Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance )
Date: 2007-03-30
Institutions: European Commission
Subjects: consumer protection, food safety, foodstuff, health control, packaging product, plastics

31.3.2007

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Official Journal of the European Union

L 91/17

DIRECTIVES

COMMISSION DIRECTIVE 2007/19/EC

of 30 March 2007

amending Directive 2002/72/EC relating to plastic materials and articles intended to come into
contact with food and Council Directive 85/572/EEC laying down the list of simulants to be
used for testing migration of constituents of plastic materials and articles intended to come into
contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1935/2004 of
the
European Parliament and of the Council of 27 October 2004
on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC (1),
and in particular Article 5(2) thereof,

After consulting the European Food Safety Authority (the
Authority),

Whereas:

(1)

(2)

(3)

Commission Directive 2002/72/EC (2)
specific
Directive within the meaning of the framework Regu-
lation (EC) No 1935/2004, harmonising the rules for
the plastics materials and articles intended to come into
contact with food.

is

a

in particular additives and monomers,

Directive 2002/72/EC establishes a list of authorised
substances for the manufacture of those materials and
articles,
the
restrictions on their use, rules on labelling as well as
the information to be given to consumers or to food
business operators concerning correct use of
those
materials and articles.

Information provided to the Commission demonstrates
that the plasticizers used e.g. in polyvinyl chloride (PVC)
gaskets in lids may migrate into fatty foods in quantities
that could endanger human health or bring about an
unacceptable change in the composition of the foods.

(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive

2005/79/EC (OJ L 302, 19.11.2005, p. 35).

the need of

lid manufacturers

It should therefore be made clear that, even if they are
part of e.g. metal
lids, gaskets fall under the scope of
Directive 2002/72/EC. At the same time, specific rules
should be laid down as regard the use of additives for the
manufacture of those gaskets. It is appropriate to take
account of
to have
sufficient time to adapt to some of the provisions of
Directive 2002/72/EC. In particular, taking into account
the time needed to prepare an application for
the
evaluation of specific additives used for the manufacture
of gaskets of lids,
it is not yet possible to establish a
timetable for their evaluation. Therefore, in a first stage,
the positive list of authorised additives that will be
adopted in the future for plastic materials and articles
should not apply for the manufacture of gaskets in
the use of other additives will remain
lids, so that
possible, subject to national
law. This situation should
be reassessed at a later stage.

On the basis of new information related to the risk
assessment of substances evaluated by the Authority
and the need to adapt to technical progress the existing
rules for calculating migration, Directive 2002/72/EC
should be updated. For reasons of clarity definitions of
technical terms used should be introduced.

The rules for overall migration and specific migration
should be based on the same principle and should
therefore, be aligned.

should be introduced to improve the
Specific rules
protection of infants, since infants ingest more food in
proportion to their body weight than adults.

(SML)

verification of

compliance with the

specific
The
migration limits
in simulant D for additives
listed in Annex III, Section B, to Directive 2002/72/EC
the other
should be applied at
provisions for calculating migration introduced in this
Directive for better estimation of the real exposure of
the consumer to those additives. Therefore, the deadline
for application of
the abovementioned verification of
compliance should be extended.

the same time as

(4)

(5)

(6)

(7)

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Official Journal of the European Union

31.3.2007

(8)

(9)

(10)

acting

additives

as polymerisation
status of
The
production aids (PPA)
should be clarified. The PPA
which also function as additives are to be evaluated
and included in the future positive list of additives.
them are already included in the current
Some of
incomplete list of additives. As regards additives which
exclusively act as PPA and are therefore not intended to
remain in the finished article,
it should be made clear
that their use will remain possible, subject to national
law, even after the adoption of the future positive list
of additives. That situation should be reassessed at a later
stage.

the

laying

general

principles

Studies have shown that azodicarbonamide decomposes
into semicarbazide during high temperature processing.
In 2003 the Authority was asked to gather data and to
assess the possible risks posed by semicarbazide in food.
Until that information was obtained and in accordance to
the
Article 7 of Regulation (EC) No 178/2002 of
European Parliament and of the Council of 28 January
down
2002
and
requirements of
food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (1), the use of azodicarbonamide
in plastic materials and articles was
suspended by
Commission Directive 2004/1/EC (2). In its opinion of
21 June 2005, the Authority (3) concluded that carcino-
genicity of semicarbazide is not of concern for human
health at the concentrations encountered in food, if the
source of semicarbazide related to azodicarbonamide is
eliminated. Therefore it is appropriate to maintain the
prohibition of use of
in plastic
materials and article.

azodicarbonamide

The concept of the plastic functional barrier, that is a
barrier within plastic materials or articles preventing or
reducing the migration from behind this barrier into the
food should be introduced. Only glass and some metals
may ensure complete blockage of migration. Plastics may
be partial functional barriers with properties and effec-
tiveness to be assessed and may help reducing the
migration of a substance below a SML or a limit of
detection. Behind a plastic functional barrier, non-
authorised substances may be used, provided they fulfil
certain criteria and their migration remains below a given
detection limit. Taking into account foods for infants and
other particularly susceptible persons as well as the diffi-
culties of
type of analysis affected by a large
analytical tolerance, a maximum level of 0,01 mg/kg in
food or a food simulant should be established for the
migration of a non-authorised substance through a
plastic functional barrier.

this

(i)

and

5(1)(h)

of Regulation

accompanied by

(11) Article 9 of Directive 2002/72/EC provides that materials
a written
and articles must be
declaration of compliance attesting that
they comply
with the rules applicable to them. In accordance with
(EC) No
Article
1935/2004, to strengthen the co-ordination and respon-
sibility of the suppliers at each stage of manufacture,
including that of the starting substances, the responsible
persons
the compliance with the
relevant rules in a declaration of compliance which is
made available to his customer. Further, at each stage
of manufacture,
substan-
tiating the declaration of compliance, should be kept
available for the enforcement authorities.

supporting documentation,

should document

to verify that

(12) Article 17(1) of Regulation (EC) No 178/2002 requires
the food business operator
foods are
compliant with the rules applicable to them. To this
end subject to the requirement of confidentiality, food
business operators
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.

should be given access

(13)

(14)

Compliance with Article 3 of Regulation (EC) No
1935/2004 for substances non-listed in Annexes II and
III of Directive 2002/72/EC such as
impurities or
reaction products referred to in point 3 of Annex II
and point 3 of Annex III
to Directive 2002/72/EC
should be assessed by the relevant business operator in
accordance with internationally recognised scientific prin-
ciples.

For a more adequate estimation of exposure of
the
consumer, a new reduction factor should be introduced
in migration testing, called Fat Reduction Factor (FRF).
Until now, the exposure to substances migrating predo-
minantly into fatty food (lipophilic substances) was based
on the general assumption that a person ingests daily 1
kg of food. However, a person ingests at most 200 g of
fat on a daily basis. This should be taken into consid-
eration through the correction of the specific migration
in
by the FRF applicable
accordance with
Scientific
the
Committee on Food (SCF) (4) and the opinion of the
Authority (5).

to lipophilic
of
opinion

substances
the

(4) SCF opinion of 4 December 2002 on the introduction of a Fat
the

in the estimation of

(Consumption) Reduction Factor (FRF)
exposure to a migrant from food contact materials.
http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(2) OJ L 7, 13.1.2004, p. 45.
(3) The EFSA Journal (2005) 219, 1-36.

(5) Opinion of

the Scientific Panel on Food Additives, Flavourings,
Processing Aids and Materials in Contact with Food (AFC) on a
request from the Commission related to the introduction of a Fat
(consumption) Reduction Factor for infants and children, The EFSA
Journal (2004) 103, 1-8.

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(15) On the basis of new information related to the risk
assessment of monomers and other starting substances
evaluated by the Authority (1), certain monomers provi-
sionally admitted at national
level as well as new
monomers should be included in the Community list
of authorised substances. For others,
the restrictions
and/or specifications already established at Community
level should be amended on the basis of the new infor-
mation available.

(16)

(17)

The incomplete list of additives which may be used in
the manufacture of plastic materials and articles should
be amended so as to include other additives evaluated by
the Authority. For certain additives,
the restrictions
and/or specifications already established at Community
those new
level should be amended on the basis of
evaluations available.

specifications

in the restrictions and/or

Commission Directive 2005/79/EC (2)
introduced the
changes
for
substance Ref. No 35760 in section A instead of
section B of Annex III to Directive 2002/72/EC and for
substance Ref. No 67180 the changes were introduced in
section B instead of section A of that Annex. In addition,
for
substances Ref. No 43480, 45200, 81760 and
88640 the indication to the restrictions and/or specifi-
to Directive 2002/72/EC is
in Annex III
cations
ambiguous. Therefore,
there is a
need to place substances Ref. No 35760 and 67180 in
the appropriate section of the list of additives and re-
introduce
for
substances Ref. No 43480, 45200, 81760 and 88640.

legal certainty,

specifications

restrictions

and

the

for

(20)

(21)

(22)

Certain phthalates are used as plasticizers in gaskets and
in other plastic applications. In its opinions on certain
phthalates (4) published in September 2005 the Authority
set tolerable daily intakes (TDI) for certain phthalates and
to certain
estimated that
phthalates is in the same range as the TDI. Therefore,
it
the
is appropriate to set a shorter deadline for
compliance of plastic materials and articles with the
restrictions
those
substances.

in Directive 2002/72/EC for

the exposure of humans

set

Council
2002/72/EC should therefore be amended accordingly.

85/572/EEC (5)

Directive

Directive

and

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 2002/72/EC is amended as follows:

1. Article 1 is amended as follows:

(a) paragraph 2 is replaced by the following:

(18)

It has been shown that distilled water, which is used at
present
for some milk
products. It should be replaced by 50 % ethanol, which
better simulates their fatty character.

is not an adequate simulant

(19)

Epoxidised soybean oil (ESBO) is used as plasticizer in
gaskets. Taking into account the opinion of the Authority
adopted on 16 March 2006 (3) concerning exposure of
adults to ESBO used in food contact materials,
is
appropriate to set a shorter deadline for the compliance
of gaskets of lids with the restrictions of ESBO and its
substitutes set out in Directive 2002/72/EC. The same
deadline should apply as regards the prohibition of use
of azodicarbonamide.

it

This Directive

shall apply to the

‘2.
following
materials and articles which,
in the finished product
state, are intended to come into contact or are
brought into contact with foodstuffs and are intended
“plastic
for
materials and articles”):

that purpose (hereafter

referred to as

(a) materials and articles and parts thereof consisting

exclusively of plastics;

(b) plastic multi-layer materials and articles;

(c) plastic layers or plastic coatings, forming gaskets in
lids that together are composed of two or more
layers of different types of materials.’

(1) The EFSA Journal (2005) 218, 1-9.

The EFSA Journal (2005) 248, 1-16.
The EFSA Journal (2005) 273, 1-26.
The EFSA Journal (2006) 316 to 318, 1-10.
The EFSA Journal (2006) 395 to 401, 1-21.

(2) OJ L 302, 19.11.2005, p. 35.
(3) The EFSA Journal (2006) 332, 1-9.

(4) The EFSA Journal (2005) 244, 1-18.
The EFSA Journal (2005) 245, 1-14.
The EFSA Journal (2005) 243, 1-20.
The EFSA Journal (2005) 242, 1-17.
The EFSA Journal (2005) 241, 1-14.

(5) OJ L 372, 31.12.1985, p. 14.

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(b) paragraph 4 is replaced by the following:

to paragraph 2(c),

‘4. Without prejudice
this
Directive shall not apply to materials and articles
composed of
two or more layers, one or more of
which does not consist exclusively of plastics, even if
the one intended to come into direct contact with food-
stuffs does consist exclusively of plastics.’

2. The following Article 1a is inserted:

(b) sheet, film or other material or articles which cannot be
filled or for which it is impracticable to estimate the
relationship between the surface area of such material
or article and the quantity of food in contact therewith.

2.
For plastic materials and articles intended to be
brought into contact with or already in contact with food
intended for infants and young children, as defined by
Commission Directives 91/321/EEC (*) and 96/5/EC (**),
the overall migration limit shall always be 60 mg/kg.

‘Article 1a

For the purpose of this Directive the following definitions
shall apply:

(a) “plastic multi-layer material or article” means a plastic
material or article composed of two or more layers of
materials, each consisting exclusively of plastics, which
are bound together by means of adhesives or by other
means;

(b) “plastic functional barrier” means a barrier consisting of
one or more layers of plastics which ensures that the
finished material or article complies with Article 3 of
Regulation (EC) No 1935/2004 of
the European
the Council (*) and with this
Parliament
Directive;

and of

(c) “non-fatty foods” means foods for which in migration
testing simulants other than simulant D are laid down
in Directive 85/572/EEC.

___________
(*) OJ L 338, 13.11.2004, p. 4.’

3. Article 2 is replaced by the following:

‘Article 2

Plastic materials and articles shall not transfer their
1.
exceeding 60
in quantities
constituents
milligrams of
the constituents released per kilogram of
foodstuff or food simulant (mg/kg) (overall migration limit).

to foodstuffs

However,
this limit shall be 10 milligrams per square
decimetre of surface area of material or article (mg/dm2)
in the case of the following:

___________
(*) OJ L 175, 4.7.1991, p. 35.
(**) OJ L 49, 28.2.1996, p. 17.’

4. In Article 4(2), the date of ‘1 July 2006’ is replaced by ‘1

April 2008’.

5. The following Articles 4c, 4d and 4e are inserted:

‘Article 4c

For the use of additives for the manufacture of plastic layers
or plastic coatings in lids referred to in Article 1(2)(c), the
following rules shall apply:

(a)

for the additives listed in Annex III, the restrictions
in that
and/or specifications on their use set out
Annex shall apply, without prejudice to Article 4(2);

(b) by way of derogation from Article 4(1) and Article
4a(1) and (5), additives not listed in Annex III may
continue to be used, until further review, subject to
national law;

(c) by way of derogation from Article 4b Member States
may continue to authorise additives for the manu-
facture of plastic layers or plastic coatings in lids
referred to in Article 1(2)(c) at national level.

Article 4d

For the use of additives exclusively acting as polymerisation
production aids which are not intended to remain in the
finished article (hereinafter PPAs), for the manufacture of
plastic materials and articles, the following rules shall apply:

(a) articles which are containers or are comparable to
containers or which can be filled, with a capacity of
less than 500 millilitres (ml) or more than 10 litres (l);

(a)

for the PPAs listed in Annex III, the restrictions and/or
specifications on their use set out in Annex III shall
apply, without prejudice to Article 4(2);

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(b) by way of derogation from Article 4(1) and Article
4a(1) and (5), the PPAs not listed in Annex III may
continue to be used, until further review, subject to
national law;

(c) by way of derogation from Article 4b, Member States
may continue to authorise PPAs at national level.

Article 4e

the substances

The migration of

referred to in
3.
into food or simulant shall not exceed
paragraph 2(b)
0,01 mg/kg, measured with statistical
certainty by a
method of analysis in accordance with Article 11 of Regu-
lation (EC) No 882/2004 of the European Parliament and
of the Council (*). This limit shall always be expressed as
concentration in foods or simulants.
It shall apply to a
group of compounds, if they are structurally and toxicolo-
gically related, in particular isomers or compounds with the
same relevant functional group, and shall include possible
set-off transfer.

The use of azodicarbonamide, Ref. No 36640 (CAS No
000123-77-3) in the manufacture of plastic materials and
articles is prohibited.’

The substances referred to in paragraph 2(b) shall not

4.
belong to either of the following categories:

6. In Article 5a paragraph 2 is replaced by the following:

‘2.
At the marketing stages other than the retail stages,
plastic materials and articles which are intended to be
placed in contact with foodstuffs and which contain
additives referred to in paragraph 1 shall be accompanied
by a written declaration containing the information referred
to in Article 9.’

7. In Article 7 the following paragraph is added:

‘For plastic materials and articles intended to be brought
into contact with or already in contact with food for
infants and young children, as defined by Directives
91/321/EEC and 96/5/EC,
shall always be
applied as mg/kg.’

the SMLs

8. The following Article 7a is inserted:

‘Article 7a

1.
In a plastic multi-layer material or article, the compo-
sition of each plastic layer shall comply with this Directive.

2.
By way of derogation from paragraph 1, a layer
which is not in direct contact with food and is separated
from the food by a plastic functional barrier, may, provided
the finished material or article complies with the
that
specific and overall migration limits
specified in this
Directive:

(a) not comply with the restrictions and specifications set

in this Directive,

(b) be manufactured with substances other

than those
included in this Directive or
lists
concerning the plastic materials and articles intended
to come into contact with food.

in the national

(a) substances
nogenic”,
substances
67/548/EEC (**);

classified as proved or
“mutagenic” or
in Annex

“toxic
to

I

suspect

“carci-
to reproduction”
Council Directive

(b) substances classified under the self-responsibility criteria
‘mutagenic’ or ‘toxic to reproduction’
to Directive

as ‘carcinogenic’,
according to the rules of Annex VI
67/548/EEC.

___________
(*) OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191,

28.5.2004, p. 1.

(**) OJ 196, 16.8.1967, p. 1.’

9. In Article 8 the following paragraph 5 is added:

the verification of

‘5.
Notwithstanding paragraph 1, for phthalates (Ref. No
74640, 74880, 74560, 75100, 75105) referred to in
Annex III Section B,
the SML shall
only be performed in food simulants. However, verification
of the SML may be performed in food where the food has
not already been in contact with the material or article and
is pre-tested for the phthalate and the level is not statis-
tically significant or greater than or equal to the limit of
quantification.’

10. Article 9 is replaced by the following:

‘Article 9

1.
At the marketing stages other than the retail stage,
plastic materials and articles as well as the substances
intended for the manufacturing of
those materials and
articles, shall be accompanied by a written declaration in
accordance with Article 16 of Regulation (EC) No
1935/2004.

2.
The declaration referred to in paragraph 1 shall be
issued by the business operator and shall contain the infor-
mation laid down in Annex VIa.

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Appropriate documentation to demonstrate that the
3.
materials and articles as well as the substances intended for
the manufacturing of those materials and articles comply
this Directive shall be made
with the requirements of
to the national
available by
competent authorities on request. That documentation
shall contain the conditions and results of testing, calcu-
lations, other analysis, and evidence on the safety or
reasoning demonstrating compliance.’

the business operator

They shall apply those provisions in such a way as to:

(a) permit the trade in and use of plastic materials and articles
intended to come into contact with food and complying
with Directive 2002/72/EC, as amended by this Directive,
from 1 April 2008;

11. Annexes I,

II and III are amended in accordance with

Annexes I, II and III to this Directive.

12. The text in Annex IV to this Directive is inserted as Annex

IVa.

13. Annexes V and VI are amended in accordance with

Annexes V and VI to this Directive.

(b) prohibit

the manufacture

and importation into the
Community of
lids containing a gasket which do not
comply with restrictions and specifications for Ref. No
30340; 30401; 36640; 56800; 76815; 76866; 88640
and 93760 laid down in Directive 2002/72/EC as
amended by this Directive from 1 June 2008;

(c) prohibit

the manufacture

and importation into the
Community of plastic materials and articles intended to
come into contact with food which do not comply with
restrictions and specifications for phthalates Ref. No 74560;
74640; 74880; 75100; 75105 laid down in Directive
2002/72/EC as amended by this Directive from 1 June
2008;

14. The text in Annex VII to this Directive is inserted as Annex

VIa.

(d) without prejudice to point (b) and (c), prohibit the manu-
facture and importation into the Community of plastic
materials and articles intended to come into contact with
food which do not comply with Directive 2002/72/EC as
amended by this Directive from 1 April 2009.

Article 2

The Annex to Directive 85/572/EEC is amended in accordance
with Annex VIII to this Directive.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 4

1. Member States shall adopt and publish, by 1 April 2008
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 30 March 2007.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Annex I to Directive 2002/72/EC is amended as follows:

(1) The following points 2a and 2b are inserted:

‘2a. Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF):

“Fat Reduction Factor” (FRF) is a factor between 1 and 5 by which measured migration of lipophilic substances
into a fatty food or simulant D and its substitutes shall be divided before comparison with the specific migration
limits.

General rules

Substances considered “lipophilic” for the application of the FRF are listed in Annex IVa. The specific migration
of lipophilic substances in mg/kg (M) shall be corrected by the FRF variable between 1 and 5 (MFRF). The
following equations shall be applied before comparison with the legal limit:

MFRF = M/FRF

and

FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100

This 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 containing less than 20 %

fat;

(b) 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 91/321/EEC and 96/5/EC;

(c)

for substances in the Community lists in Annexes II and III having a restriction in column (4) SML= ND or
non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg;

(d) 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.

This correction by the FRF is applicable under certain conditions in the following case:

For containers and other fillable articles with a capacity of less than 500 millilitres or more than 10 litres and for
sheets and films in contact with foods containing more than 20 % fat, either the migration is calculated as
concentration in the food or food simulant (mg/kg) and corrected by the FRF, or it is re-calculated as mg/dm2
without applying the FRF. If one of the two values is below the SML, the material or article shall be considered in
compliance.

The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.

2b. Correction of specific migration in food simulant D:

The specific migration of lipophilic substances into simulant D and its substitutes shall be corrected by the
following factors:

(a) the reduction factor referred to in point 3 of the Annex to Directive 85/572/EEC, hereinafter termed simulant

D Reduction Factor (DRF).

The DRF may not be applicable when the specific migration into simulant D is higher than 80 % of the
content of the substance in the finished material or article (for example thin films). Scientific or experimental
evidence (for example testing with the most critical foods) is required to determine whether the DRF is
applicable. It is also not applicable for substances in the Community lists having a restriction in column (4)
SML = ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01
mg/kg.

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(b) the FRF is applicable to migration into simulants, provided the fat content of the food to be packed is known

and the requirements mentioned in point 2a are fulfilled.

(c)

the Total Reduction Factor (TRF) is the factor, with a maximum value of 5, by which a measured specific
migration into simulant D or a substitute shall be divided before comparison with the legal
limit. It is
obtained by multiplying the DRF by the FRF, when both factors are applicable.’

(2) The following point 5a is inserted:

‘5a. Caps, lids, gaskets, stoppers and similar sealing articles:

(a)

If the intended use is known, such articles shall be tested by applying them to the containers for which they
are intended under conditions of closure corresponding to the normal or foreseeable use. It is assumed that
these articles are in contact with a quantity of food filling the container. The results shall be expressed in
mg/kg or mg/dm2 in accordance to the rules of Articles 2 and 7 taking into account the whole contact
surface of sealing article and container.

(b) If the intended use of these articles is unknown, such articles shall be tested in a separate test and the result
be expressed in mg/article. The value obtained shall be added, if appropriate, to the quantity migrated from
the container for which it is intended to be used.’

31.3.2007

EN

Official Journal of the European Union

L 91/25

ANNEX II

Annex II to Directive 2002/72/EC is amended as follows:

(1) Section A is amended as follows:

(a)

the following monomers and other starting substances are inserted, in the appropriate numerical order:

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘15267

000080-08-0

4,4′-Diaminodiphenyl sulphone

SML = 5 mg/kg

21970

000923-02-4

N-Methylolmethacrylamide

SML = 0,05 mg/kg

24886

046728-75-0

5-Sulphoisophthalic acid, mono-
lithium salt

SML = 5 mg/kg and for lithium

SML(T) = 0,6 mg/kg (8) (expressed as
lithium)’

(b) for the following monomers and other starting substances, the content of the column 4 ‘Restrictions and/or

specifications’ is replaced by the following:

Ref. No

CAS No

(1)

‘12786

(2)

Name

(3)

Restrictions and/or specifications

(4)

000919-30-2

3-Aminopropyltriethoxysilane

Residual extractable content of
3-aminopropyltriethoxysilane to be less
than 3 mg/kg filler when used for the
reactive surface treatment of inorganic
fillers and SML = 0,05 mg/kg when
used for the surface treatment of
materials and articles.

16450

000646-06-0

1,3-Dioxolane

25900

000110-88-3

Trioxane

SML = 5 mg/kg

SML = 5 mg/kg’

(2) In section B, the following monomers and other starting substances are deleted:

Ref. No

CAS No

(1)

(2)

Name

(3)

‘21970

000923-02-4

N-Methylolmethacrylamide’

Restrictions and/or specifications

(4)

L 91/26

EN

Official Journal of the European Union

31.3.2007

ANNEX III

Annex III to Directive 2002/72/EC is amended as follows:

(1) Section A is amended as follows:

(a)

the following additives are inserted in the appropriate numerical order:

Ref. No

CAS No

(1)

(2)

‘38885

002725-22-6

Name

(3)

Restrictions and/or specifications

(4)

2,4-Bis(2,4-dimethylphenyl)-6-
(2-hydroxy-4-n-octyloxyphenyl)-
1,3,5-triazine

SML = 0,05 mg/kg. For aqueous foods
only.

42080

001333-86-4

Carbon black

In compliance with the specifications
laid down in Annex V.

45705

166412-78-8

1,2-cyclohexanedicarboxylic acid,
diisononyl ester

62020

007620-77-1

12-Hydroxystearic acid, lithium salt

SML(T) = 0,6 mg/kg (8) (expressed as
lithium)

67180

—

Mixture of (50 % w/w) phthalic acid
n-decyl n-octyl ester, (25 % w/w)
phthalic acid di-n-decyl ester, (25 %
w/w) phthalic acid di-n- octyl ester.

SML = 5 mg/kg (1)

71960

003825-26-1

Perfluorooctanoic acid, ammonium
salt

Only to be used in repeated use articles,
sintered at high temperatures.

74560

000085-68-7

Phthalic acid, benzyl butyl ester

To be used only as:

(a) plasticizer in repeated use materials

and articles;

(b) plasticizer

in single-use materials

and articles contacting non-fatty
foods except for infant formulae
and follow-on formulae as defined
by Directive 91/321/EEC and
products according to Directive
96/5/EC;

(c)

technical support agent in concen-
trations up to 0,1 % in the final
product.

SML = 30 mg/kg food simulant.

74640

000117-81-7

Phthalic acid, bis (2-ethylhexyl) ester

To be used only as:

(a) plasticizer in repeated use materials
and articles contacting non-fatty
foods;

(b) technical support agent in concen-
trations up to 0,1 % in the final
product.

SML = 1,5 mg/kg food simulant.

31.3.2007

EN

Official Journal of the European Union

L 91/27

(1)

(2)

(3)

(4)

74880

000084-74-2

Phthalic acid, dibutyl ester

To be used only as:

75100

068515-48-0
028553-12-0

Phthalic acid, diesters with primary,
saturated C8-C10 branched alcohols,
more than 60 % C9.

75105

068515-49-1
026761-40-0

Phthalic acid, diesters with primary,
saturated C9-C11 alcohols more than
90 % C10

(a) plasticizer in repeated use materials
and articles contacting non-fatty
foods;

(b) technical

support agent

in poly-

olefines in concentrations up to
0,05 % in the final product.

SML = 0,3 mg/kg food simulant.

To be used only as:

(a) plasticizer in repeated use materials

and articles;

(b) plasticizer

in single-use materials

and articles contacting non-fatty
foods except for infant formulae
and follow-on formulae as defined
by Directive 91/321/EEC and
products according to Directive
96/5/EC;

(c)

technical support agent in concen-
trations up to 0,1 % in the final
product.

SML(T) = 9 mg/kg food simulant (42).

To be used only as:

(a) plasticizer in repeated use materials

and articles;

(b) plasticizer

in single-use materials

and articles contacting non-fatty
foods except for infant formulae
and follow-on formulae as defined
by Directive 91/321/EEC and
products according to Directive
96/5/EC;

(c)

technical support agent in concen-
trations up to 0,1 % in the final
product.

SML(T) = 9 mg/kg food simulant (42).

79920

009003-11-6
106392-12-5

Poly(ethylene propylene) glycol

81500

9003-39-8

Polyvinylpyrrolidone

In compliance with the specifications
laid down in Annex V.

93760

000077-90-7

Tri-n-butyl acetyl citrate

95020

6846-50-0

2,2,4-Trimethyl-1,3-pentanediol di-
isobutyrate

SML = 5 mg/kg food. To be used in
single-use gloves only.

95420

745070-61-5

1,3,5-tris (2,2-dimethylpropanamido)-
benzene

SML = 0,05 mg/kg food.’

L 91/28

EN

Official Journal of the European Union

31.3.2007

(b) for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced

by the following:

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘43480

064365-11-3

Charcoal, activated

45200

001335-23-5

Copper iodide

76845

031831-53-5

Polyester of 1,4-butanediol with
caprolactone

In compliance with the specifications
laid down in Annex V.

SML(T) = 5 mg/kg (7) (expressed as
copper) and SML = 1 mg/kg (11)
(expressed as iodine)

The restriction for Ref. No 14260 and
Ref. No 13720 shall be respected.
In compliance with the specifications
laid down in Annex V.

81760

—

Powders, flakes and fibres of brass,
bronze, copper, stainless steel, tin and
alloys of copper, tin and iron

SML(T) = 5 mg/kg (7) (expressed as
copper);

SML = 48 mg/kg (expressed as iron)

88640

008013-07-8

Soybean oil, epoxidised

SML = 60 mg/kg. However in the case
of PVC gaskets used to seal glass jars
containing infant formulae and
follow-on formulae as defined by
Directive 91/321/EEC or containing
processed cereal-based foods and baby
foods for infants and young children as
defined by Directive 96/5/EC, the SML
is lowered to 30 mg/kg.

In compliance with the specifications
laid down in Annex V.’

(c)

the following additive is deleted:

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘35760

001309-64-4

Antimony trioxide

SML = 0,04 mg/kg (39) (expressed as
antimony).’

(2) Section B is amended as follows:

(a)

the following additives are inserted, in the appropriate numerical order:

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘35760

001309-64-4

antimony trioxide

SML = 0,04 mg/kg (39) (expressed as
antimony)

47500

153250-52-3

N,N′-Dicyclohexyl-2,6-naphthalene
dicarboxamide

SML = 5 mg/kg.

31.3.2007

EN

Official Journal of the European Union

L 91/29

(1)

72081/10

93970

(2)

—

—

(3)

(4)

Petroleum hydrocarbon resins
(hydrogenated)

SML = 5 mg/kg (1) and in compliance
with the specifications laid down in
Annex V

Tricyclodecanedimethanol
bis(hexahydrophthalate)

SML = 0,05 mg/kg.’

(b) for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced

by the following:

Ref. No

CAS No

(1)

(2)

‘47600

084030-61-5

Di-n-dodecyltin bis(isooctyl
mercaptoacetate)

Name

(3)

Restrictions and/or specifications

(4)

SML(T) = 0,05 mg/kg food (41) (as sum
of mono-n-dodecyltin tris(isooctyl
mercaptoacetate), di-n- dodecyltin
bis(isooctyl mercaptoacetate), mono-
dodecyltin trichloride and di-dodecyltin
dichloride) expressed as the sum of
mono- and di-dodecyltin chloride

SML(T) = 0,05 mg/kg food (41) (as sum
of mono-n-dodecyltin tris(isooctyl
mercaptoacetate), di-n- dodecyltin
bis(isooctyl mercaptoacetate), mono-
dodecyltin trichloride and di-dodecyltin
dichloride) expressed as the sum of
mono- and di-dodecyltin chloride’

Restrictions and/or specifications

(4)

SML = 5 mg/kg (1)

67360

067649-65-4

Mono-n-dodecyltin tris(isooctyl
mercaptoacetate)

(c) The following additives are deleted:

Ref. No

CAS No

(1)

‘67180

76681

(2)

—

—

Name

(3)

Mixture of (50 % w/w) phthalic acid
n-decyl n-octyl ester, (25 % w/w)
phthalic acid di-n-decyl ester, (25 %
w/w) phthalic acid di-n- octyl ester.

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg (1)’

L 91/30

EN

Official Journal of the European Union

31.3.2007

ANNEX IV

‘ANNEX IVa

LIPOPHILIC SUBSTANCES FOR WHICH THE FRF APPLIES

Ref. No

CAS No

Name

31520

061167-58-6

Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-
methylphenyl ester

31530

123968-25-2

Acrylic acid, 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]
phenyl ester

31920

38240

38515

38560

38700

38800

38810

38820

38840

39060

39925

40000

40020

40800

42000

45450

45705

46720

47540

47600

48800

48880

49485

49840

51680

52320

000103-23-1

Adipic acid, bis(2-ethylhexyl) ester

000119-61-9

Benzophenone

001533-45-5

4,4′-Bis(2-benzoxazolyl)stilbene

007128-64-5

2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene

063397-60-4

Bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)

032687-78-8

N,N′-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide

080693-00-1

Bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite

026741-53-7

Bis(2,4-di-tert-butylphenyl)pentaerythritol diphosphite

154862-43-8

Bis(2,4-dicumylphenyl)pentaerythritoldiphosphite

035958-30-6

1,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane

129228-21-3

3,3-Bis(methoxymethyl)-2,5-dimethylhexane

000991-84-4

2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine

110553-27-0

2,4-Bis(octylthiomethyl)-6-methylphenol

013003-12-8

4,4′-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)

063438-80-2

(2-Carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)

068610-51-5

p-Cresol-dicyclopentadiene-isobutylene, copolymer

166412-78-8

1,2-cyclohexanedicarboxylic acid, diisononyl ester

004130-42-1

2,6-Di-tert-butyl-4-ethylphenol

027458-90-8

Di-tert-dodecyl disulphide

084030-61-5

Di-n-dodecyltin bis(isooctyl mercaptoacetate)

000097-23-4

2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane

000131-53-3

2,2′-Dihydroxy-4-methoxybenzophenone

134701-20-5

2,4-Dimethyl-6-(1-methylpentadecyl)-phenol

002500-88-1

Dioctadecyl disulphide

000102-08-9

N,N′-Diphenylthiourea

052047-59-3

2-(4-Dodecylphenyl)indole

31.3.2007

EN

Official Journal of the European Union

L 91/31

Ref. No

CAS No

Name

53200

023949-66-8

2-Ethoxy-2′-ethyloxanilide

54300

118337-09-0

2,2′-Ethylidenebis(4,6-di-tert-butyl phenyl) fluorophosphonite

59120

023128-74-7

1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)

59200

035074-77-2

1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl–4-hydroxyphenyl)propionate)

60320

070321-86-7

2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole

60400

003896-11-5

2-(2′-Hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole

60480

003864-99-1

2-(2′-Hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole

61280

003293-97-8

2-Hydroxy-4-n-hexyloxybenzophenone

61360

000131-57-7

2-Hydroxy-4-methoxybenzophenone

61600

001843-05-6

2-Hydroxy-4-n-octyloxybenzophenone

66360

085209-91-2

2,2′-Methylene bis(4,6-di-tert-butylphenyl) sodium phosphate

66400

000088-24-4

2,2′-Methylene bis(4-ethyl-6-tert-butylphenol)

66480

000119-47-1

2,2′-Methylene bis(4-methyl-6-tert-butylphenol)

66560

004066-02-8

2,2′-Methylene bis(4-methyl-6-cyclohexylphenol)

66580

000077-62-3

2,2′-Methylene bis(4-methyl-6-(1-methyl-cyclohexyl) phenol)

68145

080410-33-9

2,2′,2′-Nitrilo[triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-
diyl)phosphite]

68320

002082-79-3

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

68400

010094-45-8

Octadecylerucamide

69840

016260-09-6

Oleylpalmitamide

71670

178671-58-4

Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

72081/10

—

Petroleum Hydrocarbon Resins (hydrogenated)

72160

000948-65-2

2-Phenylindole

72800

001241-94-7

Phosphoric acid, diphenyl 2-ethylhexyl ester

73160

—

Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters

74010

145650-60-8

Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester

74400

76866

77440

—

—

—

Phosphorous acid, tris(nonyl- and/or dinonylphenyl) ester

Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or poly-
propyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids
C12-C18 or n-octanol and/or n-decanol

Polyethyleneglycol diricinoleate

78320

009004-97-1

Polyethyleneglycol monoricinoleate

L 91/32

EN

Official Journal of the European Union

31.3.2007

Ref. No

CAS No

Name

81200

071878-19-8

Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-
tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-
piperidyl)imino]

83599

068442-12-6

Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin,
sodium sulphide and trichloromethyltin

83700

84800

92320

92560

92700

92800

92880

93120

93280

95270

95280

000141-22-0

Ricinoleic acid

000087-18-3

Salicylic acid, 4-tert-butylphenyl ester

—

Tetradecyl-polyethyleneglycol(EO=3-8) ether of glycolic acid

038613-77-3

Tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite

078301-43-6

2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro[5.1.11.2]-
heneicosan-21-one, polymer

000096-69-5

4,4′-Thiobis(6-tert-butyl-3-methylphenol)

041484-35-9

Thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)

000123-28-4

Thiodipropionic acid, didodecyl ester

000693-36-7

Thiodipropionic acid, dioctadecyl ester

161717-32-4

2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite

040601-76-1

1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione

95360

027676-62-6

1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-
trione

95600

001843-03-4

1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane’

31.3.2007

EN

Official Journal of the European Union

L 91/33

ANNEX V

Annex V to Directive 2002/72/EC is amended as follows:

(1) Part A is replaced by the following:

‘Part A: General specifications

Plastic material and articles shall not release primary aromatic amines in a detectable quantity (DL = 0,01 mg/kg of
food or food simulant). The migration of the primary aromatic amines appearing in the lists in Annex II and III is
excluded from this restriction.’

(2) In Part B, the following new specifications are inserted, in the appropriate numerical order:

Ref. No

OTHER SPECIFICATIONS

‘42080

Carbon black

Specifications:

— Toluene extractables: maximum 0,1 %, determined according to ISO method

6209.

— UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell
or < 0,1 AU for a 5 cm cell, determined according to a generally recognised
method of analysis.

— Benzo(a)pyrene content: max 0,25 mg/kg carbon black.
— Maximum use level of carbon black in the polymer: 2,5 % w/w

72081/10

Petroleum hydrocarbon resins (hydrogenated)

Specifications:

Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or
thermal polymerisation of dienes and olefins of the aliphatic, alicyclic and/or
monobenzenoid arylalkene types from distillates of cracked petroleum stocks
with a boiling range not greater than 220 °C, as well as the pure monomers
found in these distillation streams, subsequently followed by distillation, hydro-
genation and additional processing.

Properties:

Viscosity: > 3 Pa.s at 120 °C.

Softening point: > 95 °C as determined by ASTM Method E 28-67.

Bromine number: < 40 (ASTM D1159)

The colour of a 50 % solution in toluene < 11 on the Gardner scale
Residual aromatic monomer ≤ 50 ppm

76845

81500

Polyester of 1,4-butanediol with caprolactone

MW fraction < 1 000 is less than 0,5 % (w/w)

Polyvinylpyrrolidone

The substance shall meet the purity criteria established in Commission Directive
96/77/EC (*)

88640

Soybean oil, epoxidized

Oxirane < 8 %, iodine number < 6

(*) OJ L 339, 30.12.1996, p. 1.’

L 91/34

EN

Official Journal of the European Union

31.3.2007

ANNEX VI

Annex VI to Directive 2002/72/EC is amended as follows:

(1) Note (8) is replaced by the following:

‘(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of
the following substances mentioned as Ref. Nos: 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040,
85760, 85840, 85920 and 95725.’

(2) The following notes 41 and 42 are added:

‘(41) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels

of the following substances mentioned as Ref. Nos: 47600, 67360.

(42) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels

of the following substances mentioned as Ref. Nos: 75100 and 75105.’

31.3.2007

EN

Official Journal of the European Union

L 91/35

ANNEX VII

‘ANNEX VIa

The written declaration referred to in Article 9 shall contain the following information:

DECLARATION OF COMPLIANCE

(1) the identity and address of the business operator which manufactures or imports the plastic materials or articles or

the substances intended for the manufacturing of those materials and articles;

(2) the identity of the materials, the articles or the substances intended for the manufacturing of those materials and

articles;

(3) the date of the declaration;

(4) confirmation that the plastic materials or articles meet relevant requirements laid down in this Directive and

Regulation (EC) No 1935/2004;

(5) adequate information relative to the substances used for which restrictions and/or specifications are in place under

this Directive to allow the downstream business operators to ensure compliance with those restrictions;

(6) 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
accordance with Directives 95/31/EC, 95/45/EC and 96/77/EC to enable the user of these materials or articles to
comply with the relevant Community provisions or, in their absence, with national provisions applicable to food;

(7) 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;

(8) when a plastic functional barrier is used in a plastic multi-layer material or article, the confirmation that the material

or article complies with the requirements of Article 7a(2), (3) and 4 of this Directive.

The written declaration shall permit an easy identification of the materials, articles or substances for which it is issued and
shall be renewed when substantial changes in the production bring about changes in the migration or when new scientific
data are available.’

L 91/36

EN

Official Journal of the European Union

31.3.2007

ANNEX VIII

The Annex to Directive 85/572/EEC is amended as follows:

(1) Point 3 is replaced by the following:

‘3. When “X” is followed by an oblique stroke and a figure, the result of the migration tests should be divided by the
figure indicated. In the case of certain types of fatty food, this conventional figure, known as “Simulant D
Reduction Factor” (DRF), is used to take account of the greater extractive capacity of the simulant compared
to the food.’

(2) The following point 4a is inserted:

‘4a. Where the letter (b) is shown in brackets after the “X”, the indicated test shall be carried out with ethanol 50 %

(v/v).’

(3) In the table, Section 07 is replaced by the following:

‘07

Milk products

07.01

Milk:

A. Whole

B. Partly dried

C. Skimmed or partly skimmed

D. Dried

07.02

Fermented milk such as yoghurt, buttermilk and
similar products

07.03

Cream and sour cream

07.04

Cheeses:

A. Whole, with non-edible rind

B. All others

07.05

Rennet

A. In liquid or viscous form

B. Powdered or dried’

X(b)

X(b)

X(b)

X(b)

X(b)

X

X(a)

X(a)

X(a)

X/3*

X(a)

X(a)