Federal office of public health
Annex 6 of the Ordinance of the FDHA on articles and materials of 23 November 2005 (RS 817.023.21)
Lists of permitted substances for the manufacture of packaging inks, subject to the requirements set out therein
4th edition : 1.12.2012 Entry into force : 1.04.2013
Ordinance of the FDHA on articles and materials - Annex 6, definitions and explanations
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)
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 amines released. |
Status on 1st December 2012
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Ordinance of the FDHA on articles and materials - Annex 6, definitions and explanations
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.
1.1 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.
2.1 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 December 2012
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Ordinance of the FDHA on articles and materials - Annex 6, definitions and explanations
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 December 2012
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Ordinance of the FDHA on articles and materials of 23 November 2005 (RS 817.023.21)
Lists of permitted substances from 1 April 2013 for the manufacture of packaging inks, subject to the requirements set out therein
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. hexamethylenetetramine |
| 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) | QM = 5 mg/kgin FP |
| 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 | 0.05 | |
| Glycolic acid | 0000079-14-1 | only to be used behind a PET layer |
|
| 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 |
Status on 1st December 2012
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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 |
|---|---|---|---|
| Phthalic anhydride | 0000085-44-9 | ||
| Vinylpyrrolidone | 0000088-12-0 | QMA < 10 µg/6 dm² (DL = 0.01 mg/kg) |
|
| 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 | 5 | |
| 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 | 30 | 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) |
|
| 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) |
|
| 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- hydroxypropyl)ethylenediamine |
0000102-60-3 | ||
| Triethanolamine | 0000102-71-6 | 0.05 | SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine |
| 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 |
Status on 1st December 2012
3/10
Ordinance on articles and materials - Annex 6, List of binders (monomers), Part A : evaluated substances
| Designation | CAS n° | SML [mg/kg] | Remarks |
|---|---|---|---|
| 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 | ||
| Acrylic acid, isobutyl ester | 0000106-63-8 | 6(T) | s. annex 1, list III.17 |
| Epichlorohydrin | 0000106-89-8 | n.d. | 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.) |
QM = 1 mg/kg in FP |
| 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 | 2.5 | 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 | 0.05 | |
| Pentane | 0000109-66-0 | ||
| Ethanol, 2-methoxy- | 0000109-86-4 | 0.05 | |
| 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 |
Status on 1st December 2012
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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 |
|---|---|---|---|
| Dipropyleneglycol | 0000110-98-5 0025265-71-8 |
||
| 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 | |
| 1-Dodecanol | 0000112-53-8 | ||
| Tetraethyleneglycol | 0000112-60-7 | ||
| 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 acid |
0000115-28-6 | n.d. (DL = 0.01) | |
| 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) | |
| Phosphorous acid, triethyl ester | 0000122-52-1 | n.d. | DL = 1 mg/kgin 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 |
Status on 1st December 2012
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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 |
|---|---|---|---|
| 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 | |
| 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-Methylepichlorohydrin | 0000598-09-4 | n.d.(DL = 0.01) | |
| Benzoic acid, 2-benzoyl-, methyl ester | 0000606-28-0 | 0.05 | |
| 1,6-Hexanediol | 0000629-11-8 | 0.05 | |
| 1,10-Diaminodecane | 0000646-25-3 | 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 ethyleneglycol |
0000868-77-9 | 6 (T) | s. annex 1, list III.18 |
Status on 1st December 2012
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