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FDA "GRAS" PIGMENTS LIST |
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FDA "GRAS" PIGMENTS LIST |
The use of colourants in plastics for indirect food-contact applications in the USA is controlled by the FDA and its requirements are laid down in regulation 21 CFR § 178.3297.
The FDA document gives a list of materials which may be safely used as colourants in the manufacture of articles, or components of articles, intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food. Certain restrictions are also laid down as follows :-
- the colourant must be used in accordance with current good manufacturing practice, including use levels which are not in excess of those reasonably required to accomplish the intended colouring effect.
- colourants must conform to the description and use specifications laid down in 21 CFR § 178.3297. Should the polymer itself be subject to regulation, then it too must conform to the relevant specifications and limitations which may be laid down.
- Colour additives and their lakes which are listed for direct use in foods in parts 73, 74, 81 and 82 of chapter 1 of 21 CFR 178 may also be used as colourants for food-contact polymers.
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The list below is taken from 21 CFR § 178.3297 (1st April 2009 edition) and is not complete - for example, it does not include optical brighteners. If in any doubt, please consult the latest official version which is available on-line from the US National Archives and Records Administration by using their retrieval system - please click the button. |
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Chapter 21 of the CFR is updated on 1st April every year : in the case of the 2010 updates, sections 170 - 199 of chapter 21 were not modified and the 2009 versions are, therefore, still current. Where there is mention of restrictions on the use of a specific material, the current edition of this document should be downloaded from the above address and checked for further information on the limitations which have been imposed.
Material
Restrictions ?
Aluminium Aluminium hydrate Aluminium and potassium silicate (mica) Aluminium mono-, di- and tristearate Aluminium silicate (china clay) CI Pigment Red 187 Yes
CI Pigment Yellow 181 Yes
CI Pigment Violet 29 Yes
Barium sulphate Bentonite Bentonite (modified) Yes
CI Pigment Red 254 Yes
Burnt umber Calcium carbonate Calcium silicate Calcium sulphate Carbon black (channel process) CI Pigment Yellow 191 and 191:1 Yes
Chrome antimony titanium buff rutile (CI Pigment Brown 24) Yes
Chromium oxide green (CI Pigment Green 17) Yes
Cobalt aluminate Yes
Copper chromite black spinel (CI Pigment Black 28) Yes
D&C Red No. 7 and its lakes Diatomaceous earth CI Pigment Red 202 Yes
CI Pigment Yellow 183 Yes
CI Pigment Red 179 Yes
CI Pigment Yellow 180 Yes
High-purity furnace black Yes
Iron oxides Kaolin (modified) Yes
Magnesium oxide Magnesium silicate (talc) Manganese Violet
(manganese ammonium pyrophosphate CAS 10101-66-3)Yes
Nickel antimony titanium yellow rutile (CI Pigment Yellow 53) Yes
Phthalocyanine blue (CI Pigment Blue 15, 15:1, 15:2, 15:3 and 15:4) Phthalocyanine green (CI Pigment Green 7) CI Pigment Red 38 Yes
Quinacridone Red (CI Pigment Violet 19) Sienna (raw and burnt) Silica CI Pigment Yellow 138 Yes
Titanium dioxide Titanium dioxide - barium sulphate Titanium dioxide - magnesium silicate Ultramarines Yes
Zinc carbonate Yes
Zinc chromate Yes
Zinc oxide Yes
Zinc sulphide Yes
Colourants and their lakes permanently listed for direct use in foods may also be used as food-contact polymer colourants (see above).
SINCE THE FDA LIST MAY HAVE BEEN UPDATED SINCE THIS PAGE WAS LAST REVISED, WE STRONGLY RECOMMEND CUSTOMERS TO CONSULT THE LATEST OFFICIAL VERSION OF THE REGULATIONS FOR COMPLETE INFORMATION (SEE ABOVE).
