Safety of baby diapers ANSES revised opinion Collective expert appraisal report January 2019 - Scientific Edition Safety of baby diapers Safety of baby diapers ANSES revised opinion Collective expert appraisal report January 2019 - Scientific Edition ANSES Opinion Request No 2017-SA-0019 The Director General Maisons-Alfort, 17 January 2019 Revised OPINION1 of the French Agency for Food, Environmental and Occupational Health & Safety on the safety of baby diapers ANSES undertakes independent and pluralistic scientific expert assessments. ANSES primarily ensures environmental, occupational and food safety as well as assessing the potential health risks they may entail. It also contributes to the protection of the health and welfare of animals, the protection of plant health and the evaluation of the nutritional characteristics of food. It provides the competent authorities with all necessary information concerning these risks as well as the requisite expertise and scientific and technical support for drafting legislative and statutory provisions and implementing risk management strategies (Article L.1313-1 of the French Public Health Code). Its opinions are published on its website. This opinion is a translation of the original French version. In the event of any discrepancy or ambiguity the French language text dated 17 January 2019 shall prevail. On 25 January 2017, ANSES received a formal request from the Directorate General for Health (DGS), the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) and the Directorate General for Risk Prevention (DGPR) to conduct an expert appraisal on the following issue: the safety of baby diapers. 1. BACKGROUND AND PURPOSE OF THE REQUEST At European Union (EU) level, baby diapers are subject to the general safety requirement defined by European legislation relating to consumer goods, transposed in the French Consumer Code. There is no regulatory framework specific to baby diapers in France or in the EU. However, there are harmonised regulations applying to other types of products (cosmetic products, medical devices) used in the urogenital area (e.g. incontinence products) that lay down obligations in terms of safety assessments and the listing of ingredients. In January 2017, a publication in a "popular" magazine relayed in the media reported levels of chemicals (pesticides, dioxins, furans, PAHs and volatile organic compounds) in baby diapers (60 Millions de Consommateurs, 2017). At the same time, ANSES received a formal request to assess the safety of baby diapers in terms of the risk of infection, allergy or intolerance and/or the risks associated with chemical action via dermal contact and contact with the mucous membranes. ANSES's expert appraisal was requested with the following aims: 1. undertake a chemical risk analysis, especially in the event of exposure through contact in young children (a susceptible population group); 1 Cancels and replaces the Opinion of 6 December 2018 (see change history in Annex 1). Page 1 / 32 ANSES Opinion Request No 2017-SA-0019 2. assess the relevance of defining thresholds for the presence of these substances in diapers, especially regarding hazards (with or without threshold effects) and the duration and mode of exposure; 3. where appropriate, issue recommendations to encourage better control of manufacturing methods, composition and consumer information, particularly at EU level. 2. ORGANISATION OF THE EXPERT APPRAISAL The expert appraisal was carried out in accordance with French Standard NF X 50-110 "Quality in Expert Appraisals – General Requirements of Competence for Expert Appraisals (May 2003)". The expert appraisal fell within the sphere of competence of the Expert Committee (CES) on "Assessment of chemical risks of consumer items and products", which met from May 2016 to August 2017, and was then entrusted to the CES on "Assessment of chemical risks of consumer items and products 2". The methodological and scientific aspects of the work were presented to the CESs between May 2016 and November 2018. It was adopted by the CES at its meeting on 15 November 2018. ANSES analyses interests declared by experts before they are appointed and throughout their work in order to prevent risks of conflicts of interest in relation to the points addressed in expert appraisals. The experts’ declarations of interests are made public via the ANSES website (www.anses.fr). To obtain the various stakeholders’ opinions, a series of hearings took place between April and May 2017 with consumer groups (Federal Union of Consumers - UFC), companies and trade federations (Love & Green, Procter & Gamble, Federation of Trade and Retail Companies - FCD, National Association of the Medical Technology Industry - SNITEM, French grouping of manufacturers of single-use products for hygiene, health and wiping or Group'Hygiène, the EDANA2 professional federation) and a public body (French National Consumer Institute - INC). To conduct this expert appraisal, ANSES collected all of the available data from institutional reports and scientific publications relating to the composition and technical properties of materials and the diseases caused by diapers, including dermatitis. The literature search found only a few reports by public bodies and a scarcity of independent scientific publications. Publications written by authors employed by companies selling baby diapers are marked with an asterisk (*) in the expert appraisal report. ANSES also took non-scientific publications into account, including the results of comparative tests carried out by consumer groups, particularly those behind the formal request (60 Millions de Consommateurs, 2016). Lastly, the results of tests commissioned by the DGCCRF in 2017 and 2018 from the Joint Laboratory Service (SCL) wereincorporated into the expert appraisal. ANSES also held an international consultation in order to collect information dealing with safety assessments of baby diapers, the regulations and public policies or recommendations, the composition of products, chemicals, and studies currently being undertaken on these products. 2 The European Disposables And Nonwovens Association or EDANA comprises companies in the nonwoven industry and provides recommendations that member companies undertake to follow. Page 2 / 32 ANSES Opinion Request No 2017-SA-0019 3. ANALYSIS AND CONCLUSIONS OF THE CES Since the 1990s, single-use diapers have been used by more than 90% of families in most of the European Union (EDANA, 2011). In France, disposable diapers have been worn by over 95% of babies for almost 20 years (Group’Hygiène, 2015). Estimates of the total number of disposable diapers used by a baby before the age of toilet training range from 3800 to 4800. These estimates vary depending on the age at which it is considered that children are fully toilet trained (between 2.5 and three years old). The analysis and conclusions of the expert appraisal presented here deal with the following: - The skin diseases caused by the wearing of diapers, - The chemical risks: o Types of materials used in baby diapers, o Chemicals identified in baby diapers and chemical contamination, o Quantitative health risk assessment associated with chemicals detected or quantified in single-use baby diapers. ■ Skin diseases caused by the wearing of diapers Diaper dermatitis (diaper rash) is the most common skin disease in infants. There are various forms of diaper dermatitis: - Irritant dermatitis, the most common form, which can be caused by an increase in skin moisture, a high alkaline skin pH, the mixing of urine and stools, or the mechanical action of friction between the skin and diaper (Scheinfeld, 2005; Runeman, 2008*; Tüzün et al., 2015; Atherton, 2016*; Bender and Faergemann, 2017*), - Infectious dermatitis (Staphylococci, Candida albicans) (Šikić Pogačar et al., 2017), - Inflammatory dermatitis, a less common form that includes allergic contact dermatitis, which can be caused by certain components of the diaper (Roul et al., 1998; Larralde et al., 2001; Belhadjali et al., 2001; Onken et al., 2011; Jacob et al., 2012; Chiriac et al., 2017; Yu et al., 2016 and 2017). The prevalence of diaper dermatitis is estimated to be between 7% and 50%, depending on the country and hygiene practices, keeping in mind that many cases are not reported by doctors or parents and heal within a few days without any medical treatment (Klunk et al., 2014). The frequency and severity of diaper dermatitis have decreased over time, primarily thanks to improvements in the performance and models of single-use diapers over the past 30 years. These cases of dermatitis most commonly occur between nine and 12 months of age. ■ Chemical risks The CES first studied the possible chemical risks associated with the types of materials contained in single-use baby diapers. It then undertook a quantitative health risk assessment of the chemicals found in diapers. o Types of materials used in baby diapers The data relating to the types of materials used in baby diapers came primarily from manufacturers and trade federations. Page 3 / 32 ANSES Opinion Request No 2017-SA-0019 Regarding the composition of baby diapers, macromolecular materials can be broken down into two main categories: - Products of natural origin, derived from wood cellulose, which all undergo chemical treatment (bleaching). The exact nature of these cellulose products, which influences their physicochemical properties, was not provided as part of this formal request. - Synthetic products such as polyolefins