Mandatory labelling

Since the MHLW designated shrimp/prawn and crab for mandatory labeling in June 2008 due to the almost unlimited use of crustacean in the processed foods in Japan and the status as a frequent cause of adverse food reactions in allergic patients, two ELISA methods for the determination of crustacean protein in processed foods have been developed (Seiki et al, 2007 Shibahara et al., 2007) EA test EIA-Crustacean [Nissui] produced by Nissui Pharmaceutical Co., Ltd. and Crustacean Kit [Maruha ] produced by Maruha Nichiro Eoods, Inc. Both kits have been validated according to the Japanese validation protocol (Sakai et al., 2008) and are commercially available. All the commercial ELISA kits are shown in Table 4.9. 

Since the MHLW designated shrimp/prawn and crab for mandatory labeling in June 2008, respective PCR methods to discriminate between shrimp/prawn and crabs in processed foods have been developed. 

Dyes. Dose does not appear to be a factor in patient reaction to dyes. The mandatory labeling of the azo dye tartrazine (FD C yellow No. 5) in OTC and prescription medications [58] has focused the attention of pharmaceutical manufacturers and the consumer on the potential danger of dyes in susceptible individuals. 

In addition, labels for medicines must conform to requirements for labelling described in the SUSDP. The Required Advisory Statements for Medicine Labels (RASML) document has been established to enable the transfer of aU mandatory label advisory statements from the SUSDP and the Therapeutic Goods Regulations to a new document, separate from, but linked to, TG069. 

Mandatory labeling schemes that do not provide a threshold for exemption of labeling are very difficult to enforce and are virtually impossible to comply with. Un-... 

The consumption of foods high in TFA has been shown to raise low-density lipoprotein cholesterol (LDL or bad cholesterol), which increases the risk of developing coronary heart disease (CHD). This prompted the Food and Drug Administration (FDA) to require mandatory labeling of the fran -fat content in foods. Food manufacturers have to comply by January 1, 2006. The FDA s chemical definition of TFA or trans-fats (TF) is unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in the frani-configuration. ... 

The 1962 Kefauver-Harris amendments provided further capability to FDA. They set forth the requirements of the IND process. The FDA was empowered, for the first time, to seize a drug and cause it to be withdrawn. Adverse event reporting to FDA became mandatory. Labeling and advertising requirements were clarified, and transferred that responsibility to FDA from the Federal Trade Commission. Inspections of manufacturing sites were also facilitated by these far-reaching amendments. 

Mandatory labeling required of Buckwheat, eggs, milk and milk products (lactose included), peanut and wheat. Recommended labeling required by notice of MHLW Abalone, crab, mackerel, salmon, salmon roe, shrimp, squid, beef, chicken, pork, gelatin, apple, kiwi, orange, peach, matsutake. mushroom, soybean, yam and walnut. Additionally, discussions are currently underway to declare banana as an allergen. ... 

A good illustration of the need to consider a range of communication factors is presented by the recent case of Ziglar v. El. Dupont de Nemours Co. In this case, a worker, thinking that water was in a translucent jug which was shaped similar to the type used in the retail sales of milk, drank some of the water-like contents and then died. Unfortunately, the jug contained an experimental pesticide. The manufacturer had complied with all applicable mandatory labeling requirements. However, the court found that not every reasonable warning precaution had been taken, and pointed to the following factors ... 

Between Europe and Japan are such countries as Brazil, China, Russia, and last but not least, Switzerland. These countries have typically quite stringent mandatory labeling regulations which are process based but do not require traceability. 

Efforts are under way to review currentprovisions of the Australia and New Zealand Eood Standards Code relating to the declaration of priority allergens, including the list of substances that are subject of mandatory labeling, as well as conditions of use of precautionary statements. 

Many governments have, or are in the process of implementing legislation to reduce the total TFA content of food products by introducing mandatory labeling of total isolated TFA (48), or restricting the sale of industrially produced fats and oils with more than 2% total TFA (49). CLA were excluded from the total TFA content in the U.S. regulation because there was no evidence to indicate that CLA increased... 

Yurawecz, M.P. FDA Requires Mandatory Labeling of Trans Fat, Inform 15 184-185... 

Intake of trans fatty acids is associated with a higher risk of CVD (Aro, 1998). Several countries have introduced mandatory labeling of total trans fatty acids in food products. However, the specific trans fatty acids responsible for the detrimental effects have not been identified nor is it known whether PHVO and ruminant fats present the same risk. Most work has been done using PHVO but, as noted above, ruminant fats have a different distribution. 

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