SEITE 1 VON 107  
 
 
COURTESY TRANSLATION 
 
Twenty-First Ordinance 
amending the Consumer Goods Ordinance ( Bedarfsgegenständeverordnung)*) 
 
of … 2016 
 
The Federal Ministry of Food and Agricultu re hereby issues on the following basis: 
 - Article 31(2) Clause 1 Item 2, Food and Feed  Act (LFGB), in the ve rsion stated in the 
Notice of 3 June 2013 (Federal Law Gazette I, p. 1426) and 
 - Article 32(1) Items 1, 2, 4 b) and Item 5, also in connection with Articl e 4(2) Item 2 of the 
Food and Feed Act (LFGB), in the version stated in the Notice of 3 June 2013 (Federal Law Gazette I, p. 1426), last amended by means of   Article 67 of the Ordinance of 31 Au-
gust 2015 (Federal Law Gazette I, p. 1474), in agreement with the Federal Ministry for 
Economic Affairs and Energy: 
 
           
*)  Notification given in accordan ce with Directive  (EU) 2015/1535 of the European  Parliament and of the Council of 9 September 2015 
laying down a procedure for the provision of information in the fi eld of technical  regulations and of rules on Information Soc iety services 
(Official Journal of the European Union, L 241, 17.9.2015, p.1)  
 
 
 SEITE 2 VON 107 
 Article 1 
 The Consumer Goods Ordinance   in the version stated in the Notice of 23 December 1997 
(Federal Law Gazette 1998 I, p. 5), last amended by means of  the Ordinance of 24 June 2013 
(Federal Law Gazette I, p. 1682), shall be amended as follows: 
 1. Article 2 shall be amended as follows: 
 
a) The wording hitherto in use shall be amended as follows: 
 
aa) In Item 6, the full stop sha ll be replaced by a semi-colon. 
 bb) The following Items, 7 to 12, shall be added: 
 
"7. Printing inks: Printing i nks or printing varnishes, applied onto food contact 
materials and articles in a printi ng process or varnishing process; 
 
8. printed food contact materials and artic les: food contact materials and arti-
cles produced by means of  use of printing inks; 
 
9. Nanomaterials: Material s in printing inks,  
 
a) which are of natural origin and either  emerge in manufacturing processes 
or are manufactured in a targeted way, 
  b) which contain the particles in an unbound state, as an aggregate, or as an 
agglomerate, and 
 
c) with regard to which at least 50 per ce nt of the particles, in relation to 
the number size distribution, have one or more external dimension in the range from 1 to 100 nanometres;  
 
10. Particle: a very small piece of a su bstance, with defined physical bounda-
ries; 
 11. Agglomerate: a colle ction of weakly bound particle s or aggregates in which 
the resulting surface area is  similar to the sum of th e surface areas of the in-
dividual components; 
 SEITE 3 VON 107 
 12. Aggregate: a particle comprising of  strongly bound or fused particles." 
 
b) The following sentences shall be added: 
 
"Preparations used to dye food contact materi als and articles and al so decorative inks 
for ceramic food contact materials and articl es, applied in a com bustion process, shall 
not constitute printing inks as  defined by Clause 1 Item 7. Fullerenes, graphene flakes 
and single wall carbon nanotubes with one or more external dimensions below 1 nm 
shall also constitute nanomaterials as defined by Clause 1 Item 9." 
 2. The following Paragraphs, 5 to 10, shall be added to Article 4: 
 "(5) With regard to the commer cial manufacture of printed food contact materials and articles, 
subject to Paragraphs 7 to 9, it is solely  
1. Polymers obtained from monomers or other st arting substances stated in Annex 14 Table 1  
and  
2. the substances stated in Annex 14 Table 1, as monomers or other star ting substances, or as 
colourants, solvents, photoini tiators or other additives  
that shall be permitted to be used.   The substances shall be permitted to be used onl y if they correspond to the other restrictions, 
specifications and purity require ments established in Annex 14 Table 1 Column 8. If no purity 
requirements are stipulated, the substances sha ll be of good technical qua lity with regard to 
the purity requirements. Substances in the form of nanomaterials shall not be permitted to be 
used unless explicit provision is made for this  in Annex 14 Table 1 Column 8. Apart from the 
acids, phenols and alcohols named in Annex 14 Table 1, it shall also be permitted for their salts to be used, including th e double salts and acid salts, of  aluminium, ammonium, barium, 
calcium, iron, potassium, cobalt, copper, lithium,  magnesium, manganese, sodium and zinc. If 
Annex 14 Table 1 names salts of acids, phenols or al cohols, it shall solely be these salts that it 
is permissible to use, and also the salts, in cluding the double salts a nd acid salts, of alumin-
ium, ammonium, barium, calcium, iron, potassium , cobalt, copper, lith ium, magnesium, man-
ganese, sodium and zinc of th ese acids, phenols or alcohols.  
 
(6) Subject to Paragraphs 7, 8 and 10, it shall so lely be permitted to use as additives those 
monomers or other starting substa nces stated in Annex 14 Table 1, and to use as monomers or 
other starting substances those ad ditives stated in Annex 14 Tabl e 1, provided that they corre-
spond to the other restrictions, specifications and purity requirements stipulated in Annex 14 
Table 1 Column 8. 
 SEITE 4 VON 107 
 (7) Provided that the printing i nks are not intended to come into contact with the food di-
rectly, by derogation from Paragraphs 5 and 6 th e following shall be permitted to be used in 
printing inks for the commercial manufacture of  printed food contact materials and articles: 
1.  Polymers obtained from monomers or other starting substances other than those stated in 
Annex 14 Table 1, and  
2.  Substances other than those stated in Annex 14 Table 1, used  as monomers or other start-
ing substances, or as col ourants, solvents, photoinitiat ors or other additives.  
In addition, the substances as defi ned in Clause 1 shall solely be permitted to be used if they 
are not classified as "mutagenic ", "carcinogenic" or "toxic for reproduction", as defined in the 
requirements in Annex I, Sections 3.5, 3.6 and 3.7 of Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council of 16 December 2008 on classification, labelling and 
packaging of substances and mixtures, am ending and repealing Directive 67/548/EEC and 
Directive 1999/45/EC, and amendi ng Regulation (EC) No 1907/2006 (Official Journal (OJ) of 
the European Union, L 353 of 31.12.2008, p. 1). Substa nces as defined in Clause 1 shall also 
be those in the form of nanomaterials. Clause 1 shall not apply to prin ted food contact materi-
als and articles for which it is foreseeable that  the printing inks directly come into contact 
with foods although they ar e not intended to do so. 
  (8) In addition, in the commercial manufacture of  printed food contact materials and articles 
it shall be permitted to use monomers or other starting substances or additives in the printing inks, provided that they: 
1. are listed in the respective valid vers ion of Annex I of Commission Regulation 
(EU) No 10/2011 of 14 January 2011 on plasti c materials and articles intended to 
come into contact with food (OJ of the European Union, L 12, 15.01.2011, p. 1) without group restrictions according to th e corresponding Table 1 Column 9 of that 
document, or without restrictions and specifications according to the corresponding 
Table 1 Column 10 of that document,  
2. correspond to the general requirements acco rding to Article 8 of Regulation (EU) 
No 10/2011 in the version valid on [ to be inserted: date of the latest Regulation 
amending (EU) No 10/2011 ] and 
 
3. , in relation to the printed food contact mate rial and article, co mply with the limits 
for the transfer onto food stated in Anne x I Table 1 Column 8 of Regulation (EU) 
No 10/2011, in its respective va lid version, or Article 11(2) of Regulation (EU) No 
10/2011 in the version valid on [ to be inserted: date of  the latest Regulation 
amending Regulation (EU) No 10/2011 ].  
 Paragraph 5 Clause 5 shall apply accordingly. SEITE 5 VON 107 
  
(9) By derogation from Paragraph 5 Clause 1, in printing on food contac t materials and arti-
cles referred to in Article 4(7) Clause 4, it shall also be permitted to use the pigments named in Annex 14 Table 2, according to the conditions , specifications and pur ity requirements stip-
ulated there. Paragraph 5 Clau se 3 shall apply accordingly.  
 
(10) The Paragraphs 5 to 9 shall not apply for any printed food contact materials and articles 
with regard to which it is ruled out that there wi ll be a transfer of subs tances from the printing 
ink to the food, including such substan ces in the form of nanomaterials." 
 3. The following Paragraphs, 5 to 7, shall be added to Article 8: 
 "(5) With regard to printed food contact material s and articles, the substa nces listed in Annex 
14 Tables 1 and 2 shall not be permitted to ex ceed the respective limits for the transfer onto 
foods, stated for them in Column 6 or 7 in connection with Annex 14 Table 3. Transfers of 
barium, iron, cobalt, copper, lithium, manganese  and zinc and also of primary aromatic 
amines shall not be permitted to exceed the re spective limits stipulated in Annex 14 Table 4. 
 
(6) For substances stated in Annex 14 Tabl e 1, for which Annex 14 Table 1 or 3 does not 
specify a specific migration limit, group restriction or any other restrictio ns, it shall solely be 
permitted for a maximum limit of 60 milligrams per kilogram respectively to be transferred onto food from printed food cont act materials and articles. 
 
(7) With regard to printed food contact material s and articles, a detect able transfer of sub-
stances from printing inks, used according to Article 4(7), shall not be permitted. For sub-stances other than those in the form of nanomaterials, a tran sfer of up to 0,01 milligrams per 
kilogram of food shall be d eemed to be non-detectable." 
 4. In Article 12 (2) Item 3  the word "a" is repl aced by the words "or (5) Clause 1, 2 or 4 a in 
that context mentioned".  
 
5. The following Paragraphs, namely 15, 16, 17 and 18, shall be added to Article 16: 
 "(15) Printed food contact materi als or articles placed on the market according to the rules 
valid until the [ to be inserted: the last day of the twenty-fourth ca lendar month that follows 
the announcement of this Ordinance ] shall also still be permitted to be placed on the market 
after this date, according to these rules, until the stocks have been sold.  SEITE 6 VON 107 
 (16) Article 2 Clause 1 Items 7 to  12, Clauses 2 and 3; Article 4(5)  to (9); Article 8(5) to (7); 
and Article 12(2) Item 3: these shall be applied starting on the [ to be inserted: first day of the 
twenty-fifth calendar month followin g the announcement of this Ordinance] ."  
 (17) Food contact materials as specified in Ar ticle 4(7) Clause 4, pr inted by using pigments 
listed in Annex 14 Table 2, and placed on the market market according to the rules valid until the [to be inserted: last day of  the forty-eight calendar m onth following the announcement of 
this Ordinance] shall also still be permitted to be placed  on the market after this date, accord-
ing to these rules, until th e stocks have been sold. 
 (18) Article 4(9), in connection with Annex 14 Table 2, shall no longer be applied from the 
[to be inserted: the last day of the forty-eighth calendar m onth following the announcement of 
this Ordinance ]."  
 6. After Annex 13, the following shall be added - Annex 14: 
 "Annex 14   
 The subsequent Tables, 1 and 2, shal l contain the following information: 
 Column 1 (substance name): Chemical name  Column 2 (CAS No.): Chemi cal Abstract Service number 
 Column 3 (REF No.): EEC packag ing material reference number 
 Column 4 (substance No.): Substance number  Column 5 (purpose of use): Use as -  I:  Monomers or other starting substances (substances that are polymerised to manufac-
ture macromolecules (polymers) or that ar e used to modify natural or artificially-
manufactured macromolecules (polymers); 
- II:  Colourants (colouring substa nces (pigments and colourings)); 
- III:  Solvents (fluids capable of dissolving other substances without chemically changing  
either themselves or the dissolv ed substance in the process); 
- IV: Additives (substances used in order to a ttain a technical effect during the process of 
printing or varnishing or in the end-product.  This does not include additives used for 
pigments); SEITE 7 VON 107 
 V: Photoinitiators (additives which, by being exposed to irradiation, are transferred into 
free radicals or ions and which start a chemical reaction). 
 Column 6  (SML [mg/kg]): Specific migration li mit, stated in milligrams of the substance 
affected per kilogram of food. If  "ND" is indicated, a detectable  transfer of the substance onto 
foods shall not be permitted. A transfer of up to 0,01 milligrams per kil ogram of food shall be 
deemed to be a non-detectable transfer.  Column 7 (group limit no.): Number of the substance group for which a group restriction is stipulated in Table 3.  Column 8 (other restrictions, sp ecifications and purity requireme nts): Restrictions other than 
those stated in Columns 6 and 7 in connection w ith Table 3, and also specifications and purity 
requirements. 
 
 
 SEITE 8 VON 107                         
 
 Table 1:  List of monomers or other starting substances, colo urants, solvents, photoinitia tors or other additives  
(related to Article 4 (5), (6) and (7 ), Article 8 (5) clause 1 and (6)) 
 
1 2 3 4 5 6 7 8 
intended use Substance name CAS-No REF-No Sub-
stance-
No I II III IV V SML 
[mg/kg] Group restricti-
on No Restrictions, specifications and 
purity requirements 
acetaldehyde 0000075-
07-0 10060 1 x         6     
acrylic acid, ester with tri-
methylethanolammonium chloride 0044992-
01-0   2 x         0,05     
acrylic acid 0000079-
10-7 10690 3 x     x     (20)   
acrylic acid, dicyclopenta-
dienyl ester 0050976-
02-8 11000 4 x         0,05     
adipic acid, dimethyl ester 0000627-
93-0   5     x     3     
polyester of adipic acid with 
1,3-butanediol 0024937-
93-7 76780 6       x     (28) 
(29)   
α-alkenes(C20-C24) co-
polymer with maleic anhy-dride, reaction product with 4-amino-2,2,6,6-0152261-
33-1 33535 7       x       Not to be used for articles in con-
tact with fatty foods for which simulant D is laid down. Not to be used in contact with SEITE 9 VON 107 
 tetramethylpiperidine alcoholic foods. 
alkyl(C10-C21)sulphonic 
acid, esters with phenol 0091082-
17-6 34240 8       x   0,05     
Food Red 17 (E 129) 0025956-
17-6   9   x             
amines, bis(hydrogenated 
tallow alkyl) oxidised 0143925-
92-2 34850 10       x       Not to be used for articles in con-
tact with fatty foods for which simulant D is laid down. Only to be used in: (a)  polyolefins at 0,1 % (w/w) concentration and in (b)  PET at 0,25 % (w/w) concen-tration. 
2-aminobenzamide 0000088-
68-6 34895 11       x   0,05     
2-aminoethanol 0000141-
43-5 12763 
35170 12 x     x   0,05     
N-(2-
aminoethyl)ethanolamine 0000111-
41-1 35284 13 x     x   0,05     
1-propanol, 2-amino-2-
methyl- 0000124-
68-5   14 x   x x   5     
3-aminopropyltriethoxysilane 0000919-
30-2 12786 15 x     x   0,05     
antimony trioxide 0001309- 35760 16       x   0,04   SML expressed as antimony SEITE 10 VON 107 
 64-4 
malic acid 0006915-
15-7 19965 
65020 17 x     x         
azelaic acid, bis(2-
ethylhexyl) ester 0000103-
24-2   18       x   0,05     
barium tetraborate 0012007-
55-5 36840 19       x     (14)   
1,2-benzisothiazolin-3-one 0002634-
33-5 37520 20       x   0,5     
pyromellitic acid 0000089-
05-4 24055 21 x         0,05   For the sum of pyromellitic acid 
und pyromellitic acid anhydride (CAS-No. 0000089-32-7) the transfer into food  shall not exceed 
0.05 mg/kg. 
1,2,4-benzenetricarboxylic acid, tris(decyl) ester 0004130-
35-2   22       x   0,05     
1,2,4-benzenetricarboxylic 
acid, tris(2-ethylhexyl) ester 0003319-
31-1   23     x     0,05     
phenol, 2-(2H-benzotriazol-
2-yl)-6-dodecyl-4-methyl-, branched and linear 0125304-
04-3   24       x   5     
acrylic acid, benzyl ester 0002495-
35-4 10750 25 x           (20)   
methacrylic acid, benzyl 0002495- 20080 26 x           (21)   SEITE 11 VON 107 
 ester 37-6 
cis-endo-
bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts   38507 27       x   5   Not to be used in direct contact 
with acidic foods. Purity ≥ 96 %. 
phosphorous acid, bis(2,4-di-
tert-butyl-6-methylphenyl) ethyl ester 0145650-
60-8 74010 28       x   5   expressed as sum of phosphite 
and phosphate 
bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite 0080693-
00-1 38810 29       x   5   expressed as sum of phosphite 
and phosphate 
bis(2,4-dicumylphe-nyl)pentaerythritol-diphosphite 0154862-
43-8 38840 30       x   5   expressed as sum of the substance 
itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol) 
bis(2,6-diisopropylphenyl) carbodiimide 0002162-
74-5 13303 31       x   0,05   Expressed as the sum of bis(2,6-
diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline 
2,4-bis(dodecylthiomethyl)-6-methylphenol 0110675-
26-8 38940 33       x     (22)   
adipic acid, bis(2-ethylhexyl) 
ester 0000103-
23-1 31920 34 x     x   18 (29)   
terephthalic acid, bis(2- 0006422- 92200 35       x   60 (29)   SEITE 12 VON 107 
 ethylhexyl)ester 86-2 
N,N-bis(2-
hydroxyethyl)alkyl(C8-C18)amine   39090 36       x     (5)   
N,N-bis(2-
hydroxyethyl)alkyl(C8-C18)amine hydrochlorides   39120 37       x     (5) expressed excluding HCl 
hydantoin, 1,3-
bis(hydroxymethyl)-5,5-dimethyl- 0006440-
58-0   39       x   0,05     
bis(2-
hydroxyphenyl)methane bis(2,3-epoxypropyl) ether 0054208-
63-8 12974 40 x             according to Regulation (EC) No 
1895/2005 
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether 0001675-
54-3 13510 
13610 41 x     x       In compliance with Commission 
Regulation (EC) No 1895/2005 (1) 
2,2-bis(4-hydroxyphenyl)propane bis(2-hydroxypropyl) ether 0000116-
37-0 13520 42 x         0,05     
2,4-bis(octylthiomethyl)-6-
methylphenol 0110553-
27-0 40020 43       x     (22)   
1-piperidinyloxy, 4,4'-[1,10-
dioxo-1,10-dec-0002516-
92-9   44       x   0,05     SEITE 13 VON 107 
 anediyl)bis(oxy)]bis[2,2,6,6-
tetramethyl]- 
boron nitride 0010043-
11-5 40400 45       x     (14)   
boric acid 0010043-
35-3 13620 
40320 46 x     x     (14)   
Food Brown 3 (E 155) 0004553-
89-3   47   x             
Food Black 1 (E 151) 0002519-
30-4   48   x             
1,3-propanediol, 2-bromo-2-
nitro- 0000052-
51-7   49       x   0,05     
butadiene 0000106-
99-0 13630 50 x         NN   1 mg/kg in final product 
1,4-butanediol 0000110-
63-4 13720 
40580 51     x x     (27)   
1,4-butanediol bis(2,3-
epoxypropyl)ether 0002425-
79-8 13780 52 x         NN   1 mg/kg in final product (ex-
pressed as epoxygroup, Molecular weight = 43 Da) 
2-butanol 0000078-
92-2   53     x     1    
tert-butanol 0000075-
65-0 13845 
40594 54     x     10     
2-butanone 0000078- 21827 55     x     5     SEITE 14 VON 107 
 93-3 66655 
1,2-propylene glycol 1-
monobutyl ether 0005131-
66-8   56     x     0,05     
propanol, 1(or 2)-butoxy- 0029387-
86-8   57     x     0,05     
acrylic acid, n-butyl ester 0000141-
32-2 10780 58 x           (20)   
acrylic acid, sec-bu tyl ester 0002998-
08-5 10810 59 x           (20)   
acrylic acid, tert-butyl ester 0001663-
39-4 10840 60 x           (20)   
tert-butyl-hydroquinone 
(TBHQ)  0001948-
33-0   61 x     x   42     
methacrylic acid, butyl ester 0000097-
88-1 20110 62 x           (21)   
methacrylic acid, tert-butyl 
ester 0000585-
07-9 20170 63 x           (21)   
phenol, m-tert-butyl- 0000585-
34-2   64 x         0,05     
caprolactam 0000105-
60-2 14200 
41840 65 x     x   15     
caprolacton e 0000502-
44-3 14260 66 x           (26)   
carbonyl chloride 0000075- 14380 67 x         NN   1 mg/kg in final product SEITE 15 VON 107 
 44-5 23155 
cellulose acetate pr opionate 0009004-
39-1 14512 68 x               
p-chloro-m-cresol 0000059-
50-7   69       x   5     
5-chloro-2-methyl-2H-
isothiazol-3-one, mixture with 2-methyl-2H-isothiazol-3-one (3:1) 0055965-
84-9 43730 70       x   0,15     
coumarin 0000091-
64-5   71 x         0,6     
1,4-cyclohexanedicarboxylic 
acid 0001076-
97-7 14876 72 x         5     
1,2-cyclohexanedicarboxylic 
acid, diisononyl ester 0166412-
78-8 45705 73       x     (29)   
1-decene, homopolymer, 
hydrogenated   0068037-
01-4   74       x         
dextrin 0009004-
53-9   75       x         
ammonium, diallyldimethyl-, 
chloride 0007398-
69-8   76 x         5     
pentanedinitrile, 2-bromo-2-
(bromomethyl)- 0035691-
65-7   77       x   1     
sebacic acid, dibutyl ester 0000109- 85360 78       x     (29)   SEITE 16 VON 107 
 43-3 
dibutylthiostannoic acid 
polymer 0026427-
07-6 47210 79       x       Molecular unit = (C8H18S3Sn2)n 
(n = 1,5-2) 
3(2H)-isothiazolone, 4,5-dichloro-2-octyl- 0064359-
81-5   80       x   5     
dicyclohexylmethane-4,4 ′-
diisocyanate 0005124-
30-1 13560 
15700 81 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
phthalic acid, dicyclohexyl ester 0000084-
61-7   82       x   6     
dicyclopentadiene 0000077-
73-6   83 x         5     
didecyldimethylammonium 
chloride 0007173-
51-5   84       x   5     
thiodipropionic acid, didode-
cyl ester 0000123-
28-4 93120 85       x     (12)   
di-n-dodecyltin bis(isooctyl 
mercaptoacetate) 0084030-
61-5 47600 86       x     (23)   
diethanolamine 0000111-
42-2   87 x         0,3     
methacrylic acid, 2-
(diethylamino)ethyl ester 0000105-
16-8   88 x         0,05     
diethyleneglycol 0000111-
46-6 13326 
15760 47680 89 x   x x     (1)   SEITE 17 VON 107 
 ethanamine, N-ethyl-N-
hydroxy- 0003710-
84-7   90 x     x   0,05     
ethanol, 2-(diethylamino)- 0000100-
37-8   91       x   0,05     
2,4-dihydroxybenzophenone 0000131-
56-6 48640 92       x     (6)   
4,4′-dihydroxybenzophenone 0000611-
99-4 15970 
48720 93       x     (6)   
2,2′-dihydroxy-4-
methoxybenzophenone 0000131-
53-3 48880 94       x     (6)   
N-(2,6-diisopropylphenyl)-6-
[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione 0852282-
89-4 49080 95       x   0,05     
acids, fatty, unsaturated 
(C18), dimers, non hydro-genated, distilled and non-distilled 0061788-
89-4 10599/
90A 
10599/
91 96 x     x     (16)   
acids, fatty, unsaturated 
(C18), dimers, hydrogenated, distilled and non-distilled 0068783-
41-5 10599/
92A 
10599/
93 97 x     x     (16)   
dimethylamine 0000124-   98 x         0,05     SEITE 18 VON 107 
 40-3 
acrylic acid, 2-
(dimethylamino)ethyl ester 0002439-
35-2   99 x         0,05     
3,3′-dimethyl-4,4 ′-
diaminodicyclohexylmethane 0006864-
37-5 16210 100 x         0,05     
3,3′-dimethyl-4,4 ′-
diisocyanatobiphenyl 0000091-
97-4 16240 101 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
2,6-dimethyl-4-heptanone 0000108-
83-8   102     x     0,05     
hydantoin, 5,5-dimethyl- 0000077-
71-4   103       x   5     
benzenemethanaminium, 
N,N-dimethyl-N-[2-[(1-oxo-2-propenyl)oxy]ethyl]-, chlo-ride 0046830-
22-2   104       x   0,05     
phthalic acid, dimethyl ester 0000131-
11-3   105       x   0,05     
polydimethylsiloxane (Mw > 
6 800 Da) 0063148-
62-9 23547 
76721 106 x             Viscosity at 25 °C not less than 
100 cSt (100 × 10-6 m2/s) 
dimethyltin bis(ethylhexyl mercaptoacetate) 0057583-
35-4 49595 107       x     (7)   
dimethyltin bis(isooctyl mer-
captoacetate) 0026636-
01-1 49600 108       x     (7)   
stannane, dimethylbis[(1- 0068928-   109       x   0,05     SEITE 19 VON 107 
 oxoneodecyl)oxy]- 76-7 
thiodipropionic acid, diocta-
decyl ester 0000693-
36-7 93280 110       x     (12)   
di-n-octyltin bis(n-alkyl(C10-
C16) mercaptoacetate)   50160 111       x     (8)   
di-n-octyltin bis(2-ethylhexyl 
maleate) 0010039-
33-5 50240 112       x     (8)   
di-n-octyltin bis(2-ethylhexyl 
mercaptoacetate) 0015571-
58-1 50320 113       x     (8)   
di-n-octyltin bis(ethyl malea-
te)   50360 114       x     (8)   
di-n-octyltin bis(isooctyl 
maleate) 0033568-
99-9 50400 115       x     (8)   
di-n-octyltin bis(isooctyl 
mercaptoacetate) 0026401-
97-8 50480 116       x     (8)   
di-n-octyltin 1,4-butanediol 
bis(mercaptoacetate)   50560 117       x     (8)   
di-n-octyltin dilaurate 0003648-
18-8 50640 118       x     (8)   
di-n-octyltin dimaleate 0015571-
60-5 50720 119       x     (8)   
di-n-octyltin dimaleate, pol-
ymers (n = 2-4)   50880 120       x     (8)   
di-n-octyltin dimaleate, es-   50800 121       x     (8)   SEITE 20 VON 107 
 terified 
di-n-octyltin ethyleneglycol 
bis(mercaptoacetate) 0069226-
44-4 50960 122       x     (8)   
di-n-octyltin thiobenzoate 2-
ethylhexyl mercaptoacetate   51120 123       x     (8)   
di-n-octyltin mer captoacetate 0015535-
79-2 51040 124       x     (8)   
diphenylmethane-2,4 ′-
diisocyanate 0005873-
54-1 16600 125 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
diphenylmethane-4,4 ′-
diisocyanate 0000101-
68-8 16630 126 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
dipropyleneglycol methyl ether acetate 0088917-
22-0   127     x     0,05     
dipropyleneglycol monome-
thyl ether 0034590-
94-8   128     x x   0,05     
dipropyleneglycol n-butyl 
ether 0029911-
28-2   129     x     0,05     
divinylbenzene 0001321-
74-0 16690 130 x         NN   expressed as the sum of divinyl-
benzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene. 
1-dodecanol 0000112-
53-8 16701 
51975 131 x               
gallic acid, dodecyl ester 0001166- 55200 132       x     (18)   SEITE 21 VON 107 
 52-5 
Natural Red 4 (E 120) 0001260-
17-9   133   x             
iron phosphide 0012751-
22-3 62245 134       x   0,05     
elaidic acid 0000112-
79-8   135       x         
epichlorohydrin 0000106-
89-8 14570 
16750 136 x         NN   1 mg/kg in final product 
trialkyl(C5-C15)acetic acid, 
2,3-epoxypropyl ester   25360 137 x         NN   1 mg/kg in final product ex-
pressed as epoxygroup. Molecular weight is 43 Da. 
petroleum hydrocarbon re-sins (hydrogenated)   72081/
10 138       x       Petroleum hydrocarbon resins, 
hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the ali-phatic, alicyclic and/or monoben-zenoidarylalkene types from dis-tillates 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-SEITE 22 VON 107 
 genation and additional process-
ing. Properties: — Viscosity at 120 °C: > 3 Pa.s, — 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, 
acetic acid, isobutyl ester 0000110-
19-0   139     x     1    
acetic acid, isopropyl ester 0000108-
21-4   140     x     0,05     
glycerides, castor-oil mono-, 
hydrogenated, acetates 0736150-
63-3 55910 141       x     (29)   
stearic acid, esters with eth-
yleneglycol   89440 142       x     (1)   
acrylic acid, ethyl ester 0000140-
88-5 11470 143 x           (20)   SEITE 23 VON 107 
 Ethylbenzene 0000100-
41-4 53255 144     x x   0,6     
ethylene carbonate 0000096-
49-1 16955 145 x         30   expressed as ethyleneglycol 
ethyleneglycol 0000107-
21-1 16990 
53650 146 x   x x     (1)   
ethyleneglycol butyl ether 
acetate 0000112-
07-2   147     x       (35)   
acrylic acid, monoester with 
ethyleneglycol 0000818-
61-1 11510 
11830 148 x           (20)   
ethyleneglycol monobutyl 
ether  0000111-
76-2 16993 149     x       (35) Only for use on the non food-
contact side. 
methacrylic acid, monoester with ethyleneglycol 0000868-
77-9 21190 150 x           (21)   
ethyleneglycol monopropyl 
ether 0002807-
30-9   152     x     0,05     
ethylene oxide 0000075-
21-8 17020 153 x         NN   1 mg/kg in final product 
2-ethylhexanoic acid 0000149-
57-5   154 x     x   0,05     
acrylic acid, acrylic acid, 2-
ethylhexyl ester, copolymer 0025134-
51-4 31500 155       x   0,05 (20) SMG expressed as acrylic acid, 2-
ethylhexyl ester 
benzoic acid, p-(dimethylamino)-, 2-0021245-
02-3   156       x x 0,05     SEITE 24 VON 107 
 ethylhexyl ester 
methacrylic acid, et hyl ester 0000097-
63-2 20890 157 x           (21)   
N-ethyl-
toluenesulphonamide (NET-SA) 0008047-
99-2   158       x   5     
ethylvanillin 0000121-
32-4 54420 159       x         
acids, fatty (C8-C22), esters 
with pentaerythritol 0085116-
93-4 31348 161     x x         
fatty acids, montan-wax, 1-
methyl-1,3-propanediyl es-ters 0073138-
44-0   162       x         
fatty acids, tallow, hydroge-
nated 0061790-
38-3 54760 163       x         
formaldehyde 0000050-
00-0 17260 
54880 164 x     x     (13)   
tannic acids 0001401-
55-4 92150 165       x       According to the JECFA specifi-
cations 
glass 0065997-
17-3   166       x         
gluconic acid lactone 0000090-
80-2   167       x         
gluconic acid 0000526-   168       x         SEITE 25 VON 107 
 95-4 
glycerides, montan-wax 0068476-
38-0   169       x         
glycerol monolaurate diace-
tate 0030899-
62-8 56800 170       x     (29)   
glycerol monoricinolate 0001323-
38-2 57440 171       x         
glycerol monostearate 0031566-
31-1 18115 
57520 172 x               
glycerol tris(12-
hydroxystearate) 0000139-
44-6 58160 173       x         
glycerol diacetate 0025395-
31-7 56000 174       x         
glycerol dioleate 0025637-
84-7 56080 175       x         
glycerol distearate 0001323-
83-7 56320 176       x         
glycerol monolaurate 0027215-
38-9 56780 177       x         
glycerol monomyristate 0027214-
38-6 56840 178       x         
glycerol monooleate 0025496-
72-4 56960 179       x         
glycerol tributyrate 0000060- 57840 180       x         SEITE 26 VON 107 
 01-5 
glycerol trilaurate 0000538-
24-9 57960 181       x         
glycolic acid 0000079-
14-1 18117 182 x     x   0,05     
glyoxal 0000107-
22-2   183 x         0,05     
1-heptanol 0000111-
70-6 18150 184 x               
silanamine, 1,1,1-trimethyl-
N-(trimethylsilyl)- 0000999-
97-3   185       x     (30)   
disiloxane, hexamethyl- 0000107-
46-0   186 x           (30)   
hexamethylene diisocyanate 0000822-
06-0 18640 187 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
hexamethylenetetramine 0000100-
97-0 18670 
59280 188 x     x     (13)   
hexanol 0000111-
27-3 18780 189     x           
hydrogenated homopolymers 
and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-  60027 190       x       Average molecular weight not 
less than 440 Da. Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s). SEITE 27 VON 107 
 tetradecene (Mw: 440–
12 000) 
3-hydroxybutanoic acid-3-hydroxypentanoic acid, co-polymer 0080181-
31-3 18888 191 x             The substance is used as product 
obtained by bacterial fermenta-tion. In compliance with the spec-ifications mentioned in the Table 4 of Annex I of Commission Regulation (EU) No 10/2011 of 14 January 2011. 
2-(2′-hydroxy-3 ′-tert-butyl-
5′-methylphenyl)-5-
chlorobenzotriazole 0003896-
11-5 60400 192       x     (10)   
2-(2′-hydroxy-3,5 ′-di-tert-
butylphenyl)-5-chlorobenzotriazole 0003864-
99-1 60480 193       x     (10)   
2-hydroxy-4-n-
hexyloxybenzophenone 0003293-
97-8 61280 194       x     (6)   
2-hydroxy-4-
methoxybenzophenone 0000131-
57-7 61360 195       x     (6)   
2-(2′-hydroxy-5 ′-
methylphenyl)benzotriazole 0002440-
22-4 61440 196       x     (10)   
2-hydroxy-4-n-
octyloxybenzophenone 0001843-
05-6 61600 197       x     (6)   
acrylic acid, 2-hydroxypropyl 0000999- 11530 198 x         0,05   expressed as the sum of acrylic SEITE 28 VON 107 
 ester 61-1 acid, 2-hydroxypropyl ester and 
acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2). 
1-piperidinyloxy, 4-hydroxy-2,2,6,6-tetramethyl- 0002226-
96-2   199       x   0,05     
aspartic acid, N-(1,2-
dicarboxyethyl)-, tetrasodium salt 0144538-
83-0   200       x   5     
3-iodo-2-propynyl butyl 
carbamate 0055406-
53-6   201       x   9     
propane, 2-methyl-  0000075-
28-5   202 x         1     
acrylic acid, isobutyl ester 0000106-
63-8 11590 203 x           (20)   
isobutanol 0000078-
83-1   204 x   x     1     
methacrylic acid, isobutyl 
ester 0000097-
86-9 21010 205 x           (21)   
1-isocyanato-3-
isocyanatomethyl-3,5,5-0004098-
71-9 19110 206 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety SEITE 29 VON 107 
 trimethylcyclohexane 
1-Isocyanato-3-
isocyanatomethyl-3,5,5-trimethylcyclohexane ho-mopolymer, methyl ethyl ketone oxime-blocked 0103170-
26-9 19112 207 x         0,05   expressed as blocked trimer 
isophthalic acid 0000121-
91-5 19150 208 x           (25)   
isophthalic acid dichloride 0000099-
63-8 19180 209 x           (25)   
2-methyl-1,3-butadiene 0000078-
79-5 19243 
21640 210 x         NN   1 mg/kg in final product 
acrylic acid, isopropyl ester 0000689-
12-3 11680 211 x           (20)   
2-isopropyl thioxanthone 0005495-
84-1   212         x   (32)   
4-isopropyl thioxanthone 0083846-
86-0   213         x   (32)   
potassium iodide 0007681-
11-0 81680 214       x     (4)   
naphthenic acids, cobalt salts 0061789-
51-3   215       x   0,05     
fatty acids, coco, diesters 
with polyethylene glycol   0068139-
91-3   216       x         SEITE 30 VON 107 
 fatty acids, coco, hydrogena-
ted 0068938-
15-8 17175 217 x               
copper iodide 0001335-
23-5 45200 218       x     (4)   
N,N-bis(2-
hydroxyethyl)dodecanamide 0000120-
40-1 39150 219       x   5   The residual amount of dietha-
nolamine in plastics, as an impu-rity and decomposition product of the substance, should not result in a migration of diethanolamine higher than 0,3 mg/kg food. 
Food Blue 2  0003844-
45-9   220   x             
Food Red 3 0003567-
69-9   221   x             
Food Red 7 0002611-
82-7   222   x             
Food Red 9 0000915-
67-3   223   x       30     
lignosulphonic acid 0008062-
15-5 63940 224       x   0,24     
lithium iodide 0010377-
51-2 64320 225       x     (4)   
silicic acid, magnesium-
sodium-fluoride salt 0037296-
97-2 85950 226       x   0,15   SMG expressed as fluoride. 
Only to be used in layers not SEITE 31 VON 107 
 coming into direct contact with 
food. 
maleic acid 0000110-
16-7 19540 
64800 227 x     x     (2)   
maleic anhydride 0000108-
31-6 19960 228 x           (2)   
maleic anhydride-styrene, 
copolymer, sodium salt 0025736-
61-2 64990 229       x       The fraction with molecular 
weight below 1 000 Da should not exceed 0,05 % (w/w) 
maltodextrine 0009050-
36-6   230       x         
[3-
(methacrylo-xy)propyl]trimethoxysilane 0002530-
85-0 21498 231 x     x   0,05     
methacrylic acid, ester with 
trimethylethanolammonium chloride 0005039-
78-1   232 x         0,05     
methacrylic acid 0000079-
41-4 20020 233 x           (21)   
methacrylic anhydride 0000760-
93-0 21460 234 x           (21)   
1-(2-Methoxy-1-
methylethoxy)-2-propanol 0020324-
32-7   235     x     0,05     
2-propanol, 1-methoxy- 0000107-   236     x       (38) Only for use on the non food-SEITE 32 VON 107 
 98-2 contact side. 
2-propanol, 1-methoxy-, 2-
acetate 0000108-
65-6   237     x       (38) Only for use on the non food-
contact side. 
3-methyl-1,5-pentanediol 0004457-
71-0 22074 238 x         0,05     
2-methyl-2,4-pentanediol 0000107-
41-5   239     x     0,05     
acrylic acid, methyl ester 0000096-
33-3 11710 240 x           (20)   
acrylic acid, methyl ester, 
telomer with 1-dodecanethiol, C16-C18 alkyl esters 0174254-
23-0 31542 241       x       0,5 % in final product 
benzophenone, 4-methyl- 0000134-
84-9   242         x 0,05   For the sum of 4-
methylbenzophenon und benzo-phenon (CAS-No. 0000119-61-9) the transfer into food shall not exceed 0.05 mg/kg. 
acrylamide, N,N'-methylenebis- 0000110-
26-9   243 x         0,05     
2,2′-methylene bis(4-ethyl-6-
tert-butylphenol) 0000088-
24-4 66400 244       x     (11)   
2,2′-methylene bis(4-methyl-
6-tert-butylphenol) 0000119-
47-1 66480 245       x     (11)   SEITE 33 VON 107 
 2,2′-methylenebis(4-methyl-
6-cyclohexylphenol) 0004066-
02-8 66560 246       x     (3)   
2,2′-methylenebis(4-methyl-
6-(1-methylcyclohexyl)phenol) 0000077-
62-3 66580 247       x     (3)   
2-methyl-4-isothiazolin-3-
one 0002682-
20-4 66755 248       x   0,5     
methacrylic acid, methyl 
ester 0000080-
62-6 21130 249 x           (21)   
propanoic acid, 2-methyl-, 2-
methylpropyl ester 0000097-
85-8   250     x     0,05     
2-methyl-4-pentanone 0000108-
10-1 66725 251     x     5     
2-methyl-1,3-propanediol 0002163-
42-0 22190 252 x         5     
methylsilsesquioxane 0068554-
70-1 66930 253       x       Residual monomer in methyl-
silsesquioxane: < 1 mg methyl-trimethoxysilane/kg of methyl-silsesquioxane 
paraffin wax and hydrocar-bon waxes, microcristalline 0063231-
60-7   254       x       Average molecular weight not 
less than 500 Da. Viscosity not less than 1,1 × 10 – 5 m 2 s – 1 at 100 °C or: not less than 0,8 × 10 – 5 m 2 s – 1 at 120 SEITE 34 VON 107 
 °C, if solid at 100 °C. 
Carbon number at 5 % distillation point: not more than 5 % of the molecules with Carbon number less than 25 
mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate   22332 255 x     x     (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
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.   67180 256       x   5     
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   67155 258       x       Not more than 0,05 % (w/w) 
(quantity of substance used/quantity of the formulation). Mixture obtained from the manu-facturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %). 
acetylated mono- and diglyc-erides of fatty acids   30401 259       x     (29)   SEITE 35 VON 107 
 benzene, chloro- 0000108-
90-7 67280 260 x         10     
monochloroacetic acid 0000079-
11-8 22333 261 x         0,05     
mono-n-dodecyltin 
tris(isooctyl mercaptoacetate) 0067649-
65-4 67360 262       x     (23)   
monomethyltin 
tris(ethylhexyl mercaptoace-tate) 0057583-
34-3 67515 264       x     (7)   
monomethyltin tris(isooctyl 
mercaptoacetate) 0054849-
38-6 67520 265       x     (7)   
mono-n-octyltin 
tris(alkyl(C10-C16) mercap-toacetate)   67600 266       x     (9)   
mono-n-octyltin tris(2-
ethylhexyl mercaptoacetate) 0027107-
89-7 67680 267       x     (9)   
mono-n-octyltin tris(isooctyl 
mercaptoacetate) 0026401-
86-5 67760 268       x     (9)   
starch, phosphate 0011120-
02-8   269 x               
1,5-naphthalene diisocyanate 0003173-
72-6 22420 271 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
sodium aluminate 0001302-
42-7 86440 272       x   0,9     SEITE 36 VON 107 
 sodium bisulphite 0007631-
90-5 86480 273       x     (17)   
pyrosulfurous acid, disodium 
salt 0007681-
57-4   274 x           (17)   
gluconic acid, monosodium 
salt, D- 0000527-
07-1   275 x               
sodium iodide 0007681-
82-5 86800 276       x     (4)   
stearic acid, ester with lactic 
acid bimol. ester, sodium salt 0025383-
99-7   277       x         
sodium sulphite 0007757-
83-7 86960 278       x     (17)   
sodium tetraborate 0001330-
43-4 87040 279       x     (14)   
sodium thiosulphate 0007772-
98-7 87120 280       x     (17)   
neodecanoic acid, salts   68110 281       x   0,05   expressed as neodecanoic acid 
2,2′,2′-nitrilo(triethyl 
tris(3,3′,5,5′-tetra-tert-butyl-
1,1′-bi-phenyl-2,2 ′-
diyl)phosphite) 0080410-
33-9 68145 282       x   5   expressed as sum of phosphite 
and phosphate 
1-octadecanol 0000112-
92-5 22555 
68225 283 x               
octadecyl isocyanate 0000112- 22570 284 x           (15) 1 mg/kg in final product ex-SEITE 37 VON 107 
 96-9 pressed as isocyanate moiety 
acrylic acid, n-octyl ester 0002499-
59-4 11890 285     x       (20)   
gallic acid, octyl ester 0001034-
01-1 55280 286       x     (18)   
oils, orange, sweet 0008008-
57-9   287 x               
oils, lemon  0008008-
56-8   288 x               
Acid Blue 3 (E 131) 0003536-
49-0   289   x             
pentaerythritol dioleate 0025151-
96-6 71635 290       x   0,05     
fluoropolyether dicarboxy 
derivative ammonium salt 0069991-
62-4   291       x   0,05     
2,2′-(1,4-phenylene)bis[4H-
3,1-benzoxazin-4-one] 0018600-
59-4 72141 292       x   0,05   SMG including the sum of its 
hydrolysis products 
methacrylic acid, phenyl ester 0002177-
70-0 21280 293 x           (21)   
2-phenylphenol 0000090-
43-7   294       x   12     
1,2,4-butanetricarboxylic 
acid, 2-phosphono- 0037971-
36-1   295       x   5     
phosphoric anhydride 0001314- 23173 296 x               SEITE 38 VON 107 
 56-3 
fluoropolyethers ammonium 
phosphate salt 0200013-
65-6   297       x   0,05     
phosphoric acid, octadecyl 
esters 0039471-
52-8   298       x   0,05     
phthalic acid, benzyl butyl 
ester 0000085-
68-7 74560 299       x   30 (29)   
phthalic acid, bis(2-
ethylhexyl) ester 0000117-
81-7 74640 300       x   1,5 (29) Not to be used in direct contact 
with fatty foods. 
phthalic acid, dibutyl ester 0000084-
74-2 74880 301       x   0,3 (29)   
phthalic acid, diesters with 
primary, saturated C8-C10 branched alcohols, more than 60 % C9 0068515-
48-0 0028553-12-0 75100 302       x     (24) 
(29)   
phthalic acid, diesters with 
primary, saturated C9-C11 alcohols more than 90 % C10 0068515-
49-1 0026761-40-0 75105 303       x     (24) 
(29)   
Pigment Metal 1 0007429-
90-5   304   x   x         
Pigment White 5 0001345-
05-7 64400 305   x             
poly(ethylene propyl- 0061725-   306       x   0,05     SEITE 39 VON 107 
 ene)glycol tridecyl ether 89-1 
polyacrylic acid  0009003-
01-4   307       x     (20)   
polyacrylic acid, salts   76463 308       x     (20)   
polydimethylsiloxane, 3-
aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane 0661476-
41-1 76725 309       x       The fraction with molecular 
weight below 1 000 Da should not exceed 1 % (w/w) 
polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexyl-methane-4,4 ′-diisocyanate 0167883-
16-1 76723 310       x       The fraction with molecular 
weight below 1 000 Da should not exceed 1,5 % (w/w) 
polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol 0073018-
26-5 76807 311       x     (28) 
(29)   
polyester of adipic acid with 
glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids   76815 312       x     (29) The fraction with molecular 
weight below 1 000 Da should not exceed 5 % (w/w) 
polyester of 1,4-butanediol with caprolactone 0031831-
53-5 76845 313       x     (26) 
(27) The fraction with molecular 
weight below 1 000 Da should not SEITE 40 VON 107 
 exceed 0,5 % (w/w) 
polyesters of 1,2-propanediol 
and/or 1,3- and/or 1,4-butanediol and/or polypro-pyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol   76866 314       x     (28) 
(29)   
polyethylene glycol (EO = 1-
30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate   77732 315       x   0,05     
polyethyleneglycol (EO = 1-
30, typically 5) ether of bu-tyl-2-cyano-3-(4-hydroxyphenyl) acrylate   77733 316       x   0,05     
polyethyleneglycol (EO = 1-
50) ethers of linear and branched primary (C8-C22) alcohols   77708 317       x   1,8   In compliance with the purity 
criteria for ethylen e oxide as laid 
down in Directive 2008/84/EC laying down specific purity crite-ria on food additives other than colours and sweeteners (OJ L 253, 20.9.2008, p. 1) 
polyethyleneglycol (EO = 2- 0068439- 77895 318     x x   0,05   The composition of this mixture is SEITE 41 VON 107 
 6) monoalkyl (C16-C18) 
ether 49-6 as follows: 
— polyethyleneglycol (EO = 2-6)monoalkyl (C16-C18) ether (approximately 28 %), — fatty alcohols (C16-C18) (ap-proximately 48 %), — ethyleneglycol monoalkyl (C16-C18) ether (approximately 24 %), 
polyethyleneglycol dilaurate 0009005-
02-1 77280 319       x         
polyethyleneglycol dimy-
ristate   77320 320       x         
polyethyleneglycol dioleate 0009005-
07-6 77360 321       x         
polyethyleneglycol esters of 
natural fatty acids   77660 322       x         
polyethyleneglycol monolau-
rate 0009004-
81-3 78080 323       x         
polyethyleneglycol monomy-
ristate   78120 324       x         
polyethyleneglycol monoo-
leate 0009004-
96-0 78160 325       x         
polyethyleneglycol mono- 0009004- 78240 326       x         SEITE 42 VON 107 
 palmitate 94-8 
polyethyleneglycol stearate   79520 327       x         
polyethyleneglycol tridecyl 
ether phosphate 0009046-
01-9 79600 328       x   5   Polyethyleneglycol (EO ≤ 11) 
tridecyl ether phosphate (mono-and dialkyl ester) with a maxi-mum 10 % content of polyethyle-neglycol (EO ≤ 11) tridecylether. 
polyethyleneimine, butylated   79760 329       x   6     
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 1010121-
89-7 80510 330       x       Only to be used as polymer pro-
duction aid in polyethylene (PE), polypropylene (PP) and polysty-rene (PS) 
ethenol, homopolymer 0009002-
89-5   331       x         
polyvinylpyrrolidone 0009003-
39-8 81500 332       x       The substance shall meet the 
purity criteria as laid down in Commission Directive 2008/84/EC (OJ L 253, 20.9.2008, p. 1.) 
1,3-bis(3-octadecylureido)propane 0035674-
65-8 81870 333       x   0,05     SEITE 43 VON 107 
 acrylic acid, propyl ester 0000925-
60-0 11980 334 x           (20)   
carbonic acid, cyclic propyl-
ene ester 0000108-
32-7   335     x     0,05     
propylene oxide 0000075-
56-9 24010 336 x         NN   1 mg/kg in final product 
gallic acid, propyl ester 0000121-
79-9 55360 337       x     (18)   
methacrylic acid, propyl ester 0002210-
28-8 21340 338 x           (21)   
proteins, soy 0009010-
10-0   339 x               
waxes, refined, derived from 
petroleum based or synthetic hydrocarbon feedstocks, high viscosity   95859 340       x       Average molecular weight not 
less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). 
reaction product of di-tert-butylphosphonite with bi-phenyl, obtained by conden-sation of 2,4-di-tert-butylphenol with Friedel 0119345-
01-6 83595 341       x   18   Composition: 
— 4,4′-biphenylene-bis[0,0-
bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w SEITE 44 VON 107 
 Craft reaction product of 
phosphorous trichloride and biphenyl (*)), 
— 4,3′-biphenylene-bis[0,0-
bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)), — 3,3′-biphenylene-bis[0,0-
bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)), — 4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)), — tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)), — 4,4′-biphenylene-0,0-bis(2,4-
di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*)) (*)  Quantity of substance SEITE 45 VON 107 
 used/quantity of formulation 
Other specifications: — Phosphor content of min. 5,4 % to max. 5,9 %, — Acid value of max. 10 mg KOH per gram, — Melt range of 85– 110 °C, 
reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and tri-chloromethyltin 0068442-
12-6 83599 342       x     (7)   
resorcinol diglycidyl ether 0000101-
90-6 24073 343 x         NN     
castor oil, hydrogenated 0008001-
78-3 14470 
43120 344 x     x         
castor oil fatty acids, hydro-
genated 0061790-
39-4 14453 345 x               
carbon black 0001333-
86-4 42080 346   x   x       Primary particles of 10 – 300 nm 
which are aggregated to a size of 100 – 1 200 nm which may form agglomerates within the size dis-tribution of 300 nm – mm. Toluene extractables: maximum 0,1 %, determined according to SEITE 46 VON 107 
 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. 
nitric acid 0007697-
37-2 68140 347       x         
Acid Yellow 3 (Quinoline 
Yellow) 0008004-
92-0 0095193-83-2   348   x       30     
Acid Yellow 23 0001934-
21-0   349   x             
Acid Red 51 0012227-
78-0 0016423-68-0   350   x       6     
Shellac 0009000-
59-3 24440 
85550 351 x               
silicon dioxide 0007631- 86240 352   x   x       For synthetic amorphous silicon SEITE 47 VON 107 
 86-9 
0112945 -
52-5 dioxide: primary particles of 1 – 
100 nm which are aggregated to a size of 0,1 – 1 μm which may 
form agglomerates within the size distribution of 0,3 μm to the mm 
size. 
syrups, hydrolysed starch, hydrogenated 0068425-
17-2 24903 353 x             In compliance with the purity 
criteria for maltitol syrup E 965(ii) as laid down in Commis-sion Directive 2008/60/EC (5) 
soybean oil, epoxidised 0008013-
07-8 88640 354 x     x   60 (29) Oxirane < 8 %, iodine number < 
6. 
starch, oxidised 0065996-
62-5   355       x         
tallow 0061789-
97-7 92100 356       x         
tall oil 0008002-
26-4 24905 357 x     x         
terephthalic acid 0000100-
21-0 24910 358 x         7,5     
terpinolene 0000586-
62-9   359       x   0,05     
glycoluril, 1,3,4,6-
tetrakis(hydroxymethyl)- 0005395-
50-6   360       x   0,05     SEITE 48 VON 107 
 4-(1,1,3,3-
tetramethylbutyl)phenol 0000140-
66-9   361 x         NN     
2,4,7,9-tetramethyl-5-
decyne-4,7-diol 0000126-
86-3   362 x     x     (33)   
polyethyleneglycol- 2,4,7,9-
tetramethyl-5-decyn-4,7-diol ether 0009014-
85-1 79550 363       x     (34)   
thiodipropionic acid, ditetra-
decyl ester 0016545-
54-3 93360 364       x     (12)   
titanium dioxide, coated with 
a copolymer of n-octyltrichlorosilane and [ami-notris(methylenephosphonic acid), penta sodium salt]   93450 365       x       The content of the surface treat-
ment copolymer of the coated titanium dioxide is less than 1 % w/w 
toluene 0000108-
88-3 93540 366     x     1,2     
benzene, 1,3-
diisocyanatomethyl- 0026471-
62-5 25208 367 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
2,4-toluene diisocyanate 0000584-
84-9 25210 368 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
2,4-toluene diisocyanate dimer 0026747-
90-0 25270 369 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
2,6-toluene diisocyanate 0000091-
08-7 25240 370 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety SEITE 49 VON 107 
 tri-n-butyl acetyl citrate 0000077-
90-7 93760 371       x     (29)   
triethanolamine 0000102-
71-6 94000 372 x     x   0,05   SMG expressed as the sum of 
triethanolamine and the hydro-chloride adduct expressed as triethanolamine 
citric acid, triethyl ester 0000077-
93-0 44640 373       x     (29)   
methacrylic acid, diester with 
triethylene glycol 0000109-
16-0   374 x         0,05     
phosphoric acid, tris(2-
ethylhexyl) ester 0000078-
42-2   375       x   0,05     
phosphorous acid, triethyl 
ester 0000122-
52-1 23175 376 x         NN   1 mg/kg in final product 
phosphoric acid, triisobutyl 
ester 0000126-
71-6   377       x   0,05     
trimellitic acid 0000528-
44-9 13050 
25540 378 x           (19)   
trimellitic anhydride 0000552-
30-7 25550 379 x           (19)   
2,2,4-trimethylhexane-1,6-
diisocyanate 0016938-
22-0 25573 380 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety 
2,4,4-trimethylhexane-1,6-diisocyanate 0015646-
96-5 25574 381 x           (15) 1 mg/kg in final product ex-
pressed as isocyanate moiety SEITE 50 VON 107 
 2,2,4-trimethyl-1,3-
pentanediol diisobutyrate 0006846-
50-0 95020 382     x x   5     
tripropyleneglycol monome-
thyl ether 0025498-
49-1   383     x     0,05     
2,4,6-tris(tert-butyl)phenyl-2-
butyl-2-ethyl-1,3-propanediol phosphite 0161717-
32-4 95270 384       x   2   expressed as sum of phosphite, 
phosphate and the hydrolysis product TTBP 
vanillin 0000121-
33-5 95680 385       x         
vinyl acetate-
vinylpyrrolidone, copolymer 0025086-
89-9   386       x         
vinyl chloride 0000075-
01-4 26050 387 x         NN   1 mg/kg in final product 
methyl vinyl ether 0000107-
25-5   388 x         0,05     
vinylpyrrolidone 0000088-
12-0 26230 
95810 389 x         NN     
vinyltriethoxysilane 0000078-
08-0 26305 390 x         0,05     
waxes, paraffinic, refined, 
derived from petroleum based or synthetic hydrocar-bon feedstocks, low viscosity   95858 391       x   0,05   Not to be used in direct contact 
with fatty foods. - Average molecular weight not less than 350 Da. - Viscosity at 100 °C not less than SEITE 51 VON 107 
 2,5 cSt (2,5 × 10-6 m2/s). 
- Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w). 
water 0007732-
18-5 26360 
95855 392     x x       In compliance with Directive 
98/83/EC (2) 
hydrogen peroxide 0007722-
84-1   393       x         
white mineral oils, paraffinic, 
derived from petroleum based hydrocarbon feed-stocks   95883 394       x       Average molecular weight not 
less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). 
xylene 0001330-
20-7 26370 
95945 395     x     1     
tin chloride 0007772-
99-8   396       x   12     
silver chloride (20% w/w) 
coated onto titanium dioxide (80% w/w)   86430 397       x     (36)   
curcumin 0000458-
37-7   398   x             SEITE 52 VON 107 
 riboflavin 0000083-
88-5   399   x             
riboflavin-5'-phosphate 0000130-
40-5   400   x             
Orange Yellow S 0002783-
94-0 0015790-07-5   401   x             
cochineal, carminic acid, 
carmine (Natural Red 4) 0001390-
65-4   402   x             
Patent Blue V 0020262-
76-4   403   x             
indigo carmine (indigotine, 
FD&C Blue 2) 0000860-
22-0 0016521-38-3   404   x             
chlorophylls and chlorophyl-
lins: (i) Chlorophylls (ii) Chlorophyllins 0001406-
65-1   405   x             
copper complexes of chloro-
phylls and chlorophyllins (i) Copper complexes of chloro-phylls (ii) Copper complexes of chlorophyllins 0012262-
74-7   406   x             SEITE 53 VON 107 
 Green S 0003087-
16-9   407   x             
plain caramel 0008028-
89-5   408   x             
caustic sulphite caramel 0008028-
89-5   409   x             
ammonia caramel 0008028-
89-5   410   x             
sulphite ammonia caramel 0008028-
89-5   411   x             
carotenes 
i) mixed carotenes ii) Beta-carotene 0000036-
88-4   412   x             
annatto 0001393-
63-1   413   x             
bixin 0006983-
79-5   414   x             
norbixin 0000542-
40-5   415   x             
paprika extract     416   x             
capsanthin 0000465-
42-9   417   x             
capsorubin 0000470-
38-2   418   x             SEITE 54 VON 107 
 lycopene 0000502-
65-8   419   x             
Beta-apo-8'-carotenal (C 30) 0001107-
26-2   420   x             
ethyl ester of beta-apo-8'-
carotenic acid (C 30) 0001109-
11-1   421   x             
lutein 0000127-
40-2   422   x             
canthaxanthin 0000514-
78-3   423   x             
Beetroot Red 0007659-
95-2   424   x             
anthocyanins 0011029-
12-2   425   x             
silver 0007440-
22-4   426   x         (36)   
gold 0007440-
57-5   427   x             
Lithol Rubine BK 0005281-
04-9   428   x             
tocopherols (natural)     430   x             
gamma-tocopherol 0007616-
22-0   431   x             
delta-tocopherol 0000119-   432   x             SEITE 55 VON 107 
 13-1 
agar 0009002-
18-0   434       x         
carrageenan 0009000-
07-1   435       x         
processed eucheuma seaweed     436       x         
karaya gum 0009000-
36-6   437       x         
konjac gum 0037220-
17-0   438       x         
glycerol esters of wood ros-
ins 0068475-
37-6   439     x           
sucrose esters of fatty acids 0025339-
99-5   440       x         
thermally oxidized soya bean 
oil interacted with mono- and diglycerides of fatty acids     441     x           
xylitol 0000087-
99-0   442       x         
isoascorbic acid 0000089-
65-6   443       x         
cyclohexane 0000110-
82-7   444     x     1   benzene content < 0.1% (mass) 
maltitol 0000585-   445       x         SEITE 56 VON 107 
 88-6 
acetic acid, propyl ester 0000109-
60-4   446     x           
2,2-bis(4-hydroxyphenyl) 
propane, oligomeric reaction product with epichlorohydrin and acrylic acid 0055818-
57-0   447 x         0,05   Only for use on the non food-
contact side. 
glycerol propoxylated, triac-rylate 0052408-
84-1   448 x          0,05   Only for use on the non food-
contact side. 
2,5,8,11-tetramethyl-6-dodecyne-5,8-diol 0068227-
33-8   449       x     (33)   
2,4,7,9-tetramethyl-5-
decyne-4,7-dioldi(polyoxyethylen-polyoxypropylene)ether 0182211-
02-5   450       x     (34)   
1,1,1-trimethylolpropane, 
ethoxylated, triacrylate 0028961-
43-5   451 x     x   0,05   Only for use on the non food-
contact side. 
(methylamino)diethane-2,1-diylbis(4-dimethylamino amino benzoate) 0925246-
00-0   452         x 0,05   Only for use on the non food-
contact side. 
tris{4-[(4-acetyl-phenyl)sulfanyl]phenyl}sulfonium hexafluorophosphate 0953084-
13-4   453         x 0,05   SMG expressed as sum of Tris{4-
[(4-acetyl-phenyl)sulfanyl]phenyl}sulfoniuSEITE 57 VON 107 
 m hexafluorophosphate (CAS-
No.: 953084-13-4) und 1-(4-Phenylsulfanyl-phenyl)-ethanone (CAS-No.: 10169-55-8). A transfer of 1-(4-{4-[4-(4-acetyl-phenylsulfanyl)-phenylsulfanyl]-phenylsulfanyl}phenyl)-ethanon into food shall not be detectable. Only for use on the non food-contact side. 
acetic acid esters of mono- and diglycerides of fatty acids     454     x           
lactic acid esters of mono- 
and diglycerides of fatty acids     455     x           
citric acid esters of mono- 
and diglycerides of fatty acids     456     x           
mono- and diacetyl tartaric 
acid esters of mono- and diglycerides of fatty acids     457     x           
mixed acetic and tartaric acid 
esters of mono- and diglyc-erides of fatty acids     458     x           SEITE 58 VON 107 
 2-octanol 0000123-
96-6   459     x     0,05     
1,10-decanediamine 0000646-
25-3 15260 460 x         0,05     
Pigment Blue 60 0000081-
77-6   462   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 15 0000147-
14-8   463   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 15:3 0000147-
14-8   464   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 15:4 0000147-
14-8   465   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 15:6 0000147-
14-8   466   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 59 VON 107 
 Pigment Blue 15:1 0000147-
14-8 0012239-87-1   467   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 15:2 0000147-
14-8 0012239-87-1   468   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment White 18 0000471-
34-1   469   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Natural Blue 1 0000482-
89-3   470   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 16 0000574-
93-6   471   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Violet 19 0001047-
16-1   472   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 60 VON 107 
 Pigment Red 49:2 0001103-
39-5   473   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 101 0001309-
37-1   474   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Green 7 0001328-
53-6   476   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Green 37 0001330-
37-6   477   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment White 24 0001332-
73-6   478   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 4 0001657-
16-5   479   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 61 VON 107 
 Pigment Red 3 0002425-
85-6   480   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 1 0002512-
29-0   481   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 170 0002786-
76-7   482   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 4 0002814-
77-9   483   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 202 0003089-
17-6   484   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 13 0003520-
72-7   486   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 62 VON 107 
 Pigment Red 166 0003905-
19-9   487   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 43 0004424-
06-0   488   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 17 0004531-
49-1   489   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 149 0004948-
15-6   490   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 13 0005102-
83-0   491   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 146 0005280-
68-2   492   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 63 VON 107 
 Pigment Red 144 0005280-
78-4   493   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 95 0005280-
80-8   494   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 14 0005468-
75-7   496   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 83 0005567-
15-7   497   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 93 0005580-
57-4   498   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 110 0005590-
18-1 0106276-80-6   499   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 64 VON 107 
 Pigment Yellow 16 0005979-
28-2   500   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 2 0006041-
94-7   501   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Violet 23 0006358-
30-1 0215247-95-3   502   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 12 0006410-
32-8   503   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 3 0006486-
23-3   504   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 16 0006505-
28-8   505   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 65 VON 107 
 Pigment Red 112 0006535-
46-2   506   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 48:2 0007023-
61-2   507   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Metal 2 0007440-
50-8   508   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 53 0008007-
18-9   509   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment White 25 0010101-
41-4   510   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Violet 32 0012225-
08-0   511   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 66 VON 107 
 Pigment Black 11 0012227-
89-3   512   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 36 0012236-
62-3   513   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 62 0012286-
66-7   514   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 27 0014038-
43-8 0012240-15-2   515   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 48:3 0015782-
05-5   516   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 122 0016043-
40-6 0000980-26-7   517   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 67 VON 107 
 Pigment Violet 37 0017741-
63-8   518   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 52:1 0017852-
99-2   519   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 138 0030125-
47-4   520   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 208 0031778-
10-6   521   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Brown 23 0035869-
64-8   522   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 139 0036888-
99-0   523   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 68 VON 107 
 Pigment Red 214 0040618-
31-3   524   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 61 0040716-
47-0   525   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 42 0051274-
00-1   526   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 242 0052238-
92-3   527   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Blue 29 0057455-
37-5   528   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 220 0068259-
05-2   529   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 69 VON 107 
 Pigment Yellow 155 0068516-
73-4   530   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 64 0072102-
84-2   531   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 180 0077804-
81-0   532   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Yellow 128 0079953-
85-8   533   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Orange 71 0084632-
50-8   534   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. 
Pigment Red 264 0088949-
33-1   535   x       NN   May also be used as nanomaterial 
according to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food occurs. SEITE 70 VON 107 
 1,2,4-benzenetricarboxylic 
acid, mixed decyl and octyl triesters 0090218-
76-1   606       x   0,05   Only for use on the non food-
contact side. 
diethyleneglycol butyl ether 0000112-
34-5   607 x   x       (35) Only for use on the non food-
contact side. 
diethyleneglycol monoethyl ether 0000111-
90-0   608     x     5   Only for use on the non food-
contact side. 
trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids   94987 609     x     5   Only for use on the non food-
contact side. 
1-ethoxy-2-propanol 0001569-
02-4   610     x       (37) Only for use on the non food-
contact side. 
1-ethoxy-2-propy lacetat 0054839-
24-6   611     x       (37) Only for use on the non food-
contact side. 
diethylene glycol butyl ether acetate 0000124-
17-4   613     x       (35) Only for use on the non food-
contact side. 
1,3-benzenedimethanamine 0001477-
55-0 13000 614 x           (39)   
adipic acid, dibutyl ester 0000105-
99-7 32240 615       x   0,05     
tris(2-ethylhexyl) acetylcitra-
te 0000144-
15-0 95440 616       x   0,05     
citric acid, diethyl ester 0032074-   617       x   0,05     SEITE 71 VON 107 
 56-9 
aluminium hydroxy chloride 0001327-
41-9 34660 618       x   0,4     
1-propoxy-2-propanol 0001569-
01-3   619     x     5   Content of  2-propoxy-1-propanol 
(CAS-No.: 10215-30-2) not more than 5%. Only for use on the non food-contact side. 
 SEITE 72 VON 107 
 Table 2  List of pigments permitted to be used additionally to table 1 for printing of food contact materials and articles desc ribed in  
Article 4 (7) clause 4 (related to Article 4 (9), Article 8 (5) clause 1)  
 
1 2 3 4 5 6 7 8 
intended use Substance name CAS-No REF-
No Sub-
stance-
No I II III IV V SML 
[mg/kg] Group 
restricti-
on No Restrictions, specifications and purity 
requirements 
Calcium-Aluminium-Borosilicate     538   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Calcium-Sodium-Borosilicate     539   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Iron oxide, (Fe3O4) 0001317-61-9   541   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Iron hydroxide oxide (Fe(OH)O) 0020344-49-4   542   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 73 VON 107 
 Pigment Black 16  0007440-66-6   546   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Black 32 0083524-75-8   547   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Blue 27 0025869-00-5   548   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Blue 79 0014154-42-8   549   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Green 36 0014302-13-7   550   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Pigment Orange 34 0015793-73-4   551   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 74 VON 107 
 Pigment Orange 38 0012236-64-5   552   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Orange 46 0067801-01-8   553   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Orange 72 0078245-94-0   554   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Orange 73 0084632-59-7   555   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 48:4 0005280-66-0   556   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 63:1 0006417-83-0   557   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 75 VON 107 
 Pigment Red 147 0068227-78-1   558   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 148 0094276-08-1   559   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 176 0012225-06-8   560   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 177 0004051-63-2   561   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 184 0099402-80-9   562   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Pigment Red 185 0061951-98-2 
0051920-12-8   563   x       NN   May al so be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 76 VON 107 
 Pigment Red 200 0032041-58-0   564   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 200 0058067-05-3   565   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 210 0061932-63-6   566   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 238 0140114-63-2   567   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 254 0084632-65-5   568   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 254 0122390-98-1   569   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 77 VON 107 
 Pigment Red 266 0036968-27-1   570   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 268 0016403-84-2   571   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Pigment Red 269 0067990-05-0   572   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 282 0938065-79-3   573   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 12 0006358-85-6   574   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 109 0005045-40-9   57 5   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 78 VON 107 
 Pigment Yellow 111 0015993-42-7   57 6   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 120 0029920-31-8   57 7   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 126 0090268-23-8   57 8   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Pigment Yellow 127 0068610-86-6   57 9   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 138 0056731-19-2   58 0   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 151 0061036-28-0   58 2   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 79 VON 107 
 Pigment Yellow 174 0078952-72-4   58 3   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 175 0035636-63-6   58 4   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 181 0074441-05-7   58 5   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 185 0076199-85-4   58 6   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 188 0023792-68-9   58 7   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs.. 
Pigment Yellow 55 0006358-37-8   588   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 80 VON 107 
 Pigment Yellow 74 0006358-31-2   589   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 97 0012225-18-2   590   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Tin oxide 0018282-10-5   593   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Zirconium dioxide 0001 314-23-4   594   x       NN   Ma y also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 81:1  0080083-40-5    598   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Red 81:2  0075627-12-2    599   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 81 VON 107 
 Pigment Red 169  0012237-63-7    600   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 150  0068511-62-6 
0025157-64-6 0086249-83-4   601   x       NN   May al so be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Yellow 154  0068134-22-5    602   x       NN   May also  be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Violet 27  0012237-62-6    603   x       NN   May also  be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Blue 1  0001325-87-7    604   x       NN   May also be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. 
Pigment Blue 61  0001324-76-1    605   x       NN   May also  be used as nanomaterial accord-
ing to Article 2 clause 1 No 9, provided that no transfer of nanoparticles to food 
occurs. SEITE 82 VON 107                        
 
 Table 3: Group restrictions 
(related to Article 8 (5) clause 1)  Table 3 contains the following information:  Column 1 (Goup restriction No): number of the group of substances for which a group restric-
tion according to Table 1 column 7 has been established.  Column 2 (Substance No): Substance nu mber according to Table 1 column 4  
 Column 3 (SML (T) [mg/kg]): specific mi gration limit for the sum of the namend sub-
stance(s) of the respective subs tance group in milligram substance per kilogram food. If "ND" 
is indicated, a detectable tran sfer of the substance onto foods shall not be permitted. A trans-
fer of up to 0.01 milligrams per kilogram of fo od shall be deemed to be a non-detectable 
transfer.  Column 4 (Group restriction sp ecification): indication of the substance whose molecular 
weight forms the basis for expression of the result.   
1 2 3 4 
Group restriction 
No Substance-No SML (T) 
[mg/kg] Group restriction specification 
1 89 
142 146 30 expressed as ethyleneglycol 
2 227 
228 30 expressed as maleic acid 
3 246 
247 3 expressed as the sum of the substances 
4 214 
218 225 276 1 expressed as iodine 
5 36 
37 1,2 expressed as tertiary amine 
6 92 
93 94 6 expressed as the sum of the substances SEITE 83 VON 107 
 194 
195 197 
7 107 
108 264 265 342 0,18 expressed as tin 
8 111 
112 113 114 115 116 117 118 119 120 121 122 123 124 0,006 expressed as tin 
9 266 
267 268 1,2 expressed as tin 
10 192 
193 196 30 expressed as the sum of the substances 
11 244 
245 1,5 expressed as the sum of the substances 
12 85 
110 364 5 expressed as the sum of the substances 
13 164 
188 15 expressed as formaldehyde 
14 19 
45 46 
279 6 expressed as boron 
Without prejudice to the provisions of Direc-tive 98/83/EC SEITE 84 VON 107 
 15 81 
101 125 126 187 206 255 271 284 367 368 369 370 380 381 
460* 476* NN expressed as isocyanate moiety 
16 96 
97 0,05 expressed as the sum of the substances 
17 273 
274 278 280 10 expressed as SO
2 
18 132 
286 337 30 expressed as the sum of the substances 
19 378 
379 5 expressed as trimellitic acid 
20 3 
25 58 59 60 
143 148 155 203 211 240 6 expressed as acrylic acid SEITE 85 VON 107 
 285 
307 308 334 
21 26 
62 63 
150 157 205 233 234 249 293 338 
457* 482* 6 expressed as methacrylic acid 
22 33 
43 5 expressed as the sum of the substances 
23 86 
262 0,05 sum of mono-n-dodecyltin 
tris(isooctylmercaptoacet ate), di-n-dodecyltin 
bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin di-chloride) expressed as the sum of mono- and di-dodecyltin chloride 
24 302 
303 9 expressed as the sum of the substances 
25 208 
209 5 expressed as isophthalic acid 
26 66 
313 0,05 expressed as terephthalic acid 
27 51 
313 5 expressed as 1,4-butanediol 
28 6 
311 314 30 expressed as the sum of the substances 
29 6 
34 35 60 expressed as the sum of the substances SEITE 86 VON 107 
 73 
78 
141 170 259 299 300 301 302 303 311 312 314 354 371 373 
810* 815* 
30 185 
186 0,05 expressed as hexamethyldisiloxane 
32 212 
213 0,05 expressed as the sum of the substances 
33 362 
449 0,05 expressed as the sum of the substances 
34 363 
450 5 expressed as the sum of the substances 
35 147 
149 607 613 5 expressed as the sum of the substances 
36 397 
426 0,05 expressed as silver 
37 610 
611 5 expressed as the sum of the substances 
content of   2-Ethoxy-1-propanol (CAS-No.: 19089-47-5) and 2-Et hoxy-1-propylacetat 
(CAS-No.: 57350-24-0) not more than 3%, expressed as the sum of the substances . 
38 236 
237 5 expressed as the sum of the substances 
content of   2-Methoxy-1-propanol (CAS-SEITE 87 VON 107 
 No.: 1589-47-5) und 2-Methoxy-1-
propylacetat (CAS-No. : 70657-70-4) not 
more than 0.3%, expressed as the sum of the substances . 
39 614 
988* 0,05 expressed as 1,3-benzenedimethanamine 
* Substance No as in Annex I Table 1 Column 1 of  Regulation (EU) No 10/2011 
 
 SEITE 88 VON 107 
 Table 4: Additional limi t for specific substances 
(related to Article 8 (5) clause 2)  
Substance Limit expressed in  milligram per kilogram 
food 
Barium 1 
Iron 48 
Cobalt 0,05 
Copper 5 
Lithium 0,6 
Manganese 0,6 
Zinc 25 
Primary aromatic amines, 
except those listed in table 1 A transfer onto food shall no t be detectable. A transfer 
up to 0,01 milligrams of the sum of primary aromatic amines per kilogram food sh all be deemed to be a non-
detectable transfer. Additionally, for primary aromatic amines listed in Annex 1 No 7 a detection limit of 0,002 milligrams per kilogram food applies per single substance. SEITE 89 VON 107 
  
Article 2 
 
This Regulation shall enter into force on the day after its announcement. 
 
___________________ 
 
The Bundesrat  - Germany's Upper House of Parliament - has given its consent. 
 Bonn, (date) … 2016 
The Federal Minister 
of Food and Agriculture SEITE 90 VON 107 
  
Statement of Reasons 
 
A. General Provisions 
 
Situation at the outset 
 
Food contact materials and articles, for inst ance food packaging, are printed on for the pur-
poses of information and advertising. The prin ting inks used contain chemical substances 
which, unless precautions are taken, can be tran sferred to food and thereby be absorbed by 
consumers.   According to information from EuPIA (the Euro pean Printing Inks Asso ciation) the quantity 
of substances used in printing inks amounts to  almost 6 000. Only a small part of these sub-
stances (around 15 %) has been sufficiently assessed in toxicological terms,  in such a way that 
content limits can be deduced for the transfer of  substances onto foods, below which no health 
disadvantages are to be feared. For the remaini ng substances, there are either no toxicological 
data or no sufficient toxicological data availa ble which would permit a health assessment and 
thus the deduction of safe limits for the transfer of substances onto foods. 
 Constituent parts of printing inks can get into  foods through set-off processes, through migra-
tion or through the gas phase. In instances of set-off, the transfer of substances takes place 
through food contact materials and ar ticles being handled on rolls or  in piles, with the printed 
outside coming into contact with the inside; consequently parts of the printing inks are passed 
over onto foods. In the case of migration, prin ting ink chemicals stray from the printed food 
contact material and article and into the food. In the gas phase, constituent parts of high vola-
tility and of medium volatility respectively, e.g. mineral oils, can get into foods by means of 
vaporisation and subsequent absorption. In some instances, items of packaging are also print-
ed upon on the inside; this can also result in a contamination of foods. 
 In 2005, the public food control auth orities  proved the presence of the printing ink chemical 
ITX (isoprophylthioxanthon) in foods; ITX was hitherto unknown with regard to migration 
from printed food contact materi als and articles, and was detect ed in fruit juices, milk prod-
ucts and yoghurt products and also in baby f oods, among other products. Only limited toxico-
logical data are available for ITX. The Federal Institute for Risk Assessment (BfR) was in fact 
able to rule out that the substance has any t oxic effect on reproduction;  however, the release 
level that the BfR was able to categorise as  being acceptable in health terms was no higher SEITE 91 VON 107 
 than 50 micrograms per kilogram of food. In some instances, the content le vels detected in the 
foods were significantly above this value,  at up to 600 micrograms per kilogram.  
 The relevant business sector has given an assu rance that it has converted its printing ink sys-
tems after the first findings in 2005 and that it no longer uses ITX since then. However, in 
checks by public authorities in 2009, 2010 and 2011, the presence of ITX was again detected 
in foods, even in quantities significantly above 50 micrograms per kilogram of food. 
 At the end of 2008, the Laender  authorities competent for food control ascertained the pres-
ence of 4-methylbenzophenone, another constituen t part of printing inks previously unknown 
with regard to its migration properties from pr inted food contact materials and articles; it was 
detected initially in breakfast cer eals (muesli, cornflakes, etc.),  then later in other foods, in-
cluding foods frequently eaten by children. The highest level, measured in tacos, amounted to 
50 milligrams per kilogram. Taking as its basis a struct urally-related compound, namely  benzophenone, the European 
Food Safety Authority (EFSA) established th at there is reason to presume that 4-
methylbenzophenone is damaging to  the kidneys and is carcinoge nic in higher concentrations. 
Therefore the EFSA's view is that, in the cas e of long-term consumption of contaminated 
foods, health risks cannot be ruled out. A limit for the sum of benzophenone and 4-methylbenzophenone was set at 0.6 milligrams per kilogram of food, as recommended by the European Commission Standing Committee on th e Food Chain and Animal Health, and tak-
ing into account the EFSA assessm ent; in 2009, many products exceeded this limit, as further 
studies conducted by the c ontrol authorities showed. 
Likewise, in 2010 and 2011, public food control authorities ascertained benzophenone con-
tent-levels above the recommended limit, in vermicelli, biscuits, savoury snacks, couscous, wheat starch, rice paper and cinnamon powder,  among other products. The highest content-
level ascertained was 50.2 millig rams per kilogram of food. 
 In addition, in 2009, 2010 and 2011, the Laender  food control instituti ons and also a project 
conducted as a decision-making aid on this topic, financially assisted by the Federal Ministry 
of Food and Agriculture, provided proof that a range of other printing ink chemicals were 
present in foods, in some cases in considerable  amounts. In this cont ext, please note the fol-
lowing overview: 
 
Constituent part of printing ink Food Content level 
 
1-Chloro-4-propoxy-9H-thioxanthen-9-one Sausage Up to 35 
µg/kg
1)  SEITE 92 VON 107 
 1-Hydroxycyclohexyl phenyl ketone  Breakfast cereals, wok noo-
dles, biscuits,  milk-drink powder, cinnamon powder, rice paper, marshmallow con-fectionery, marzipan confec-tionery Up to 4300 
µg/kg 
1,6-Hexandiol diacrylate Chocolate bars Up to 37 
µg/kg2) 
 
2,2-Dimethoxy-2-phenylacetophenone Breakfast cereals, flour, wok 
noodles  Up to 1455 
µg/kg 
2,4-Diethyl-9H-thioxanthen-9-one Snack products, fresh cheese 
 Up to 130 
µg/kg 
2-Hydroxy-1-{4-[4-(2-hydroxy-2-methyl-propionyl)-benzyl]-phenyl}-2-methyl-propane-1-one Sausage Up to 160 
µg/kg  
2-Hydroxy-2-methylpropiophenone  Rice wafer snack, rice wafers 
 Up to 6100 
µg/kg 
2-Hydroxy-4-(octyloxy)benzophenone  Asian dried meat Up to 12 µg/kg 
 
2-Methyl-4-(methylthio)-2-morpho-linopropiophenone  Snack products, fresh cheese Up to 1568 
µg/kg 
3-Methyl-1,5-pentan diy diacrylat e  Chocolate bars Up to 37 
µg/kg2)  
4,4’-Bis(diethylamino)-benzophenone  Baked goods with long prod-
uct-life (e.g. biscuits) Up to 14 µg/kg 
4-Benzoylbiphenyl  Snack products, yoghurt prod-
ucts,  chocolate bars  Up to 630 
µg/kg 
Cyclohexanone Chocolate eggs Up to 800 
µg/kg  SEITE 93 VON 107 
 Di-(ethylhexyl) sebacate  Whey bars, snack products, 
biscuits, puffed rice Up to 1340 
µg/kg 
Diphenyl-(2,4,6-trimethylbenzoyl)-phosphine oxide  Rice wafer snack Up to 40 µg/kg 
Ethyl(2,4,6-trimethylbenzoyl)-              
phenylphosphinate  Snack products Up to 64 µg/kg 
Ethyl-4-dimethylaminobenzoate 
   Fresh cheese, chocolate bars Up to 116 
µg/kg 
Mesitylene-2-carbaldehyde   Chocolate bars Up to 45 µg/kg 
 
Methyl-2-benzoylbenzoate  Breakfast cereals, poppadoms, 
marshmallow confectionery  Up to 10795 
µg/kg 
Phosphoric acid diphenyl 2-ethylhexyl ester Snacks, ready-made meals, 
drink-powders Up to 7000 
µg/kg  
α-Benzyl-α-(dimethylamino)-4-
morpholinobutyrophenone Fresh cheese, dairy products, 
sausage, snack products  Up to 55 µg/kg 
1) µg/kg = micrograms per kilogram 
2) Sum of 1,6-hexandioldi acrylate and 3-methyl-1,5-pentanediyl diacrylate 
 
It transpires that for these substances there ar e no toxicological data available or no data of 
this type sufficient for a risk assessment. The BfR has given notific ation that corresponding 
constituent parts of printing inks must not be tr ansferred into foods, because a health risk can-
not be ruled out.  Furthermore, in April 2010, in the context of a further project financially supported by the 
Federal Ministry of Food and Agriculture and intended to provide decision-making assistance, 
mineral-oil hydrocarbons were ascertained as be ing present in foods packaged using printed 
folding box boards. Within this, the content-leve ls of saturated hydrocar bons found to be pre-
sent were frequently far above a value that, acco rding to the BfR's information, can still be 
categorised as being acceptable  in health terms (in individu al instances up to one hundred 
times that value). Hydrocarbons of this kind can be stored in the body and can damage the 
liver and the lymph glands, as reported by the BfR. Furthermore, the foods additionally exam-
ined to check for aromatic hydrocarbons were f ound to have them in relevant quantities. In 
the BfR's view, one should avoid consuming such foods because it cannot be ruled out that they include substances that, even in the smalle st quantities, can give rise to health damage, 
such as cancer. SEITE 94 VON 107 
 A wide range of foods is affected by this, e.g. flour, semolina, rice, bread, noodles, cornflakes, 
muesli, oat flakes, dumplings, sugar, chocolate,  cakes or baking mixes,  thereby also including 
many staple foods and foods frequently eaten by children. The source of the mineral oil is the 
printing inks used in printing the folding box board s, in addition to recycled paper fibres used 
as a raw material in the manufacture of recycled car tons or cardboard boxes. 
 Finally, in 2011 the BfR ascertain ed instances of transfer of primary aromatic amines (PAA) 
onto various foods, when examining napkins. This  also included compounds categorised as 
being carcinogenic and mutagenic. The primary aromatic amines originate from the printed 
matter on the napkins. In some instances, the co ntent-levels in the foods were found to be 
significantly above the limits sets  for amines. The BfR's view is that, because of the presence 
of substances with carcinogenic and mutagenic char acteristics, it shall be ensured that there is 
no detectable transfer of PAA from food c ontact materials and ar ticles onto foods. 
 The ascertained instances of food contaminati on by constituent parts of printing inks show 
that Regulation (EC) No 2023/2006 on good manufactur ing practice for materials and articles 
intended to come into contact with food (the  GMP Regulation), issued by the European 
Commission as a reaction to the ITX case in 200 5, did not produce the desired effect. At all 
levels of the value chain (the manufacture of starting substances const itutes an exception), the 
GMP Regulation requires companies to establis h quality-assurance systems and to implement 
quality checks which ensure conformity with Article 3(1)  of Regulation (EC) No 1935/2004 
on materials and articles intended to come in to contact with food and repealing Directive 
80/590/EEC and Directive 89/109/EEC. The Regulat ion also includes requirements with re-
gard to documentation and stipulates specific technical rules for good manufacturing practice 
with regard to printing inks. By means of this Regulation, following the ITX case, the Com-
mission sought to address the matter of transfer of substances from printing inks, without is-
suing substance-specific rules such as setting obligatory maximum limits. However, despite 
the GMP Regulation, the presence of constituent parts of printing inks continues to be ascer-
tained in foods, at levels beyond limits that ar e acceptable in health-p rotection terms: as a 
result, damage to health cannot be ruled out. Substances also emerge  in foods which cannot 
be assessed because toxicologica l data are either una vailable or those th at are available are 
insufficient. The consequences of this for c onsumers' health are not currently foreseeable. 
Against this background, it is necessa ry to establish specific rules. 
 Content of the Ordinance  The present Ordinance stipulates a list of substa nces that shall be permitted to be used in 
printing inks involved in the manufacture of f ood contact materials and articles (a positive 
list); this is done to protect c onsumers from possible health risk  connected with the commerce SEITE 95 VON 107 
 of printed food contact material s and  articles; the positive li st includes permissible maximum 
limits for the transfer of substances onto foods . The substances included in the positive list 
shall solely be those for which a risk assessment is available or toxicological data sufficient 
and suitable for that purpose are available; this is so that their effects on health can be checked 
and, on that basis, safe limits can be deduced re garding the transfer of  substances onto food. 
 In addition, the Ordinance stipulates that also substances are permitted to be used for which 
either no documents, or no documents sufficient for a health assessment, are available. How-
ever, this shall apply solely to  those food contact materials an d articles for which no direct 
contact between the food and th e printing ink or its constituen t parts is intended or foresee-
able. It shall also be a prerequisite for the us e of substances not assessed or not sufficiently 
assessed that these substances are not transferred from the printing inks onto the food, i.e. that 
their presence is not det ectable in the foods.  
 So-called CMR substances, with the characterist ics of being carcinogenic,  mutagenic or toxic 
for reproduction, shall not be permitted to be used  unless a safety assessment is available that 
renders it possible both to jus tify their use and to derive lim its regarding transfer onto food, 
thus enabling the substance to be  taken up into the positive list. 
  The Ordinance takes into account  the ResAP Resolution (2005)2 of the Council of Europe, on 
printing inks for food packaging materials, su bject to adaptation to the latest knowledge on 
science and technology.  As far as documentation of compliance with the provisions of this Ordi nance and the general 
rules applicable to food contact materials and ar ticels, especially Article 3 of Regulation (EC) 
No 1935/2004 relating to the safety of food contact  materials and articles , is concerned, refer-
ence is made to  Article 7 of Regulation (EC) No 2023/2006. According to this provision, 
amongst others, appropriate documentation is requ ired relating to spec ifications, manufactur-
ing formulae and processing which are relevant to  compliance and safety of the finished mate-
rial or article. For instance, this documentati on could relate to the compliance with specific 
migration limtis or the use of non-evaluated substances.   Resource commitment to fulf il Ordinance; other costs 
 The Ordinance will not impose a cost burden on th e Federal Government. It is estimated that 
the BfR will be able to conduct the safety assessment for new substances, regarding inclusion 
in the positive list, without additional commitme nt of personnel resources and in the context 
of the BfR's customary assessment work.  SEITE 96 VON 107 
 The Laender  have reported the following implementation costs on the basis of the Ordinance, 
with Berlin, Brandenburg and Bremen not submitting information on the subject:  Bavaria:
 
One-off personnel costs and costs of materials:   approx. €110 000 
Annual personnel costs and costs of  materials:    approx. €66 000 
 Baden-Württemberg
: 
Annual personnel costs and costs of  materials:  approx. €170 000  
 Baden-Württemberg attributes these costs to th e provision both of anal ytical procedures, lend-
ing themselves to implementation on a routine basis, and also of suitable personnel with re-gard to analysis, and also to the checking of substances used and documentation available in 
the companies.   North German Cooperation (
Hamburg, Schleswig-Holstein, Mecklenburg-West Pomerania): 
One-off personnel costs and costs of  materials:   approx. €565 000  
Annual personnel costs and costs of ma terials:      approx. €130 000 € 
 Additionally, costs up to or over a million Euro were indicated regarding the rules on nano-technology, for the acquisition of new measuring e quipment or respectively the establishment 
of new facilities, among other cost  factors (1/3 of these one-o ff personnel costs and costs of 
materials were taken into account in the above estimate: see below). However, rulings with 
regard to nanotechnology are not being introdu ced for the first time by this Ordnance, but 
rather they are already to be found in other rulings in the cont ext of food contact materials and 
articles. In this regard, reference is also made to the specific details stated below. 
 Hesse: 
 
One-off personnel costs and costs of  materials:  approx. €1 010 000  
Annual personnel costs and costs of materials:     approx. €310 000 or respectively, in the 
event that analyses regarding nanomaterials are commissioned, approx. €280 000 
 
Hesse cites the acquisition of  new analytical equipment (LC-MS/MS, GC-MS/MS, HPLC 
with FLD and DAD, equipment for processing of samples) as the reason for the additional costs. Additionally, extra expend iture (equipment for analysis a nd for preparation of samples) 
is indicated as being caused by the rulings on nanotechnology (see below).  
  SEITE 97 VON 107 
 Lower Saxony:  
One-off personnel costs and costs of  materials:    approx. €490 000 
Annual personnel costs and costs of ma terials:       approx. €52 000 
 Lower Saxony's stated grounds for the additional co sts of materials are the acquisition of a 
high-resolution LC-MS and also of standard substances.  
 North-Rhine Westphalia:
 
One-off personnel costs and costs of  materials:    approx. €570 000  
Annual personnel costs and costs of ma terials:       approx. €236 000 
 North-Rhine Westphalia attributes these costs to  the development of methods relating to the 
substances used, among other cost factors.  Rhineland Palatinate:
 
One-off personnel costs and costs of  materials:    approx. €200 000 
Annual personnel costs and costs of ma terials:       approx. €64 000 
 Saarland:
 
One-off personnel costs and costs of  materials:    approx. €1 000 000 
Annual personnel costs and costs of ma terials:       approx. €150 000  
 According to Saarland's information, the costs ar ise due to the acquisition of a new item  of 
analytical equipment (LC-MS/MS), standard su bstances, and chemicals. Moreover, Saarland 
states that additional personne l are necessary for method development and method validation 
and also for the GMP checks.   Saxony:
 
One-off personnel costs and costs of materials:  approx. €600 000 
Annual personnel costs and costs of  materials:     approx. €62 000 
 Saxony-Anhalt:
 
One-off personnel costs and costs of  materials:    approx. €400 000 
Annual personnel costs and costs of materials:     approx. €230 000  
 Saxony-Anhalt's stated grounds for the additional costs are the acquisiti on of measurement 
equipment (HPLC, HPLC/GC/MS),  the lasting commitment of time resources by one scientist 
and by two technical members of staff, and also  the purchase of such relevant consumable 
items as are required. Saxony-Anhalt  continues to assert that the checks on transfer of con-SEITE 98 VON 107 
 stituent parts of printing inks, not yet implemen ted, would already be necessary in principle 
according to existing rules, independently of th e passing of the planned ruling into law, yet 
even the checks currently required are not bei ng implemented due to la ck of capacity. More-
over, the general requirement s of Regulation (EC) No 1935/2004 demanded a check on all 
transfers of substances.  Thuringia:
 
One-off personnel costs and costs of  materials:    approx. €500 000 
Annual personnel costs and costs of ma terials:       approx. €40 000  
 Thuringia attributes the costs to the acquisiti on of analytical technol ogy (LC-MS/MS) and to 
analysis-related materials costs, among other factors.    Total costs for the Laender : 
One-off personnel costs and costs of  materials:    approx. €5 445 000 
   Annual personnel costs and costs of materials:       approx. €1 510 000 
 Some Laender  indicated costs arising specifically due to the in troduction of rules governing 
nanomaterials. However, only 1/3 of these costs were entered into the calculation; the reason 
is that requirements already emerge with re gard to nanomaterials, as well as corresponding 
personnel costs and costs of materials, because of  the rules stated in the following: Regulation 
(EU) No 10/2011 on plastic materials and articles  intended to come into contact with food, 
and also Regulation (EC) No 450/2009 on active a nd intelligent materials and articles in-
tended to come into contact with food. Thus, the national rulings on pr inting inks cannot be 
designated as the sole cost factor both for th e acquisition of corresponding equipment and also 
for the provision of suitable personnel.  The business community and, in particular, sma ll to medium-sized businesses are faced with 
additional costs because of the Ordinance. The printing inks industry quantified these costs at 
approx. EUR 18 million for the 20 companies based in Germany: stated reasons are expendi-
ture on testing, work needed to meet the pr econditions for being listed, rearrangement of 
product formulations, and specification of the prin ting inks in accordance with the Ordinance. 
The information from the business community st ates the following factors (among others): 
costs of approx. EUR 100 000 per substance in order to meet the preconditions for being 
listed, EUR 100 000 Euro company for obtaining in formation relating to  raw materials and 
for its assessment, and also very substantial costs for adjustments of product formulations 
(where applicable), because of substances not  being listed. The need to convert a product 
formulation arises if a listing of  the relevant substances is not applied for, or respectively if 
this application would be declined because of  negative effects being ascertained for human SEITE 99 VON 107 
 health, or there is a failure to comply with th e relevant maximum values for the transfer of 
substances from printed food cont act materials and articles.   
 According to the information from the printing i nks industry, at this stage in the value chain 
the estimated costs of EUR 18 million are comprised as follows:  Costs per company:
 
 1. Communication with suppliers and a ssessment of suppliers' information 
- Enquiries per raw materi al and per supplier: 1400 
- Time expended per enquiry: one hour - Total commitment: 1 400 hours, corresponding to full-time use of one worker: €100 000
 
 2. Ongoing costs  - Customer care/communicating the compliance related work:  
 equivalent to the full-time use of one worker      € 100 000
 
 3. Resource commitment involved in reformulation  - 1 400 basic substances per company; a basic su bstance substitution rate of 5% is assumed 
(70 basic substances) 
Costs per basic substance substitution: 10 000 € Total costs – basic substance s ubstitution:          € 700 000
 
                              
Total expenditure – printing inks industry: -  Number of companies: 20 -  Costs per company: € 900 000 -  Total costs for the printing inks industry:           €18 000 000
 
 Likewise, a very substantial a nd lasting additional resource co mmitment was indicated for the 
downstream business operators.   The following exemplary scenario was presente d: one single, small to medium-sized food 
company, packaging its own products and with 20  different packaging types in its product 
portfolio, faces costs of EUR 5 000 Euro to EU R 20 000 per packaging type in order to im-
plement the Ordinance: these arise due to necessary chemical analyses, the additional compli-ance work, and the new qualification process (thi s depends on the composition of the printing 
inks, the technical changes, or the upstream  work undertaken by supp liers). The ongoing costs 
(compliance work specific to the printing ink, an d also chemical analyses) would amount to 
EUR 1 000 per packaging type annually. In total, what results for such a company, at this par-SEITE 100 VON 107 
 ticular stage in the value chain, is implemen tation costs of EUR 100 000 to EUR 500 000 and 
ongoing costs of EUR 20 000 per year.  Taking into account approximately 20 000 different  articles on offer for the end-consumer in 
the national market, the costs for the business community as a whole were estimated to be around EUR 660 million (one-time implementing cost s). However, it was also stated that a 
sound estimation of the real cost s is quite difficult to provide. 
It is not possible at present to fully estimate the annual consequential costs incurred by the 
entire value-added chain that  result from new developments  and production switches. The 
economic operators concerned cannot provide re levant data either. The above-mentioned ex-
ample has been randomly selected to illustrate  possible scenarios. However, the types of 
packaging used vary in their number and type from business to business. Any need for struc-
tural adjustment in individual companies also ne eds to be considered on a case-by-case basis 
and the frequency and scope cannot be reliably predicted or estimated.   
The printing inks industry presumes that the listing of new substances  will cause around EUR 
2 million in annual costs. It can be assumed that th is also contains costs that generally arise in 
the use of new substances if only because of  the general legislation governing food contact 
materials, notably in order to prove the safe ty of corresponding products. For the use of new 
substances in the production of food contact mate rials, thus also for printing, generally pre-
supposes a check of the suitability and safety of th e use in order to be able to comply with the 
general requirements laid down in Regulati on (EC) No 1935/2004. With regard to the com-
munication with suppliers and as sessment (see no 1 above), the annual consequential costs per 
business are estimated at around 20% of the am ount stated for a one-off switchover (EUR 20 
000), with the running costs (no 2) remaining steady at EUR 100 000. With respect to the ex-
penditure involved in reformulation (no 3), the printing inks industry as sumes that the cost 
level will remain stable possibly in the first five  years after the entry in to force of the Regula-
tion (EUR 700 000), because they expect a grad ual conversion of the printing ink formula-
tions used until the printing companies and users of printed food contact materials have suffi-
cient knowledge of the possible ap plications of specific printing ink formulations in terms of 
their migration procedures. The additional curr ent compliance costs incurred by the printing 
inks industry was thus estimated at a total of  EUR 16 million annually in the first five years 
after the entry into force of the Regulation (i ncluding any business-as-usual costs). Costs are 
expected to decrease substant ially afterwards, however.  
It can generally be assumed that the total cost s indicated by the industr y contain a significant 
proportion of so-called business-as- usual costs that either cannot or not exclusively be attrib-
uted to the new regime. The existing general legislation for food contact materials already 
involves different obligations imposed on the manuf acturers or distributors  of these products.  
Thus, producers or any other distri butors have to ensure the safe ty of the food contact materi-
als, in particular. This also comprises suitable mi gration or other tests with a view to the trans-
fer of substances from food contact materials to foodstuffs. This can also be done by the food SEITE 101 VON 107 
 packers depending on the case concerned. In light of the rules laid down in this Regulation, 
notably due to the stipulation of defined specifi c migration limits derived from pertinent risk 
assessments, such tests, also on the basis of model calculations, should become much easier. 
Thus, the case-by-case evaluation which the in dustry would otherwise be required to conduct 
in order to determine to what ex tent specific levels of a substa nce that migrated to foods pose 
a danger to human health or not  can be dispensed with in th e future because one can now 
draw on uniform officially derive d limits.  However, at present,  it cannot be quantify to what 
extent this will ease the cost burden on the industry on the basis of the available data.  
It is not to be ruled out that this additiona l burden placed on business has an effect on the de-
velopment of end-consumer prices. However, in relation to specific prod ucts the scope of any 
price increases cannot be quantified exactly. Ne vertheless, effects on th e general price level 
and, in particular, the consumer pr ice level are not to be expected. 
 For members of the public, no commitment of res ources is required for the Ordinance to be 
fulfilled.  It is envisaged that the effects of this Regulation are to be ev aluated no later than five years 
after the rules enter into force. In particular, this should also in clude the actual cost effects.  
 The ‘one in, one out-rule’ does not apply to th e estimated one-time implementing costs result-
ing from this Ordinance. However, the addito nal current compliance costs expected by indus-
try are covered by the aforementioned rule. Comp ensation of these costs cannot be realised 
within this Ordinance. Therefore, it will have to  be evaluated whether or not possibilities for 
compensation can be identified in an other cont ext than within this  regulatory project. 
 Gender-specific effects  The Ordinance includes no rulings that exert an effect specific to women's or men's respective 
life situations. Health protecti on is taken into account for women and for men in equal meas-
ure. Thus effects on equal opportunity for women and men are not to be expected. 
 Sustainable development The Ordinance serves the protection of consum ers against possible health dangers in their 
dealings with printed food contact materials and articles; it thereby cont ributes to sustainable 
development.     SEITE 102 VON 107 
 B. Particular provisions 
 Relating to Article 1  Relating to Item 1
 
 Item 1 includes the definitions necessary  in order to apply this Ordinance. 
 Items deemed to be printing inks shall be the following: printing inks or printing varnishes 
which are applied to food contact materials a nd articles in a printing process or varnishing 
process and which come or can come into contact  with the food, direc tly or indirectly. An 
indirect contact takes place, in  particular, if printing inks, even without being used on the 
food-contact side of the food cont act material and article, releas e or can release their constitu-
ent parts onto the food. In this context, referen ce is also made to the ruling in Article 4(7), 
from which it is likewise clear th at these rules cover direct as  well as indirect food contact. 
"Printing inks" and "printing va rnishes" are fixed terms estab lished in the supply chain. In 
accordance with this, these terms shall include printing inks a nd printing varnishes used, in 
particular, for inscription, for co louring, for imaging, or for atta ining gloss effects, and also 
those used for adhesion or protecti on of the inks or varnishes.  
Varnishes other than printing varnishes shall be  outside the scope of the Ordinance, for in-
stance those intended to exercise a protective f unction in relation to th e food contact materials 
and article onto which they are applied (e.g. varn ish for the interior of tins, as corrosion pro-
tection). In addition, decorative inks for ceramic food contact mate rials and articles, applied in 
a combustion process, shall not form part of  this Ordinance's scope of application.  
The definition used for nanomaterials takes as  its point of referen ce the Commission Recom-
mendation (2011/696/EU) of 18 October 2011 on the de finition of nanomaterials. In the event 
of any future amendment of the Recommendation, a check would be made on whether to adapt the definition used for this Regulation.   Relating to Item 2
 
 Item 2 determines which monomers or other starting substances for polymers, colourants, 
solvents, photoinitiators or other additives in pr inting inks shall be permitted to be used in the 
manufacture of printed food cont act materials and articles.  
Here, as is otherwise customary, the term "to use" shall be understood as meaning "planned 
using". Consequently, the following shall not constitute substances that are used, as defined in Item 2: "non-intentionally added substances" (N IAS), i.e. impurities in  the substances used; SEITE 103 VON 107 
 intermediate products from the reaction, which have formed in the manufacturing process; 
degradation products; reaction products.  
To the extent that this Ordinance does not in clude any specific ruling for NIAS, the rules in 
Article 3(1) of Regulation (E C) No 1935/2004 shall apply. Whethe r the relevant NIAS corre-
spond to Article 3(1)(a) of Regulation (EC)  No 1935/2004 shall be checked in accordance 
with internationally reco gnised scientific principl es of risk assessment. 
 Article 4(5) and (6) respectiv ely of the Consumer Goods Ordinance make provision for au-
thorisation of substances for which a risk asse ssment is available, or for which toxicological 
data suitable and sufficient for this  are available; this is done so  that such substances' effects 
on health can be checked by the BfR and, on this basis, limits can be deduced for the transfer 
onto foods, as can other restric tions, specifications and purity re quirements (a positive list). If 
no purity requirements are stipulated, the substa nces shall be of good technical quality with 
regard to the purity requirements. This is th e case if Article 3(1) of Regulation (EC) No 
1935/2004 does not constitute an obstacle to the use. A basis for the positive list is the ResAP ( 2005) 2 Resolution of the Council of Europe on 
printing inks for food packaging. Adaptations were  made to the current level of knowledge of 
scientific and technology; in this context, among other things , the Ordinance by Switzerland's 
Eidgenössische Departement des Innern  (EDI) of 7 March 2008 am ending the EDI Ordinance 
of 23 November 2005 on utility articles (SR 817 .023.21) was taken into account. By means of 
this Ordinance, Switzerland has i ssued specific rulings with rega rd to food contact materials 
and articles manufactured  involving the use of printing inks. These rulings have been in force 
since 1 April 2010.  An amendment or an addition to the positive list can be applied for to the Federal Ministry of 
Food and Agriculture (BMEL). Together with the application, documents shall be submitted 
in accordance with the guideline published by the BfR, regarding the safety assessment for substances in printing inks used in the manuf acture of food contact mate rials and articles. The 
BMEL shall decide regarding the amendment of or addition to th e positive list, taking into 
account the opinion issued by the BfR. Furthermore, upon request  and according to Articles 
54 and 68 respectively of the Food and Feed Act (LFGB), general decrees can be issued or 
respectively exceptions to the rules stated  in this Ordinance can be authorised. 
 Article 4(7) and (8) of the Consumer Goods Ordinance make provision for permitting the use 
of substances other than those st ated in the positive list. In this  context, on the one hand, ref-
erence is made to substances authorised according to Regulation (EU) No 10/2011 without 
group restrictions or without re strictions and specifications (s o-called dynamic reference) (cf. 
Paragraph 8). On the other hand, substances are permitted for which no toxicological docu-ments or no such documents sufficient for a hea lth assessment are available; it is a prerequi-SEITE 104 VON 107 
 site that the substances in question do not  have carcinogenic, mu tagenic or toxic-for-
reproduction characteristics as defined in Cate gories 1 and 2, Annex I, Regulation (EC) No 
1272/2008 (so-called CMR substances) (cf. Paragr aph 7). CMR substances shall be excluded 
from use because otherwise, without a safety assessment, as stated in Article 8(7) of the Con-sumer Goods Ordinance, they can be expected to be transferred onto food in quantities of up 
to 0.01 milligrams per kilogram. This could adve rsely affect consumers in ways associated 
with an unacceptable health risk. This rule adop ts the approach hitherto taken in EU law with 
regard to the use of substances not assessed in health terms in the real m of food contact mate-
rials and articles (cf. Regulation (EC) No 450/2009 and Regulation (EU) No 10/2011).  
The possibility, provided for by Ar ticle 4(7) and (8), for use either of substances other than 
those stated in the positive lis t or of those encompassed by th e reference to Regulation (EU) 
No 10/2011, shall apply solely to the manufacture of food contact materials and articles with 
regard to which the printing inks or what is printed on the articles ar e not intended to come 
into contact with the food direc tly; thus, for example, it relate s to an item of food packaging 
with print on the outside. However, Article 4(7)  Clause 4 additionally states that this ruling 
shall not apply to printed food contact materials and articles not intended to have direct food 
contact but with regard to whic h direct contact of the printing inks with the foods is foresee-
able under normal conditions of use (cf. Ar ticle 1(2)(c) of Regulation (EC) No 1935/2004). 
For example, this can be the case with napkins or traymats. These may indeed not necessarily 
be intended to have food placed upon them, th ereby causing direct contact. Yet without doubt 
it is foreseeable that napkins, for example, are also used for such purposes. Reference is made 
to Article 1(2)(c) of Regulation (EC) No 1935/2004.  Article 4(9) takes into account the fact that not enough of the re levant data are yet available 
for the assessment of some substances alrea dy used for printing on food contact materials and 
articles, such as napkins or traymats. On princi ple, for direct food cont act, substances used in 
printing inks shall solely be those that have b een health-assessed and are stated in the positive 
list in Annex 14 Table 1, or ar e authorised via the referenc e to Regulation (EU) No 10/2011. 
Provided that no transfer is pr ovably taking place, and based on a detection limit of 0.01 mil-
ligrams per kilogram of food, substances not asse ssed in health terms sh all be permitted solely 
on the printed part of the food c ontact material and article that is not intended to come into 
contact with the food directly, or with regard to which no direct contact is foreseeable. Nap-
kins, traymats, etc. are food contact materials an d articles with regard to which a direct con-
tact with the food is foreseeable but the duration of contact is frequently short. Therefore, as 
an exception, for these cases the transitional period shall be prolonged by two years, thus 
amounting to four years in total. During this tr ansitional period, the pigments stated in Annex 
14 Table 2 shall be permitted to continue to be  used. A transfer of these pigments onto foods 
shall not be detectable, i.e. a detection limit of 0.01 mg of pigment per kilogram of food ap-
plies. Within this period, the business sector  affected should make sufficient toxicology-SEITE 105 VON 107 
 related documents available for a health assessment, so that the substances are able to be tak-
en up into the positive list (Annex 14 Table 1) , preferably before the transition deadline. 
 Article 4(10) excludes from the ruling those printed food contact materials and articles with 
regard to which a transfer of substances from the printing ink onto the food is ruled out. Ex-
amples for such food contact materials and ar ticles include glass bottles or metal cans on 
which the printed labels or similar material are printed on the side that is turned away from 
the food. Based on their nature and their mode of  handling, it can be assu med with regard to 
such food contact materials and articles that no transfer can take place from the constituent 
parts of the printing inks onto the food.  Relating to Item 3
 
 Item 3 determines which limits shall not be perm itted to be exceeded with regard to the trans-
fer of substances from printed food contact ma terials articles and pr inting inks onto foods. 
 Article 8(5) of the Consumer G oods Ordinance establishes limits for substances stated in An-
nex 14 of the Consumer Goods Ordinance. For th ese substances, risk assessments or toxico-
logical data suitable and sufficient for such assess ments are available; this in order that their 
effects on health can be checked by the BfR and that, on this basis, maximum tolerable intake 
levels can be deduced. A limited-duration ruling on an exception exists for food contact mate-
rials and articles referred to in Ar ticle 4(7) Clause 4, with regard to which it is foreseeable that 
the printing inks come into direct contact with  foods, although they ar e not intended to do so, 
such as napkins and traymats (see in this rega rd Art. 4(9) and Annex 14 Table 2). For primary 
aromatic amines categorised as Category 1A  and Category 2B carcinogens respectively ac-
cording to Regulation (EC) No 1272/2008, the de tection limit provided for by Annex 14 Ta-
ble 4 with regard to transfer  onto foods (namely 0.01 milligrams of the sum of primary aro-
matic amines per kilogram of the food), shall be  deemed to be insufficient as defined in con-
sumer-protection terms: this is based on a risk  assessment with that conclusion, made by the 
BfR. For these substances, listed in Annex 1 It em 7 of the Consumer Goods Ordinance, a de-
tection limit of 0.002 milligrams per kilogram of  food shall additionally  apply per individual 
substance.   Article 8(6) of the Consumer Goods Ordinan ce sets at 60 milligrams per kilogram respec-
tively the limit for the transfer of substances from food contact materials and articles listed in 
Annex 14 Table 1, for which no specific migra tion limit, no group restriction or no other re-
strictions are established.   SEITE 106 VON 107 
 The rules in Article 8(5) and (6) of the Consumer Goods Ordi nance shall apply respectively, 
subject to the rulings for printed plastic food cont act materials and articles: for the latter, rules 
are already stated in Ar ticle 11(1) and (2) of Regulation (EU) No 10/2011. 
 Article 8(7) of the Consumer Goods Ordinance stipulates that it shall not be permitted for 
transfer of printing inks onto food to take pl ace in detectable quantities from substances per-
mitted to be used, but for which either no documents are available or no documents sufficient for a health assessment are available. For substa nces other than those in the form of nanoma-
terials, the detection limit shall be set at 0.01 milligrams per kilogram of food respectively. 
For analytical reasons, it is not  currently possible to establish a uniform detection limit for 
substances in the form of nanomaterials. It sh all be for the competent authority to decide in 
the particular cases what is deemed to be non-detectable. Likewise, these stipulations follow an establishe d approach used at EU level. Regulation (EC) 
No 450/2009 and Regulation (EU) No 10/2011 contain rules comparable to Article 8(7) of the 
Consumer Goods Ordinance.   Relating to Item 4
 
 Item 4 establishes rules for sanctioning of breach es of the rules in Article 4(5) of the Con-
sumer Goods Ordinance.  It is not necessary to sanction a breach of Article  4(7) of the Consumer Goods Ordinance: this 
is because the use of CMR substances in a way that violates Article 4(7) would constitute a breach of Article 4(5).  The sanctioning of any breach of Article 8(5), (6) and (7) respectively of the Consumer Goods 
Ordinance is effected via Ar ticle 31(2) Clause 2 of the Food and Feed Act (LFGB). 
 Relating to Item 5
 
 Item 5 includes the necessa ry rules for the transition. 
 Article 16(15) of the Consumer Goods Ordinance stipulates that printed food contact materi-
als and articles that have been placed on the market in accordan ce with the rules that were in 
force until the Ordinance entered into force, sh all also be permitted to be placed on the market 
after the Ordinance enters into force, until the st ocks have been sold ("free right of sell-off"). 
 SEITE 107 VON 107 
 Article 16(16) of the Consumer Goods Ordinance includes the necessary rules for the transi-
tion, with regard to application of the new ru lings of Articles 2, 4, 8 and 12. Provision is made 
for a transition period of twenty-four months.  Article 16(18) includes an extended transitional period for printed food contact materials and 
articles with regard to which a direct contact of the printing inks with the food is foreseeable 
even if this is not the intention; see also th e reasoning on Item 2 (Article 4(9)). For printed 
food contact materials and articles that have been placed on the market  in accordance with the 
rules that were in force until the expire date of this transitional period,  a free right of sell-off 
is regulated in Article 16(17).  Relating to Item 6
 
 Reference is made to the reas oning given for Items 1, 2, 3 and 4. 
 Relating to Article 2  Article 2 establishes the ruling for the entry of the Ordinance into force.