EN    EN EN 
SANCO/2009/05907 
 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
 
  
Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Directive 2002/72/EC relating to plas tic materials and articles intended to 
come into contact with foodstuffs 
 
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Directive 2002/72/EC relating to plas tic 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 esta blishing 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 Directiv es 80/590/EEC and 89/109/EEC1, and in particular Article 5 (2) thereof, 
Whereas: (1) Commission Directive 2002/72/EC of 6 Augus t 2002 relating to plas tic materials and 
articles intended to come into contact with foodstuffs
 2 establishes a Community list of 
monomers and other starting substances, wh ich may be used for the manufacture of 
plastic materials and articles. Recently addi tional monomers and starting substances 
have received a favourable scientific evaluation by the European Food Safety 
Authority (‘the Authority’) and should  now be added to the existing list. 
(2) Directive 2002/72/EC also contains a Commun ity list of additives which may be used 
for the manufacture of plastic materials a nd articles. Recently additional additives 
have received a favourable scientific eval uation by the Authority and should now be 
added to the existing list. 
(3) Directive 2002/72/EC should therefore be amended accordingly. 
(4) According to Article 4(1) of Directive 2002/72/EC, the Community  list of additives 
contained in Annex III to that Directive will become a positive list from 1 January 
2010. Consequently, the titles in Annex II to that Directive shoul d no longer refer to 
an "incomplete" list of additives. 
(5) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,  
                                                 
1 OJ L 338, 13.11.2004, p. 4.  
2 OJ L 220, 15.8.2002, p. 18.     EN 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes II, III, IVa, V and VI of Directiv e 2002/72/EC are amended in accordance with 
Annexes I to V to this Regulation. 
 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 […]  Member of the Commission EN 4   EN ANNEX I  
Annex II to Directive 2002/72/ EC is amended as follows: 
(1) In section A the following lines are in serted in the table in numerical order: 
'Ref. No  CAS No  Name  Restrictions and/or specifications  
(1) (2) (3) (4) 
14627 0000117-21-5 3-chlorophthalic anhydride SML = 0,05 mg/kg expressed as 3-chlorophthalic 
acid 
14628 0000118-45-6 4-chlorophthalic anhydride SML = 0,05 mg/kg expressed as 4-chlorophthalic 
acid 
14876 0001076-97-7 1,4-cyclohexanedicarboxylic 
acid SML = 5 mg/kg 
Only to be used for manufacture of polyesters 
18117 0000079-14-1 glycolic acid For indirect food contact only, behind a 
polyethylene terephthalate (PET) layer 
19965 0006915-15-7 malic acid Only to be used as a co-monomer in aliphatic 
polyesters up to maximum level of 1 % on a 
molar basis  
21498 0002530-85-0 [3-
(methacryloxy)propyl]trimetho
xysilane SML = 0,05 mg/kg 
Only to be used as a surface treatment agent of 
inorganic fillers' EN 5   EN ANNEX II  
Annex III to Directive 2002/72/EC is amended as follows: 
(1) The word "incomplete" is deleted from the general title of Annex III as well as from 
the titles of Sections A and B. 
(2) In section A the following lines are inserted in numerical order: 
'Ref. No  CAS No  Name  Restrictions and/or specifications  
(1) (2) (3) (4) 
30607 — acids, C 2-C24, aliphatic, linear, 
monocarboxylic, from natural 
oils and fats, lithium salt SML(T) = 0,6 mg/kg (expressed as Lithium) (8) 
33105 0146340-15-0 alcohols, C12-14 secondary, β-
(2-hydroxyethoxy), ethoxylatedSML = 5 mg/kg (44) 
 
33535 0152261-33-1 α-alkenes(C 20-C24) maleic 
anhydride-4-amino-2,2,6,6-
tetramethylpiperidine, polymer Not to be used for articles in contact with fatty 
foods for which simulant D is laid down 
Not to be used in contact with alcoholic foods 
38550 0882073-43-0 bis(4-
propylbenzylidene)propylsorbit
ol SML = 5 mg/kg (including the sum of its 
hydrolysis products) 
40155 0124172-53-8 N,N'-bis(2,2,6,6-tetramethyl-4-
piperidyl)-N,N'-
diformylhexamethylenediamineSML = 0,05 mg/kg (1) (44) 
 
49080 0852282-89-4 N-(2,6-Diisopropylphenyl)-6-
[4-(1,1,3,3-
tetramethylbutyl)phenoxy]-1H-
benzo[de]isoquinolin-1,3(2H)-
dione SML = 0,05 mg/kg (39)  (45)  (46)   
Only for use in polyethy lene terephthalate (PET) 
 
60027 — hydrogenated homopolymers 
and/or copolymers made of 1-
hexene and/or 1-octene and/or 
1-decene and/or 1-dodecene 
and/or 1-tetradecene (Mw: 440-
12000) Not to be used for articles in contact with fatty 
foods for which simulant D is laid down. 
In compliance with the specification laid down in 
Annex V 
62215 0007439-89-6 iron SML = 48 mg/kg  
68119 - neopentyl glycol, diesters and 
monoesters with benzoic acid 
and 2-ethylhexanoic acid SML = 5 mg/kg  
Not to be used for articles in contact with fatty 
foods for which simulant D is laid down.   
72141 0018600-59-4 2,2’-(1,4-phenylene)bis[4H-
3,1-benzoxazin-4-one] SML = 0,05 mg/kg (including the sum of its 
hydrolysis products) EN 6   EN 'Ref. No  CAS No  Name  Restrictions and/or specifications  
76807 00073018-26-5 polyester of adipic acid with 
1,3-butanediol, 1,2- propanediol 
and 2-ethyl-1-hexanol SML = 30 mg/kg  
77708 — polyethyleneglycol (EO = 1-50) 
ethers of linear and branched 
primary (C 8 - C 22) alcohols SML = 1,8 mg/kg 
In compliance with the specification laid down in 
Annex V 
80077 0068441-17-8 polyethylene waxes, oxidised SML = 60 mg/kg 
80350 0124578-12-7 poly(12-hydroxystearic acid)-
polyethyleneimine copolymer Only to be used in polyethylene terephthalate 
(PET), polystyrene (PS), high impact polystyrene 
(HIPS) and polyamide (PA) up to 0,1% w/w. 
In compliance with the specification laid down in 
Annex V 
80480 0090751-07-8; 
0082451-48-7 poly(6-morpholino-1,3,5-
triazine-2,4-diyl)-[(2,2,6,6-
tetramethyl-4- 
piperidyl)imino)]-
hexamethylene-[(2,2,6,6-
tetramethyl-4- 
piperidyl)imino)] SML = 5 mg/kg (47) 
In compliance with the specification laid down in 
Annex V 
80510 1010121-89-7 poly(3-nonyl-1,1-dioxo-1-
thiopropane-1,3-diyl)-block-
poly(x-oleyl-7-hydroxy-1,5-
diiminooctane-1,8-diyl), 
process mixture with x=1 and/ 
or 5, neutralised with 
dodecylbenzenesulfonic acid Only to be used as a polymerisation production 
aid in polyethylene (PE),  polypropylene (PP) and 
polystyrene (PS) 
91530 — sulphosuccinic acid, alkyl (C 4-
C20) or cyclohexyl diesters,
salts SML = 5 mg/kg 
91815 — sulphosuccinic acid monoalkyl 
(C10-C16) polyethyleneglycol 
esters, salts SML = 2 mg/kg 
92200 0006422-86-2 terephthalic acid, bis(2-
ethylhexyl)ester SML = 60 mg/kg  
92470 0106990-43-6 N,N’,N’’,N’’-tetrakis(4,6-
bis(N-butyl-(N-methyl-2,2,6,6-
tetramethylpiperidin-4-
yl)amino)triazin-2-yl)-4,7-
diazadecane-1,10- 
diamine SML = 0,05 mg/kg 
92475 0203255-81-6 3,3’,5,5’-tetrakis(tert-butyl)-
2,2’-dihydroxybiphenyl, cyclic SML= 5 mg/kg (expressed as the sum of 
phosphite and phosphate form of the substance EN 7   EN 'Ref. No  CAS No  Name  Restrictions and/or specifications  
ester 
with [3-(3-tert-butyl-4-
hydroxy-5- 
methylphenyl)propyl]oxyphosp
honous acid and the hydrolysis products) 
93450 — titanium dioxide, coated with a 
copolymer of n-
octyltrichlorosilane and 
[aminotris(methylenephosphoni
c acid), penta sodium salt] In compliance with the specification laid down in 
Annex V  
94000 0000102-71-6 triethanolamine SML = 0,05 mg/kg  (including the hydrochloride 
adduct) 
94425 0000867-13-0 triethyl phosphonoacetate Only for use in polyethy lene terephthalate (PET) 
94985 - trimethylolpropane, mixed 
triesters and diesters with 
benzoic acid and 2-
ethylhexanoic acid  SML = 5mg/kg 
Not to be used for articles in contact with fatty 
food for which simulant D is laid down' EN 8   EN ANNEX III  
Annex IVa to Directive 2002/72/EC is amended as follows: 
(1) The following lines are inserted in numerical order: 
'REF. No  CAS No NAME 
49080 852282-89-4 N-(2,6-Diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-
benzo[de]isoquinolin-1,3(2H)-dione 
72141 0018600-59-4 2,2’-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] 
76807 0007308-26-5 polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-
hexanol 
92475 0203255-81-6 3,3’,5,5’-tetrakis(tert-butyl)-2,2’-dihydroxybiphenyl, cyclic ester 
with [3-(3-tert-butyl-4-hydroxy-5- 
methylphenyl)propyl]oxyphosphonous acid' EN 9   EN ANNEX IV  
Annex V to Directive 2002/72/EC is amended as follows: 
(1) In Part B of Annex V, the following lines are inserted in numerical order: 
‘Ref. No OTHER SPECIFICATIONS 
60027 hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-
decene and/or 1-dodecene and/or 1-tetradecene (M w: 440-12000) 
Average molecular weight not less than 440 Da 
Viscosity at 100 °C. Not less than 3,8 cSt (3,8 x 10-6 m2/s) 
77708 polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C 8 - C 22) alcohols 
Maximum residual quantity of ethylene oxide in the material or article = 1 mg/kg  
80350 poly(12-hydroxystearic acid)-polyethyleneimine copolymer 
Prepared by the reaction of poly(12-hydr oxystearic acid) with  polyethyleneimine 
80480 poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]-
hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] 
Average molecular weight not less than 2400 Da  
Residual content of morpholine ≤30 mg/kg, of N,N’-bis(2,2,6,6-tetramethylpiperidin-4-
yl)hexane-1,6-diamine <15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤20 
mg/kg  
93450 titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and 
[aminotris(methylenephosphonic acid), penta sodium salt] 
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % 
w/w' EN 10   EN  
ANNEX V  
Annex VI to Directive 2002/72/EC is amended as follows: 
1. The 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 fo llowing substances mentioned as Ref. Nos: 
24886, 62020, 30607, 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.' 
2. The following notes are added: 
'(44) The SML could be exceeded from polyolefins. (45) The SML could be exceeded from plas tics containing more  than 0,5 % w/w of 
the substance. 
(46) The SML could be exceeded in contact with foods with high alcoholic content. 
(47) The SML could be exceeded from lo w-density polyethylene (LDPE) containing 
more than 0,3 % w/w of the substance when in contact with fatty foods.'