32005L0079

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Document 32005L0079

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)

SL L 302, 19.11.2005, p. 35–45 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
SL L 321M, 21.11.2006, p. 163–173 (MT)

(BG, RO)
⏵Ovaj dokument objavljen je u određenim posebnim izdanjima (BG, RO)
Posebno izdanje na bugarskom jeziku: Poglavlje 13 Svezak 049 Str. 218 - 228
Posebno izdanje na rumunjskom jeziku: Poglavlje 13 Svezak 049 Str. 218 - 228

Legal status of the document No longer in force, Date of end of validity: 30/04/2011; Implicitno stavljeno izvan snage 32011R0010

ELI: http://data.europa.eu/eli/dir/2005/79/oj

Date of document:: 18/11/2005
Date of effect:: 09/12/2005; Stupanje na snagu Datum objavljivanja + 20 Vidi čl. 4
Date of transposition:: 19/11/2006; Najkasnije Vidi čl. 3.1
Date of end of validity:: 30/04/2011; Implicitno stavljeno izvan snage 32011R0010

Author:: Europska komisija
Form:: Direktiva
Addressee:: Dvadeset pet država članica: Belgija, Češka, Danska, Njemačka, Estonija, Irska, Grčka, Španjolska, Francuska, Italija, Cipar, Latvija, Litva, Luksemburg, Mađarska, Malta, Nizozemska, Austrija, Poljska, Portugal, Slovenija, Slovačka, Finska, Švedska, Ujedinjena Kraljevina
Additional information:: Direktiva o izmjeni, Značajno za EGP, Prošireno na EGP 22006D0045
Authentic language:: španjolski, češki, danski, njemački, estonski, grčki, engleski, francuski, talijanski, latvijski, litavski, mađarski, malteški, nizozemski, poljski, portugalski, slovački, slovenski, finski, švedski, islandski, norveški

Treaty:

Ugovor o osnivanju Europske zajednice

Legal basis:

32004R1935 - A05P2

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Modifies:

Relation	Act	Comment	Subdivision concerned	From
Modifies	32002L0072	Izmjena	prilog 3	09/12/2005
Modifies	32002L0072	Izmjena	prilog 2	09/12/2005
Modifies	32002L0072	Izmjena	prilog 1	09/12/2005
Modifies	32002L0072	Izmjena	prilog 6	09/12/2005
Modifies	32002L0072	Izmjena	prilog 5	09/12/2005

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13.30.14.00 Industrijska politika i unutarnje tržište / Unutarnje tržište: usklađivanje prava / Hrana

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Official Journal

19.11.2005

Official Journal of the European Union

L 302/35

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:

Article 1

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

Article 2

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).

Article 3

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.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 18 November 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1) OJ L 338, 13.11.2004, p. 4.

(2) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2004/19/EC (OJ L 71, 10.3.2004, p. 8).

(3) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(4) OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(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).

ANNEX I

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

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.’;

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 anti-stick 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’

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:

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.’;

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
31542	174254-23-0	Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	QM = 0,5 % (w/w) in FP
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
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)	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
76415	019455-79-9	Pimelic acid, calcium salt
76815	—	Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids	In compliance with the specifications laid down in Annex V
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 dipolyhydroxystearate
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)
81760	—	Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron	SML(T) = 5 mg/kg (7) (expressed as Copper)
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’

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-tert-butylphenyl) 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-sodium-fluoride 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)
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 mercaptoacetate)	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)
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)’

(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:

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.’;

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.’

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