
and 
as 
additive for reason s 
of clarity they should b e 
published 
in 
one 
list of authorised sub stances 
indicating 
the authorised 
function.
(15) Polymers can  not only be used as main  structural compo­
nent 
of plastics b ut 
also as additives achieving defin ed 
tech­
nological 
effects in 
the plastic. I f 
such a polymeric additive 
is identical 
to a polymer that can  
form the main  
structural 
component
 of a plastic material the risk from polymeric 
additive can  
be 
regarded 
as evaluated if the mon omers 
have 
already been
 evaluated an d
 authorised. I n
 such a case it 
should not 
be 
necessary 
to authorise the polymeric addi­
tive but 
it could b e 
used on 
the basis 
of the authorisation  
of
 its monomers
 and
 other startin g
 subst
ance
s. If
 such a 
polymeric additive is n ot
 identical
 to a polymer that can 
form the main  
structural compon ent 
of a plastic material 
then 
the risk 
of the polymeric additive can  
not 
be 
regarded 
as 
evaluated b y 
evaluation  
of the mon omers. 
In 
such a case 
the polymeric additive should b e 
risk 
assessed as reg ards 
its 
low molecular weig ht 
fraction 
below 1 
000 Da an d 
autho­
rised before 
its use in 
the manufacture 
of plastic materials 
and 
articles.
(16) In the past n o clear differen tiation has been made between 
additives
 that have a fun ction
 in the fin al
 polymer an d
 
polymer production  
aids (PPA) that on ly 
exhibit 
a function 
in
 the manufacturing
 process an d
 are not
 int
ended to b e
 
present 
in 
the final 
article. Some sub stances 
acting 
as PPA 
had already b een
 included
 in the incompl
ete list of addi­
tives in 
the past. These PPA should remain  
in 
the Union 
list 
of authorised sub stances. 
However, it should b e 
made clear that the use of other PPA will remain  
possible, 
subject 
to 
national 
law. That situation  
should be 
reassessed at a later 
stage.
(17) The Union list contains substances authorised to b e used 
in 
the manufacture 
of plastics. Sub stances 
such as acids, 
alcohols an d 
phenols 
can 
also occur in  
form of salts. As the 
salts usually are tran sformed 
in 
the stomach to acid, alco­
hol or phen ol 
the use of salts with cation s 
that have un der­
gone 
a safety evaluation  
should in 
principle 
be 
authorised 
together 
with the acid, alcohol or phen ol. 
In 
certain 
cases, 
where the safety assessmen t 
indicates 
concerns 
on 
the use 
of the free acids, on ly
 the salts should b e
 authorised b y
 
indicating 
in 
the list the n ame 
as ‘… acid(s), salts’.
(18) Substances used in the manufacture of plastic materials or 
articles
 may con tain
 impurities orig inating
 from their 
manufacturing 
or extraction  
process. These impurities are 
non-intentionally 
added tog ether 
with the sub stance 
in 
the 
manufacture
 of the plastic material (n on-intentionally
 
added sub stance 
– NIAS). 
As far as they are relevan t 
for the 
risk 
assessmen t 
the main 
impurities of a sub stance 
should 
be 
considered 
and 
if necessary 
be 
included 
in 
the specifi­
cations 
of a substance. 
However it is n ot 
possible 
to list 
and 
consider 
all impurities in  
the authorisation . 
Therefore 
they may b e 
present 
in 
the material or article b ut 
not 
included 
in 
the Union 
list.
(19) In the manufacture of polymers sub stances are used to in i­
tiate
 the polymerisation reaction such as catalysts an d
 to 
control 
the polymerisation  
reaction 
such as chain  
transfer, 
chain 
extending 
or chain 
stop reagents. 
These aids to poly­
merisation are used in min ute
 amounts
 and
 are not
 
intended
 to remain in the fin al
 polymer. Therefore they 
should at this poin t 
of time not 
be 
subject 
to the authori­
sation 
procedure at E U 
level. Any 
potential 
health risk  
in 
the 
final 
material or article arisin g 
from their use should b e 
assessed 
by 
the manufacturer 
in 
accordance 
with interna­
tionally 
recognised 
scientific 
principles 
on 
risk 
assessmen t.
(20) During the manufacture and use of plastic materials an d 
articles 
reaction 
and 
degradation 
products can  
be 
formed. 
These reaction an d
 degradation
 products are n on-
intentionally 
present 
in 
the plastic material (NI AS). 
As far 
as they are relevan t 
for the risk  
assessmen t 
the main 
reac­
tion 
and 
degradation 
products of the in tended 
application  
of 
a substance 
should be 
considered 
and 
included 
in 
the 
restriction s 
of the sub stance. 
However it is n ot 
possible 
to 
list and 
consider 
all reaction  
and 
degradation 
products in  
the 
authorisation . 
Therefore they should n ot 
be 
listed as 
single 
entries 
in 
the Union 
list. Any 
potential 
health risk  
in 
the 
final 
material or article arisin g 
from reaction  
and 
deg­
radation 
products should b e 
assessed b y 
the manufacturer 
in 
accordance 
with internationally 
recognised 
scientific 
principles 
on 
risk 
assessmen t.(1)
(2)(3)L 12/4 EN Official Journ alof the EuropeanUnion 15.1.2011
(21) Prior to the estab lishment of the Un ion list of additives, 
other 
additives than  
those authorised at E U 
level could b e 
used
 in the man ufacture
 of plastics. For those additives 
which were permitted in  
the Memb er 
States, the time limit 
for the sub mission 
of data for their safety evaluation  
by 
the 
Authority with a view to their in clusion 
in 
the Union 
list 
expired on  31 
December 
2006. Additives for which a valid 
application  
was submitted 
within 
this time limit were listed 
in 
a provision al 
list. For certain  
additives on  
the provision al 
list 
a decision  
on 
their authorisation  
at EU 
level has n ot 
yet 
been
 taken.
 For those additives, it should b e
 possible
 to 
continue 
to be 
used in 
accordance 
with national 
law until 
their
 evaluation is completed an d
 a decision is taken on 
their inclusion 
in 
the Union 
list.
(22) When an additive in cluded in the provision al list is inserted 
in 
the Union 
list or when  
it is decided n ot 
to include 
it in 
the
 Union
 list, that additive should be removed from the 
provisional 
list of additives.
(23) New techn ologies engineer substances in particle size that 
exhibit 
chemical an d 
physical properties that sig nificantly 
differ
 from those at a larg er
 scale, for example, n anopar
­
ticles. These differen t 
properties may lead to differen t 
toxi­
cological 
properties an d 
therefore these sub stances 
should 
be
 assessed on a case-b y-case
 basis
 by
 the Authority as 
regards 
their risk 
until 
more information 
is known 
about 
such 
new 
technology. 
Therefore it should b e 
made clear 
that authorisation s 
which are b ased 
on 
the risk 
assessmen t 
of 
the conventional 
particle size of a sub stance 
do not 
cover 
engineered 
nanoparticles.
(24) Based on the risk assessmen t the authorisation  should if 
necessary
 set out specific mig ration
 limits to en sure
 the 
safety of the fin al 
material or article. I f 
an 
additive that is 
authorised for the man ufacture
 of plastic materials an d
 
articles is at the same time authorised as food additive or 
flavouring 
substance 
it should b e 
ensured 
that the release 
of the sub stance 
does not 
change 
the composition  
of the 
food in 
an 
unacceptable 
way. Therefore the release of such 
a dual use additive or flavourin g 
should not 
exhibit 
a tech­
nological 
function 
on 
the food un less 
such a fun ction 
is 
intended 
and 
the food con tact 
material complies with the 
requiremen ts 
on 
active food con tact 
materials set out in  
Regulation 
(EC) 
No 1935/2004 an d 
Commission  
Regula­
tion 
(EC) 
No 450/2009 of 29 May 2009 on  
active and 
intelligent 
materials an d 
articles in tended 
to come in to 
contact 
with food
(1) OJ L 135, 30.5.2009, p. 3.. The requiremen ts of Regulations (EC) 
No 
1333/2008 of the E uropean 
Parliamen t 
and 
of the 
Council 
of 16 Decemb er 
2008 on 
food additives
(2) OJ L 354, 31.12.2008, p. 16. or (EC) No 
1334/2008 of the E uropean 
Parliamen t 
and 
of the 
Council 
of 16 Decemb er 
2008 on 
flavourings 
and 
certain 
food 
ingredients 
with flavourin g 
properties for use in  
and 
on
 foods an d
 amending
 Council
 Regulation
 (EEC)
 
No  1601/91, Reg ulations
 (EC)
 No  2232/96 an d
  (EC)
 
No  110/2008 an d 
Directive 2000/13/E C
(3) OJ L 354, 31.12.2008, p. 34. should be 
respected 
where applicab le.
(25) According to Article  3(1)(b ) of Reg ulation (EC) 
No
 1935/2004 the release of sub stances
 from food con­
tact materials an d
 articles should n ot
 bring
 about
 unac
­
ceptable
 changes
 in the composition of the food. 
According 
to good 
manufacturing 
practice it is feasib le 
to 
manufacture 
plastic materials in  
such a way that they are 
not 
releasing 
more than  
10 mg 
of substances 
per 1 dm2 of 
surface area of the plastic material. I f 
the risk 
assessment of 
an 
individual 
substance 
is not 
indicating 
a lower level, this 
level should b e 
set as a generic 
limit for the in ertness 
of a 
plastic material, the overall mig ration
 limit. In
 order to 
achieve comparab le
 results in the verification of compli­
ance
 with the overall mig ration
 limit, testin g
 should b e
 
performed un der 
standardised 
test conditions 
including 
testing 
time, temperature an d 
test medium (food simulan t) 
representing 
worst foreseeab le 
conditions 
of use of the 
plastic material or article.
(26) The overall mig ration limit of 10 mg  per 1 dm2 results for 
a cubic 
packaging 
containing 
1kg 
of food to a mig ration 
of 
60 mg 
per kg 
food. For small pack aging 
where the sur­
face to volume ratio is hig her 
the resultin g 
migration 
into 
food 
is higher. 
For infants 
and 
small children  
which have a 
higher 
consumption 
of food per k ilogram 
bodyweight 
than 
adults and 
do not 
yet have a diversified n utrition, 
spe­
cial provision s 
should be 
set in 
order to limit the in take 
of 
substances 
migrating 
from food con tact 
materials. In order 
to allow also for small volume pack aging 
the same protec­
tion as for hig h
 volume pack aging,
 the overall mig ration
 
limit for food con tact 
materials that are dedicated for pack ­
aging 
foods for in fants 
and 
small children  
should be 
linked 
to 
the limit in  
food and 
not 
to the surface area of the 
packaging.
(27) In recent years plastic food con tact materials are b eing 
developed 
that do not 
only 
consist 
of one 
plastic but 
com­
bine
 up to 15 differen t
 plastic layers to attain optimum 
functionality
 and
 protection of the food, while reducin g
 
packaging 
waste. In 
such a plastic multi-layer material or 
article, layers may b e 
separated from the food b y 
a func­
tional 
barrier. 
This barrier 
is a layer within  
food contact 
materials 
or articles preven ting 
the migration 
of substances 
from 
behind 
that barrier 
into 
the food. Behin d 
a functional 
barrier, 
non-authorised 
substances 
may be 
used, provided(1)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/5
 they fulfil certain criteria an d
 their mig r
ation remains 
below
 a given
 detection limit. Tak ing
 into
 account
 foods 
for infants
 and
 other particularly susceptib le
 persons,
 as 
well as the larg e 
analytical 
tolerance 
of the mig ration 
analy­
sis,
 a maximum level of 0,01 mg /kg
 in food should b e
 
established 
for the mig ration 
of a non-authorised 
sub­
stance
 through
 a functional
 barrier.
 Substances
 that are 
mutagenic,
 carcinogenic
 or toxic to reproduction should 
not
 be
 used in food con tact
 materials or articles without 
previous authorisation an d
 should therefore n ot
 be
 cov­
ered by
 the functional
 barrier
 concept.
 New technologies 
that engineer 
substances 
in 
particle size that exhib it 
chemi­
cal and
 physical properties that sig nificantly
 differ from 
those at a larg er 
scale, for example, n anoparticles, 
should 
be 
assessed on  
a case-by-case 
basis 
as regards 
their risk 
until 
more information 
is known 
about 
such new 
technol­
ogy. 
Therefore, they should n ot 
be 
covered b y 
the func­
tional 
barrier 
concept.
(28) In recent years food con tact materials an d articles are b eing 
developed 
that consist 
of a comb ination 
of several materi­
als to achieve optimum fun ctionality 
and 
protection  
of the 
food while reducin g
 packaging
 waste. In
 these multi-
material multi-layer materials an d 
articles plastic layers 
should comply with the same composition al 
requiremen ts 
as 
plastic layers which are n ot 
combined 
with other mate­
rials. For plastic layers in  
a multi-material multi-layer which 
are separated from the food b y
 a funct
ional
 barrier
 the 
functional 
barrier 
concept 
should apply. As other materi­
als are comb ined 
with the plastic layers an d 
for these other 
materials specific measures are n ot 
yet adopted at E U 
level 
it is not 
yet possib le 
to set out requiremen ts 
for the fin al 
multi-material 
multi-layer materials an d 
articles. Therefore 
specific mig ration 
limits and 
the overall mig ration 
limit 
should not 
be 
applicable 
except for vin yl 
chloride mon o­
mer 
for which such a restriction  
is already in  
place. In 
the 
absence 
of a specific measure at E U 
level coverin g 
the 
whole multi-material multi-layer material or article Mem­
ber 
States may main tain 
or adopt n ational 
provisions 
for 
these materials an d 
articles provided they comply with the 
rules of the Treaty.
(29) Article 16(1) of Reg ulation (EC) No 1935/2004 provides 
that 
materials an d 
articles covered b y 
specific measures b e 
accompan ied 
by 
a written 
declaration  
of complian ce 
stat­
ing 
that they comply with the rules applicab le 
to them. To 
strengthen 
the coordin ation 
and 
responsibility 
of the sup­
pliers at each stag e
 of manufacture,
 includi
ng that of the 
starting 
substances, 
the respon sible 
persons 
should docu­
ment 
the complian ce 
with the relevan t 
rules in 
a declara­
tion of complian ce
 which is made availab le
 to their 
customers.
(30) Coatings, printing inks and adhesives are n ot yet covered 
by 
a specific E U 
legislation 
and 
therefore n ot 
subject 
to the 
requiremen t 
of a declaration  
of complian ce. 
However, for coatings, 
printing 
inks 
and 
adhesives to b e 
used in 
plastic 
materials an d 
articles adequate in formation 
should be 
pro­
vided to the man ufacturer
 of the fin al
 plastic article that 
would enable 
him to en sure 
compliance 
for substances 
for 
which mig ration
 limits have b een
 established
 in this 
Regulation.
(31) Article 17(1) of Reg ulation (EC) No 178/2002 of the E uro­
pean 
Parliamen t 
and 
of the Coun cil 
of 28 January 
2002 
laying
 down the g eneral
 principles
 and
 requiremen ts
 of 
food law, estab lishing 
the European 
Food Safety Authority 
and
 laying
 down procedures in matters of food safety
(1) OJ L 31, 1.2.2002, p. 1.requires the food b usiness operator to verify that foods are 
compliant
 with the rules applicab le
 to them. To this en d
 
and 
subject 
to the requiremen t 
of confidentiality, 
food 
business 
operators should b e 
given 
access to the relevan t 
information
 to enable
 them to en sure
 that the mig ration
 
from the materials an d 
articles to food complies with the 
specification s 
and 
restriction s 
laid down  
in 
food legislation.
(32) At each stag e of manufacture, supportin g documentation, 
substantiating
 the declaration of complian ce,
 should b e
 
kept 
available 
for the en forcement 
authorities. Such dem­
onstration 
of complian ce 
may be 
based 
on 
migration 
test­
ing.
 As migration
 testing
 is complex, costly and time 
consuming 
it should b e 
admissible 
that complian ce 
can 
be 
demonstrated
 also by
 calculation s,
 including
 modellin g,
 
other analysis, 
and 
scientific 
evidence 
or reasoning 
if these 
render 
results which are at least as severe as the mig ration 
testing. 
Test results should b e 
regarded 
as valid as lon g 
as 
formulation s
 and
 processin g
 conditions
 remain con stant
 
as part of a quality assuran ce 
system.
(33) When testing articles not yet in contact with food, for cer­
tain 
articles, such as films or lids, it is often  
not 
feasible 
to 
determine 
the surface area that is in  
contact 
with a defin ed 
volume 
of food. For these articles specific rules should b e 
set 
out for verification  
of complian ce.
(34) The settin g of migration limits tak es into account a con­
ventional 
assumption  
that 1kg 
of food is con sumed 
daily 
by 
a person 
of 60 kg 
bodyweight 
and 
that the food is pack ­
aged 
in 
a cubic 
container 
of 6 dm2 surface area releasin g 
the 
substance. 
For very small an d 
very large 
containers 
the 
real surface area to volume of pack aged 
food is varyin g 
a 
lot from the con ventional 
assumption . 
Therefore, their sur­
face area should b e
 normalised
 before
 comparin g
 testing
 
results with mig ration
 limits. These rules should b e
 
reviewed when  
new 
data on 
food pack aging 
uses become 
available.(1)
(2)(3)L 12/6 EN Official Journ alof the EuropeanUnion 15.1.2011
(35) The specific mig ration limit is a maximum permitted 
amount 
of a substance 
in 
food. This limit should en sure 
that 
the food con tact 
material does n ot 
pose a risk  
to 
health. It 
should be 
ensured 
by 
the manufacturer 
that 
materials an d
 articles n ot
 yet in con tact
 with food will 
respect these limits when  
brought 
into 
contact 
with food 
under 
the worst foreseeab le 
contact 
conditions. 
Therefore 
compliance 
of materials an d 
articles not 
yet in con tact 
with 
food should b e 
assessed an d 
the rules for this testin g 
should 
be 
set out.
(36) Food is a complex matrix an d therefore the an alysis of 
migrating 
substances 
in 
food may pose an alytical 
difficul­
ties. Therefore test media should b e 
assigned 
that simulate 
the transfer
 of substances
 from the plastic material in to
 
food. They should represen t
 the major physico-chemical 
properties exhib ited 
by 
food. When  
using 
food simulan ts 
standard
 testing
 time and
 temperature should reproduce, 
as far as possib le, 
the migration 
which may occur from the 
article into 
the food.
(37) For determin ing the appropriate food simulan t for certain  
foods 
the chemical composition  
and 
the physical proper­
ties of the food should b e 
taken 
into 
account. 
Research 
results are availab le 
for certain  
representative 
foods com­
paring 
migration 
into 
food with mig ration 
into 
food simu­
lants. 
On 
the basis 
of the results, food simulan ts 
should be 
assigned. 
In 
particular, for fat con taining 
foods the result 
obtained
 with food simulan t
 may in certain cases signifi­
cantly
 overestimate mig ration
 into
 food. In
 these cases it 
should be 
foreseen 
that the result in  
food simulan t 
is cor­
rected by 
a reduction  
factor.
(38) The exposure to sub stances migrating from food con tact 
materials 
was based 
on 
the conventional 
assumption  
that 
a person 
consumes 
daily 1 kg 
of food. However, a person  
ingests 
at most 200 g  
of fat on 
a daily basis. 
For lipophilic 
substances 
that only 
migrate 
into 
fat this should b e 
taken 
into
 consideration.
 Therefore a correction of the specific 
migration
 by
 a correction factor applicab le
 to lipophilic 
substances 
in 
accordance 
with the opin ion 
of the Scien tific 
Committee
 on Food (SCF)
(1) SCF opinion of 4 Decemb er 2002 on the introduction of a Fat (Con ­
sumption ) 
Reduction  
Factor (FRF) in  
the estimation  
of the exposure to
a migrant 
from food con tact 
materials.
http://ec.europa.eu/food/fs/sc/scf/out149_en .pdf and the opin ion  of the 
Authority
(2) Opinion  of the Scien tific  Panel  on Food Additives, Flavourin gs,  Pro­
cessing
 Aids and
 Materials in Con tact
 with Food (AFC) on a request
from the Commission  
related to the in troduction 
of a Fat (con sump­
t
ion) Reduction Factor for in fants
 and
 children,
 The EFSA
 Journal
(2004) 
103, 1-8. should be foreseen.
(39) Official con trol should estab lish testing strategies which 
allow
 the enforcement
 authorities to perform con trols
 efficiently
 making
 best
 use of availab le
 resources. There­
fore it should b e 
admissible 
to use screen ing 
methods for 
checking
 complian ce
 under
 certain con ditions.
 Non-
compliance 
of a material or article should b e 
confirmed 
by 
a 
verification  
method.
(40) Basic rules on mig ration testing should b e set out in this 
Regulation.
 As migration
 testing
 is a very complex issue, 
these basic
 rules can ,
 however, n ot
 cover all foreseeab le
 
cases and 
details necessary 
for performin g 
the testin g. 
Therefore 
a EU 
guidance 
document 
should be 
established, 
dealing 
with more detailed aspects of the implemen tation 
of 
the basic 
migration 
testing 
rules.
(41) The updated rules on food simulan ts and migration test­
ing
 provided b y
 this Regulation
 will supersede those in 
Directive 78/142/E EC 
and 
the Annex 
to Council 
Directive 
82/711/EEC
 of 18 Octob er
 1982 laying
 down the b asic
 
rules necessary 
for testing 
migration 
of the con stituents 
of 
plastic materials an d
 articles in tended
 to come in to
 con­
tact with foodstuffs
(3) OJ L 297, 23.10.1982, p. 26..
(42) Substances present in the plastic b ut not listed in Annex I 
to 
this Regulation 
have not 
necessarily 
been 
risk 
assessed 
as they had n ot 
been 
subject 
to an 
authorisation  
procedure. 
Complian ce
 with Article  3 of Reg ulation
 (EC)
 
No 1935/2004 for these sub stances 
should be 
assessed b y 
the 
relevant 
business 
operator in  
accordance 
with interna­
tionally 
recognised 
scientific 
principles 
taking 
into 
account 
exposure 
from food con tact 
materials an d 
other sources.
(43) Recently additional monomers, other startin g substances 
and 
additives have received a favourab le 
scientific 
evalua­
tion 
by 
the Authority an d 
should now 
be 
added to the 
Union 
list.
(44) As new substances are added to the Un ion list the Reg ula­
tion 
should apply as soon  
as possible 
to allow for man u­
facturers
 to adapt to techn ical
 progress
 and
 allow for 
innovation.
(45) Certain migration testing rules should b e updated in  view 
of 
new 
scientific 
knowledge. 
Enforcement 
authorities an d 
industry 
need 
to adapt their curren t 
testing 
regime 
to these 
updated rules. To allow for this adaptation  
it seems appro­
priate that the updated rules on ly
 apply 2 years after the 
adoption 
of the Reg ulation.(1)
(2)
(3)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/7
(46) Business operators are curren tly basing their declaration  of 
compliance
 on supportin g
 documen tation
 following
 the 
requiremen ts 
set out in 
Directive 2002/72/E C. 
Declaration  
of 
compliance 
need, 
in 
principle, 
only 
to be 
updated when  
substantial 
changes 
in 
the production  
bring 
about 
changes 
in 
the migration 
or when 
new 
scientific 
data are availab le. 
In 
order to limit the b urden 
to business 
operators, materi­
als which have b een 
lawfully placed on  
the market 
based 
on
 the requiremen ts
 set out in Directive 2002/72/E C
 
should be 
able 
to be 
placed on  
the market 
with a declara­
tion 
of complian ce 
based 
on 
supportin g 
documentation 
in 
accordance 
with Directive 2002/72/E C 
until 
5 years after 
the adoption  
of the Reg ulation.
(47) Analytical methods for testin g migration and residual con ­
tent 
of vinyl 
chloride mon omer 
as describ ed 
in 
Commis­
sion 
Directives 80/766/E EC 
of 8 July 1980 layin g 
down 
the 
Community 
method of an alysis 
for the official con trol 
of
 the vinyl
 chloride mon omer
 level in materials an d
 
articles which are in tended 
to come in to 
contact 
with 
foodstuffs
(1) OJ L 213, 16.8.1980, p. 42. and 81/432/E EC  of 29 April 1981  laying  
down the Commun ity
 method of an alysis
 for the official 
control 
of vinyl 
chloride released b y 
materials an d 
articles 
into 
foodstuffs
(2) OJ L 167, 24.6.1981, p. 6. are outdated. An alytical methods should 
comply with the criteria set out in  
Article 11 of Reg ulation 
(EC) 
No 882/2004
(3) OJ L 165, 30.4.2004, p. 1. of the European Parliamen t and of 
the Council 
on 
official con trols 
performed to en sure 
the 
verification  
of complian ce 
with feed an d 
food law, an imal 
health
 and
 animal
 welfare rules. Therefore Directives 
80/766/EEC 
and 
81/432/EEC 
should be 
repealed.
(48) The measures provided for in  this Regulation are in accor­
dance 
with the opin ion 
of the Stan ding 
Committee on  
the 
Food Chain  
and 
Animal 
Health,
HAS ADOPTE D THIS REGULATION:
CHAPTER 
I
GENERAL PROVISIONS
Article 1
Subject 
matter
1. This Regulation 
is a specific measure within  
the meaning 
of 
Article 5 of Reg ulation 
(EC) 
No 1935/2004.
2. This Regulation 
establishes 
specific requiremen ts 
for the 
manufacture 
and 
marketing 
of plastic materials an d 
articles: 
(a) intended 
to come in to 
contact 
with food; or(b) already 
in 
contact 
with food; or
(c) which can  
reasonably 
be 
expected to come in to 
contact 
with 
food.
Article 2
Scope
1. This Regulation 
shall apply to materials an d 
articles which 
are placed on the E U
 market
 and
 fall under
 the followin g
 
categories: 
(a) materials 
and 
articles an d 
parts thereof con sisting 
exclusively 
of plastics;
(b) plastic 
multi-layer materials an d 
articles held tog ether 
by 
adhesives 
or by 
other mean s;
(c)
 materials an d
 articles referred to in poin t
s a) or b)
 that are 
printed 
and/or 
covered b y 
a coating;
(d) plastic 
layers or plastic coatin gs, 
forming 
gaskets 
in 
caps and 
closures, 
that together 
with those caps an d 
closures compose 
a set of two or more layers of differen t 
types of materials;
(e) plastic layers in multi-material multi-layer materials an d
 
articles.
2. This Regulation
 shall not
 apply to the followin g
 materials 
and 
articles which are placed on  
the EU 
market 
and 
are intended 
to 
be 
covered b y 
other specific measures: 
(a) ion 
exchange 
resins;
(b) rubber;
(c) silicones.
3.
 This Regulation
 shall be
 without prejudice to the E U
 or 
national provision s applicab le to printing inks, adhesives or 
coatings.
Article 
3
Definitions
For 
the purpose of this Reg ulation, 
the followin g 
definitions 
shall 
apply:
(1) ‘plastic materials an d 
articles’ mean s:
(a) materials 
and 
articles referred to in  
points 
(a), (b) 
and 
(c) 
of Article 2(1); an d
(b) plastic 
layers referred to in  
Article 2(1)(d) an d 
(e);L 12/8 EN Official Journ alof the EuropeanUnion 15.1.2011
(2) ‘plastic’ means  polymer to which additives or other sub­
stances 
may have b een 
added, which is capab le 
of function­
ing 
as a main  
structural compon ent 
of final 
materials an d 
articles;
(3)
 ‘polymer’ means
 any
 macromolecular sub stance
 obtained
 
by:
(a) a 
polymerisation  
process such as polyaddition  
or poly­
condensation, 
or by 
any 
other similar process of mon o­
mers 
and 
other startin g 
substances; 
or
(b)
 chemical modification of n atural
 or synthetic
 macro­
molecules; or
(c) microbial 
fermentation;
(4) ‘
plastic multi-layer’ mean s 
a material or article composed of 
two or more layers of plastic;
(5) ‘multi-material multi-layer’ mean s 
a material or article com­
posed of two or more layers of differen t 
types of materials, 
at least on e 
of them a plastic layer;
(6) ‘monomer 
or other startin g 
substance
’ means:
(a) a 
substance 
undergoing 
any 
type of polymerisation  
pro­
cess to man ufacture 
polymers; or
(b)
 a natural
 or synthetic
 macromolecular sub stance
 used 
in 
the manufacture 
of modified macromolecules; or
(c) a substance 
used to modify existin g 
natural 
or synthetic 
macromolecules;
(7) ‘
additive’ mean s 
a substance 
which is in tentionally 
added to 
plastics to achieve a physical or chemical effect durin g 
pro­
cessing 
of the plastic or in  
the final 
material or article; it is 
intended 
to be 
present 
in 
the final 
material or article;
(8) ‘polymer production  
aid’ mean s 
any 
substance 
used to pro­
vide a suitab le 
medium for polymer or plastic man ufactur­
ing; 
it may be 
present 
but 
is neither 
intended 
to be 
present 
in 
the final 
materials or articles n or 
has a physical or chemi­
cal effect in  
the final 
material or article;
(9) ‘non-intentionally
 added sub stance
’ means
 an impurity in 
the substances 
used or a reaction  
intermediate 
formed dur­
ing 
the production  
process or a decomposition  
or reaction  
product;(10)  ‘aid to polymerisation ’ means  a substance  which in itiates  
polymerisation  
and/or 
controls 
the formation  
of the macro­
molecular structure;
(11) ‘overall mig ration 
limit’ (OML) mean s 
the maximum permit­
ted amoun t 
of non-volatile 
substances 
released from a mate­
rial or article in to 
food simulan ts;
(12)
 ‘food simulan t
’ means
 a test medium imitatin g
 food; in its 
behaviour 
the food simulan t 
mimics mig ration 
from food 
contact 
materials;
(13) ‘specific mig ration 
limit’ (SML) mean s 
the maximum permit­
ted amoun t 
of a given 
substance 
released from a material or 
article into 
food or food simulan ts;
(14) ‘
total specific mig ration 
limit’ (SML(T)) mean s 
the maximum
permitted sum of particular sub stances
 released in food or
food simulan ts 
expressed as total of moiety of the sub stances
indicated;
(15) ‘
functional 
barrier
’ means 
a barrier 
consisting 
of one 
or more
layers of an y
 type of material which en sures
 that the fin al
material 
or article complies with Article 3 of Reg ulation
 (EC)
No 
1935/2004 an d 
with the provision s 
of this Reg ulation;
(16) ‘
non-fatty 
food’ mean s 
a food for which in  
migration 
testing
only 
food simulan ts 
other than  
food simulan t
s D1 or D2 are
laid down  
in 
Table 
2 of Annex 
V to this Reg ulation;
(17) ‘
restriction ’ means 
limitation  
of use of a sub stance 
or migra­
tion 
limit or limit of con tent 
of the sub stance 
in 
the material
or article;
(18) ‘specification ’ means 
composition  
of a substance, 
purity cri­
teria for a sub stance,
 physico-chemical characteristics of a
substance, 
details con cerning 
the manufacturing 
process of
a substance
 or further in formation
 concerning
 the expres­
sion 
of migration 
limits.
Article 4
Placing on the market of plastic materials and articles
Plastic materials an d 
articles may on ly 
be 
placed on  
the market 
if
they:
(a) comply with the relevan t 
requiremen ts 
set out in 
Article 3 of
Regulation 
(EC) 
No 1935/2004 un der 
intended 
and 
foresee­
able 
use; and
(b) comply 
with the lab elling 
requiremen ts 
set out in 
Article 15
of Regulation 
(EC) 
No 1935/2004; an d(1)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/9
(c) comply with the traceab ility  requiremen ts  set out in
Article 17 of Reg ulation 
(EC) 
No 1935/2004; an d
(d) are 
manufactured 
according 
to good 
manufacturing 
practice
as set out in  
Commission  
Regulation 
(EC) 
No 2023/2006
(1) OJ L 384, 29.12.2006, p. 75.;
and
(e) comply 
with the composition al 
and 
declaration  
requiremen ts
set 
out in 
Chapters I I, 
III 
and 
IV 
of this Reg ulation.
CHAPTER II
COMPOSITIONAL 
REQUIREMENTS
SECTION 1
Authorised substances
Article 5
Union list of au thorised 
substances
1. Only 
the substances 
included 
in 
the Union 
list of authorised
substances
 (hereinafter
 referred to as the Union list) set out in
Annex 
I 
may be 
intentionally 
used in 
the manufacture 
of plastic
layers in 
plastic materials an d 
articles.
2. The Union 
list shall con tain: 
(a) monomers 
or other startin g 
substances;
(b) additives 
excluding 
colorants;
(c) polymer 
production  
aids excludin g 
solvents;
(d) macromolecules 
obtained 
from microb ial 
fermentation.
3. The 
Union 
list may be 
amended 
in 
accordance 
with the pro­
cedure estab lished
 by
 Articles  8 to  12 of Reg ulation
 (EC)
No 
1935/2004.
Article 6
Derogations 
for substances 
not inclu ded 
in the Union list
1. By way of derog ation 
from Article 5, sub stances 
other than
those included 
in 
the Union 
list may b e 
used as polymer produc­
tion 
aids in 
the manufacture 
of plastic layers in  
plastic materials
and 
articles sub ject 
to national 
law.
2. By way of derog ation 
from Article 5, coloran ts 
and 
solvents
may 
be 
used in 
the manufacture 
of plastic layers in  
plastic mate­
rials and 
articles sub ject 
to national 
law.3. The followin g 
substances 
not 
included 
in 
the Union 
list are
authorised sub ject 
to the rules set out in  
Articles 8, 9, 10, 11
and 
12: 
(a) salts (including
 double
 salts and
 acid salts) of alumin ium,
ammonium,
 barium,
 calcium, cob alt,
 copper, iron ,
 lithium,
magnesium,
 manganese,
 potassium, sodium, an d
 zinc
 of
authorised acids, phen ols 
or alcohols;
(b) mixtures 
obtained 
by 
mixing 
authorised sub stances 
without
a chemical reaction  
of the compon ents;
(c) when 
used as additives, n atural 
or synthetic 
polymeric sub ­
stances 
of a molecular weig ht 
of at least 1 000 Da, except
macromolecules ob tained
 from microb ial
 fermentation,
complying 
with the requiremen ts 
of this Reg ulation, 
if they
are capable 
of functioning 
as the main  
structural compon ent
of final materials or articles;
(d) when 
used as mon omer 
or other startin g 
substance, 
pre-
polymers an d
 natural
 or synthetic
 macromolecular sub­
stances,
 as well as their mixtures, except macromolecules
obtained
 from microb ial
 fermentation,
 if the mon omers
 or
starting 
substances 
required to syn thesise 
them are in cluded
in 
the Union 
list.
4. The followin g 
substances 
not 
included 
in 
the Uni
on list may
be 
present 
in 
the plastic layers of plastic materials or articles: 
(a) non-intentionally 
added sub stances;
(b) aids 
to polymerisation .
5. By 
derogation 
from Article 5, additives n ot 
included 
in 
the
Union 
list may con tinue 
to be 
used subject 
to national 
law after
1 January
 2010 until
 a decision is tak en
 to include
 or not
 to
include 
them in 
the Union 
list provided they are in cluded 
in 
the
provisional 
list referred to in  
Article 7.
Article 7
Establishment and management of the provisional list
1. The provision al 
list of additives that are un de
r evaluation  
by
the 
European 
Food Safety Authority (herein after 
referred to as the
Authority) that was made pub lic
 by
 the Commission in 2008
shall be 
regularly 
updated.
2. An 
additive shall b e 
removed from the provision al 
list: 
(a) when 
it is included 
in 
the Union 
list set out in  
Annex 
I; 
or
(b) when 
a decision  
is taken 
by 
the Commission  
not 
to include
it 
in 
the Union 
list; or
(c) if during 
the examin ation 
of the data, the Authority calls for
supplemen tary 
information 
and 
that information 
is not 
sub­
mitted 
within 
the time limits specified b y 
the Authority.(1) (2)L 12/10 EN Official Journ alof the EuropeanUnion 15.1.2011
SECTION 2
General requirements, restrictions and specifications
Article 8
General requ irement 
on substances
Substances 
used in 
the manufacture 
of plastic layers in  
plastic
materials an d 
articles shall b e 
of a techn ical 
quality an d 
a purity
suitable 
for the in tended 
and 
foreseeable 
use of the materials or
articles. The composition  
shall be 
known 
to the man ufacturer 
of
the substance 
and 
made availab le 
to the competen t 
authorities on
request.
Article 9
Specific requ irements 
on substances
1. Substances 
used in 
the manufacture 
of plastic layers in  
plas­
tic materials an d 
articles shall b e 
subject 
to the followin g 
restric­
tions 
and 
specification s: 
(a) the 
specific mig ration 
limit set out in  
Article 11;
(b) the 
overall mig ration 
limit set out in  
Article 12;
(c) the restriction s
 and
 specification s
 set out in column 10 of
Table 
1 of point 
1 of Annex 
I;
(d) the 
detailed specification s 
set out in 
point 
4 of Annex 
I.
2. Substances 
in 
nanoform 
shall only 
be 
used if explicitly
authorised an d 
mentioned 
in 
the specification s 
in 
Annex 
I.
Article 
10
General restrictions on plastic materials and articles
General 
restriction s 
related to plastic materials an d 
articles are laid
down 
in 
Annex 
II.
Article 
11
Specific migration limits
1. Plastic materials an d 
articles shall n ot 
transfer their con stitu­
ents 
to foods in  
quantities 
exceeding 
the specific mig ration 
limits
(SML) set out in  
Annex 
I. 
Those specific mig ra
tion 
limits (SML) are
expressed in  
mg 
of substance 
per kg 
of food (mg /kg).
2. For 
substances 
for which n o 
specific mig ration 
limit or
other restriction s 
are provided in  
Annex 
I, 
a generic 
specific
migration 
limit of 60 mg /kg 
shall apply.3. By derogation 
from parag raphs 
1 and 
2, additives which are
also authorised as food additives b y
 Regulation
 (EC)
No   1333/2008 or as flavourin gs  by  Regulation  (EC)
No 
1334/2008 shall n ot 
migrate 
into 
foods in 
quantities 
having
a 
technical 
effect in 
the final 
foods and 
shall not: 
(a)
 exceed the restriction s
 provided for in Reg ulation
 (EC)
No
 1333/2008 or in Reg ulation
 (EC)
 No 1334/2008 or in
Annex
 I to this Reg ulation
 for foods for which their use is
authorised as food additive or flavourin g 
substances; 
or
(b) exceed 
the restriction s 
set out in 
Annex 
I 
to this Reg ulation
in 
foods for which their use is n ot 
authorised as food addi­
tive or flavourin g 
substances.
Article 
12
Overall migration limit
1. Plastic materials an d 
articles shall n ot 
transfer their con stitu­
ents
 to food simulan ts
 in quantities
 exceeding
 10 millig rams
 of
total con stituents
 released per dm2 of food con tact surface
(mg/dm2).
2. By derog ation
 from parag raph
  1, plastic materials an d
articles
 intended
 to be
 brought
 into
 contact
 with food in tended
for 
infants 
and 
young 
children, 
as defined 
by 
Commission  
Direc­
tives 2006/141/E C
(1) OJ L 401, 30.12.2006, p. 1. and 2006/125/E C
(2) OJ L 339, 6.12.2006, p. 16., shall not transfer
their
 constituents
 to food simulan ts
 in quan tities
 exceedin g
60
 milligrams
 of total of con stituents
 released per k g
 of food
simulant.
CHAPTER III
SPECIFIC 
PROVISIONS F OR 
CERTAIN MATERIALS AND
ARTICLES
Article 13
Plastic mu lti-layer 
materials and articles
1. In 
a plastic multi-layer material or article, the composition
of each plastic layer shall comply with this Reg ulation.
2. By 
derogation 
from parag raph 
1, a plastic layer which is n ot
in
 direct con tact
 with food an d
 is separated from the food b y
 a
functional 
barrier, 
may: 
(a) not 
comply with the restriction s 
and 
specification s 
set out in
this Regulation
 except for vin yl
 chloride mon omer
 as pro­
vided in 
Annex 
I; 
and/or
(b) be 
manufactured 
with substances 
not 
listed in 
the Union 
list
or in 
the provision al 
list.(1)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/11
3. The migration of the sub stances under paragraph  2(b) into
food 
or food simulan t 
shall not 
be 
detectable 
measured with sta­
tistical certain ty 
by 
a method of an alysis 
set out in 
Article 11 of
Regulation
 (EC)
 No  882/2004 with a limit of detection of
0,01 mg/kg. 
That limit shall always b e 
expressed as con centration
in 
foods or food simulan ts. 
That limit shall apply to a g roup 
of
compoun ds, 
if they are structurally an d 
toxicologically 
related, in
particular isomers or compoun ds
 with the same relevan t
 func
­
tional 
group, 
and 
shall include 
possible 
set-off tran sfer.
4. The 
substances 
not 
listed in 
the Union 
list or provision al 
list
referred to in  
paragraph 
2(b) 
shall not 
belong 
to either of the fol­
lowing 
categories: 
(a) substances 
classified as ‘mutagenic
’, ‘carcinogenic
’ or ‘toxic to
reproduction ’ in 
accordance 
with the criteria set out in  
sec­
tions
  3.5, 3.6. an d
  3.7 of An nex
  I to Reg ulation
 (EC)
No
  1272/2008 of the E uropean
 Parliamen t
 and
 the
Council
(1) OJ L 353, 31.12.2008, p. 1.;
(b) substances 
in 
nanoform.
5. The 
final 
plastic multi-layer material or article shall comply
with the specific mig ration 
limits set out in  
Article 11 an d 
the
overall mig ration 
limit set out in  
Article 12 of this Reg ulation.
Article 
14
Multi-material 
multi-layer 
materials and articles
1. In 
a multi-material multi-layer material or article, the com­
position 
of each plastic layer shall comply with this Reg ulation.
2. By 
derogation 
from parag raph 
1, in 
a multi-material multi-
layer material or article a plastic layer which is n ot 
in 
direct con ­
tact 
with food an d 
is separated from the food b y 
a functional
barrier, 
may be 
manufactured 
with substances 
not 
listed in 
the
Union 
list or the provision al 
list.
3. The substances 
not 
listed in 
the Union 
list or provision al 
list
referred to in parag raph
 2 shall n ot
 belo
ng
 to either of the fol­
lowing 
categories: 
(a) substances 
classified as ‘mutagenic
’, ‘carcinogenic
’ or ‘toxic to
reproduction ’ in 
accordance 
with the criteria set out in  
sec­
tions
  3.5, 3.6. an d
  3.7 of An nex
  I to Reg ulation
 (EC)
No 
1272/2008;
(b) substances 
in 
nanoform.4. By 
derogation 
from parag raph 
1, Articles 11 an d 
12 of this
Regulation 
do not 
apply to plastic layers in  
multi-material multi-
layer materials an d 
articles.
5. The plastic layers in  
a multi-material multi-layer material or
article shall always comply with the restriction s 
for vinyl 
chloride
monomer 
laid down  
in 
Annex 
I 
to this Reg ulation.
6.
 In
 a multi-material multi-layer material or article, specific
and
 overall mig ration
 limits for plastic layers an d
 for the fin al
material 
or article may b e 
established 
by 
national 
law.
CHAPTER IV
DECLARATION 
OF 
COMPLIANCE AND  
DOCUMENTATION
Article 15
Declaration 
of compliance
1. At the mark eting 
stages 
other than  
at the retail stag e, 
a writ­
ten 
declaration  
in 
accordance 
with Article 16 of Reg ulation 
(EC)
No 
1935/2004 shall b e 
available 
for plastic materials an d 
articles,
products from in termediate 
stages 
of their man ufacturing 
as well
as for the sub stances
 intended
 for the man ufacturing
 of those
materials an d 
articles.
2. The written  
declaration  
referred to in  
paragraph 
1 shall be
issued 
by 
the business 
operator an d 
shall contain 
the information
laid 
down 
in 
Annex 
IV.
3. The 
written 
declaration  
shall permit an  
easy identification 
of
the materials, articles or products from intermediate stag es
 of
manufacture 
or substances 
for which it is issued. I t 
shall be
renewed 
when 
substantial 
changes 
in 
the composition  
or produc­
tion 
occur that b ring 
about 
changes 
in 
the migration 
from the
materials or articles or when n ew
 scientific
 data becomes
available.
Article 
16
Supporting 
documents
1. Appropriate 
documentation 
to demon strate 
that the mate­
rials and
 articles, products from in termediate
 stages
 of their
manufacturing 
as well as the sub stances 
intended 
for the man u­
facturing 
of those materials an d 
articles comply with the require­
ments 
of this Reg ulation 
shall be 
made availab le 
by 
the business
operator 
to the national 
competen t 
authorities on  
request.
2. That documen tation 
shall contain 
the conditions 
and 
results
of testing,
 calculation s,
 including
 modellin g,
 other ana
lysis, and
evidence
 on the safety or reason ing
 demonstrating
 complian ce.
Rules 
for experimen tal 
demonstration 
of complian ce 
are set out
in 
Chapter V.L 12/12 EN Official Journ alof the EuropeanUnion 15.1.2011
CHAPTER V
COMPLIANCE
Article 17
Expression of migration test resu lts
1. To 
check 
the complian ce, 
the specific mig ration 
values shall
be 
expressed in  
mg/kg 
applying 
the real surface to volume ratio
in 
actual or foreseen  
use.
2. By derogation 
from parag raph 
1 for: 
(a) containers 
and 
other articles, con taining 
or intended 
to con­
tain, 
less than 
500 millilitres or g rams 
or more than  
10 litres,
(b) materials 
and 
articles for which, due to their form it is
impracticab le
 to estimate the relation ship
 between
 the sur­
face area of such materials or articles an d 
the quantity 
of food
in 
contact 
therewith,
(c) sheets and 
films that are n ot 
yet in 
contact 
with food,
(d) sheets and 
films containing 
less than 
500 millilitres or g rams
or 
more than  
10 litres,
the value of mig ration 
shall be 
expressed in  
mg/kg 
applying 
a sur­
face to volume ratio of 6 dm2 per kg of food.
This parag raph
 does not
 apply to plastic materials an d
 articles
intended 
to be 
brought 
into 
contact 
with or already in  
contact
with 
food for in fants 
and 
young 
children, 
as defined 
by 
Directives
2006/141/E C 
and 
2006/125/E C.
3. By 
derogation 
from parag raph 
1, for caps, g askets, 
stoppers
and
 similar sealin g
 articles the specific migration value shall b e
expressed 
in: 
(a) mg/kg 
using 
the actual con tent 
of the con tainer 
for which the
closure is in tended 
or in 
mg/dm2 applying the total con tact
surface 
of sealing 
article and 
sealed con tainer 
if the intended
use 
of the article is k nown, 
while taking 
into 
account 
the pro­
visions 
of paragraph 
2;
(b) mg/article 
if the intended 
use of the article is un known.
4.
 For caps, g askets,
 stoppers an d
 similar sealin g
 articles the
overall mig ration 
value shall b e 
expressed in : 
(a) mg/dm2 applying the total con tact surface of sealin g article
and 
sealed con tainer 
if the intended 
use of the article is
known;
(b) mg/article 
if the intended 
use of the article is un known.Article 
18
Rules 
for assessing compliance with migration limits
1. For materials an d 
articles already in  
contact 
with food veri­
fication 
of complian ce 
with specific mig ration 
limits shall b e 
car­
ried out in accordan ce
 with the rules set out in Chapter 1 of
Annex 
V.
2. For materials an d 
articles not 
yet in 
contact 
with food veri­
fication 
of complian ce 
with specific mig ration 
limits shall b e 
car­
ried out in food or in food simulan ts
 set out in An nex
 III
 in
accordance
 with the rules set out in Chapter 2, Section 2.1 of
Annex 
V.
3. For materials an d 
articles not 
yet in 
contact 
with food
screening 
of complian ce 
with the specific mig ration 
limit can 
be
performed 
applying 
screening 
approaches in  
accordance 
with the
rules set out in  
Chapter 2, Section  
2.2 of Annex 
V. If 
a material or
article fails to comply with the mig ration 
limits in 
the screen ing
approach 
a conclusion 
of non-compliance 
has to be 
confirmed 
by
verification  
of complian ce 
in 
accordance 
with parag raph 
2.
4. For materials an d 
articles not 
yet in 
contact 
with food veri­
fication of complian ce
 with the overall mig ration
 limit shall b e
carried 
out in 
food simulan ts 
A, B, C, D1 an d 
D2 as set out in
Annex 
III 
in 
accordance 
with the rules set out in  
Chapter 3, Sec­
tion 
3.1 of An nex 
V.
5. For materials an d 
articles not 
yet in 
contact 
with food
screening 
of complian ce 
with the overall mig ration 
limit can 
be
performed 
applying 
screening 
approaches in  
accordance 
with the
rules set out in  
Chapter 3, Section  
3.4 of Annex 
V. If 
a material or
article fails to comply with the mig ration
 limit in the screen ing
approach 
a conclusion 
of non-compliance 
has to be 
confirmed 
by
verification  
of complian ce 
in 
accordance 
with parag raph 
4.
6. The results of specific mig ration
 testing
 obtained
 in food
shall prevail over the results ob tained 
in 
food simulan t. 
The results
of specific mig ration 
testing 
obtained 
in 
food simulan t 
shall pre­
vail over the results ob tained 
by 
screening 
approaches.
7. Before comparin g 
specific an d 
overall mig ration 
test results
with the mig ration
 limits the correction factors in Chapter 4 of
Annex 
V shall be 
applied in  
accordance 
with the rules set out
therein.
Article 
19
Assessment of su bstances 
not inclu ded 
in the Union list
Complian ce 
with Article 3 of Reg ulation 
(EC) 
No 1935/2004 of
substances 
referred to in  
Articles 6(1), 6(2), 6(4), 6(5) an d 
14(2)
of this Reg ulation 
which are n ot 
covered b y 
an 
inclusion 
in
Annex
 I to this Reg ulation
 shall be
 assessed in accordan ce
 with
internationally 
recognised 
scientific 
principles 
on 
risk 
assessmen t.(1)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/13
CHAPTER VI
FINAL 
PROVISIONS
Article 20
Amendments of EU acts
The Annex 
to Council 
Directive 85/572/E EC
(1) OJ L 372, 31.12.1985, p. 14. is replaced b y the 
following:
‘
The food simulan ts 
to be 
used for testin g 
migration 
of constitu­
ents 
of plastic materials an d 
articles in tended 
to come in to 
con­
tact 
with a sin gle 
food or specific g roups 
of foods are set out
in point
  3 of An nex
  III
 to Commission Reg ulation
 (EU)
No 
10/2011.’
Article 21
Repeal of EU acts
Directives 80/766/E EC, 
81/432/EEC, 
and 
2002/72/E C 
are hereby 
repealed 
with effect from 1 May 2011.
References 
to the repealed Directives shall b e 
construed 
as refer­
ences 
to this Reg ulation 
and 
shall be 
read in 
accordance 
with the 
correlation  
tables 
in 
Annex 
VI.
Article 
22
Transitional provisions
1. Until
 31  Decemb er
 2012 the supportin g
 documen ts
 
referred to in  
Article 16 shall b e 
based 
on 
the basic 
rules for over­
all and 
specific mig ration 
testing 
set out in  
the Annex 
to Direc­
tive 82/711/E EC.2. As 
from 1 January 
2013 the supportin g 
documents 
referred 
to in Article 16 for materials, articles an d
 substances
 placed on 
the market 
until 31 
December 
2015, may b e 
based 
on:
(a) the 
rules for mig ration 
testing 
set out in  
Article 18 of this 
Regulation; 
or
(b)
 the basic
 rules for overall an d
 specific mig ration
 testing
 set 
out in 
the Annex 
to Directive 82/711/E EC.
3. As from 1 January 2016, the supportin g documents referred 
to in 
Article 16 shall b e 
based 
on 
the rules for mig ration 
testing 
set
 out in Article 18, without prejudice to parag raph
 2 of this 
Article.
4. Until 31 
December 
2015 additives used in  
glass 
fibre 
sizing 
for 
glass 
fibre 
reinforced 
plastics which are n ot 
listed in 
Annex 
I 
have
 to comply with the risk assessmen t
 provision s
 set out in 
Article 19.5. Materials an
d 
articles that have b een 
lawfully placed on  
the 
market 
before 1 
May 2011 may b e 
placed on  
the market 
until
31 
December 
2012.
Article 23
Entry into force and application
This Regulation 
shall enter 
into 
force on 
the 20th day followin g 
its 
publication 
in 
the Official Journal of the European Union.
It 
shall apply from 1 May 2011.
The provision  
of Article 5 as reg ards 
the use of additives, others 
than 
plasticisers, shall apply for plastic layers or plastic coatin gs 
in
 caps an d
 closures referred to in Article  2(1)(d), as from
31 Decemb er 
2015.
The provision  
of Article 5 as reg ards 
the use of additives used in  
glass
 fibre
 sizing
 for glass
 fibre
 reinforced
 plastics, shall apply 
from 31 Decemb er 
2015.
The provision s 
of Articles 18(2), 18(4) an d 
20 shall apply from
31 Decemb er 
2012.
This Regulation 
shall be 
binding 
in 
its entirety 
and 
directly applicab le 
in 
the Memb er 
States in 
accordance 
with the Treaties.
Done 
at Brussels, 14 Jan uary 
2011.
For the Commission
The President
José Manuel BARROSOL 12/14 EN Official Journ alof the EuropeanUnion 15.1.2011
ANNEX I
Substances
1.
 Union list of au thorised 
monomers, other starting su bstances, 
macromolecu les 
obtained from microbial fer­
mentation, additives and polymer produ ction 
aids
Table 
1 contains 
the followin g 
information:
Column 
1 (FCM sub stance 
No): the un ique 
identification 
number 
of the sub st
ance
Column 
2 (Ref. No): the E EC 
packaging 
material referen ce 
number
Column 
3 (CAS No): the Chemical Ab stracts 
Service (CAS) reg istry 
number
Column 
4 (Substance 
Name): the chemical n ame
Column 
5 (Use as additive or polymer production  
aid (PPA) (yes/n o)): 
an 
ind
ication 
if the substance 
is authorised to b e 
used 
as additive or polymer production  
aid (yes) or if the sub stance 
is not 
authorised to b e 
used as additive or polymer 
production  
aid (no). 
If 
the substance 
is only 
authorised as PPA it is in dica
ted (yes) an d 
in 
the specification s 
the use is 
restricted to PPA.
Column 6 (Use as mon omer
 or other startin g
 substance
 or macromolecule ob ta
ined
 from microb ial
 fermentation
 
(yes/no)): 
an 
indication 
if the substance 
is authorised to b e 
used as mon om
er or other startin g 
substance 
or macromol­
ecule obtained 
from microb ial 
fermentation 
(yes) or if the sub stance 
is no
t authorised to b e 
used as mon omer 
or other 
starting 
substance 
or macromolecule ob tained 
from microb ial 
fermentati
on 
(no). 
If 
the substance 
is authorised as mac­
romolecule ob tained 
from microb ial 
fermentation 
it is indicated 
(yes) and in  
the specification s 
it is indicated 
that the 
substance 
is a macromolecule ob tained 
from microb ial 
fermentation.
Column 
7 (FRF applicab le 
(yes/no)): 
an 
indication 
if for the sub stance 
the migration 
results can  
be 
corrected b y 
the Fat 
Consumption 
Reduction  
Factor (FRF) (yes) or if they can not 
be 
corrected b y 
the FRF (n o).
Column 
8 (SML [mg /kg]): 
the specific mig ration 
limit applicab le 
for the sub stance. 
It 
is expressed in  
mg 
substance 
per 
kg 
food. It 
is indicated 
ND if the sub stance 
shall not 
migrate 
in 
detectable 
quantities.
Column 
9 (SML(T) [mg /kg] 
(group 
restriction  
No)): contains 
the identific
ation 
number 
of the group 
of substances 
for 
which the g roup 
restriction  
in 
Column 
1 in 
Table 
2 of this An nex 
applies.
Column 
10 (Restriction s 
and 
specification s): 
contains 
other restriction s
 than 
the specific mig ration 
limit specifically men ­
tioned
 and
 it contains
 specification s
 related to the sub stance.
 In
 case detailed specifications are set out a referen ce
 to 
Table 
4 is included.
Column 
11 (Notes on  
verification  
of complian ce): 
contains 
the Notes n umbe
r which refers to the detailed rules appli­
cable 
for verification  
of complian ce 
for this sub stance 
included 
in 
Column 
1 in 
Table 
3 of this An nex.
If 
a substance 
appearing 
on 
the list as an  
individual 
compoun d 
is also covered b y 
a generic 
term, the restriction s 
apply­
ing 
to this sub stance 
shall be 
those indicated 
for the individual 
compoun d
.
If 
in 
Column 
8 the specific mig ration 
limit is non-detectable 
(ND) a detection  
limit of 0,01 mg  
substance 
per kg 
food is 
applicable 
unless 
specified differen tly 
for an 
individual 
substance.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/15Table 1
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
FCM 
substance NoRef. No CAS No Substance nameUse as additive 
or polymer 
production aid
(yes/no)Use as mono­
mer or other 
starting 
substance or 
macromolecule 
obtained from 
microbial 
fermentation
(yes/no)FRF applicable
(yes/no)SML
[mg/kg]SML(T)
[mg/kg]
(Group 
restriction 
No)Restrictions and specificationsNotes on 
verification of 
compliance
1 12310 0266309-43-7 albumin no yes no
2 12340 — albumin, coagulated by formal­
dehydeno yes no
3 12375 — alcohols, aliphatic, monohydric, saturated, linear, primary (C
4-C22)no yes no
4 22332 — mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanateno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety.(10)
5 25360 — trialkyl(C
5-C15)acetic acid, 2,3-
epoxypropyl esterno yes no ND 1 mg/kg in final product 
expressed as epoxygroup.
Molecular weight is 43 Da.
6 25380 — trialkyl acetic acid (C7-C17), 
vinyl estersno yes no 0,05 (1)
7 30370 — acetylacetic acid, salts yes no no
8 30401 — acetylated mono- and diglycer­
ides of fatty acidsyes no no (32)
9 30610 — acids, C2-C24, aliphatic, linear, 
monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included)yes no no
10 30612 — acids, C
2-C24, aliphatic, linear, 
monocarboxylic, synthetic and their mono-, di- and triglycerol estersyes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/16 EN Official Journ alof the EuropeanUnion 15.1.201111 30960 — acids, aliphatic, monocarboxylic 
(C6-C22), esters with 
polyglycerolyes no no
12 31328 — acids, fatty, from animal or vegetable food fats and oilsyes no no
13 33120 — alcohols, aliphatic, monohydric, saturated, linear, primary (C
4-C24)yes no no
14 33801 — n-alkyl(C10-C13) 
benzenesulphonic acidyes no no 30
15 34130 — alkyl, linear with even number of carbon atoms (C
12-C20) 
dimethylaminesyes no yes 30
16 34230 — alkyl(C8-C22)sulphonic acids yes no no 6
17 34281 — alkyl(C8-C22)sulphuric acids, 
linear, primary with an even number of carbon atomsyes no no
18 34475 — aluminium calcium hydroxide phosphite, hydrateyes no no
19 39090 — N,N-bis(2-hydroxyethyl)alkyl (C
8-C18)amineyes no no (7)
20 39120 — N,N-bis(2-hydroxyethyl)alkyl (C
8-C18)amine hydrochloridesyes no no (7) SML(T) expressed excluding 
HCl
21 42500 — carbonic acid, salts yes no no
22 43200 — castor oil, mono- and diglyceridesyes no no
23 43515 — chlorides of choline esters of coconut oil fatty acidsyes no no 0,9 (1)
24 45280 — cotton fibers yes no no
25 45440 — cresols, butylated, styrenated yes no no 12(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/1726 46700 — 5,7-di-tert-butyl-3-(3,4- and 
2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w)yes no no 5
27 48960 — 9,10-dihydroxy stearic acid and its oligomersyes no no 5
28 50160 — di-n-octyltin bis(n-alkyl(C
10-C16) 
mercaptoacetate)yes no no (10)
29 50360 — di-n-octyltin bis(ethyl maleate) yes no no (10)
30 50560 — di-n-octyltin 1,4-butanediol bis(mercaptoacetate)yes no no (10)
31 50800 — di-n-octyltin dimaleate, 
esterifiedyes no no (10)
32 50880 — di-n-octyltin dimaleate, 
polymers (n = 2-4)yes no no (10)
33 51120 — di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetateyes no no (10)
34 54270 — ethylhydroxymethylcellulose yes no no
35 54280 — ethylhydroxypropylcellulose yes no no
36 54450 — fats and oils, from animal or vegetable food sourcesyes no no
37 54480 — fats and oils, hydrogenated, 
from animal or vegetable food 
sourcesyes no no
38 55520 — glass fibers yes no no
39 55600 — glass microballs yes no no
40 56360 — glycerol, esters with acetic acid yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/18 EN Official Journ alof the EuropeanUnion 15.1.201141 56486 — glycerol, esters with acids, 
aliphatic, saturated, linear, with an even number of carbon atoms (C
14-C18) and with acids, 
aliphatic, unsaturated, linear, with an even number of carbon atoms (C
16-C18)yes no no
42 56487 — glycerol, esters with butyric acid yes no no
43 56490 — glycerol, esters with erucic acid yes no no
44 56495 — glycerol, esters with 12-hydroxystearic acidyes no no
45 56500 — glycerol, esters with lauric acid yes no no
46 56510 — glycerol, esters with linoleic acid yes no no
47 56520 — glycerol, esters with myristic acidyes no no
48 56535 — glycerol, esters with nonanoic acidyes no no
49 56540 — glycerol, esters with oleic acid yes no no
50 56550 — glycerol, esters with palmitic acidyes no no
51 56570 — glycerol, esters with propionic acidyes no no
52 56580 — glycerol, esters with ricinoleic acidyes no no
53 56585 — glycerol, esters with stearic acid yes no no
54 57040 — glycerol monooleate, ester with ascorbic acidyes no no
55 57120 — glycerol monooleate, ester with citric acidyes no no
56 57200 — glycerol monopalmitate, ester with ascorbic acidyes no no
57 57280 — glycerol monopalmitate, ester with citric acidyes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/1958 57600 — glycerol monostearate, ester 
with ascorbic acidyes no no
59 57680 — glycerol monostearate, ester with citric acidyes no no
60 58300 — glycine, salts yes no no
62 64500 — lysine, salts yes no no
63 65440 — manganese pyrophosphite yes no no
64 66695 — methylhydroxymethylcellulose yes no no
65 67155 — mixture of 4-(2-benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl) stilbene, 4,4′-bis (2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbeneyes no no Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formu­lation).
Mixture obtained from the 
manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %).
66 67600 — mono-n-octyltin tris(alkyl (C
10-C16) mercaptoacetate)yes no no (11)
67 67840 — montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerolyes no no
68 73160 — phosphoric acid, mono- and di-n-alkyl (C
16 and C18) estersyes no yes 0,05
69 74400 — phosphorous acid, tris(nonyl-and/or dinonylphenyl) esteryes no yes 30
70 76463 — polyacrylic acid, salts yes no no (22)
71 76730 — polydimethylsiloxane, γ-hydroxypropylatedyes no no 6
72 76815 — polyester of adipic acid with 
glycerol or pentaerythritol, 
esters with even numbered, unbranched C
12-C22 fatty acidsyes no no (32) The fraction with molecular weight below 1 000 Da 
should not exceed 5 % 
(w/w)
73 76866 — polyesters of 1,2-propanediol 
and/or 1,3- and/or 1,4-butanediol and/or polypropyle­neglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C
12-C18 or 
n-octanol and/or n-decanolyes no yes (31)
(32)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/20 EN Official Journ alof the EuropeanUnion 15.1.201174 77440 — polyethyleneglycol diricinoleate yes no yes 42
75 77702 — polyethyleneglycol esters of 
aliph. monocarb. acids (C6-C22) 
and their ammonium and sodium sulphatesyes no no
76 77732 — polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylateyes no no 0,05 Only for use in PET
77 77733 — polyethyleneglycol (EO = 1-30, 
typically 5) ether of 
butyl-2-cyano-3-(4-hydroxyphenyl) acrylateyes no no 0,05 Only for use in PET
78 77897 — polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C
8-C20) sulphate, saltsyes no no 5
79 80640 — polyoxyalkyl (C2-C4) 
dimethylpolysiloxaneyes no no
80 81760 — powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and ironyes no no
81 83320 — propylhydroxyethylcellulose yes no no
82 83325 — propylhydroxymethylcellulose yes no no
83 83330 — propylhydroxypropylcellulose yes no no
84 85601 — silicates, natural (with the exception of asbestos)yes no no
85 85610 — silicates, natural, silanated (with the exception of asbestos)yes no no
86 86000 — silicic acid, silylated yes no no
87 86285 — silicon dioxide, silanated yes no no
88 86880 — sodium monoalkyl dialkylphe­noxybenzenedisulphonateyes no no 9
89 89440 — stearic acid, esters with ethyleneglycolyes no no (2)
90 92195 — taurine, salts yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/2191 92320 — tetradecyl-polyethyleneglycol 
(EO = 3-8) ether of glycolic acidyes no yes 15
92 93970 — tricyclodecanedimethanol bis(hexahydrophthalate)yes no no 0,05
93 95858 — waxes, paraffinic, refined, 
derived from petroleum based 
or synthetic hydrocarbon feedstocks, low viscosityyes no no 0,05 Not to be used for articles 
in contact with fatty foods 
for which simulant D is laid down.
Average molecular weight 
not less than 350 Da.
Viscosity at 100 °C not less 
than 2,5 cSt (2,5 × 10
-6 m2/s).
Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).
94 95859 — waxes, refined, derived from 
petroleum based or synthetic 
hydrocarbon feedstocks, high viscosityyes no no Average molecular weight 
not less than 500 Da.
Viscosity at 100 °C not less 
than 11 cSt ( 1 1  ×  1 0
-6 m2/s).
Content of mineral hydro­carbons with Carbon num­ber less than 25, not more than 5 % (w/w).
95 95883 — white mineral oils, paraffinic, derived from petroleum based 
hydrocarbon feedstocksyes no no Average molecular weight 
not less than 480 Da.
Viscosity at 100 °C not less 
than 8,5 cSt 
(8,5 × 10
-6 m2/s).
Content of mineral hydro­carbons with Carbon num­ber less than 25, not more than 5 % (w/w).
96 95920 — wood flour and fibers, untreated yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/22 EN Official Journ alof the EuropeanUnion 15.1.201197 72081/10 — petroleum hydrocarbon resins 
(hydrogenated)yes no no Petroleum hydrocarbon 
resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks 
with a boiling range not 
greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently fol­lowed by distillation, hydro­genation and additional processing.
Properties:
—Viscosity at 120 °C: 
> 3 Pa.s, 
—Softening point: > 95 °C as determined by ASTM Method E 28-67, 
—Bromine number: < 40 (ASTM D1159), 
—The colour of a 50 % solution in toluene 
< 11 on the Gardner 
scale, 
—Residual aromatic monomer ≤ 50 ppm,
98 17260 0000050-00-0 formaldehyde yes yes no (15)
54880
99 19460 0000050-21-5 lactic acid yes yes no
62960
100 24490 0000050-70-4 sorbitol yes yes no
88320
101 36000 0000050-81-7 ascorbic acid yes no no
102 17530 0000050-99-7 glucose no yes no
103 18100 0000056-81-5 glycerol yes yes no
55920(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/23104 58960 0000057-09-0 hexadecyltrimethylammonium 
bromideyes no no 6
105 22780 0000057-10-3 palmitic acid yes yes no
70400
106 24550 0000057-11-4 stearic acid yes yes no
89040
107 25960 0000057-13-6 urea no yes no
108 24880 0000057-50-1 sucrose no yes no
109 23740 0000057-55-6 1,2-propanediol yes yes no
81840
110 93520 0000059-02-9
0010191-41-0α-tocopherol yes no no
111 53600 0000060-00-4 ethylenediaminetetraacetic acid yes no no
112 64015 0000060-33-3 linoleic acid yes no no
113 16780 0000064-17-5 ethanol yes yes no
52800
114 55040 0000064-18-6 formic acid yes no no
115 10090 0000064-19-7 acetic acid yes yes no
30000
116 13090 0000065-85-0 benzoic acid yes yes no
37600
117 21550 0000067-56-1 methanol no yes no
118 23830 0000067-63-0 2-propanol yes yes no
81882
119 30295 0000067-64-1 acetone yes no no
120 49540 0000067-68-5 dimethyl sulphoxide yes no no
121 24270 0000069-72-7 salicylic acid yes yes no
84640
122 23800 0000071-23-8 1-propanol no yes no
123 13840 0000071-36-3 1-butanol no yes no
124 22870 0000071-41-0 1-pentanol no yes no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/24 EN Official Journ alof the EuropeanUnion 15.1.2011125 16950 0000074-85-1 ethylene no yes no
126 10210 0000074-86-2 acetylene no yes no
127 26050 0000075-01-4 vinyl chloride no yes no ND 1 mg/kg in final product
128 10060 0000075-07-0 acetaldehyde no yes no (1)
129 17020 0000075-21-8 ethylene oxide no yes no ND 1 mg/kg in final product (10)
130 26110 0000075-35-4 vinylidene chloride no yes no ND (1)
131 48460 0000075-37-6 1,1-difluoroethane yes no no
132 26140 0000075-38-7 vinylidene fluoride no yes no 5
133 14380 0000075-44-5 carbonyl chloride no yes no ND 1 mg/kg in final product (10)
23155
134 43680 0000075-45-6 chlorodifluoromethane yes no no 6 Content of 
chlorofluoromethane less 
than 1 mg/kg of the substance
135 24010 0000075-56-9 propylene oxide no yes no ND 1 mg/kg in final product
136 41680 0000076-22-2 camphor yes no no (3)
137 66580 0000077-62-3 2,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)yes no yes (5)
138 93760 0000077-90-7 tri-n-butyl acetyl citrate yes no no (32)
139 14680 0000077-92-9 citric acid yes yes no
44160
140 44640 0000077-93-0 citric acid, triethyl ester yes no no (32)
141 13380 0000077-99-6 1,1,1-trimethylolpropane yes yes no 6
25600
94960
142 26305 0000078-08-0 vinyltriethoxysilane no yes no 0,05 Only to be used as a surface 
treatment agent(1)
143 62450 0000078-78-4 isopentane yes no no
144 19243 0000078-79-5 2-methyl-1,3-butadiene no yes no ND 1 mg/kg in final product
21640(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/25145 10630 0000079-06-1 acrylamide no yes no ND
146 23890 0000079-09-4 propionic acid yes yes no
82000
147 10690 0000079-10-7 acrylic acid no yes no (22)
148 14650 0000079-38-9 chlorotrifluoroethylene no yes no ND (1)
149 19990 0000079-39-0 methacrylamide no yes no ND
150 20020 0000079-41-4 methacrylic acid no yes no (23)
151 13480 0000080-05-7 2,2-bis(4-hydroxyphenyl) 
propaneno yes no 0,6
13607
152 15610 0000080-07-9 4,4′-dichlorodiphenyl sulphone no yes no 0,05
153 15267 0000080-08-0 4,4′-diaminodiphenyl sulphone no yes no 5
154 13617 0000080-09-1 4,4′-dihydroxydiphenyl sulphoneno yes no 0,05
16090
155 23470 0000080-56-8 α-pinene no yes no
156 21130 0000080-62-6 methacrylic acid, methyl ester no yes no (23)
157 74880 0000084-74-2 phthalic acid, dibutyl ester yes no no 0,3 (32) Only to be used as:
(a) plasticiser in repeated use materials and articles contacting non-fatty foods;
(b) technical support agent in polyolefins in con­centrations up to 0,05 % in the final product.(7)
158 23380 0000085-44-9 phthalic anhydride yes yes no
76320(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/26 EN Official Journ alof the EuropeanUnion 15.1.2011159 74560 0000085-68-7 phthalic acid, benzyl butyl ester yes no no 30 (32) Only to be used as:
(a) plasticiser in repeated 
use materials and articles;
(b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and 
follow-on formulae as 
defined by Directive 2006/141/EC or pro­cessed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.(7)
160 84800 0000087-18-3 salicylic acid, 4-tert-butylphenyl esteryes no yes 12
161 92160 0000087-69-4 tartaric acid yes no no
162 65520 0000087-78-5 mannitol yes no no
163 66400 0000088-24-4 2,2′-methylene bis(4-ethyl-6-tert-butylphenol)yes no yes (13)
164 34895 0000088-68-6 2-aminobenzamide yes no no 0,05 Only for use in PET for 
water and beverages
165 23200 0000088-99-3 o-phthalic acid yes yes no
74480
166 24057 0000089-32-7 pyromellitic anhydride no yes no 0,05
167 25240 0000091-08-7 2,6-toluene diisocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate moiety(10)
168 13075 0000091-76-9 2,4-diamino-6-phenyl-1,3,5-triazineno yes no 5 (1)
15310(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/27169 16240 0000091-97-4 3,3′-dimethyl-
4,4′-diisocyanatobiphenylno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety(10)
170 16000 0000092-88-6 4,4′-dihydroxybiphenyl no yes no 6
171 38080 0000093-58-3 benzoic acid, methyl ester yes no no
172 37840 0000093-89-0 benzoic acid, ethyl ester yes no no
173 60240 0000094-13-3 4-hydroxybenzoic acid, propyl 
esteryes no no
174 14740 0000095-48-7 o-cresol no yes no
175 20050 0000096-05-9 methacrylic acid, allyl ester no yes no 0,05
176 11710 0000096-33-3 acrylic acid, methyl ester no yes no (22)
177 16955 0000096-49-1 ethylene carbonate no yes no 30 SML expressed as ethyleneg­
lycol.
Residual content of 5 mg 
ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
178 92800 0000096-69-5 4,4′-thiobis(6-tert-butyl-3-methylphenol)yes no yes 0,48
179 48800 0000097-23-4 2,2′-dihydroxy-–5,5′-dichlorodiphenylmethaneyes no yes 12
180 17160 0000097-53-0 eugenol no yes no ND
181 20890 0000097-63-2 methacrylic acid, ethyl ester no yes no (23)
182 19270 0000097-65-4 itaconic acid no yes no
183 21010 0000097-86-9 methacrylic acid, isobutyl ester no yes no (23)
184 20110 0000097-88-1 methacrylic acid, butyl ester no yes no (23)
185 20440 0000097-90-5 methacrylic acid, diester with ethyleneglycolno yes no
0,05
186 14020 0000098-54-4 4-tert-butylphenol no yes no 0,05
187 22210 0000098-83-9 α-methylstyrene no yes no 0,05
188 19180 0000099-63-8 isophthalic acid dichloride no yes no (27)
189 60200 0000099-76-3 4-hydroxybenzoic acid, methyl esteryes no no
190 18880 0000099-96-7 p-hydroxybenzoic acid no yes no
191 24940 0000100-20-9 terephthalic acid dichloride no yes no (28)
192 23187 — phthalic acid no yes no (28)
193 24610 0000100-42-5 styrene no yes no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/28 EN Official Journ alof the EuropeanUnion 15.1.2011194 13150 0000100-51-6 benzyl alcohol no yes no
195 37360 0000100-52-7 benzaldehyde yes no no (3)
196 18670 0000100-97-0 hexamethylenetetramine yes yes no (15)
59280
197 20260 0000101-43-9 methacrylic acid, cyclohexyl 
esterno yes no 0,05
198 16630 0000101-68-8 diphenylmethane-4,4′-diisocyanateno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety(10)
199 24073 0000101-90-6 resorcinol diglycidyl ether no yes no ND Not to be used for articles 
in contact with fatty foods for which simulant D is laid down.
For indirect food contact 
only, behind a PET layer.(8)
200 51680 0000102-08-9 N,N′-diphenylthiourea yes no yes 3
201 16540 0000102-09-0 diphenyl carbonate no yes no 0,05
202 23070 0000102-39-6 (1,3-phenylenedioxy) diacetic acidno yes no 0,05 (1)
203 13323 0000102-40-9 1,3-bis(2-hydroxyethoxy) benzeneno yes no 0,05
204 25180 0000102-60-3 N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamineyes yes no
92640
205 25385 0000102-70-5 triallylamine no yes no 40 mg/kg hydrogel at a 
ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydro­
gels intended for non-direct food contact use.
206 11500 0000103-11-7 acrylic acid, 2-ethylhexyl ester no yes no 0,05
207 31920 0000103-23-1 adipic acid, bis(2-ethylhexyl) esteryes no yes 18 (32) (2)
208 18898 0000103-90-2 N-(4-hydroxyphenyl) acetamide no yes no 0,05
209 17050 0000104-76-7 2-ethyl-1-hexanol no
yes no 30
210 13390 0000105-08-8 1,4-bis(hydroxymethyl) cyclohexaneno yes no
14880(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/29211 23920 0000105-38-4 propionic acid, vinyl ester no yes no (1)
212 14200 0000105-60-2 caprolactam yes yes no (4)
41840
213 82400 0000105-62-4 1,2-propyleneglycol dioleate yes no no
214 61840 0000106-14-9 12-hydroxystearic acid yes no no
215 14170 0000106-31-0 butyric anhydride no yes no
216 14770 0000106-44-5 p-cresol no yes no
217 15565 0000106-46-7 1,4-dichlorobenzene no yes no 12
218 11590 0000106-63-8 acrylic acid, isobutyl ester no yes no (22)
219 14570 0000106-89-8 epichlorohydrin no yes no ND 1 mg/kg in final product (10)
16750
220 20590 0000106-91-2 methacrylic acid, 
2,3-epoxypropyl esterno yes no 0,02 (10)
221 40570 0000106-97-8 butane yes no no
222 13870 0000106-98-9 1-butene no yes no
223 13630 0000106-99-0 butadiene no yes no ND 1 mg/kg in final product
224 13900 0000107-01-7 2-butene no yes no
225 12100 0000107-13-1 acrylonitrile no yes no ND
226 15272 0000107-15-3 ethylenediamine no yes no 12
16960
227 16990 0000107-21-1 ethyleneglycol yes yes no (2)
53650
228 13690 0000107-88-0 1,3-butanediol no yes no
229 14140 0000107-92-6 butyric acid no yes no
230 16150 0000108-01-0 dimethylaminoethanol no yes no 18
231 10120 0000108-05-4 acetic acid, vinyl ester no yes no 12
232 10150 0000108-24-7 acetic anhydride yes yes no
30280
233 24850 0000108-30-5 succinic anhydride no yes no
234 19960 0000108-31-6 maleic anhydride no yes no (3)
235 14710 0000108-39-4 m-cresol no yes no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/30 EN Official Journ alof the EuropeanUnion 15.1.2011236 23050 0000108-45-2 1,3-phenylenediamine no yes no ND
237 15910 0000108-46-3 1,3-dihydroxybenzene no yes no 2,4
24072
238 18070 0000108-55-4 glutaric anhydride no yes no
239 19975 0000108-78-1 2,4,6-triamino-1,3,5-triazine yes yes no 30
25420
93720
240 45760 0000108-91-8 cyclohexylamine yes no no
241 22960 0000108-95-2 phenol no yes no
242 85360 0000109-43-3 sebacic acid, dibutyl ester yes no no (32)
243 19060 0000109-53-5 isobutyl vinyl ether no yes no 0,05 (10)
244 71720 0000109-66-0 pentane yes no no
245 22900 0000109-67-1 1-pentene no yes no 5
246 25150 0000109-99-9 tetrahydrofuran no yes no 0,6
247 24820 0000110-15-6 succinic acid yes yes no
90960
248 19540 0000110-16-7 maleic acid yes yes no (3)
64800
249 17290 0000110-17-8 fumaric acid yes yes no
55120
250 53520 0000110-30-5 N,N′-ethylenebisstearamide yes no no
251 53360 0000110-31-6 N,N′-ethylenebisoleamide yes no no
252 87200 0000110-44-1 sorbic acid yes no no
253 15250 0000110-60-1 1,4-diaminobutane no yes no
254 13720 0000110-63-4 1,4-butanediol yes yes no (30)
40580
255 25900 0000110-88-3 trioxane no yes no 5
256 18010 0000110-94-1 glutaric acid yes yes no
55680
257 13550 0000110-98-5 dipropyleneglycol yes yes no
16660
51760(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/31258 70480 0000111-06-8 palmitic acid, butyl ester yes no no
259 58720 0000111-14-8 heptanoic acid yes no no
260 24280 0000111-20-6 sebacic acid no yes no
261 15790 0000111-40-0 diethylenetriamine no yes no 5
262 35284 0000111-41-1 N-(2-aminoethyl)ethanolamine yes no no 0,05 Not to be used for articles 
in contact with fatty foods 
for which simulant D is laid down.
For indirect food contact 
only, behind a PET layer.
263 13326 0000111-46-6 diethyleneglycol yes yes no (2)
15760
47680
264 22660 0000111-66-0 1-octene no yes no 15
265 22600 0000111-87-5 1-octanol no yes no
266 25510 0000112-27-6 triethyleneglycol yes yes no
94320
267 15100 0000112-30-1 1-decanol no yes no
268 16704 0000112-41-4 1-dodecene no yes no 0,05
269 25090 0000112-60-7 tetraethyleneglycol yes yes no
92350
270 22763 0000112-80-1 oleic acid yes yes no
69040
271 52720 0000112-84-5 erucamide yes no no
272 37040 0000112-85-6 behenic acid yes no no
273 52730 0000112-86-7 erucic acid yes no no
274 22570 0000112-96-9 octadecyl isocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety(10)
275 23980 0000115-07-1 propylene no yes no
276 19000 0000115-11-7 isobutene no yes no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/32 EN Official Journ alof the EuropeanUnion 15.1.2011277 18280 0000115-27-5 hexachloroendomethylenetetra­
hydrophthalic anhydrideno yes no ND
278 18250 0000115-28-6 hexachloroendomethylenetetra­hydrophthalic acidno yes no ND
279 22840 0000115-77-5 pentaerythritol yes yes no
71600
280 73720 0000115-96-8 phosphoric acid, trichloroethyl esteryes no no ND
281 25120 0000116-14-3 tetrafluoroethylene no yes no 0,05
282 18430 0000116-15-4 hexafluoropropylene no yes no ND
283 74640 0000117-81-7 phthalic acid, bis(2-ethylhexyl) esteryes no no 1,5 (32) Only to be used as:
(a) plasticiser in repeated 
use materials and articles contacting non-fatty foods;
(b) technical support agent in concentrations up to 0,1 % in the final product.(7)
284 84880 0000119-36-8 salicylic acid, methyl ester yes no no 30
285 66480 0000119-47-1 2,2′-methylene bis(4-methyl-6-tert-butylphenol)yes no yes (13)
286 38240 0000119-61-9 benzophenone yes no yes 0,6
287 60160 0000120-47-8 4-hydroxybenzoic acid, ethyl esteryes no no
288 24970 0000120-61-6 terephthalic acid, dimethyl ester no yes no
289 15880 0000120-80-9 1,2-dihydroxybenzene no yes no 6
24051
290 55360 0000121-79-9 gallic acid, propyl ester yes no no (20)
291 19150 0000121-91-5 isophthalic acid no yes no (27)
292 94560 0000122-20-3 triisopropanolamine yes no no 5
293 23175 0000122-52-1 phosphorous acid, triethyl ester no yes no ND 1 mg/kg in final product (1)
294 93120 0000123-28-4 thiodipropionic acid, didodecyl esteryes no yes (14)
295 15940 0000123-31-9 1,4-dihydroxybenzene yes yes no 0,6
18867
48620(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/33296 23860 0000123-38-6 propionaldehyde no yes no
297 23950 0000123-62-6 propionic anhydride no yes no
298 14110 0000123-72-8 butyraldehyde no yes no
299 63840 0000123-76-2 levulinic acid yes no no
300 30045 0000123-86-4 acetic acid, butyl ester yes no no
301 89120 0000123-95-5 stearic acid, butyl ester yes no no
302 12820 0000123-99-9 azelaic acid no yes no
303 12130 0000124-04-9 adipic acid yes yes no
31730
304 14320 0000124-07-2 caprylic acid yes yes no
41960
305 15274 0000124-09-4 hexamethylenediamine no yes no 2,4
18460
306 88960 0000124-26-5 stearamide yes no no
307 42160 0000124-38-9 carbon dioxide yes no no
308 91200 0000126-13-6 sucrose acetate isobutyrate yes no no
309 91360 0000126-14-7 sucrose octaacetate yes no no
310 16390 0000126-30-7 2,2-dimethyl-1,3-propanediol no yes no 0,05
22437
311 16480 0000126-58-9 dipentaerythritol yes yes no
51200
312 21490 0000126-98-7 methacrylonitrile no yes no ND
313 16650 0000127-63-9 diphenyl sulphone yes yes no 3
51570
314 23500 0000127-91-3 β-pinene no yes no
315 46640 0000128-37-0 2,6-di-tert-butyl-p-cresol yes no no 3
316 23230 0000131-17-9 phthalic acid, diallyl ester no yes no ND
317 48880 0000131-53-3 2,2′-dihydroxy-
4-methoxybenzophenoneyes no yes (8)
318 48640 0000131-56-6 2,4-dihydroxybenzophenone yes no no (8)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/34 EN Official Journ alof the EuropeanUnion 15.1.2011319 61360 0000131-57-7 2-hydroxy-
4-methoxybenzophenoneyes no yes (8)
320 37680 0000136-60-7 benzoic acid, butyl ester yes no no
321 36080 0000137-66-6 ascorbyl palmitate yes no no
322 63040 0000138-22-7 lactic acid, butyl ester yes no no
323 11470 0000140-88-5 acrylic acid, ethyl ester no yes no (22)
324 83700 0000141-22-0 ricinoleic acid yes no yes 42
325 10780 0000141-32-2 acrylic acid, n-butyl ester no yes no (22)
326 12763 0000141-43-5 2-aminoethanol yes yes no 0,05 Not to be used for articles 
in contact with fatty foods for which simulant D is laid down.
For indirect food contact 
only, behind a PET layer.35170
327 30140 0000141-78-6 acetic acid, ethyl ester yes no no
328 65040 0000141-82-2 malonic acid yes no no
329 59360 0000142-62-1 hexanoic acid yes no no
330 19470 0000143-07-7 lauric acid yes yes no
63280
331 22480 0000143-08-8 1-nonanol no yes no
332 69760 0000143-28-2 oleyl alcohol yes no no
333 22775 0000144-62-7 oxalic acid yes yes no 6
69920
334 17005 0000151-56-4 ethyleneimine no yes no ND
335 68960 0000301-02-0 oleamide yes no no
336 15095 0000334-48-5
n-decanoic acid yes yes no
45940
337 15820 0000345-92-6 4,4′-difluorobenzophenone no yes no 0,05
338 71020 0000373-49-9 palmitoleic acid yes no no
339 86160 0000409-21-2 silicon carbide yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/35340 47440 0000461-58-5 dicyanodiamide yes no no
341 13180 0000498-66-8 bicyclo[2.2.1]hept-2-ene no yes no 0,05
22550
342 14260 0000502-44-3 caprolactone no yes no (29)
343 23770 0000504-63-2 1,3-propanediol no yes no 0,05
344 13810 0000505-65-7 1,4-butanediol formal no yes no ND (10)
21821
345 35840 0000506-30-9 arachidic acid yes no no
346 10030 0000514-10-3 abietic acid no yes no
347 13050 0000528-44-9 trimellitic acid no yes no (21)
25540
348 22350 0000544-63-8 myristic acid yes yes no
67891
349 25550 0000552-30-7 trimellitic anhydride no yes no (21)
350 63920 0000557-59-5 lignoceric acid yes no no
351 21730 0000563-45-1 3-methyl-1-butene no yes no ND Only to be used in 
polypropylene(1)
352 16360 0000576-26-1 2,6-dimethylphenol no yes no 0,05
353 42480 0000584-09-8 carbonic acid, rubidium salt yes no no 12
354 25210 0000584-84-9 2,4-toluene diisocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety(10)
355 20170 0000585-07-9 methacrylic acid, tert-butyl ester no yes no (23)
356 18820 0000592-41-6 1-hexene no yes no 3
357 13932 0000598-32-3 3-buten-2-ol no yes no ND Only to be used as a 
co-monomer for the preparation of polymeric additive(1)
358 14841 0000599-64-4 4-cumylphenol no yes no 0,05
359 15970 0000611-99-4 4,4′-dihydroxybenzophenone yes yes no (8)
48720
360 57920 0000620-67-7 glycerol triheptanoate yes no no
361 18700 0000629-11-8 1,6-hexanediol no yes no 0,05(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/36 EN Official Journ alof the EuropeanUnion 15.1.2011362 14350 0000630-08-0 carbon monoxide no yes no
363 16450 0000646-06-0 1,3-dioxolane no yes no 5
364 15404 0000652-67-5 1,4:3,6-dianhydrosorbitol no yes no 5 Only to be used as a 
co-monomer in 
poly(ethylene-co-isosorbide terephthalate)
365 11680 0000689-12-3 acrylic acid, isopropyl ester no yes no (22)
366 22150 0000691-37-2 4-methyl-1-pentene no yes no 0,05
367 16697 0000693-23-2 n-dodecanedioic acid no yes no
368 93280 0000693-36-7 thiodipropionic acid, dioctadecyl esteryes no yes (14)
369 12761 0000693-57-2 12-aminododecanoic acid no yes no 0,05
370 21460 0000760-93-0 methacrylic anhydride no yes no (23)
371 11510 0000818-61-1 acrylic acid, monoester with ethyleneglycolno yes no (22)
11830
372 18640 0000822-06-0 hexamethylene diisocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate moiety(10)
373 22390 0000840-65-3 2,6-naphthalenedicarboxylic acid, dimethyl esterno yes no 0,05
374 21190 0000868-77-9 methacrylic acid, monoester with ethyleneglycolno yes no (23)
375 15130 0000872-05-9 1-decene no yes no 0,05
376 66905 0000872-50-4 N-methylpyrrolidone yes no no
377 12786 0000919-30-2 3-aminopropyltriethoxysilane no yes no 0,05 Residual extractable 
content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.
SML = 0,05 mg/kg when 
used for the surface treat­ment of materials and articles.
378 21970 0000923-02-4
N-methylolmethacrylamide no yes no 0,05
379 21940 0000924-42-5 N-methylolacrylamide no yes no ND(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/37380 11980 0000925-60-0 acrylic acid, propyl ester no yes no (22)
381 15030 0000931-88-4 cyclooctene no yes no 0,05 Only to be used in 
polymers contacting foods 
for which simulant A is laid down
382 19490 0000947-04-6 laurolactam no yes no 5
383 72160 0000948-65-2 2-phenylindole yes no yes 15
384 40000 0000991-84-4 2,4-bis(octylmercapto)-6-
(4-hydroxy-3,5-di-tert-
butylanilino)-1,3,5-triazineyes no yes 30
385 11530 0000999-61-1 acrylic acid, 2-hydroxypropyl esterno yes no 0,05 SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.
It may contain up to 25 % 
(m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).(1)
386 55280 0001034-01-1 gallic acid, octyl ester yes no no (20)
387 26155 0001072-63-5 1-vinylimidazole no yes no 0,05 (1)
388 25080 0001120-36-1 1-tetradecene no yes no 0,05
389 22360 0001141-38-4 2,6-naphthalenedicarboxylic acidno yes no 5
390 55200 0001166-52-5 gallic acid, dodecyl ester yes no no (20)
391 22932 0001187-93-5 perfluoromethyl perfluorovinyl etherno yes no 0,05 Only to be used in anti-stick coatings
392 72800 0001241-94-7 phosphoric acid, diphenyl 2-ethylhexyl esteryes no yes 2,4
393 37280 0001302-78-9 bentonite yes no no
394 41280 0001305-62-0 calcium hydroxide yes no no
395 41520 0001305-78-8 calcium oxide yes no no
396 64640 0001309-42-8
magnesium hydroxide yes no no
397 64720 0001309-48-4 magnesium oxide yes no no
398 35760 0001309-64-4 antimony trioxide yes no no 0,04 SML expressed as antimony (6)
399 81600 0001310-58-3 potassium hydroxide yes no no
400 86720 0001310-73-2 sodium hydroxide yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/38 EN Official Journ alof the EuropeanUnion 15.1.2011401 24475 0001313-82-2 sodium sulphide no yes no
402 96240 0001314-13-2 zinc oxide yes no no
403 96320 0001314-98-3 zinc sulphide yes no no
404 67200 0001317-33-5 molybdenum disulphide yes no no
405 16690 0001321-74-0 divinylbenzene no yes no ND SML expressed as the sum 
of divinylbenzene and eth­
ylvinylbenzene.
It may contain up to 45 % 
(m/m) of ethylvinylbenzene.(1)
406 83300 0001323-39-3 1,2-propyleneglycol monostear­ateyes no no
407 87040 0001330-43-4 sodium tetraborate yes no no (16)
408 82960 0001330-80-9 1,2-propyleneglycol monooleate yes no no
409 62240 0001332-37-2 iron oxide yes no no
410 62720 0001332-58-7 kaolin yes no no
411 42080 0001333-86-4 carbon black yes no no Primary particles of 10 – 
300 nm which are aggre­gated to a size of 100 –1 200 nm which may form agglomerates within the size distribution of 300 nm – mm.
Toluene extractables: maxi­
mum 0,1 %, determined 
according to ISO method 6209.
UV absorption of cyclohex­
ane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.
Benzo(a)pyrene content: 
max 0,25 mg/kg carbon black.
Maximum use level of car­
bon black in the polymer: 2,5 % w/w.
412 45200 0001335-23-5 copper iodide yes no no (6)
413 35600 0001336-21-6 ammonium hydroxide yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/39414 87600 0001338-39-2 sorbitan monolaurate yes no no
415 87840 0001338-41-6 sorbitan monostearate yes no no
416 87680 0001338-43-8 sorbitan monooleate yes no no
417 85680 0001343-98-2 silicic acid yes no no
418 34720 0001344-28-1 aluminium oxide yes no no
419 92150 0001401-55-4 tannic acids yes no no According to the JECFA 
specifications
420 19210 0001459-93-4 isophthalic acid, dimethyl ester no yes no 0,05
421 13000 0001477-55-0 1,3-benzenedimethanamine no yes no 0,05
422 38515 0001533-45-5 4,4′-bis(2-benzoxazolyl)stilbene yes no yes 0,05 (2)
423 22937 0001623-05-8 perfluoropropylperfluorovinyl 
etherno yes no 0,05
424 15070 0001647-16-1 1,9-decadiene no yes no 0,05
425 10840 0001663-39-4 acrylic acid, tert-butyl ester no yes no (22)
426 13510 0001675-54-3 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) etherno yes no In compliance with Commission Regulation (EC) No 1895/2005 (
1) 13610
427 18896 0001679-51-2 4-(hydroxymethyl)-1-cyclohexene no yes no 0,05
428 95200 0001709-70-2 1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl) benzeneyes no no
429 13210 0001761-71-3 bis(4-aminocyclohexyl)methane no yes no 0,05
430 95600 0001843-03-4 1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butaneyes no yes 5
431
61600 0001843-05-6 2-hydroxy-4-n-octyloxybenzophenoneyes no yes (8)
432 12280 0002035-75-8 adipic anhydride no yes no
433 68320 0002082-79-3 octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionateyes no yes 6
434 20410 0002082-81-7 methacrylic acid, diester with 1,4-butanediolno yes no 0,05
435 14230 0002123-24-2 caprolactam, sodium salt no yes no (4)
436 19480 0002146-71-6 lauric acid, vinyl ester no yes no
437 11245 0002156-97-0 acrylic acid, dodecyl ester no yes no 0,05 (2)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/40 EN Official Journ alof the EuropeanUnion 15.1.2011438 38875 0002162-74-5 bis(2,6-diisopropylphenyl) 
carbodiimideyes no no 0,05 For indirect food contact only, behind a PET layer
439 21280 0002177-70-0 methacrylic acid, phenyl ester no yes no (23)
440 21340 0002210-28-8 methacrylic acid, propyl ester no yes no (23)
441 38160 0002315-68-6 benzoic acid, propyl ester yes no no
442 13780 0002425-79-8 1,4-butanediol bis(2,3-epoxypropyl)etherno yes no ND Residual content = 1 mg/kg in final product expressed 
as epoxygroup.
Molecular weight is 43 Da.(10)
443 12788 0002432-99-7 11-aminoundecanoic acid no yes no 5
444 61440 0002440-22-4 2-(2′-hydroxy-5′-
methylphenyl)benzotriazoleyes no no (12)
445 83440 0002466-09-3 pyrophosphoric acid yes no no
446 10750 0002495-35-4 acrylic acid, benzyl ester no yes no (22)
447 20080 0002495-37-6 methacrylic acid, benzyl ester no yes no (23)
448 11890 0002499-59-4 acrylic acid, n-octyl ester no yes no (22)
449 49840 0002500-88-1 dioctadecyl disulphide yes no yes 3
450 24430 0002561-88-8 sebacic anhydride no yes no
451 66755 0002682-20-4 2-methyl-4-isothiazolin-3-one yes no no 0,5 Only to be used in aqueous 
polymer dispersions and emulsions
452 38885 0002725-22-6 2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazineyes no no 0,05 Only to be used in aqueous foods
453 26320 0002768-02-7 vinyltrimethoxysilane no yes no 0,05 (10)
454 12670
0002855-13-2 1-amino-3-aminomethyl-3,5,5-trimethylcyclohexaneno yes no 6
455 20530 0002867-47-2 methacrylic acid, 2-(dimethylamino)-ethyl esterno yes no ND
456 10810 0002998-08-5 acrylic acid, sec-butyl ester no yes no (22)
457 20140 0002998-18-7 methacrylic acid, sec-butyl ester no yes no (23)
458 36960 0003061-75-4 behenamide yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/41459 46870 0003135-18-0 3,5-di-tert-butyl-4-
hydroxybenzylphosphonic acid, dioctadecyl esteryes no no
460 14950 0003173-53-3 cyclohexyl isocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate moiety(10)
461 22420 0003173-72-6 1,5-naphthalene diisocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate moiety(10)
462 26170 0003195-78-6 N-vinyl-N-methylacetamide no yes no 0,02 (1)
463 25840 0003290-92-4 1,1,1-trimethylolpropane trimethacrylateno yes no 0,05
464 61280 0003293-97-8 2-hydroxy-4-n-hexyloxybenzophenoneyes no yes (8)
465 68040 0003333-62-8 7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarinyes no no
466 50640 0003648-18-8 di-n-octyltin dilaurate yes no no (10)
467 14800 0003724-65-0 crotonic acid yes yes no 0,05 (1)
45600
468 71960 0003825-26-1 perfluorooctanoic acid, ammonium saltyes no no Only to be used in repeated use articles, sintered at high temperatures
469 60480 0003864-99-1 2-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazoleyes no yes (12)
470 60400 0003896-11-5 2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazoleyes no yes (12)
471 24888 0003965-55-7 5-sulphoisophthalic acid, monosodium salt, dimethyl esterno yes no 0,05
472 66560 0004066-02-8 2,2′-methylenebis(4-methyl-6-cyclohexylphenol)yes no yes (5)
473 12265 0004074-90-2 adipic acid, divinyl ester no yes no ND 5 mg/kg in final product.
Only to be used as co-monomer.(1)
474 43600 0004080-31-3 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chlorideyes no
no 0,3
475 19110 0004098-71-9 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexaneno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety(10)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/42 EN Official Journ alof the EuropeanUnion 15.1.2011476 16570 0004128-73-8 diphenylether-4,4′-diisocyanate no yes no (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety(10)
477 46720 0004130-42-1 2,6-di-tert-butyl-4-ethylphenol yes no yes 4,8 (1)
478 60180 0004191-73-5 4-hydroxybenzoic acid, isopropyl esteryes no no
479 12970 0004196-95-6 azelaic anhydride no yes no
480 46790 0004221-80-1 3,5-di-tert-butyl-4-hydroxybenzoic acid, 
2,4-di-tert-butylphenyl esteryes no no
481 13060 0004422-95-1 1,3,5-benzenetricarboxylic acid 
trichlorideno yes no 0,05 SML expressed as 1,3,5-benzenetricarboxylic acid(1)
482 21100 0004655-34-9 methacrylic acid, isopropyl ester no yes no (23)
483 68860 0004724-48-5 n-octylphosphonic acid yes no no 0,05
484 13395 0004767-03-7 2,2-bis(hydroxymethyl) propionic acidno yes no 0,05 (1)
485 13560 0005124-30-1 dicyclohexylmethane-4,4′-diisocyanateno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety(10)
15700
486 54005 0005136-44-7 ethylene-N-palmitamide-N′-stearamideyes no no
487 45640 0005232-99-5 2-cyano-3,3-diphenylacrylic acid, ethyl esteryes no no 0,05
488 53440 0005518-18-3 N,N′-ethylenebispalmitamide yes no no
489 41040 0005743-36-2 calcium butyrate yes no no
490 16600 0005873-54-1 diphenylmethane-2,4′-diisocyanateno yes no (17) 1 mg/kg in final product expressed as isocyanate moiety(10)
491 82720 0006182-11-2 1,2-propyleneglycol distearate yes no no
492 45650
0006197-30-4 2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl esteryes no no 0,05
493 39200 0006200-40-4 bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chlorideyes no no 1,8
494 62140 0006303-21-5 hypophosphorous acid yes no no
495 35160 0006642-31-5 6-amino-1,3-dimethyluracil yes no no 5
496 71680 0006683-19-8 pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/43497 95020 0006846-50-0 2,2,4-trimethyl-1,3-pentanediol 
diisobutyrateyes no no 5 Only to be used in single-use gloves
498 16210 0006864-37-5 3,3′-dimethyl-4,4′-diaminodicyclohexylmethaneno yes no 0,05 Only to be used in polyamides(5)
499 19965 0006915-15-7 malic acid yes yes no In case of use as a 
monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a 
molar basis65020
500 38560 0007128-64-5 2,5-bis(5-tert-butyl-2-
benzoxazolyl)thiopheneyes no yes 0,6
501 34480 — aluminium fibers, flakes and powdersyes no no
502 22778 0007456-68-0 4,4′-oxybis(benzenesulphonyl azide)no yes no 0,05 (1)
503 46080 0007585-39-9 β-dextrin yes no no
504 86240 0007631-86-9 silicon dioxide yes no no For synthetic amorphous 
silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 µm which may form agglomerates within the size distribution 
of 0,3 µm to the mm size.
505 86480 0007631-90-5 sodium bisulphite yes no no (19)
506 86920 0007632-00-0 sodium nitrite yes no no 0,6
507 59990 0007647-01-0 hydrochloric acid yes no no
508 86560 0007647-15-6 sodium bromide yes no no
509 23170 0007664-38-2 phosphoric acid yes yes no
72640
510 12789 0007664-41-7 ammonia yes yes no
35320
511 91920 0007664-93-9 sulphuric acid yes no no
512 81680 0007681-11-0 potassium iodide yes no no (6)
513 86800 0007681-82-5 sodium iodide yes no
no (6)
514 91840 0007704-34-9 sulphur yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/44 EN Official Journ alof the EuropeanUnion 15.1.2011515 26360 0007732-18-5 water yes yes no In compliance with 
Directive 98/83/EC  (2)
95855
516 86960 0007757-83-7 sodium sulphite yes no no (19)
517 81520 0007758-02-3 potassium bromide yes no no
518 35845 0007771-44-0 arachidonic acid yes no no
519 87120 0007772-98-7 sodium thiosulphate yes no no (19)
520 65120 0007773-01-5 manganese chloride yes no no
521 58320 0007782-42-5 graphite yes no no
522 14530 0007782-50-5 chlorine no yes no
523 45195 0007787-70-4 copper bromide yes no no
524 24520 0008001-22-7 soybean oil no yes no
525 62640 0008001-39-6 japan wax yes no no
526 43440 0008001-75-0 ceresin yes no no
527 14411 0008001-79-4 castor oil yes yes no
42880
528 63760 0008002-43-5 lecithin yes no no
529 67850 0008002-53-7 montan wax yes no no
530 41760 0008006-44-8 candelilla wax yes no no
531 36880 0008012-89-3 beeswax yes no no
532 88640 0008013-07-8 soybean oil, epoxidised yes no no 60
30(*)(32) (*) In the case of PVC gas­
kets used to seal glass 
jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML 
is lowered to 30 mg/kg.
Oxirane < 8 %, iodine 
number < 6.(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/45533 42720 0008015-86-9 carnauba wax yes no no
534 80720 0008017-16-1 polyphosphoric acids yes no no
535 24100 0008050-09-7 rosin yes yes no
24130
24190
83840
536 84320 0008050-15-5 rosin, hydrogenated, ester with 
methanolyes no no
537 84080 0008050-26-8 rosin, ester with pentaerythritol yes no no
538 84000 0008050-31-5 rosin, ester with glycerol yes no no
539 24160 0008052-10-6 rosin tall oil no yes no
540 63940 0008062-15-5 lignosulphonic acid yes no no 0,24 Only to be used as 
dispersant for plastics dispersions
541 58480 0009000-01-5 gum arabic yes no no
542 42640 0009000-11-7 carboxymethylcellulose yes no no
543 45920 0009000-16-2 dammar yes no no
544 58400 0009000-30-0 guar gum yes no no
545 93680 0009000-65-1 tragacanth gum yes no no
546 71440 0009000-69-5 pectin yes no no
547 55440 0009000-70-8 gelatin yes no no
548 42800 0009000-71-9 casein yes no no
549 80000 0009002-88-4 polyethylene wax yes no no
550 81060 0009003-07-0 polypropylene wax yes no no
551 79920 0009003-11-6
0106392-12-5poly(ethylene propylene) glycol yes no no
552 81500 0009003-39-8 polyvinylpyrrolidone yes no no The substance shall meet 
the purity criteria as laid down in Commission Direc­tive 2008/84/EC  (
3)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/46 EN Official Journ alof the EuropeanUnion 15.1.2011553 14500 0009004-34-6 cellulose yes yes no
43280
554 43300 0009004-36-8 cellulose acetate butyrate yes no no
555 53280 0009004-57-3 ethylcellulose yes no no
556 54260 0009004-58-4 ethylhydroxyethylcellulose yes no no
557 66640 0009004-59-5 methylethylcellulose yes no no
558 60560 0009004-62-0 hydroxyethylcellulose yes no no
559 61680 0009004-64-2 hydroxypropylcellulose yes no no
560 66700 0009004-65-3 methylhydroxypropylcellulose yes no no
561 66240 0009004-67-5 methylcellulose yes no no
562 22450 0009004-70-0 nitrocellulose no yes no
563 78320 0009004-97-1 polyethyleneglycol 
monoricinoleateyes no yes 42
564 24540 0009005-25-8 starch, edible yes yes no
88800
565 61120 0009005-27-0 hydroxyethyl starch yes no no
566 33350 0009005-32-7 alginic acid yes no no
567 82080 0009005-37-2 1,2-propyleneglycol alginate yes no no
568 79040 0009005-64-5 polyethyleneglycol sorbitan monolaurateyes no no
569 79120 0009005-65-6 polyethyleneglycol sorbitan monooleateyes no no
570 79200 0009005-66-7 polyethyleneglycol sorbitan monopalmitateyes no no
571 79280 0009005-67-8 polyethyleneglycol sorbitan monostearateyes
no no
572 79360 0009005-70-3 polyethyleneglycol sorbitan trioleateyes no no
573 79440 0009005-71-4 polyethyleneglycol sorbitan tristearateyes no no
574 24250 0009006-04-6 rubber, natural yes yes no
84560
575 76721 0063148-62-9 polydimethylsiloxane (Mw > 6 800 Da)yes no no Viscosity at 25 °C not less than 100 cSt (100 × 10
-6 m2/s)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/47576 60880 0009032-42-2 hydroxyethylmethylcellulose yes no no
577 62280 0009044-17-1 isobutylene-butene copolymer yes no no
578 79600 0009046-01-9 polyethyleneglycol tridecyl ether 
phosphateyes no no 5 For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol 
(EO ≤ 11) tridecyl ether phosphate (mono-and 
dialkyl ester) with a maxi­
mum 10 % content of poly­ethyleneglycol (EO ≤ 11) tridecylether.
579 61800 0009049-76-7 hydroxypropyl starch yes no no
580 46070 0010016-20-3 α-dextrin yes no no
581 36800 0010022-31-8 barium nitrate yes no no
582 50240 0010039-33-5 di-n-octyltin bis(2-ethylhexyl maleate)yes no no (10)
583 40400 0010043-11-5 boron nitride yes no no (16)
584 13620 0010043-35-3 boric acid yes yes no (16)
40320
585 41120 0010043-52-4 calcium chloride yes no no
586 65280 0010043-84-2 manganese hypophosphite yes no no
587 68400 0010094-45-8 octadecylerucamide yes no yes 5
588 64320 0010377-51-2 lithium iodide yes no no (6)
589 52645 0010436-08-5 cis-11-eicosenamide yes no no
590 21370 0010595-80-9 methacrylic acid, 2-sulphoethyl esterno yes no ND (1)
591 36160 0010605-09-1 ascorbyl stearate yes no no
592 34690 0011097-59-9 aluminium magnesium carbon­ate hydroxideyes no no
593 44960 0011104-61-3 cobalt oxide
yes no no
594 65360 0011129-60-5 manganese oxide yes no no
595 19510 0011132-73-3 lignocellulose no yes no
596 95935 0011138-66-2 xanthan gum yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/48 EN Official Journ alof the EuropeanUnion 15.1.2011597 67120 0012001-26-2 mica yes no no
598 41600 0012004-14-7
0037293-22-4calcium sulphoaluminate yes no no
599 36840 0012007-55-5 barium tetraborate yes no no (16)
600 60030 0012072-90-1 hydromagnesite yes no no
601 35440 0012124-97-9 ammonium bromide yes no no
602 70240 0012198-93-5 ozokerite yes no no
603 83460 0012269-78-2 pyrophyllite yes no no
604 60080 0012304-65-3 hydrotalcite yes no no
605 11005 0012542-30-2 acrylic acid, dicyclopentenyl 
esterno yes no 0,05 (1)
606 65200 0012626-88-9 manganese hydroxide yes no no
607 62245 0012751-22-3 iron phosphide yes no no Only to be used in PET 
polymers and copolymers
608 40800 0013003-12-8 4,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phos­phite)yes no yes 6
609 83455 0013445-56-2 pyrophosphorous acid yes no no
610 93440 0013463-67-7 titanium dioxide yes no no
611 35120 0013560-49-1 3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) etheryes no no
612 16694 0013811-50-2 N,N′-divinyl-2-imidazolidinone no yes no 0,05 (10)
613 95905 0013983-17-0 wollastonite yes no no
614 45560 0014464-46-1 cristobalite yes no no
615 92080 0014807-96-6 talc yes no no
616 83470 0014808-60-7 quartz yes no no
617 10660 0015214-89-8 2-acrylamido-2-methylpropanesulphonic acidno yes no 0,05
618 51040 0015535-79-2 di-n-octyltin mercaptoacetate yes no no (10)
619 50320 0015571-58-1 di-n-octyltin bis(2-ethylhexyl 
mercaptoacetate)yes no no (10)
620 50720 0015571-60-5 di-n-octyltin dimaleate yes no no (10)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/49621 17110 0016219-75-3 5-ethylidenebicyclo[2,2,1] 
hept-2-eneno yes no 0,05 (9)
622 69840 0016260-09-6 oleylpalmitamide yes no yes 5
623 52640 0016389-88-1 dolomite yes no no
624 18897 0016712-64-4 6-hydroxy-2-naphthalenecarboxylic acidno yes no 0,05
625 36720 0017194-00-2 barium hydroxide yes no no
626 57800 0018641-57-1 glycerol tribehenate yes no no
627 59760 0019569-21-2 huntite yes no no
628 96190 0020427-58-1 zinc hydroxide yes no no
629 34560 0021645-51-2 aluminium hydroxide yes no no
630 82240 0022788-19-8 1,2-propyleneglycol dilaurate yes no no
631 59120 0023128-74-7 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)yes no yes 45
632 52880 0023676-09-7 4-ethoxybenzoic acid, ethyl esteryes no no 3,6
633 53200 0023949-66-8 2-ethoxy-2′-ethyloxanilide yes no yes 30
634 25910 0024800-44-0 tripropyleneglycol no yes no
635 40720 0025013-16-5 tert-butyl-4-hydroxyanisole yes no no 30
636 31500 0025134-51-4 acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymeryes no no 0,05 (22) SML expressed as acrylic acid, 2-ethylhexyl ester
637 71635 0025151-96-6 pentaerythritol dioleate yes no no 0,05 Not to be used for articles 
in contact with fatty foods for which simulant D is laid down
638 23590
0025322-68-3 polyethyleneglycol yes yes no
76960
639 23651 0025322-69-4 polypropyleneglycol yes yes no
80800
640 54930 0025359-91-5 formaldehyde-1-naphthol, copolymeryes no no 0,05(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/50 EN Official Journ alof the EuropeanUnion 15.1.2011641 22331 0025513-64-8 mixture of (35-45 % w/w) 
1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexaneno yes no 0,05 (10)
642 64990 0025736-61-2 maleic anhydride-styrene, copolymer, sodium saltyes no no The fraction with molecular weight below 1 000 Da 
should not exceed 0,05 % (w/w)
643 87760 0026266-57-9 sorbitan monopalmitate yes no no
644 88080 0026266-58-0 sorbitan trioleate yes no no
645 67760 0026401-86-5 mono-n-octyltin tris(isooctyl mercaptoacetate)yes no no (11)
646 50480 0026401-97-8 di-n-octyltin bis(isooctyl mercaptoacetate)yes no no (10)
647 56720 0026402-23-3 glycerol monohexanoate yes no no
648 56880 0026402-26-6 glycerol monooctanoate yes no no
649 47210 0026427-07-6 dibutylthiostannoic acid polymeryes no no Molecular unit = (C
8H18S3Sn2)n (n = 1,5-2)
650 49600 0026636-01-1 dimethyltin bis(isooctyl mercaptoacetate)yes no no (9)
651 88240 0026658-19-5 sorbitan tristearate yes no no
652 38820 0026741-53-7 bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphiteyes no yes 0,6
653 25270 0026747-90-0 2,4-toluene diisocyanate dimer no yes no (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety(10)
654 88600 0026836-47-5 sorbitol monostearate yes no no
655 25450 0026896-48-0 tricyclodecanedimethanol no yes no 0,05
656 24760 0026914-43-2 styrenesuphonic acid no yes no 0,05
657 67680 0027107-89-7 mono-n-octyltin 
tris(2-ethylhexyl mercaptoacetate)yes no no
(11)
658 52000 0027176-87-0 dodecylbenzenesulphonic acid yes no no 30
659 82800 0027194-74-7 1,2-propyleneglycol monolaurateyes no no
660 47540 0027458-90-8 di-tert-dodecyl disulphide yes no yes 0,05(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/51661 95360 0027676-62-6 1,3,5-tris(3,5-di-tert-butyl-4-
hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trioneyes no yes 5
662 25927 0027955-94-8 1,1,1-tris(4-hydroxyphenol) ethaneno yes no 0,005 Only to be used in polycarbonates(1)
663 64150 0028290-79-1 linolenic acid yes no no
664 95000 0028931-67-1 trimethylolpropane trimethacrylate-methyl methacrylate copolymeryes no no
665 83120 0029013-28-3 1,2-propyleneglycol monopalmitateyes no no
666 87280 0029116-98-1 sorbitan dioleate yes no no
667 55190 0029204-02-2 gadoleic acid yes no no
668 80240 0029894-35-7 polyglycerol ricinoleate yes no no
669 56610 0030233-64-8 glycerol monobehenate yes no no
670 56800 0030899-62-8 glycerol monolaurate diacetate yes no no (32)
671 74240 0031570-04-4 phosphorous acid, tris(2,4-di-tert-butylphenyl)esteryes no no
672 76845 0031831-53-5 polyester of 1,4-butanediol with caprolactoneyes no no (29)
(30)The fraction with molecular 
weight below 1 000 Da 
should not exceed 0,5 % (w/w)
673 53670 0032509-66-3 ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]yes no yes 6
674 46480 0032647-67-9 dibenzylidene sorbitol yes no no
675 38800 0032687-78-8 N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hy­drazideyes no yes 15
676 50400 0033568-99-9 di-n-octyltin bis(isooctyl male­ate)yes no no (10)
677 82560 0033587-20-1 1,2-propyleneglycol dipalmitate yes no no
678 59200
0035074-77-2 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)yes no yes 6
679 39060 0035958-30-6 1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethaneyes no yes 5(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/52 EN Official Journ alof the EuropeanUnion 15.1.2011680 94400 0036443-68-2 triethyleneglycol bis[3-(3-tert-
butyl-4-hydroxy-5-methylphenyl) propionate]yes no no 9
681 18310 0036653-82-4 1-hexadecanol no yes no
682 53270 0037205-99-5 ethylcarboxymethylcellulose yes no no
683 66200 0037206-01-2 methylcarboxymethylcellulose yes no no
684 68125 0037244-96-5 nepheline syenite yes no no
685 85950 0037296-97-2 silicic acid, magnesium-sodium-fluoride saltyes no no 0,15 SML expressed as fluoride.
Only to be used in layers of 
multi-layer materials not coming into direct contact with food.
686 61390 0037353-59-6 hydroxymethylcellulose yes no no
687 13530 0038103-06-9 2,2-bis(4-hydroxyphenyl) propane bis(phthalic anhydride)no yes no 0,05
13614
688 92560 0038613-77-3 tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphoniteyes no yes 18
689 95280 0040601-76-1 1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trioneyes no yes 6
690 92880 0041484-35-9 thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propi­onate)yes no yes 2,4
691 13600 0047465-97-4 3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinoneno yes no 1,8
692 52320 0052047-59-3 2-(4-dodecylphenyl)indole yes no yes 0,06
693 88160 0054140-20-4 sorbitan tripalmitate yes no no
694 21400 0054276-35-6 methacrylic acid, sulphopropyl esterno yes no 0,05 (1)
695 67520 0054849-38-6 monomethyltin tris(isooctyl 
mercaptoacetate)yes no no (9)
696 92205 0057569-40-1 terephthalic acid, diester with 
2,2′-methylenebis(4-methyl-6-tert-butylphenol)yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/53697 67515 0057583-34-3 monomethyltin tris(ethylhexyl 
mercaptoacetate)yes no no (9)
698 49595 0057583-35-4 dimethyltin bis(ethylhexyl mercaptoacetate)yes no no (9)
699 90720 0058446-52-9 stearoylbenzoylmethane yes no no
700 31520 0061167-58-6 acrylic acid, 2-tert-butyl-6-(3-
tert-butyl-2-hydroxy-5-
methylbenzyl)-4-methylphenyl esteryes no yes 6
701 40160 0061269-61-2 N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymeryes no no 2,4
702 87920 0061752-68-9 sorbitan tetrastearate yes no no
703 17170 0061788-47-4 fatty acids, coco no yes no
704 77600 0061788-85-0 polyethyleneglycol ester of hydrogenated castor oilyes no no
705 10599/90A 0061788-89-4 acids, fatty, unsaturated (C
18), 
dimers, non hydrogenated, distilled and non-distilledno yes no (18) (1)
10599/91
706 17230 0061790-12-3 fatty acids, tall oil no yes no
707 46375 0061790-53-2 diatomaceous earth yes no no
708 77520 0061791-12-6 polyethyleneglycol ester of castor oilyes no no 42
709 87520 0062568-11-0 sorbitan monobehenate yes no no
710 38700 0063397-60-4 bis(2-carbobutoxyethyl)tin-bis (isooctyl mercaptoacetate)yes no yes 18
711 42000 0063438-80-2 (2-carbobutoxyethyl)tin-tris (isooctyl mercaptoacetate)yes no yes 30
712 42960 0064147-40-6 castor oil, dehydrated yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/54 EN Official Journ alof the EuropeanUnion 15.1.2011713 43480 0064365-11-3 charcoal, activated yes no no Only for use in PET at 
maximum 10 mg/kg of 
polymer.
Same purity requirements as 
for Vegetable Carbon (E 153) set out by Commis­sion Directive 95/45/EC  (
4) 
with exception of ash con­tent which can be up to 10 % (w/w).
714 84400 0064365-17-9 rosin, hydrogenated, ester with pentaerythritolyes no no
715 46880 0065140-91-2 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium saltyes no no 6
716 60800 0065447-77-0 1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymeryes no no 30
717 84210 0065997-06-0 rosin, hydrogenated yes no no
718 84240 0065997-13-9 rosin, hydrogenated, ester with glycerolyes no no
719 65920 0066822-60-4 N-methacryloyloxyethyl-N,N-dimethyl-N-
carboxymethylammonium 
chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymersyes no no
720 67360 0067649-65-4 mono-n-dodecyltin tris(isooctyl mercaptoacetate)yes no no (25)
721 46800 0067845-93-6 3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl esteryes no no
722 17200 0068308-53-2 fatty acids, soya no yes no
723 88880 0068412-29-3 starch, hydrolysed yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/55724 24903 0068425-17-2 syrups, hydrolysed starch, 
hydrogenatedno yes no In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC  (
5)
725 77895 0068439-49-6 polyethyleneglycol (EO = 2-6) monoalkyl (C
16-C18) etheryes no no 0,05 The composition of this 
mixture is as follows:
—polyethyleneglycol 
(EO = 2-6)monoalkyl (C
16-C18) ether 
(approximately 28 %), 
—fatty alcohols (C16-C18) 
(approximately 48 %), 
—ethyleneglycol monoalkyl (C
16-C18) 
ether (approximately 24 %),
726 83599 0068442-12-6 reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltinyes no yes (9)
727 43360 0068442-85-3 cellulose, regenerated yes no no
728 75100 0068515-48-0
0028553-12-0phthalic acid, diesters with pri­
mary, saturated C
8-C10 
branched alcohols, more than 60 % C
9yes no no (26)
(32)Only to be used as:
(a) plasticiser in repeated 
use materials and articles;
(b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and 
follow-on formulae as 
defined by Directive 2006/141/EC or pro­cessed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.(7)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/56 EN Official Journ alof the EuropeanUnion 15.1.2011729 75105 0068515-49-1
0026761-40-0phthalic acid, diesters with pri­
mary, saturated C9-C11 alcohols 
more than 90 % C10yes no no (26)
(32)Only to be used as:
(a) plasticiser in repeated 
use materials and articles;
(b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and 
follow-on formulae as 
defined by Directive 2006/141/EC or pro­cessed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.(7)
730 66930 0068554-70-1 methylsilsesquioxane yes no no Residual monomer in meth­
ylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane
731 18220 0068564-88-5 N-heptylaminoundecanoic acid no yes no 0,05 (2)
732 45450 0068610-51-5 p-cresol-dicyclopentadiene-isobutylene, copolymeryes no yes 5
733 10599/92A 0068783-41-5 acids, fatty, unsaturated (C
18), 
dimers, hydrogenated, distilled and non-distilledno yes no (18) (1)
10599/93
734 46380 0068855-54-9 diatomaceous earth, soda ash flux-calcinedyes no no
735 40120 0068951-50-8 bis(polyethyleneglycol)hy­
droxymethylphosphonateyes no no 0,6
736 50960 0069226-44-4 di-n-octyltin ethyleneglycol bis­
(mercaptoacetate)yes no no (10)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/57737 77370 0070142-34-6 polyethyleneglycol-30 
dipolyhydroxystearateyes no no
738 60320 0070321-86-7 2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl] benzotriazoleyes no yes 1,5
739 70000 0070331-94-1 2,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-
propionate]yes no no
740 81200 0071878-19-8 poly[6-[(1,1,3,3-
tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino] hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]yes no yes 3
741 24070 0073138-82-6 resin acids and rosin acids yes yes no
83610
742 92700 0078301-43-6 2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymeryes no yes 5
743 38950 0079072-96-1 bis(4-ethylbenzylidene)sorbitol yes no no
744 18888 0080181-31-3 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymerno yes no The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I
745 68145 0080410-33-9 2,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite)yes no yes 5 SML expressed as sum of phosphite and phosphate
746 38810 0080693-00-1 bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphiteyes no yes 5 SML expressed as sum of phosphite and phosphate(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/58 EN Official Journ alof the EuropeanUnion 15.1.2011747 47600 0084030-61-5 di-n-dodecyltin bis(isooctyl 
mercaptoacetate)yes no yes (25)
748 12765 0084434-12-8 N-(2-aminoethyl)-β-alanine, sodium saltno yes no 0,05
749 66360 0085209-91-2 2,2′-methylene 
bis(4,6-di-tert-butylphenyl) 
sodium phosphateyes no yes 5
750 66350 0085209-93-4 2,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphateyes no no 5
751 81515 0087189-25-1 poly(zinc glycerolate) yes no no
752 39890 0087826-41 – 
30069158-41 – 40054686-97 – 
40081541-12-0bis(methylbenzylidene)sorbitol yes no no
753 62800 0092704-41-1 kaolin, calcined yes no no
754 56020 0099880-64-5 glycerol dibehenate yes no no
755 21765 0106246-33-7 4,4′-methylenebis(3-chloro-2,6-diethylaniline)no yes no 0,05 (1)
756 40020 0110553-27-0 2,4-bis(octylthiomethyl)-6-methylphenolyes no yes (24)
757 95725 0110638-71-6 vermiculite, reaction product with citric acid, lithium saltyes no no
758 38940 0110675-26-8 2,4-bis(dodecylthiomethyl)-6-methylphenolyes no yes (24)
759 54300 0118337-09-0 2,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphoniteyes no yes 6(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/59760 83595 0119345-01-6 reaction product of 
di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenylyes no no 18 Composition:
—4,4′-biphenylene-
bis[0,0-bis(2,4-di-tert-butylphenyl) phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)), 
—4,3′-biphenylene-bis[0,0-bis(2,4-di-tert-
butylphenyl) 
phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)), 
—3,3′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl) phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)), 
—4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl) phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)), 
—tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)), 
—4,4′-biphenylene-0,0-bis(2,4-di-tert-butylphenyl) phosphonate-0,0-bis(2,4-di-tert-butylphenyl) phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))
(*) Quantity of substance used/quantity of formu­lation
Other specifications:
—Phosphor content of 
min. 5,4 % to max. 5,9 %, 
—Acid value of max. 10 mg KOH per gram,  
—Melt range of 85– 
110 °C,(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/60 EN Official Journ alof the EuropeanUnion 15.1.2011761 92930 0120218-34-0 thiodiethanolbis(5-
methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate)yes no no 6
762 31530 0123968-25-2 acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl esteryes no yes 5
763 39925 0129228-21-3 3,3-bis(methoxymethyl)-2,5-
dimethylhexaneyes no yes 0,05
764 13317 0132459-54-2 N,N′-bis[4-(ethoxycarbonyl) 
phenyl]-1,4,5,8-naphthalenetetracarboxydiimideno yes no 0,05 Purity > 98,1 % (w/w).
Only to be used as 
co-monomer (max 4 %) for polyesters (PET, PBT).
765 49485 0134701-20-5 2,4-dimethyl-6-(1-methylpentadecyl)phenolyes no yes 1
766 38879 0135861-56-2 bis(3,4-dimethylbenzylidene) sorbitolyes no no
767 38510 0136504-96-6 1,2-bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazineyes no no 5
768 34850 0143925-92-2 amines, bis(hydrogenated tallow alkyl) oxidisedyes no no Not to be used for articles in contact with fatty foods 
for which simulant D is laid 
down.
Only to be used in:(a) polyolefins at 0,1 % 
(w/w) concentration and in
(b) PET at 0,25 % (w/w) concentration.(1)
769 74010 0145650-60-8 phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl esteryes no yes 5 SML expressed as sum of phosphite and phosphate
770 51700 0147315-50-2 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenolyes no no 0,05
771 34650 0151841-65-5 aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate]yes no no 5(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
N
N15.1.2011 EN Official Journ alof the EuropeanUnion L 12/61772 47500 0153250-52-3 N,N′-dicyclohexyl-2,6-
naphthalene dicarboxamideyes no no 5
773 38840 0154862-43-8 bis(2,4-dicumylphenyl) pentaerythritol-diphosphiteyes no yes 5 SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl) pentaerythritol-phosphate and its hydrolysis product 
(2,4-dicumylphenol)
774 95270 0161717-32-4 2,4,6-tris(tert-butyl)phenyl-2-
butyl-2-ethyl-1,3-propanediol phosphiteyes no yes 2 SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP
775 45705 0166412-78-8 1,2-cyclohexanedicarboxylic acid, diisononyl esteryes no no (32)
776 76723 0167883-16-1 polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanateyes no no The fraction with molecular weight below 1 000 Da 
should not exceed 1,5 % (w/w)
777 31542 0174254-23-0 acrylic acid, methyl ester, telomer with 1-dodecanethiol, C
16-C18 alkyl estersyes no no 0,5 % in final product (1)
778 71670 0178671-58-4 pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)yes no yes 0,05
779 39815 0182121-12-6 9,9-bis(methoxymethyl)fluorene yes no yes 0,05 (1)
780 81220 0192268-64-7 poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl) imino]]-α-[N,N,N′,N′-tetrabutyl-
″-(2,2,6,6-tetramethyl-4-
piperidinyl)- ″-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-
triamine]-ω-N,N,N′,N′-
tetrabutyl-1,3,5-triazine-2,4-diamine]yes no no 5(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/62 EN Official Journ alof the EuropeanUnion 15.1.2011781 95265 0227099-60-7 1,3,5-tris(4-benzoylphenyl) 
benzeneyes no no 0,05
782 76725 0661476-41-1 polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexaneyes no no The fraction with molecular weight below 1 000 Da 
should not exceed 1 % (w/w)
783 55910 0736150-63-3 glycerides, castor-oil mono-, 
hydrogenated, acetatesyes no no (32)
784 95420 0745070-61-5 1,3,5-tris 
(2,2-dimethylpropanamido) benzeneyes no no 0,05
785 24910 0000100-21-0 terephthalic acid no yes no (28)
786 14627 0000117-21-5 3-chlorophthalic anhydride no yes no 0,05 SML expressed as 
3-chlorophthalic acid
787 14628 0000118-45-6 4-chlorophthalic anhydride no yes no 0,05 SML expressed as 
4-chlorophthalic acid
788 21498 0002530-85-0 [3-(methacryloxy)propyl] trimethoxysilaneno yes no 0,05 Only to be used as a surface treatment agent of 
inorganic fillers(1)
(11)
789 60027 — hydrogenated homopolymers 
and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440–12 000)yes no no Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less 
than 3,8 cSt (3,8 × 10
-6 m2/s).(2)
790 80480 0090751-07-8
0082451-48-7poly(6-morpholino-1,3,5-
triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]yes no no 5 Average molecular weight not less than 2 400 Da.
Residual content of mor­pholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-
tetramethylpiperidin-4-
yl)hexane-1,6-diamine < 15 000 mg/kg, and of 
2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.(16)(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/63791 92470 0106990-43-6 N,N′,N″,N″-tetrakis(4,6-bis 
(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl) amino)triazin-2-yl)-4,7-diazadecane-1,10-diamineyes no no 0,05
792 92475 0203255-81-6 3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-
hydroxy-5-methylphenyl) 
propyl]oxyphosphonous acidyes no yes 5 SML expressed as the sum of phosphite and phosphate form of the substance and 
the hydrolysis products
793 94000 0000102-71-6 triethanolamine yes no no 0,05 SML expressed as the sum 
of triethanolamine and the 
hydrochloride adduct expressed as triethanolamine
794 18117 0000079-14-1 glycolic acid no yes no For indirect food contact 
only, behind a PET layer
795 40155 0124172-53-8 N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamineyes no no 0,05 (2)
(12)
796 72141 0018600-59-4 2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]yes no yes 0,05 SML including the sum of its hydrolysis products
797 76807 0007328-26-5 polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanolyes no yes (31)
(32)
798 92200 0006422-86-2 terephthalic acid, bis(2-
ethylhexyl)esteryes no no 60 (32)
799 77708 — polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C
8-C22) alcoholsyes no no 1,8 In compliance with the purity criteria for ethylene oxide as laid down in Direc­tive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 253, 20.9.2008, p. 1)
800 94425 0000867-13-0 triethyl phosphonoacetate yes no no Only for use in PET(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/64 EN Official Journ alof the EuropeanUnion 15.1.2011801 30607 — acids, C2-C24, aliphatic, linear, 
monocarboxylic, from natural 
oils and fats, lithium saltyes no no
802 33105 0146340-15-0 alcohols, C12-C14 secondary, 
β-(2-hydroxyethoxy), ethoxylatedyes no no 5 (12)
803 33535 0152261-33-1 α-alkenes(C
20-C24) copolymer 
with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidineyes no no Not to be used for articles in contact with fatty foods for which simulant D is laid down.
Not to be used in contact 
with alcoholic foods.(13)
804 80510 1010121-89-7 poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-
diiminooctane-1,8-diyl), process 
mixture with  x  =  1  and/or 5, 
neutralised with dodecylbenze­nesulfonic acidyes no no Only to be used as polymer production aid in polyethyl­ene (PE), polypropylene (PP) 
and polystyrene (PS)
805 93450 — titanium dioxide, coated with a 
copolymer of n-octyltrichlorosilane and [ami­notris(methylenephosphonic acid), penta sodium salt]yes no no The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w
806 14876 0001076-97-7 1,4-cyclohexanedicarboxylic acidno yes no 5 Only to be used for manu­facture of polyesters
807 93485 — titanium nitride, nanoparticles yes no no No migration of titanium 
nitride nanoparticles.
Only to be used in PET 
bottles up to 20 mg/kg.
In the PET, the agglomerates 
have a diameter of 100 – 500 nm consisting of pri­mary titanium nitride nano­particles; primary particles have a diameter of approxi­mately 20 nm.
808 38550 0882073-43-0 bis(4-propylbenzylidene) propylsorbitolyes no no 5 SML including the sum of its hydrolysis products(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/65809 49080 0852282-89-4 N-(2,6-diisopropylphenyl)-6-
[4-(1,1,3,3-tetramethylbutyl) phenoxy]-1H-benzo[de] isoquinolin-1,3(2H)-dioneyes no yes 0,05 Only for use in PET (6)
(14)
(15)
810 68119 neopentyl glycol, diesters and 
monoesters with benzoic acid and 2-ethylhexanoic acidyes no no 5 (32) Not to be used for articles in contact with fatty foods for which simulant D is laid down.
811 80077 0068441-17-8 polyethylene waxes, oxidised yes no no 60
812 80350 0124578-12-7 poly(12-hydroxystearic acid)-polyethyleneimine copolymeryes no no Only to be used in polyeth­ylene terephthalate (PET), polystyrene (PS), high impact polystyrene (HIPS) and polyamide (PA) up to 0,1 % w/w.
Prepared by the reaction of 
poly(12-hydroxystearic acid) with polyethyleneimine.
813 91530 — sulphosuccinic acid alkyl (C
4-C20) or cyclohexyl diesters, 
saltsyes no no 5
814 91815 — sulphosuccinic acid monoalkyl (C
10-C16) polyethyleneglycol 
esters, saltsyes no no 2
815 94985 — trimethylolpropane, mixed tri­esters and diesters with benzoic acid and 2-ethylhexanoic acidyes no no 5 (32) Not to be used for articles in contact with fatty foods for which simulant D is laid down
816 45704 — cis-1,2-cyclohexanedicarboxylic acid, saltsyes no no 5
817 38507 — cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, saltsyes no no 5 Not to be used with poly­ethylene in contact with acidic foods.
Purity ≥ 96 %.
818 21530 — methallylsulphonic acid, salts no yes no 5(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/66 EN Official Journ alof the EuropeanUnion 15.1.2011819 68110 — neodecanoic acid, salts yes no no 0,05 Not to be used in polymers 
contacting fatty foods.
Not to be used for articles 
in contact with fatty foods for which simulant D is laid down.
SML expressed as neode­
canoic acid.
820 76420 — pimelic acid, salts yes no no
821 90810 — stearoyl-2-lactylic acid, salts yes no no
822 71938 — perchloric acid, salts yes no no 0,05 (4)
823 24889 — 5-Sulphoisophthalic acid, salts no yes no 5
854 71943 0329238-24-6 perfluoro acetic acid, α-substituted with the copoly­mer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groupsyes no no Only to be used in concen­trations up to 0,5 % w/w in the polymerisation of fluo­ropolymers that are pro­cessed at temperatures at or above 340 °C and are intended for use in repeated use articles
860 71980 0051798-33-5 perfluoro[2-(poly(n-propoxy))propanoic acid]yes no no Only to be used in the poly­merisation of fluoropoly­
mers that are processed at 
temperatures at or above 265 °C and are intended for use in repeated use articles
861 71990 0013252-13-6 perfluoro[2-(n-propoxy)propanoic acid]yes no no Only to be used in the poly­merisation of fluoropoly­mers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles
862 15180 0018085-02-4 3,4-diacetoxy-1-butene no yes no 0,05 SML including the hydroly­
sis product 3,4-dihydroxy-1-butene.
Only for use as a 
co-monomer for ethyl vinyl alcohol copolymers.(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/67864 46330 0000056-06-4 2,4-diamino-6-
hydroxypyrimidineyes no no 5 Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food
865 40619 0025322-99-0 (butyl acrylate, methyl methacrylate, butyl methacrylate) copolymeryes no no Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 1 %
866 40620 — (butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylateyes no no Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %
867 40815 0040471-03-2 (butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymeryes no no Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %
868 53245 0009010-88-2 (ethyl acrylate, methyl methacrylate) copolymeryes no no Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %
869 66763 0027136-15-8 (butyl acrylate, methyl methacrylate, styrene) copolymeryes no no Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %
870 95500 0160535-46-6 N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamideyes no no 5
875 80345 0058128-22-6 poly(12-hydroxystearic acid) stearateyes no yes 5
878 31335 — acids, fatty (C
8-C22) from 
animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C
3-C22)yes no no
879 31336 — acids, fatty (C8-C22) from 
animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C
1-C22)yes no no(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)L 12/68 EN Official Journ alof the EuropeanUnion 15.1.2011880 31348 0085116-93-4 acids, fatty (C8-C22), esters with 
pentaerythritolyes no no
881 25187 0003010-96-6 2,2,4,4-tetramethylcyclobutane-
1,3-diolno yes no 5 Only for repeated use articles for long term storage at room temperature or below and hotfill
882 25872 0002416-94-6 2,3,6-trimethylphenol no yes no 0,05
883 22074 0004457-71-0 3-methyl-1,5-pentanediol no yes no 0,05 Only to be used in 
materials in contact with food at a surface to mass ratio up to 0,5 dm
2/kg
884 34240 0091082-17-6 alkyl(C10-C21)sulphonic acid, 
esters with phenolyes no no 0,05 Not to be used for articles in contact with fatty foods for which simulant D is laid down.
885 45676 0263244-54-8 cyclic oligomers of (butylene terephthalate)yes no no Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact 
with aqueous, acidic and 
alcoholic foods, for long term storage at room temperature.
(1)OJ L 302, 19.11.2005, p. 28. 
(2)OJ L 330, 5.12.1998, p. 32. 
(3)OJ L 253, 20.9.2008, p. 1. 
(4)OJ L 226, 22.9.1995, p. 1. 
(5)OJ L 158, 18.6.2008, p. 17.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/69
2. Group restriction of su bstances
Table 
2 on 
Group restriction s 
contains 
the followin g 
information:
Column 
1 (Group restriction  
No): contains 
the identification 
number 
of the group 
of substances 
for which the g roup 
restriction  
applies. It 
is the number 
referred to in  
Column 
9 in 
Table 
1 of this An nex.
Column 
2 (FCM sub stance 
No): contains 
the unique 
identification 
numbers 
of the sub stances 
for which the g roup 
restric­
tion 
applies. It 
is the number 
referred to in  
Column 
1 in 
Table 
1 of this An nex
.
Column 3 (SML (T) [mg /kg]):
 contains
 the total specific mig ration
 limit for the sum of sub stances
 applicable
 to this 
group. 
It 
is expressed in  
mg 
substance 
per kg 
food. It 
is indicated 
ND if the sub stance 
shall not 
migrate 
in 
detectable 
quantities.
Column 
4 (Group restriction  
specification ): 
contains 
an 
indication 
of the sub stance 
whose molecular weig ht 
forms the 
basis 
for expression  
of the result.
Table 2
(1) (2) (3) (4)
Group 
Restriction  
NoFCM 
substance 
NoSML (T)
[mg/kg]Group 
restriction  
specification
1 128
2116 expressed as acetaldehyde
28 9
22726330 expressed as ethylen
eglycol
3 234
24830 expressed 
as maleic acid
4 212
43515 expressed as caprolactam
5 1374723 expressed as the sum of the sub
stances
6 4125125135881 expressed 
as iodine
7
19
201,2 expressed as tertiary amin e
8 317318319359
431
4646 expressed 
as the sum of the sub stances
9 6506956976987260,18 expressed 
as tin(1) (2) (3) (4)L 12/70 EN Official Journ alof the EuropeanUnion 15.1.2011
10 28
2930313233
466582618619620
646
6767360,006 expressed as tin
11 66
6456571,2 expressed as tin
12 44446947030 expressed as the sum of the sub
stances
13 1632851,5 expressed 
as the sum of the sub stances
14 294
3685 expressed 
as the sum of the sub stances
15 98
19615 expressed 
as formaldehyde
16 407
5835845996 expressed as b
oron
Without 
prejudice to the provision s 
of Directive 98/83/E C
17 4
167169198274354372460461
475
476485490653ND expressed 
as isocyan ate 
moiety
18 7057330,05 expressed as the sum of the sub
stances
19 50551651910 expressed 
as SO2
20 29038639030 expressed as the sum of the sub
stances
21 3473495 expressed 
as trimellitic acid(1) (2) (3) (4)15.1.2011 EN Official Journ alof the EuropeanUnion L 12/71
22 70
147
176218323325365371
380
4254464484566366 expressed as acrylic acid
23 1501561811831843553703744394404474574826 expressed as methacrylic acid
24 7567585 expressed as the sum of the sub
stances
25 7207470,05 sum 
of mono-n-dodecyltin 
tris(isooctylmercaptoacetate), di-n -
dodecyltin  
bis(isooctyl 
mercaptoacetate), mon o-dodecyltin 
trichloride 
and 
di-dodecyltin  
dichloride) expressed as the sum 
of mono- 
and 
di-dodecyltin  
chloride
26 7287299 expressed as the sum of the sub
stances
27 1882915 expressed 
as isophthalic acid
28 1911927857,5 expressed as terephthalic acid
29 3426720,05 expressed as the sum of 6-hydroxyhexan
oic 
acid and 
caprolac­
tone
30 254
6725 expressed 
as 1,4-butanediol
31 73
79730 expressed 
as the sum of the sub stances
32 8
72
73
138140157159207242283532670728729775783
797
79881081560 expressed 
as the sum of the sub stancesL 12/72 EN Official Journ alof the EuropeanUnion 15.1.2011
3. Notes on verification of compliance
Table 
3 on 
notes 
on 
verification  
of complian ce 
contains 
the followin g 
info
rmation:
Column 
1 (Note No): con tains 
the identification 
number 
of the Note. I t 
is the number 
referred to in  
Column 
11 in 
Table 
1 
of this An nex.
Column 
2 (Notes on  
verification  
of complian ce): 
contains 
rules that shall b e 
respected when  
testing 
for complian ce 
of 
the substance 
with specific mig ration 
limits or other restriction s 
or it contains 
remarks 
on 
situations 
where there is a 
risk 
of non-compliance.
Table 
3
(1) (2)
Note No Notes on 
verification  
of complian ce
(1) Verification  of complian ce by residual con tent per food con tact surface area (QMA) pen ding the 
availability 
of an 
analytical 
method.
(2) There is a risk  
that the SML or OML could b e 
exceeded in  
fatty food simulants.
(3) There is a risk  
that the mig ration 
of the sub stance 
deteriorates the organ oleptic 
characteristics of the 
food in 
contact 
and 
then, 
that the fin al 
product does n ot 
comply with Article 3(1) c of the Framework  
Regulation 
(EC) 
No 1935/2004.
(4) Complian ce
 testing
 when there is a fat contact should b e
 performed usin g saturated fatty food 
simulants 
as simulan t 
D.
(5) Complian ce 
testing 
when 
there is a fat con tact 
should be 
performed using  
isooctane 
as substitute 
of 
simulant 
D2 (unstable).
(6) Migration 
limit might 
be 
exceeded at very hig h 
temperature.
(7) If 
testing 
in 
food is performed, An nex 
V 1.4 shall b e 
taken 
into 
account.
(8) Verification
 of complian ce
 by
 residual con tent
 per food con tact
 surface area (QMA); QMA = 
0,005 mg /6 
dm2.
(9) Verification  
of complian ce 
by 
residual con tent 
per food con tact 
surface area (QMA) pen ding 
the 
availability 
of analytical 
method for mig ration 
testing. 
The ratio surface to quan tity 
of food shall b e 
lower 
than 
2dm2/kg.
(10) Verification  
of complian ce 
by 
residual con tent 
per food con tact 
surface area (QMA) in  
case of reaction  
with 
food or simulan t.
(11) Only 
a method of an alysis 
for the determin ation 
of the residual mon ome
r in 
the treated filler is 
available.
(12) There 
is a risk 
that the SML could b e 
exceeded from polyolefin s.
(13) Only 
a method for determin ation 
of the con tent 
in 
polymer an d 
a method for determin ation 
of the 
starting 
substances 
in 
food simulan ts 
are availab le.
(14) There 
is a risk 
that the SML could b e 
exceeded from plastics con taining 
more than  
0,5 % w/w of the 
substance.
(15) There 
is a risk 
that the SML could b e 
exceeded in  
contact 
with foods with hig h 
alcoholic con tent.
(16) There 
is a risk 
that the SML could b e 
exceeded from low-den sity 
polyethylen e 
(LDPE) 
containing 
more 
than 
0,3 % w/w of the sub stance 
when 
in 
contact 
with fatty foods
(17) Only 
a method for determin ation 
of the residual con tent 
of the sub stan
ce in 
the polymer is availab le
4.
 Detailed 
specification on su bstances
Table 
4 on 
detailed specification s 
on 
substances 
contains 
the followin g 
information
Column 
1 (FCM sub stance 
No): contains 
the unique 
identification 
number 
of the sub stances 
referred to in  
Column 
1 in 
Table 
1 of Annex 
I 
to which the specification  
applies.
Column 
2 (Detailed specification  
on 
the substance): 
contains 
the specification  
on 
the substance.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/73Table 4
(1) (2)
FCM 
substance NoDetailed specification on the substance
744 Definition The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used 
has not been genetically engineered and has been derived from a single wildtype organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications
Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number 0080181-31-3
Structural formula
where n/(m + n) greater than 0 and less or equal to 0,25
Average molecular weightNot less than 150 000 Daltons (measured by gel permeation chromatography)
Assay Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentanoate) analysed after hydrolysis as a mixture of 3-D-hydro-xybutanoic and 3-D-hydroxypentanoic acids
Description White to off-white powder after isolation
Characteristics
Identification tests:Solubility Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
Restriction QMA for crotonic acid is 0,05 mg/6 dm
2
Purity Prior to granulation the raw material copolymer powder must contain:
—nitrogen, Not more than 2 500 mg/kg of plastic
—zinc, Not more than 100 mg/kg of plastic
—copper, Not more than 5 mg/kg of plastic
—lead, Not more than 2 mg/kg of plastic
—arsenic, Not more than 1 mg/kg of plastic
—chromium, Not more than 1 mg/kg of plasticL 12/74 EN Official Journ alof the EuropeanUnion 15.1.2011
ANNEX II
Restrictions on materials and articles
1. Plastic materials an d 
articles shall n ot 
release the followin g 
substan
ces in 
quantities 
exceeding 
the specific mig ration 
lim­
its below: 
Barium 
= 1 mg/kg 
food or food simulan t. 
Cobalt 
= 0,05 mg /kg 
food or food simulan t. 
Copper 
= 5 mg/kg 
food or food simulan t. 
Iron 
= 48 mg/kg 
food or food simulan t. 
Lithium 
= 0,6 mg/kg 
food or food simulan t. 
Manganese 
= 0,6 mg/kg 
food or food simulan t. 
Zinc 
= 25 mg/kg 
food or food simulan t. 
2. Plastic 
materials an d 
articles shall n ot 
release primary aromatic amines, excludin g 
those appearin g 
in 
Table 
1 of Annex 
I, 
in 
a detectab le 
quantity 
into 
food or food simulan t. 
The detection  
limit is 0,01 mg  
of substance 
per kg 
of food or food 
simulant. 
The detection  
limit applies to the sum of primary aromatic amin e
s released. 15.1.2011 EN Official Journ alof the EuropeanUnion L 12/75
ANNEX III
Food 
simulants
1.
 Food 
simulants
For 
demonstration 
of complian ce 
for plastic materials an d 
articles not 
yet in 
contact 
with food the food simulan ts 
listed 
in 
Table 
1 below 
are assigned.
Table 
1
List of food simu lants
Food simulan t Abbreviation
Ethanol 10 % (v/v) Food simulant A
Acetic acid 3 % (w/v) Food simulan t 
B
Ethanol 
20 % (v/v) Food simulan t 
C
Ethanol 
50 % (v/v) Food simulan t 
D1
Vegetable 
oil (*) Food simulan t D2
poly(2,6-diphen yl-p-phenylene 
oxide), particle size 
60-80 mesh, pore size 200 n mFood 
simulant 
E
(*)This may b e any vegetable oil with a fatty acid distrib ution of
No of carb on 
atoms in 
fatty acid chain : 
No of 
unsaturation6-12 14 16 18:0 18:1 18:2 18:3
Range 
of fatty acid composition  
expressed % 
(w/w) of methyl esters b y 
Gas chromatog raphy<
 1 < 1 1,5-20 < 7 15-85 5-70 < 1,5
2. General assignment of food simu lants to foods
Food simulan ts 
A, B and 
C are assig ned 
for foods that have a hydrophilic character an d 
are able 
to extract hydrophilic 
substances. 
Food simulan t 
B shall be 
used for those foods which have a pH b el
ow 4.5. Food simulan t 
C shall be 
used for 
alcoholic foods with an  
alcohol con tent 
of up to 20 % an d 
those foods which contain a relevant amount of org anic 
ingre­
dients 
that render 
the food more lipophilic.
Food simulan ts 
D1 and 
D2 are assig ned 
for foods that have a lipophilic character an d 
are able 
to extract lipophilic sub ­
stances. 
Food simulan t 
D1 shall b e 
used for alcoholic foods with an  
alcohol con tent 
of above 
20 % and 
for oil in 
water 
emulsions. 
Food simulan t 
D2 shall b e 
used for foods which con tain 
free fats at the surface.
Food simulan t 
E 
is assigned 
for testing 
specific mig ration 
into 
dry foods.
3. Specific assignment of food simu lants 
to foods for migration testing of materials and articles not yet in contact 
with food
For testing 
migration 
from materials an d 
articles not 
yet in 
contact 
with food the food simulan ts 
that correspon ds 
to a 
certain 
food categ ory 
shall be 
chosen 
according 
Table 
2 below.
For 
testing 
overall mig ration 
from materials an d 
articles intended 
to come in to 
contact 
with differen t 
food categ ories 
or 
a combination 
of food categ ories 
the food simulan t 
assignment 
in 
point 
4 is applicab le.
Table 
2 contains 
the followin g 
information:
Column 
1 (Referen ce 
number): 
contains 
the referen ce 
number 
of the food categ ory.
Column 
2 (Description  
of food): con tains 
a description  
of the foods covered b y 
the food categ ory
Column 
3 (Food simulan ts): 
contains 
sub-columns 
for each of the food simulan tsL 12/76 EN Official Journ alof the EuropeanUnion 15.1.2011
The food simulan t for which a cross is con tained in the respective sub -column of column  3 shall be used when  testing 
migration 
of materials an d 
articles not 
yet in 
contact 
with food.
For food categ ories 
where in 
sub-column 
D2 the cross is followed b y 
an 
obliq
ue stroke 
and 
a figure, 
the migration 
test 
result shall b e 
divided by 
this figure 
before 
comparin g 
the result with the mig ration 
limit. The fig ure 
is the correction  
factor 
referred to in  
point 
4.2 of An nex 
V to this Reg ulation.
For 
food categ ory 
01.04 food simulan t 
D2 shall b e 
replaced b y 
95 % ethan ol.
For 
food categ ories 
where in 
sub-column 
B the cross is followed b y 
(*) the testin g 
in 
food simulan t 
B can 
be 
omitted if 
the food has a pH of more than  
4.5.
For food categ ories 
where in 
sub-column 
D2 the cross is followed b y 
(**) the testin g 
in 
food simulan t 
D2 can 
be 
omitted 
if it can 
be 
demonstrated 
by 
means 
of an 
appropriate test that there is n o ‘
fatty contact
’ with the plastic food con tact 
material.
Table 
2
food category specific assignment of food simu lants
(1) (2) (3)
Reference 
numberDescription  
of foodFood simulan ts
A
B C D1 D2 E
01 Beverages
01.01 Non-alcoholic 
beverages 
or alcoholic b everages 
of
 an alcoholic stren gth
 lower than or equal 
to 6 % vol.:
A. Clear drin ks:
Water,
 ciders, clear fruit or veg etable
 juices of 
normal
 strength
 or concentrated,
 fruit nectars,
 
lemonades, 
syrups, bitters, 
infusions, 
coffee, tea, 
beers, 
soft drinks, 
energy 
drinks 
and 
the like, 
fla­
voured water, liquid coffee extractX(*) X
B. cloudy drin ks:
juices 
and 
nectars 
and 
soft drinks 
containing 
fruit 
pulp, musts con taining 
fruit pulp, liquid choco­
lateX(*) X
01.02 Alcoholic b everages
 of an alcoholic stren gth
 of 
between 
6 %vol an d 
20 %.X
01.03 Alcoholic b everages
 of an alcoholic stren gth
 
above 
20 % and 
all cream liquorsX
01.04 Miscellaneous: 
undenaturated 
ethyl alcohol X(*) Substitute 
95 
% 
ethanol
02 Cereals,
 cereal produ cts,
 pastry, biscu its,
 
cakes and other bakers’ wares
02.01 Starches X
02.02 Cereals, un processed, 
puffed, in 
flakes 
(including 
popcorn, 
corn 
flakes 
and 
the like)X
02.03 Cereal 
flour and 
meal X
02.04 Dry pasta e.g .
 macaron i,
 spaghetti
 and
 similar 
products an d 
fresh pastaX(1) (2) (3)
Reference
numberDescription
of foodFood simulan ts
AB
C D 1 D 2E15.1.2011 EN Official Journ alof the EuropeanUnion L 12/77
02.05 Pastry, biscuits, cakes, bread, and other bakers’ 
wares, 
dry:
A. With fatty sub stances 
on 
the surface X/3
B. Other X
02.06 Pastry, cak es, 
bread, 
dough 
and 
other bakers’ 
wares, 
fresh:
A. With fatty sub stances 
on 
the surface X/3
B. Other X
03 Chocolate, su gar 
and produ cts 
thereof
Confectionery produ cts
03.01 Chocolate,  
chocolate-coated products, sub sti
­
tutes and 
products coated with sub stitutesX/3
03.02 Confectionery 
products:
A. In 
solid form:
I. With 
fatty substances 
on 
the surface X/3
II. Other X
B. In 
paste form:
I. With 
fatty substances 
on 
the surface X/2
II. Moist X
03.03 Sugar 
and 
sugar 
products
A. In 
solid form: crystal or powder X
B. Molasses, sug ar 
syrups, hon ey 
and 
the like X
04 Fruit, 
vegetables and produ cts 
thereof
04.01 Whole fruit, fresh or chilled, un peeled
04.02 Processed 
fruit:
A. Dried or dehydrated fruits, whole, sliced, 
flour or powderX
B. Fruit in 
the form of purée, preserves, pastes 
or in 
its own 
juice or in  
sugar 
syrup (jams, 
compote, an d 
similar products)X(*) X
C. Fruit preserved in  
a liquid medium:
I. In 
an 
oily medium X
II. In 
an 
alcoholic medium X
04.03 Nuts (pean uts,
 chestnuts,
 almonds,
 hazelnuts,
 
walnuts, 
pine 
kernels 
and 
others):
A. Shelled, dried, flak ed 
or powdered X
B. Shelled an d 
roasted X
C. In 
paste or cream form X X(1) (2) (3)
Reference
numberDescription
of foodFood simulan ts
AB
C D 1 D 2EL 12/78 EN Official Journ alof the EuropeanUnion 15.1.2011
04.04 Whole veg etables, fresh or chilled, un peeled
04.05 Processed 
vegetables:
A. Dried 
or dehydrated veg etables 
whole, sliced 
or in 
the form of flour or powderX
B. Fresh vegetables, 
peeled or cut X
C. Vegetables
 in the form of purée, preserves, 
pastes or in  
its own 
juice (including 
pickled 
and 
in 
brine)X(*) X
D. Preserved 
vegetables:
I. In 
an 
oily medium X X
II. In 
an 
alcoholic medium X
05 Fats 
and oils
05.01 Animals 
and 
vegetable 
fats and 
oils, whether 
natural
 or treated (in cluding
 cocoa butter,
 lard, 
resolidified b utter)X
05.02 Margarine,
 butter
 and
 other fats an d
 oils made 
from water emulsion s 
in 
oilX/2
06 Animal produ cts 
and eggs
06.01 Fish:
A. Fresh, chilled, processed, salted or smok ed
 
including 
fish eggsX X/3(**)
B. Preserved 
fish:
I. In 
an 
oily medium X X
II. In 
an 
aqueous medium X(*) X
06.02 Crustacean s
 and 
molluscs (in cluding
 oysters, 
mussels, sn ails)
A. Fresh 
within 
the shell
B. Shell removed, processed, preserved or 
cooked 
with the shell
I. In 
an 
oily medium X X
II. In 
an 
aqueous medium X(*) X
06.03 Meat of all zoolog ical 
species (in cluding 
poultry 
and 
game):
A. Fresh, 
chilled, salted, smok ed X X/4(**)
B.
 Processed meat products (such as ham, 
salami, bacon, 
sausages, 
and 
other) or in  
the 
form of paste, creamsX X/4(**)
C. Marinated 
meat products in  
an 
oily medium X X
06.04 Preserved meat:A. I
n 
an 
fatty or oily medium X X/3
B. In 
an 
aqueous medium X(*) X
06.05 Whole eg gs, 
egg 
yolk, 
egg 
white
A. Powdered or dried or frozen X
B. Liquid and 
cooked X(1) (2) (3)
Reference
numberDescription
of foodFood simulan ts
AB
C D 1 D 2E15.1.2011 EN Official Journ alof the EuropeanUnion L 12/79
07 Milk produ cts
07.01 Milk
A. Milk 
and 
milk 
based 
drinks 
whole, partly 
dried and 
skimmed 
or partly sk immedX
B. Milk 
powder in cluding 
infant 
formula (b ased 
on 
whole milk  
powder)X
07.02 Fermented 
milk 
such as yog hurt, 
buttermilk 
and 
similar 
productsX(*) X
07.03 Cream an d 
sour cream X(*) X
07.04 Cheeses:A. Whole, with n
ot 
edible 
rind X
B.
 Natural cheese without rin d
 or with edib le
 
rind
 (gouda,
 camemb ert,
 and
 the like)
 and
 
melting 
cheeseX/3(**)
C. Processed cheese (soft cheese, cottag e 
cheese 
and 
similar)X(*) X
D. Preserved cheese:
I. In 
an 
oily medium X X
II.
 In
 an aqueous medium (feta, mozarella, 
and 
similar)X(*) X
08 Miscellaneou s 
products
08.01 Vinegar X
08.02 Fried 
or roasted foods:
A. Fried potatoes, fritters an d 
the like X X/5
B. Of 
animal 
origin X X/4
08.03 Preparation s 
for soups, b roths, 
sauces, in  
liquid, 
solid or powder form (extracts, con centrates); 
homogenised 
composite food preparation s, 
pre­
pared dishes in cluding 
yeast and 
raising 
agents
A. Powdered 
or dried:
I. With 
fatty character X/5
II. Other X
B. any 
other form than  
powdered or dried:
I. With 
fatty character X X(*) X/3
II. Other X(*) X
08.04 Sauces:A. With 
aqueous character X(*) X
B. With fatty character e.g . 
mayonnaise, 
sauces 
derived from mayon naise, 
salad creams an d 
other
 oil/water mixtures e.g .
 coconut
 based
 
saucesX X(*) X
08.05 Mustard (except powdered mustard un der 
head­
ing 
08.14)X X(*) X/3(**)(1) (2) (3)
Reference
numberDescription
of foodFood simulan ts
AB
C D 1 D 2EL 12/80 EN Official Journ alof the EuropeanUnion 15.1.2011
08.06 Sandwiches,  toasted bread  pizza and the lik e  
containing 
any 
kind 
of foodstuff
A. With fatty sub stances 
on 
the surface X X/5
B. Other X
08.07 Ice-creams X
08.08 Dried 
foods:
A. With fatty sub stances 
on 
the surface X/5
B. Other X
08.09 Frozen 
or deep-frozen  
foods X
08.10 Concentrated
 extracts of an alcoholic stren gth
 
equal to or exceedin g 
6 % vol.X(*) X
08.11 Cocoa:
A. Cocoa powder, in cluding
 fat-reduced an d
 
highly 
fat reducedX
B. Cocoa paste X/3
08.12 Coffee, whether or n ot 
roasted, decaffein ated 
or 
soluble,
 coffee sub stitutes,
 granulated
 or pow­
deredX
08.13 Aromatic herb s
 and
 other herb s
 such as camo­
mile, mallow, min t, 
tea, lime b lossom 
and 
othersX
08.14 Spices and 
seasonings 
in 
the natural 
state such as 
cinnamon, 
cloves, powdered mustard, pepper, 
vanilla, 
saffron, 
salt and 
otherX
08.15 Spices an d 
seasoning 
in 
oily medium such as 
pesto, curry pasteX
4. Food 
simulant 
assignment for testing overall migration
To demon strate 
compliance 
with the overall mig ration 
limit for all type of foods testin g 
in 
distilled water or water of 
equivalent 
quality or food simulan t 
A and 
food simulan t 
B and 
simulant 
D2 shall b e 
performed.
To demon strate 
compliance 
with the overall mig ration 
limit for all types of food except for acidic foods testin g 
in 
dis­
tilled water or water of equivalen t 
quality or food simulan t 
A and 
food simulan t 
D2 shall b e 
performed.
To demon strate 
compliance 
with the overall mig ration 
limit for all aqueous an d 
alcoholic foods an d 
milk 
products test­
ing 
in 
food simulan t 
D1 shall b e 
performed.
To demon strate 
compliance 
with the overall mig ration 
limit for all aqueous, acidic an d 
alcoholic foods an d 
milk 
prod­
ucts testin g 
in 
food simulan t 
D1 and 
food simulan t 
B shall be 
performed.
To demon strate 
compliance 
with the overall mig ration 
limit for all aqueous foods an d 
alcoholic foods up to an  
alcohol 
content 
of 20 % testin g 
in 
food simulan t 
C shall be 
performed.
To demon strate 
compliance 
with the overall mig ration 
limit for all aqueous an d 
acidic foods an d 
alcoholic foods up to 
an 
alcohol con tent 
of 20 % testin g 
in 
food simulan t 
C and 
food simulan t 
B shall be 
performed.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/81
ANNEX IV
Declaration 
of compliance
The written  
declaration  
referred to in  
Article 15 shall con tain 
the followin g 
information:
(1) the 
identity 
and 
address of the b usiness 
operator issuin g 
the declaration  
of complian ce;
(2)
 the identity
 and
 address of the b usiness
 operator which man ufactures
 or imports the plastic materials or articles or 
products from in termediate 
stages 
of their man ufacturing 
or the sub stanc
es intended 
for the man ufacturing 
of those 
materials an d 
articles;
(3) the identity 
of the materials, the articles, products from in termedia
te stages 
of manufacture 
or the sub stances 
intended 
for 
the manufacturing 
of those materials an d 
articles;
(4) the date of the declaration ;
(5) confirmation 
that the plastic materials or articles, products from intermediate stag es 
of manufacture 
or the sub stances 
meet 
relevant 
requiremen ts 
laid down  
in 
this Regulation 
and 
Regulation 
(EC) No 1935/2004;
(6) adequate in formation 
relative to the sub stances 
used or products of deg radation 
thereof for which restriction s 
and/or 
specification s 
are set out in  
Annexes 
I 
and 
II 
to this Reg ulation 
to allow the down stream 
business 
operators to en sure 
compliance 
with those restriction s;
(7) adequate 
information 
relative to the sub stances 
which are sub ject 
to a restriction  
in 
food, obtained 
by 
experimen tal 
data 
or theoretical calculation  
about 
the level of their specific mig rati
on 
and, 
where appropriate, purity criteria in  
accor­
dance 
with Directives 2008/60/E C, 
95/45/EC 
and 
2008/84/E C 
to enable 
the user of these materials or articles to com­
ply with the relevan t 
EU 
provisions 
or, in 
their absence, 
with national 
provisions 
applicable 
to food;
(8) specification s 
on 
the use of the material or article, such as:
(i) type or types of food with which it is in tended 
to be 
put in 
contact;
(ii) time 
and 
temperature of treatmen t 
and 
storage 
in 
contact 
with the food;
(iii) ratio of food con tact 
surface area to volume used to estab lish 
the complian ce 
of the material or article;
(9) when 
a functional 
barrier 
is used in 
a multi-layer material or article, the con firmation 
that the material or article com­
plies with the requiremen ts 
of Article 13(2), (3) an d 
(4) or Article 14(2) an d 
(3) of this Reg ulation.L 12/82 EN Official Journ alof the EuropeanUnion 15.1.2011
ANNEX V
COMPLIANCE TESTING
For testing 
compliance 
of migration 
from plastic food con tact 
materials an d 
articles the followin g 
general 
rules apply.
CHAPTER 
1
Testing for specific migration of materials and articles already in contact with food
1.1. Sample preparation
The material or article shall b e 
stored as in dicated 
on 
the packaging 
label 
or under 
conditions 
adequate for the pack ­
aged 
food if no 
instructions 
are given. 
The food shall b e 
removed from con ta
ct with the material or article b efore 
its 
expiration  
date or an y 
date by 
which the man ufacturer 
has indicated 
the product should b e 
used for reason s 
of quality 
or safety.
1.2. Conditions of testing
The food shall b e 
treated in 
accordance 
with the cook ing 
instructions 
on 
the package 
if the food is to b e 
cooked 
in 
the 
package. 
Parts of the food which are n ot 
intended 
to be 
eaten 
shall be 
removed an d 
discarded. The remain der 
shall be 
homogenised 
and 
analysed 
for migration. 
The analytical results shall always b e 
expressed on  
the basis 
of the food mass 
that is intended 
to be 
eaten, 
in 
contact 
with the food con tact 
material.
1.3. Analysis of migrated su bstances
The 
specific mig ration 
is analysed 
in 
the food usin g 
an 
analytical 
method in  
accordance 
with the requiremen ts 
of 
Article 11 of Reg ulation 
(EC) 
No 882/2004.
1.4. Special cases
When 
contamination 
occurs from sources other than  
food contact 
materials this has to b e 
taken 
into 
account 
when 
testing 
for complian ce 
of the food con tact 
materials, in  
particular for phthalates (FCM sub stance 
157, 159, 283, 728, 
729) referred to in  
Annex 
I.
CHAPTER 
2
Testing for specific migration of materials and articles not yet in contact with food
2.1. Verification method
Verification of complian ce
 of migration
 into
 foods with the migration limits shall b e
 carried out un der
 the most 
extreme con ditions 
of time an d 
temperature foreseeab le 
in 
actual use tak i
ng 
into 
account 
paragraphs 
1.4, 2.1.1, 2.1.6 
and 
2.1.7.
Verification  
of complian ce 
of migration 
into 
food simulan ts 
with the mig r
ation 
limits shall b e 
carried out usin g 
con­
ventional 
migration 
tests accordin g 
to the rules set out in  
paragraphs 
2.1.1 to 2.1.7.
2.1.1. Sample preparation
The material or article shall b e 
treated as describ ed 
by 
accompan ying 
inst
ructions 
or by 
provisions 
given 
in 
the dec­
laration 
of complian ce.
Migration 
is determin ed 
on 
the material or article or, if this is impractical, on  
a specimen  
taken 
from the material or 
article, or a specimen  
representative 
of this material or article. For each food simulan t 
or food type, a n ew 
test speci­
men 
is used. On ly 
those parts of the sample which are in tended 
to come in to 
contact 
with foods in  
actual use shall 
be 
placed in 
contact 
with the food simulan t 
or the food.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/83
2.1.2. Choice of food simulant
Materials an d 
articles in tended 
for contact 
with all types of food shall b e 
tested with food simulan t 
A, B and 
D2. 
However, if sub stances 
that may react with acidic food simulan t 
or foods are n ot 
present 
testing 
in 
food simulan t 
B 
can 
be 
omitted.
Materials an d 
articles in tended 
only 
for specific types of foods shall b e 
tested with the food simulan ts 
indicated 
for 
the food types in  
Annex 
III.
2.1.3.
 Conditions of contact when using food simulants
The sample shall b e 
placed in 
contact 
with the food simulan t 
in 
a manner 
representing 
the worst of the foreseeab le 
conditions 
of use as reg ard 
contact 
time in 
Table 
1 and 
as regard 
contact 
temperature in  
Table 
2.
If
 it is foun d
 that carryin g
 out the tests under the comb ination
 of contact
 conditions
 specified in Tab les
 1 and
 2 
causes physical or other chan ges 
in 
the test specimen  
which do n ot 
occur und
er worst foreseeab le 
conditions 
of use 
of the material or article un der 
examination, 
the migration 
tests shall b e 
carried out un der 
the worst foreseeab le 
con­
ditions 
of use in 
which these physical or other chan ges 
do not 
take 
place.
Table 1
Contact time
Contact time in worst foreseeab le use Test time
t ≤ 5 min 5 min
5   m i n  <  t  ≤  0 , 5  hour 0,5 hour
0,5 hours  <  t  ≤  1  hour 1 hour
1   h o u r  <  t  ≤  2  hours 2 hours
2 hours  <  t  ≤  6  hours 6 hours
6 hours  <  t  ≤  2 4  hours 24 hours
1  d a y  <  t  ≤  3  days 3 days
3  d a y s  <  t  ≤  3 0  days 10 days
Above 
30 days See specific con ditions
Table 
2
Contact temperatu re
Conditions of contact in worst foreseeab le use Test conditions
Contact 
temperature Test temperature
T  ≤  5   ° C 5   ° C
5   ° C  <  T  ≤  2 0   ° C 2 0   ° C
2 0   ° C  <  T  ≤  4 0   ° C 4 0   ° C
4 0   ° C  <  T  ≤  7 0   ° C 7 0   ° C
7 0   ° C  <  T  ≤  1 0 0   ° C 1 0 0   ° C  o r  reflux temperature
1 0 0   ° C  <  T  ≤  1 2 1   ° C 1 2 1   ° C  (*)
1 2 1   ° C  <  T  ≤  1 3 0   ° C 1 3 0   ° C  (*)
1 3 0   ° C  <  T  ≤  1 5 0   ° C 1 5 0   ° C  (*)
1 5 0   ° C  <  T  <  1 7 5   ° C 1 7 5   ° C  (*)
T > 175 ° C Adjust 
the temperature to the real temperature at the 
interface 
with the food (*)
(*)This temperature shall b e used only for food simulan ts D2 and E. For application s heated un der pressure mig ration testing under 
pressure 
at the relevan t 
temperature may b e 
performed. For food simulan ts 
A, B, C or D1 the test may b e 
replaced b y 
a test at 
100 °C 
or at reflux temperature for duration  
of four times the time selected accordin g 
to the con ditions 
in 
Table 
1.L 12/84 EN Official Journ alof the EuropeanUnion 15.1.2011
2.1.4. Specific conditions for contact times above 30 days at room temperature and below
For contact 
times above 
30 days at room temperature an d 
below 
the specimen  
shall be 
tested in 
an 
accelerated test 
at elevated temperature for a maximum of 10 days at 60 ° C. 
Testing 
time and 
temperature con ditions 
shall be 
based 
on 
the followin g 
formula.
t2 = t1 * E xp 
((-Ea/R) 
* (1/T1-1/T2))
Ea 
is the worst case activation  
energy 
80kJ/mol
R 
is a factor 8,31 J/K elvin/mol
Exp 
-9627 * (1/T1-1/T2)
t1 is the con tact 
time
t2 is the testin g 
time
T1 is the con tact 
temperature in  
Kelvin. 
For room temperature storag e 
this is set at 298 K  
(25 °C). 
For refrigerated 
and 
frozen 
conditions 
it is set at 278 K  
(5 °C).
T2 
is the testin g 
temperature in  
Kelvin.
Testing 
for 10 days at 20 ° C 
shall cover all storag e 
times at frozen  
conditio
n.
Testing 
for 10 days at 40 ° C 
shall cover all storag e 
times at refrig erated 
and frozen  
conditions 
including 
heating 
up 
to 70 °C 
for up to 2 hours, or heatin g 
up to 100 ° C 
for up to 15 min utes.
Testing 
for 10 days at 50 ° C 
shall cover all storag e 
time at refrig erated 
and 
frozen 
conditions 
including 
heating 
up 
to 70 °C 
for up to 2 hours, or heatin g 
up to 100 ° C 
for up to 15 min utes 
and 
storage times of up to 6 mon ths 
at 
room temperature.
Testing 
for 10 days at 60 ° C 
shall cover lon g 
term storag e 
above 
6 months 
at room temperature an d 
below 
includ­
ing 
heating 
up to 70 ° C 
for up to 2 hours, or heatin g 
up to 100 ° C 
for up to 15 min u
tes.
The maximum testin g 
temperature is g overned 
by 
the phase tran sition 
temperature of the polymer. At the test tem­
perature the test specimen  
should not 
undergo 
any 
physical chan ges.
For 
storage 
at room temperature testin g 
time can 
be 
reduced to 10 days at 40 °C if there is scien tific 
evidence 
that 
migration 
of the respective sub stance 
in 
the polymer has reached equilib r
ation 
under 
this test con dition.
2.1.5.
 Specific conditions for combinations of contact times and temperature
If 
a material or article is in tended 
for differen t 
application s 
covering 
different 
combinations 
of contact 
time and 
tem­
perature the testin g 
should be 
restricted to the test con ditions 
which are recog nised 
to be 
the most severe on  
the 
basis 
of scientific 
evidence.
If 
the material or article is in tended 
for a food con tact 
application  
where it is successively sub ject 
to a comb ination 
of 
two or more times an d 
temperatures, the mig ration 
test shall b e 
carried out sub jecting 
the test specimen  
succes­
sively to all the applicab le 
worst foreseeab le 
conditions 
appropriate to the sample, usin g 
the same portion  
of food 
simulant.
2.1.6.
 Repeated use articles
If 
the material or article is in tended 
to come in to 
repeated con tact 
with foods, the mig ration 
test(s) shall b e 
carried 
out three times on  
a single 
sample usin g 
another 
portion 
of food simulan t 
on 
each occasion . 
Its 
compliance 
shall be 
checked 
on 
the basis 
of the level of the mig ration 
found 
in 
the third test.
However, if there is con clusive 
proof that the level of the mig ration 
does not in crease 
in 
the second 
and 
third tests 
and 
if the mig ration 
limits are n ot 
exceeded on  
the first test, n o 
further test is n ecessary.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/85
The material or article shall respect the specific mig ration limit already in  the first test for sub stances for which in  
Annex 
I 
Table 
1 column  
8 or Table 
2 column  
3 the specific mig ration 
limit is set as n on-detectable 
and 
for non-
listed 
substances 
used behind 
a plastic fun ctional 
barrier 
covered b y 
the rules of poin t 
(b) 
of Articles 13(2) which 
should not 
migrate 
in 
detectable 
amounts.
2.1.7.
 Analysis of migrating substances
At the end 
of the prescrib ed 
contact 
time, the specific mig ration 
is analys
ed in 
the food or food simulan t 
using 
an 
analytical 
method in  
accordance 
with the requiremen ts 
of Article 11 of Regulation  
(EC) 
No 882/2004.
2.1.8. Verification of compliance by residual content per food contact surface area (QMA)
For substances 
which are un stable 
in 
food simulan t 
or food or for which n o 
adequate an alytical 
method is availab le 
it 
is indicated 
in 
Annex 
I 
that verification  
of complian ce 
shall be 
underta
ken 
by 
verification  
of residual con tent 
per 
6  d m2 of contact surface. For materials an d articles between 500 ml an d 10 l the real con tact surface is applied. For 
materials an d 
articles below 
500 ml an d 
above 
10 l as well as for articles for which it is impractical to calculate the 
real contact 
surface the con tact 
surface is assumed to b e 
6 dm2 per kg food.
2.2. Screening approaches
To screen  
if a material or article complies with the mig ration 
limits any 
of the followin g 
approaches can  
be 
applied 
which are con sidered 
more severe than  
the verification  
method describ ed 
in 
section 
2.1.
2.2.1. Replacing specific migration by overall migration
To screen 
for specific mig ration 
of non-volatile 
substances, 
determinat
ion 
of overall mig ration 
under 
test conditions 
at 
least as severe as for specific mig ration 
can 
be 
applied.
2.2.2. Residual content
To screen  
for specific mig ration 
the migration 
potential 
can 
be 
calculated b ased 
on 
the residual con tent 
of the sub ­
stance 
in 
the material or article assumin g 
complete mig ration.
2.2.3.
 Migration modelling
To screen  
for specific mig ration 
the migration 
potential 
can 
be 
calculated b ased 
on 
the residual con tent 
of the sub ­
stance 
in 
the material or article applyin g 
generally 
recognised 
diffusion 
models based 
on 
scientific 
evidence 
that are 
constructed 
such as to overestimate real mig ration.
2.2.4.
 Food simulant substitutes
To screen  
for specific mig ration, 
food simulan ts 
can 
be 
replaced b y 
substi
tute food simulan ts 
if it is based 
on 
sci­
entific 
evidence 
that the sub stitute 
food simulan ts 
overestimate mig rat
ion 
compared to the reg ulated 
food simulants.
CHAPTER 
3
Testing for overall migration
Overall mig ration 
testing 
shall be 
performed un der 
the standardised 
testing 
conditions 
set out in 
this chapter.
3.1. Standardised testing conditions
The overall mig ration 
test for materials an d 
articles in tended 
for the food con tact 
conditions 
described 
in 
column 
3 
of Table 
3 shall be 
performed for the time specified an d 
at the temperature specified in  
column 
2. For test OM5 the 
test can 
be 
performed either for 2 hours at 100 ° C 
(food simulan t 
D2) or at reflux (food simulan t 
A, B, C, D1) or for 
1 hour at 121 ° C. 
The food simulan t 
shall be 
chosen 
in 
accordance 
with Annex 
III.L 12/86 EN Official Journ alof the EuropeanUnion 15.1.2011
If it is found that carryin g out the tests un der the contact conditions specified in  Table 3 causes physical or other 
changes 
in 
the test specimen  
which do n ot 
occur under 
worst foreseeab le 
condition s 
of use of the material or article 
under 
examination, 
the migration 
tests shall b e 
carried out un der 
the worst foreseeab le 
conditions 
of use in 
which 
these physical or other chan ges 
do not 
take 
place.
Table 3
Standardised testing conditions
Column 1 Column 2 Column 3
Test numberContact 
time in 
days [d] or hours [h] at Con tact 
temperature 
in 
[°C]Intended 
food contact 
conditions
OM1 10 d at 20 °C Any  food con tact  at frozen an d  
refrigerated 
conditions.
OM2 10
 d at 40 °C Any
 long
 term storag e
 at room 
temperature or b elow,
 including
 
heating 
up to 70 ° C 
for up to 2 hours, 
or heatin g
 up to 100 ° C
 for up 
to 15 min utes.
OM3 2 
h at 70 °C Any 
contact 
conditions 
that include 
heating 
up to 70 ° C 
for up to 2 hours, 
or up to 100 ° C 
for up to 15 min utes, 
which 
are not 
followed b y 
long 
term 
room or refrig erated
 temperature 
storage.
OM4 1 
h at 100 ° C High 
temperature application s 
for all 
food simulan ts
 at temperature up 
to 100 °C.
OM5 2 
h at 100 ° C 
or at reflux or altern atively 
1 h at 
121 °CHigh
 temperature application s
 up 
to 121 °C.
OM6 4
 h at 100 ° C
 or at reflux Any
 food con tact
 conditions
 with 
food simulan ts
 A, B or C, at 
temperature exceedin g 
40 °C.
OM7 2
 h at 175 ° C High
 temperature application s
 with 
fatty foods exceedin g 
the conditions 
of 
OM5.
Test OM 7 covers also food con tact 
conditions 
described 
for OM1, OM2, OM3, OM4, OM5. I t 
represents 
the worst 
case conditions 
for fatty food simulan ts 
in 
contact 
with non-polyolefins
. In 
case it is techn ically 
not 
feasible 
to per­
form OM 7 with food simulan t 
D2 the test can  
be 
replaced as set out in  
paragrap
h 3.2.
Test OM 6 covers also food con tact 
conditions 
described 
for OM1, OM2, OM3, OM4 an d 
OM5. It 
represents 
worst 
case conditions 
for food simulan ts 
A, B and 
C in 
contact 
with non-polyolefi
ns.
Test 
OM 5 covers also food con tact 
conditions 
described 
for OM1, OM2, OM3, OM4. I t 
represents 
the worst case 
conditions 
for all food simulan ts 
in 
contact 
with polyolefin s.
Test 
OM 2 covers also food con tact 
conditions 
described 
for OM1 an d 
OM3.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/87
3.2. Substitute test for OM7 with food simu lant D2
In 
case it is techn ically 
NOT feasib le 
to perform OM7 with food simulan t 
D2 the test can  
be 
replaced b y 
test OM 8 
or OM9. Both test con ditions 
described 
under 
the respective test shall b e 
performed with a n ew 
test sample.
Test number Test conditionsIntended food contact condi­
tionsCovers the intended food contact 
conditions described in
OM 8 Food simulan t E for 2 hours 
at 175 °C 
and 
food simulan t 
D2 
for 2 hours at 100 ° CHigh  temperature applica­
tions 
onlyOM1,  OM3, OM4, OM5, an d  
OM6
OM 9 Food simulan t 
E 
for 2 hours 
at 175 °C 
and 
food simulan t 
D2 
for 10 days at 40 ° CHigh
 temperature applica­
tions
 including
 long
 term 
storage 
at room temperatureOM1, OM2, OM3, OM4, OM5 
and 
OM6
3.3. Repeated u se 
articles
Where a material or article is in tended 
to come in to 
repeated con tact 
with foods, the mig ration 
test shall b e 
carried 
out three times on  
a single 
sample usin g 
another 
sample of the food simulan t 
on 
each occasion .
Its 
compliance 
shall be 
checked 
on 
the basis 
of the level of the mig ration 
found 
in 
the third test. However, if there is 
conclusive
 proof that the level of the migration does not in crease
 in the secon d
 and
 third tests an d
 if the overall 
migration 
limit is not 
exceeded on  
the first test, n o 
further test is n ecess
ary.
3.4. Screening approaches
To screen  
if a material or article complies with the mig ration 
limits any 
of the followin g 
approaches can  
be 
applied 
which are con sidered 
more severe than  
the verification  
method describ ed 
in 
sections 
3.1. and 
3.2.
3.4.1. Residual content
To screen 
for overall mig ration 
the migration 
potential 
can 
be 
calculated b ased 
on 
the residual con tent 
of migratable 
substances 
determined 
in 
a complete extraction  
of the material or article.
3.4.2. Food simulant substitutes
To screen  
for overall mig ration 
food simulan ts 
can 
be 
replaced if b ased 
on 
scientific 
evidence 
the substitute 
food 
simulants 
overestimate mig ration 
compared to the reg ulated 
food simulants.
CHAPTER 
4
Correction factors applied when comparing migration test results with migration limits
4.1. Correction of specific migration in foods containing more than 20 % fat by the F at 
Reduction 
Factor 
(FRF)
For 
lipophilic sub stances 
for which in  
Annex 
I 
it is indicated 
in 
column 
7 that the FRF is applicab le 
the specific mig ra­
tion 
can 
be 
corrected b y 
the FRF. The FRF is determin ed 
according 
to the formula FRF = (g  
fat in 
food/kg 
of food)/200 = 
(% fat × 5)/100.
The FRF shall b e 
applied accordin g 
to the followin g 
rules.
The migration 
test results shall b e 
divided by 
the FRF b efore 
comparin g 
with the mig ration 
limits.L 12/88 EN Official Journ alof the EuropeanUnion 15.1.2011
The correction  by the FRF is n ot applicable in the followin g cases:
(a) when 
the material or article is or is in tended 
to be 
brought 
in 
contact 
with food in tended 
for infants 
and 
young 
children 
as defined 
by 
Directives 2006/141/E C 
and 
2006/125/E C;
(b) for 
materials an d 
articles for which it is impracticab le 
to estimate the relation ship 
between 
the surface area an d 
the 
quantity 
of food in  
contact 
therewith, for example due to their shape or use, an d 
the migration 
is calculated 
using 
the conventional 
surface area/volume con version 
factor of 6 dm2/kg.
The 
application  
of the FRF shall n ot 
lead to a specific mig ration 
exceeding 
the overall mig ration 
limit.
4.2. Correction of migration into food simu lant 
D2
For 
the food categ ories 
where in 
sub-column 
D2 of column  
3 of Table 
2 of Annex 
III 
the cross is followed b y 
a figure 
the 
migration 
test result in to 
food simulan t 
D2 shall b e 
divided by 
this figure.
The migration 
test results shall b e 
divided by 
the correction  
factor befor
e comparin g 
with the mig ration 
limits.
The correction  
is not 
applicable 
to the specific mig ration 
for substances 
in 
the Union 
list in 
Annex 
I 
for which the 
specific mig ration 
limit in 
column 
8 is ‘not 
detectable
’ and 
for non-liste
d substances 
used behind 
a plastic fun ctional 
barrier 
covered b y 
the rules of Article 13(2)(b ) 
which should n ot 
migrate 
in 
detectable 
amounts.
4.3.
 Combination of correction factors 4. 1 
and 4.2.
The 
correction  
factors describ ed 
in 
4.1 and 
4.2 can 
be 
combined 
for migration 
of substances for which the FRF is appli­
cable 
when 
testing 
is performed in  
food simulan t 
D2 by 
multiplyin g 
both 
factors. The applied maximum factor shall 
not 
exceed 5.15.1.2011 EN Official Journ alof the EuropeanUnion L 12/89
ANNEX VI
Correlation tables
Directive 2002/72/E C This Regulation
Article 1(1) Article 1
Article 1(2), (3) an d 
(4) Article 2
Article 1a Article 3
Article 3(1), Article 4(1) an d 
Article 5 Article 5
Article 4(2), Article 4a(1) an d 
(4), Article 4d, An nex 
II 
(2) and 
(3) and 
Ann
ex III 
(2) 
and 
(3)Article 6
Article 4a(3) an d 
(6) Article 7
Annex 
II 
(4) and 
Annex 
III 
(4) Article 8
Article 3(1) an d 
Article 4(1) Article 9
Article 6 Article 10
Article 5a(1) an d 
Annex 
I 
(8) Article 11
Article 2 Article 12
Article 7a Article 13
Article 9(1) an d 
(2) Article 15
Article 9(3) Article 16
Article 7 an d 
Annex 
I 
(5a) Article 17
Article 8 Article 18
Annex 
II 
(3) and 
Annex 
III 
(3) Article 19
Annex 
I, 
Annex 
II, 
Annex 
IV, 
Annex 
IVa, 
Annex 
V Part B, an d 
Annex 
VI Annex 
I
Annex 
II 
(2), Annex 
III 
(2) and 
Annex 
V, Part A Annex 
II
Article 
8(5) and 
Annex 
VIa Annex 
IV
Annex 
I Annex 
V
Directive 93/8/E EC This Regulation
Article 1 Article 11
Article 1 Article 12
Article 1 Article 18
Annex Annex 
III
Annex Annex 
V
Directive 97/48/E C This Regulation
Annex Annex III
Annex Annex 
V