Call fr evidence n the use f skin sensitisers, skin irritants and crrsive substances in textile and leather articles, hides and furs Backgrund dcument Backgrund Prductin and prcessing f textile and leather articles, hides and furs invlves a large number f chemicals. These chemicals are used (intentinally r as impurities) in all parts f the prcess frm fibre t finished prduct, as well as in prduct distributin. Sme f them remain in the final article f clthing, ftwear and ther articles that cme int cntact with the human skin in cncentratins high enugh t cnstitute a risk fr expsed individuals. There are cncerns that sme f thse chemicals are likely t be respnsible fr allergic cntact dermatitis and skin irritatin in the EU. Allergic textile dermatitis and irritatin may have a significant impact n a persn s quality f life, partly because f skin reactins frm expsures but als as a cnsequence f the measures they must take t avid articles that may cause prblems. In 2016, KemI (Swedish Chemicals Agency) published a RMOA (Risk Management Optin analysis) cncluding that the mst efficient regulatry apprach t mitigate allergic textile dermatitis is t intrduce a new restrictin entry in Annex XVII in the REACH regulatin 1. In January 2018, KemI and Anses (French Agency fr Fd, Envirnmental and Occupatinal Health & Safety) ntified ECHA their intentin t jintly prepare an Annex XV restrictin dssier accrding t article 69 f REACH Regulatin N 1907/2006 2. Scpe In the RMOA, KemI mainly fcussed n sensitising substances (addressed as a grup) and cncluded that skin sensitising substances that may be present in finished textile articles shuld be included in the scpe and that a harmnised classificatin as Skin Sens. 1/1A/1B under CLP Regulatin N 1272/2008 shuld be a criteria fr inclusin in a pssible restrictin. Taking int accunt the mst recent available infrmatin, including an Anses 2018 study n the safety f ftwear and garments, KemI and Anses are nw jintly investigating a brader scpe including skin irritants and skin crrsive substances as well as skin sensitising substances. The starting pint f the scpe is therefre substances present in the relevant articles (such as listed belw in table 1), which are either harmnised classified as Skin Sens. 1/1A/1B and/r Skin Irrit. 2 and/r Skin Crr. 1/1A/1B/1C, self-classified substances that meet the 1 https://echa.eurpa.eu/pact/-/substancerev/13911/del/50/cl/synnymdynamicfield_497/type/desc/pre/1/view. 2 https://echa.eurpa.eu/sv/registry-f-restrictin-intentins/-/dislist/details/0b0236e182446136 1
criteria fr thse classificatins, r are recmmended t be classified as such by RAC. Other substances that have been identified as f cncern are als included in the scpe. There are currently 1 846 substances with a harmnised classificatin fr either Skin Sens. 1/1A/1B, Skin Crr. 1/1A/1B/1C and/r Skin Irrit. 2. In additin, there are 10 substances with an adpted RAC pinin fr either f these classificatins that are nt yet included in Annex VI f the CLP Regulatin. KemI and Anses have identified ~6,000 substances ptentially used in textiles, leather, furs and/r hides. In additin, anther ~6,000 substances with structural similarities t these have been identified. Out f these ~12,000 substances ptentially used in textiles, leather, furs and/r hides, 321 substances have at least ne f the harmnised classificatins listed abve. Furthermre, a number f substances used in textiles and ftwear withut any f the harmnised classificatins abve have been identified t cause allergic dermatitis in clinical tests. The cmpiled list f the substances in the scpe is available in a separate excel-file (see the Appendix attached t the Call fr Evidence). The preliminary scpe f the restrictin prpsal cvers the placing n the market f finished textile and leather articles, hides and furs intended t cme int direct and prlnged cntact with the skin under nrmal and reasnably freseeable cnditins f use. These articles aim t be sld t the general public, therefre, the cnsumers are the ppulatin at risk. Table 1. Preliminary scpe f the restrictin prpsal Substances Materials Articles Substances with a harmnised classificatin as Skin Sens. 1/1A/1B, Skin Irrit. 2, and/r Skin Crr. 1/1A/1B/1C Textiles, leather, furs and hides. 4 Clthing and related accessries. Articles ther than clthing which cme int cntact with the human skin under nrmal r reasnably freseeable cnditin f use, such as: accrding t Table 3 in - bed linen, Annex VI f the CLP Regulatin (EC - blankets, thrws, 1272/2008) 3. Substances which meet criteria fr classificatin as Skin Sens 1/1A/1B, Skin Irrit. 2, Skin Crr. 1/1A/1B/1C under CLP. - uphlstery (fabric cvering chairs, armchairs and sfas etc.) - cushin cvers - bathrbes, twels - re-usable nappies and sanitary twels - sleeping bags 3 https://echa.eurpa.eu/infrmatin-n-chemicals/annex-vi-t-clp 4 The definitins used fr the animal based materials are as fllws: Hide is animal skin treated fr human use. Leather is a hide that has been subject t tanning. Fur is treated pelt, which in turn is animal skin with the hair retained. 2
Substances fr which RAC has prvided an pinin fr the classificatins abve. Additinal substances f cncern. (see the Appendix attached t the Call fr Evidence). - yarn and fabrics intended fr use by the final cnsumer - carpets, mats and rugs - bags, like handbags, backpacks, briefcases, - fashin accessries - sles Ftwear (such as defined by Directive 94/11/EC) The articles nt cvered by the scpe are the fllwing Jewellery glasses and sunglasses curtains textile lampshades and wall decratins napkins and table linen filling materials in chairs, armchairs and sfas secnd hand articles dispsable nappies and sanitary twels articles within the scpe f Regulatin (EU) 2016/425 f the Eurpean Parliament and f the Cuncil n persnal prtective equipment articles within the scpe f Regulatin (EU) 2017/745 f the Eurpean Parliament and f the Cuncil n medical devices Objective f the call fr evidence The gal f prpsing a restrictin is t sufficiently reduce the risks fr allergic textile dermatitis and skin irritatin in the EU withut causing a disprprtinate burden n the EU market fr the articles in the scpe. Therefre, in rder t carry ut an in-depth analysis n the prprtinality f a restrictin, mre infrmatin abut the uses, the expsures as well as the pssibilities fr substitutin t safer alternatives is needed. Fr that purpse, KemI and Anses are undertaking this call fr evidence and infrmatin. Specific questins: 1. Which f the substances in the prvided excel-file are likely t remain in any f the finished articles listed in Table 1 t be sld t the general public? If available, als prvide infrmatin n cncentratin f the substance in the finished prducts. Relevant substances are thse that are used (either intentinally added r as impurities) anywhere in the supply chain and that are likely t remain in the finished prduct. 3
2. Hw are these substances used in the articles f cncern? In what quantity (tns r number f articles per year) is the substance used in the articles that are sld (including imprted articles) and/r prduced in the EU? Is the annual quantity increasing r decreasing? In what way is the substance used and fr what purpse? Is it a prcess chemical (e.g. slvent) r a functinal substance (e.g. fragrance, clurants, etc.)? Where in the supply chain is the substance used? 3. Can yu prvide any human health expsure data related t the substances likely t be fund in the relevant finished articles t be sld t the general public (including parameters such as migratin rates, leaching, slubility, hw the substance is cntained in the matrix, etc.)? 4. Can these substances be substituted, and, if s, hw? Nte that substitutin is nt nly replacing a hazardus substance with a less hazardus substance, it als includes replacing a hazardus substance with anther technlgy. Ecnmic feasibility f substitutin: what wuld be the cst f substitutin (per tn, per article, per business and/r in ttal fr textiles n the EU market) and the cmpsitin f this cst (alternative substance price, new equipment, training, research and develpment etc.)? If the substance can t be substituted at this pint f time: Prvide ecnmic and technical infrmatin as t why these substances cannt be substituted tday. Are substitutes lacking because they are nt available r are the perfrmance f alternatives nt cnsidered adequate? Will substitutes be available within a freseeable future? If s, which are these substitutes and when will they be available in sufficient quantities t supply the market? The infrmatin gathered will be used t determine whether these uses pse a risk n an EU-wide basis and assess the sci-ecnmic impacts f the restrictin prpsed. Wh shuld participate in the call fr evidence? This call fr evidence is intended fr interested parties such as cmpanies (manufacturers, imprters, frmulatrs, distributrs f mixtures used in textile and leather articles hides and furs -frm fiber prductin t finishing treatments- and/r used befre/during transprt, distributin, sales and retail; and manufacturers, imprters, distributrs, suppliers f textile and leather articles hides and furs), trade assciatins, scientific bdies and any ther stakehlders r Member State Authrity hlding relevant infrmatin. 4
Infrmatin can be submitted cnfidentially and will be treated as such by ECHA. Any infrmatin prvided will be used, amngst ther issues, t determine if any dergatins are required fr any ptential restrictin that is prpsed. Hwever, dergatins cannt be prpsed withut adequate infrmatin n risk and sciecnmic infrmatin, including alternatives. If a dergatin is nt prpsed in the initial restrictin prpsal then it will be incumbent n relevant stakehlders t prvide a full justificatin based n a cmprehensive infrmatin n risk, sci-ecnmic elements and alternatives, during the pinin-making prcess. ECHA invites interested parties t respnd t the call fr evidence by 01 September 2018. https://echa.eurpa.eu/calls-fr-cmments-and-evidence Fr any clarificatins n the call, please cntact Dr. Karine Fire: Karine.FIORE@anses.fr 5