# Commission Directive 2005/79/Ec Of 18 November 2005 Amending Directive 2002/72/Ec Relating To Plastic Materials And Articles Intended To Come Into Contact With Food

(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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, Whereas:

(1)
Commission Directive 2002/72/EC (2) establishes a list of
monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive.
(2)
Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic
materials
and
articles.
That
list
should
be
amended so as to include other additives evaluated by the European Food Safety Authority (the Authority).
(3)
For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications.
(4)
A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006.
(5)
Directive 2002/72/EC should therefore be amended accordingly.
(6)
The measures provided for in this Directive are in accordance
with
the
opinion
of
the
Standing
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive.

PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles. The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive. The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5).

(5) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive
2003/89/EC (OJ L 308, 25.11.2003, p. 15).
1.

Member States shall adopt and publish, by 19 November
2006 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. 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 this Directive, from 19 November 2006;
(b) prohibit
the
manufacture
and
importation
into
the
Community of plastic materials and articles intended to
come into contact with food and which do not comply with this Directive, from 19 November 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.

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.

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

This Directive is addressed to the Member States.

Done at Brussels, 18 November 2005.

For the Commission Markos KYPRIANOU
Member of the Commission

## Annex I

Annex II to Directive 2002/72/EC is amended as follows:
1. point 2 of the general introduction is replaced by the following:
'2. The following substances are not included even if they are intentionally used and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium
and sodium of authorised acids, phenols or alcohols. However, names containing "… acid(s), salts" appear in
the lists, if the corresponding free acid(s) is (are) not mentioned;
(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a
Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:
(i) substances whose name contains "… acid(s), salts" which appear in the lists, if the corresponding free
acid(s) is (are) not mentioned,
(ii) substances referred to in note 38 of Annex VI.';
2. section A is amended as follows:
(a) the following lines are inserted in the table in numerical order:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'11005
012542-30-2
Acrylic acid, dicyclopentenyl ester
QMA = 0,05 mg/6 dm2
11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester
SML = 0,05 mg/kg
12786
000919-30-2
3-Aminopropyltriethoxysilane
Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. To
be used only for the reactive surface treatment
of inorganic fillers
13317
132459-54-2
N,N′-Bis[4-(ethoxycarbonyl)-
phenyl]-1,4,5,8-naphthalenetetracarboxydiimide
SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT)
14260
000502-44-3
Caprolactone
SML = 0,05 mg/kg (expressed as the sum of
caprolactone and 6-hydroxyhexanoic acid)
16955
000096-49-1
Ethylene carbonate
Residual content = 5 mg/kg of hydrogel at a
maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg
21370
010595-80-9
Methacrylic acid, 2-sulphoethyl
ester
QMA = ND (DL = 0,02 mg/6 dm2)
22210
000098-83-9
alpha-Methylstyrene
SML = 0,05 mg/kg
22932
001187-93-5
Perfluoromethyl perfluorovinyl
ether
SML = 0,05 mg/kg. Only to be used for antistick coatings
24903
068425-17-2
Syrups, hydrolysed starch, hydrogenated
In compliance with the specifications laid down in Annex V
25540
000528-44-9
Trimellitic acid
SML(T) = 5 mg/kg (35)
25550
000552-30-7
Trimellitic anhydride
SML(T) = 5 mg/kg (35) (expressed as trimellitic
acid)'

(b) in the following lines the content of the columns 'CAS No' or 'Restrictions and/or specifications' is replaced by the
following:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'10690
000079-10-7
Acrylic acid
SML(T) = 6 mg/kg (36)
10750
002495-35-4
Acrylic acid, benzyl ester
SML(T) = 6 mg/kg (36)
10780
000141-32-2
Acrylic acid, n-butyl ester
SML(T) = 6 mg/kg (36)
10810
002998-08-5
Acrylic acid, sec-butyl ester
SML(T) = 6 mg/kg (36)
10840
001663-39-4
Acrylic acid, tert-butyl ester
SML(T) = 6 mg/kg (36)
11470
000140-88-5
Acrylic acid, ethyl ester
SML(T) = 6 mg/kg (36)
11590
000106-63-8
Acrylic acid, isobutyl ester
SML(T) = 6 mg/kg (36)
11680
000689-12-3
Acrylic acid, isopropyl ester
SML(T) = 6 mg/kg (36)
11710
000096-33-3
Acrylic acid, methyl ester
SML(T) = 6 mg/kg (36)
11830
000818-61-1
Acrylic acid, monoester with
ethyleneglycol
SML(T) = 6 mg/kg (36)
11890
002499-59-4
Acrylic acid, n-octyl ester
SML(T) = 6 mg/kg (36)
11980
000925-60-0
Acrylic acid, propyl ester
SML(T) = 6 mg/kg (36)
13720
000110-63-4
1,4-Butanediol
SML(T) = 5 mg/kg (24)
20020
000079-41-4
Methacrylic acid
SML(T) = 6 mg/kg (37)
20080
002495-37-6
Methacrylic acid, benzyl ester
SML(T) = 6 mg/kg (37)
20110
000097-88-1
Methacrylic acid, butyl ester
SML(T) = 6 mg/kg (37)
20140
002998-18-7
Methacrylic acid, sec-butyl ester
SML(T) = 6 mg/kg (37)
20170
000585-07-9
Methacrylic acid, tert-butyl ester
SML(T) = 6 mg/kg (37)
20890
000097-63-2
Methacrylic acid, ethyl ester
SML(T) = 6 mg/kg (37)
21010
000097-86-9
Methacrylic acid, isobutyl ester
SML(T) = 6 mg/kg (37)
21100
004655-34-9
Methacrylic acid, isopropyl ester
SML(T) = 6 mg/kg (37)
21130
000080-62-6
Methacrylic acid, methyl ester
SML(T) = 6 mg/kg (37)
21190
000868-77-9
Methacrylic acid, monoester with
ethyleneglycol
SML(T) = 6 mg/kg (37)
21280
002177-70-0
Methacrylic acid, phenyl ester
SML(T) = 6 mg/kg (37)
21340
002210-28-8
Methacrylic acid, propyl ester
SML(T) = 6 mg/kg (37)
21460
000760-93-0
Methacrylic anhydride
SML(T) = 6 mg/kg (37)
24190
008050-09-7
Rosin wood
See "Rosin" (Reference No 24100)'

(c) the following line is deleted:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'11000
050976-02-8
Acrylic acid, dicyclopentadienyl
ester
QMA = 0,05 mg/6 dm2'

3. in section B the following lines are deleted:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester
14260
000502-44-3
Caprolactone
21370
010595-80-9
Methacrylic acid, 2-sulphoethyl
ester
22210
000098-83-9
alpha-Methylstyrene
25540
000528-44-9
Trimellitic acid
QM(T) = 5 mg/kg in FP
25550
000552-30-7
Trimellitic anhydride
QM(T) = 5 mg/kg in FP (expressed as trimellitic
acid)'

## Annex Ii

Annex III to Directive 2002/72/EC is amended as follows:
1. point 2 is replaced by the following:
'2. The following substances are not included even if they are intentionally used and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium
and sodium of authorised acids, phenols or alcohols. However, names containing "… acid(s), salts" appear in
the lists, if the corresponding free acid(s) is (are) not mentioned;
(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a
Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to: (i) substances whose name contains "… acid(s), salts" which appear in the lists, if the corresponding free
acid(s) is (are) not mentioned,
(ii) substances referred to in note 38 of Annex VI.';
2. section A is amended as follows:
(a) the following lines are inserted in numerical order:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'30340
330198-91-9
12-(Acetoxy)stearic acid, 2,3-bis
(acetoxy)propyl ester
30401
—
Acetylated mono- and diglycerides of fatty acids
QM = 0,5 % (w/w) in FP
31542
174254-23-0
Acrylic acid, methyl ester, telomer
with 1-dodecanethiol, C16-C18
alkyl esters
43480
064365-11-3
Charcoal, activated
In compliance with the specifications laid down
in Annex V, Part B
62245
012751-22-3
Iron phosphide
For PET polymers and copolymers only
64990
025736-61-2
Maleic anhydride-styrene,
copolymer, sodium salt
In compliance with specifications laid down in Annex V
66905
000872-50-4
N-Methylpyrrolidone
66930
068554-70-1
Methylsilsesquioxane
Residual monomer in methylsilsesquioxane:
< 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane
Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation). In compliance with the specifications laid down in Annex V
67155
—
Mixture of 4-(2-Benzoxazolyl)-4′- (5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene
and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene)
76415
019455-79-9
Pimelic acid, calcium salt
| (1)                                              | (2)         | (3)                               |
|--------------------------------------------------|-------------|-----------------------------------|
| In compliance with the specifications laid down  |             |                                   |
| in Annex V                                       |             |                                   |
| 76815                                            |             |                                   |
| -                                                |             |                                   |
| Polyester of adipic acid with                    |             |                                   |
| glycerol or pentaerythritol, esters              |             |                                   |
| with even numbered, unbranched                   |             |                                   |
| C                                                |             |                                   |
| 12                                               |             |                                   |
| -C                                               |             |                                   |
| 22                                               |             |                                   |
| fatty acids                                      |             |                                   |
| 76845                                            | 031831-53-5 | Polyester of 1,4-butanediol with  |
| caprolactone                                     |             |                                   |
| In compliance with the specifications laid down  |             |                                   |
| in Annex V                                       |             |                                   |
| 77370                                            | 070142-34-6 | Polyethyleneglycol-30 dipolyhy-   |
| droxystearate                                    |             |                                   |
| 79600                                            | 009046-01-9 | Polyethyleneglycol tridecyl ether |
| phosphate                                        |             |                                   |
| SML = 5 mg/kg. For materials and articles        |             |                                   |
| intended for contact with aqueous foods only. In |             |                                   |
| compliance with the specification laid down in   |             |                                   |
| Annex V                                          |             |                                   |
| 80000                                            | 009002-88-4 | Polyethylene wax                  |
| 81060                                            | 009003-07-0 | Polypropylene wax                 |
| '                                                |             |                                   |

(b) in the following lines the content of the columns 'Name' and 'Restrictions and/or specifications' is replaced by the following:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'30080
004180-12-5
Acetic acid, copper salt
SML(T) = 5 mg/kg (7) (expressed as Copper)
35760
001309-64-4
Antimony trioxide
SML = 0,04 mg/kg (39) (expressed as Antimony)
40580
000110-63-4
1,4-Butanediol
SML(T) = 5 mg/kg (24)
42320
007492-68-4
Carbonic acid, copper salt
SML(T) = 5 mg/kg (7) (expressed as Copper)
45195
007787-70-4
Copper bromide
SML(T) = 5 mg/kg (7) (expressed as Copper)
45200
001335-23-5
Copper iodide
SML(T) = 5 mg/kg (7) (expressed as Copper)
53610
054453-03-1
Ethylenediaminetetraacetic acid,
copper salt
SML(T) = 5 mg/kg (7) (expressed as Copper)
81515
087189-25-1
Poly(zinc glycerolate)
SML(T) = 25 mg/kg (38) (as Zinc)
SML(T) = 5 mg/kg (7) (expressed as Copper)
81760
—
Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron
88640
008013-07-08
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 Commission 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
89200
007617-31-4
Stearic acid, copper salt
SML(T) = 5 mg/kg (7) (expressed as Copper)
92030
010124-44-4
Sulphuric acid, copper salt
SML(T) = 5 mg/kg (7) (expressed as Copper)
96190
020427-58-1
Zinc hydroxide
SML(T) = 25 mg/kg (38) (as Zinc)
96240
001314-13-2
Zinc oxide
SML(T) = 25 mg/kg (38) (as Zinc)
96320
001314-98-3
Zinc sulphide
SML(T) = 25 mg/kg (38) (as Zinc)'

(c) the following lines are deleted:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'30400
—
Acetylated glycerides
38320
005242-49-9
4-(2-Benzoxazolyl)-4′-(5-methyl-
2-benzoxazolyl)stilbene
In compliance with the specifications laid down in Annex V'

3. section B is amended as follows:
(a) the following lines are inserted in numerical order:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'31500
025134-51-4
Acrylic acid, acrylic acid,
2-ethylhexyl ester, copolymer
SML(T) = 6 mg/kg (36) (expressed as acrylic acid)
and SML = 0,05 mg/kg (expressed as acrylic
acid, 2-ethylhexyl ester)
38505
351870-33-2
cis-endo-Bicyclo[2.2.1]heptane-
2,3-dicarboxylic acid, disodium
salt
SML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity
≥96 %
38940
110675-26-8
2,4-Bis(dodecylthiomethyl)-6-
methylphenol
SML(T) = 5 mg/kg (40)
49595
057583-35-4
Dimethyltin bis(ethylhexyl
mercaptoacetate)
SML(T) = 0,18 mg/kg (16) (expressed as Tin)
63940
008062-15-5
Lignosulphonic acid
SML = 0,24 mg/kg and to be used only as
dispersant for plastics dispersions
66350
085209-93-4
2,2′-Methylenebis(4,6-di-tertbutylphenyl) lithium phosphate
SML = 5 mg/kg and SML(T) = 0,6 (8) (expressed
as Lithium)
67515
057583-34-3
Monomethyltin tris(ethylhexyl
mercaptoacetate)
SML(T) = 0,18 mg/kg (16) (expressed as Tin)
69160
014666-94-5
Oleic acid, cobalt salt
SML(T) = 0,05 mg/kg (14) (expressed as Cobalt)
76681
—
Polycyclopentadiene, hydrogenated
SML = 5 mg/kg (1)
85950
037296-97-2
Silicic acid, magnesium-sodiumfluoride salt
SML = 0,15 mg/kg (expressed as fluoride). Only to be used in layers of multilayers materials not coming into direct contact with food
95265
227099-60-7
1,3,5-Tris(4-benzoylphenyl)
benzene
SML = 0,05 mg/kg'

(b) in the following lines the content of the columns 'Name' and 'Restrictions and/or specifications' is replaced by the following:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'40020
110553-27-0
2,4-Bis(octylthiomethyl)-6-methylphenol
SML(T) = 5 mg/kg (40)
50160
—
Di-n-octyltin bis(n-alkyl(C10-C16)
mercaptoacetate)
SML(T) = 0,006 mg/kg (17) (expressed as Tin)
| (1)                                  | (2)                    | (3)                                 | (4)                    |
|--------------------------------------|------------------------|-------------------------------------|------------------------|
| 50240                                | 010039-33-5            | Di-n-octyltin bis(2-ethylhexyl      |                        |
| maleate)                             |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50320                                | 015571-58-1            | Di-n-octyltin bis(2-ethylhexyl      |                        |
| mercaptoacetate)                     |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50360                                |                        |                                     |                        |
| -                                    |                        |                                     |                        |
| Di-n-octyltin bis(ethyl maleate)     | SML(T) = 0,006 mg/kg ( |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50400                                | 033568-99-9            | Di-n-octyltin bis(isooctyl maleate) | SML(T) = 0,006 mg/kg ( |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50480                                | 026401-97-8            | Di-n-octyltin bis(isooctyl mercap-  |                        |
| toacetate)                           |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50560                                |                        |                                     |                        |
| -                                    |                        |                                     |                        |
| Di-n-octyltin 1,4-butanediol         |                        |                                     |                        |
| bis(mercaptoacetate)                 |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50640                                | 003648-18-8            | Di-n-octyltin dilaurate             | SML(T) = 0,006 mg/kg ( |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50720                                | 015571-60-5            | Di-n-octyltin dimaleate             | SML(T) = 0,006 mg/kg ( |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50800                                |                        |                                     |                        |
| -                                    |                        |                                     |                        |
| Di-n-octyltin dimaleate, esterified  | SML(T) = 0,006 mg/kg ( |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50880                                |                        |                                     |                        |
| -                                    |                        |                                     |                        |
| Di-n-octyltin dimaleate, polymers    |                        |                                     |                        |
| (n = 2-4)                            |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 50960                                | 069226-44-4            | Di-n-octyltin ethyleneglycol        |                        |
| bis(mercaptoacetate)                 |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 51040                                | 015535-79-2            | Di-n-octyltin mercaptoacetate       | SML(T) = 0,006 mg/kg ( |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| 51120                                |                        |                                     |                        |
| -                                    |                        |                                     |                        |
| Di-n-octyltin thiobenzoate           |                        |                                     |                        |
| 2-ethylhexyl mercaptoacetate         |                        |                                     |                        |
| SML(T) = 0,006 mg/kg (               |                        |                                     |                        |
| 17                                   |                        |                                     |                        |
| ) (expressed as Tin)                 |                        |                                     |                        |
| SML = 5 mg/kg (                      |                        |                                     |                        |
| 1                                    |                        |                                     |                        |
| )                                    |                        |                                     |                        |
| '                                    |                        |                                     |                        |
| 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                          |                        |                                     |                        |

(c) The following line is deleted:

Reference
No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
'76680
068132-00-3
Polycyclopentadiene, hydrogenated
SML = 5 mg/kg (1)'

## Annex Iii

In Part B of Annex V, the following lines are inserted in numerical order:

| Reference No                                                                                       | OTHER SPECIFICATIONS                                                                                  |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| '                                                                                                  |                                                                                                       |
| 24903                                                                                              | Syrups, hydrolysed starch, hydrogenated                                                               |
| In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC |                                                                                                       |
| (OJ L 178, 28.7.1995, p. 1) as last amended by 2004/46/EC (OJ L 114, 21.04.2004, p. 15))           |                                                                                                       |
| 43480                                                                                              | Charcoal, activated                                                                                   |
| To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for             |                                                                                                       |
| Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC ((OJ L 226, 22.9.1995,           |                                                                                                       |
| p. 1). Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)) with        |                                                                                                       |
| exception of ash content which can be up to 10 % (w/w).                                            |                                                                                                       |
| 64990                                                                                              | Maleic anhydride-styrene, copolymer, sodium salt                                                      |
| MW fraction < 1 000 is less than 0,05 % (w/w)                                                      |                                                                                                       |
| 67155                                                                                              | Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene |
| and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene                                                      |                                                                                                       |
| Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):       |                                                                                                       |
| (13-17 %).                                                                                         |                                                                                                       |
| 76845                                                                                              | Polyester of 1,4-butanediol with caprolactone                                                         |
| MW fraction < 1 000 is less than 0,05 % (w/w)                                                      |                                                                                                       |
| 76815                                                                                              | Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched      |
| C12-C22 fatty acids                                                                                |                                                                                                       |
| MW fraction < 1 000 is less than 5 % (w/w)                                                         |                                                                                                       |
| 79600                                                                                              | Polyethyleneglycol tridecyl ether phosphate                                                           |
| Polyethyleneglycol (EO                                                                             |                                                                                                       |
| ≤                                                                                                  |                                                                                                       |
| 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum                               |                                                                                                       |
| 10 % content of polyethyleneglycol (EO                                                             |                                                                                                       |
| ≤                                                                                                  |                                                                                                       |
| 11) tridecylether                                                                                  |                                                                                                       |
| '                                                                                                  |                                                                                                       |

## Annex Iv

Annex VI is amended as follows:
1. the notes (8), (14) and (16) are 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 Reference Nos 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.
(14) 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 Reference Nos 44960, 68078, 69160, 82020 and 89170.
(16) 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 Reference Nos 49595, 49600, 67520, 67515 and 83599.';
2. the following notes are added:
'(35) 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 Reference Nos 25540 and 25550.
(36) 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 Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590,
11680, 11710, 11830, 11890, 11980 and 31500.
(37) 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 Reference Nos 20020, 20080, 20110, 20140, 20170, 20890, 21010,
21100, 21130, 21190, 21280, 21340 and 21460.
(38) 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 Reference Nos 81515, 96190, 96240 and 96320 as well as of salts
(including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. The same restriction for Zn
applies to the names containing "… acid(s), salts" which appear in the lists, if the corresponding free acid(s) is (are)
not mentioned.
(39) Migration limit might be exceeded at very high temperature.
(40) 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 Reference Nos 38940 and 40020.'