For the past couple of years, Karine Fiore and Céline Dubois from Anses, have been assessing the potential health risks of hazardous chemicals found in baby nappies. They are now preparing a REACH restriction proposal to make sure that future single-use baby nappies will not contain harmful chemicals.
Their focus is on PAHs, furans, dioxins, PCBs and formaldehyde – all chemicals that can be harmful to babies wearing nappies.
Where it all started
Ms Dubois works as a scientific Project manager at the French Agency for Food, Environmental and Occupation Health & Safety (Anses). She was in the lead of their study on baby nappies published in January 2019. “We used the results of tests performed by two different laboratories to check 23 products available on the French market to see if wearing baby nappies can be associated with negative health effects,” she tells.
So far, no epidemiological studies exist on the association between these chemicals in baby nappies and health effects, but some hazardous chemicals were found in the tested nappies. Diaper dermatitis is the most common and well known skin disease for babies wearing nappies, but the potential health effects that could be caused by the presence of the chemicals in nappies include cancer, reproductive toxicity and neurological effects.
“Our own risk assessment is based on the laboratory test results and the available literature data. Based on this analysis, we could see that health thresholds were exceeded for PAHs, furans, dioxins and PCBs and for the sums of these chemicals. This led us to conclude that, with our current knowledge, we cannot rule out health risks associated with wearing single-use baby nappies,” Ms Dubois explains.
Although the conducted tests didn’t show exceeded levels for formaldehyde, the substance scored very close to the accepted threshold, and is therefore also included in the restriction intention, submitted in October 2019.
Most of the hazardous chemicals found in baby nappies are considered contaminants because only perfumes and fragrances are intentionally added. “During our risk assessment in summer 2019, we consulted stakeholders and companies to find out why these substances are being found in nappies. We also received some comments to the French regulatory management option analysis after it was published. Based on this information, the substances we are talking about may come from two possible sources. Either they are contaminants that come through the manufacturing process, or they are contained in the raw materials that companies use when producing baby nappies,” says Socio-economic project manager Ms Fiore.
Examining the critical points in the manufacturing process and in the raw material supply chain could help companies to remove the unwanted contaminants. “Since we know that some of the raw materials may come from non-EU countries, European companies would need to work closely with their suppliers and demand less hazardous materials. The good news is that some companies have already started taking voluntary actions to reduce these contaminants in their products,” Ms Fiore tells.
Choosing the right risk management option
Before Anses decided to pursue a restriction on the chemicals, they carried out a regulatory management option analysis to see what would be the most appropriate and effective means for protecting European babies.
According to Ms Fiore, many options from harmonised classification and labelling to other regulations were discussed.
“We considered, for example, labelling but concluded that since these contaminants can be found in almost all nappies, it is not protective enough to add a warning about a contaminant in the label or packaging. Although not all contaminants were present in all nappies, many of the nappies contained several contaminants. So even if consumers check the labels and choose their brand based on that information, they would still, in the end, have to choose a product containing some of these hazardous chemicals,” she explains.
Anses also investigated if harmonised classification and labelling could be an appropriate route to take but according to their analysis, the process is lengthy and resource consuming, and sometimes its outcome can be quite uncertain. Additionally, some of the substances, such as formaldehyde, already have a harmonised classification but, based on Anses’ assessment, it may still be of concern in baby nappies.
France could also propose the targeted substances to be identified as substances of very high concern under REACH but this would need to be done separately for each substance because it cannot be done for a group of substances. “In addition, even if some or all of these substances would later be added to the REACH Authorisation List, this would only apply to nappies manufactured within the EU and the European Economic Area, leaving out imported nappies. For us, this would be unacceptable,” Ms Fiore points out.
Ms Fiore tells that Anses also investigated if baby nappies could be addressed through other directives or regulations but none of them turned out to be a perfect match. “We looked, for example, at the General Product Safety Directive, Medical Devices Regulation and the Toys Directive, but either baby nappies didn’t fit to their scope or we would need to settle for a directive and miss out on the benefits of harmonised regulation.”
“So in the end, we concluded that REACH restriction would be the best risk management option to assess the identified risks,” she says.
To be able to prepare the restriction proposal, Anses needs more information. Ms Dubois and Ms Fiore look forward to receiving this through the call for evidence that is running until 31 March 2020.
Evidence to be gathered covers, for example:
1. the scope of the restriction proposal – types of baby nappies and information about the substances included in the scope;
2. exposure assessment – babies’ exposure to substances, use of single-use nappies in different EU countries;
3. concentration limits and analytical methods – information about standardised methods for testing;alternatives – considering the substances are not intentionally added but contaminants or residues; and
4. socio-economic impact of a possible restriction – taking into account the costs and benefits for all affected actors.
Out of this list, Ms Dubois is particularly interested in learning more about the possible alternatives. “Since we know that the substances we are targeting are contaminants, they can’t simply be replaced with safer substances, which in other cases can be a viable solution,” Ms Dubois says.
Another important area that Ms Fiore points out is the socio-economic analysis. “We hope to get information related to costs for any changes in manufacturing processes, better selection of raw materials and improved monitoring and measurements. And naturally we want to find out what impact all of this would have on employment rate. But we also look forward to learning about the possible benefits on reputation and image if companies would be able to say that they use better and safer materials in their baby nappies,” she concludes.
The restriction dossier is expected to be submitted in October 2020.