02.05.2022
New maximum levels for morphine and codeine
Opium poppy (Papaver Somniferum) has been known as a cultivated and intoxicating plant in many cultures in Europe and also Asia since the Neolithic and is considered one of the most important medicinal plants in pharmaceutical history. Until today, the analgesic effect is mainly used against strong or long-lasting pain. This effect is due to the natural components of the dried milk juice of the poppy, the opiates. These include morphine and codeine.
The seeds of the poppy, which themselves contain no or only traces of opium alkaloids, can contain morphine and codeine through contamination with the milk juice of the plants, e.g. during harvesting. This involves the risk of undesirable pharmacological effects when poppy seeds are consumed. The European Food Safety Authority (EFSA) had therefore derived an acute reference dose of 10 µg morphine/kg body weight in a toxicological assessment, codeine should be taken into account by converting codeine to morphine equivalents, using a factor of 0,2. If these amounts are exceeded, a pharmacological effect on the consumer cannot be excluded.
Therefore, with Regulation (EU) 2021/2142, the European Commission has set the following maximum levels (see Table 1) for the sum of morphine + 0.2 codeine in poppy seeds and poppy products in Regulation (EC) 1881/2006, these will apply from July 1st 2022.
Table 1: Maximum levels for morphine and codeine
| Products | Maximum level |
| Whole, ground or milled poppy seeds placed on the market for the final consumer |
20 mg/kg |
| Bakery products containing poppy seeds and/or derived products thereof |
1.5 mg/kg |
In the course of the new maximum levels, our experts in contaminant analysis have extended our existing method for the analysis of morphine to include codeine. With this method, the analytes can be determined quickly and reliably by means of extraction and subsequent quantification via LC-MS/MS.
We will be happy to advise you. Contact us for more information.
Source:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2142&qid=1651213945553&from=DE