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Risks from chemicals in baby diapers not demonstrated

ECHA/NR/21/21

ECHA’s Committee for Risk Assessment (RAC) considers that there is not enough scientific evidence to conclude that certain chemicals found in single-use diapers or nappies pose a risk. This conclusion follows an evaluation of a proposal to restrict formaldehyde, PAHs, dioxins, furans and PCBs in baby diapers throughout the EU.

Helsinki, 10 September 2021 – RAC has adopted its opinion on the French authority ANSES’s proposal to restrict substances in single-use baby diapers under the EU’s chemicals legislation, REACH. RAC evaluated the information related to the identified risks and the options proposed to reduce them, as presented in the restriction proposal. The committee also assessed the information received during a six-month stakeholder consultation.

RAC’s evaluation concluded that the available scientific data and risk assessment do not demonstrate that the substances included in the proposal are present in diapers at levels that pose a risk. RAC found that the data on the amount of some of the substances in diapers was inconclusive – particularly for polycyclic aromatic hydrocarbons (PAHs). In addition, the methodology likely overestimated any exposure. The committee also provided advice on what kind of information would be necessary to address the identified shortcomings.

Tim Bowmer, Chair of RAC says: “RAC takes the health of small children very seriously. The restriction proposal does not provide sufficient scientific evidence of a risk at EU level. However, it also does not allow the committee to completely rule out risks from some of the substances. It is important to note that none of the chemicals seem to be deliberately added during the manufacture of diapers but are rather background residues from raw materials or contaminants from ambient air. We highlight that, in any case, these chemicals should be kept to the lowest possible levels in diapers.

The Committee for Socio-Economic Assessment (SEAC) has also agreed on its draft opinion on the costs and benefits of the proposal for society. The committee considers that the evidence available does not demonstrate that the proposed restriction would be proportionate to the risk.

The opinion of RAC and draft opinion of SEAC will be available on ECHA’s website shortly after administrative checks have been completed. The key points from the opinions are in the Q&A document.

Next steps

A 60-day consultation of SEAC’s draft opinion will start on 15 September 2021. The combined opinion of both committees is expected to be ready by the end of 2021 and will be sent to the European Commission for decision making in early 2022.

Background

In October 2020, France proposed a REACH restriction concerning hazardous substances such as formaldehyde, PAHs, dioxins, furans and polychlorinated biphenyls (PCBs) found in baby diapers by a French national control laboratory. The proposed restriction would limit these chemicals to very low levels in diapers placed on the EU/EEA market. 

The REACH restriction process relies on EU Member States to make proposals for EU-wide restrictions. Recently, the European Commission adopted a restriction introduced by Germany and Sweden to limit uses of a subgroup of PFAS, perfluorinated carboxylic acids (C9-14 PFCAs). In September 2020, ECHA’s committees supported a proposal by the French and Swedish authorities to restrict over 1 000 skin sensitising chemicals in clothing and other articles, including single-use baby diapers. This proposal is currently in the Commission for decision making.