Progress in evaluation in 2021

ECHA reports on the progress made in 2021 in dossier and substance evaluation in line with Article 54 of REACH. 

further information requests 2021 - 1

Dossier evaluation

In 2021, ECHA adopted 278 compliance check decisions addressing 1746 information requirements for which data gaps were identified. In addition, the Agency adopted 165 testing proposal decisions addressing 277 information requirements for which testing was originally proposed. 

406 of the adopted decisions were adopted without the Member State Committee’s (MSC) involvement (i.e. the Member States did not send proposals for amendments). 37 decisions were adopted with the MSC’s involvement: 32 in written procedure and 5 during the MSC meetings
 

further information requests 2021 - Graph 2

Further informatin requests2021 2nd table heading

Information requests made in the adopted dossier evaluation decisions

further information requests 2021 - 2 table

Information requirements Number of requests in
278 compliance check
decisions		 Number of requests in
165 testing proposal
decisions		 Number of requests in
all 443
decisions
Carcinogenicity 0 0 0
Mutagenicity/genotoxicity 260 79 339
Pre-natal developmental toxicity 134 51 185
Reproduction toxicity 129 17 146
Repeated-dose toxicity 79 37 116
Biodegradation 187 18 205
Bioaccumulation 53 1 54
Long-term aquatic toxicity 344 41 385
Physico-chemical properties 60 8 68
Other human health 71 0 71
Other environment 408 25 433
Annex I (incl. CSR, RSS, PBT) 0 N/A 0
Annex VI (incl. SID, C&L) 21 N/A 21
Total 1746 277 2023

 

further information requests 2021 - Graph 3

further information requests 2021 - 3

Substance evaluation

In 2021, ECHA adopted 10 substance evaluation decisions, with 14 requests for further information to assess the safety of substances of potential concern. 

All 10 of these decisions were adopted with the MSC’s involvement: 9 in written procedure and 1 during the MSC meetings. 
 

further information requests 2021 - 4 table

Suspected concern Substance
EC / List number		 Information requested to
clarify the concern		 Total requests *
Endocrine disruption 216-133-4 Fish sexual development test 1
203-585-2 Larval amphibian growth and
development assay		 1
PBT/vPvB** 267-636-0
267-636-0
429-320-2
229-782-3
458-680-3
700-992-1		 Simulation biodegradation test 7
203-372-4 Ready biodegradation test 1
429-320-2
458-680-3
206-420-2		 Bioaccumulation test in aquatic species 3
Other hazard-based
concern		 236-675-5 Intra-tracheal instillation study
combined with comet assay		 1
Total 14

 

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

further information requests 2021 - related