In response to cases of skin allergies and irritation related to clothing and/or shoes reported to the health authorities, the Ministries of Health and the Economy asked ANSES to identify the skin irritant or sensitising chemicals, regulated or non-regulated, liable to be found in these articles. The Ministries also asked ANSES to conduct a review of knowledge on the toxicity of these substances and formulate recommendations regarding manufacture, storage and shipment, as well as on whether or not to limit the use of certain substances.
To carry out this expert appraisal, the Agency conducted a review of the scientific literature, as well as tests on samples of new clothing taken from several points of sale and footwear that had been the subject of customer complaints, in order to investigate the presence of skin irritants or allergenic substances. In total, 20 groups of chemical substances were screened for in clothing and around 50 substances in shoes.
These analyses were used to adapt the groups of substances to be screened for, and confirmed the presence of nonylphenols, nonylphenol ethoxylates and formaldehyde, among others. They also identified substances not routinely tested for that can cause contact dermatitis, such as 1,4-paraphenylenediamine, organotin derivatives and azo dyes.
Establishment of a ground-breaking biomedical study in France
ANSES also set up a ground-breaking project in France: a biomedical study to investigate cases of skin allergy or intolerance possibly related to chemicals in clothing or shoes.
To do this, ANSES mobilised a network of physicians (dermatologist-allergists, toxicologists, etc.) and initiated analyses on the articles worn by patients and suspected of being associated with skin reactions, in order to characterise the chemical substances found in these articles. The first phase of the study included around 30 adult patients and took place between January and September 2017. In some cases it was able to identify the chemicals found in the articles worn by a patient and responsible for their symptoms (e.g. benzidine, chromium VI, nickel, 4-tert-butylphenol formaldehyde resin and azo dye). In view of its initial results, the Agency decided to extend the study until October 2018 and the final results will be presented in an additional Agency opinion.
The Agency’s recommendations
Further to this expert appraisal, ANSES is issuing the following major recommendations for the authorities:
- maintain control pressure for footwear and textile clothing placed on the market, to avoid the presence of articles that do not comply with the regulations regarding the chemicals detected in these articles;
- revise the regulatory threshold for chromium VI in leather articles;
- set a regulatory threshold for nickel in textiles;
- propose a classification as "skin sensitiser and/or irritant" for non-regulated substances identified as responsible for skin allergies, in the framework of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation).
In addition, the Agency is issuing the following recommendations for the organisations responsible for placing textile clothing and/or footwear on the market:
- ascertain with their suppliers the absence of CMR, skin sensitising and irritating substances in their footwear or textile clothing;
- conduct studies to obtain toxicological data on the dyes CI Disperse Orange 37/76 and CI Disperse Yellow 23, two dyes highlighted in the expert appraisal and previously not identified, for which no toxicological data are available. These data will also be useful for developing patch tests;
- work to establish a consumer information plan (labelling, packaging), mainly targeting populations that are already sensitised, indicating the potential presence of such substances.
Lastly, ANSES recommends reminding consumers of the importance of washing any clothing likely to come in contact with the skin before it is worn for the first time, and following the washing recommendations issued by the manufacturer.
The results of this expert appraisal will serve to support the EU-level restriction proposal under the REACh Regulation being submitted by France and Sweden, on skin sensitising or irritating substances found in clothing and shoes.