France finds unclear disinfectant labeling to blame for chemical burns in children
The French environment and safety agency (ANSES) has identified a pattern of chemical incidents, reporting more than one hundred cases of schoolchildren sustaining chemical burns in recent years. It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products.
- Biocides are regulated primarily by the Biocidal Products Regulation (BPR) (528/2012/EU). This regulation divides biocidal products into 22 product-types categorized within four main groups: (1) disinfectants, (2) preservatives, (3) pest control, and (4) other biocidal products. Group 1 for disinfectants contains five product-types. Product-type 2 encompasses disinfectants applied to surfaces.
- Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants. Subsection (i) mandates that warnings for vulnerable groups are provided where necessary. It is unambiguous that children are seen as vulnerable groups given that they are explicitly named as such in the Chemicals Strategy for Sustainability (CSS).
- Subsections (f) and (g) of this same article mandate that all authorized uses, as well as the directions for those uses, are printed clearly and indelibly on labels. A label for a ready-to-use product that is ambiguous as to its application could be considered non-compliant with these rules . Additionally, a label which has offloaded essential directions to technical sheets could be construed as non-compliant even though it may contain the statement, “Read attached instructions before use.”
- Article 65 provides that member states must monitor biocidal products and treated articles to establish whether they are in compliance. Manufacturers of biocidal products placed on the market in the European Union must maintain documentation on the quality and safety of the biocidal product and store production batch samples. The required documentation includes: (1) safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product; (2) records of the various manufacturing operations performed; (3) results of internal quality controls; and (4) identification of production batches, among others. Reports of poisonings, and incidents especially among vulnerable groups must be made to the Commission by June 30 annually along with specific mitigation measures taken to avoid future cases. These reports are made available by the Commission online.
- Member states are aso required by the Classification Labelling and Packaging (CLP) Regulation (1272/2008/EC) to establish poison centers capable of “ receiving information on the composition of hazardous mixtures (detergents, paints, adhesives etc.)” [The respective poison centers for all member states are listed here.]
Chemical burns in children
- Since the start of 2016, the French environment and safety agency known as ANSES has coordinated a national toxicovigilance scheme and has overseen the vigilance activities of France’s poison control centers (CAPs). The purpose of this system is to monitor chemical exposure incidents and trends amongst French citizens to undertake alerting and prevention procedures. There are currently eight CAPs in metropolitan France which operate a 24-hour hotline aiding with chemical and toxicity incidents. All of these incidents are entered into a dedicated information system (SICAP).
- A new report (in French) from ANSES leverages poison control center records from SICAP to identify 118 cases of skin damage in children from 2017-2022. Most stemmed from the disinfection of school lavatories with biocidal disinfectants. A strong uptick is observed in 2020 and 2021, most likely a result of heightened pandemic disinfection standards.
- In fact, in 2019 no chemical burn events were reported, as compared to 22 in 2020 and 58 in 2021. Eleven children suffered second-degree burns while one sustained a third-degree burn warranting a skin transplant. It is probable that these figures are underestimations and more chemical incidents have occurred without being reported to a CAP
- Although 2023 was not within the scope of the study, ANSES confirms that these incidents have persisted well into the current year. This would suggest that the issue has become entrenched, carrying on even after the peak of COVID-era sanitation standards.
- Children under the age of six are uniquely susceptible to these types of chemical burns due to the fragility of their skin. Products that may have little effect on adults can have markedly more severe outcomes with young children.
It appears that some chemical burn incidents could have been prevented with more intuitive labeling or instructions.
- Specifically, misleading use of the phrase “ready-to-use” on labels, when the product must be diluted prior to use accounted for some of the burns. In some cases, the fact that product instructions varied based on use confused those handling disinfectants. For example, some products were ready-to-use with respect to cleaning the floor but needed to be diluted for all other surfaces.
- The study also notes that sometimes instructions were only printed on technical sheets not made available to handlers, instead of being printed on the product label itself. Though instructions may have been included in some capacity, they were not provided to those using the product itself, resulting in its misuse and ultimately the injury of children. This may be an instance of labeling technically complying with provisions but not abiding by the spirit of the regulation itself which sees the protection of the public from chemical risk as the end goal.
- This trend of chemical burns in children is noted at a time when the European Commission has actively pledged to ensure their chemical safety. Specifically, the commission aspires to “minimize the presence of substances of concern in products… giving priority to those product categories that affect vulnerable populations.”
- Member states can refer objections to a coordination group established by article 35 of the BPR if it suspects a product has been authorized despite having non-compliant labeling. If this coordination group cannot reach a conclusion within 60 days, the issue is referred to the European Commission. There is no indication, yet that ANSES plans to pursue this matter with a coordination group, though it is always an option should it feel the need to go further to protect children from confusingly labeled disinfectants.
- ANSES has not yet proposed that any type of regulatory action be taken to combat these injuries caused by the disinfectants. It has simply provided a list of six safety recommendations and reminders aimed at the users and handlers of biocidal disinfectants. ANSES recommends staff should be trained on proper use, favoring truly ready-to-use products that do not require dilution, and enforcing a waiting time after treating products with disinfectant.
- It is likely that ANSES may keep this dangerous trend affecting children in mind when evaluating whether biocidal products should receive domestic market authorization. Market authorization for a biocidal disinfectant product can be applied for at the national or EU-wide level. Biocidal disinfectant companies who take the national application route in France must first demonstrate to ANSES that their products do not present unacceptable risk to humans and the environment. It is feasible that ANSES could redouble its scrutiny for labeling in future evaluations having now noted the adverse effects that unclear labeling can impose upon children.