ECHA pre­vails: mela­mi­ne remains SVHC

Com­pa­nies lose befo­re the Gene­ral Court: mela­mi­ne remains on the REACH can­di­da­te list as an SVHC

The Gene­ral Court con­firms: ECHA acted lawful­ly in inclu­ding mela­mi­ne in the can­di­da­te list – no pro­ce­du­ral errors identified.

The Back­ground

On August 26, 2022, Ger­ma­ny sub­mit­ted a dos­sier in accordance with Annex XV of Regu­la­ti­on (EC) No. 1907/2006 (“REACH Regu­la­ti­on“) to the Euro­pean Che­mi­cals Agen­cy (“ECHA”) to include mela­mi­ne in the “can­di­da­te list of sub­s­tances of very high con­cern for aut­ho­ri­sa­ti­on” as a sub­s­tance of very high con­cern (“SVHC”) due to its hazar­dous pro­per­ties. On Sep­tem­ber 2, 2022, the ECHA ope­ned a public con­sul­ta­ti­on pha­se. After its con­clu­si­on on Octo­ber 17, 2022, it for­ward­ed the dos­sier to the Mem­ber Sta­te Com­mit­tee (“MSC”), which unani­mously appro­ved it in Decem­ber. The decis­i­on on inclu­si­on was taken on Decem­ber 16, 2022 and published on Janu­ary 17, 2023.

The pro­ce­du­re and the decision

Seve­ral com­pa­nies chal­len­ged the decis­i­on and asked for it to be can­cel­led, sin­ce ECHA took new info into account after the con­sul­ta­ti­on ended wit­hout giving the stake­hol­ders a chan­ce to com­ment. In its judgments of 9 July 2025 (T‑163/23,Egger and Others v ECHA and T‑167/23, LAT Nitro­gen Piesteritz and Cor­ner­stone Che­mi­cal v ECHA), the Gene­ral Court dis­missed the actions in their entirety.

The grounds

The ECHA’s assess­ment was coher­ent, sci­en­ti­fi­cal­ly sound and pro­ce­du­ral­ly flawless.

  • Right to be heard (only) in the con­sul­ta­ti­on pha­se
    Artic­le 59 sec. 4 of the REACH Regu­la­ti­on grants mar­ket ope­ra­tors the right to sub­mit writ­ten comm­ents, but not a com­pre­hen­si­ve right to be heard or to par­ti­ci­pa­te in MSC mee­tings. New data may be con­side­red after the con­sul­ta­ti­on if it is based on sub­mis­si­ons made during the con­sul­ta­ti­on, even if this data (e.g. a stu­dy on lay­ing hens) was only pro­du­ced after the consultation.
  • For­ma­li­ties do not jus­ti­fy pro­tec­tion of legi­ti­ma­te expec­ta­ti­ons
    The ECHA has ful­fil­led the for­mal requi­re­ments of Annex XV REACH Regu­la­ti­on and the gui­de­lines, alt­hough the gui­de­lines for deter­mi­ning the levels of con­cern and the cri­te­ria spe­ci­fied the­r­ein are purely indi­ca­ti­ve. A tabu­lar pre­sen­ta­ti­on of risks was not requi­red; the­re is no entit­le­ment to retain pre­vious formats.
  • Com­pre­hen­si­ve assess­ment of serious effects based on all available evi­dence
    The ECHA has com­pre­hen­si­ve­ly asses­sed the health risks. In doing so, it reli­ed not only on the har­mo­nis­ed clas­si­fi­ca­ti­ons in accordance with Regu­la­ti­on (EC) No. 1272/2008 (“CLP Regu­la­ti­on“), but also on sci­en­ti­fic stu­dies on irrever­si­ble dama­ge to the uri­na­ry tract and repro­duc­ti­ve toxi­ci­ty. Regar­ding intrin­sic pro­per­ties, the ECHA did not need to re-evaluate the CLP clas­si­fi­ca­ti­on. An exis­ting clas­si­fi­ca­ti­on is suf­fi­ci­ent to jus­ti­fy inclu­si­on in the REACH Can­di­da­te List.

The con­se­quen­ces

  • Mela­mi­ne remains on the REACH can­di­da­te list
    Mela­mi­ne remains on the can­di­da­te list. Sup­pli­ers and importers con­ti­nue to be sub­ject to infor­ma­ti­on and com­mu­ni­ca­ti­on obli­ga­ti­ons along the sup­p­ly chain and towards authorities.
  • Pre­pa­ra­ti­on for the aut­ho­ri­sa­ti­on pro­ce­du­re
    Com­pa­nies should now exami­ne pos­si­ble sub­sti­tu­ti­on stra­te­gies and pro­vi­de com­pre­hen­si­ble jus­ti­fi­ca­ti­on for essen­ti­al uses.
  • Limi­t­ed par­ti­ci­pa­ti­on rights requi­re ear­ly moni­to­ring
    Influence can only be exer­ted during the writ­ten con­sul­ta­ti­on. Bey­ond that, the­re is no right to fur­ther par­ti­ci­pa­ti­on. Ear­ly moni­to­ring of regu­la­to­ry initia­ti­ves the­r­e­fo­re remains essential.
  • ECHA’s exten­ded scope for action con­firm­ed
    The ruling streng­thens the ECHA in its approach under Artic­le 57(f) of the REACH Regu­la­ti­on, in par­ti­cu­lar regar­ding the use of exis­ting clas­si­fi­ca­ti­ons under the CLP Regu­la­ti­on and new sci­en­ti­fic findings.

Con­clu­si­on

The ruling shows that regu­la­to­ry pro­jects must be moni­to­red at an ear­ly stage – other­wi­se mar­ket play­ers will miss the (pos­si­bly only) oppor­tu­ni­ty to repre­sent their inte­rests in the proceedings.

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