Certification-exempt

Certifiable and certification-exempt colour additives must undergo the FDA pre-market approval process in order to be listed. A proposal to list a new colottr additive or new uses of a colour additive is made by petition to the FDA as desoibed in 21 CFR Part 71. Descriptions of the approval process can be found on the FDA website (see references). The listing regulations desoibe the identity of each colottr additive, specifications, uses and restrictions, labeling requirmnents, and the requirement for or exanption lirom batch certification. In addition, a regttlation must specifically authorize use of the colottr additive in the area of the eye (21 CFR Section 70.5(a)), in injections (21 CFR Section 70.5(b), currently, no colour additive is listed for use in injections), and in surgical sutures (21 CFR Section 70.5(c)). 

Colour Index (Cl) number. Not used in the U.S. for certification-exempt color additives. Chemical Abstracts Service (CAS) number. 

In U.S., for example, the colouring agents that are part of a cosmetic product must be declared by name on the product s label (21 CFR Section 701.3). Analysis of the cosmetic may find undeclared certified or certification-exempt colour additives. If the information is not complete or not correct, the product is misbranded and may also be adulterated depending on what is found. 

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. 

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. 

This pigment is recognized by the U.S. Food and Drug Administration (21 Code of Federal Regulations, Part 73) as a color additive exempted from certification (Subpart A, Foods, Section 73.35, Astaxanthin). Formulations containing astaxanthin include soft gelatin capsules containing 100 mg equivalents of total carotenoids, a skin care... 

Color additives are naturally and synthetically derived. In the past 20 years, consumers have become increasingly aware of the ingredients in their foods and they desire foods be as natural as possible. This fact combined with technological developments have fueled the increases in uses of naturally derived colors. Moreover, additives must be safe and stable in food matfices. Legislation has established which colorants may be used as food additives, taking into account toxicity of compounds and methods of assessment. The European Union currently allows the use of 13 naturally derived colors but 26 colors are exempt from certification... 

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. 

Colorants exempt from certification are derived from animal, vegetable, or mineral origin or are synthetic duplicates of naturally existing colors. They contain complex mixtures of numerous components and are listed in 21 CFR, part 73. 

From a regulatory view, there is no such thing as a natural color, although it is generally accepted that colorants exempt from certification are usually naturally derived. ... 

Hallagan, J.B., Allen, D.C., and Borzelleca, J.F., The safety and regulatory status of food, drug and cosmetic color additives exempt from certification. Food Chem.Tox-icoL, 33, 515, 1995. 

Synthetic colorants are classified by the FDA as certified color additives and are defined as synthetically produced organic molecules that have their purities checked by the FDA. " A second category, colorants exempt from certification, includes naturally derived (animal, vegetal, mineral) compounds or their synthetic duplicates. Table 7.3.2 presents a summary of synthetic colorants and their utilization as food additives. 

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

In the United Kingdom, clinical trial applications are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). There are several schemes for clinical trial application the major two are the Clinical Trial Certificate (CTC) and Clinical Trial Exemption (CTX) schemes. 

Medicines Control Agency. Medicines Act 1968. Guidance Notes on Applications for Clinical Trial Exemptions Clinical Trial Certificates. Revised December 1995. London HMSO, 1995. 

The regulations introduce a number of amendments into Schedule 3 (standard provisions for wholesale dealer s licences) of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971. The 1999 Regulations reproduce the relevant wording from the Directive (including the reference to special needs ). Supply of an exempt imported product falling within the scope of this wording is only permitted provided certain conditions are complied with ... 

Prior to the introduction of EU Clinical Trials Directive, there were four ways of seeking approval for the commencement of clinical trials in the United Kingdom. These were by means of a Clinical Trial Certificate (CTC), a Clinical Trial Exemption (CTX), a Doctor s and Dentist s Exemption (DDX) or as a Clinical Trial on a Marketed Product (CTMP). Each required provision of a detailed protocol of the proposed trial. 

The addition of additives to food, including colour additives, is strictly regulated in the developed world, for example by the Food and Drug Administration in the USA." Colonr additives are classified by the FDA as either certifiable or exempt from certification . 

The final cost and time saving to be discussed is the batch certification provision. The important aspect of this provision is that FDA, not industry as in the past, will now be responsible for certifying the quality of batches of such drugs as antibiotics. Hence, given that FDA would be paying the bill and would be responsible in part for an adequate supply of drugs such as antibiotics, the certification process is expected to be timely. Furthermore, under this provision, companies can establish a certification record that will allow them to be exempted from this requirement—a time as well as cost savings. 

Exempt colors do not have to undergo formal FDA certification requirements, hut are monitored for purity. The colorants exempt from FD C certification are annatto extract, /i-carolene, beet powder, 0-apo—8 -carntenol. canlhaxanthin. caramel, carmine, carrot oil. cochineal extract, cottonseed Hour, ferrous gluconate, fruit juices, grape skin extract, paprika, paprika oleoresin. riboflavin, saffron, titanium dioxide, turmeric, turmeric oleoresin. ultramarine blue, and vegetable juices. See also Colorants (Foods). 

Food colours are broadly divided into two classes natural and artificial. In the United States, these are listed as either exempt from certification or certified . The natural colours are botanical extracts, with the exception of carmine (a red colour), which should perhaps be termed an entomological extract as it is obtained from the insect Dactilopius coccus, sometimes termed the cochineal beetle, which breeds and feeds on particular cacti indigenous to Central and South America. Table 5.6 lists artificial colours permitted in soft drinks under EU legislation. 

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