Certification, of colorants

Certification of Colorants. A further distinction between color additives is made relative to whether there is requirement for FDA certification. In general, only synthetic organic colorants are now subject to certification, whereas natural organic and inorganic colorants, such as turmeric and titanium dioxide, are not. The exemption from certification for a particular colorant holds whether the colorant is obtained from natural sources or is synthetically produced, as in the case of natural and synthetic -carotene. 

In the performance of its functions, the U. S. Food and Drug Administration has issued Service and Regulatory Announcements 2, as revised from time to time, on Definitions and Standards of Foods, No. 3 on certification of colors, and also Notices of Judgement under the Federal Food, Drug, and Cosmetic Act, which contains information necessary for nearly all food processors. Many states and cities have sanitary codes to regulate the production and sale of foods. There are available legal texts which cover this phase of the subject. 

The Color Additive Amendment of 1960 regulates the listing and certification of color additives. About 1,700 samples are examined annually by FDA scientists. 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

The terms FD C, D C, and External D C (Ext. D C), which are part of the name of colorants, reflect the FDA s colorant certification. FD C dyes may be used for foods, dmgs, and cosmetics D C dyes are allowed in dmgs and cosmetics and Ext. D C dyes are permitted only in topical products. Straight colorants include both the organic dyes and corresponding lakes, made by extending the colorant on a substrate such as aluminum hydroxide or barium sulfate. The pure dye content of these lakes varies from 2 to 80% the organic dyes contain over 80% pure dye. Colorants certified for cosmetic use may not contain more than 0.002% of lead, not more than 0.0002% of arsenic, and not more than 0.003% of heavy metals other than lead and arsenic. 

U.S. Eood and Drug Administration, Listing of color additives exempt from certification sodium copper chlorophyllin, 21CER Part 73, 67 Fed. Reg. 35429, May 20, 2002. 

Part 73 Listing of color additives exempt from certification — This part identifies listed color additives exempt from certification, provides chemical specifications for these color additives, and identifies uses, restrictions, labeling requirements, and requirements for certification. 

Copies of regulations governing the listing, certification, and use of colors in foods, drags, devices, and cosmetics shipped in interstate commerce or offered for entry into the United States, or answers to questions concerning them, are available from the Food and Drag Administration. Recommendations on submission of chemical and technological data are provided in the FDA s online publication (http //vm.cfsan.fda.gov/ -dms/opa-coll.html). 

Table 8.1 Regulatory and safety status of colorants exempt from certification in the USa...

Although the Kohnstamm certificate for light green was certainly a major step, the project was far from finished. This was only one color, and a small laboratory test batch at that. Still, it now seemed certain to Hesse that all seven colors would eventually be available for sale with certification of their quality, and the promise of FID 76, that use of any dye other than one of the seven in certified form would be ground for prosecution, could be realized. 

Once the material has been packaged, it must then be checked for uniformity. Any additional characterization of the material, in the form in which it will be distributed (e.g., grain size, color) should be conducted at this stage. Subsequently, the material is analyzed for the analyte(s) of interest for certification purposes, after which the certificate of analysis can be prepared. It is also imperative that a certified reference material or reference material be continually monitored for stability throughout its... 

In the United States two classes of color additives are recognized colorants exempt from certification and colorants subject to certification. The former are obtained from vegetable, animal, or mineral sources or are synthetic forms of naturally occurring compounds. The latter group of synthetic dyes and pigments is covered by the Color Additives Amendment of the U.S. Food, Drug and Cosmetic Act. In the United States these color compounds are not known by their common names but as FD C colors (Food, Drug and Cosmetic colors) with a color and a number (Noonan 1968). As an example,... 

A color technician tests 3-10 batch samples on each piece of equipment two to three times each. The AV now becomes appraisal reproducibility for each EV piece of plastics dispersion equipment. This technique is also useful for comparing supplier Certificate of analysis (COA) data against your own incoming quality control (QC) testing to determine reliability between the two sets of data. To accomplish this, you must request duplicate sets of color data for each lot over 3-10 consecutive lots. 

It is advisable to use a color-coded labeling system to keep track of the test stages. In our case, a yellow spot was added after successful heat cycling with test software loaded, and a green spot half covering the yellow spot was added once the validated software had been loaded and the board tested successfully no device could be shipped unless both spots are present. The manufacturer will be expected to supply a certificate of conformity for the devices produced and packed with each batch. 

The Pure Food and Drug Act of 1906 listed seven colors, based on the work of Dr. Bernhard Hesse, and the Department of Agriculture made provisions for certification of all food colors on a voluntary basis. 

Table 3 List of color additives exempt from certification permitted for use in the U.S. in 2000 ... 

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