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Regulatory | Regulatory Information

21CFR 178.3297-2% (US FDA)

Approved for use as a colorant in all polymers intended to contact food, at a level not to exceed 2% by weight. Listed under 21CFR 178.3297

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21CFR 73.2775 (US FDA)

Approved for use as a colorant for cosmetics, including those applied in the area of the eye. Listed under 21CFR 73.2775.

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AP(89)1 (Europe)

Council of Europe AP(89)1 Approved Pigments - migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium from the following pigments are typically below the limits set forth in the Council of Europe?s resolution AP(89)1 on the use of colourants in plastic materials coming into contact with food, 13 September 1989.

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AS2070-1999 (Australia)

Australian Standard AS 2070-1999 Approved Pigments - migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium from the following pigments are typically below the limits set forth in the Australian Standard AS 2070-1999, Plastics materials for food contact use (4.1.2 Colourants), published 5 March, 1999.

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BfR (Germany)

List of the BfR Approved Pigments: Pigments are not regulated by the Bundesinstitut für Risikobewertung (BfR) unless they contain dangerous substances. The following Shepherd pigments are free of dangerous sunstances and therefore do not require BfR registration.

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CONEG (United States)

The following pigments typically contain a sum total of the regulated metals lead, cadmium, mercury, and hexavalent chromium below the strictest specification of 100 ppm set forth in the Model Toxics in Packaging (CONEG) legislation.

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EU Packaging - 94/62/EC (EU)

The following pigments typically contain a sum total of the regulated metals lead, cadmium, mercury, and hexavalent chromium below the strictest specification of 100 ppm set forth in the Council of Europe Directive 94/62/EC, on packaging and packaging waste.

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FDA Drugs (US FDA)

Approved for use as a coloring agent indrugs for external use only in an amendment to the Food and Drug Regulations, Schedule No. 846, Department of National Health and Welfare, March 11, 1995.

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GB9685 : 2016 (China)

Pigments typically meet the purity requirements set forth in the National Food Safety of the People?s Republic of China, GB9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles. Please see GB9685:2016 document for limitations.

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RoHS/ELV/WEEE (EU)

List of the ELV, RoHS and WEE Approved Pigments: The following pigments meet the purity thresholds for lead, cadmium, mercury and hexavalent chromium as specified in European Directives for the End of Life Vehicles (ELV), Restrictions on the use of hazardous substances in electrical and electronic equipment (RoHS) and Waste electronic and Electrical Equipment (WEEE) as they are currently written.

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TCLP (USA)

List of TCLP Approved Pigments: The following pigments typically do not exhibit extractable contaminants in excess of those listed in 40CFR 261.24, using the Toxic Characteristic Leaching Procedure, Method 1311, 40CFR 261 appendix II. These products are thus not considered toxic for disposal purposes.

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