Update on the REACH Regu­la­ti­on: addi­ti­ons, chan­ges and consultations

Addi­ti­ons to the Can­di­da­te List

Eight new mate­ri­als have been added to the REACH Regu­la­ti­on Can­di­da­te List due to their hazar­dous pro­per­ties, so that the list now includes 219 sub­s­tances. The new­ly added sub­s­tances are used for a wide varie­ty of pur­po­ses, e.g. as sol­vents or fla­me retar­dants, while others are used to manu­fac­tu­re pla­s­tics and cer­tain con­su­mer goods, such as cos­me­tics, rub­ber and textiles. 

The fol­lo­wing sub­s­tances were added:

• 2-(4‑tert-butylbenzyl)propionaldehyde and its indi­vi­du­al stereoisomers;
• ort­ho­bo­ric acid, sodium salt;
• 2,2‑bis(bromomethyl)propane1,3‑diol (BMP), 2,2‑dimethylpropan-1-ol, tri­bro­mo derivative/3‑bromo‑2,2‑bis(bromomethyl)-1-propanol (TBNPA); and 2,3‑dibromo-1-propanol (2,3‑DBPA);
• Glu­taral;
• medium-chain chlo­ri­na­ted par­af­fins (MCCP); (UVCB sub­s­tances con­sis­ting of more than or equal to 80% line­ar chlo­ro­al­ka­nes with car­bon chain lengths within the ran­ge from C14 to C17);
• phe­nol, alky­la­ti­on pro­ducts (main­ly in para posi­ti­on) with C12-rich bran­ched alkyl chains from oli­go­me­riza­ti­on, cove­ring any indi­vi­du­al iso­mers and/or com­bi­na­ti­ons the­reof (PDDP);
• 1,4‑dioxane;
• 4,4′-(1‑methylpropylidene)bisphenol.

The addi­ti­on of the­se sub­s­tances to the REACH Can­di­da­te List will crea­te exten­si­ve noti­fi­ca­ti­on and com­mu­ni­ca­ti­on requi­re­ments for affec­ted mar­ket ope­ra­tors, some of which will car­ry pen­al­ties, vis-à-vis cus­to­mers in the sup­p­ly chain, con­su­mers and the ECHA. 

Updated infor­ma­ti­on requi­re­ments for regis­tra­ti­on of chemicals

In Regu­la­ti­on (EU) 2021/979 (PDF), the Euro­pean Com­mis­si­on revi­sed cer­tain infor­ma­ti­on requi­re­ments for the regis­tra­ti­on of che­mi­cals within the scope of the REACH Regu­la­ti­on. Its goal in making the­se adjus­t­ments was to make the ECHA’s eva­lua­ti­on pro­cess more trans­pa­rent. The chan­ges include both gene­ral and substance-specific rules for stu­dies and exposure-based test­ing, as well as addi­tio­nal requi­re­ments for health and envi­ron­men­tal test­ing.  The Regu­la­ti­on took effect on 8 July and will beco­me bin­ding and direct­ly appli­ca­ble in all mem­ber sta­tes as of 8 Janu­ary 2022. Affec­ted com­pa­nies should the­r­e­fo­re prepa­re them­sel­ves for the new requi­re­ments in a time­ly manner.

Con­sul­ta­ti­on pro­cess for the rest­ric­tion of per- and poly­fluo­ro­al­kyl sub­s­tances (PFAS)

PFAS are per­sis­tent sub­s­tances, some of which have been shown to have toxic and bio­ac­cu­mu­la­ti­ve pro­per­ties. As sta­ted in their for­mal decla­ra­ti­on of intent, some natio­nal aut­ho­ri­ties (inclu­ding the one from Ger­ma­ny) have sub­mit­ted a rest­ric­tion pro­po­sal to the ECHA for per- and poly­fluo­ro­al­kyl sub­s­tances (PFAS). The second stake­hol­der con­sul­ta­ti­on pha­se is now ongo­ing, in the cour­se of which affec­ted com­pa­nies and asso­cia­ti­ons, as well as manu­fac­tu­r­ers of alter­na­ti­ve sub­s­tances, will be cal­led upon to com­ment and pro­vi­de addi­tio­nal infor­ma­ti­on about the pro­po­sal. They should take advan­ta­ge of this oppor­tu­ni­ty, as exemp­ti­ons for cer­tain uses of PFAS will only be taken into con­side­ra­ti­on if they are for­mal­ly pro­po­sed in the cour­se of the con­sul­ta­ti­on pro­cess. Inte­res­ted par­ties can take part in the con­sul­ta­ti­on through 19 Sep­tem­ber 2021 via this link.