HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"15.1.2011
EN
Official Journal of the European Union
L 12/1
II
(Non-legislative acts)
REGULATIONS

COMMISSION REGULATION (EU) No10/2011
of 14 January 2011
on plastic materials and articles intended to come into contact with food
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(2)
This Regulation is a specific measure within the meaning
of Article 5(1) of Regulation (EC) No 1935/2004. This
Regulation should establish the specific rules for plastic
materials and articles to be applied for their safe use and
repeal Commission Directive 2002/72/EC of 6 August
Having regard to the Treaty on the Functioning of the European
2002 on plastic materials and articles intended to come
Union,
into contact with foodstuffs (2).
Having regard to Regulation (EC) No1935/2004 of the European
Parliament and of the Council of 27October 2004 on materials
and articles intended to come into contact with food and repeal
ing Directives 80/590/EEC and89/109/EEC (1), and in particular
(3)
Directive 2002/72/EC sets out basic rules for the manufac
Article5(1)(a), (c), (d), (e), (f), (h), (i) and(j) thereof,
ture of plastic materials and articles. The Directive has been
substantially amended 6 times. For reasons of clarity the
text should be consolidated and redundant and obsolete
parts removed.
After consulting the European Food Safety Authority,
Whereas:
(4)
In the past Directive 2002/72/EC and its amendments have
been transposed into national legislation without any
major adaptation. For transposition into national law usu
(1)
Regulation (EC) No 1935/2004 lays down the general
ally a time period of 12 months is necessary. In case of
principles for eliminating the differences between the laws
amending the lists of monomers and additives in order to
of the Member States as regards food contact materials.
authorise new substances this transposition time leads to a
Article5(1) of that Regulation provides for the adoption of
retardation of the authorisation and thus slows down inno
specific measures for groups of materials and articles and
vation. Therefore it seems appropriate to adopt rules on
describes in detail the procedure for the authorisation of
plastic materials and articles in form of a Regulation
substances at EU level when a specific measure provides
directly applicable in all Member States.
for a list of authorised substances.
(1) OJL338, 13.11.2004, p.4.
(2) OJL220, 15.8.2002, p.18.

---

L 12/2
EN
Official Journal of the European Union
15.1.2011
(5)
Directive 2002/72/EC applies to materials and articles
substances with a molecular weight above 1000Da usu
purely made of plastics and to plastic gaskets in lids. In the
ally cannot be absorbed in the body the potential health
past these were the main use of plastics on the market.
risk from the polymer itself is minimal. Potential health
However, in recent years, besides materials and articles
risk may occur from non- or incompletely reacted mono
purely made of plastics, plastics are also used in combina
mers or other starting substances or from low molecular
tion with other materials in so called multi-material multi-
weight additives which are transferred into food via migra
layers. Rules on the use of vinyl chloride monomer laid
tion from the plastic food contact material. Therefore
down in Council Directive 78/142/EEC of 30 January
monomers, other starting substances and additives should
1978 on the approximation of the laws of the Member
be risk assessed and authorised before their use in the
States relating to materials and articles which contain vinyl
manufacture of plastic materials and articles.
chloride monomer and are intended to come into contact
with foodstuffs (1) already apply to all plastics. Therefore it
seems appropriate to extend the scope of this Regulation
to plastic layers in multi-material multi-layers.
(9)
The risk assessment of a substance to be performed by the
European Food Safety Authority (hereinafter the Author
ity) should cover the substance itself, relevant impurities
and foreseeable reaction and degradation products in the
intended use. The risk assessment should cover the poten
(6)
Plastic materials and articles may be composed of different
tial migration under worst foreseeable conditions of use
layers of plastics held together by adhesives. Plastic mate
and the toxicity. Based on the risk assessment the authori
rials and articles may also be printed or coated with an
sation should if necessary set out specifications for the sub
organic or inorganic coating. Printed or coated plastic
stance and restrictions of use, quantitative restrictions or
materials and articles as well as those held together by
migration limits to ensure the safety of the final material or
adhesives should be within the scope of the Regulation.
article.
Adhesives, coatings and printing inks are not necessarily
composed of the same substances as plastics. Regulation
(EC) No 1935/2004 foresees that for adhesives, coatings
and printing inks specific measures can be adopted. There
fore plastic materials and articles that are printed, coated or
held together by adhesives should be allowed to contain in
the printing, coating or adhesive layer other substances
(10)
No rules have yet been set out at EU level for the risk
than those authorised at EU level for plastics. Those layers
assessment and use of colorants in plastics. Therefore their
may be subject to other EU or national rules.
use should remain subject to national law. That situation
should be reassessed at a later stage.
(7)
Plastics as well as ion exchange resins, rubbers and sili
(11)
Solvents used in the manufacture of plastics to create a
cones are macromolecular substances obtained by poly
suitable reaction environment are expected to be removed
merisation processes. Regulation (EC) No 1935/2004
in the manufacturing process as they are usually volatile.
foresees that for ion exchange resins, rubbers and silicones
No rules have yet been set out at EU level for the risk
specific measures can be adopted. As those materials are
assessment and use of solvents in the manufacture of plas
composed of different substances than plastics and have
tics. Therefore their use should remain subject to national
different physico-chemical properties specific rules for
law. That situation should be reassessed at a later stage.
them need to apply and it should be made clear that they
are not within the scope of this Regulation.
(12)
Plastics can also be made of synthetic or natural occurring
macromolecular structures which are chemically reacted
with other starting substances to create a modified macro
(8)
Plastics are made of monomers and other starting sub
molecule. Synthetic macromolecules used are often inter
stances which are chemically reacted to a macromolecular
mediate structures which are not fully polymerised.
structure, the polymer, which forms the main structural
Potential health risk may occur from the migration of non-
component of the plastics. To the polymer additives are
or incompletely reacted other starting substances used to
added to achieve defined technological effects. The poly
modify the macromolecule or an incompletely reacted
mer as such is an inert high molecular weight structure. As
macromolecule. Therefore the other starting substances as
well as the macromolecules used in the manufacture of
modified macromolecules should be risk assessed and
authorised before their use in the manufacture of plastic
(1) OJL44, 15.2.1978, p.15.
materials and articles.

---

15.1.2011
EN
Official Journal of the European Union
L 12/3
(13)
Plastics can also be made by micro-organisms that create
that the use of other PPA will remain possible, subject to
macromolecular structures out of starting substances by
national law. That situation should be reassessed at a later
fermentation processes. The macromolecule is then either
stage.
released to a medium or extracted. Potential health risk
may occur from the migration of non- or incompletely
reacted starting substances, intermediates or by-products
of the fermentation process. In this case the final product
should be risk assessed and authorised before its use in the
(17)
The Union list contains substances authorised to be used
manufacture of plastic materials and articles.
in the manufacture of plastics. Substances such as acids,
alcohols and phenols can also occur in form of salts. As the
salts usually are transformed in the stomach to acid, alco
hol or phenol the use of salts with cations that have under
gone a safety evaluation should in principle be authorised
together with the acid, alcohol or phenol. In certain cases,
where the safety assessment indicates concerns on the use
(14)
Directive 2002/72/EC contains different lists for mono
of the free acids, only the salts should be authorised by
mers or other starting substances and for additives autho
indicating in the list the name as ‘… acid(s), salts’.
rised for the manufacture of plastic materials and articles.
For monomers, other starting substances and additives the
Union list is now complete, this means that only sub
stances authorised at EU level may be used. Therefore a
separation of monomers or other starting substances and
(18)
Substances used in the manufacture of plastic materials or
of additives in separate lists due to their authorisation sta
articles may contain impurities originating from their
tus is no longer necessary. As certain substances can be
manufacturing or extraction process. These impurities are
used both as monomer or other starting substances and as
non-intentionally added together with the substance in the
additive for reasons of clarity they should be published in
manufacture of the plastic material (non-intentionally
one list of authorised substances indicating the authorised
added substance – NIAS). As far as they are relevant for the
function.
risk assessment the main impurities of a substance should
be considered and if necessary be included in the specifi
cations of a substance. However it is not possible to list
and consider all impurities in the authorisation. Therefore
they may be present in the material or article but not
included in the Union list.
(15)
Polymers can not only be used as main structural compo
nent of plastics but also as additives achieving defined tech
nological effects in the plastic. If such a polymeric additive
(19)
In the manufacture of polymers substances are used to ini
is identical to a polymer that can form the main structural
tiate the polymerisation reaction such as catalysts and to
component of a plastic material the risk from polymeric
control the polymerisation reaction such as chain transfer,
additive can be regarded as evaluated if the monomers have
chain extending or chain stop reagents. These aids to poly
already been evaluated and authorised. In such a case it
merisation are used in minute amounts and are not
should not be necessary to authorise the polymeric addi
intended to remain in the final polymer. Therefore they
tive but it could be used on the basis of the authorisation
should at this point of time not be subject to the authori
of its monomers and other starting substances. If such a
sation procedure at EU level. Any potential health risk in
polymeric additive is not identical to a polymer that can
the final material or article arising from their use should be
form the main structural component of a plastic material
assessed by the manufacturer in accordance with interna
then the risk of the polymeric additive can not be regarded
tionally recognised scientific principles on risk assessment.
as evaluated by evaluation of the monomers. In such a case
the polymeric additive should be risk assessed as regards its
low molecular weight fraction below 1000Da and autho
rised before its use in the manufacture of plastic materials
and articles.
(20)
During the manufacture and use of plastic materials and
articles reaction and degradation products can be formed.
These reaction and degradation products are non-
intentionally present in the plastic material (NIAS). As far
as they are relevant for the risk assessment the main reac
tion and degradation products of the intended application
of a substance should be considered and included in the
(16)
In the past no clear differentiation has been made between
restrictions of the substance. However it is not possible to
additives that have a function in the final polymer and
list and consider all reaction and degradation products in
polymer production aids (PPA) that only exhibit a function
the authorisation. Therefore they should not be listed as
in the manufacturing process and are not intended to be
single entries in the Union list. Any potential health risk in
present in the final article. Some substances acting as PPA
the final material or article arising from reaction and deg
had already been included in the incomplete list of addi
radation products should be assessed by the manufacturer
tives in the past. These PPA should remain in the Union list
in accordance with internationally recognised scientific
of authorised substances. However, it should be made clear
principles on risk assessment.

---

L 12/4
EN
Official Journal of the European Union
15.1.2011
(21)
Prior to the establishment of the Union list of additives,
No 1334/2008 of the European Parliament and of the
other additives than those authorised at EU level could be
Council of 16December 2008 on flavourings and certain
used in the manufacture of plastics. For those additives
food ingredients with flavouring properties for use in and
which were permitted in the Member States, the time limit
on foods and amending Council Regulation (EEC)
for the submission of data for their safety evaluation by the
No 1601/91, Regulations (EC) No 2232/96 and (EC)
Authority with a view to their inclusion in the Union list
No 110/2008 and Directive 2000/13/EC (3) should be
expired on 31December 2006. Additives for which a valid
respected where applicable.
application was submitted within this time limit were listed
in a provisional list. For certain additives on the provisional
list a decision on their authorisation at EU level has not yet
been taken. For those additives, it should be possible to
continue to be used in accordance with national law until
their evaluation is completed and a decision is taken on
(25)
According to Article 3(1)(b) of Regulation (EC)
their inclusion in the Union list.
No 1935/2004 the release of substances from food con
tact materials and articles should not bring about unac
ceptable changes in the composition of the food.
According to good manufacturing practice it is feasible to
manufacture plastic materials in such a way that they are
not releasing more than 10mg of substances per 1dm2 of
(22)
When an additive included in the provisional list is inserted
surface area of the plastic material. If the risk assessment of
in the Union list or when it is decided not to include it in
an individual substance is not indicating a lower level, this
the Union list, that additive should be removed from the
level should be set as a generic limit for the inertness of a
provisional list of additives.
plastic material, the overall migration limit. In order to
achieve comparable results in the verification of compli
ance with the overall migration limit, testing should be
performed under standardised test conditions including
testing time, temperature and test medium (food simulant)
representing worst foreseeable conditions of use of the
(23)
New technologies engineer substances in particle size that
plastic material or article.
exhibit chemical and physical properties that significantly
differ from those at a larger scale, for example, nanopar
ticles. These different properties may lead to different toxi
cological properties and therefore these substances should
be assessed on a case-by-case basis by the Authority as
(26)
The overall migration limit of 10mg per 1dm2 results for
regards their risk until more information is known about
a cubic packaging containing 1kg of food to a migration
such new technology. Therefore it should be made clear
of 60mg per kg food. For small packaging where the sur
that authorisations which are based on the risk assessment
face to volume ratio is higher the resulting migration into
of the conventional particle size of a substance do not
food is higher. For infants and small children which have a
cover engineered nanoparticles.
higher consumption of food per kilogram bodyweight
than adults and do not yet have a diversified nutrition, spe
cial provisions should be set in order to limit the intake of
substances migrating from food contact materials. In order
to allow also for small volume packaging the same protec
tion as for high volume packaging, the overall migration
(24)
Based on the risk assessment the authorisation should if
limit for food contact materials that are dedicated for pack
necessary set out specific migration limits to ensure the
aging foods for infants and small children should be linked
safety of the final material or article. If an additive that is
to the limit in food and not to the surface area of the
authorised for the manufacture of plastic materials and
packaging.
articles is at the same time authorised as food additive or
flavouring substance it should be ensured that the release
of the substance does not change the composition of the
food in an unacceptable way. Therefore the release of such
a dual use additive or flavouring should not exhibit a tech
nological function on the food unless such a function is
(27)
In recent years plastic food contact materials are being
intended and the food contact material complies with the
developed that do not only consist of one plastic but com
requirements on active food contact materials set out in
bine up to 15 different plastic layers to attain optimum
Regulation (EC) No1935/2004 and Commission Regula
functionality and protection of the food, while reducing
tion (EC) No 450/2009 of 29 May 2009 on active and
packaging waste. In such a plastic multi-layer material or
intelligent materials and articles intended to come into
article, layers may be separated from the food by a func
contact with food (1). The requirements of Regulations (EC)
tional barrier. This barrier is a layer within food contact
No 1333/2008 of the European Parliament and of the
materials or articles preventing the migration of substances
Council of 16December 2008 on food additives (2) or(EC)
from behind that barrier into the food. Behind a functional
barrier, non-authorised substances may be used, provided
(1) OJL135, 30.5.2009, p.3.
(2) OJL354, 31.12.2008, p.16.
(3) OJL354, 31.12.2008, p.34.

---

15.1.2011
EN
Official Journal of the European Union
L 12/5
they fulfil certain criteria and their migration remains
coatings, printing inks and adhesives to be used in plastic
below a given detection limit. Taking into account foods
materials and articles adequate information should be pro
for infants and other particularly susceptible persons, as
vided to the manufacturer of the final plastic article that
well as the large analytical tolerance of the migration analy
would enable him to ensure compliance for substances for
sis, a maximum level of 0,01mg/kg in food should be
which migration limits have been established in this
established for the migration of a non-authorised sub
Regulation.
stance through a functional barrier. Substances that are
mutagenic, carcinogenic or toxic to reproduction should
not be used in food contact materials or articles without
previous authorisation and should therefore not be cov
ered by the functional barrier concept. New technologies
(31)
Article17(1) of Regulation (EC) No178/2002 of the Euro
that engineer substances in particle size that exhibit chemi
pean Parliament and of the Council of 28 January 2002
cal and physical properties that significantly differ from
laying down the general principles and requirements of
those at a larger scale, for example, nanoparticles, should
food law, establishing the European Food Safety Authority
be assessed on a case-by-case basis as regards their risk
and laying down procedures in matters of food safety (1)
until more information is known about such new technol
ogy. Therefore, they should not be covered by the func
requires the food business operator to verify that foods are
tional barrier concept.
compliant with the rules applicable to them. To this end
and subject to the requirement of confidentiality, food
business operators should be given access to the relevant
information to enable them to ensure that the migration
from the materials and articles to food complies with the
specifications and restrictions laid down in food legislation.
(28)
In recent years food contact materials and articles are being
developed that consist of a combination of several materi
als to achieve optimum functionality and protection of the
food while reducing packaging waste. In these multi-
material multi-layer materials and articles plastic layers
(32)
At each stage of manufacture, supporting documentation,
should comply with the same compositional requirements
substantiating the declaration of compliance, should be
as plastic layers which are not combined with other mate
kept available for the enforcement authorities. Such dem
rials. For plastic layers in a multi-material multi-layer which
onstration of compliance may be based on migration test
are separated from the food by a functional barrier the
ing. As migration testing is complex, costly and time
functional barrier concept should apply. As other materi
consuming it should be admissible that compliance can be
als are combined with the plastic layers and for these other
demonstrated also by calculations, including modelling,
materials specific measures are not yet adopted at EU level
other analysis, and scientific evidence or reasoning if these
it is not yet possible to set out requirements for the final
render results which are at least as severe as the migration
multi-material multi-layer materials and articles. Therefore
testing. Test results should be regarded as valid as long as
specific migration limits and the overall migration limit
formulations and processing conditions remain constant
should not be applicable except for vinyl chloride mono
as part of a quality assurance system.
mer for which such a restriction is already in place. In the
absence of a specific measure at EU level covering the
whole multi-material multi-layer material or article Mem
ber States may maintain or adopt national provisions for
these materials and articles provided they comply with the
rules of the Treaty.
(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 defined
volume of food. For these articles specific rules should be
set out for verification of compliance.
(29)
Article16(1) of Regulation (EC) No1935/2004 provides
that materials and articles covered by specific measures be
accompanied by a written declaration of compliance stat
ing that they comply with the rules applicable to them. To
(34)
The setting of migration limits takes into account a con
strengthen the coordination and responsibility of the sup
ventional assumption that 1kg of food is consumed daily
pliers at each stage of manufacture, including that of the
by a person of 60kg bodyweight and that the food is pack
starting substances, the responsible persons should docu
aged in a cubic container of 6dm2 surface area releasing
ment the compliance with the relevant rules in a declara
the substance. For very small and very large containers the
tion of compliance which is made available to their
real surface area to volume of packaged food is varying a
customers.
lot from the conventional assumption. Therefore, their sur
face area should be normalised before comparing testing
results with migration limits. These rules should be
reviewed when new data on food packaging uses become
available.

(30)
Coatings, printing inks and adhesives are not yet covered
by a specific EU legislation and therefore not subject to the
requirement of a declaration of compliance. However, for
(1) OJL31, 1.2.2002, p.1.

---

L 12/6
EN
Official Journal of the European Union
15.1.2011
(35)
The specific migration limit is a maximum permitted
efficiently making best use of available resources. There
amount of a substance in food. This limit should ensure
fore it should be admissible to use screening methods for
that the food contact material does not pose a risk to
checking compliance under certain conditions. Non-
health. It should be ensured by the manufacturer that
compliance of a material or article should be confirmed by
materials and articles not yet in contact with food will
a verification method.
respect these limits when brought into contact with food
under the worst foreseeable contact conditions. Therefore
compliance of materials and articles not yet in contact with
food should be assessed and the rules for this testing should
be set out.
(40)
Basic rules on migration testing should be set out in this
Regulation. As migration testing is a very complex issue,
these basic rules can, however, not cover all foreseeable
cases and details necessary for performing the testing.
Therefore a EU guidance document should be established,
(36)
Food is a complex matrix and therefore the analysis of
dealing with more detailed aspects of the implementation
migrating substances in food may pose analytical difficul
of the basic migration testing rules.
ties. Therefore test media should be assigned that simulate
the transfer of substances from the plastic material into
food. They should represent the major physico-chemical
properties exhibited by food. When using food simulants
standard testing time and temperature should reproduce,
(41)
The updated rules on food simulants and migration test
as far as possible, the migration which may occur from the
ing provided by this Regulation will supersede those in
article into the food.
Directive 78/142/EEC and the Annex to Council Directive
82/711/EEC of 18 October 1982 laying down the basic
rules necessary for testing migration of the constituents of
plastic materials and articles intended to come into con
tact with foodstuffs (3).
(37)
For determining the appropriate food simulant for certain
foods the chemical composition and the physical proper
ties of the food should be taken into account. Research
results are available for certain representative foods com
paring migration into food with migration into food simu
(42)
Substances present in the plastic but not listed in AnnexI
lants. On the basis of the results, food simulants should be
to this Regulation have not necessarily been risk assessed
assigned. In particular, for fat containing foods the result
as they had not been subject to an authorisation procedure.
obtained with food simulant may in certain cases signifi
Compliance with Article 3 of Regulation (EC)
cantly overestimate migration into food. In these cases it
No1935/2004 for these substances should be assessed by
should be foreseen that the result in food simulant is cor
the relevant business operator in accordance with interna
rected by a reduction factor.
tionally recognised scientific principles taking into account
exposure from food contact materials and other sources.
(38)
The exposure to substances migrating from food contact
materials was based on the conventional assumption that
(43)
Recently additional monomers, other starting substances
a person consumes daily 1kg of food. However, a person
and additives have received a favourable scientific evalua
ingests at most 200g of fat on a daily basis. For lipophilic
tion by the Authority and should now be added to the
substances that only migrate into fat this should be taken
Union list.
into consideration. Therefore a correction of the specific
migration by a correction factor applicable to lipophilic
substances in accordance with the opinion of the Scientific
Committee on Food (SCF) (1) and the opinion of the
Authority (2) should be foreseen.
(44)
As new substances are added to the Union list the Regula
tion should apply as soon as possible to allow for manu
facturers to adapt to technical progress and allow for
innovation.
(39)
Official control should establish testing strategies which
allow the enforcement authorities to perform controls
(45)
Certain migration testing rules should be updated in view
(1) SCF opinion of 4December 2002 on the introduction of a Fat (Con
of new scientific knowledge. Enforcement authorities and
sumption) Reduction Factor (FRF) in the estimation of the exposure to
industry need to adapt their current testing regime to these
a migrant from food contact materials.
updated rules. To allow for this adaptation it seems appro
http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf
priate that the updated rules only apply 2 years after the
(2) Opinion of the Scientific Panel on Food Additives, Flavourings, Pro
cessing Aids and Materials in Contact with Food (AFC) on a request
adoption of the Regulation.
from the Commission related to the introduction of a Fat (consump
tion) Reduction Factor for infants and children, The EFSA Journal
(2004) 103, 1-8.
(3) OJL297, 23.10.1982, p.26.

---

15.1.2011
EN
Official Journal of the European Union
L 12/7
(46)
Business operators are currently basing their declaration of
(b) already in contact with food; or
compliance on supporting documentation following the
requirements set out in Directive 2002/72/EC. Declaration
of compliance need, in principle, only to be updated when
(c) which can reasonably be expected to come into contact with
substantial changes in the production bring about changes
food.
in the migration or when new scientific data are available.
In order to limit the burden to business operators, materi
als which have been lawfully placed on the market based
Article2
on the requirements set out in Directive 2002/72/EC
should be able to be placed on the market with a declara
Scope
tion of compliance based on supporting documentation in
accordance with Directive 2002/72/EC until 5 years after
1.
This Regulation shall apply to materials and articles which
the adoption of the Regulation.
are placed on the EU market and fall under the following
categories:
(47)
Analytical methods for testing migration and residual con
tent of vinyl chloride monomer as described in Commis
(a) materials and articles and parts thereof consisting exclusively
sion Directives 80/766/EEC of 8 July 1980 laying down
of plastics;
the Community method of analysis for the official control
of the vinyl chloride monomer level in materials and
(b) plastic multi-layer materials and articles held together by
articles which are intended to come into contact with
adhesives or by other means;
foodstuffs (1) and 81/432/EEC of 29 April 1981 laying
down the Community method of analysis for the official
control of vinyl chloride released by materials and articles
(c) materials and articles referred to in points a) or b) that are
into foodstuffs (2) are outdated. Analytical methods should
printed and/or covered by a coating;
comply with the criteria set out in Article11 of Regulation
(EC) No882/2004 (3) of the European Parliament and of
(d) plastic layers or plastic coatings, forming gaskets in caps and
the Council on official controls performed to ensure the
closures, that together with those caps and closures compose
verification of compliance with feed and food law, animal
a set of two or more layers of different types of materials;
health and animal welfare rules. Therefore Directives
80/766/EEC and81/432/EEC should be repealed.
(e) plastic layers in multi-material multi-layer materials and
articles.
(48)
The measures provided for in this Regulation are in accor
dance with the opinion of the Standing Committee on the
2.
This Regulation shall not apply to the following materials
Food Chain and Animal Health,
and articles which are placed on the EU market and are intended
to be covered by other specific measures:
HAS ADOPTED THIS REGULATION:
(a) ion exchange resins;
(b) rubber;
CHAPTER I
GENERAL PROVISIONS
(c) silicones.
3.
This Regulation shall be without prejudice to the EU or
Article1
national provisions applicable to printing inks, adhesives or
coatings.
Subject matter
Article3
1.
This Regulation is a specific measure within the meaning of
Article5 of Regulation (EC) No1935/2004.
Definitions
For the purpose of this Regulation, the following definitions shall
2.
This Regulation establishes specific requirements for the
apply:
manufacture and marketing of plastic materials and articles:
(1) ‘plastic materials and articles’ means:
(a) intended to come into contact with food; or
(a) materials and articles referred to in points(a), (b) and(c)
of Article2(1); and
(1) OJL213, 16.8.1980, p.42.
(2) OJL167, 24.6.1981, p.6.
(3) OJL165, 30.4.2004, p.1.
(b) plastic layers referred to in Article2(1)(d) and(e);

---

L 12/8
EN
Official Journal of the European Union
15.1.2011
(2) ‘plastic’ means polymer to which additives or other sub
(10) ‘aid to polymerisation’ means a substance which initiates
stances may have been added, which is capable of function
polymerisation and/or controls the formation of the macro
ing as a main structural component of final materials and
molecular structure;
articles;
(11) ‘overall migration limit’ (OML) means the maximum permit
(3) ‘polymer’ means any macromolecular substance obtained
ted amount of non-volatile substances released from a mate
by:
rial or article into food simulants;
(a) a polymerisation process such as polyaddition or poly
(12) ‘food simulant’ means a test medium imitating food; in its
condensation, or by any other similar process of mono
behaviour the food simulant mimics migration from food
mers and other starting substances; or
contact materials;
(13) ‘specific migration limit’ (SML) means the maximum permit
(b) chemical modification of natural or synthetic macro
ted amount of a given substance released from a material or
molecules; or
article into food or food simulants;
(c) microbial fermentation;
(14) ‘total specific migration limit’ (SML(T)) means the maximum
permitted sum of particular substances released in food or
food simulants expressed as total of moiety of the substances
(4) ‘plastic multi-layer’ means a material or article composed of
indicated;
two or more layers of plastic;
(15) ‘functional barrier’ means a barrier consisting of one or more
(5) ‘multi-material multi-layer’ means a material or article com
layers of any type of material which ensures that the final
posed of two or more layers of different types of materials,
material or article complies with Article3 of Regulation (EC)
at least one of them a plastic layer;
No1935/2004 and with the provisions of this Regulation;
(6) ‘monomer or other starting substance’ means:
(16) ‘non-fatty food’ means a food for which in migration testing
only food simulants other than food simulants D1 orD2 are
laid down in Table 2 of AnnexV to this Regulation;
(a) a substance undergoing any type of polymerisation pro
cess to manufacture polymers; or
(17) ‘restriction’ means limitation of use of a substance or migra
tion limit or limit of content of the substance in the material
or article;
(b) a natural or synthetic macromolecular substance used
in the manufacture of modified macromolecules; or
(18) ‘specification’ means composition of a substance, purity cri
teria for a substance, physico-chemical characteristics of a
(c) a substance used to modify existing natural or synthetic
substance, details concerning the manufacturing process of
macromolecules;
a substance or further information concerning the expres
sion of migration limits.
(7) ‘additive’ means a substance which is intentionally added to
plastics to achieve a physical or chemical effect during pro
cessing of the plastic or in the final material or article; it is
Article4
intended to be present in the final material or article;
Placing on the market of plastic materials and articles
(8) ‘polymer production aid’ means any substance used to pro
Plastic materials and articles may only be placed on the market if
vide a suitable medium for polymer or plastic manufactur
they:
ing; it may be present but is neither intended to be present
in the final materials or articles nor has a physical or chemi
cal effect in the final material or article;
(a) comply with the relevant requirements set out in Article3 of
Regulation (EC) No1935/2004 under intended and foresee
able use; and
(9) ‘non-intentionally added substance’ means an impurity in
the substances used or a reaction intermediate formed dur
ing the production process or a decomposition or reaction
(b) comply with the labelling requirements set out in Article15
product;
of Regulation (EC) No1935/2004; and

---

15.1.2011
EN
Official Journal of the European Union
L 12/9
(c) comply with the traceability requirements set out in
3.
The following substances not included in the Union list are
Article17 of Regulation (EC) No1935/2004; and
authorised subject to the rules set out in Articles 8, 9, 10, 11
and12:
(d) are manufactured according to good manufacturing practice
as set out in Commission Regulation (EC) No2023/2006 (1);
(a) salts (including double salts and acid salts) of aluminium,
and
ammonium, barium, calcium, cobalt, copper, iron, lithium,
magnesium, manganese, potassium, sodium, and zinc of
authorised acids, phenols or alcohols;
(e) comply with the compositional and declaration requirements
set out in Chapters II, III andIV of this Regulation.
(b) mixtures obtained by mixing authorised substances without
a chemical reaction of the components;
CHAPTER II
(c) when used as additives, natural or synthetic polymeric sub
COMPOSITIONAL REQUIREMENTS
stances of a molecular weight of at least 1000 Da, except
macromolecules obtained from microbial fermentation,
complying with the requirements of this Regulation, if they
SECTION1
are capable of functioning as the main structural component
of final materials or articles;
Authorised substances
(d) when used as monomer or other starting substance, pre-
Article5
polymers and natural or synthetic macromolecular sub
stances, as well as their mixtures, except macromolecules
Union list of authorised substances
obtained from microbial fermentation, if the monomers or
starting substances required to synthesise them are included
in the Union list.
1.
Only the substances included in the Union list of authorised
substances (hereinafter referred to as the Union list) set out in
AnnexI may be intentionally used in the manufacture of plastic
4.
The following substances not included in the Union list may
layers in plastic materials and articles.
be present in the plastic layers of plastic materials or articles:
2.
The Union list shall contain:
(a) non-intentionally added substances;
(a) monomers or other starting substances;
(b) aids to polymerisation.
(b) additives excluding colorants;
5.
By derogation from Article5, additives not included in the
Union list may continue to be used subject to national law after
1 January 2010 until a decision is taken to include or not to
(c) polymer production aids excluding solvents;
include them in the Union list provided they are included in the
provisional list referred to in Article7.
(d) macromolecules obtained from microbial fermentation.
Article7
3.
The Union list may be amended in accordance with the pro
Establishment and management of the provisional list
cedure established by Articles 8 to 12 of Regulation (EC)
No1935/2004.
1.
The provisional list of additives that are under evaluation by
the European Food Safety Authority (hereinafter referred to as the
Article6
Authority) that was made public by the Commission in 2008
shall be regularly updated.
Derogations for substances not included in the Union list
2.
An additive shall be removed from the provisional list:
1.
By way of derogation from Article5, substances other than
those included in the Union list may be used as polymer produc
tion aids in the manufacture of plastic layers in plastic materials
(a) when it is included in the Union list set out in AnnexI; or
and articles subject to national law.
(b) when a decision is taken by the Commission not to include
2.
By way of derogation from Article5, colorants and solvents
it in the Union list; or
may be used in the manufacture of plastic layers in plastic mate
rials and articles subject to national law.
(c) if during the examination of the data, the Authority calls for
supplementary information and that information is not sub
(1) OJL384, 29.12.2006, p.75.
mitted within the time limits specified by the Authority.

---

L 12/10
EN
Official Journal of the European Union
15.1.2011
SECTION2
3.
By derogation from paragraphs1 and2, additives which are
also authorised as food additives by Regulation (EC)
General requirements, restrictions and specifications
No 1333/2008 or as flavourings by Regulation (EC)
No1334/2008 shall not migrate into foods in quantities having
a technical effect in the final foods and shall not:
Article8
General requirement on substances
(a) exceed the restrictions provided for in Regulation (EC)
No 1333/2008 or in Regulation (EC) No 1334/2008 or in
Annex I to this Regulation for foods for which their use is
Substances used in the manufacture of plastic layers in plastic
authorised as food additive or flavouring substances; or
materials and articles shall be of a technical quality and a purity
suitable for the intended and foreseeable use of the materials or
articles. The composition shall be known to the manufacturer of
(b) exceed the restrictions set out in AnnexI to this Regulation
the substance and made available to the competent authorities on
in foods for which their use is not authorised as food addi
request.
tive or flavouring substances.
Article9
Article12
Specific requirements on substances
Overall migration limit
1.
Substances used in the manufacture of plastic layers in plas
1.
Plastic materials and articles shall not transfer their constitu
tic materials and articles shall be subject to the following restric
ents to food simulants in quantities exceeding 10milligrams of
tions and specifications:
total constituents released per dm2 of food contact surface
(mg/dm2).
(a) the specific migration limit set out in Article11;
2.
By derogation from paragraph 1, plastic materials and
articles intended to be brought into contact with food intended
(b) the overall migration limit set out in Article12;
for infants and young children, as defined by Commission Direc
tives 2006/141/EC (1) and 2006/125/EC (2), shall not transfer
their constituents to food simulants in quantities exceeding
(c) the restrictions and specifications set out in column 10 of
60milligrams of total of constituents released per kg of food
Table 1 of point1 of AnnexI;
simulant.
(d) the detailed specifications set out in point4 of AnnexI.
CHAPTER III
SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND
2.
Substances in nanoform shall only be used if explicitly
ARTICLES
authorised and mentioned in the specifications in AnnexI.
Article13
Article10
Plastic multi-layer materials and articles
General restrictions on plastic materials and articles
1.
In a plastic multi-layer material or article, the composition
General restrictions related to plastic materials and articles are laid
of each plastic layer shall comply with this Regulation.
down in AnnexII.
2.
By derogation from paragraph1, a plastic layer which is not
in direct contact with food and is separated from the food by a
Article11
functional barrier, may:
Specific migration limits
(a) not comply with the restrictions and specifications set out in
1.
Plastic materials and articles shall not transfer their constitu
this Regulation except for vinyl chloride monomer as pro
ents to foods in quantities exceeding the specific migration limits
vided in AnnexI; and/or
(SML) set out in AnnexI. Those specific migration limits (SML) are
expressed in mg of substance per kg of food (mg/kg).
(b) be manufactured with substances not listed in the Union list
or in the provisional list.
2.
For substances for which no specific migration limit or
other restrictions are provided in Annex I, a generic specific
(1) OJL401, 30.12.2006, p.1.
migration limit of 60mg/kg shall apply.
(2) OJL339, 6.12.2006, p.16.

---

15.1.2011
EN
Official Journal of the European Union
L 12/11
3.
The migration of the substances under paragraph2(b) into
4.
By derogation from paragraph1, Articles11 and12 of this
food or food simulant shall not be detectable measured with sta
Regulation do not apply to plastic layers in multi-material multi-
tistical certainty by a method of analysis set out in Article11 of
layer materials and articles.
Regulation (EC) No 882/2004 with a limit of detection of
0,01mg/kg. That limit shall always be expressed as concentration
in foods or food simulants. That limit shall apply to a group of
5.
The plastic layers in a multi-material multi-layer material or
compounds, if they are structurally and toxicologically related, in
article shall always comply with the restrictions for vinyl chloride
particular isomers or compounds with the same relevant func
monomer laid down in AnnexI to this Regulation.
tional group, and shall include possible set-off transfer.
6.
In a multi-material multi-layer material or article, specific
4.
The substances not listed in the Union list or provisional list
and overall migration limits for plastic layers and for the final
referred to in paragraph2(b) shall not belong to either of the fol
material or article may be established by national law.
lowing categories:
CHAPTER IV
(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to
reproduction’ in accordance with the criteria set out in sec
DECLARATION OF COMPLIANCE AND DOCUMENTATION
tions 3.5, 3.6. and 3.7 of Annex I to Regulation (EC)
No 1272/2008 of the European Parliament and the
Council (1);
Article15
Declaration of compliance
(b) substances in nanoform.
1.
At the marketing stages other than at the retail stage, a writ
ten declaration in accordance with Article16 of Regulation (EC)
5.
The final plastic multi-layer material or article shall comply
No1935/2004 shall be available for plastic materials and articles,
with the specific migration limits set out in Article 11 and the
products from intermediate stages of their manufacturing as well
overall migration limit set out in Article12 of this Regulation.
as for the substances intended for the manufacturing of those
materials and articles.
Article14
2.
The written declaration referred to in paragraph1 shall be
Multi-material multi-layer materials and articles
issued by the business operator and shall contain the information
laid down in AnnexIV.
1.
In a multi-material multi-layer material or article, the com
3.
The written declaration shall permit an easy identification of
position of each plastic layer shall comply with this Regulation.
the materials, articles or products from intermediate stages of
manufacture or substances for which it is issued. It shall be
renewed when substantial changes in the composition or produc
2.
By derogation from paragraph1, in a multi-material multi-
tion occur that bring about changes in the migration from the
layer material or article a plastic layer which is not in direct con
materials or articles or when new scientific data becomes
tact with food and is separated from the food by a functional
available.
barrier, may be manufactured with substances not listed in the
Union list or the provisional list.
Article16
Supporting documents
3.
The substances not listed in the Union list or provisional list
referred to in paragraph 2 shall not belong to either of the fol
lowing categories:
1.
Appropriate documentation to demonstrate that the mate
rials and articles, products from intermediate stages of their
manufacturing as well as the substances intended for the manu
(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to
facturing of those materials and articles comply with the require
reproduction’ in accordance with the criteria set out in sec
ments of this Regulation shall be made available by the business
tions 3.5, 3.6. and 3.7 of Annex I to Regulation (EC)
operator to the national competent authorities on request.
No1272/2008;
2.
That documentation shall contain the conditions and results
(b) substances in nanoform.
of testing, calculations, including modelling, other analysis, and
evidence on the safety or reasoning demonstrating compliance.
Rules for experimental demonstration of compliance are set out
(1) OJL353, 31.12.2008, p.1.
in Chapter V.

---

L 12/12
EN
Official Journal of the European Union
15.1.2011
CHAPTER V
Article18
COMPLIANCE
Rules for assessing compliance with migration limits
Article17
1.
For materials and articles already in contact with food veri
fication of compliance with specific migration limits shall be car
Expression of migration test results
ried out in accordance with the rules set out in Chapter 1 of
AnnexV.
1.
To check the compliance, the specific migration values shall
be expressed in mg/kg applying the real surface to volume ratio
in actual or foreseen use.
2.
For materials and articles not yet in contact with food veri
fication of compliance with specific migration limits shall be car
ried out in food or in food simulants set out in Annex III in
2.
By derogation from paragraph1 for:
accordance with the rules set out in Chapter 2, Section 2.1 of
AnnexV.
(a) containers and other articles, containing or intended to con
tain, less than 500millilitres or grams or more than 10litres,
3.
For materials and articles not yet in contact with food
screening of compliance with the specific migration limit can be
performed applying screening approaches in accordance with the
(b) materials and articles for which, due to their form it is
rules set out in Chapter 2, Section2.2 of AnnexV. If a material or
impracticable to estimate the relationship between the sur
article fails to comply with the migration limits in the screening
face area of such materials or articles and the quantity of food
approach a conclusion of non-compliance has to be confirmed by
in contact therewith,
verification of compliance in accordance with paragraph2.
(c) sheets and films that are not yet in contact with food,
4.
For materials and articles not yet in contact with food veri
fication of compliance with the overall migration limit shall be
(d) sheets and films containing less than 500millilitres or grams
carried out in food simulants A, B, C, D1 and D2 as set out in
or more than 10litres,
AnnexIII in accordance with the rules set out in Chapter 3, Sec
tion3.1 of AnnexV.
the value of migration shall be expressed in mg/kg applying a sur
face to volume ratio of 6dm2 per kg of food.
5.
For materials and articles not yet in contact with food
screening of compliance with the overall migration limit can be
This paragraph does not apply to plastic materials and articles
performed applying screening approaches in accordance with the
intended to be brought into contact with or already in contact
rules set out in Chapter 3, Section3.4 of AnnexV. If a material or
with food for infants and young children, as defined by Directives
article fails to comply with the migration limit in the screening
2006/141/EC and2006/125/EC.
approach a conclusion of non-compliance has to be confirmed by
verification of compliance in accordance with paragraph4.
3.
By derogation from paragraph1, for caps, gaskets, stoppers
and similar sealing articles the specific migration value shall be
6.
The results of specific migration testing obtained in food
expressed in:
shall prevail over the results obtained in food simulant. The results
of specific migration testing obtained in food simulant shall pre
vail over the results obtained by screening approaches.
(a) mg/kg using the actual content of the container for which the
closure is intended or in mg/dm2 applying the total contact
surface of sealing article and sealed container if the intended
use of the article is known, while taking into account the pro
7.
Before comparing specific and overall migration test results
visions of paragraph2;
with the migration limits the correction factors in Chapter 4 of
Annex V shall be applied in accordance with the rules set out
therein.
(b) mg/article if the intended use of the article is unknown.
4.
For caps, gaskets, stoppers and similar sealing articles the
Article19
overall migration value shall be expressed in:
Assessment of substances not included in the Union list
(a) mg/dm2 applying the total contact surface of sealing article
and sealed container if the intended use of the article is
Compliance with Article3 of Regulation (EC) No1935/2004 of
known;
substances referred to in Articles6(1), 6(2), 6(4), 6(5) and14(2)
of this Regulation which are not covered by an inclusion in
AnnexI to this Regulation shall be assessed in accordance with
(b) mg/article if the intended use of the article is unknown.
internationally recognised scientific principles on risk assessment.

---

15.1.2011
EN
Official Journal of the European Union
L 12/13
CHAPTER VI
2.
As from 1January 2013 the supporting documents referred
to in Article 16 for materials, articles and substances placed on
FINAL PROVISIONS
the market until 31December 2015, may be based on:
(a) the rules for migration testing set out in Article 18 of this
Article20
Regulation; or
Amendments of EU acts
(b) the basic rules for overall and specific migration testing set
out in the Annex to Directive 82/711/EEC.
The Annex to Council Directive 85/572/EEC (1) is replaced by the
3.
As from 1January 2016, the supporting documents referred
following:
to in Article16 shall be based on the rules for migration testing
set out in Article 18, without prejudice to paragraph 2 of this
‘The food simulants to be used for testing migration of constitu
Article.
ents of plastic materials and articles intended to come into con
4.
Until 31December 2015 additives used in glass fibre sizing
tact with a single food or specific groups of foods are set out
for glass fibre reinforced plastics which are not listed in AnnexI
in point 3 of Annex III to Commission Regulation (EU)
have to comply with the risk assessment provisions set out in
No10/2011.’
Article19.
5.
Materials and articles that have been lawfully placed on the
Article21
market before 1 May 2011 may be placed on the market until
31December 2012.
Repeal of EU acts
Article23
Directives 80/766/EEC, 81/432/EEC, and2002/72/EC are hereby
Entry into force and application
repealed with effect from 1May 2011.
This Regulation shall enter into force on the 20th day following
References to the repealed Directives shall be construed as refer
its publication in the Official Journal of the European Union.
ences to this Regulation and shall be read in accordance with the
It shall apply from 1May 2011.
correlation tables in AnnexVI.
The provision of Article5 as regards the use of additives, others
than plasticisers, shall apply for plastic layers or plastic coatings
Article22
in caps and closures referred to in Article 2(1)(d), as from
31December 2015.
Transitional provisions
The provision of Article5 as regards the use of additives used in
glass fibre sizing for glass fibre reinforced plastics, shall apply
1.
Until 31 December 2012 the supporting documents
from 31December 2015.
referred to in Article16 shall be based on the basic rules for over
all and specific migration testing set out in the Annex to Direc
The provisions of Articles18(2), 18(4) and20 shall apply from
tive 82/711/EEC.
31December 2012.
This Regulation shall be binding in its entirety and directly applicable in the Member States in
accordance with the Treaties.
Done at Brussels, 14 January 2011.
For the Commission
The President
José Manuel BARROSO
(1) OJL372, 31.12.1985, p.14.

---

L 12/14
EN
Official Journal of the European Union
15.1.2011
ANNEXI
Substances
1. Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fer
mentation, additives and polymer production aids
Table 1 contains the following information:
Column 1 (FCM substance No): the unique identification number of the substance
Column 2 (Ref. No): the EEC packaging material reference number
Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number
Column 4 (Substance Name): the chemical name
Column 5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be
used as additive or polymer production aid (yes) or if the substance is not authorised to be used as additive or polymer
production aid (no). If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is
restricted to PPA.
Column 6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation
(yes/no)): an indication if the substance is authorised to be used as monomer or other starting substance or macromol
ecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other
starting substance or macromolecule obtained from microbial fermentation (no). If the substance is authorised as mac
romolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is indicated that the
substance is a macromolecule obtained from microbial fermentation.
Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat
Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by the FRF (no).
Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per
kg food. It is indicated ND if the substance shall not migrate in detectable quantities.
Column 9 (SML(T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for
which the group restriction in Column 1 in Table 2 of this Annex applies.
Column 10 (Restrictions andspecifications): contains other restrictions than the specific migration limit specifically men
tioned and it contains specifications related to the substance. In case detailed specifications are set out a reference to
Table 4 is included.
Column 11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules appli
cable for verification of compliance for this substance included in Column 1 in Table 3 of this Annex.
If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions apply
ing to this substance shall be those indicated for the individual compound.
If in Column 8 the specific migration limit is non-detectable (ND) a detection limit of 0,01mg substance per kg food is
applicable unless specified differently for an individual substance.

---

15.1.2011
Table 1
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Use as mono
mer or other
Use as additive
starting
SML(T)
substance or
[mg/kg]
FCM
or polymer
FRF applicable
SML
Notes on
E
macromolecule
(Group
Restrictions and specifications
verification of
N
substance No
Ref. No
CAS No
Substance name
production aid
(yes/no)
[mg/kg]
compliance
(yes/no)
obtained from
restriction
microbial
No)
fermentation
(yes/no)
1
12310
0266309-43-7
albumin
no
yes
no
2
12340
—
albumin, coagulated by formal
no
yes
no
dehyde
Official
3
12375
—
alcohols, aliphatic, monohydric,
no
yes
no
saturated, linear, primary
(C4-C22)
Journ
4
22332
—
mixture of (40% w/w) 2,2,4-
no
yes
no
(17)
1mg/kg in final product
(10)
al
trimethylhexane-1,6-
expressed as isocyanate
of
diisocyanate and (60% w/w)
moiety.
the
2,4,4-trimethylhexane-1,6-
diisocyanate
E
uropean
5
25360
—
trialkyl(C5-C15)acetic acid, 2,3-
no
yes
no
ND
1mg/kg in final product
epoxypropyl ester
expressed as epoxygroup.
Molecular weight is 43 Da.
Un
ion
6
25380
—
trialkyl acetic acid (C7-C17),
no
yes
no
0,05
(1)
vinyl esters
7
30370
—
acetylacetic acid, salts
yes
no
no
8
30401
—
acetylated mono- and diglycer
yes
no
no
(32)
ides of fatty acids
9
30610
—
acids, C2-C24, aliphatic, linear,
yes
no
no
monocarboxylic from natural
oils and fats, and their mono-,
di- and triglycerol esters
(branched fatty acids at naturally
occuring levels are included)
10
30612
—
acids, C2-C24, aliphatic, linear,
yes
no
no
L
monocarboxylic, synthetic and
12/15
their mono-, di- and triglycerol
esters

---

L
12/16
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
11
30960
—
acids, aliphatic, monocarboxylic
yes
no
no
(C6-C22), esters with
polyglycerol
12
31328
—
acids, fatty, from animal or
yes
no
no
E
vegetable food fats and oils
N
13
33120
—
alcohols, aliphatic, monohydric,
yes
no
no
saturated, linear, primary
(C4-C24)
14
33801
—
n-alkyl(C10-C13)
yes
no
no
30
benzenesulphonic acid
15
34130
—
alkyl, linear with even number
yes
no
yes
30
Official
of carbon atoms (C12-C20)
dimethylamines
Journ
16
34230
—
alkyl(C8-C22)sulphonic acids
yes
no
no
6
al
of
17
34281
—
alkyl(C8-C22)sulphuric acids,
yes
no
no
the
linear, primary with an even
number of carbon atoms
E
uropean
18
34475
—
aluminium calcium hydroxide
yes
no
no
phosphite, hydrate
Un
ion
19
39090
—
N,N-bis(2-hydroxyethyl)alkyl
yes
no
no
(7)
(C8-C18)amine
20
39120
—
N,N-bis(2-hydroxyethyl)alkyl
yes
no
no
(7)
SML(T) expressed excluding
(C8-C18)amine hydrochlorides
HCl
21
42500
—
carbonic acid, salts
yes
no
no
22
43200
—
castor oil, mono- and
yes
no
no
diglycerides
23
43515
—
chlorides of choline esters of
yes
no
no
0,9
(1)
coconut oil fatty acids
15.1.2011
24
45280
—
cotton fibers
yes
no
no
25
45440
—
cresols, butylated, styrenated
yes
no
no
12

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
26
46700
—
5,7-di-tert-butyl-3-(3,4- and
yes
no
no
5
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%
E
N
w/w) and b) 5,7-di-tert-butyl-3-
(2,3-dimethylphenyl)-3H-
benzofuran-2-one (0 to
20% w/w)
27
48960
—
9,10-dihydroxy stearic acid and
yes
no
no
5
its oligomers
28
50160
—
di-n-octyltin bis(n-alkyl(C10-C16)
yes
no
no
(10)
mercaptoacetate)
Official
29
50360
—
di-n-octyltin bis(ethyl maleate)
yes
no
no
(10)
Journ
30
50560
—
di-n-octyltin 1,4-butanediol
yes
no
no
(10)
bis(mercaptoacetate)
al
of
31
50800
—
di-n-octyltin dimaleate,
yes
no
no
(10)
the
esterified
E
uropean
32
50880
—
di-n-octyltin dimaleate,
yes
no
no
(10)
polymers (n = 2-4)
Un
33
51120
—
di-n-octyltin thiobenzoate
yes
no
no
(10)
ion
2-ethylhexyl mercaptoacetate
34
54270
—
ethylhydroxymethylcellulose
yes
no
no
35
54280
—
ethylhydroxypropylcellulose
yes
no
no
36
54450
—
fats and oils, from animal or
yes
no
no
vegetable food sources
37
54480
—
fats and oils, hydrogenated,
yes
no
no
from animal or vegetable food
sources
38
55520
—
glass fibers
yes
no
no
39
55600
—
glass microballs
yes
no
no
L
12/17
40
56360
—
glycerol, esters with acetic acid
yes
no
no

---

L
12/18
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
41
56486
—
glycerol, esters with acids,
yes
no
no
aliphatic, saturated, linear, with
an even number of carbon
atoms (C14-C18) and with acids,
aliphatic, unsaturated, linear,
with an even number of carbon
E
N
atoms (C16-C18)
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
yes
no
no
12-hydroxystearic acid
45
56500
—
glycerol, esters with lauric acid
yes
no
no
Official
46
56510
—
glycerol, esters with linoleic acid
yes
no
no
Journ
47
56520
—
glycerol, esters with myristic
yes
no
no
acid
al
of
48
56535
—
glycerol, esters with nonanoic
yes
no
no
the
acid
E
uropean
49
56540
—
glycerol, esters with oleic acid
yes
no
no
50
56550
—
glycerol, esters with palmitic
yes
no
no
acid
Un
ion
51
56570
—
glycerol, esters with propionic
yes
no
no
acid
52
56580
—
glycerol, esters with ricinoleic
yes
no
no
acid
53
56585
—
glycerol, esters with stearic acid
yes
no
no
54
57040
—
glycerol monooleate, ester with
yes
no
no
ascorbic acid
55
57120
—
glycerol monooleate, ester with
yes
no
no
citric acid
56
57200
—
glycerol monopalmitate, ester
yes
no
no
15.1.2011
with ascorbic acid
57
57280
—
glycerol monopalmitate, ester
yes
no
no
with citric acid

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
58
57600
—
glycerol monostearate, ester
yes
no
no
with ascorbic acid
59
57680
—
glycerol monostearate, ester
yes
no
no
with citric acid
E
60
58300
—
glycine, salts
yes
no
no
N
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)-
yes
no
no
Not more than 0,05%
4′-(5-methyl-2-benzoxazolyl)
(w/w) (quantity of substance
stilbene, 4,4′-bis
used/quantity of the formu
(2-benzoxazolyl) stilbene and
lation).
Official
4,4′-bis(5-methyl-2-
Mixture obtained from the
benzoxazolyl)stilbene
manufacturing process in
the typical ratio of (58-
Journ
62%):(23-27%):(13-17%).
66
67600
—
mono-n-octyltin tris(alkyl
yes
no
no
(11)
al
(C
of
10-C16) mercaptoacetate)
the
67
67840
—
montanic acids and/or their
yes
no
no
esters with ethyleneglycol
E
uropean
and/or with 1,3-butanediol
and/or with glycerol
68
73160
—
phosphoric acid, mono- and
yes
no
yes
0,05
Un
di-n-alkyl (C16 and C18) esters
ion
69
74400
—
phosphorous acid, tris(nonyl-
yes
no
yes
30
and/or dinonylphenyl) ester
70
76463
—
polyacrylic acid, salts
yes
no
no
(22)
71
76730
—
polydimethylsiloxane,
yes
no
no
6
γ-hydroxypropylated
72
76815
—
polyester of adipic acid with
yes
no
no
(32)
The fraction with molecular
glycerol or pentaerythritol,
weight below 1000 Da
esters with even numbered,
should not exceed 5%
unbranched C12-C22 fatty acids
(w/w)
73
76866
—
polyesters of 1,2-propanediol
yes
no
yes
(31)
and/or 1,3- and/or 1,4-
(32)
butanediol and/or polypropyle
neglycol with adipic acid, which
L
may be end-capped with acetic
12/19
acid or fatty acids C12-C18 or
n-octanol and/or n-decanol

---

L
12/20
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
74
77440
—
polyethyleneglycol diricinoleate
yes
no
yes
42
75
77702
—
polyethyleneglycol esters of
yes
no
no
aliph. monocarb. acids (C6-C22)
and their ammonium and
sodium sulphates
E
N
76
77732
—
polyethylene glycol (EO = 1-30,
yes
no
no
0,05
Only for use in PET
typically 5) ether of butyl
2-cyano 3-(4-hydroxy-
3-methoxyphenyl) acrylate
77
77733
—
polyethyleneglycol (EO = 1-30,
yes
no
no
0,05
Only for use in PET
typically 5) ether of
butyl-2-cyano-3-
(4-hydroxyphenyl) acrylate
Official
78
77897
—
polyethyleneglycol (EO = 1-50)
yes
no
no
5
monoalkylether (linear and
branched, C8-C20) sulphate, salts
Journ
79
80640
—
polyoxyalkyl (C2-C4)
yes
no
no
dimethylpolysiloxane
al
of
80
81760
—
powders, flakes and fibres of
yes
no
no
the
brass, bronze, copper, stainless
E
steel, tin, iron and alloys of
uropean
copper, tin and iron
81
83320
—
propylhydroxyethylcellulose
yes
no
no
Un
82
83325
—
propylhydroxymethylcellulose
yes
no
no
ion
83
83330
—
propylhydroxypropylcellulose
yes
no
no
84
85601
—
silicates, natural (with the
yes
no
no
exception of asbestos)
85
85610
—
silicates, natural, silanated (with
yes
no
no
the exception of asbestos)
86
86000
—
silicic acid, silylated
yes
no
no
87
86285
—
silicon dioxide, silanated
yes
no
no
88
86880
—
sodium monoalkyl dialkylphe
yes
no
no
9
noxybenzenedisulphonate
15.1.2011
89
89440
—
stearic acid, esters with
yes
no
no
(2)
ethyleneglycol
90
92195
—
taurine, salts
yes
no
no

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
91
92320
—
tetradecyl-polyethyleneglycol
yes
no
yes
15
(EO = 3-8) ether of glycolic acid
92
93970
—
tricyclodecanedimethanol
yes
no
no
0,05
E
bis(hexahydrophthalate)
N
93
95858
—
waxes, paraffinic, refined,
yes
no
no
0,05
Not to be used for articles
derived from petroleum based
in contact with fatty foods
or synthetic hydrocarbon
for which simulant D is laid
feedstocks, low viscosity
down.
Average molecular weight
not less than 350 Da.
Viscosity at 100°C not less
Official
than 2,5 cSt
(2,5 × 10-6 m2/s).
Content of hydrocarbons
Journ
with Carbon number less
than 25, not more than
al
40% (w/w).
of
the
E
uropean
94
95859
—
waxes, refined, derived from
yes
no
no
Average molecular weight
petroleum based or synthetic
not less than 500 Da.
hydrocarbon feedstocks, high
Viscosity at 100°C not less
viscosity
than 11 cSt
Un
(11 × 10-6 m2/s).
ion
Content of mineral hydro
carbons with Carbon num
ber less than 25, not more
than 5% (w/w).
95
95883
—
white mineral oils, paraffinic,
yes
no
no
Average molecular weight
derived from petroleum based
not less than 480 Da.
hydrocarbon feedstocks
Viscosity at 100°C not less
than 8,5 cSt
(8,5 × 10-6 m2/s).
Content of mineral hydro
carbons with Carbon num
ber less than 25, not more
than 5% (w/w).
L
12/21
96
95920
—
wood flour and fibers, untreated
yes
no
no

---

L
12/22
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
97
72081/10
—
petroleum hydrocarbon resins
yes
no
no
Petroleum hydrocarbon
(hydrogenated)
resins, hydrogenated are
produced by the catalytic or
thermalpolymerisation of
dienes and olefins of the
aliphatic, alicyclic and/or
E
N
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 fol
lowed by distillation, hydro
genation and additional
processing.
Official
Properties:
— Viscosity at 120°C:
> 3Pa.s,
Journ
— Softening point:
al
> 95°C as determined
of
by ASTM Method
the
E 28-67,
— Bromine number: < 40
E
uropean
(ASTM D1159),
— The colour of a 50%
solution in toluene
Un
< 11 on the Gardner
ion
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
15.1.2011
103
18100
0000056-81-5
glycerol
yes
yes
no
55920

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
104
58960
0000057-09-0
hexadecyltrimethylammonium
yes
no
no
6
bromide
105
22780
0000057-10-3
palmitic acid
yes
yes
no
70400
E
N
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
α-tocopherol
yes
no
no
Official
0010191-41-0
111
53600
0000060-00-4
ethylenediaminetetraacetic acid
yes
no
no
Journ
112
64015
0000060-33-3
linoleic acid
yes
no
no
al
113
16780
0000064-17-5
ethanol
yes
yes
no
of
the
52800
E
uropean
114
55040
0000064-18-6
formic acid
yes
no
no
115
10090
0000064-19-7
acetic acid
yes
yes
no
Un
30000
ion
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
L
123
13840
0000071-36-3
1-butanol
no
yes
no
12/23
124
22870
0000071-41-0
1-pentanol
no
yes
no

---

L
12/24
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
125
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
1mg/kg in final product
E
128
10060
0000075-07-0
acetaldehyde
no
yes
no
(1)
N
129
17020
0000075-21-8
ethylene oxide
no
yes
no
ND
1mg/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
1mg/kg in final product
(10)
Official
23155
134
43680
0000075-45-6
chlorodifluoromethane
yes
no
no
6
Content of
Journ
chlorofluoromethane less
than 1mg/kg of the
substance
al
of
135
24010
0000075-56-9
propylene oxide
no
yes
no
ND
1mg/kg in final product
the
E
136
41680
0000076-22-2
camphor
yes
no
no
(3)
uropean
137
66580
0000077-62-3
2,2′-methylenebis(4-methyl-6-
yes
no
yes
(5)
(1-methylcyclohexyl)phenol)
Un
138
93760
0000077-90-7
tri-n-butyl acetyl citrate
yes
no
no
(32)
ion
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
(1)
treatment agent
143
62450
0000078-78-4
isopentane
yes
no
no
15.1.2011
144
19243
0000078-79-5
2-methyl-1,3-butadiene
no
yes
no
ND
1mg/kg in final product
21640

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
145
10630
0000079-06-1
acrylamide
no
yes
no
ND
146
23890
0000079-09-4
propionic acid
yes
yes
no
82000
E
N
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)
no
yes
no
0,6
Official
propane
13607
Journ
152
15610
0000080-07-9
4,4′-dichlorodiphenyl sulphone
no
yes
no
0,05
al
of
153
15267
0000080-08-0
4,4′-diaminodiphenyl sulphone
no
yes
no
5
the
E
154
13617
0000080-09-1
4,4′-dihydroxydiphenyl
no
yes
no
0,05
uropean
sulphone
16090
Un
155
23470
0000080-56-8
α-pinene
no
yes
no
ion
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:
(7)
(a) plasticiser in repeated
use materials and
articles contacting
non-fatty foods;
(b) technical support agent
in polyolefins in con
centrations up to
0,05% in the final
product.
158
23380
0000085-44-9
phthalic anhydride
yes
yes
no
L
12/25
76320

---

L
12/26
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
159
74560
0000085-68-7
phthalic acid, benzyl butyl ester
yes
no
no
30
(32)
Only to be used as:
(7)
(a) plasticiser in repeated
use materials and
articles;
(b) plasticiser in single-use
E
materials and articles
N
contacting non-fatty
foods except for infant
formulae and
follow-on formulae as
defined by Directive
2006/141/EC or pro
cessed cereal-based
foods and baby foods
for infants and young
children as defined by
Official
Directive
2006/125/EC;
(c) technical support agent
Journ
in concentrations up
to 0,1% in the final
al
product.
of
the
160
84800
0000087-18-3
salicylic acid, 4-tert-butylphenyl
yes
no
yes
12
ester
E
uropean
161
92160
0000087-69-4
tartaric acid
yes
no
no
162
65520
0000087-78-5
mannitol
yes
no
no
Un
ion
163
66400
0000088-24-4
2,2′-methylene bis(4-ethyl-6-
yes
no
yes
(13)
tert-butylphenol)
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)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
15.1.2011
168
13075
0000091-76-9
2,4-diamino-6-phenyl-1,3,5-
no
yes
no
5
(1)
triazine
15310

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
169
16240
0000091-97-4
3,3′-dimethyl-
no
yes
no
(17)
1mg/kg in final product
(10)
4,4′-diisocyanatobiphenyl
expressed as isocyanate
moiety
170
16000
0000092-88-6
4,4′-dihydroxybiphenyl
no
yes
no
6
171
38080
0000093-58-3
benzoic acid, methyl ester
yes
no
no
E
N
172
37840
0000093-89-0
benzoic acid, ethyl ester
yes
no
no
173
60240
0000094-13-3
4-hydroxybenzoic acid, propyl
yes
no
no
ester
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.
Official
Residual content of 5mg
ethylene carbonate per kg
of hydrogel with max 10g
Journ
of hydrogel in contact with
1kg of food.
al
of
178
92800
0000096-69-5
4,4′-thiobis(6-tert-butyl-3-
yes
no
yes
0,48
the
methylphenol)
E
179
48800
0000097-23-4
2,2′-dihydroxy-–5,5′-
yes
no
yes
12
uropean
dichlorodiphenylmethane
180
17160
0000097-53-0
eugenol
no
yes
no
ND
Un
181
20890
0000097-63-2
methacrylic acid, ethyl ester
no
yes
no
(23)
ion
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
no
yes
no
0,05
ethyleneglycol
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
yes
no
no
ester
190
18880
0000099-96-7
p-hydroxybenzoic acid
no
yes
no
191
24940
0000100-20-9
terephthalic acid dichloride
no
yes
no
(28)
L
192
23187
—
phthalic acid
no
yes
no
(28)
12/27
193
24610
0000100-42-5
styrene
no
yes
no

---

L
12/28
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
194
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
E
N
197
20260
0000101-43-9
methacrylic acid, cyclohexyl
no
yes
no
0,05
ester
198
16630
0000101-68-8
diphenylmethane-
no
yes
no
(17)
1mg/kg in final product
(10)
4,4′-diisocyanate
expressed as isocyanate
moiety
199
24073
0000101-90-6
resorcinol diglycidyl ether
no
yes
no
ND
Not to be used for articles
(8)
in contact with fatty foods
for which simulant D is laid
down.
Official
For indirect food contact
only, behind a PET layer.
Journ
200
51680
0000102-08-9
N,N′-diphenylthiourea
yes
no
yes
3
al
201
16540
0000102-09-0
diphenyl carbonate
no
yes
no
0,05
of
202
23070
0000102-39-6
(1,3-phenylenedioxy)
no
yes
no
0,05
(1)
the
diacetic acid
E
uropean
203
13323
0000102-40-9
1,3-bis(2-hydroxyethoxy)
no
yes
no
0,05
benzene
204
25180
0000102-60-3
N,N,N′,N′-tetrakis(2-
yes
yes
no
Un
hydroxypropyl)ethylenediamine
ion
92640
205
25385
0000102-70-5
triallylamine
no
yes
no
40mg/kg hydrogel at a
ratio of 1kg food to a
maximum of 1,5grams 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)
yes
no
yes
18
(32)
(2)
ester
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
15.1.2011
210
13390
0000105-08-8
1,4-bis(hydroxymethyl)
no
yes
no
cyclohexane
14880

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
211
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
E
N
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
1mg/kg in final product
(10)
Official
16750
220
20590
0000106-91-2
methacrylic acid,
no
yes
no
0,02
(10)
2,3-epoxypropyl ester
Journ
221
40570
0000106-97-8
butane
yes
no
no
al
of
222
13870
0000106-98-9
1-butene
no
yes
no
the
223
13630
0000106-99-0
butadiene
no
yes
no
ND
1mg/kg in final product
E
uropean
224
13900
0000107-01-7
2-butene
no
yes
no
225
12100
0000107-13-1
acrylonitrile
no
yes
no
ND
Un
226
15272
0000107-15-3
ethylenediamine
no
yes
no
12
ion
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
L
234
19960
0000108-31-6
maleic anhydride
no
yes
no
(3)
12/29
235
14710
0000108-39-4
m-cresol
no
yes
no

---

L
12/30
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
236
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
E
N
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)
Official
244
71720
0000109-66-0
pentane
yes
no
no
245
22900
0000109-67-1
1-pentene
no
yes
no
5
Journ
246
25150
0000109-99-9
tetrahydrofuran
no
yes
no
0,6
al
247
24820
0000110-15-6
succinic acid
yes
yes
no
of
the
90960
E
248
19540
0000110-16-7
maleic acid
yes
yes
no
(3)
uropean
64800
249
17290
0000110-17-8
fumaric acid
yes
yes
no
Un
ion
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
15.1.2011
257
13550
0000110-98-5
dipropyleneglycol
yes
yes
no
16660
51760

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
258
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
E
261
15790
0000111-40-0
diethylenetriamine
no
yes
no
5
N
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
Official
47680
Journ
264
22660
0000111-66-0
1-octene
no
yes
no
15
al
265
22600
0000111-87-5
1-octanol
no
yes
no
of
266
25510
0000112-27-6
triethyleneglycol
yes
yes
no
the
E
94320
uropean
267
15100
0000112-30-1
1-decanol
no
yes
no
268
16704
0000112-41-4
1-dodecene
no
yes
no
0,05
Un
ion
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)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
L
275
23980
0000115-07-1
propylene
no
yes
no
12/31
276
19000
0000115-11-7
isobutene
no
yes
no

---

L
12/32
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
277
18280
0000115-27-5
hexachloroendomethylenetetra
no
yes
no
ND
hydrophthalic anhydride
278
18250
0000115-28-6
hexachloroendomethylenetetra
no
yes
no
ND
hydrophthalic acid
279
22840
0000115-77-5
pentaerythritol
yes
yes
no
E
N
71600
280
73720
0000115-96-8
phosphoric acid, trichloroethyl
yes
no
no
ND
ester
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)
yes
no
no
1,5
(32)
Only to be used as:
(7)
ester
(a) plasticiser in repeated
Official
use materials and
articles contacting
non-fatty foods;
Journ
(b) technical support agent
in concentrations up
al
to 0,1% in the final
of
product.
the
284
84880
0000119-36-8
salicylic acid, methyl ester
yes
no
no
30
E
uropean
285
66480
0000119-47-1
2,2′-methylene bis(4-methyl-6-
yes
no
yes
(13)
tert-butylphenol)
286
38240
0000119-61-9
benzophenone
yes
no
yes
0,6
Un
287
60160
0000120-47-8
4-hydroxybenzoic acid, ethyl
yes
no
no
ion
ester
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
1mg/kg in final product
(1)
294
93120
0000123-28-4
thiodipropionic acid, didodecyl
yes
no
yes
(14)
ester
15.1.2011
295
15940
0000123-31-9
1,4-dihydroxybenzene
yes
yes
no
0,6
18867
48620

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
296
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
E
N
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
Official
41960
305
15274
0000124-09-4
hexamethylenediamine
no
yes
no
2,4
Journ
18460
al
306
88960
0000124-26-5
stearamide
yes
no
no
of
the
307
42160
0000124-38-9
carbon dioxide
yes
no
no
E
uropean
308
91200
0000126-13-6
sucrose acetate isobutyrate
yes
no
no
309
91360
0000126-14-7
sucrose octaacetate
yes
no
no
Un
310
16390
0000126-30-7
2,2-dimethyl-1,3-propanediol
no
yes
no
0,05
ion
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-
yes
no
yes
(8)
L
4-methoxybenzophenone
12/33
318
48640
0000131-56-6
2,4-dihydroxybenzophenone
yes
no
no
(8)

---

L
12/34
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
319
61360
0000131-57-7
2-hydroxy-
yes
no
yes
(8)
4-methoxybenzophenone
320
37680
0000136-60-7
benzoic acid, butyl ester
yes
no
no
321
36080
0000137-66-6
ascorbyl palmitate
yes
no
no
E
N
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
35170
for which simulant D is laid
down.
Official
For indirect food contact
only, behind a PET layer.
Journ
al
of
327
30140
0000141-78-6
acetic acid, ethyl ester
yes
no
no
the
E
328
65040
0000141-82-2
malonic acid
yes
no
no
uropean
329
59360
0000142-62-1
hexanoic acid
yes
no
no
330
19470
0000143-07-7
lauric acid
yes
yes
no
Un
ion
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
15.1.2011
338
71020
0000373-49-9
palmitoleic acid
yes
no
no
339
86160
0000409-21-2
silicon carbide
yes
no
no

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
340
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)
E
N
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)
Official
25540
348
22350
0000544-63-8
myristic acid
yes
yes
no
Journ
67891
al
349
25550
0000552-30-7
trimellitic anhydride
no
yes
no
(21)
of
350
63920
0000557-59-5
lignoceric acid
yes
no
no
the
351
21730
0000563-45-1
3-methyl-1-butene
no
yes
no
ND
Only to be used in
(1)
E
uropean
polypropylene
352
16360
0000576-26-1
2,6-dimethylphenol
no
yes
no
0,05
Un
353
42480
0000584-09-8
carbonic acid, rubidium salt
yes
no
no
12
ion
354
25210
0000584-84-9
2,4-toluene diisocyanate
no
yes
no
(17)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
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
(1)
co-monomer for the
preparation of polymeric
additive
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
L
360
57920
0000620-67-7
glycerol triheptanoate
yes
no
no
12/35
361
18700
0000629-11-8
1,6-hexanediol
no
yes
no
0,05

---

L
12/36
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
362
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
E
poly(ethylene-co-isosorbide
N
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,
yes
no
yes
(14)
dioctadecyl ester
369
12761
0000693-57-2
12-aminododecanoic acid
no
yes
no
0,05
Official
370
21460
0000760-93-0
methacrylic anhydride
no
yes
no
(23)
Journ
371
11510
0000818-61-1
acrylic acid, monoester with
no
yes
no
(22)
ethyleneglycol
11830
al
of
372
18640
0000822-06-0
hexamethylene diisocyanate
no
yes
no
(17)
1mg/kg in final product
(10)
the
expressed as isocyanate
E
moiety
uropean
373
22390
0000840-65-3
2,6-naphthalenedicarboxylic
no
yes
no
0,05
acid, dimethyl ester
Un
374
21190
0000868-77-9
methacrylic acid, monoester
no
yes
no
(23)
ion
with ethyleneglycol
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 3mg/kg
filler when used for the
reactive surface treatment of
inorganic fillers.
SML = 0,05mg/kg when
used for the surface treat
ment of materials and
articles.
15.1.2011
378
21970
0000923-02-4
N-methylolmethacrylamide
no
yes
no
0,05
379
21940
0000924-42-5
N-methylolacrylamide
no
yes
no
ND

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
380
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
E
N
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-
yes
no
yes
30
(4-hydroxy-3,5-di-tert-
butylanilino)-1,3,5-triazine
385
11530
0000999-61-1
acrylic acid, 2-hydroxypropyl
no
yes
no
0,05
SML expressed as the sum
(1)
ester
of acrylic acid,
2-hydroxypropyl ester and
Official
acrylic acid,
2-hydroxyisopropyl ester.
It may contain up to 25%
Journ
(m/m) of acrylic acid,
2-hydroxyisopropyl ester
(CAS No 0002918-23-2).
al
of
386
55280
0001034-01-1
gallic acid, octyl ester
yes
no
no
(20)
the
387
26155
0001072-63-5
1-vinylimidazole
no
yes
no
0,05
(1)
E
uropean
388
25080
0001120-36-1
1-tetradecene
no
yes
no
0,05
389
22360
0001141-38-4
2,6-naphthalenedicarboxylic
no
yes
no
5
Un
acid
ion
390
55200
0001166-52-5
gallic acid, dodecyl ester
yes
no
no
(20)
391
22932
0001187-93-5
perfluoromethyl perfluorovinyl
no
yes
no
0,05
Only to be used in anti-stick
ether
coatings
392
72800
0001241-94-7
phosphoric acid, diphenyl
yes
no
yes
2,4
2-ethylhexyl ester
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)
L
399
81600
0001310-58-3
potassium hydroxide
yes
no
no
12/37
400
86720
0001310-73-2
sodium hydroxide
yes
no
no

---

L
12/38
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
401
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
E
N
405
16690
0001321-74-0
divinylbenzene
no
yes
no
ND
SML expressed as the sum
(1)
of divinylbenzene and eth
ylvinylbenzene.
It may contain up to 45%
(m/m) of ethylvinylbenzene.
406
83300
0001323-39-3
1,2-propyleneglycol monostear
yes
no
no
ate
407
87040
0001330-43-4
sodium tetraborate
yes
no
no
(16)
Official
408
82960
0001330-80-9
1,2-propyleneglycol monooleate
yes
no
no
409
62240
0001332-37-2
iron oxide
yes
no
no
Journ
410
62720
0001332-58-7
kaolin
yes
no
no
al
of
411
42080
0001333-86-4
carbon black
yes
no
no
Primary particles of 10 –
the
300nm which are aggre
gated to a size of 100 –
E
uropean
1200nm which may form
agglomerates within the size
distribution of 300nm –
mm.
Un
Toluene extractables: maxi
ion
mum 0,1%, determined
according to ISO method
6209.
UV absorption of cyclohex
ane extract at 386nm:
< 0,02 AU for a 1cm cell
or < 0,1 AU for a 5cm cell,
determined according to a
generally recognised
method of analysis.
Benzo(a)pyrene content:
max 0,25mg/kg carbon
black.
Maximum use level of car
bon black in the polymer:
2,5% w/w.
15.1.2011
412
45200
0001335-23-5
copper iodide
yes
no
no
(6)
413
35600
0001336-21-6
ammonium hydroxide
yes
no
no

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
414
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
E
N
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)
Official
423
22937
0001623-05-8
perfluoropropylperfluorovinyl
no
yes
no
0,05
ether
424
15070
0001647-16-1
1,9-decadiene
no
yes
no
0,05
Journ
425
10840
0001663-39-4
acrylic acid, tert-butyl ester
no
yes
no
(22)
al
of
426
13510
0001675-54-3
2,2-bis(4-hydroxyphenyl)
no
yes
no
In compliance with
propane bis(2,3-epoxypropyl)
Commission Regulation
the
13610
ether
(EC) No 1895/2005(1)
E
uropean
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-
yes
no
no
Un
di-tert-butyl-4-hydroxybenzyl)
benzene
ion
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-
yes
no
yes
5
5-tert-butylphenyl) butane
431
61600
0001843-05-6
2-hydroxy-4-n-
yes
no
yes
(8)
octyloxybenzophenone
432
12280
0002035-75-8
adipic anhydride
no
yes
no
433
68320
0002082-79-3
octadecyl 3-(3,5-di-tert-butyl-4-
yes
no
yes
6
hydroxyphenyl)propionate
434
20410
0002082-81-7
methacrylic acid, diester with
no
yes
no
0,05
1,4-butanediol
435
14230
0002123-24-2
caprolactam, sodium salt
no
yes
no
(4)
L
436
19480
0002146-71-6
lauric acid, vinyl ester
no
yes
no
12/39
437
11245
0002156-97-0
acrylic acid, dodecyl ester
no
yes
no
0,05
(2)

---

L
12/40
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
438
38875
0002162-74-5
bis(2,6-diisopropylphenyl)
yes
no
no
0,05
For indirect food contact
carbodiimide
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)
E
N
441
38160
0002315-68-6
benzoic acid, propyl ester
yes
no
no
442
13780
0002425-79-8
1,4-butanediol
no
yes
no
ND
Residual content = 1mg/kg
(10)
bis(2,3-epoxypropyl)ether
in final product expressed
as epoxygroup.
Molecular weight is 43 Da.
443
12788
0002432-99-7
11-aminoundecanoic acid
no
yes
no
5
444
61440
0002440-22-4
2-(2′-hydroxy-5′-
yes
no
no
(12)
Official
methylphenyl)benzotriazole
445
83440
0002466-09-3
pyrophosphoric acid
yes
no
no
Journ
446
10750
0002495-35-4
acrylic acid, benzyl ester
no
yes
no
(22)
al
447
20080
0002495-37-6
methacrylic acid, benzyl ester
no
yes
no
(23)
of
the
448
11890
0002499-59-4
acrylic acid, n-octyl ester
no
yes
no
(22)
E
uropean
449
49840
0002500-88-1
dioctadecyl disulphide
yes
no
yes
3
450
24430
0002561-88-8
sebacic anhydride
no
yes
no
Un
451
66755
0002682-20-4
2-methyl-4-isothiazolin-3-one
yes
no
no
0,5
Only to be used in aqueous
ion
polymer dispersions and
emulsions
452
38885
0002725-22-6
2,4-bis(2,4-dimethylphenyl)-6-
yes
no
no
0,05
Only to be used in aqueous
(2-hydroxy-4-n-
foods
octyloxyphenyl)-1,3,5-triazine
453
26320
0002768-02-7
vinyltrimethoxysilane
no
yes
no
0,05
(10)
454
12670
0002855-13-2
1-amino-3-aminomethyl-3,5,5-
no
yes
no
6
trimethylcyclohexane
455
20530
0002867-47-2
methacrylic acid,
no
yes
no
ND
2-(dimethylamino)-ethyl ester
456
10810
0002998-08-5
acrylic acid, sec-butyl ester
no
yes
no
(22)
15.1.2011
457
20140
0002998-18-7
methacrylic acid, sec-butyl ester
no
yes
no
(23)
458
36960
0003061-75-4
behenamide
yes
no
no

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
459
46870
0003135-18-0
3,5-di-tert-butyl-4-
yes
no
no
hydroxybenzylphosphonic acid,
dioctadecyl ester
460
14950
0003173-53-3
cyclohexyl isocyanate
no
yes
no
(17)
1mg/kg in final product
(10)
expressed as isocyanate
E
moiety
N
461
22420
0003173-72-6
1,5-naphthalene diisocyanate
no
yes
no
(17)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
462
26170
0003195-78-6
N-vinyl-N-methylacetamide
no
yes
no
0,02
(1)
463
25840
0003290-92-4
1,1,1-trimethylolpropane
no
yes
no
0,05
trimethacrylate
464
61280
0003293-97-8
2-hydroxy-4-n-
yes
no
yes
(8)
hexyloxybenzophenone
Official
465
68040
0003333-62-8
7-[2H-naphtho-(1,2-D)triazol-
yes
no
no
2-yl]-3-phenylcoumarin
Journ
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)
al
of
45600
the
468
71960
0003825-26-1
perfluorooctanoic acid,
yes
no
no
Only to be used in repeated
E
ammonium salt
use articles, sintered at high
uropean
temperatures
469
60480
0003864-99-1
2-(2′-hydroxy-3,5′-di-tert-
yes
no
yes
(12)
Un
butylphenyl)-5-
chlorobenzotriazole
ion
470
60400
0003896-11-5
2-(2′-hydroxy-3′-tert-butyl-5′-
yes
no
yes
(12)
methylphenyl)-5-
chlorobenzotriazole
471
24888
0003965-55-7
5-sulphoisophthalic acid,
no
yes
no
0,05
monosodium salt, dimethyl
ester
472
66560
0004066-02-8
2,2′-methylenebis(4-methyl-6-
yes
no
yes
(5)
cyclohexylphenol)
473
12265
0004074-90-2
adipic acid, divinyl ester
no
yes
no
ND
5mg/kg in final product.
(1)
Only to be used as
co-monomer.
474
43600
0004080-31-3
1-(3-chloroallyl)-3,5,7-triaza-1-
yes
no
no
0,3
azoniaadamantane chloride
L
475
19110
0004098-71-9
1-isocyanato-3-
no
yes
no
(17)
1mg/kg in final product
(10)
12/41
isocyanatomethyl-3,5,5-
expressed as isocyanate
trimethylcyclohexane
moiety

---

L
12/42
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
476
16570
0004128-73-8
diphenylether-4,4′-diisocyanate
no
yes
no
(17)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
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,
yes
no
no
E
N
isopropyl ester
479
12970
0004196-95-6
azelaic anhydride
no
yes
no
480
46790
0004221-80-1
3,5-di-tert-butyl-4-
yes
no
no
hydroxybenzoic acid,
2,4-di-tert-butylphenyl ester
481
13060
0004422-95-1
1,3,5-benzenetricarboxylic acid
no
yes
no
0,05
SML expressed as
(1)
trichloride
1,3,5-benzenetricarboxylic
acid
482
21100
0004655-34-9
methacrylic acid, isopropyl ester
no
yes
no
(23)
Official
483
68860
0004724-48-5
n-octylphosphonic acid
yes
no
no
0,05
484
13395
0004767-03-7
2,2-bis(hydroxymethyl)
no
yes
no
0,05
(1)
Journ
propionic acid
al
485
13560
0005124-30-1
dicyclohexylmethane-4,4′-
no
yes
no
(17)
1mg/kg in final product
(10)
of
diisocyanate
expressed as isocyanate
15700
the
moiety
E
486
54005
0005136-44-7
ethylene-N-palmitamide-N′-
yes
no
no
uropean
stearamide
487
45640
0005232-99-5
2-cyano-3,3-diphenylacrylic
yes
no
no
0,05
acid, ethyl ester
Un
ion
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′-
no
yes
no
(17)
1mg/kg in final product
(10)
diisocyanate
expressed as isocyanate
moiety
491
82720
0006182-11-2
1,2-propyleneglycol distearate
yes
no
no
492
45650
0006197-30-4
2-cyano-3,3-diphenylacrylic
yes
no
no
0,05
acid, 2-ethylhexyl ester
493
39200
0006200-40-4
bis(2-hydroxyethyl)-2-
yes
no
no
1,8
hydroxypropyl-3-(dodecyloxy)
methylammonium chloride
494
62140
0006303-21-5
hypophosphorous acid
yes
no
no
495
35160
0006642-31-5
6-amino-1,3-dimethyluracil
yes
no
no
5
15.1.2011
496
71680
0006683-19-8
pentaerythritol tetrakis[3-(3,5-
yes
no
no
di-tert-butyl-4-hydroxyphenyl)-
propionate]

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
497
95020
0006846-50-0
2,2,4-trimethyl-1,3-pentanediol
yes
no
no
5
Only to be used in
diisobutyrate
single-use gloves
498
16210
0006864-37-5
3,3′-dimethyl-4,4′-
no
yes
no
0,05
Only to be used in
(5)
diaminodicyclohexylmethane
polyamides
499
19965
0006915-15-7
malic acid
yes
yes
no
In case of use as a
E
N
monomer only to be used
as a co-monomer in
aliphatic polyesters up to
65020
maximum level of 1% on a
molar basis
500
38560
0007128-64-5
2,5-bis(5-tert-butyl-2-
yes
no
yes
0,6
benzoxazolyl)thiophene
501
34480
—
aluminium fibers, flakes and
yes
no
no
powders
Official
502
22778
0007456-68-0
4,4′-oxybis(benzenesulphonyl
no
yes
no
0,05
(1)
azide)
Journ
503
46080
0007585-39-9
β-dextrin
yes
no
no
al
504
86240
0007631-86-9
silicon dioxide
yes
no
no
For synthetic amorphous
of
silicon dioxide: primary
the
particles of 1 – 100nm
which are aggregated to a
E
uropean
size of 0,1 – 1m which
may form agglomerates
within the size distribution
of 0,3m to the mm size.
Un
ion
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)
L
513
86800
0007681-82-5
sodium iodide
yes
no
no
(6)
12/43
514
91840
0007704-34-9
sulphur
yes
no
no

---

L
12/44
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
515
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)
E
517
81520
0007758-02-3
potassium bromide
yes
no
no
N
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
Official
523
45195
0007787-70-4
copper bromide
yes
no
no
524
24520
0008001-22-7
soybean oil
no
yes
no
Journ
525
62640
0008001-39-6
japan wax
yes
no
no
al
526
43440
0008001-75-0
ceresin
yes
no
no
of
the
527
14411
0008001-79-4
castor oil
yes
yes
no
E
uropean
42880
528
63760
0008002-43-5
lecithin
yes
no
no
Un
529
67850
0008002-53-7
montan wax
yes
no
no
ion
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
(32)
(*) In the case of PVC gas
30(*)
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
15.1.2011
2006/125/EC, the SML
is lowered to 30mg/kg.
Oxirane < 8%, iodine
number < 6.

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
533
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
E
24130
N
24190
83840
536
84320
0008050-15-5
rosin, hydrogenated, ester with
yes
no
no
methanol
537
84080
0008050-26-8
rosin, ester with pentaerythritol
yes
no
no
Official
538
84000
0008050-31-5
rosin, ester with glycerol
yes
no
no
539
24160
0008052-10-6
rosin tall oil
no
yes
no
Journ
540
63940
0008062-15-5
lignosulphonic acid
yes
no
no
0,24
Only to be used as
dispersant for plastics
al
dispersions
of
the
541
58480
0009000-01-5
gum arabic
yes
no
no
E
uropean
542
42640
0009000-11-7
carboxymethylcellulose
yes
no
no
543
45920
0009000-16-2
dammar
yes
no
no
Un
544
58400
0009000-30-0
guar gum
yes
no
no
ion
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
poly(ethylene propylene) glycol
yes
no
no
0106392-12-5
552
81500
0009003-39-8
polyvinylpyrrolidone
yes
no
no
The substance shall meet
L
the purity criteria as laid
12/45
down in Commission Direc
tive 2008/84/EC(3)

---

L
12/46
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
553
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
E
N
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
Official
563
78320
0009004-97-1
polyethyleneglycol
yes
no
yes
42
monoricinoleate
Journ
564
24540
0009005-25-8
starch, edible
yes
yes
no
al
88800
of
the
565
61120
0009005-27-0
hydroxyethyl starch
yes
no
no
E
566
33350
0009005-32-7
alginic acid
yes
no
no
uropean
567
82080
0009005-37-2
1,2-propyleneglycol alginate
yes
no
no
568
79040
0009005-64-5
polyethyleneglycol sorbitan
yes
no
no
Un
monolaurate
ion
569
79120
0009005-65-6
polyethyleneglycol sorbitan
yes
no
no
monooleate
570
79200
0009005-66-7
polyethyleneglycol sorbitan
yes
no
no
monopalmitate
571
79280
0009005-67-8
polyethyleneglycol sorbitan
yes
no
no
monostearate
572
79360
0009005-70-3
polyethyleneglycol sorbitan
yes
no
no
trioleate
573
79440
0009005-71-4
polyethyleneglycol sorbitan
yes
no
no
tristearate
574
24250
0009006-04-6
rubber, natural
yes
yes
no
84560
15.1.2011
575
76721
0063148-62-9
polydimethylsiloxane
yes
no
no
Viscosity at 25°C not less
(Mw > 6800 Da)
than 100 cSt
(100 × 10-6 m2/s)

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
576
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
yes
no
no
5
For materials and articles
phosphate
intended for contact with
E
aqueous foods only.
N
Polyethyleneglycol
(EO ≤ 11) tridecyl ether
phosphate (mono-and
dialkyl ester) with a maxi
mum 10% content of poly
ethyleneglycol (EO ≤ 11)
tridecylether.
579
61800
0009049-76-7
hydroxypropyl starch
yes
no
no
580
46070
0010016-20-3
α-dextrin
yes
no
no
Official
581
36800
0010022-31-8
barium nitrate
yes
no
no
Journ
582
50240
0010039-33-5
di-n-octyltin bis(2-ethylhexyl
yes
no
no
(10)
maleate)
al
of
583
40400
0010043-11-5
boron nitride
yes
no
no
(16)
the
584
13620
0010043-35-3
boric acid
yes
yes
no
(16)
E
uropean
40320
585
41120
0010043-52-4
calcium chloride
yes
no
no
Un
586
65280
0010043-84-2
manganese hypophosphite
yes
no
no
ion
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
no
yes
no
ND
(1)
ester
591
36160
0010605-09-1
ascorbyl stearate
yes
no
no
592
34690
0011097-59-9
aluminium magnesium carbon
yes
no
no
ate hydroxide
593
44960
0011104-61-3
cobalt oxide
yes
no
no
594
65360
0011129-60-5
manganese oxide
yes
no
no
L
595
19510
0011132-73-3
lignocellulose
no
yes
no
12/47
596
95935
0011138-66-2
xanthan gum
yes
no
no

---

L
12/48
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
597
67120
0012001-26-2
mica
yes
no
no
598
41600
0012004-14-7
calcium sulphoaluminate
yes
no
no
0037293-22-4
599
36840
0012007-55-5
barium tetraborate
yes
no
no
(16)
E
N
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
no
yes
no
0,05
(1)
ester
Official
606
65200
0012626-88-9
manganese hydroxide
yes
no
no
Journ
607
62245
0012751-22-3
iron phosphide
yes
no
no
Only to be used in PET
polymers and copolymers
al
608
40800
0013003-12-8
4,4′-butylidene-bis(6-tert-butyl-
yes
no
yes
6
of
3-methylphenyl-ditridecyl phos
the
phite)
E
uropean
609
83455
0013445-56-2
pyrophosphorous acid
yes
no
no
610
93440
0013463-67-7
titanium dioxide
yes
no
no
Un
611
35120
0013560-49-1
3-aminocrotonic acid, diester
yes
no
no
ion
with thiobis (2-hydroxyethyl)
ether
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-
no
yes
no
0,05
methylpropanesulphonic acid
618
51040
0015535-79-2
di-n-octyltin mercaptoacetate
yes
no
no
(10)
15.1.2011
619
50320
0015571-58-1
di-n-octyltin bis(2-ethylhexyl
yes
no
no
(10)
mercaptoacetate)
620
50720
0015571-60-5
di-n-octyltin dimaleate
yes
no
no
(10)

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
621
17110
0016219-75-3
5-ethylidenebicyclo[2,2,1]
no
yes
no
0,05
(9)
hept-2-ene
622
69840
0016260-09-6
oleylpalmitamide
yes
no
yes
5
623
52640
0016389-88-1
dolomite
yes
no
no
E
N
624
18897
0016712-64-4
6-hydroxy-2-
no
yes
no
0,05
naphthalenecarboxylic acid
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
Official
629
34560
0021645-51-2
aluminium hydroxide
yes
no
no
630
82240
0022788-19-8
1,2-propyleneglycol dilaurate
yes
no
no
Journ
631
59120
0023128-74-7
1,6-hexamethylene-bis(3-(3,5-
yes
no
yes
45
al
di-tert-butyl-4-hydroxyphenyl)
of
propionamide)
the
632
52880
0023676-09-7
4-ethoxybenzoic acid, ethyl
yes
no
no
3,6
E
uropean
ester
633
53200
0023949-66-8
2-ethoxy-2′-ethyloxanilide
yes
no
yes
30
Un
634
25910
0024800-44-0
tripropyleneglycol
no
yes
no
ion
635
40720
0025013-16-5
tert-butyl-4-hydroxyanisole
yes
no
no
30
636
31500
0025134-51-4
acrylic acid, acrylic acid,
yes
no
no
0,05
(22)
SML expressed as acrylic
2-ethylhexyl ester, copolymer
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
L
12/49
640
54930
0025359-91-5
formaldehyde-1-naphthol,
yes
no
no
0,05
copolymer

---

L
12/50
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
641
22331
0025513-64-8
mixture of (35-45% w/w)
no
yes
no
0,05
(10)
1,6-diamino-2,2,4-
trimethylhexane and
(55-65% w/w)1,6-diamino-
2,4,4-trimethylhexane
E
642
64990
0025736-61-2
maleic anhydride-styrene,
yes
no
no
The fraction with molecular
N
copolymer, sodium salt
weight below 1000 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
yes
no
no
(11)
mercaptoacetate)
Official
646
50480
0026401-97-8
di-n-octyltin bis(isooctyl
yes
no
no
(10)
mercaptoacetate)
647
56720
0026402-23-3
glycerol monohexanoate
yes
no
no
Journ
648
56880
0026402-26-6
glycerol monooctanoate
yes
no
no
al
of
649
47210
0026427-07-6
dibutylthiostannoic acid
yes
no
no
Molecular unit =
the
polymer
(C8H18S3Sn2)n (n = 1,5-2)
E
650
49600
0026636-01-1
dimethyltin bis(isooctyl
yes
no
no
(9)
uropean
mercaptoacetate)
651
88240
0026658-19-5
sorbitan tristearate
yes
no
no
Un
652
38820
0026741-53-7
bis(2,4-di-tert-butylphenyl)
yes
no
yes
0,6
ion
pentaerythritol diphosphite
653
25270
0026747-90-0
2,4-toluene diisocyanate dimer
no
yes
no
(17)
1mg/kg in final product
(10)
expressed as isocyanate
moiety
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
yes
no
no
(11)
tris(2-ethylhexyl
mercaptoacetate)
658
52000
0027176-87-0
dodecylbenzenesulphonic acid
yes
no
no
30
15.1.2011
659
82800
0027194-74-7
1,2-propyleneglycol
yes
no
no
monolaurate
660
47540
0027458-90-8
di-tert-dodecyl disulphide
yes
no
yes
0,05

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
661
95360
0027676-62-6
1,3,5-tris(3,5-di-tert-butyl-4-
yes
no
yes
5
hydroxybenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione
662
25927
0027955-94-8
1,1,1-tris(4-hydroxyphenol)
no
yes
no
0,005
Only to be used in
(1)
ethane
polycarbonates
E
N
663
64150
0028290-79-1
linolenic acid
yes
no
no
664
95000
0028931-67-1
trimethylolpropane
yes
no
no
trimethacrylate-methyl
methacrylate copolymer
665
83120
0029013-28-3
1,2-propyleneglycol
yes
no
no
monopalmitate
666
87280
0029116-98-1
sorbitan dioleate
yes
no
no
Official
667
55190
0029204-02-2
gadoleic acid
yes
no
no
668
80240
0029894-35-7
polyglycerol ricinoleate
yes
no
no
Journ
669
56610
0030233-64-8
glycerol monobehenate
yes
no
no
al
670
56800
0030899-62-8
glycerol monolaurate diacetate
yes
no
no
(32)
of
671
74240
0031570-04-4
phosphorous acid,
yes
no
no
the
tris(2,4-di-tert-butylphenyl)ester
E
uropean
672
76845
0031831-53-5
polyester of 1,4-butanediol with
yes
no
no
(29)
The fraction with molecular
caprolactone
(30)
weight below 1000 Da
should not exceed 0,5%
Un
(w/w)
ion
673
53670
0032509-66-3
ethylene glycol bis[3,3-bis(3-
yes
no
yes
6
tert-butyl-4-
hydroxyphenyl)butyrate]
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-
yes
no
yes
15
hydroxyphenyl)propionyl)hy
drazide
676
50400
0033568-99-9
di-n-octyltin bis(isooctyl male
yes
no
no
(10)
ate)
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-
yes
no
yes
6
tert-butyl-4-
hydroxyphenyl)propionate)
L
12/51
679
39060
0035958-30-6
1,1-bis(2-hydroxy-3,5-di-tert-
yes
no
yes
5
butylphenyl)ethane

---

L
12/52
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
680
94400
0036443-68-2
triethyleneglycol bis[3-(3-tert-
yes
no
no
9
butyl-4-hydroxy-5-
methylphenyl) propionate]
681
18310
0036653-82-4
1-hexadecanol
no
yes
no
E
682
53270
0037205-99-5
ethylcarboxymethylcellulose
yes
no
no
N
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-
yes
no
no
0,15
SML expressed as fluoride.
sodium-fluoride salt
Only to be used in layers of
multi-layer materials not
coming into direct contact
with food.
Official
686
61390
0037353-59-6
hydroxymethylcellulose
yes
no
no
687
13530
0038103-06-9
2,2-bis(4-hydroxyphenyl)
no
yes
no
0,05
Journ
propane bis(phthalic anhydride)
13614
al
of
688
92560
0038613-77-3
tetrakis(2,4-di-tert-butyl-
yes
no
yes
18
the
phenyl)-4,4′-biphenylylene
diphosphonite
E
uropean
689
95280
0040601-76-1
1,3,5-tris(4-tert-butyl-3-
yes
no
yes
6
hydroxy-2,6-dimethylbenzyl)-
1,3,5-triazine-2,4,6(1H,3H,5H)-
Un
trione
ion
690
92880
0041484-35-9
thiodiethanol bis(3-(3,5-di-tert-
yes
no
yes
2,4
butyl-4-hydroxy phenyl) propi
onate)
691
13600
0047465-97-4
3,3-bis(3-methyl-4-
no
yes
no
1,8
hydroxyphenyl)2-indolinone
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
no
yes
no
0,05
(1)
ester
695
67520
0054849-38-6
monomethyltin tris(isooctyl
yes
no
no
(9)
mercaptoacetate)
15.1.2011
696
92205
0057569-40-1
terephthalic acid, diester with
yes
no
no
2,2′-methylenebis(4-methyl-6-
tert-butylphenol)

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
697
67515
0057583-34-3
monomethyltin tris(ethylhexyl
yes
no
no
(9)
mercaptoacetate)
698
49595
0057583-35-4
dimethyltin bis(ethylhexyl
yes
no
no
(9)
mercaptoacetate)
E
N
699
90720
0058446-52-9
stearoylbenzoylmethane
yes
no
no
700
31520
0061167-58-6
acrylic acid, 2-tert-butyl-6-(3-
yes
no
yes
6
tert-butyl-2-hydroxy-5-
methylbenzyl)-4-methylphenyl
ester
701
40160
0061269-61-2
N,N′-bis(2,2,6,6-tetramethyl-4-
yes
no
no
2,4
piperidyl)hexamethylenediamine-
Official
1,2-dibromoethane, copolymer
702
87920
0061752-68-9
sorbitan tetrastearate
yes
no
no
Journ
703
17170
0061788-47-4
fatty acids, coco
no
yes
no
al
of
the
704
77600
0061788-85-0
polyethyleneglycol ester of
yes
no
no
hydrogenated castor oil
E
uropean
705
10599/90A
0061788-89-4
acids, fatty, unsaturated (C18),
no
yes
no
(18)
(1)
dimers, non hydrogenated,
distilled and non-distilled
Un
10599/91
ion
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
yes
no
no
42
castor oil
709
87520
0062568-11-0
sorbitan monobehenate
yes
no
no
710
38700
0063397-60-4
bis(2-carbobutoxyethyl)tin-bis
yes
no
yes
18
(isooctyl mercaptoacetate)
711
42000
0063438-80-2
(2-carbobutoxyethyl)tin-tris
yes
no
yes
30
(isooctyl mercaptoacetate)
L
12/53
712
42960
0064147-40-6
castor oil, dehydrated
yes
no
no

---

L
12/54
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
713
43480
0064365-11-3
charcoal, activated
yes
no
no
Only for use in PET at
maximum 10mg/kg of
polymer.
Same purity requirements as
for Vegetable Carbon
(E 153) set out by Commis
E
N
sion Directive 95/45/EC(4)
with exception of ash con
tent which can be up to
10% (w/w).
714
84400
0064365-17-9
rosin, hydrogenated, ester with
yes
no
no
pentaerythritol
715
46880
0065140-91-2
3,5-di-tert-butyl-4-
yes
no
no
6
hydroxybenzylphosphonic acid,
Official
monoethyl ester, calcium salt
716
60800
0065447-77-0
1-(2-hydroxyethyl)-4-hydroxy-
yes
no
no
30
Journ
2,2,6,6-tetramethyl piperidine-
succinic acid, dimethyl ester,
al
copolymer
of
the
717
84210
0065997-06-0
rosin, hydrogenated
yes
no
no
E
uropean
718
84240
0065997-13-9
rosin, hydrogenated, ester with
yes
no
no
glycerol
Un
ion
719
65920
0066822-60-4
N-methacryloyloxyethyl-N,N-
yes
no
no
dimethyl-N-
carboxymethylammonium
chloride, sodium salt -octadecyl
methacrylate-ethyl methacrylate-
cyclohexyl methacrylate-N-
vinyl-2-pyrrolidone, copolymers
720
67360
0067649-65-4
mono-n-dodecyltin tris(isooctyl
yes
no
no
(25)
mercaptoacetate)
721
46800
0067845-93-6
3,5-di-tert-butyl-4-
yes
no
no
hydroxybenzoic acid, hexadecyl
ester
15.1.2011
722
17200
0068308-53-2
fatty acids, soya
no
yes
no
723
88880
0068412-29-3
starch, hydrolysed
yes
no
no

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
724
24903
0068425-17-2
syrups, hydrolysed starch,
no
yes
no
In compliance with the
hydrogenated
purity criteria for maltitol
syrup E 965(ii) as laid down
in Commission Directive
2008/60/EC(5)
E
N
725
77895
0068439-49-6
polyethyleneglycol (EO = 2-6)
yes
no
no
0,05
The composition of this
monoalkyl (C16-C18) ether
mixture is as follows:
— polyethyleneglycol
(EO = 2-6)monoalkyl
(C16-C18) ether
(approximately 28%),
— fatty alcohols (C16-C18)
(approximately 48%),
— ethyleneglycol
monoalkyl (C
Official
16-C18)
ether (approximately
24%),
Journ
726
83599
0068442-12-6
reaction products of oleic acid,
yes
no
yes
(9)
2-mercaptoethyl ester, with
al
dichlorodimethyltin, sodium
of
sulphide and trichloromethyltin
the
E
727
43360
0068442-85-3
cellulose, regenerated
yes
no
no
uropean
728
75100
0068515-48-0
phthalic acid, diesters with pri
yes
no
no
(26)
Only to be used as:
(7)
0028553-12-0
mary, saturated C8-C10
(32)
(a) plasticiser in repeated
Un
branched alcohols, more than
use materials and
ion
60% C9
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 pro
cessed cereal-based
foods and baby foods
for infants and young
children as defined by
Directive
2006/125/EC;
(c) technical support agent
L
in concentrations up
12/55
to 0,1% in the final
product.

---

L
12/56
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
729
75105
0068515-49-1
phthalic acid, diesters with pri
yes
no
no
(26)
Only to be used as:
(7)
0026761-40-0
mary, saturated C9-C11 alcohols
(32)
(a) plasticiser in repeated
more than 90% C10
use materials and
articles;
(b) plasticiser in single-use
E
materials and articles
N
contacting non-fatty
foods except for infant
formulae and
follow-on formulae as
defined by Directive
2006/141/EC or pro
cessed cereal-based
foods and baby foods
for infants and young
children as defined by
Official
Directive
2006/125/EC;
(c) technical support agent
Journ
in concentrations up
to 0,1% in the final
al
product.
of
the
730
66930
0068554-70-1
methylsilsesquioxane
yes
no
no
Residual monomer in meth
E
ylsilsesquioxane: < 1mg
uropean
methyltrimethoxysilane/kg
of methylsilsesquioxane
Un
731
18220
0068564-88-5
N-heptylaminoundecanoic acid
no
yes
no
0,05
(2)
ion
732
45450
0068610-51-5
p-cresol-dicyclopentadiene-
yes
no
yes
5
isobutylene, copolymer
733
10599/92A
0068783-41-5
acids, fatty, unsaturated (C18),
no
yes
no
(18)
(1)
dimers, hydrogenated, distilled
and non-distilled
10599/93
734
46380
0068855-54-9
diatomaceous earth, soda ash
yes
no
no
flux-calcined
735
40120
0068951-50-8
bis(polyethyleneglycol)hy
yes
no
no
0,6
droxymethylphosphonate
15.1.2011
736
50960
0069226-44-4
di-n-octyltin ethyleneglycol bis
yes
no
no
(10)
(mercaptoacetate)

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
737
77370
0070142-34-6
polyethyleneglycol-30
yes
no
no
dipolyhydroxystearate
738
60320
0070321-86-7
2-[2-hydroxy-3,5-bis(1,1-
yes
no
yes
1,5
dimethylbenzyl)phenyl]
E
benzotriazole
N
739
70000
0070331-94-1
2,2′-oxamidobis[ethyl-3-(3,5-
yes
no
no
di-tert-butyl-4-hydroxyphenyl)-
propionate]
740
81200
0071878-19-8
poly[6-[(1,1,3,3-
yes
no
yes
3
tetramethylbutyl)amino]-1,3,5-
triazine-2,4-diyl]-[(2,2,6,6-
tetramethyl-4-piperidyl)-imino]
Official
hexamethylene[(2,2,6,6-
tetramethyl-4-piperidyl) imino]
Journ
741
24070
0073138-82-6
resin acids and rosin acids
yes
yes
no
al
of
83610
the
E
uropean
742
92700
0078301-43-6
2,2,4,4-tetramethyl-20-(2,3-
yes
no
yes
5
epoxypropyl)-7-oxa-3,20-
diazadispiro-[5.1.11.2]-
heneicosan-21-one, polymer
Un
ion
743
38950
0079072-96-1
bis(4-ethylbenzylidene)sorbitol
yes
no
no
744
18888
0080181-31-3
3-hydroxybutanoic
no
yes
no
The substance is used as
acid-3-hydroxypentanoic acid,
product obtained by
copolymer
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
yes
no
yes
5
SML expressed as sum of
tris(3,3′,5,5′-tetra-tert-
phosphite and phosphate
butyl-1,1′-bi-phenyl-2,2′-
diyl)phosphite)
L
746
38810
0080693-00-1
bis(2,6-di-tert-butyl-4-
yes
no
yes
5
SML expressed as sum of
12/57
methylphenyl)pentaerythritol
phosphite and phosphate
diphosphite

---

L
12/58
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
747
47600
0084030-61-5
di-n-dodecyltin bis(isooctyl
yes
no
yes
(25)
mercaptoacetate)
748
12765
0084434-12-8
N-(2-aminoethyl)-β-alanine,
no
yes
no
0,05
sodium salt
E
N
749
66360
0085209-91-2
2,2′-methylene
yes
no
yes
5
bis(4,6-di-tert-butylphenyl)
sodium phosphate
750
66350
0085209-93-4
2,2′-methylenebis(4,6-di-tert-
yes
no
no
5
butylphenyl) lithium phosphate
Official
751
81515
0087189-25-1
poly(zinc glycerolate)
yes
no
no
Journ
752
39890
0087826-41 – bis(methylbenzylidene)sorbitol
yes
no
no
30069158-41 –
al
40054686-97 –
of
40081541-12-0
the
E
uropean
753
62800
0092704-41-1
kaolin, calcined
yes
no
no
Un
754
56020
0099880-64-5
glycerol dibehenate
yes
no
no
ion
755
21765
0106246-33-7
4,4′-methylenebis(3-chloro-
no
yes
no
0,05
(1)
2,6-diethylaniline)
756
40020
0110553-27-0
2,4-bis(octylthiomethyl)-6-
yes
no
yes
(24)
methylphenol
757
95725
0110638-71-6
vermiculite, reaction product
yes
no
no
with citric acid, lithium salt
758
38940
0110675-26-8
2,4-bis(dodecylthiomethyl)-6-
yes
no
yes
(24)
methylphenol
15.1.2011
759
54300
0118337-09-0
2,2′-ethylidenebis(4,6-di-tert-
yes
no
yes
6
butylphenyl) fluorophosphonite

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
760
83595
0119345-01-6
reaction product of
yes
no
no
18
Composition:
di-tert-butylphosphonite with
— 4,4′-biphenylene-
biphenyl, obtained by
bis[0,0-bis(2,4-di-tert-
condensation of
butylphenyl)
2,4-di-tert-butylphenol with
phosphonite] (CAS
Friedel Craft reaction product of
No 0038613-77-3)
E
N
phosphorous trichloride and
(36-46% w/w (*)),
biphenyl
— 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)
Official
phosphonite] (CAS
No 0118421-01-5)
(1-5% w/w (*)),
Journ
— 4-biphenylene-0,0-
bis(2,4-di-tert-
butylphenyl)
al
of
phosphonite (CAS
No 0091362-37-7)
the
(11-19% w/w (*)),
E
uropean
— tris(2,4-di-tert-
butylphenyl)phosphite
(CAS No 0031570-
04-4) (9-18% w/w (*)),
Un
— 4,4′-biphenylene-0,0-
ion
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 formu
lation
Other specifications:
— Phosphor content of
min. 5,4% to max.
5,9%,
— Acid value of max.
L
10mg KOH per gram,
12/59
— Melt range of 85–
110°C,

---

L
12/60
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
761
92930
0120218-34-0
thiodiethanolbis(5-
yes
no
no
6
methoxycarbonyl-2,6-dimethyl-
1,4-dihydropyridine-3-
carboxylate)
762
31530
0123968-25-2
acrylic acid, 2,4-di-tert-pentyl-6-
yes
no
yes
5
E
(1-(3,5-di-tert-pentyl-2-
N
hydroxyphenyl)ethyl)phenyl
ester
763
39925
0129228-21-3
3,3-bis(methoxymethyl)-2,5-
yes
no
yes
0,05
dimethylhexane
764
13317
0132459-54-2
N,N′-bis[4-(ethoxycarbonyl)
no
yes
no
0,05
Purity > 98,1% (w/w).
phenyl]-1,4,5,8-
Only to be used as
naphthalenetetracarboxydiimide
co-monomer (max 4%) for
polyesters (PET, PBT).
Official
765
49485
0134701-20-5
2,4-dimethyl-6-(1-
yes
no
yes
1
methylpentadecyl)phenol
Journ
766
38879
0135861-56-2
bis(3,4-dimethylbenzylidene)
yes
no
no
sorbitol
al
of
767
38510
0136504-96-6
1,2-bis(3-aminopropyl)
yes
no
no
5
the
ethylenediamine, polymer with
E
N-butyl-2,2,6,6-tetramethyl-4-
uropean
piperidinamine and 2,4,6-
trichloro-1,3,5-triazine
768
34850
0143925-92-2
amines, bis(hydrogenated tallow
yes
no
no
Not to be used for articles
(1)
Un
alkyl) oxidised
in contact with fatty foods
ion
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.
769
74010
0145650-60-8
phosphorous acid, bis(2,4-di-
yes
no
yes
5
SML expressed as sum of
tert-butyl-6-methylphenyl) ethyl
phosphite and phosphate
ester
770
51700
0147315-50-2
2-(4,6-diphenyl-1,3,5-triazin-2-
yes
no
no
0,05
yl)-5-(hexyloxy)phenol
15.1.2011
771
34650
0151841-65-5
aluminium hydroxybis [2,2′-
yes
no
no
5
methylenebis (4,6-di-tert-
butylphenyl) phosphate]

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
772
47500
0153250-52-3
N,N′-dicyclohexyl-2,6-
yes
no
no
5
naphthalene dicarboxamide
773
38840
0154862-43-8
bis(2,4-dicumylphenyl)
yes
no
yes
5
SML expressed as sum of
pentaerythritol-diphosphite
the substance itself, its
oxidised form bis(2,4-
E
N
dicumylphenyl)
pentaerythritol-phosphate
and its hydrolysis product
(2,4-dicumylphenol)
774
95270
0161717-32-4
2,4,6-tris(tert-butyl)phenyl-2-
yes
no
yes
2
SML expressed as sum of
butyl-2-ethyl-1,3-propanediol
phosphite, phosphate and
phosphite
the hydrolysis product =
TTBP
Official
775
45705
0166412-78-8
1,2-cyclohexanedicarboxylic
yes
no
no
(32)
acid, diisononyl ester
Journ
776
76723
0167883-16-1
polydimethylsiloxane,
yes
no
no
The fraction with molecular
3-aminopropyl terminated,
weight below 1000 Da
al
polymer with
should not exceed 1,5%
of
dicyclohexylmethane-
(w/w)
the
4,4′-diisocyanate
E
uropean
777
31542
0174254-23-0
acrylic acid, methyl ester,
yes
no
no
0,5% in final product
(1)
telomer with 1-dodecanethiol,
C16-C18 alkyl esters
Un
ion
778
71670
0178671-58-4
pentaerythritol tetrakis
yes
no
yes
0,05
(2-cyano-3,3-diphenylacrylate)
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-
yes
no
no
5
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-
N″-(2,2,6,6-tetramethyl-4-
piperidinyl)-N″-[6-(2,2,6,6-
tetramethyl-4-piperidinylamino)-
hexyl]-[1,3,5-triazine-2,4,6-
L
triamine]-ω-N,N,N′,N′-
12/61
tetrabutyl-1,3,5-triazine-
2,4-diamine]

---

L
12/62
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
781
95265
0227099-60-7
1,3,5-tris(4-benzoylphenyl)
yes
no
no
0,05
benzene
782
76725
0661476-41-1
polydimethylsiloxane,
yes
no
no
The fraction with molecular
3-aminopropyl terminated,
weight below 1000 Da
E
polymer with 1-isocyanato-3-
should not exceed 1%
N
isocyanatomethyl-3,5,5-
(w/w)
trimethylcyclohexane
783
55910
0736150-63-3
glycerides, castor-oil mono-,
yes
no
no
(32)
hydrogenated, acetates
784
95420
0745070-61-5
1,3,5-tris
yes
no
no
0,05
(2,2-dimethylpropanamido)
benzene
Official
785
24910
0000100-21-0
terephthalic acid
no
yes
no
(28)
Journ
786
14627
0000117-21-5
3-chlorophthalic anhydride
no
yes
no
0,05
SML expressed as
3-chlorophthalic acid
al
of
the
787
14628
0000118-45-6
4-chlorophthalic anhydride
no
yes
no
0,05
SML expressed as
4-chlorophthalic acid
E
uropean
788
21498
0002530-85-0
[3-(methacryloxy)propyl]
no
yes
no
0,05
Only to be used as a surface
(1)
trimethoxysilane
treatment agent of
(11)
Un
inorganic fillers
ion
789
60027
—
hydrogenated homopolymers
yes
no
no
Average molecular weight
(2)
and/or copolymers made of
not less than 440 Da.
1-hexene and/or 1-octene
Viscosity at 100°C not less
and/or 1-decene and/or
than 3,8 cSt
1-dodecene and/or
(3,8 × 10-6 m2/s).
1-tetradecene (Mw:
440–12000)
790
80480
0090751-07-8
poly(6-morpholino-1,3,5-
yes
no
no
5
Average molecular weight
(16)
0082451-48-7
triazine-2,4-diyl)-[(2,2,6,6-
not less than 2400 Da.
tetramethyl-4-piperidyl)imino)]
Residual content of mor
hexa-methylene-[(2,2,6,6-
pholine ≤ 30mg/kg, of
tetramethyl-4-piperidyl)imino)]
N,N′-bis(2,2,6,6-
tetramethylpiperidin-4-
15.1.2011
yl)hexane-1,6-diamine
< 15000mg/kg, and of
2,4-dichloro-6-morpholino-
1,3,5-triazine ≤ 20mg/kg.

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
791
92470
0106990-43-6
N,N′,N″,N″-tetrakis(4,6-bis
yes
no
no
0,05
(N-butyl-(N-methyl-2,2,6,6-
tetramethylpiperidin-4-yl)
amino)triazin-2-yl)-4,7-
diazadecane-1,10-diamine
E
N
792
92475
0203255-81-6
3,3′,5,5′-tetrakis(tert-butyl)-
yes
no
yes
5
SML expressed as the sum
2,2′-dihydroxybiphenyl, cyclic
of phosphite and phosphate
ester with [3-(3-tert-butyl-4-
form of the substance and
hydroxy-5-methylphenyl)
the hydrolysis products
propyl]oxyphosphonous acid
793
94000
0000102-71-6
triethanolamine
yes
no
no
0,05
SML expressed as the sum
of triethanolamine and the
hydrochloride adduct
expressed as
Official
triethanolamine
Journ
794
18117
0000079-14-1
glycolic acid
no
yes
no
For indirect food contact
only, behind a PET layer
al
of
795
40155
0124172-53-8
N,N′-bis(2,2,6,6-tetramethyl-4-
yes
no
no
0,05
(2)
the
piperidyl)-N,N′-
(12)
E
diformylhexamethylenediamine
uropean
796
72141
0018600-59-4
2,2′-(1,4-phenylene)bis[4H-3,1-
yes
no
yes
0,05
SML including the sum of
benzoxazin-4-one]
its hydrolysis products
Un
ion
797
76807
0007328-26-5
polyester of adipic acid with
yes
no
yes
(31)
1,3-butanediol, 1,2-propanediol
(32)
and 2-ethyl-1-hexanol
798
92200
0006422-86-2
terephthalic acid, bis(2-
yes
no
no
60
(32)
ethylhexyl)ester
799
77708
—
polyethyleneglycol (EO = 1-50)
yes
no
no
1,8
In compliance with the
ethers of linear and branched
purity criteria for ethylene
primary (C8-C22) alcohols
oxide as laid down in Direc
tive 2008/84/EC laying
down specific purity criteria
on food additives other than
colours and sweeteners
(OJ L 253, 20.9.2008, p. 1)
L
12/63
800
94425
0000867-13-0
triethyl phosphonoacetate
yes
no
no
Only for use in PET

---

L
12/64
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
801
30607
—
acids, C2-C24, aliphatic, linear,
yes
no
no
monocarboxylic, from natural
oils and fats, lithium salt
802
33105
0146340-15-0
alcohols, C12-C14 secondary,
yes
no
no
5
(12)
E
β-(2-hydroxyethoxy),
N
ethoxylated
803
33535
0152261-33-1
α-alkenes(C20-C24) copolymer
yes
no
no
Not to be used for articles
(13)
with maleic anhydride, reaction
in contact with fatty foods
product with 4-amino-2,2,6,6-
for which simulant D is laid
tetramethylpiperidine
down.
Not to be used in contact
with alcoholic foods.
Official
804
80510
1010121-89-7
poly(3-nonyl-1,1-dioxo-1-
yes
no
no
Only to be used as polymer
thiopropane-1,3-diyl)-block-
production aid in polyethyl
poly(x-oleyl-7-hydroxy-1,5-
ene (PE), polypropylene (PP)
Journ
diiminooctane-1,8-diyl), process
and polystyrene (PS)
mixture with x = 1 and/or 5,
al
neutralised with dodecylbenze
of
nesulfonic acid
the
E
805
93450
—
titanium dioxide, coated with a
yes
no
no
The content of the surface
uropean
copolymer of
treatment copolymer of the
n-octyltrichlorosilane and [ami
coated titanium dioxide is
notris(methylenephosphonic
less than 1% w/w
Un
acid), penta sodium salt]
ion
806
14876
0001076-97-7
1,4-cyclohexanedicarboxylic
no
yes
no
5
Only to be used for manu
acid
facture 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 20mg/kg.
In the PET, the agglomerates
have a diameter of 100 –
500nm consisting of pri
mary titanium nitride nano
particles; primary particles
have a diameter of approxi
mately 20nm.
15.1.2011
808
38550
0882073-43-0
bis(4-propylbenzylidene)
yes
no
no
5
SML including the sum of
propylsorbitol
its hydrolysis products

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
809
49080
0852282-89-4
N-(2,6-diisopropylphenyl)-6-
yes
no
yes
0,05
Only for use in PET
(6)
[4-(1,1,3,3-tetramethylbutyl)
(14)
phenoxy]-1H-benzo[de]
(15)
isoquinolin-1,3(2H)-dione
E
810
68119
neopentyl glycol, diesters and
yes
no
no
5
(32)
Not to be used for articles
N
monoesters with benzoic acid
in contact with fatty foods
and 2-ethylhexanoic acid
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)-
yes
no
no
Only to be used in polyeth
polyethyleneimine copolymer
ylene terephthalate (PET),
polystyrene (PS), high
Official
impact polystyrene (HIPS)
and polyamide (PA) up to
0,1% w/w.
Journ
Prepared by the reaction of
poly(12-hydroxystearic acid)
al
with polyethyleneimine.
of
the
813
91530
—
sulphosuccinic acid alkyl
yes
no
no
5
E
uropean
(C4-C20) or cyclohexyl diesters,
salts
Un
814
91815
—
sulphosuccinic acid monoalkyl
yes
no
no
2
ion
(C10-C16) polyethyleneglycol
esters, salts
815
94985
—
trimethylolpropane, mixed tri
yes
no
no
5
(32)
Not to be used for articles
esters and diesters with benzoic
in contact with fatty foods
acid and 2-ethylhexanoic acid
for which simulant D is laid
down
816
45704
—
cis-1,2-cyclohexanedicarboxylic
yes
no
no
5
acid, salts
817
38507
—
cis-endo-bicyclo[2.2.1]heptane-
yes
no
no
5
Not to be used with poly
2,3-dicarboxylic acid, salts
ethylene in contact with
acidic foods.
Purity ≥ 96%.
L
12/65
818
21530
—
methallylsulphonic acid, salts
no
yes
no
5

---

L
12/66
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
819
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.
E
N
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)
Official
823
24889
—
5-Sulphoisophthalic acid, salts
no
yes
no
5
Journ
854
71943
0329238-24-6
perfluoro acetic acid,
yes
no
no
Only to be used in concen
α-substituted with the copoly
trations up to 0,5% w/w in
al
mer of perfluoro-1,2-propylene
the polymerisation of fluo
of
glycol and perfluoro-1,1-
ropolymers that are pro
the
ethylene glycol, terminated with
cessed at temperatures at or
chlorohexafluoropropyloxy
above 340°C and are
E
uropean
groups
intended for use in repeated
use articles
Un
860
71980
0051798-33-5
perfluoro[2-(poly(n-
yes
no
no
Only to be used in the poly
ion
propoxy))propanoic acid]
merisation 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-
yes
no
no
Only to be used in the poly
propoxy)propanoic acid]
merisation of fluoropoly
mers 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-
15.1.2011
1-butene.
Only for use as a
co-monomer for ethyl vinyl
alcohol copolymers.

---

15.1.2011
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
864
46330
0000056-06-4
2,4-diamino-6-
yes
no
no
5
Only to be used in rigid
hydroxypyrimidine
poly(vinyl chloride) (PVC) in
contact with non-acidic and
non-alcoholic aqueous food
E
865
40619
0025322-99-0
(butyl acrylate, methyl
yes
no
no
Only to be used in rigid
N
methacrylate, butyl
poly(vinyl chloride) (PVC) at
methacrylate) copolymer
a maximum level of 1%
866
40620
—
(butyl acrylate, methyl
yes
no
no
Only to be used in rigid
methacrylate) copolymer,
poly(vinyl chloride) (PVC) at
cross-linked with allyl
a maximum level of 7%
methacrylate
867
40815
0040471-03-2
(butyl methacrylate, ethyl
yes
no
no
Only to be used in rigid
Official
acrylate, methyl methacrylate)
poly(vinyl chloride) (PVC) at
copolymer
a maximum level of 2%
Journ
868
53245
0009010-88-2
(ethyl acrylate, methyl
yes
no
no
Only to be used in rigid
al
methacrylate) copolymer
poly(vinyl chloride) (PVC) at
of
a maximum level of 2%
the
E
uropean
869
66763
0027136-15-8
(butyl acrylate, methyl
yes
no
no
Only to be used in rigid
methacrylate, styrene)
poly(vinyl chloride) (PVC) at
copolymer
a maximum level of 3%
Un
ion
870
95500
0160535-46-6
N,N′,N″-tris(2-
yes
no
no
5
methylcyclohexyl)-1,2,3-
propane-tricarboxamide
875
80345
0058128-22-6
poly(12-hydroxystearic acid)
yes
no
yes
5
stearate
878
31335
—
acids, fatty (C8-C22) from
yes
no
no
animal or vegetable fats and
oils, esters with branched
alcohols, aliphatic, monohydric,
saturated, primary (C3-C22)
879
31336
—
acids, fatty (C8-C22) from
yes
no
no
animal or vegetable fats and
L
oils, esters with alcohols, linear,
12/67
aliphatic, monohydric,
saturated, primary (C1-C22)

---

L
12/68
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
880
31348
0085116-93-4
acids, fatty (C8-C22), esters with
yes
no
no
pentaerythritol
881
25187
0003010-96-6
2,2,4,4-tetramethylcyclobutane-
no
yes
no
5
Only for repeated use
1,3-diol
articles for long term
storage at room
E
temperature or below and
N
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 dm2/kg
884
34240
0091082-17-6
alkyl(C10-C21)sulphonic acid,
yes
no
no
0,05
Not to be used for articles
esters with phenol
in contact with fatty foods
Official
for which simulant D is laid
down.
885
45676
0263244-54-8
cyclic oligomers of (butylene
yes
no
no
Only to be used in
Journ
terephthalate)
poly(ethylene terephthalate)
(PET), poly(butylene
al
terephthalate) (PBT),
of
polycarbonate (PC),
the
polystyrene (PS) and rigid
poly(vinyl chloride) (PVC)
E
uropean
plastics in concentrations
up to 1% w/w, in contact
with aqueous, acidic and
alcoholic foods, for long
Un
term storage at room
ion
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

---

15.1.2011
EN
Official Journal of the European Union
L 12/69
2. Group restriction of substances
Table 2 on Group restrictions contains the following information:
Column 1 (Group restriction No): contains the identification number of the group of substances for which the group
restriction applies. It is the number referred to in Column 9 in Table 1 of this Annex.
Column 2 (FCM substance No): contains the unique identification numbers of the substances for which the group restric
tion applies. It is the number referred to in Column 1 in Table 1 of this Annex.
Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to this
group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable
quantities.
Column 4 (Group restriction specification): contains an indication of the substance whose molecular weight forms the
basis for expression of the result.
Table 2
(1)
(2)
(3)
(4)
Group
FCM
SML (T)
Restriction No
substance No
[mg/kg]
Group restriction specification
1
128
6
expressed as acetaldehyde
211
2
89
30
expressed as ethyleneglycol
227
263
3
234
30
expressed as maleic acid
248
4
212
15
expressed as caprolactam
435
5
137
3
expressed as the sum of the substances
472
6
412
1
expressed as iodine
512
513
588
7
19
1,2
expressed as tertiary amine
20
8
317
6
expressed as the sum of the substances
318
319
359
431
464
9
650
0,18
expressed as tin
695
697
698
726

---

L 12/70
EN
Official Journal of the European Union
15.1.2011
(1)
(2)
(3)
(4)
10
28
0,006
expressed as tin
29
30
31
32
33
466
582
618
619
620
646
676
736
11
66
1,2
expressed as tin
645
657
12
444
30
expressed as the sum of the substances
469
470
13
163
1,5
expressed as the sum of the substances
285
14
294
5
expressed as the sum of the substances
368
15
98
15
expressed as formaldehyde
196
16
407
6
expressed as boron
583
584
Without prejudice to the provisions of Directive 98/83/EC
599
17
4
ND
expressed as isocyanate moiety
167
169
198
274
354
372
460
461
475
476
485
490
653
18
705
0,05
expressed as the sum of the substances
733
19
505
10
expressed as SO2
516
519
20
290
30
expressed as the sum of the substances
386
390
21
347
5
expressed as trimellitic acid
349

---

15.1.2011
EN
Official Journal of the European Union
L 12/71
(1)
(2)
(3)
(4)
22
70
6
expressed as acrylic acid
147
176
218
323
325
365
371
380
425
446
448
456
636
23
150
6
expressed as methacrylic acid
156
181
183
184
355
370
374
439
440
447
457
482
24
756
5
expressed as the sum of the substances
758
25
720
0,05
sum of mono-n-dodecyltin tris(isooctylmercaptoacetate), di-n-
747
dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin
trichloride and di-dodecyltin dichloride) expressed as the sum
of mono- and di-dodecyltin chloride
26
728
9
expressed as the sum of the substances
729
27
188
5
expressed as isophthalic acid
291
28
191
7,5
expressed as terephthalic acid
192
785
29
342
0,05
expressed as the sum of 6-hydroxyhexanoic acid and caprolac
672
tone
30
254
5
expressed as 1,4-butanediol
672
31
73
30
expressed as the sum of the substances
797
32
8
60
expressed as the sum of the substances
72
73
138
140
157
159
207
242
283
532
670
728
729
775
783
797
798
810
815

---

L 12/72
EN
Official Journal of the European Union
15.1.2011
3. Notes on verification of compliance
Table 3 on notes on verification of compliance contains the following information:
Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table
1 of this Annex.
Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of
the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a
risk of non-compliance.
Table 3
(1)
(2)
Note No
Notes on verification of compliance
(1)
Verification of compliance by residual content per food contact surface area (QMA) pending the
availability of an analytical method.
(2)
There is a risk that the SML or OML could be exceeded in fatty food simulants.
(3)
There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the
food in contact and then, that the final product does not comply with Article 3(1) c of the Framework
Regulation (EC) No 1935/2004.
(4)
Compliance testing when there is a fat contact should be performed using saturated fatty food
simulants as simulant D.
(5)
Compliance testing when there is a fat contact should be performed using isooctane as substitute of
simulant D2 (unstable).
(6)
Migration limit might be exceeded at very high temperature.
(7)
If testing in food is performed, Annex V 1.4 shall be taken into account.
(8)
Verification of compliance by residual content per food contact surface area (QMA); QMA =
0,005mg/6 dm2.
(9)
Verification of compliance by residual content per food contact surface area (QMA) pending the
availability of analytical method for migration testing. The ratio surface to quantity of food shall be
lower than 2dm2/kg.
(10)
Verification of compliance by residual content per food contact surface area (QMA) in case of reaction
with food or simulant.
(11)
Only a method of analysis for the determination of the residual monomer in the treated filler is
available.
(12)
There is a risk that the SML could be exceeded from polyolefins.
(13)
Only a method for determination of the content in polymer and a method for determination of the
starting substances in food simulants are available.
(14)
There is a risk that the SML could be exceeded from plastics containing more than 0,5% w/w of the
substance.
(15)
There is a risk that the SML could be exceeded in contact with foods with high alcoholic content.
(16)
There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more
than 0,3% w/w of the substance when in contact with fatty foods
(17)
Only a method for determination of the residual content of the substance in the polymer is available
4. Detailed specification on substances
Table 4 on detailed specifications on substances contains the following information
Column 1 (FCM substance No): contains the unique identification number of the substances referred to in Column 1 in
Table 1 of AnnexI to which the specification applies.
Column 2 (Detailed specification on the substance): contains the specification on the substance.

---

15.1.2011
Table 4
(1)
(2)
FCM
substance No
Detailed 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.
E
N
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
Official
Journ
al
of
the
where n/(m + n) greater than 0 and less or equal to 0,25
E
uropean
Average molecular
Not less than 150000 Daltons (measured by gel permeation chromatography)
weight
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
Un
Description
White to off-white powder after isolation
ion
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 0,05mg/6 dm2
Purity
Prior to granulation the raw material copolymer powder must contain:
— nitrogen,
Not more than 2500mg/kg of plastic
— zinc,
Not more than 100mg/kg of plastic
— copper,
Not more than 5mg/kg of plastic
— lead,
Not more than 2mg/kg of plastic
— arsenic,
Not more than 1mg/kg of plastic
— chromium,
Not more than 1mg/kg of plastic
L
12/73

---

L 12/74
EN
Official Journal of the European Union
15.1.2011
ANNEXII
Restrictions on materials and articles
1. Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration lim
its below:
Barium = 1mg/kg food or food simulant.
Cobalt = 0,05mg/kg food or food simulant.
Copper = 5mg/kg food or food simulant.
Iron = 48mg/kg food or food simulant.
Lithium = 0,6mg/kg food or food simulant.
Manganese = 0,6mg/kg food or food simulant.
Zinc = 25mg/kg food or food simulant.
2. Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of AnnexI,
in a detectable quantity into food or food simulant. The detection limit is 0,01mg of substance per kg of food or food
simulant. The detection limit applies to the sum of primary aromatic amines released.

---

15.1.2011
EN
Official Journal of the European Union
L 12/75
ANNEXIII
Food simulants
1. Food simulants
For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed
in Table 1 below are assigned.
Table 1
List of food simulants
Food simulant
Abbreviation
Ethanol 10% (v/v)
Food simulant A
Acetic acid 3% (w/v)
Food simulant B
Ethanol 20% (v/v)
Food simulant C
Ethanol 50% (v/v)
Food simulant D1
Vegetable oil(*)
Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size
Food simulant E
60-80 mesh, pore size 200nm
(*) This may be any vegetable oil with a fatty acid distribution of
No of carbon atoms in fatty acid chain: No of
unsaturation
6-12
14
16
18:0
18:1
18:2
18:3
Range of fatty acid composition expressed%
(w/w) of methyl esters by Gas chromatography
< 1
< 1
1,5-20
< 7
15-85
5-70
< 1,5
2. General assignment of food simulants to foods
Food simulants A, B andC are assigned for foods that have a hydrophilic character and are able to extract hydrophilic
substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for
alcoholic foods with an alcohol content of up to20% and those foods which contain a relevant amount of organic ingre
dients that render the food more lipophilic.
Food simulants D1 andD2 are assigned for foods that have a lipophilic character and are able to extract lipophilic sub
stances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20% and for oil in water
emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for testing specific migration into dry foods.
3. Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact
with food
For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a
certain food category shall be chosen according Table 2 below.
For testing overall migration from materials and articles intended to come into contact with different food categories or
a combination of food categories the food simulant assignment in point4 is applicable.
Table 2 contains the following information:
Column 1 (Reference number): contains the reference number of the food category.
Column 2 (Description of food): contains a description of the foods covered by the food category
Column 3 (Food simulants): contains sub-columns for each of the food simulants

---

L 12/76
EN
Official Journal of the European Union
15.1.2011
The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing
migration of materials and articles not yet in contact with food.
For food categories where in sub-column D2 the cross is followed by an oblique stroke and a figure, the migration test
result shall be divided by this figure before comparing the result with the migration limit. The figure is the correction
factor referred to in point4.2 of AnnexV to this Regulation.
For food category01.04 food simulant D2 shall be replaced by 95% ethanol.
For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if
the food has a pH of more than 4.5.
For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted
if it can be demonstrated by means of an appropriate test that there is no ‘fatty contact’ with the plastic food contact
material.
Table 2
food category specific assignment of food simulants
(1)
(2)
(3)
Reference
Food simulants
number
Description of food
A
B
C
D1
D2
E
01
Beverages
01.01
Non-alcoholic beverages or alcoholic beverages
of an alcoholic strength lower than or equal
to 6% vol.:
A. Clear drinks:
X(*)
X
Water, ciders, clear fruit or vegetable 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 extract
B. cloudy drinks:
X(*)
X
juices and nectars and soft drinks containing fruit
pulp, musts containing fruit pulp, liquid choco
late
01.02
Alcoholic beverages of an alcoholic strength of
X
between 6%vol and 20%.
01.03
Alcoholic beverages of an alcoholic strength
X
above 20% and all cream liquors
01.04
Miscellaneous: undenaturated ethyl alcohol
X(*)
Substitute
95%
ethanol
02
Cereals, cereal products, pastry, biscuits,
cakes and other bakers’ wares
02.01
Starches
X
02.02
Cereals, unprocessed, puffed, in flakes (including
X
popcorn, corn flakes and the like)
02.03
Cereal flour and meal
X
02.04
Dry pasta e.g. macaroni, spaghetti and similar
X
products and fresh pasta

---

15.1.2011
EN
Official Journal of the European Union
L 12/77
(1)
(2)
(3)
Reference
Food simulants
number
Description of food
A
B
C
D1
D2
E
02.05
Pastry, biscuits, cakes, bread, and other bakers’
wares, dry:
A. With fatty substances on the surface
X/3
B. Other
X
02.06
Pastry, cakes, bread, dough and other bakers’
wares, fresh:
A. With fatty substances on the surface
X/3
B. Other
X
03
Chocolate, sugar and products thereof
Confectionery products
03.01
Chocolate, chocolate-coated products, substi
X/3
tutes and products coated with substitutes
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, sugar syrups, honey and the like
X
04
Fruit, vegetables and products thereof
04.01
Whole fruit, fresh or chilled, unpeeled
04.02
Processed fruit:
A. Dried or dehydrated fruits, whole, sliced,
X
flour or powder
B. Fruit in the form of purée, preserves, pastes
X(*)
X
or in its own juice or in sugar syrup (jams,
compote, and similar products)
C. Fruit preserved in a liquid medium:
I. In an oily medium
X
II. In an alcoholic medium
X
04.03
Nuts (peanuts, chestnuts, almonds, hazelnuts,
walnuts, pine kernels and others):
A. Shelled, dried, flaked or powdered
X
B. Shelled and roasted
X
C. In paste or cream form
X
X

---

L 12/78
EN
Official Journal of the European Union
15.1.2011
(1)
(2)
(3)
Reference
Food simulants
number
Description of food
A
B
C
D1
D2
E
04.04
Whole vegetables, fresh or chilled, unpeeled
04.05
Processed vegetables:
A. Dried or dehydrated vegetables whole, sliced
X
or in the form of flour or powder
B. Fresh vegetables, peeled or cut
X
C. Vegetables in the form of purée, preserves,
X(*)
X
pastes or in its own juice (including pickled
and in brine)
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
X
natural or treated (including cocoa butter, lard,
resolidified butter)
05.02
Margarine, butter and other fats and oils made
X/2
from water emulsions in oil
06
Animal products and eggs
06.01
Fish:
A. Fresh, chilled, processed, salted or smoked
X
X/3(**)
including fish eggs
B. Preserved fish:
I. In an oily medium
X
X
II. In an aqueous medium
X(*)
X
06.02
Crustaceans and molluscs (including oysters,
mussels, snails)
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 zoological species (including poultry
and game):
A. Fresh, chilled, salted, smoked
X
X/4(**)
B. Processed meat products (such as ham,
X
X/4(**)
salami, bacon, sausages, and other) or in the
form of paste, creams
C. Marinated meat products in an oily medium
X
X
06.04
Preserved meat:
A. In an fatty or oily medium
X
X/3
B. In an aqueous medium
X(*)
X
06.05
Whole eggs, egg yolk, egg white
A. Powdered or dried or frozen
X
B. Liquid and cooked
X

---

15.1.2011
EN
Official Journal of the European Union
L 12/79
(1)
(2)
(3)
Reference
Food simulants
number
Description of food
A
B
C
D1
D2
E
07
Milk products
07.01
Milk
A. Milk and milk based drinks whole, partly
X
dried and skimmed or partly skimmed
B. Milk powder including infant formula (based
X
on whole milk powder)
07.02
Fermented milk such as yoghurt, buttermilk and
X(*)
X
similar products
07.03
Cream and sour cream
X(*)
X
07.04
Cheeses:
A. Whole, with not edible rind
X
B. Natural cheese without rind or with edible
X/3(**)
rind (gouda, camembert, and the like) and
melting cheese
C. Processed cheese (soft cheese, cottage cheese
X(*)
X
and similar)
D. Preserved cheese:
I. In an oily medium
X
X
II. In an aqueous medium (feta, mozarella,
X(*)
X
and similar)
08
Miscellaneous products
08.01
Vinegar
X
08.02
Fried or roasted foods:
A. Fried potatoes, fritters and the like
X
X/5
B. Of animal origin
X
X/4
08.03
Preparations for soups, broths, sauces, in liquid,
solid or powder form (extracts, concentrates);
homogenised composite food preparations, pre
pared dishes including 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
X
X(*)
X
derived from mayonnaise, salad creams and
other oil/water mixtures e.g. coconut based
sauces
08.05
Mustard (except powdered mustard under head
X
X(*)
X/3(**)
ing 08.14)

---

L 12/80
EN
Official Journal of the European Union
15.1.2011
(1)
(2)
(3)
Reference
Food simulants
number
Description of food
A
B
C
D1
D2
E
08.06
Sandwiches, toasted bread pizza and the like
containing any kind of foodstuff
A. With fatty substances on the surface
X
X/5
B. Other
X
08.07
Ice-creams
X
08.08
Dried foods:
A. With fatty substances on the surface
X/5
B. Other
X
08.09
Frozen or deep-frozen foods
X
08.10
Concentrated extracts of an alcoholic strength
X(*)
X
equal to or exceeding 6% vol.
08.11
Cocoa:
A. Cocoa powder, including fat-reduced and
X
highly fat reduced
B. Cocoa paste
X/3
08.12
Coffee, whether or not roasted, decaffeinated or
X
soluble, coffee substitutes, granulated or pow
dered
08.13
Aromatic herbs and other herbs such as camo
X
mile, mallow, mint, tea, lime blossom and others
08.14
Spices and seasonings in the natural state such as
X
cinnamon, cloves, powdered mustard, pepper,
vanilla, saffron, salt and other
08.15
Spices and seasoning in oily medium such as
X
pesto, curry paste
4. Food simulant assignment for testing overall migration
To demonstrate compliance with the overall migration limit for all type of foods testing in distilled water or water of
equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all types of food except for acidic foods testing in dis
tilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products test
ing in food simulant D1 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk prod
ucts testing in food simulant D1 and food simulant B shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol
content of 20% testing in food simulant C shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to
an alcohol content of 20% testing in food simulant C and food simulant B shall be performed.

---

15.1.2011
EN
Official Journal of the European Union
L 12/81
ANNEXIV
Declaration of compliance
The written declaration referred to in Article15 shall contain the following information:
(1) the identity and address of the business operator issuing the declaration of compliance;
(2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or
products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those
materials and articles;
(3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended
for the manufacturing of those materials and articles;
(4) the date of the declaration;
(5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances
meet relevant requirements laid down in this Regulation and Regulation (EC) No1935/2004;
(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or
specifications are set out in AnnexesI andII to this Regulation to allow the downstream business operators to ensure
compliance with those restrictions;
(7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental
data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accor
dance with Directives 2008/60/EC, 95/45/EC and2008/84/EC to enable the user of these materials or articles to com
ply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
(8) specifications on the use of the material or article, such as:
(i) type or types of food with which it is intended to be put in contact;
(ii) time and temperature of treatment and storage in contact with the food;
(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article;
(9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article com
plies with the requirements of Article13(2), (3) and(4) or Article14(2) and(3) of this Regulation.

---

L 12/82
EN
Official Journal of the European Union
15.1.2011
ANNEXV
COMPLIANCE TESTING
For testing compliance of migration from plastic food contact materials and articles the following 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 be stored as indicated on the packaging label or under conditions adequate for the pack
aged food if no instructions are given. The food shall be removed from contact with the material or article before its
expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality
or safety.
1.2. Conditions of testing
The food shall be treated in accordance with the cooking instructions on the package if the food is to be cooked in the
package. Parts of the food which are not intended to be eaten shall be removed and discarded. The remainder shall be
homogenised and analysed for migration. The analytical results shall always be expressed on the basis of the food mass
that is intended to be eaten, in contact with the food contact material.
1.3. Analysis of migrated substances
The specific migration is analysed in the food using an analytical method in accordance with the requirements of
Article11 of Regulation (EC) No882/2004.
1.4. Special cases
When contamination occurs from sources other than food contact materials this has to be taken into account when
testing for compliance of the food contact materials, in particular for phthalates (FCM substance 157, 159, 283, 728,
729) referred to in AnnexI.
CHAPTER 2
Testing for specific migration of materials and articles not yet in contact with food
2.1.
Verification method
Verification of compliance of migration into foods with the migration limits shall be carried out under the most
extreme conditions of time and temperature foreseeable in actual use taking into account paragraphs1.4, 2.1.1, 2.1.6
and2.1.7.
Verification of compliance of migration into food simulants with the migration limits shall be carried out using con
ventional migration tests according to the rules set out in paragraphs2.1.1 to2.1.7.
2.1.1. Sample preparation
The material or article shall be treated as described by accompanying instructions or by provisions given in the dec
laration of compliance.
Migration is determined 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 simulant or food type, a new test speci
men is used. Only those parts of the sample which are intended to come into contact with foods in actual use shall
be placed in contact with the food simulant or the food.

---

15.1.2011
EN
Official Journal of the European Union
L 12/83
2.1.2. Choice of food simulant
Materials and articles intended for contact with all types of food shall be tested with food simulant A, B andD2.
However, if substances that may react with acidic food simulant or foods are not present testing in food simulant B
can be omitted.
Materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for
the food types in AnnexIII.
2.1.3. Conditions of contact when using food simulants
The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable
conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.
If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2
causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use
of the material or article under examination, the migration tests shall be carried out under the worst foreseeable con
ditions of use in which these physical or other changes do not take place.
Table 1
Contact time
Contact time in worst foreseeable use
Test time
t ≤ 5min
5min
5min < t ≤ 0,5hour
0,5hour
0,5hours < t ≤ 1hour
1hour
1hour < t ≤ 2hours
2hours
2hours < t ≤ 6hours
6hours
6hours < t ≤ 24hours
24hours
1 day < t ≤ 3 days
3 days
3 days < t ≤ 30 days
10 days
Above 30 days
See specific conditions
Table 2
Contact temperature
Conditions of contact in worst foreseeable use
Test conditions
Contact temperature
Test temperature
T ≤ 5°C
5°C
5°C < T ≤ 20°C
20°C
20°C < T ≤ 40°C
40°C
40°C < T ≤ 70°C
70°C
70°C < T ≤ 100°C
100°C or reflux temperature
100°C < T ≤ 121°C
121°C(*)
121°C < T ≤ 130°C
130°C(*)
130°C < T ≤ 150°C
150°C(*)
150°C < T < 175°C
175°C(*)
T > 175°C
Adjust the temperature to the real temperature at the
interface with the food(*)
(*) This temperature shall be used only for food simulants D2 and E. For applications heated under pressure migration testing under
pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at
100°C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.

---

L 12/84
EN
Official Journal of the European Union
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 and 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 conditions shall be based
on the following formula.
t2 = t1 * Exp ((-Ea/R) * (1/T1-1/T2))
Ea is the worst case activation energy 80kJ/mol
R is a factor 8,31 J/Kelvin/mol
Exp -9627 * (1/T1-1/T2)
t1 is the contact time
t2 is the testing time
T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25°C). For refrigerated
and frozen conditions it is set at 278K (5°C).
T2 is the testing temperature in Kelvin.
Testing for 10 days at 20°C shall cover all storage times at frozen condition.
Testing for 10 days at 40°C shall cover all storage times at refrigerated and frozen conditions including heating up
to70°C for up to2hours, or heating up to100°C for up to15minutes.
Testing for 10 days at 50°C shall cover all storage time at refrigerated and frozen conditions including heating up
to70°C for up to2hours, or heating up to100°C for up to15minutes and storage times of up to6 months at
room temperature.
Testing for 10 days at 60°C shall cover long term storage above 6 months at room temperature and below includ
ing heating up to70°C for up to2hours, or heating up to100°C for up to15minutes.
The maximum testing temperature is governed by the phase transition temperature of the polymer. At the test tem
perature the test specimen should not undergo any physical changes.
For storage at room temperature testing time can be reduced to10 days at 40°C if there is scientific evidence that
migration of the respective substance in the polymer has reached equilibration under this test condition.
2.1.5. Specific conditions for combinations of contact times and temperature
If a material or article is intended for different applications covering different combinations of contact time and tem
perature the testing should be restricted to the test conditions which are recognised to be the most severe on the
basis of scientific evidence.
If the material or article is intended for a food contact application where it is successively subject to a combination
of two or more times and temperatures, the migration test shall be carried out subjecting the test specimen succes
sively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food
simulant.
2.1.6. Repeated use articles
If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried
out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be
checked on the basis of the level of the migration found in the third test.
However, if there is conclusive proof that the level of the migration does not increase in the second and third tests
and if the migration limits are not exceeded on the first test, no further test is necessary.

---

15.1.2011
EN
Official Journal of the European Union
L 12/85
The material or article shall respect the specific migration limit already in the first test for substances for which in
AnnexI Table 1 column 8 or Table 2 column 3 the specific migration limit is set as non-detectable and for non-
listed substances used behind a plastic functional barrier covered by the rules of point(b) of Articles13(2) which
should not migrate in detectable amounts.
2.1.7. Analysis of migrating substances
At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an
analytical method in accordance with the requirements of Article11 of Regulation (EC) No882/2004.
2.1.8. Verification of compliance by residual content per food contact surface area (QMA)
For substances which are unstable in food simulant or food or for which no adequate analytical method is available
it is indicated in AnnexI that verification of compliance shall be undertaken by verification of residual content per
6dm2 of contact surface. For materials and articles between 500ml and10l the real contact surface is applied. For
materials and articles below 500ml and above 10l as well as for articles for which it is impractical to calculate the
real contact surface the contact surface is assumed to be 6dm2 per kg food.
2.2.
Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied
which are considered more severe than the verification method described in section2.1.
2.2.1. Replacing specific migration by overall migration
To screen for specific migration of non-volatile substances, determination of overall migration under test conditions
at least as severe as for specific migration can be applied.
2.2.2. Residual content
To screen for specific migration the migration potential can be calculated based on the residual content of the sub
stance in the material or article assuming complete migration.
2.2.3. Migration modelling
To screen for specific migration the migration potential can be calculated based on the residual content of the sub
stance in the material or article applying generally recognised diffusion models based on scientific evidence that are
constructed such as to overestimate real migration.
2.2.4. Food simulant substitutes
To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on sci
entific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAPTER 3
Testing for overall migration
Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.
3.1.
Standardised testing conditions
The overall migration test for materials and articles intended for the food contact conditions described in column 3
of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the
test can be performed either for 2hours at 100°C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for
1hour at 121°C. The food simulant shall be chosen in accordance with AnnexIII.

---

L 12/86
EN
Official Journal of the European Union
15.1.2011
If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other
changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article
under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which
these physical or other changes do not take place.
Table 3
Standardised testing conditions
Column 1
Column 2
Column 3
Test number
Contact time in days [d] or hours [h] at Contact
temperature in [°C]
Intended food contact conditions
OM1
10 d at 20°C
Any food contact at frozen and
refrigerated conditions.
OM2
10 d at 40°C
Any long term storage at room
temperature or below, including
heating up to 70°C for up to 2hours,
or heating up to 100°C for up
to 15minutes.
OM3
2h at 70°C
Any contact conditions that include
heating up to 70°C for up to 2hours,
or up to 100°C for up to 15minutes,
which are not followed by long term
room or refrigerated temperature
storage.
OM4
1h at 100°C
High temperature applications for all
food simulants at temperature up
to 100°C.
OM5
2h at 100°C or at reflux or alternatively 1h at
High temperature applications up
121°C
to 121°C.
OM6
4h at 100°C or at reflux
Any food contact conditions with
food simulants A, B or C, at
temperature exceeding 40°C.
OM7
2h at 175°C
High temperature applications with
fatty foods exceeding the conditions
of OM5.
Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, OM4, OM5. It represents the worst
case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to per
form OM 7 with food simulant D2 the test can be replaced as set out in paragraph3.2.
Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst
case conditions for food simulants A, B andC in contact with non-polyolefins.
Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, OM4. It represents the worst case
conditions for all food simulants in contact with polyolefins.
Test OM 2 covers also food contact conditions described for OM1 and OM3.

---

15.1.2011
EN
Official Journal of the European Union
L 12/87
3.2.
Substitute test for OM7 with food simulant D2
In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8
or OM9. Both test conditions described under the respective test shall be performed with a new test sample.
Test number
Test conditions
Intended food contact condi
Covers the intended food contact
tions
conditions described in
OM 8
Food simulant E for 2hours High temperature applica OM1, OM3, OM4, OM5, and
at 175°C and food simulant tions only
OM6
D2 for 2hours at 100°C
OM 9
Food simulant E for 2hours High temperature applica OM1, OM2, OM3, OM4, OM5
at 175°C and food simulant tions including long term and OM6
D2 for 10 days at 40°C
storage at room temperature
3.3.
Repeated use articles
Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried
out three times on a single sample using another sample of the food simulant on each occasion.
Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is
conclusive proof that the level of the migration does not increase in the second and third tests and if the overall
migration limit is not exceeded on the first test, no further test is necessary.
3.4.
Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied
which are considered more severe than the verification method described in sections3.1. and3.2.
3.4.1. Residual content
To screen for overall migration the migration potential can be calculated based on the residual content of migratable
substances determined in a complete extraction of the material or article.
3.4.2. Food simulant substitutes
To screen for overall migration food simulants can be replaced if based on scientific evidence the substitute food
simulants overestimate migration compared to the regulated 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 Fat Reduction Factor (FRF)
For lipophilic substances for which in AnnexI it is indicated in column 7 that the FRF is applicable the specific migra
tion can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 =
(% fat × 5)/100.
The FRF shall be applied according to the following rules.
The migration test results shall be divided by the FRF before comparing with the migration limits.

---

L 12/88
EN
Official Journal of the European Union
15.1.2011
The correction by the FRF is not applicable in the following cases:
(a) when the material or article is or is intended to be brought in contact with food intended for infants and young
children as defined by Directives 2006/141/EC and2006/125/EC;
(b) for materials and articles for which it is impracticable to estimate the relationship between the surface area and
the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated
using the conventional surface area/volume conversion factor of 6 dm2/kg.
The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.
4.2. Correction of migration into food simulant D2
For the food categories where in sub-column D2 of column 3 of Table 2 of AnnexIII the cross is followed by a figure
the migration test result into food simulant D2 shall be divided by this figure.
The migration test results shall be divided by the correction factor before comparing with the migration limits.
The correction is not applicable to the specific migration for substances in the Union list in AnnexI for which the
specific migration limit in column 8 is ‘not detectable’ and for non-listed substances used behind a plastic functional
barrier covered by the rules of Article13(2)(b) which should not migrate in detectable amounts.
4.3. Combination of correction factors 4.1 and4.2.
The correction factors described in 4.1 and4.2 can be combined for migration of substances for which the FRF is appli
cable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall
not exceed 5.

---

15.1.2011
EN
Official Journal of the European Union
L 12/89
ANNEXVI
Correlation tables
Directive 2002/72/EC
This Regulation
Article 1(1)
Article 1
Article 1(2), (3) and (4)
Article 2
Article 1a
Article 3
Article 3(1), Article 4(1) and Article 5
Article 5
Article 4(2), Article 4a(1) and (4), Article 4d, Annex II (2) and (3) and Annex III
Article 6
(2) and (3)
Article 4a(3) and (6)
Article 7
Annex II (4) and Annex III (4)
Article 8
Article 3(1) and Article 4(1)
Article 9
Article 6
Article 10
Article 5a(1) and Annex I (8)
Article 11
Article 2
Article 12
Article 7a
Article 13
Article 9(1) and (2)
Article 15
Article 9(3)
Article 16
Article 7 and 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, and 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/EEC
This Regulation
Article 1
Article 11
Article 1
Article 12
Article 1
Article 18
Annex
Annex III
Annex
Annex V
Directive 97/48/EC
This Regulation
Annex
Annex III
Annex
Annex V

---