Paracetamol in the Netherlands is safe to use, drug authority MEB and the Health and Youth Care Inspectorate (IGJ) conclude on Thursday from their own research. No paracetamol has been sold in Dutch supermarkets, drugstores and pharmacies that does not meet the strict safety requirements.
Previously wrote NRC in Zembla that possibly contaminated paracetamol had entered the Dutch market. The paracetamol from the Chinese manufacturer Anqiu Lu’an Pharmaceutical is said to contain an excessive amount of the carcinogenic substance 4-chloroaniline (PCA). The Chinese factory has also supplied the Netherlands in recent years.
Following the article, the Minister for Medical Care and Sport instructed the MEB and IGJ to investigate the possible contamination.
Documents requested by the MEB and IGJ show that 144 batches of paracetamol from the Chinese raw material supplier were processed in the Netherlands between 1 January 2019 and 7 July 2020. The certificates of analysis show that this does not contain paracetamol in which the permitted amount of PCA and other impurities has been exceeded. The health risks for consumers are therefore negligible, say the MEB and the IGJ.
‘Impurities in paracetamol cannot be prevented’
So-called impurities, other substances that are released during the ‘complicated chemical process’ of making paracetamol, according to the research firms, cannot be prevented. A small proportion of these impurities are potentially carcinogenic. Therefore, strict limits have been set for the amount of impurity in Dutch paracetamol.
There is a strict limit of a maximum intake of 34 micrograms per day for the prevention of PCA in medicines. This means that if 100,000 people take the maximum amount of paracetamol daily for a lifetime, one person will develop cancer as a result. “With short-term use and lower doses, the risk is many times lower”, according to the CBG and IGJ.
Also NRC in Zembla commissioned research into paracetamol on the Dutch market in response to the possible contamination. They had eleven popular brands of paracetamol tested in a certified laboratory in Belgium. None of these pills, which are sold in Albert Heijn, Kruidvat, Jumbo and Etos, among others, contained a detectable amount of PCA.
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