Chlorinated paraffins: Only small amounts of these chemicals are ingested in Germany and the EU No impairment to health to be expected according to current knowledge
What it's about:
Chlorinated paraffins (CP) are chemicals that are used, among other things, as flame retardants, plasticisers or as additives in lubricants, paints and coatings. Due to decades of worldwide manufacture and high production volumes, they can be found almost everywhere today. They degrade very slowly in the environment and accumulate in the food chain and in tissues. For this reason, their use has long been subject to scientific and regulatory monitoring. The use of short-chain CPs has been banned in Europe since 2012. Scientific studies have shown that the chronic (lifelong) intake of very high amounts of these short-chain CPs can cause tumours in laboratory animals. An EU-wide ban will follow for the medium-chain representatives of the substance group, but there is currently no evidence of a tumour-causing effect.
Scientific studies show that the daily intake levels of short- and medium-chain CP in Europe are so low that, according to current knowledge, they do not give cause for concern. The amounts ingested are far below the amounts that can be ingested over a lifetime without any impairment to health being expected.
The European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) last assessed short- and medium-chain CP in 2020. An update should be considered, since new data has been collected in recent years and open questions have been clarified, especially regarding the prevalence of CPs, but also regarding toxicological effects.
Chlorinated paraffins (CP), also known as polychlorinated alkanes, generally consist of a linear hydrocarbon chain in which some hydrogen atoms are replaced by chlorine atoms. The degree of chlorination can vary between 30 and 70 per cent. Depending on the chain length, CPs are categorised as short-chain (SCCP; C10 -13), medium-chain (MCCP; C14 -17) and long-chain CPs (LCCP; C>17). The physico-chemical properties of CP are determined by the chain length and the degree of chlorination. CPs are often used as flame retardants, plasticisers or other additives in plastics such as polyvinyl chloride (PVC), paints, coatings or sealants. In metal processing, they are used as coolants and lubricants. It is estimated that around 33 million tonnes of CP were produced and used worldwide between 1930 and 2020. A large proportion of this probably ended up in the environment. As a result, CP are now detected in air, water, soil and house dust as well as in various foodstuffs and consumer goods.
Humans mainly take up CP via food, but also through the air or house dust. They can be metabolized by humans and animals, but only very slowly, so that an accumulation in tissues and in the food chain can be observed. In humans, CPs are also detected in blood and breast milk.
The EFSAshort forEuropean Food Safety Authority assessed the health risk assessment of short- and medium-chain CPs in 2020. Long-chain CPs could not be assessed due to a lack of data. Changes in the liver, kidney and thyroid gland were observed in animal experiments with a daily intake of short- and medium-chain CPs in the diet over a longer period of time. Based on the renal changes in rats with dietary intake of CP, EFSAshort forEuropean Food Safety Authority has calculated an amount of SCCP and MCCP to serve as reference points for hazard characterisation. It is 2.3 milligrams (mgshort formilligram) per kilogram (kgshort forkilogram) of body weight (bw) per day for SCCP and 36 mgshort formilligram/kgshort forkilogram bw for MCCP. For the assessment of a possible risk, these values are compared with the intake amount. If the exposureExposureTo glossary is 1000-fold lower than the reference point, the probability of impairment is considered to be very low. In recent years, data on the daily intake of CP via various foods and house dust (oral) have been published and the total exposure estimated.
According to measurements and calculations , the daily uptake by people in Europe via air and food are significantly (tens of thousands of times) below the reference points mentioned above. In the case of SCCP, the daily uptakes are 0.135 micrograms (µgshort formicrogram)/kgshort forkilogram bw for infants, 0.27 µgshort formicrogram/kgshort forkilogram bw for toddlers and 0.071 µgshort formicrogram/kgshort forkilogram bw for adults, respectively. A microgram is one millionth of a gram or one thousandth of a milligram. In the case of MCCP, the calculated daily intake is 0.809 µgshort formicrogram/kgshort forkilogram bw for infants, 0.333 µgshort formicrogram/kgshort forkilogram bw for toddlers and 0.068 µgshort formicrogram/kgshort forkilogram bw for adults.
Scientific studies show that most consumer goods made of rubber or PVC in Germany do not contain chlorinated paraffins. Occasionally, high concentrations of CP have been detected in fatty foods, which are probably due to improper production or impurities in the raw materials. The consumption of such foods can lead to a significantly increased intake of CP in the short term. However, as long as they are not consumed daily and over many years, the probability of impairment to health is considered to be very low according to current knowledge.
Following the ban on the use of SCCPs, medium-chain chlorinated paraffins (MCCPs) have been increasingly used in products in recent years. Based on animal experiments, MCCPs must be labelled according to the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation, (EC) No. 1272/2008) with the addition "May cause harm to breast-fed children". In contrast to SCCPs, there is no evidence that MCCPs can cause tumours. However, there are studies that show that some MCCPs are very persistent and very bioaccumulative (vPvB) or persistent, bioaccumulative and toxic (PBT). For this reason, they were assessed as substances of very high concern under the European REACH Regulation in 2021; their inclusion into the EU Regulation on Persistent Organic Pollutants ("POP Regulation", EU 2019/1021) will follow.
The detection of long-chain chlorinated paraffins (LCCPs) is very complex and currently only possible in a few analytical laboratories. There have been few studies on the effects of LCCPs to date and therefore hardly any hazard or risk assessments.
Chlorinated paraffins are an almost ubiquitous group of substances due to the high production quantities and decades of worldwide production. However, the daily intake levels in Europe are so low that, from today's perspective, they do not give cause for concern. People in the producing countries China (and India), in contrast, are exposed to significantly higher amounts of CP, as the concentrations in the environment in those countries are much higher than in Europe.
Short-chain chlorinated paraffins have been listed as persistent organic pollutants (POPs) under the Stockholm Convention, a treaty on global rules for banning and restricting these chemicals, since 2018, and medium-chain chlorinated paraffins since 2025. The inclusion of short-chain chlorinated paraffins in the list of POPs in the Stockholm Convention means that they will be completely banned after the expiry of the exemptions for their use in 2024. For medium-chain chlorinated paraffins, there are temporary exemptions for individual applications that cannot yet be replaced. The decision of the Stockholm Convention will be implemented in the European Union in the EU POP Regulation.
As many open questions have been clarified in recent years, an update the EFSAshort forEuropean Food Safety Authority opinion should be considered. Further toxicological studies have been carried out, the analysis of CP has been significantly refined and new calculations on the daily intake of CP have been published.
Further information on the BfRshort forGerman Federal Institute for Risk Assessment website on chemical safety
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