Ordinance of the FDHA on articles and materials (RS 817.023.21) of 23 November 2005

Annex 6

Lists of permitted substances from 1 May 2011 for the manufacture of packaging inks, subject to the requirements set out therein

Definitions and explanations concerning the lists I - V

• I List of binders (monomers)

• II List of dyes and pigments

III List of solvents (including the "energy curing monomers")

IV List of additives (without the additives used in the preparation of pigments)

• V List of photoinitiators

Packaging inks may only be manufactured from the substances set out in annex 1 (lists I, II and III) and annex 6 (lists I - V), subject to the requirements set out therein.

The lists do not include the salts (including double salts and acid salts) of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing ‘… acid(s), salts’ appear in the lists if the corresponding free acid(s) is (are) not mentioned. In these cases, the meaning of the term ‘salts’ is ‘salts of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium and zinc’.

Printed articles and materials shall not release the following substances in quantities exceeding the specific migration limits below:

Substance	SML [mg/kg of food or food simulant]
Barium	1
Cobalt	0.05
Copper	5
Iron	48
Lithium	0.6
Manganese	0.6
Zinc	25
Primary aromatic amines, excluding those listed in annex 6, Part A	Not detectable (DL = 0.01 mg/kg of food or food simulant). The detection limit (DL) applies to the sum of the primary aromatic aminesreleased.

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Ordinance of the FDA on articles and materials - Annex 6, definitions and explanations

Parts A and B

The lists of Part A contain evaluated substances, subject to the requirements set out therein, intended to be used in the manufacture of food contact materials. For the substances without a numerical value in the column SML, the value of the global migration of 10 mg/dm² or 60 mg/kg according to the cases (cf Art. 3 of annex 1) is considered as the limit value.

The substances listed in Part B of the lists have not been subjected to any officially recognised scientific testing (such as that of the scientific committee of the EFSA). The use of these substances is permitted if no transfer of these substances to food or food simulants can be detected. The relevant proof can be provided by means of a "worst case" calculation or by a practical experiment.

The substances in Part B of the lists must not be detectable in a migration test in the lowest possible concentration at which a substance may be detected using a valid method of analysis. The detection limit depends on the composition of the substance; this limit, expressed as a concentration, must in no case exceed 0.01 mg/kg of food or food simulants (including the analytical tolerance). For substances that can be allocated to a group of compounds with similar toxicology or similar basic structure (e.g. isomers), this limit value applies to the sum of the concentrations of the substances.

1 I - List of binders (monomers)

1.1 The term binders (monomers) is understood to mean all substances involved in the preparation of macromecules such as:

a. substances undergoing polymerisation, which includes polycondensation, polyaddition or any other similar processes,

b. natural products or synthetic substances - also of high molecular weight - used in the manufacture or the modification of natural or synthetic macromolecules,

1.2 The binders (monomers) may be used as additives and inversely, as long as the specific migration limits and the restrictive requirements are respected.

2 IV - List of additives

• 2.1 The list IV of the annex includes an exhaustive list of substances, which are:

  • a. incorporated into inks to achieve a technical effect in the finished product and which, in accordance with the use of the finished product, remain there;

b. used to provide a suitable medium in which polymerisation occurs (e.g. emulsifiers, surfactants, buffer substances, etc).

2.2. The list IV of the annex does not include substances which directly influence the formation of polymers (e.g. catalysts) and additives used in the preparation of pigments.

• 2.3 The additives may be used as binders (monomers) and inversely, as long as the specific migration limits and the restrictive requirements are respected.

Status on 1st February 2011

Ordinance of the FDA on articles and materials - Annex 6, definitions and explanations

Meanings of the used abbreviations

The abbreviations used in the lists mean:

• DL = detection limit of the method of analysis EO = ethylene oxide ECM = energy curing monomer FP = finished material or article NCO = isocyanate group QM = maximum permitted quantity of the residual substance in the material or article QM (T) = maximum permitted quantity of the residual substance in the material or article, expressed as the total of the group of the indicated substances

• QMA = maximum permitted quantity of the residual substance in the finished material or article, expressed as mg per 6 dm² of the surface in contact with foodstuffs

• SML = specific migration limit SML (T) = specific migration limit expressed as the total of the group or of the substance(s) indicated MW = molecular weight a. = as w. = with e.a. = expressed as s. = cf. n.d. = not detectable a.t.i. = analytical tolerance included

Status on 1st February 2011

Ordinance of the FDHA on articles and materials (RS 817.023.21) of 23 November 2005

Annex 6

Lists of permitted substances from 1 May 2011 for the manufacture of packaging inks, subject to the requirements set out therein

• I. List of binders (monomers)

Part A. evaluated substances

Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
Formaldehyde	0000050-00-0	15 (T)	w. hexamethylene- tetramine
Lactic acid	0000050-21-5
Sorbitol	0000050-70-4
D-Glucose	0000050-99-7
Glycerol	0000056-81-5
Palmitic acid	0000057-10-3
Stearic acid	0000057-11-4
Urea	0000057-13-6
Sucrose	0000057-50-1
Linoleic acid	0000060-33-3
Ethanol	0000064-17-5
Formic acid	0000064-18-6
Acetic acid	0000064-19-7
Benzoic acid	0000065-85-0
Methanol	0000067-56-1
Acetone	0000067-64-1
Dimethyl sulphoxide	0000067-68-5
Salicylic acid	0000069-72-7
1-Butanol	0000071-36-3
1-Pentanol	0000071-41-0
Ethylene	0000074-85-1
Acetylene	0000074-86-2
Vinyl Chloride	0000075-01-4	n.d.(DL = 0.01)
Acetaldehyde	0000075-07-0	6
Ethylene oxide	0000075-21-8	n.d.	QM = 1 mg/kgin FP
Propane,2-methyl-	0000075-28-5	1
Vinylidene chloride	0000075-35-4	n.d.(DL = 0.05)
Carbonyl chloride	0000075-44-5	n.d.	QM = 1 mg/kgin FP
Propylene oxide	0000075-56-9	n.d.	QM = 1 mg/kgin FP
Dicyclopentadiene	0000077-73-6	5
Citric acid	0000077-92-9
1,1,1-Trimethylolpropane	0000077-99-6	6
Vinyltriethoxysilane	0000078-08-0	0.05
2-Methyl-1,3-butadiene	0000078-79-5	n.d.(DL = 0.02)
Isobutanol	0000078-83-1	1
Acrylamide	0000079-06-1	n.d.(DL = 0.01)
Propionic acid	0000079-09-4
Acrylic acid	0000079-10-7	6(T)	s. annex 1,list III.17
Monochloroacetic acid	0000079-11-8
Glycolic acid	0000079-14-1
Methacrylamide	0000079-39-0	n.d.(DL = 0.02)
Methacrylic acid	0000079-41-4	6(T)	s. annex 1,list III.18
2,2-Bis(4-hydroxyphenyl)propane	0000080-05-7	0.6
alpha-Pinene	0000080-56-8
Methacrylic acid,methyl ester	0000080-62-6	6(T)	s. annex 1,list III.18
Phthalic anhydride	0000085-44-9
Vinylpyrrolidone	0000088-12-0		QMA < 10 µg/6 dm² (DL = 0.01 mg/kg)

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Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
o-Phthalic acid	0000088-99-3
Pyromellitic acid	0000089-05-4	0.05
Pyromellitic anhydride	0000089-32-7	0.05 (e.a. pyromellitic acid)
2,6-Toluene diisocyanate	0000091-08-7		QM (T) = 1 mg/kg (e.a. NCO)
Coumarin	0000091-64-5	0.6
2,4-Diamino-6-phenyl-1,3,5-triazine	0000091-76-9
3,3'-Dimethyl-4,4'-diisocyanatobiphenyl	0000091-97-4		QM (T) = 1 mg/kg in FP (e.a. NCO)
o-Cresol	0000095-48-7
Methacrylic acid,allyl ester	0000096-05-9	0.05
Acrylic acid,methyl ester	0000096-33-3	6(T)	s. annex 1,list III.17
Ethylene carbonate	0000096-49-1		s. annex 1,list III.20
Eugenol	0000097-53-0	n.d.(DL = 0.02,a.t.i.)
Methacrylic acid,ethyl ester	0000097-63-2	6(T)	s. annex 1,list III.18
Itaconic acid	0000097-65-4
Methacrylic acid,isobutyl ester	0000097-86-9	6(T)	s. annex 1,list III.18
Methacrylic acid,butyl ester	0000097-88-1	6(T)	s. annex 1,list III.18
Methacrylic acid,diester with ethyleneglycol	0000097-90-5	0.05
4-tert-Butylphenol	0000098-54-4	0.05
alpha-Methylstyrene	0000098-83-9	0.05
Isophthalic acid dichloride	0000099-63-8	5 (T) (e.a. isophthalic acid)	a. sum of 99-63-8 and 121-91-5
p-Hydroxybenzoic acid	0000099-96-7
Terephthalic acid	0000100-21-0	7.5
Styrene	0000100-42-5
Benzyl alcohol	0000100-51-6
Hexamethylenetetramine	0000100-97-0	15 (T) (e.a. formaldehyde)
Methacrylic acid,cyclohexyl ester	0000101-43-9	0.05
Diphenylmethane-4,4'-diisocyanate	0000101-68-8		QM (T) = 1 mg/kg in FP (e.a. NCO)
Bis(4-aminophenyl)methane	0000101-77-9	n.d.(DL = 0.01)
Resorcinol diglycidyl ether	0000101-90-6	n.d.	QMA = 0.005 mg/6 dm² s. annex 1,list III.11
Diphenyl carbonate	0000102-09-0	0.05
(1,3- Phenylenedioxy)diacetic acid	0000102-39-6		QMA = 0.05 mg/6 dm²
N,N,N′,N′,-Tetrakis(2-	0000102-60-3
hydroxypropyl)ethylenediamine
Triethanolamine	0000102-71-6	0.05
Acrylic acid,2-ethylhexyl ester	0000103-11-7	0.05
Adipic acid,bis(2-ethylhexyl)ester	0000103-23-1	18
N-(4-Hydroxyphenyl)acetamide	0000103-90-2	0.05
1,4-Bis(hydroxymethyl)cyclohexane	0000105-08-8
Methacrylic acid,2-(diethylamino)ethyl ester	0000105-16-8	0.05
Caprolactam	0000105-60-2	15
12-Hydroxystearic acid	0000106-14-9
Butyric anhydride	0000106-31-0
p-Cresol	0000106-44-5

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Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
Acrylic acid,isobutyl ester	0000106-63-8	6(T)	s. annex 1,list III.17
Epychlorhydrin	0000106-89-8		QM = 1 mg/kgin FP
Glycidyl methacrylate	0000106-91-2	0.02
Butane	0000106-97-8
1-Butene	0000106-98-9
1,3-Butadiene	0000106-99-0	n.d.(DL = 0.02,a.t.i.)
Acrylonitrile	0000107-13-1	n.d.(DL = 0.02,a.t.i.)
1,2-Diaminoethane	0000107-15-3	12
Ethyleneglycol	0000107-21-1	30(T)	w. diethyleneglycol
Glyoxal	0000107-22-2	0.05
Methyl vinyl ether	0000107-25-5	0.05
Disiloxane,hexamethyl-	0000107-46-0	0.05
1,3-Butanediol	0000107-88-0
Butyric acid	0000107-92-6
Dimethylaminoethanol	0000108-01-0	18
Acetic acid,vinyl ester	0000108-05-4	12
Acetic anhydride	0000108-24-7
Succinic anhydride	0000108-30-5
Maleic anhydride	0000108-31-6	30 (T) (e.a maleic acid)
m-Cresol	0000108-39-4
1,3-Dihydroxybenzene	0000108-46-3	2.4	Resorcinol
2,4,6-Triamino-1,3,5-triazine	0000108-78-1	30	Melamine
Benzene,chloro-	0000108-90-7	10
Phenol	0000108-95-2
Methacrylic acid,diester with triethyleneglycol	0000109-16-0	0.05
Pentanoic acid	0000109-52-4
Isobutyl vinyl ether	0000109-53-5		QM = 5 mg/kgin FP
Pentane	0000109-66-0
Ethanol,2-methoxy-	0000109-86-4
Tetrahydrofuran	0000109-99-9	0.6
Succinic acid	0000110-15-6
Maleic acid	0000110-16-7	30(T)
Fumaric acid	0000110-17-8
Acrylamide,N,N'-methylenebis-	0000110-26-9	0.05
Ethyleneglycol monoethyl ether	0000110-80-5	1
Piperazine	0000110-85-0
Trioxane	0000110-88-3	5
Sebacic acid	0000111-20-6
Diethylenetriamine	0000111-40-0	5
N-(2-Aminoethyl)ethanolamine	0000111-41-1	0.05	s. annex 1,list III.11
Diethanolamine	0000111-42-2	0.3
Diethyleneglycol	0000111-46-6	30(T)	w. ethyleneglycol
1-Octene	0000111-66-0	15
1-Heptanol	0000111-70-6
Nonanoic acid	0000112-05-0
Triethyleneglycol	0000112-27-6
1-Decanol	0000112-30-1
1-Dodecene	0000112-41-4	0.05

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Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
1-Dodecanol	0000112-53-8
Tetraethyleneglycol	0000112-60-7
1-Tetradecanol	0000112-72-1
Oleic acid	0000112-80-1
Behenic acid	0000112-85-6
Erucic acid	0000112-86-7
1-Octadecanol	0000112-92-5
Octadecyl isocyanate	0000112-96-9		QM (T) = 1 mg/kg in FP (e.a. NCO)
Propylene	0000115-07-1
Isobutene	0000115-11-7
Hexachloroendomethylenetetrahydrophthalic anhydride	0000115-27-5	n.d. (DL = 0.01)
Hexachloroendomethylenetetrahydrophthalic	0000115-28-6	n.d. (DL = 0.01)
acid
Pentaerythritol	0000115-77-5
Tetrafluorethylene	0000116-14-3	0.05
2,2-Bis(4-hydroxyphenyl)propane bis(2- hydroxypropyl)ether	0000116-37-0	0.05
Terephthalic acid,dimethyl ester	0000120-61-6
1,2-Dihydroxybenzene	0000120-80-9	6
Isophthalic acid	0000121-91-5	5 (T)	a. sum of 99-63-8 and 121-91-5
Phosphorous acid, triethyl ester	0000122-52-1		QM = n.d. (DL = 1 mg/kg in FP)
1,4-Dihydroxybenzene	0000123-31-9	0.6
Propionaldehyde	0000123-38-6
Propionic anhydride	0000123-62-6
Butyraldehyde	0000123-72-8
Azelaic acid	0000123-99-9
Adipic acid	0000124-04-9
Caprylic acid	0000124-07-2
1,6-Diaminohexane	0000124-09-4	2.4
Dimethylamine	0000124-40-3	0.05
1-Propanol,2-amino-2-methyl-	0000124-68-5	5
1,3-Propanediol,2,2-dimethyl-	0000126-30-7	0.05
Dipentaerythritol	0000126-58-9
2,4,7,9-Tetramethyl-5-decyne-4,7-diol	0000126-86-3	5
beta-Pinene	0000127-91-3
Phthalic acid,diallyl ester	0000131-17-9	n.d.(DL = 0.01)
4-(1,1,3,3-Tetramethylbutyl)phenol	0000140-66-9	n.d.
Acrylic acid,ethyl ester	0000140-88-5	6(T)	s. annex 1,list III.17
Ricinoleic acid	0000141-22-0	42
Acrylic acid,n-butyl ester	0000141-32-2	6(T)	s. annex 1,list III.17
2-Aminoethanol	0000141-43-5	0.05	s. annex 1,list III.11
Hexanoic acid	0000142-62-1
Lauric acid	0000143-07-7
1-Nonanol	0000143-08-8
Oxalic acid	0000144-62-7	6
2-Ethylhexanoic acid	0000149-57-5	0.05

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Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
Ethyleneimine	0000151-56-4	n.d.(DL = 0.01)
n-Decanoic acid	0000334-48-5
Palmitoleic acid	0000373-49-9
Dicyanodiamide	0000461-58-5
Linolenic acid	0000463-40-1
Norbornene	0000498-66-8	0.05
2-Oxepanone	0000502-44-3	0.05	(e.a the sum of caprolactone and 6- hydroxyhexanoic acid)
Arachidic acid	0000506-30-9
Abietic acid	0000514-10-3
Gluconic acid,monosodium salt,D-	0000527-07-1		E576
1,2,4-Benzenetricarboxylic acid	0000528-44-9	5	Trimellitic acid
Myristic acid	0000544-63-8
Trimellitic anhydride	0000552-30-7	5(e.a trimellitic acid)
2,6-Dimethylphenol	0000576-26-1	0.05
2,4-Toluene diisocyanate	0000584-84-9		QM (T) = 1 mg/kg (e.a. NCO)
Methacrylic acid,tert-butyl ester	0000585-07-9	6(T)	s. annex 1,list III.18
Phenol,m-tert-butyl-	0000585-34-2	0.05
1-Hexene	0000592-41-6	3
2-Methylepichlorhydrine	0000598-09-4	n.d.(DL = 0.01)
Benzoic acid,2-benzoyl-,methyl ester	0000606-28-0	0.05	under re-evaluation
1,6-Hexanediol	0000629-11-8	0.05
Acrylic acid,isopropyl ester	0000689-12-3	6(T)	s. annex 1,list III.17
4-Methyl-1-pentene	0000691-37-2	0.05
n-Dodecanedioic acid	0000693-23-2
Methacrylic anhydride	0000760-93-0	6(T)	s. annex 1,list III.18
Acrylic acid,monoester with ethyleneglycol	0000818-61-1	6(T)	s. annex 1,list III.17
Hexamethylene diisocyanate	0000822-06-0		QM (T) = 1mg/kg in FP (e.a. NCO)
Methacrylic acid, monoester with	0000868-77-9	6 (T)	s. annex 1, list III.18
ethyleneglycol
1-Decene	0000872-05-9	0.05
3-Aminopropyltriethoxysilane	0000919-30-2	0.05	s. annex 1,list III.19
N-Methylolmethacrylamide	0000923-02-4	0.05
N-Methylolacrylamide	0000924-42-5	n.d. (DL = 0.01 e.a.acrylamide)
Acrylic acid, propyl ester	0000925-60-0	6(T)	s. annex 1,list III.17
Laurolactam	0000947-04-6	5
Acrylic acid,2-hydroxypropyl ester	0000999-61-1		QMA = 0.05 mg/6 dm²
1-Vinylimidazole	0001072-63-5		QM = 5 mg/kgin FP
1,4-Cyclohexanedicarboxylic acid	0001076-97-7	5
1-Tetradecene	0001120-36-1	0.05
2,6-Naphthalenedicarboxylic acid	0001141-38-4	5
Phosphoric anhydride	0001314-56-3
Divinylbenzene	0001321-74-0	n.d.(DL = 0.02,a.t.i.)
Isophthalic acid,dimethyl ester	0001459-93-4	0.05
1,3-Benzenedimethanamine	0001477-55-0	0.05
Methallylsulphonic acid,sodium salt	0001561-92-8	5

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Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances

Designation	CAS n°	SML [mg/kg]	Remarks
Acrylic acid,tert-butyl ester	0001663-39-4	6(T)	s. annex 1,list III.17
2,2-Bis(4-Hydroxyphenyl)propane bis(2,3- epoxypropyl)ether(=BADGE)	0001675-54-3		s. annex 1, list III.5
4-(Hydroxymethyl)-1-cyclohexene	0001679-51-2	0.05
Bis(4-Aminocyclohexyl)methane	0001761-71-3	0.05
tert-Butyl-hydroquinone(TBHQ)	0001948-33-0	42
Methacrylic acid,diester with 1,4-butanediol	0002082-81-7	0.05
Acrylic acid,dodecyl ester	0002156-97-0	0.05	ECM
2-Methyl-1,3-propanediol	0002163-42-0
Methacrylic acid, phenyl ester	0002177-70-0	6(T)	s. annex 1,list III.18
Methacrylic acid, propyl ester	0002210-28-8	6(T)	s. annex 1,list III.18
1,4-Butanediol bis(2,3-epoxypropyl) ether	0002425-79-8		QM = 1 mg/kg in FP (e.a. epoxy group,MW = 43)
Acrylic acid,2-(dimethylamino)ethyl ester	0002439-35-2	0.05
Acrylic acid,benzyl ester	0002495-35-4	6(T)	s. annex 1,list III.17
Methacrylic acid,benzyl ester	0002495-37-6	6(T)	s. annex 1,list III.18
Methacrylic acid,3-(trimethoxysilyl)propyl ester	0002530-85-0	0.05
Vinyltrimethoxysilane	0002768-02-7		QM = 5 mg/kgin FP
1-Amino-3-Aminoethyl-3,5,5- trimethylcyclohexane	0002855-13-2	6
Methacrylic acid,2-(dimethylamino)ethyl ester	0002867-47-2	n.d.(DL = 0.02,a.t.i.)
Acrylic acid,sec-butyl ester	0002998-08-5	6(T)	s. annex 1,list III.17
Isocyanic acid, 1,5-naphthylene ester	0003173-72-6		QM (T) = 1mg/kg in FP (e.a. NCO)
N-Vinyl-N-methylacetamide	0003195-78-6	0.05
1,1,1-Trimethylolpropane trimethacrylate	0003290-92-4	0.05
Ethanamine,N-ethyl-N-hydroxy-	0003710-84-7	0.05
Crotonic acid	0003724-65-0		QMA = 0.05 mg/6 dm²
1-Isocyanato-3 -isocyanatomethyl-3,5,5- trimethylcyclohexane	0004098-71-9		QM (T) = 1mg/kg in FP (e.a. NCO)
1,5-Pentanediol,3-methyl-	0004457-71-0	0.05
2,2-Bis(hydroxymethyl)propionic acid	0004767-03-7	0.05
Methacrylic acid, ester with trimethylethanolammonium chloride	0005039-78-1	0.05
Dicyclohexylmethane-4,4′-diisocyanate	0005124-30-1		QM (T) = 1 mg/kg in FP (e.a. NCO)
Diphenylmethane-2,4'-diisocyanate	0005873-54-1		QM (T) = 1 mg/kg in FP (e.a. NCO)
Hypophosphorous acid	0006303-21-5
3,3'-Dimethyl-4,4'-	0006864-37-5	0.05
diaminodicyclohexylmethane
Malic acid	0006915-15-7		racemic mixture
Ammonium,diallyldimethyl-,chloride	0007398-69-8	5
Phosphoric acid	0007664-38-2
Ammonia	0007664-41-7
Pyrosulfurous acid,disodium salt .	0007681-57-4		E223
Chlorine	0007782-50-5
Castor oil,hydrogenated	0008001-78-3
Castor oil	0008001-79-4
Tall oil	0008002-26-4

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