Progress in evaluation in 2019

ECHA is reporting on the progress made in 2019 in dossier and substance evaluation in line with Article 54 of REACH.

Dossier evaluation 

ECHA adopted 150 compliance check decisions addressing 721 information requirements for which data gaps were identified, and 102 testing proposal decisions addressing 183 information requirements for which testing was originally proposed.

Out of the 252 adopted decisions, 192 were adopted without the Member State Committee’s (MSC) involvement (no proposal for amendments were received from Member States). 60 decisions were adopted with the MSC’s involvement: 45 in written procedure and 15 during the MSC meetings

Information requests made in the adopted dossier evaluation decisions

Information requirements Number of requests in 150 compliance check decisions Number of requests in 102 testing proposal decisions Number of requests in all 252 decisions
Carcinogenicity 0 0 0
Mutagenicity/genotoxicity 132 15 147
Pre-natal developmental toxicity 126 55 181
Reproduction toxicity 19 26 45
Repeated-dose toxicity 69 40 109
Biodegradation 61 4 65
Bioaccumulation 16 3 19
Long-term aquatic toxicity 86 10 96
Physico-chemical properties 14 6 20
Other human health 51 1 52
Other environment 83 23 106
Annex I (incl. CSR, RSS, PBT) 32 N/A 32
Annex VI (incl. SID, C&L) 32 N/A 32
Total 721 183 904

CSR: chemical safety report; RSS: robust study summary; PBT: persistent, bioaccumulative and toxic; SID: substance identification; C&L: classification and labelling.

Substance evaluation 

ECHA adopted 15 substance evaluation decisions consisting of 48 requests for further information to clarify concerns.

Out of the 15 adopted decisions, one was adopted without the Member State Committee’s (MSC) involvement (no proposal for amendments were received from Member States). 14 decisions were adopted with the MSC’s involvement: four in written procedure and 10 during the MSC meetings.

Information requests made in the adopted substance evaluation decisions

Suspected concern Information requested to clarify the concern Total requests*
Carcinogenicity Carcinogenicity study 1
Mutagenicity In vivo mammalian comet assay 2
Reproductive toxicity Extended one generation reproductive toxicity study (EOGRTS) 1
Endocrine disruption Fish sexual development test 6
Amphibian metamorphosis assay 2
PBT/vPvB** Simulation biodegradation test 4
Physico-chemical test  4
Fish early-life stage (FELS) toxicity test 2
Daphnia magna reproduction test 2
Bioaccumulation in fish: aqueous and dietary exposure 2
Other hazard-based concern In vitro study for serious eye damage 4
Algae, growth inhibition test  1
Daphnia magna reproduction test 1
Dispersion stability of nanomaterials in simulated environmental media 1
Combined sub-chronic 90d toxicity study and reproduction/developmental toxicity screening test 1
Combined sub-chronic 90d toxicity study and comet assay 1
In vitro study for skin irritation 1
Human biomonitoring study 1
Screening test (24h) on transformation/dissolution of metals and metal compounds in aqueous media 1
Determination of presence and size distribution of fibres 1
Dustiness test using a rotating drum 1
Further information on exposure and/or risk assessment   8
Total   48

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

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