Bovine spongiform encephalopathy regulations

The normal cellular form of prion protein (PrPc) can exist as a Cu-metalloprotein in vivo (492). This PrPc is a precursor of the pathogenic protease-resistant form PrPsc, which is thought to cause scrapie, bovine spongiform encephalopathy (BSE), and Creutzfeldt—Jakob disease. Two octa-repeats of PHGGGWGQ have been proposed as Cu(II) binding sites centered on histidine (493). They lack secondary and tertiary structure in the absence of Cu(II). Neurons may therefore have special mechanisms to regulate the distribution of copper. 

EFSA was legally established by a European Parliament and Council Regulation adopted in 2002 following a series of food scares in the 1990s including the Bovine Spongiform Encephalopathy and dioxins scandals, which undermined consumer confidence in the safety of the food chain (EFSA 2007). 

In the period prior to launch of the White Paper, the European Community had experienced consumer disquiet due to a number of food scares. These included contamination of animal feed, bovine spongiform encephalopathy (BSE), concern about the use of antimicrobial feed additive used to increase productivity in animal production, and genetically modified food. The White Paper identified the need to reestablish consumer confidence in the European food supply and to reassure trading partners of the Communities ability to regulate and control die safety of its food supply. 

The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use,, Guidance for Industry,. US Dept, of Health and Human Services, FDA, Sept. 1997.,. 

Cholesterol is generally regarded as an essentially nontoxic and nonirritant material at the levels employed as an excipient. It has, however, exhibited experimental teratogenic and reproductive effects, and mutation data have been reported. Cholesterol is often derived from animal sources and this must be done in accordance with the regulations for human consumption. The risk of bovine spongiform encephalopathy (BSE) contamination has caused some concern over the use of animal-derived cholesterol in pharmaceutical products. However, synthetic methods of cholesterol manufacture have been developed. ... 

MHLW (Ministry of Health, Labour and Welfare). 2005. Enforcement regulation for the law on special measures against Bovine Spongiform Encephalopathy under jurisdiction of the Ministry of Health, Labour and Welfare. Ministry of Health, Labour and Welfare Ordinance No. 110, Article 2. Tokyo, Japan. 

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