Official regulations

Products used around the eye EU also mucous membrane 500 100  

Specific micro-organisms Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli. 

Micro-organism limits (see Table 4) are listed in guidelines published in Annex VIII of the SCCNFP/031/00 Final (The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers). They also reflect the dermatological and toxicological safety of cosmetic materials. 

In the EU (EC Directive 76/768) a product is considered a cosmetic as long as its intended use is as a care or protective product, and it makes no illness-specific claims and is not used internally (Heinzel, 1999b). Products claiming an antiseptic effect (medical claim against sepsis) are not considered cosmetics, but pharmaceutical products (EEC, 1965). Disinfectants are either classified as medieal produets (EEC, 1993) or fall under the jurisdietion of bioeide guidelines (EC, 1998). 

In the USA, products with anti-microbial claims are sold as over-the-counter (OTC) drugs. This may include cosmetics, with supplementary uses as infection inhibitors, or with healing and palliative (soothing) properties. In contrast to US pharmaceutical products, OTC products may not contain active agents listed in the US Pharmacopoeia, National Formulary or Homeopathic Pharmacopoeia. 

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The following criteria have not been established as anything other than guidelines and are offered not as definitive or official regulations but rather as informed advice (based on more than thirty years of experience) insofar as the subject matter is specific to both public and private sectors. 

Official Regulation Regarding Mycotoxin Content in Food and Methods for its Control... 

OFFICIAL REGULATION REGARDING MYCOTOXIN CONTENT IN FOOD AND METHODS FOR ITS CONTROL... 

For allergen cross-contamination, no official regulation or guidance exists so industry depends on its own risk analysis or consultancy to set risk management options. 

If official regulations permit this method to be used, it can be useful provided that the analyst is aware of the problem of species differences which can lead to erroneous conclusions. If the animal is more sensitive to the toxin than man (e.g. benzoic acid in the cat), a false positive result would be obtained. Alternatively, a false negative result would be obtained if the animal were more resistant (e.g. Amanita phalloides and the rabbit). This aspect is illustrated by TCDD (2,3,7,8-tetrachlorodibenzo-/ -dioxin), the extremely persistent impurity, present in the systemic herbicide trichlorophenoxy-acetic acid, which was released in the Seveso... 

Association of American Feed Control Officials Regulations... 

The prescription is the means by which medicines that are not considered safe for sale directly to the public are delivered to patients. Its format is officially regulated to ensure precision in the interests of safety... 

Chapter 4. Evaluation of drugs in man Chapter 5. Official regulation of medicines Chapter 6. Classification and naming of drugs... 

According to official regulations, solid standard sources are generally submitted to classical tests of non-contamination by wiping or by immersion, as required. However, in view of the meteorological quality required, some standards being brittle and of low level activity, these tests are not performed in order to avoid any alteration of the standards or of their accuracies. On the other hand, the sealed sources are submitted to strict tests. 

Inconsistencies and Deficiencies in Current Official Regulations Concerning Photolytic Degradation of Drugs... 

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