- Publication date
- 31 March 2021
- Scientific Committee on Consumer Safety (SCCS)
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
On request from: European Commission
SCCS Number: SCCS/1620/20
Adopted on: 30-31 March 2021
Conclusion of the opinion:
1. To review the available data on the presence and activity of Bisphenol A in clothing articles, taking into consideration the adopted opinions on tolerable intake limits and the legislative framework in other products (food contact materials, toys and printed paper)
Regarding potential health effects of BPA, this Opinion is based on the information present in the most recent health risk assessments conducted by EFSA (2015) and ECHA (2015). SCCS is, however, aware of the fact that EFSA is currently re-evaluating the huge amount of data on BPA toxicity that came available since December 2012, i.e. the cut-off point for their latest assessment published in 2015. Hence, all outcomes and conclusions reported in this document with respect to human health might be subject of change in the near future. If this is the case, the Opinion should be updated accordingly.
Exposure to BPA may occur from various sources, both dietary and non-dietary. In this Opinion, the assessment is based only on one source of BPA (i.e. textiles) and does not take into account the contribution of other sources, nor does it apply to BPA analogues.
Only one study provides experimental migration rates of BPA from clothing into artificial sweat (Wang et al. 2019). Based on these reported migration rates, migration fractions were calculated under conservative assumptions, with a 2-hour chronic daily contact of the whole trunk to clothes fully soaked in sweat for men and women. As for children, exposure to sweaty clothes was considered with additional oral exposure due to sucking on clothes. From these calculations, it can be estimated that for adults the internal total BPA exposure due to clothing is between 1.56 - 9.90 ng/kg bw/d. For toddlers, exposure to total BPA via clothing is higher i.e. between 2.37 – 14.8 ng/kg bw/d. Compared to the dietary exposure previously assessed by EFSA (2015), the exposure to BPA through clothing is at least 25 times lower. Due to the many upper bound scenario decisions made in the exposure assessment, this difference may be much larger in reality. Moreover, taking into account that Wang et al. (2019) is the only study as yet available for BPA migration rates from clothes and that very large migration fractions have been determined, it has to be confirmed that migration of BPA from clothes is really that high. In future studies, reproducibility of the migration experiment should be investigated, and time-dependent and fabric-specific migration rates derived.
2. To determine whether the exposure levels to BPA due to the use of clothing articles raises health concerns for consumers and, if possible, to provide indications on limit values for BPA content/release from clothing articles.
For the following scenario considered for adults and toddlers, the MoS is 1406 and 931, respectively. Hence, there is no risk for adverse effects of the estimated exposure levels of BPA resulting from the use of clothes, independent of the age group of the consumer. BPA has been detected in clothing articles and taken into account its hazard profile, this might be of concern as clothing articles are in direct and prolonged contact with the skin. Moreover, in case of young children, oral exposure due to sucking on clothes can contribute to total BPA exposure.
All clothing exposure scenarios analysed in this Opinion result in an exposure level of BPA that is below the t-TDI of 4 μg/kg bw/d based on increased kidney weight in a 2-year generation study in mice as critical endpoint with a BMDL10 of 8.96 mg/kg bw/d. However, regarding the dermal exposure via clothing, it is necessary to take into account the huge difference in dermal bioavailability of parent BPA when compared to the oral route. Therefore, the SCCS considered it appropriate to follow a MoS approach and to make the comparison using an internal HED (HEDi, 6.09 μg/kg bw/d when assuming 1 % free BPA after uptake by the oral route) rather than the external HED value. From a conservative point of view, SCCS further decided not to consider skin metabolism.
Furthermore, using a surface weight of 0.013 g/cm2 textile and a migration fraction of 0.085 (1/d) derived from the experimental BPA migration rates from sweaty clothes by Wang et al. (2019), a maximum amount of BPA of around 0.8 mg/kg textile could be established via back calculations to protect against systemic effects that BPA may exert in humans when present in clothing.
However, a major source of uncertainty in the determination of the limit value for BPA in clothing articles is that only one study is available that reports BPA-specific migration rates. The migration fractions derived from these migration rates are particularly large compared to previously determined, non-specific, migration fractions (BfR 2012; Kraetke and Platzek 2004). It is therefore essential to confirm the findings by Wang et al. (2019) before advising on limit values of BPA in clothing. Even though it may be possible to establish limit values based on the data available, the reliability remains unknown until additional research becomes available.
3. To identify whether vulnerable consumers such as infants and young children (who might put such articles in their mouth) or pregnant women are in particular risk. On the basis of the risk assessment, could it be indicated what level of exposure to BPA from textiles can be accepted in such groups.
Based on the conservative BPA exposure estimates identified in this Opinion for adults and toddlers, there is no risk for systemic health effects due to the use of clothing articles. This also applies for young children as, compared to toddlers, less mouthing of textiles would result even in decreased oral exposure, and therefore overall BPA exposure.
In the present Opinion, the SCCS relies on the same PoD for risk assessment, as used by EFSA to set the t-TDI. This PoD results from a two-generation study in mice, and therefore covers more vulnerable windows of susceptibility in the population such as pregnancy and perinatality. Therefore, SCCS considers that vulnerable consumers have been properly addressed in this assessment.
SCCS, scientific opinion, Bisphenol A, clothing, 2,2-bis(4-hydroxyphenyl)propane, CAS Number 80-05-7, Regulation 1223/2009
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of the presence of Bisphenol A in clothing articles - 2,2-bis(4-hydroxyphenyl)propane (CAS Number 80-05-7), preliminary version of 16 October 2020, final version of 30-31 March 2021, SCCS/1620/20.