- Progress in evaluation
- Progress in evaluation 2018
- Further information requests 2018
Progress in evaluation in 2018
Under Article 54 of REACH, ECHA is reporting on the progress made in 2018 in dossier and substance 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|
|Pre-natal developmental toxicity||98||79||177|
|Long-term aquatic toxicity||74||20||94|
|Other human health||2||0||2|
|Annex I (incl. CSR, RSS, PBT)||68||N/A||68|
|Annex VI (incl. SID, C&L)||43||N/A||43|
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.
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|
|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|
* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.