Japanese official method

The MHLW described the validation protocol criteria in the 2006 official guidelines to standardize the Japanese official method for specific allergenic ingredient detection. The outlines of the validation protocol criteria for the food allergenic ingredient quantitative and qualitative detection methods are shown in Tables 4.7 and 4.8, respectively. 

In September 2010, CAA annoimced the addition of ALLERGENEYE ELISA series of kits for egg, milk, wheat, buckwheat, and peanut as Japanese official methods based on their validation determined by the Japanese validation protocol. 

Alternative methods are possible the three regional pharmacopeias (United States, European, and Japanese) allow an individual laboratory able to do the official method to validate an alternative method of analysis. The latter is chosen usually for speed, eonvenience, or expense but also to incorporate an existing database when a new or revised pharmaeopeial method is adopted. Under those provisions, a laboratory ean validate a method from another pharmacopeia, thereby avoiding duplication of routine work. In all three cases, only the official method could be used in eompli-ance or contest. One point of harmonization is to avoid even the more remote in-stanees of duplieative testing in addition to international produet registration. 

In JP monographs, the specification value and testing procedure are described as a comparative limit test for the quantity of heavy metals that exist in drug substances as inorganic impurities. The permissible limit on the ppm scale for heavy metals (as Pb) is prescribed as the specification value. From the development stage to the establishment of the limit test method for a monograph, the validation in place has to be done for both the quantitative method for actual measurement and the comparative limit method with the control solution. However, the quantitative procedure has not been stated in the section on the heavy metals limit test in the JP s General Tests and other Japanese official... 

Naphazoline hydrochloride dmg substance may be titrimetrically assayed as described in the USP monographic. The hydrochloride salt is dissolved in glacial acetic add with mercuric acetate and titrated with dilute perchloric add using crystal violet as the indicator. Also, nonaqueous titration of naphazoline hyd Uoride in acetic anhydrid gladal acetic add with dilute perchloric add and potentiometric detection h been described as an official method in the Japanese Pharmacopoeia. In addition, nonaqueous titration with dioctylsulfosucdnate sodium salt using 3 3 5 5"-tetrabromophenolph-thalein as the indicator has also been reported. ... 

Japanese Pharmacopoeia (JP), and the EP. In addition, a CZE method is currently used as an identification test for EPO concentrated solution in the EP. This represents the first example of the use of CE for the monitoring of a biopharmaceutical by an official method. A second example is in the final stage of implementation and involves the determination by CZE of charge variants in somatropin preparations. This test, which was found to provide more precise quantitative data, will replace the current isoelectric focusing method. 

Figure 1. Number of Pesticides Regulated and Official Methods under the Japanese Food Sanitation Law...

As was also mentioned in Section 2.1, there are no official methods for preservative determination pubhshed by FDA and Japanese authorities. 

Most new patent cases of interest are pubHshed by at least one of the U.S., European, or Japanese patent offices, and WIPO (PCT). Japan presents problems for those not able to read Japanese, but the U.S. Official Ga tte (with representative claims) and PCT Ga tte (with English-language abstracts) can be in one s hands within a week of patent pubHcation. Similar timing is available for the European Patent Office bulletin which contains trilingual tides and the on-line EPAT file and various CD-ROM products. A highly effective alerting program can be developed from a combination of these methods. 

Ministry of Environment, The Official Analytical Methods of the Ministry of Environment, Japan, Ministry of Environment, Tokyo, mefenacet (1993), clomeprop (1996), naproanriide (2000) (in Japanese). 

According to the official Japanese HPLC/UV method, the average recovery for grapes fortified with 0.2mgkg of acetamiprid was 96% and that for tomato fortified with 0.4mgkg of imidacloprid was 90% (personal data). The recovery of nitenpyram from fruits, vegetables and rice was 66-85% at 0.2-0.8 mg kg fortification levels. The LOD was 0.0025-0.01 mg kg ... 

Fig. 1 Exemplified overview and interconnectivity of standardization of analytical methods for food. CEN The European Committee for Standardization, ISO International Organization for Standardization, JSA Japanese Standardization Agency, AACC American Association of Cereal Chemists, AOAC Association of Official Analytical Chemists, CCMAS Codex Committee of Methods of Analysis and Sampling...

Suzuki, T, Jin, T, Shirota, Y, Mitsuya, T, Okumura, Y, and Kamiyama, T. 2005b. Quantification of lipophilic toxins associated with diarrhetic shellfish poisoning (DSP) in Japanese bivalves by liquid chromatography-mass spectrometry (LC-MS) and comparison with mouse bioassay (MBA) as the official testing method in Japan. Fish Sci 71, 1370-1378. 

Official. Those 590 excipients that have been recognized in the JP, Japanese Pharmaceutical Codex, and Japanese Pharmaceutical Excipients, and for which testing methods and standards have been determined. Table 11 summarizes official excipients used in parenteral products. 

To assure drug quality, various countries have published texts commonly called compendia or pharmacopoeias that list official test methods as well as specifications for commonly used drug products. Three notable examples of such compendia are the United States Pharmacopoeia (USP), the European Pharmacopoeia, and the Japanese Pharmacopoeia. Compendial methods should be implemented as written except where scientifically justified changes are necessary. Although considerable efforts are ongoing to standardize pharmacopoeias, differences may exist between the USP and other pharmacopoeias. In these instances, testing should be done in accordance with the procedures... 

So, methods of analysis for the final product do exist and are in the possession of the Japanese authorities for all active ingredients in quasi-drugs, but they are not officially published. 

In summary, in the ROK there are official specifications for cosmetic ingredients found in the Japanese or Korean dictionaries (JSCI and JCID, KSCI and JSCI, INCI dictionary) and official analytical methods for some heavy metals, methanol and pH. The manufacturers must have analytical methods available to check the content of active ingredients in quasi-drugs or cosmeceuticals in the finished product, and submit these to the authorities, which will use them to control products at the time of registration and once the product is on the market. These methods are not officially published. 

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