Disponemos de un amplio Porfolio de Colorantes grado FDC (food Drugs and Cosmetics)
Colorantes
SICOVIT PIGMENTS
Colors Represent Mass Tone and Tint Tone 1:3 / 1:9
Product Regulations
Application
Pharma
Cosmetics
Pet food
Animal Feed
Food
SICOVIT Pigments
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SICOVIT®
E172 – Regulation (EU) 231/2012
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Cosmetics – Regulation (EU) 1223/2009
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Cosmetics – FDA 21CFR73.2250
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Cosmetics – NATRUE Label criteria Annex 2: Nature-identical inorganic pigments and minerals approved in natural and organic cosmetics.
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Safety and Technical Standard for Cosmetics
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Foods – FDA 21CFR73.200
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Feed additives – Regulation (EC) No.1831/2008 – Regulation (EC) No. 183/2005
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JECFA
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Kosher
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HALAL
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VEGAN
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PHARMACOPEIAL STANDARDS – United States Pharmacopeia (USP-NF), Japanese Pharmaceutical Excipients (JPE), Chinese Pharmacopoeia (ChP) and European Pharmacopeia (Ph. Eur). [only for SICOVIT]
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Drugs – FDA 21CFR73.1200 & Medical Devices 21CFR73.3125
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EXCiPACT Certification Standard for Pharmaceutical Excipient Suppliers: (GMP/GDP/GWP)
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UK Cosmetics Status
Iron oxides are listed in Annex IV of Schedule 34 of the Product Safety and Metrology Statutory Instrument, which itself is an amendment of Annex IV of European Regulation (EU) No. 1223/2009, under the reference numbers 137, 135 and 136 as color allowed in cosmetic product without restriction on the type of product or body part when complying with E172 food colour specification.
FDA
The U.S. Code of Federal Regulations: 21CF73.200 for use in food (sausage casings up to 0.1%, soft and hard candy, mints and chewing gums at GMP level and 0.25% limit in cat and dog food) – 21CFR73.1200 for use in drug products – 21CFR73.2250 for use in cosmetics – 21CFR73.3125 for use in medical devices (e.g. contact lenses).
E172
Regulation (EU) 231/2012 European Union Commission Regulation laying down specifications for food additives. Recommended application areas are based on the regulatory guidelines listed above; please refer to local regulatory requirements.
China Cosmetic Status
Iron oxides are listed in the China Inventory of Existing Cosmetic Ingredients (IECIC) under their colour index number and listed in Table 6 of chapter 3 of the Chinese Safety and Technical Standard for Cosmetics (2015) under Pigment Black 11, Pigment Red 101 and Pigment Yellow 42 as permitted colourants in all cosmetics without restriction. High Purity products were registered as raw materials under CSAR (China-Cosmetic Supervision and Administration Regulation).
JAPAN Cosmetics Status
Black, red, yellow iron oxides are listed in the list of quasi-drugs additives (Pharmaceutical Affairs Bureau Notification No. 0327004, Food and Drug Evaluation & Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW, Oct. 13, 2016) respectively under the codes 109024, 109870 and 107704 without safety report required for usage in specified categories.
EXCIPACT (GMP/GDP/GWP)
Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Warehousing Practices (GWP)
JECFA
Joint FAO/WHO Expert Committee on Food Additives.