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3. Clearance certificate

The marker process uses markerpolyethyleneglycol (macrogol) as urine identifier. The individual marker fluid ingredients differ in the number of repetition units and hence molecular weight and chain length.

Macrogol is used in manufacturing virtually all drug groups, e.g. in many fizzy antitussive tablets cleared for use by children. It’s also contained in tablets and dragees including garlic dragees, antihypertonic drugs, sedatives, relaxants, painkillers and many others. It is also used as a solvent in fat-soluble substances and as an antidote to poisons for external use on the skin and is being tested for internal use as a bolus in tablet form.

Although the marker substances are used in various drugs they are not themselves drugs in law and are hence not subject to drug approval law. The marker substances would have to meet criteria in the Arzneimittelgesetz (AMG) [German Drugs Act] per § 2 paragraph 1 no. 1-5 to be considered drugs.

In this case the only possibly applicable criterion would be that of a diagnostic drug. Per § 2 paragraph 1 no. 2 AMG diagnostic drugs are those that can detect characteristics, conditions or functions of the human body or the human mind. This solely applies to drugs serving to detect damage to same.

The marker substances are not diagnostic drugs in this sense as they are solely capable of uniquely marking urine. Only if they could be used to prepare that urine for later testing and such testing be impossible without said marker substances would they be considered drugs in German law. This is not the case here.

These substances do not fall under the Medizinproduktegesetz (MPG) [German Medical Products Act]. To do so a marker would per §3 paragraph 1 MPG have to be a substance or compound of substances intended by the maker for use in detecting or treating illnesses in humans.

This does not apply here as they do not detect illnesses. These substances serve only to uniquely mark urine samples. The marker substances are not used for testing that would be impossible without them.

The Cologne municipal government took this view in a letter dated 26 June 2002 and certified that the aforementioned German laws did not apply to the marker substances. No certification is hence needed and the substances can be used without risk.

The legal clearance certificate can be downloaded as a PDF file if desired.