Faced with cases of allergies and skin irritation linked to clothing and/or shoes reported to the health authorities, the ministries in charge of health and the economy contacted ANSES to identify chemical substances skin irritants or sensitizers, regulated or not, likely to be present in these articles. The ministries also asked ANSES to carry out an inventory of knowledge on the toxicity of these substances and to draw up recommendations for the manufacture, storage, transport and on whether or not to limit the use of certain substances.
To carry out this expert appraisal, the Agency carried out a study of the scientific literature, supplemented by tests on a sample of new clothes taken from several points of sale and shoes which had led to customer complaints, to check for the presence of skin irritants or allergens. In total, around twenty families of chemical substances were searched for in clothing and around fifty substances in shoes.
These analyzes made it possible to adjust the families of chemical substances to be searched for and to confirm, among other things, the presence of nonylphenols, nonylphenol ethoxylates or even formaldehyde. They also made it possible to identify substances not analyzed routinely, which can cause contact dermatitis such as 1,4-paraphenylenediamine or organotin derivatives, or azo dyes.
Setting up a pioneering biomedical study in France
ANSES has also set up a biomedical study, a pioneer in France, to investigate cases of skin allergy or intolerance that may be linked to chemical substances in clothing or shoes.
To do this, ANSES mobilized a network of doctors (dermatologist-allergists, toxicologists, etc.) and set up analyzes on the articles worn by the patient and suspected of being associated with skin reactions, in order to characterize the chemical substances present in these articles. The first phase of the study included around thirty adult patients between January and September 2017. In some cases, it made it possible to identify chemical substances present in worn articles that caused symptoms (e.g. benzidine, chromium VI, nickel, 4-tertbutylphenolformaldehyde resin, azo dye). In view of the first results of the study, the Agency has decided to continue the study until October 2018 and the results will be the subject of an additional opinion from the Agency.
The Agency’s recommendations
Following this expert appraisal, ANSES issues the main recommendations for the attention of the authorities:
- maintain pressure to control footwear and textile clothing placed on the market in order to avoid the presence of articles that do not comply with the regulations relating to chemical substances in these articles;
- revise the regulatory threshold for chromium VI in leather articles;
- set a regulatory threshold for nickel in textiles;
- propose a classification within the framework of European regulation n°1272/2008 relating to classification, labeling and packaging (CLP), for non-regulated substances and identified as being responsible for skin allergies as “sensitisers and/or skin irritant”.
In addition, the Agency issues the following recommendations to those responsible for placing clothing textiles and/or footwear on the market:
- ensure with their suppliers that there are no CMR or skin sensitizing or irritating substances in the footwear or clothing textiles;
- carry out studies to acquire toxicological data concerning the dyes CI Disperse Orange 37/76 and CI Disperse Yellow 23, two dyes highlighted in the expert appraisal and not revealed until now, for which no toxicological data is available. These data will also be useful for the development of patch tests;
- work on setting up an information system (labelling, packaging) for the consumer, in particular populations already sensitized, making it possible to signal the potential presence of such substances.
Finally, ANSES recommends that consumers be made aware of the importance of washing, before wearing them for the first time, any clothing likely to come into contact with the skin, by following the washing recommendations recommended by the manufacturer.
The results of this expertise will support the restriction file within the framework of the REACh regulation, carried out by France and Sweden at European level, on substances that sensitize or irritate the skin present in clothing and footwear.
