Progress in evaluation in 2018

Under Article 54 of REACH, ECHA is reporting on the progress made in 2018 in dossier and substance evaluation. 

Dossier evaluation 

ECHA adopted 144 compliance check decisions addressing 640 information requirements for which data gaps were identified, and 130 testing proposal decisions addressing 248 information requirements for which testing was originally proposed.

Information requests made in the adopted (i.e. final) dossier evaluation decisions

Information requirements Number of requests in 144 compliance check decisions Number of requests in 130 testing proposal decisions Number of requests in all 274 decisions
Carcinogenicity 0 0 0
Mutagenicity/genotoxicity 91 11 102
Pre-natal developmental toxicity 98 79 177
Reproduction toxicity* 79 38 117
Repeated-dose toxicity 55 41 96
Biodegradation 41 7 48
Bioaccumulation 7 3 10
Long-term aquatic toxicity 74 20 94
Physico-chemical properties 7 9 16
Other human health 2 0 2
Other environment 75 40 115
Annex I (incl. CSR, RSS, PBT) 68 N/A 68
Annex VI (incl. SID, C&L) 43 N/A 43
Total 640 248 888

CSR: chemical safety report; RSS: robust study summary; PBT: persistent, bioaccumulative and toxic; SID: substance identification; C&L: classification and labelling
* 35 of these were requests for Annex VIII, 8.7.1 screening studies.

Substance evaluation 

ECHA adopted 21 substance evaluation decisions consisting of 63 requests for further information to clarify concerns.

Information requests made in the adopted (i.e. final) substance evaluation decisions

Suspected concern Information requested to clarify the concern Total requests*
Mutagenicity Transgenic rodent somatic and germ cell gene mutation assay 2
In vivo mammalian bone marrow chromosomal aberration test 1
Combined mammalian erythrocyte micronucleus test and mammalian alkaline comet assay 1
Reproductive toxicity Combined developmental neurotoxicity study and neurotoxicity study 1
Developmental neurotoxicity study 1
Prenatal developmental toxicity study 1
Sensitisation Skin sensitisation local lymph node assay 1
PBT/vPvB** Bioaccumulation in fish: aqueous and dietary exposure 5
Simulation biodegradation test 4
Physico-chemical test 3
Fish, early-life stage (FELS) toxicity test 2
Daphnia magna reproduction test 2
Algae growth inhibition test 2
Enhanced ready biodegradation test 1
Endocrine disruption Fish sexual development test 3
Amphibian metamorphosis assay 2
Larval amphibian growth and development assay 2
Other hazard-based concern Daphnia magna reproduction test 1
Sub-chronic 90-day toxicity study 1
Short time exposure method for identifying chemicals inducing serious eye damage and chemicals not requiring classification for eye irritation/serious eye damage 1
  Further information on exposure and/or risk assessment 26
  Total 63

* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.

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