The aim of the project entitled "ALTERNATIVES OF SKIN SENSITISING SUBSTANCES IN CONSUMER MIXTURES" was to: - identify market-relevant consumer mixtures that contain skin sensitising substances and are representative of the product type and to - identify and assess potential alternatives. For the acquisition of information on potential alternatives without sensitising properties, i.e., alternative products or alternative substances with equivalent technical function to the skin sensitising substances used in the consumer mixtures identified, two approaches were performed: 1. a market analysis on the basis of targeted internet search, including the analysis of about 1200 safety data sheets for consumer mixtures and 2. an industry stakeholder survey with 49 responses from 45 companies on consumer mixtures with skin sensitising substances in various product categories. The data obtained from the two approaches were collected and analysed independently.The collection of market data was carried out through internet searches on online sales platforms (hereinafter referred to as Point of Sale - PoS). Market-relevant consumer mixtures (products) containing skin sensitising substances which may get into contact with the skin when used as intended and that represent the individual product categories / product types (PC/PT) were to be identified. The targeted internet search also determined how many products were labelled as skin sensitising mixtures (H317) or as mixtures containing skin sensitising substances (EUH statements). A minimum dataset of 10 products per PT (if available) was created. Information for detailed data analysis, in particular information on the substance concentration and technical function, was retrieved from safety data sheets and other sources. PCs considered according to their relevance of the products to overall consumer use and the assumed likelihood that there may be skin contact during use included: - PC1 Adhesives, sealants - PC3 Air care products (with foreseeable skin contact e.g., sauna infusion) - PC4 Anti-freeze and de-icing products - PC9a Coatings and paints, thinners, paint removers - PC9b Fillers, putties, plasters, modelling clay - PC15 Non-metal-surface treatment products - PC18 Ink and toners - PC23 Leather treatment products - PC24 Lubricants, greases, release products - PC31 Polishes and wax blends - PC34 Textile dyes and impregnating products - PC35 Washing and cleaning products The PCs covered in this work refer to the REACH use descriptor system (
ECHAshort forEuropean Chemicals Agency, 2015) The PCs define product categories of different sizes. In some cases, they cover very narrow product areas with similar use pattern (e.g., PC34 Textile dyes and impregnating agents), but in others they bundle numerous and diverse consumer products. For the latter, on average more products were covered in the analysis to get a better picture of the use of skin sensitising substances in those PCs. PTs were chosen to better describe and categorise specific product variations within a category and to provide further detail and differentiation of representative products with regard to use pattern and technical features. PTs in selected PCs were identified in Germany, Sweden, the Czech Republic, Lithuania, Italy, Poland and Ireland. The distribution of products assessed in the selected EU countries gives an impression of the order of magnitude of the products of a product type. A deviating approach was undertaken for the analysis of PC1, PC9b, and PC9a (only paint removers), where the search had already been conducted in 2019/2020 focussing on products on the German market and without the focus on skin sensitising substances. A detailed analysis had been carried out for many more products identified at various consumer retail outlets (online as well as physically in stores) to gain a comprehensive market overview. However, the transferability of the information to other EU countries remains unclear. In the market analysis, 1028 individual products were assessed and 269 skin sensitising substances contained in the products were identified, including 61 substances with a harmonised classification as skin sensitisers according to CLP Regulation. In order to obtain this information, it was necessary to get the specific safety data sheets and to analyse those.Widespread presence of skin sensitising ingredients (> 50 % of products), with significant fractions of products (> 30 %) classified and labelled as skin sensitising is indicated for the following types of consumer mixtures: - PT1_1 Acrylate based adhesives - PT1_2 Expoxy resin-based adhesives - PT3_1 Liquid essential oils - PT3_2 Room spray - PT3_4 Room scent diffusers - PT9b_1 Expoxy resin-based fillers/sealants- PT9b_2 Polyurethan based fillers/foams - PT18_2 Gel pens and other inks - PT31_1 Car body polish - PT34_1 Textile dyes A closer look reveals that even in one PT, products can be further assigned to sub-groups, which are distinctly different with regard to the proportions of products containing skin sensitising substances and products without skin sensitising substances, as for example shown for PC1, PT1_1 Acrylate-based adhesives. Market data should therefore be interpreted with appropriate granularity for the respective PC/PT.For many PTs, a significant proportion of products in the survey (> 30 % of products) seems to serve its intended purpose without the necessity of using skin sensitising substances. These products are presented in the following PTs: - PT4_1 Antifreeze and de-icing agents - PT9a_1 Thinner and paint strippers - PT15_1 Treatment of plastic and rubber surfaces - PT15_2 Treatment of stone and ceramics - PT24_1 Household lubricants - PT31_3 Stainless steel polish - PT35_4 Special cleaner In these PTs, a sufficient number of products without skin sensitising substances, representing alternative products seems to be available.Products that are largely free from skin sensitising substances (0-11 % of products with skin sensitisers; 0-5 % of products classified as H317) are consumer mixtures comprised in the following PTs: - PT9a_1 Thinner and paint strippers - PT15_2 Treatment of stone and ceramics - PT31_3 Stainless steel polish If skin sensitising substances are occasionally present in these PTs, they partly serve main technical functions for the purpose of the product. Searching for substances that can replace the skin sensitising substance in a product by providing the equivalent function, requires information on the technical function. The most common technical functions delivered by skin sensitising substances in the consumer mixtures assessed were: - Preservatives - Fragrances - Colourants for textiles and inks - Functional agents for binding and matrix forming systems - Other functional additives (e.g., UV protectors) Some of these technical functions enable the main use of the product. Thus, for some PCs, skin sensitising substances seem to be critical, mostly for reactive binding systems within adhesives, coatings and sealants as well as fragrances in air care products. However, in other products the same technical function may not be essential for the main purpose of the product (e.g., fragrances in car polish, in-can-preservatives for products where biological degradation is unlikely). Water-based products often contain preservatives regardless of the respective PC/PT. In some PCs, these products are the alternatives to solvent-based products, e.g. in paints, antifreeze agents or writing inks, and thus offer so-called environmentally friendly variants. Even though preservatives do not serve the main purpose of the product they enable an extended shelf life. The concentrations of skin sensitising substances in products are highly product-specific. For the assessment of technically required minimum concentrations, a detailed analysis of the products is needed. The broad approach of this project appeared not to be suitable for this question.An industry stakeholder survey was conducted using an online survey (open for 6 weeks between December 2023 - January 2024) complemented by targeted follow-up interviews with stakeholders. The stakeholders were manufacturers, formulators and distributors identified during the market analysis or otherwise known to the consultant teams. Industry associations were contacted to encourage their members to participate. The survey followed a single, non-sector specific approach, designed to facilitate a high response rate, but nevertheless ensuring high quality of responses. The questionnaire was intended to be completed by an individual company at the overall company level rather than at the individual site level. Each questionnaire addressed consumer products within one PC. If a company was involved in manufacturing/formulating or placing on the market of consumer mixtures of more than one PC, separate questionnaires needed to be filled in for each PC. A total of 49 responses were received from 45 separate companies. Three companies provided more than one response to account for their involvement in different PCs. The majority of survey responses pertained to PC3 (33 %), PC9a (24 %), and PC35 (25 %). One or two responses each were received for PC1 (4 %), PC9b (2 %), PC31 (4 %), and PC34 (4 %). No response was received for PC4, PC15, PC18, PC23 or PC24. All responses submitted were handled confidentially by the consultant team. Only aggregated and anonymised data was shared with the contracting authority (
BfRshort forGerman Federal Institute for Risk Assessment) to protect individual companies’ confidentiality. Overall, the companies responding to the survey claimed they were not aware of suitable alternatives already available. Hence, in the event that skin sensitisers could no longer be used, effects may result in, for example, discontinuation of products, closure of product lines, and relocation to areas outside the EU. For some product types, companies reported their engagement in research and development (R&D) activities aiming to develop alternatives to the use of skin sensitising substances (e.g. in the detergents and cleaner industry); for other areas, substantial proactive R&D activities to develop alternatives to skin sensitising substances were not reported (e.g. for air cleaning products).It became evident from both the market analysis and company survey datasets that product alternatives, which do not contain skin sensitising substances are available for some PCs. However, neither the safety data sheets, nor the information from the company survey provided more in-depth information for identification of suitable alternatives that could potentially replace skin sensitisers in the respective products or PTs. Often, specific expert knowledge from manufacturers would be required to identify suitable alternatives with technical and economic feasibility. This information is rarely found in the open literature and could not be obtained through the survey. Sometimes functional alternatives are known, but also have skin sensitising properties. In order to identify suitable substance alternatives, a narrow approach for specific PTs and/or groups of substances should be considered.